User:GobsPint/sandbox

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S[edit]

  • In 1989, Michael Waldholz Walt Bogdanich Warm Bodies: Doctor Owned Labs Earn Lavish Profits in a Captive Market [2]Cite error: A <ref> tag is missing the closing </ref> (see the help page).[3]

DTC[edit]

In an attempt to bypass CLIA, Direct-to-consumer (DTC) genetics laboratories have tried to rebrand themselves as research laboratories, without success.[4] Orig3n, a Boston genetics startup, was not CLIA certified and described its tests as geared toward "customers" and not patients, and its terms of service stated "Orig3n’s genetic tests are not diagnostic tests and cannot predict your future health. We do not provide professional medical or clinical services or advice.” CMS countered that because the company “offers genetic testing that provides information for the assessment of health" it would be subject to CLIA regulations.[4] Orig3n subsequently bought a CLIA certified laboratory, Interleukin Genetics, to address regulatory concerns.[5][6]

CLIA Test Categorization[edit]

The FDA determines a test’s complexity by reviewing the test Instructions For Use (IFU), and using a criteria “scorecard” to categorize a test as moderate or high complexity.[7][8] Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria on the scorecard.[8] The scores for the 7 criteria are added together and tests with a score of 12 or less are categorized as moderate complexity, while those with a score above 12 are categorized as high complexity.[8] Test systems that have not been CLIA categorized default to high complexity until they have been categorized.[8]

Following initial categorization, a manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA.[8] The guidance recommends that CLIA waiver applications include a description of the features of the device that make it ‘‘simple’’; a report describing a hazard analysis that identifies potential sources of error, including a summary of the design and results of flex studies and conclusions drawn from the flex studies; a description of fail safe and failure alert mechanisms and a description of the studies validating these mechanisms; a description of clinical tests that demonstrate the accuracy of the test in the hands of intended operators; and statistical analyses of clinical study results.[9]

CLIA categorization is determined after the FDA has cleared or approved a marketing submission, or upon request for legally marketed devices.[8] For new commercial test systems, assays, or examinations, the manufacturer, as part of its 510(k) and PMA application to FDA, will submit supporting data for device/test categorization.[7] FDA will determine the complexity category, notify the manufacturers directly, and will simultaneously inform both CMS and CDC of the device/test category.[7] FDA will consult with CDC concerning test categorization in the following three situations: when categorizing previously uncategorized new technology, when FDA determines it to be necessary in cases involving a request for a change in categorization; or If a manufacturer requests review of a categorization decision by FDA.[7] Test categorization will be effective as of the notification to the applicant.[7]

Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device.[9] In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or premarket approval application.[9] One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization or when a device is exempt from premarket review.[9] A test system manufacturer may also submit a standalone request for categorization for legally marketed tests that do not have a marketing submission, such as those that are Class I or Class II 510(k)-exempt.[8]

For test systems, assays, or examinations not commercially available, a laboratory or professional group may submit a written request for categorization to PHS.[7] These requests will be forwarded to CDC for evaluation; CDC will determine complexity category and notify the applicant, CMS, and FDA of the categorization decision.[7] In the case of request for a change of category or for previously uncategorized new technology, PHS will receive the request application and forward it to CDC for categorization.[7]

A request for recategorization will be accepted for review if it is based on new information not previously submitted in a request for categorization or recategorization by the same applicant and will not be considered more frequently than once per year.[7]

CLIA categorization is currently conducted by the FDA Center for Devices and Radiological Health (CDRH) and tracked through CLIA Record (CR) submissions.[8] There are two types of CLIA Record (CR) submissions: concurrent and standalone.[8] Concurrent CLIA Records are automatically created upon receipt of in vitro diagnostic (IVD) marketing submissions (e.g., 510(k), De Novo, PMA, HDE) reviewed by CDRH. Standalone CLIA Records are created upon request for CLIA categorization of legally marketed IVD test systems for which a new CDRH marketing submission is not needed, or CRs created following a cleared/approved/licensed/granted marketing submission for tests reviewed by other FDA Centers.[8] In cases where the marketing submission is reviewed by another FDA Center (e.g., Center for Biologics Evaluation and Research (CBER)), the other Center will notify CDRH at the time of clearance/approval/licensing/granting of the test and at that time, the FDA will create a CR to track CDRH’s categorization of the test.[8] Standalone CR are submitted for the following reasons: Changes to the trade name, manufacturer, or distributor name of a legally marketed test, including adding a new distributor and/or trade name; new test systems (new reagent and instrument combinations) covered by the FDA guidance Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; and new IVDs that are exempt from premarket notification.[8] There are no Medical Device User Fee Amendments (MDUFA) fees for a CLIA Record.[8]

PHS will publish revisions periodically to the list of moderate and high complexity tests in the Federal Register in a notice with opportunity for comment.[7]

Since November 13, 2003, the Food and Drug Administration (FDA) is responsible for implementing CLIA test complexity categorization provisions, which includes, but is not limited to the following: interpreting the CLIA provisions related to complexity categorization, holding public workshops and meetings on CLIA complexity categorization; and, developing and issuing implementing rules and guidance for CLIA complexity categorization. [10][11] Responsibility for determining whether a particular device is waived was transferred from the CDC to FDA on January 21, 2000.[12]


FDA CLIA Test Categorization Criteria Scorecard for Moderate and High Complexity[8]
Criteria Score 1 Score 3
Knowledge
  • Minimal scientific and technical knowledge is required to perform the test
  • Knowledge required to perform the test may be obtained through on-the-job instruction.
  • Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing.
Training and experience
  • Minimal training is required for preanalytic, analytic and postanalytic phases of the testing process.
  • Limited experience is required to perform the test.
  • Specialized training is essential to perform the preanalytic, analytic or postanalytic testing process; or Substantial experience may be necessary for analytic test performance.
Reagents and materials preparation
  • Reagents and materials are generally stable and reliable.
  • Reagents and materials are prepackaged, or premeasured, or require no special handling, precautions or storage conditions.
  • Reagents and materials may be labile and may require special handling to assure reliability.
  • Reagents and materials preparation may include manual steps such as gravimetric or volumetric measurements.
Characteristics of operational steps
  • Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled.
  • Operational steps in the testing process require close monitoring or control, and may require special specimen preparation, precise temperature control or timing of procedural steps, accurate pipetting, or extensive calculations.
Calibration, quality control, and proficiency testing materials
  • Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled.
  • Operational steps in the testing process require close monitoring or control, and may require special specimen preparation, precise temperature control or timing of procedural steps, accurate pipetting, or extensive calculations.
Test system troubleshooting and equipment maintenance
  • Test system troubleshooting is automatic or self-correcting, or clearly described or requires minimal judgment.
  • Equipment maintenance is provided by the manufacturer, is seldom needed, or can easily be performed.
  • Troubleshooting is not automatic and requires decision-making and direct intervention to resolve most problems
  • Maintenance requires special knowledge, skills, and abilities.
Interpretation and judgment
  • Minimal interpretation and judgment are required to perform preanalytic, analytic and postanalytic processes.
  • Resolution of problems requires limited independent interpretation and judgment.
  • Extensive independent interpretation and judgment are required to perform the preanalytic, analytic or postanalytic processes.
  • Resolution of problems requires extensive interpretation and judgment.
  • A score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level.
  • A score of 2 is assigned to a criteria heading when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.

Ratings[edit]

To minimize disruption to physician office laboratories (POLs), several tests received context-dependent complexity ratings. Manual white blood cell differentials that lack atypical cells are categorized as moderate complexity, whereas differentials with atypical cells are categorized as high complexity.[13][14] Manual reticulocyte counts are moderate complexity, whereas as manual white blood cell count, red blood cell count, and platelet count procedures are high complexity.[15] Nasal smears for eosinophils are moderate complexity, whereas eosinophil count procedures are high complexity.[16][17]All manual erythrocyte sedimentation rate (ESR) are categorized as waived, whereas semi-automated, and automated ESR analyzers are moderate complexity.[18][19] All manual spun microhematocrits are waived, whereas most semi-automated and automated hematocrits are moderate complexity.[20] For gram stains, endocervical and urethral sources, such as urine cultures, are moderate complexity, whereas other sources are classified as high complexity.[21][22][23] All direct acid-fast smear procedures are moderate complexity, whereas concentrated acid-fast smear tests are high complexity.[24][25] All manual male semen analysis is high complexity, whereas female oocyte analysis is not covered by CLIA and is unregulated.[26]


L[edit]

CLIA waived[edit]

For many Americans, the accuracy of clinical laboratory test results can mean the difference between life and death. For example, a clinical laboratory's incorrect reading of a patient's cholesterol level could stop that patient from receiving the necessary treatment for preventing a heart attack. To better encourage quality laboratory testing, in April 2002, CMS initiated on-site visits to approximately 2% of laboratories that have been issued a certificate of waiver (CoW) under the Clinical Laboratory Improvement Amendment (CLIA) This is the first time that CMS has conducted educational visits in all 50 states, though two previous studies did include visits to a smaller number of states.

These visits are announced, information gathering and are designed to help educate the laboratories on sound laboratory practices. The State agency surveyors will ensure that personnel conduct quality testing in a manner which protects patient safety, determine each laboratory's regulatory compliance, and make certain that each laboratory is only conducting the more simple tests that are appropriate for a certificate of waiver facility. If problems are uncovered, the surveyors will provide education and assistance to the laboratories to help them achieve more accurate, reliable and timely test results.

Information about these visits was sent to the laboratory community, including State survey directors and medical and laboratory professional organizations. The information included the following (listed as a download below): a FACT sheet, the letter sent to the participating laboratories, and the questions the surveyor uses during the visit. Preliminary follow-up data from the expanded pilot study indicates that the education provided during these on-site visits is effective.

CMS will continue to visit two percent of these laboratories throughout the United States each year. Through a partnership with laboratory professional and accrediting organizations, manufacturers, states, the CDC, the FDA, and the educational community, we will ensure that CoW laboratories can receive the education needed to achieve accurate and reliable test results, and ultimately improve the quality of health care. [27]

The eight original waived tests stem from a temporary regulatory exemption in Pennsylvania following a legal battle between the Pennsylvania Medical Society and the Pennsylvania Bureau of Laboratories in the 1970s after the Medical Society claimed Bureau regulations improperly encroached their members ability to practice medicine.[a]

Histology Personnel[edit]

Under CLIA, histology is considered processing, not testing, and thus no aspect of histology is assigned a complexity level. This includes histology processing, embedding, microtomy, and staining (including special stains or IHC). As such, there are no regulatory personnel or proficiency requirements for histology under CLIA. Several states do license.

Grossing, which requires interpretation, is considered a high-complexity test requiring a minimum of an associate's degree.[29]

The National Society for Histotechnology(NSH) has lobbied for CLIA to impose histology personnel qualifications.[30][31][32][33]

O[edit]

  • https://www.google.com/books/edition/Clinical_Laboratory_Improvement_Act_of_1/WWqYkI19gpkC?hl=en&gbpv=1&dq=RMT+(ISCLT)&pg=PA210&printsec=frontcover
  • https://alliedhealth.ceconnection.com/files/AReviewandAnalysisoftheClinicalLaboratory-1345755011670.pdf
  • https://scholarship.law.wm.edu/wmlr/vol60/iss6/2/
  • doi:10.1177/1073110520916998

LDT[edit]

Waived[edit]

If a waived test is performed outside of its intended use, it defaults to a high complexity test, and the laboratory must meet the standards for high complexity testing or stop using the test.[34] In 2010, the American Diabetes Association (ADA) recognized that hemoglobin A1C measurements had become relatively uniform and published recommendations to allow the diagnosis of diabetes based on A1c assays certified to the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT).[35][34] At the time, the ADA recommendations excluded point-of-care (POCT) A1C assays as not sufficiently accurate for diabetes diagnostic purposes.[35] Since the intended use of waived tests for hemoglobin A1c does not include diagnosis of diabetes, their use for this purpose would be outside of the intended use and thus considered an off-label high complexity test.[34] A laboratory’s waiver certificate can be removed if manufacturer’s instructions are not being followed.[34]

DCLS[edit]

Nursing[edit]

Example 5: A CLIA surveyor evaluating qualifications of a nurse performing moderate complexity laboratory testing is presented with a nursing license as evidence of compliance. What would the surveyor do? Answer: CLIA surveyors do not accept nursing licenses as evidence of compliance. An associate’s or bachelor’s degree in nursing meets the requirement of having earned a degree in a biological science for moderate complexity testing personnel. The laboratory must provide the surveyor with a PSV report verifying the type of degree earned, a diploma showing the type of degree earned, or transcripts as evidence of meeting the personnel requirement.[36]


e PHSA permits authorized officials to make announced or unannounced surveys of laboratories holding any type of CLIA certificate, at any time uring the laboratory’s normal hours of operation. If access is refused, the SA documents the identity (name and title) of the individual refusing admission and the reasons given, and submits this documentation immediately to the RO, i.e., by email, telephone or fax. The CLIA regulations at 42 CFR §493.1771and §493.1773 permits the SA to cite the laboratory for refusal to allow a survey on a CMS Form 2567. In addition, the regulation at 42 CFR §1001.1301 permits the OIG to exclude a laboratory from the CLIA program if it fails to grant immediate access upon reasonable request. The exclusion may be in effect up to a period equal to the sum of the length of the period during which immediate access was not granted, plus an additional 90 days. The RO will make the referral to the OIG.[37] [38]

Specimen ownership and utilization[edit]

Main articles: biorepository and tissue bank

The US currently does not have well-defined federal regulations regarding the ownership and utilization of physical human tissue specimens, their derivatives, as well as the biological information they contain.[39][40][41][42][43] The current standing by bioethicists is that patients who have consented to have their diagnostic specimens collected have also abandoned them, and thus have no ownership rights.[41][44] The Common Rule permits the use of biospecimens that would otherwise be discarded provided that the donor can not be identified, though utilization of the materials for research may require Institutional review board (IRB) approval..[41] The Association of American Medical Colleges (AAMC) has taken the stance that it "unambiguously rejects the concept that individuals retain any property interest in their excised tissues."[45]

Proponents of patient ownership rights advocate that patients must own their samples so that they can make informed decisions about how the tissues will be used, such as in stem cell research or for-profit ventures.[43]

The probability that a patient may sue researchers who utilize tissues that would typically be discarded is low, but as genetics research becomes more prevalent, this likelihood may increase.[41] Ideally, researchers should obtain informed consent from individuals, and aim for transparency in their intended use for the human tissue while protecting the privacy of the donor.[41]

CAP and other laboratory accreditation organizations (AO) have additional requirements and protocols for repurposing biospecimens that would otherwise be discarded.[43]

Genetic Testing[edit]

In July 2000, the Secretary’s Advisory Committee on Genetic Testing (SACGT) published a report entitled Enhancing the Oversight of Genetic Tests advocating for the augmentation of CLIA and for FDA regulatory oversight of genetic testing.[46][47]

[48] [49] [50]

Direct-to-Consumer (DTC) Testing[edit]

Ot[edit]

CLIA Provider Performed Microscopy Procedures (PPMP) Brochure

[51]

CLIA permits anyone with a concern about a laboratory to lodge an anonymous complaint, though relatively few laboratory complaints have been filed. This may due to a lack of publicity on complaint filing, since CLIA does not require that laboratory employees or patients be made aware on how to file a complaint, and privacy concerns from the lack whistleblower protections.

r 2024, CLIA budgeted for approximately 209 onsite complaint surveys, representing ~0.06% of the 320,000 CLIA labs.

H2[edit]

Some places bring people in off the street and train them, which you can do under CLIA for anything moderately complex." That includes almost any automated analyzer...The people trained to be operators often don’t understand what the results mean, and don’t know when they don’t make sense. That doesn’t mean they can’t turn out reliable lab work, but it does put an additional burden on the lab’s quality system.

Dr. Pennell Painter, CAP Today (2005)[52]

Laboratory instrumental and noninstrumental testing systems are inherently unstable, meaning laboratory testing systems will go wrong. Not 'might,' but 'will.' Laboratory testing is very complex and some institutions don’t give adequate credence to just how likely a bad result is to occur. There is no magic bullet that can allow you to skip steps and still maintain consistent quality.

Dr. Pennell Painter, CAP Today (2005)[52]

On September 15, 1995,the Health Care Financing Administration and the US Public Health Service issued a proposed rule to create a subcategory of moderate-complexity test procedures to be called "accurate and precise technology" (APT) tests.[53]

On April 4, 1995, a pair of bills, Clinical Laboratory Improvement Act Amendments of 1995, HR 1386 and S 877, were introduced in Congress to exempt physician office laboratories (POLs) from CLIA '88.[53] HR 1386 was incorporated into the House Medicare Preservation Act of 1995 and passed the house on October 19,1995, but was exemption provision was defeated in the Senate by a was defeated by narrow vote of 49 to 50 on October 27, 1995.[53]

On Augut 29, 1995, the Consumer Federation of America anad Public Citizen sued the United States Department of Health and Human Services for allegedly failing to to achieve the congressional goal of protecting patients from laboratory errors through CLIA '88.[53] The court found that DDHS failed toconider the "risks and consequences of erroneous test results" and the criteria for the categorization of laboratory tests was "capricious and arbitrary."[53]

The court also determined that DHHS's cytology proficiency testing failed "to require that cytologists be tested, to the extent practicable, under normal working conditions."[53] On November 30, 1995, DDHS would revise CLIA '88 regulations to require that proficiency testing be conducted at a pace corresponding to the maximum workload rate for individuals who examine cytology slides.[53]


[54]

H[edit]

In the the 1970s and 1980s, there existed a dual laboratory regulatory structure: one for regulated hospital and independent laboratories under Medicare, and an exemption for physician owned labs performing test on their own patients.[55] This approach sought to protect customers, e.g. when physicians used a hospital or independent laboratory, the physician was thee customer.[55] Between 1965 and 1988, physician office laboratories (POLs) began offering more testing as technology advanced. Additionally, the number of POLs had dramatically increased an estimated 6700 hospitals and 12,000 independent laboratories under regulation, and “several hundred thousand” exempt physician office laboratories.[55] A 1989 OIG report found patients of physician laboratory owners received more services the practice of physician laboratory ownership and self-referral was concerning.[56] Prior to 1987 , neither the CLIA 1967 , which covers interstate laboratory activities, nor the Medicare program, which certifies laboratories for payment, regulated-the vast majority of POLs.[57] In 1987, the Omnibus Budget Reconciliation Act of 1987 required that effective January 1, 1990, POLs performing over 5,000 tests a year meet Medicare quality standards.[57]

Healthcare regulatory changes in the 1980s provided strong financial incentives for the growth of POLs.[57] When the Medicare program began in 1965 , physicians were allowed to bill for laboratory services which they performed in their offices and for laboratory services they pur­chased from independent laboratories (ILs). The ILs typically discounted their charges to physicians.[57] Many physicians "marked up" the charges they incurred from ILs, creating higher costs for consumers including Medicare--and higher profits for themselves.[57] Physicians justified charging a higher price to their patients and third-party insurers by claiming the markup was an interpretation fee.[57] Physician markups were prevalent despite HCFA and American Medical Association policies that physicians should not profit from work performed by others.[57]

The Omnibus Budget Reconciliation Act of 1980 tired to eliminate markups on purchased laboratory services by requiring physicians to disclose the actual cost of services purchased from ILs, but enforcement of this law was difficult and many physicians continued to purchase laboratory services at discounted prices and bill at marked up prices.[57] Other physicians began operating their own laboratories or offered expanded laboratory services to preserve their profits and avoid violating the law.[57]

In 1983, the Medicare Prospective Payment System was implemented.[57] Laboratory services performed by hospitals on their inpatients were included in the diagnosis related group (DRG) payment.[57] Thus, the more effectively hospitals contained laboratory costs, the more profit they made from the DRG payment.[57] Hospital laboratories became cost centers instead of revenue centers. This resulted in the following: (1) physicians began performing pre-admission and post-hospital laboratory testing procedures that were previously done in hospitals; and (2) hospitals reduced purchases of laboratory equipment which caused manufacturers to focus their equipment sales on the POL and home testing markets.[57]

In 1984, Congress again tried to address the problem of physician laboratory markups.[57] The Omnibus Deficit Reduction Act of 1984 prohibited physicians from billing for laboratory work they did not perform.[57] It also established regional fee schedules (carrier specific) for reimbursement of Medicare laboratory services performed by ILs or hospital laboratories :it required them to accept assignment for Medicare services. In other words , hospitals and ILs could not collect more than the amount Medicare recognized as reasonable for a laboratory procedure. Physicians were exempt from the mandatOry assignment requirement. Services performed in POLs were paid at 80 percent of the established regional fee schedules, while physicians who submitted assigned claims were paid 100 percent of the schedules. During part of 1984, reimbursement for physician services was frozen, however, laboratory services billed by physicians were not subject to the freeze. Therefore, increasing their laboratory services was one way physicians could recoup lost revenues.[57]

Other factors besides Federal regulation have influenced the growth in POL testing: (1) convenience afforded the physician and patient; (2) quick turnaround time of test results which permits expeditious treatment decisions; (3) development of reasonable priced, " user friendly. automated, desktop analyzers and (4) increased competition among physicians which encouraged them to offer a broader rage of patient services.[57]

The regulated laboratory industry and others expressed concern to Congress that these factors and Federal regulations had resulted in a restructuring of the clinical laboratory industry which gave POLs an unfair market advantage. Consequently, millions of laboratory tests, once performed in ILs and hospitals, have shifted to non-regulated settings primary under the control of physicians. Not only were POLs not subject to the same payment provisions as ILs and hospitals, they were also exempt from Medicare proficiency testing, personnel, health and safety, and record standards.[57]

Congress responded by including in the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) and the Omnibus Budget Reconciliation Act of 1986, provisions which subjected services performed in POLs to the same percentage of regional fee schedules in effect for independent and hospital laboratories. Previously, fees were set at 60 percent of the prevailing charge levels for tests performed by ILs and by physicians in their offices, and at 62 percent of prevailing charge levels for tests performed by a hospital laboratory for outpatients. They also required POLs to accept assignment, and mandated a move to eventually brig all laboratories under a national fee schedule. In addition, COBRA of 1985 also requird the Secretary of Health and Human Services to submit to Congress a report on POLs and to discuss appropriate quality standards that might be imposed on them. [57]

A 1989 OIG report highlighted concerns with the quality of testing at POLs noting a risk from a lack of mandatory quality assurance programs, proficiency testing, and untrained or unqualified staff.[57] It was found that efforts by the private sector to address the quality of testing in POLs have not been effective because participation is voluntary.[57]

...a laboratory equipment manufacturer, reported receiving a call from a POL employee who wanted to know "where do you get the serum?" The "serum" was the patient blood sample needed to run the test.

OIG, Quality Assurance in Physician Office Labs (1989)[57]


nowledgeable and expert in this area, believe a national problem exists and that there ShOll!, be Federal intervention in this area. State concerns focused on the lack of quality control procedures and untrained staff. All professional associations representing laboratorians had grave concerns regarding the quality, of testing in POLs. The lack of mandatory quality assurance programs, proficiency testing, and untrained or unqualified staf were problems most often mentioned by these respondents, All of the laboratory equipment manufacturers agree there are difficulties in maintaining quality control in POLs. Many felt that physicians were reluctant to commit the necessary staff time and resources needed to maitain adequate quality control. They believe , as do others, that POLs lack an understanding as ro the purpose of quality control in the laboratory, One respondent summed up the problem by stating that POL personnel (physicians, physician assistants, nurses, receptionists) are "people oriented, not technicaly oriented. Most of the laboratory experts we spoke to, and the studies we read, acknowledge the ab

A 2002 study of waived laboratories in the CDC Laboratory Sentinel Monitoring Network found that almost than half of the laboratories did not follow manufacturer's instructions for recommended QC and QA.[55]

In the late 1980s, a series of exposes bought the lack of laboratory oversight and quality to the public attention.[58]In 1987, Walt Bogdanich published a series of Pulitzer Prize for Specialized Reporting articles in the Wall Street Journal highlighting the lax oversight of gynecologic cytology practices, hospitals barred Medicare could perform non-Medicare testing, a lack of proficiency testing and oversight of physician owned laboratories (POL).[59][60]The articles denounced high volume commerical cytology operations, colloquially described as "Pap mills" that exploited overwoked and underpaid cytotechnologits to churn out dubious results. [60] [61]

In November 1987, WRC-TV in Washington, DC aired a Peabody Award winning five-part series dubbed "Deadly Mistakes" led by investigative Lea Thompson that exposed deficiencies in laboratory testing accuracy and oversight.[62][63]The expose highlighted the serious medical and psychological trauma by those impacted including prenatal screening that was ineffective, deaths from missed cervical cancer screenings, and breakups and ruined careers due to false-positive tests and led to the introduction of "Medical Testing Improvement Act of 1988" (HR 4325).[62][64][65]

Cyto PT statistics ct.[66]

[67]

[68]


[60]

[69]

[70]

consultation between labs may be permissible in other circumstances, before or after a proficiency test, asking an outsider for help during a test corrupts the process and defeats its purpose. Indeed, this type of double-checking is exactly what Congress sought to prevent in the CLIA. It is not just passing off another’s work as one’s own that concerned Congress: “Run[ning] repeated tests on the sample, us[ing] more highly qualified personnelthan are routinely used for testing, or send[ing] the sample out to anotherlaboratory” are all among the many practices that “obviously undermine the purpose of proficiency testing.” H.R. Rep. No. 100-899, at 16, 24 (1988), asreprinted in 1988 U.S.C.C.A.N. 3828.[71][72]

O[edit]

Fl

Florida Senator Ana Maria Rodriguez - Senate Bill 1734 – Clinical Laboratory Testing (SB 1734) 2021. Testifying before the Senator Rodriguez, testimony Florida Senate Committee on Health Policy - “There are simply not enough available clinical lab technicians — on a permanent or temporary basis — available to conduct the necessary lab testing… we would like to help address that shortage….”[73]

In 1989, during unionization attempts at Twin City Hospital, the National Labor Relations Board (NLRB) ruled that medical technologists were not "professional employees" at the the Joint Commission accredited laboratory, and thus could not be included in the professional bargaining unit, which included nurses.[74][75]

Medical technologist and medical laboratory technologists not professional employees since work does not involve consistent exercise of discretion and judgement in its performance nor is it predominantly intellectual in nature, where 70 to 85% of testing is highly mechanized and completely automated, and no discretion in determining what tests to run or what constitutes abnormal results. Even checking for source of abnormal results is routine work and not predominantly intellectual and is mandated by policies and procedure manuals. Work requiring most discretion and judgement (microbiology) constitutes only small part of workload.

— National Labor Relations Board, SCO 304 NLRB No. 31 (1991)[76]

In 1988, Norton Community Hospital requested that medical technologists be excluded from the bargaining unit for professionals employees, and it was found that 19 of the 20 technologists employed were not professional employees.[77]

...laboratory technologists excluded from unit of all professional employees at community hospital, although majority had college degrees and of those who did not 5 out of 8 had passed the HEW proficiency exam based on a 4-year college degree program, since their work did not involve a consistent exercise of discretion and judgment in its performance where they exercise judgement only as to whether their machines were working properly where test results were unusual, and if retest result were also unusual they made no recommendation but relied on supervisor to determine problem's cause

— National Labor Relations Board, 291 NLRB No. 150 (1991)[76]

Provider-performed Microscopy (PPM)[edit]

The following is the lit of PPM[78][79]

Test HCPS/CPT Notes
Wet mounts, including preparations of vaginal, cervical or skin specimens Q0111
potassium hydroxide (KOH test) Q0112
Pinworm examinations Q0113
Fern test Q0114
Postcoital test Q0115
Urinalysis; microscopic only 81015
rinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, with microscopy 81000
Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any numberof these constituents; automated, with microscopy (NOTE: May only be used when the lab is using an automated dipstick urinalysis instrument approved as waived. 81001
Urinalysis; two or three glass test 81020
Fecal leukocyte examination (Effective: January 1, 2004) 89055
Semen analysis G0027
Nasal smears for eosinophils 89190
CLIA

[80] [81] [82] [83] [84][85] [86]

Waived

[87] [88]

An example laboratory state license for California.
Annual


[89]

Budget

For the 2024 fiscal year, CLIA was budgeted US$23.5 million.[90] The approximately 86 surveyors conduct 120 surveys annually, 112 initial/recertification and eight follow-up surveys, spending an average of up to 14 hours per survey.[90] The staffing ratio is one clerk per three surveyors, one professional support staff per six surveyors, and one supervisory surveyor per seven surveyors.[90] The projected workload is 9,172 compliance initial and recertification surveys, 642 complaint/follow-up onsite laboratory surveys (approximately 209 of the 642 will be complaint surveys), and 433 validations of accredited laboratory surveys.[90] The Waived Laboratory Survey Initiative remains discontinued and CLIA waived and PPM laboratories will not receive routine inspection.[90]

Disclosure

Upon request, CLIA will disclose forms "STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION" (CMS-2567), "CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION" (CMS-116), and other federal CLIA survey documents as well as the names of the laboratory director & laboratory owners.[91] Under CLIA, laboratory directors are accountable for all activities of the laboratory related and thus have a diminished expectation of privacy.[91] Additionally, the release of the laboratory owners names promotes transparency and aligns with other CMS provider/supplier types.[91]

Research laboratories[edit]

See also: Human subject research legislation in the United States
External videos
video icon HHS Return of Research Test Results by Mark Barnes

For research, CLIA does not permit the release of clinical results conducted in non-CLIA laboratories, which many research laboratories are not.[92] Where feasible, testing may be repeated in a CLIA laboratory, and those results may be disclosed to participants.[92] For tests that are being researched, there are challenges as to current clinical validity of the tests, and the responsibility of investigators to notify subjects if new clinical interpretations are found.[92] For these reasons, Institutional review board (IRBs) typically do not require that participants be notified of their clinical results.[92]

Secretary’s Advisory Committee on Human Research Protections (SACHRP)


CLIA requirements are “inadequate to ensure the overall quality of genetic testing because they are not specifically designed for genetic tests and because they do not give sufficient emphasis to pre- and post-analytic phases of testing."[93]

  • Holtzman, NA (May 1999). "Promoting safe and effective genetic tests in the United States: work of the task force on genetic testing". Clinical Chemistry. 45 (5): 732–8. doi:10.1093/clinchem/45.5.732. PMID 10222375.
Table
CLIA Annual Accreditation Organization (AO) Validation Survey Results
AABB
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 225 209 206 206 200 187 186
Validation Surveys 0 12 4 1 5 0 1
Surveys with Condition-Level Deficiencies 0 0 NA NA 1 NA NA
Surveys with One or More Condition-Level Deficiencies missed by AO 0 0 NA NA 1 NA NA
Disparity Rate 0% 0% NA NA 20% NA NA
A2LA
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs NA 2 2 3 3 5 3
Validation Surveys NA 2 0 0 0 0 1
Surveys with Condition-Level Deficiencies NA 2 NA NA NA NA NA
Surveys with One or More Condition-Level Deficiencies missed by AO NA 1 NA NA NA NA NA
Disparity Rate NA NA NA NA NA NA NA
ACHC (formerly AOA/AAHHS/HFAP)
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 130 127 129 126 129 132 127
Validation Surveys 6 7 3 10 4 10 NA
Surveys with Condition-Level Deficiencies 0 1 NA 0 NA 0 NA
Surveys with One or More Condition-Level Deficiencies missed by AO 0 1 NA 0 NA 0 NA
Disparity Rate 0% 14.3% NA 0% NA 0% NA
ASHI
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 121 111 110 111 113 113 111
Validation Surveys 8 6 1 4 2 3 1
Surveys with Condition-Level Deficiencies 0 0 NA NA NA NA NA
Surveys with One or More Condition-Level Deficiencies missed by AO 0 0 NA NA NA NA NA
Disparity Rate 0% 0% NA NA NA NA NA
COLA
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 6612 6667 6614 6628 6510 6375 5965
Validation Surveys 167 182 202 184 158 145 71
Surveys with Condition-Level Deficiencies 20 22 22 24 12 18 10
Surveys with One or More Condition-Level Deficiencies missed by AO 14 17 15 20 9 14 8
Disparity Rate 8.4% 9.4% 7.4% 10.9% 5.7% 9.75 11.3%
CAP
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 5968 6183 6237 6323 6364 6341 6339
Validation Surveys 88 98 95 96 113 124 38
Surveys with Condition-Level Deficiencies 12 13 11 6 13 13 2
Surveys with One or More Condition-Level Deficiencies missed by AO 12 13 8 6 11 12 1
Disparity Rate 13.6% 13.5% 8.4% 6.3% 9.7% 9.7% 2.6%
TJC
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 2347 2231 2209 2155 2136 2059 1927
Validation Surveys 55 58 51 45 45 43 10
Surveys with Condition-Level Deficiencies 7 9 10 9 5 8 4
Surveys with One or More Condition-Level Deficiencies missed by AO 7 7 8 8 5 8 3
Disparity Rate 12.7% 12.1% 15.7% 17.8% 11.1% 18.6% 30%
Total
Year 2014 2015 2016 2017 2018 2019 2020
Number of Accredited Labs 15403 155536 15507 15552 15454 15212 14658
Validation Surveys 331 365 356 340 327 325 123
Surveys with Condition-Level Deficiencies 39 47 46 39 33 39 16
Surveys with One or More Condition-Level Deficiencies missed by AO 33 39 33 34 28 34 12
Disparity Rate 10% 14.2% 9.3% 10% 8.6% 10.5% 14.6%
  • N/A: When a minimum sample size of five is not achieved for an AO, no data is reported given the lack of statistical significance.

[95] [96] [97] [98] [99] [100]

False Claims


[89]

Regional Offices[edit]

CMS CLIA Regions[106]
Region Office States and territories covered
I Boston Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont
II New York City New York, New Jersey, U.S. Virgin Islands, and Puerto Rico
III Philadelphia Delaware, Maryland, Pennsylvania, Virginia and West Virginia and the District of Columbia
IV Atlanta Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina and Tennessee
V Chicago Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin
VI Dallas Arkansas, Louisiana, New Mexico, Oklahoma, and Texas
VII Kansas City Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming
IX San Francisco Arizona, California, Hawaii and Nevada, the territories of American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands
X Seattle Alaska, Idaho, Oregon and Washington
CLIA Laboratories by Certification Types (Non-Exempt) in Dec 2023[107]
Region Office CoC CoW PPM CoA
I Boston 670 10,737 1,407 508
II New York 2,184 12,454 923 532
III Philadelphia 1,293 21,721 3,307 1,234
IV Chicago 1716 44,213 4,586 2,867
V Atlanta 4,706 63,536 5,801 3,942
VI Dallas 1,750 37,611 3,414 3574
VII Kansas 1,003 12,870 1,195 617
VIII Denver 872 8,713 1,236 665
IX San Francico 2,155 29,443 3,233 1,732
X Seattle 430 4,682 884 270
Totals 16779 245980 25986 15941
CLIA labs per AO 1995-2024[108][107]
Year COLA CAP TJC ACHC AABB ASHI A2LA
2023 6052 6,441 1,933 121 181 112 6
2022
2021 5,930 6,677 2,119 116 226 120 4
2020 5,983 6,461 1,952 127 191 118 4
2019 6,140 6,402 2,000 125 189 104 3
2018 6,409 6,385 2,065 134 192 112 5
2017 6,510 6,364 2,136 129 200 112 3
2016 6,628 6,323 2,155 126 206 111 3
2015 6,614 6,237 2,209 129 206 110 1
2014 6,657 6,169 2,278 130 216 110 1
2013 6,612 5,968 2,347 130 225 121 NA
2012 6,463 5,728 2,380 128 218 122 NA
2011 6,623 5,602 2,431 110 219 124 NA
2010 6,796 5,580 2,458 107 215 130 NA
2009 7,057 5,476 2,580 77 203 125 NA
2008 6,348 5,448 2,730 81 211 125 NA
2007 6,465 5,386 2,753 73 214 127 NA
2006 6,289 5,385 2,928 62 218 132 NA
2005 6,256 5,229 3,127 49 219 128 NA
2004 6,179 5,179 3,467 34 223 124 NA
2003 6,218 4,872 3,797 43 221 126 NA
2002 6,335 4,583 4,397 49 214 119 NA
2001 6,881 4,547 4,471 53 219 125 NA
2000 6,618 4,540 4,416 56 550 118 NA
1999 6,773 4,352 4,384 52 1,632 117 NA
1998 7,334 4,251 6,481 60 1,666 125 NA
1997 6,836 4,241 6,166 48 1,635 120 NA
1996 7,870 4,139 7,161 53 1,716 185 NA
1995 7,528 4,933 6,455 161 2,008 179 NA


Complaint Handling[edit]

CLIA complaints tri-fold

Under CLIA, anyone, including patients and their families, laboratory personnel, and the general public, can submit anonymous complaints if there are concerns about the quality of laboratory testing.[109] The most common CLIA complaints are concerns about a laboratory's operations, such as: unlabeled specimens, unqualified staff, record falsification, missing or incorrect test results and the confidentiality of patient information.[109] For laboratories accredited by a laboratory Accreditation Organization (AO), complaints may be referred to the laboratory’s AO.[109]


Though anyone may lodge a complaint, relatively few laboratory complaints have been filed.

This may due to a lack of publicity on complaint filing, since CLIA does not require that laboratory employees or patients be made aware on how to file a complaint, and privacy concerns from the lack whistleblower protections. Other limiting factors include an increasing reliance of on-the-job (OTJ) trained lab personnel unaware of regulatory requirements, foreign sponsored H1b medical technologists fearing retaliatory deportation, and an aging workforce awaiting retirement. Laboratory whistleblowers may face countersteps such as cover-ups, loss of income, position, employment, punitive lawsuits, and attacks on the individual's reputation which would degrade their living conditions and dissuade bringing fraud to light.[110]

A June 2006 GAO report found that lab workers may file complaints infrequently because of concern about retaliation and a lack of understanding about how to file a complaint.[111] The report that CMS require labs to prominently display complaint posters instructing lab workers how to file anonymous complaints.[111] In a July 2007 response to the GAO, CMS said that they lacked the legal authority to mandate labs to display posters.[111] They plan to take several other steps to increase awareness of complaint processes including: (1) posting fact sheet on the CMS web site on complaint filing (2) adding information on filing complaints to the interpretive guidelines used by surveyors (3) adding complaints received by accrediting organizations to their complaints database and (4) reminding states and accrediting organizations by letter about the importance of complaints.[111] CMS reported that it sent a letter about complaint tracking to accreditation organizations, exempt states, and professional laboratory organizations on November 30, 2007.[111] According to CMS, this letter highlighted the importance of complaint tracking and filing, and encouraged the publication of compliant processes.[111] CMS has also developed a CLIA Brochure on Complaints which was being prepared for release as of September 2008.[111] Once released, CMS anticipates posting the brochure on its website and printing copies for distribution to laboratories. We will continue to monitor implementation of this recommendation.[111] In 2009, the GAO recommended that CMS require all survey organizations to develop and require labs to prominently display posters instructing lab workers how to file anonymous complaints.[111] CMS determined that this would not be practical and instead is working on publishing a brochure that will be distributed by surveyors to labs, published on the CMS CLIA Web site, and distributed at lab professional meetings. [111] Few labs were the subject of a complaint each year from 2002 through 2004—significantly less than one complaint per lab per year.[111] Concerns that labs can easily identify the lab workers who file complaints and lab workers’ lack of familiarity with how to file a complaint may explain why so few laboratory workers report problems.[111] Complaints are an important tool in detecting quality problems between lab surveys.[111] For example, complaints about testing at a hospital lab were crucial because information had been concealed, complicating the detection of quality problems during the lab’s surveys.[111] As a result of a complaint, surveyors were able to substantiate inadequate calibration of testing equipment that could adversely affect patient care. [111]

Several of the AOs, such as CAP, require laboratories to post the complaint contact signs, but only in employee areas.[112]

Whistleblower Protection[edit]

Main article: Whistleblower protection in the United States

Few labs are subject to complaints.[111] For 2024, CLIA budgeted for approximately 209 onsite complaint surveys, representing ~0.06% of the 320,000 CLIA labs.[90] The low volume of lab complaints may be related to complainants’ concerns about anonymity and fear of retaliation for filing a complaint.[111] It may be easy for a lab to determine the source of a complaint filed by a lab worker.[111] For example, in some cases, either the nature of the complaint or the piece of testing equipment in question could narrow the list of possible complainants.[111] Because of the difficulty of protecting the anonymity of lab workers who file complaints, whistle-blower protections for such individuals are particularly important. Following congressional testimony by a Maryland hospital lab worker that she and her colleagues feared losing their jobs because of the complaints, a whistleblower protection bill entitled "Clinical Laboratory Compliance Improvement Act of 2005" was introduced, but died in committee.[113][114][111]

CLIA and federal law provide no specific whistleblower protection to laboratory employees who report CLIA violations.[114] However, CLIA complaints made under the False Claims Act (FCA) may be afforded by whistleblower protections.[114] The FCA which prohibits fraud against government programs, including Medicare and Medicaid, may cover CLIA violations that give rise to FCA violations such as laboratory deficiencies that render billed services medically worthless.[114] Whether CLIA compliance is a condition of Medicare payment is a contested issue.[114] To qualify for protection under FCA, the whistleblower must demonstrate that they were engaged in FCA-protected activity and that the employer knew their activity was protected under the FCA, which presents a challenge for whistleblowers who merely report regulatory violations.[114] To be protected under the FCA, they must reasonably believe the regulatory noncompliance has or will amount to fraud against the government and they they must put the employer on notice that their protected activity relates to the filing of false or fraudulent claims.[114] Laboratory workers who merely report CLIA violations without tying the issues to Medicare or Medicaid reimbursement are unlikely to receive FCA whistleblower protection.[114]

We also found that there are relatively few complaints about lab quality problems. This may be due to insufficient publicity on how to file a complaint, and privacy complaints resulting from limited whistleblower protections for lab workers.[115]

In September 2015, a Theranos employee email complaint to the Centers for Medicare and Medicaid Services (CMS) outlining regulatory noncompliance led to the company's exposure as a fraud and subsequent downfall.[114]

Maryland General

[116]

External videos
video icon CBS COVID LAB: State Secrets Exposed

The Valencia Lab fiasco was exposed by whistleblowers, and eventually the lab’s contract was quietly cancelled—a testament to the importance of the role of whistleblowers in exposing problems.

Scott Wilk, California State Senator (2022)[117]

In Feb 2021, a series of whistleblowers reached out to the CBS Sacramento alleging improprieties and CLIA violations at the CAP accredited California Department of Public Health (CPDH) Valencia Branch Laboratory that had partnered with PerkinElmer in a $1.7 Billion no-bid contract. PerkinElmer subsequently sued the whistleblowers for breach of confidentiality.[118] CBS 13 subsequently investigated the Valencia laboratory along with CDPH which investigated itself and found the allegations substantiated. The laboratory was found to have significant immediate jeparody deficiencies, but was not sanctioned. The laboratory medical director had previously overseen Theranos. [119][120] In response, California State Senator Scott Wilk introduced the The Whistleblower Protection Act (SB 947) in February 2022, to extend the existing California Whistleblower Protection Act (CWPA) afforded to California state employees to the employees of government contractors that hold state contracts over $5 million dollars.[121] Wilk noted how "brave whistleblowers from the lab risked their livelihoods to expose unlicensed lab techs sleeping on the job, a lack of supervision over untrained staff, contaminated tests, swapped samples, testing errors, a high rate of "inconclusive" results, and inaccurate results, with no process for addressing or rectifying errors" were subsequently "subject to litigation in response to their brave actions to expose the abuse of state funding in the lab, and the potential public health issues stemming from improperly processing and handling COVID 19 specimens."[122] The bill passed unanimously in the California State Senate[117], but died in the California State Assembly. The CPDH partnership contract with PerkinElmer was terminated on May 15, 2022 and was subsequently criticized for its excess costs, failure to meet expectation, and the states poor handling of the investigation. [123].[121]



“T”


False Claims Act[edit]

Main article: False Claims Act

In recent years, there have been several successful FCA claims related to CLIA that have opened a new avenue of regulatory liability to laboratories and provided a financial incentive to whistleblowers. Historically, laboratory complianace issues have primarily been viewed as billing issues, but increasingly, quality of care issues are recieving attention as whistleblower lawsuits allege substandard or poor quality testing, which is actionable under the False Claims Act as "worthless service."[124] An improper proficiency testing (PT) referral may result in an FCA claim under the "false certification" theory.[114][125][126]

In 2021, an oncology clinic in St. Petersburg, Florida was subject to an FCA claim that resulted in a total judgment of US$1.179 million on 214 fraudulent claims to Medicare that totaled US$755.54 stemming from the lack of a CLIA certificate. The oncology practice had its own CLIA certificate and acquired another oncology clinic with an in-house lab, but did not acquire the CLIA license and the existing CLIA certificate did not cover the new practice. Because the lab at the newly aquired oncology practice lacked the a proper CLIA certificate, reimbursement was denied, but the practice opted to resubmit the bills to fraudulently show the tests were performed at an office that had a valid CLIA certificate. In doing so 214 times, the federal government suffered $755.54 in damages. The court trebled the damages to $2,266.62 and imposed the minimum statutory penalty of $5500 per violation, for each of the 214 violations. The Elevth ciruit noted that “[s]eeing a judgment of $1.179 million based on $755.54 in actual damages may raise an eyebrow,” noting that “[f]raud harms the United States in ways untethered to the value of any ultimate payment” and that “[i]n the context of the FCA, we also consider the deterrent effect of a monetary award.” [127][128][129][130][131][132]

In 2020, an FCA claim against DaVita was filed under the “implied false certification” alleged that specimens from around the country were shipped under poorly controlled environmental conditions to Florida, where Davita maintained its laboratories for tax benefits, without validating specimen storage conditions. The case settled.[133][134]

In 2011, a medical technologist filed a FCA claim under the "worthless services" theory against the Mimbres Memorial Hospital in Deming, New Mexico alleging that routine quality control for microbiology was not performed per CLIA and that the hospital knowingly released and billed for non-verifiable results before the department was shutdown.[135] In 2013, theUnited States District Court for the District of New Mexico dismissed the FCA claim since maintaining compliance with a CLIA Certificate of Compliance (CoC) was not a condition of payment under Medicare, only a condition of participation. [136]

Laboratory definition & applicability[edit]

CLIA defines a medical laboratory as follows:

Laboratory means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.

— Clinical Laboratory Improvement Amendments (CLIA) 1988, §42 CFR 493.2 “Laboratory”[137]

CLIA applies when: (1) patient-specific results are reported from the laboratory to another entity; AND (2) the results are made available "for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings."[138] When a facility performs tests for the above-stated purposes must obtain a certificate from the CLIA program that corresponds to the highest complexity of tests performed for its location.[138] When testing is performed in a mobile entity, such as glucometer testing in an ambulance, medivac helicopter, or boat rescue craft, that entity or its home base are required to be registered under CLIA. Whether a test service is billed has no bearing on CLIA applicability.[138]

CLIA does not apply to the following testing/laboratories:[139]

  • Forensic testing
  • Research laboratories that do not report patient specific results back to individuals
  • Drug testing under Substance Abuse and Mental Health Services Administration SAMHSA
  • Employment drugs of abuse
  • Physiological testing, e.g. spirometry, slit-lamp test for eyes, breath analysis, pulse oximetry
  • Facilities that only serve as collection points (no testing performed).
  • Laboratories licensed in a state whose laboratory licensure program is approved by CMS (New York and Washington). A CLIA certificate is still required for Medicare billing
  • Federal laboratories including Department of Veterans Affair (VA) and Department of Defense(DoD)
  • Laboratory testing conducted as part of home health or hospice care in an individual's home, where the employee only assists the individual in performing a test

Laboratory Registry[edit]

Under CLIA, CMS publishes an annual blacklist of all laboratories and persons who have run afoul of CLIA known as the "Laboratory Registry."[140][141] The Laboratory Registry is compiled for the calendar year preceding the date the information is made available and also contains corrections of any erroneous statements of information that appeared in the previous registry. Civil settlements reached with clinical laboratories are listed as well as a final section includes other specific information that may be useful in evaluating the performance of laboratories.[141]

The Laboratory Registry listing includes:[141]

  1. A list of laboratories that have been convicted, under Federal or State laws relating to fraud and abuse, false billing, or kickbacks.
  2. A list of laboratories that have had their CLIA certificates suspended, limited, or revoked, and the reason for the adverse actions.
  3. A list of persons who have been convicted of violating CLIA requirements, as specified in section 353(1) of the PHS Act, together with the circumstances of each case and the penalties imposed.
  4. A list of laboratories on which alternative sanctions have been imposed, showing—
    1. The effective date of the sanctions;
    2. The reasons for imposing them;
    3. Any corrective action taken by the laboratory; and
    4. If the laboratory has achieved compliance, the verified date of compliance.
  5. A list of laboratories whose accreditation has been withdrawn or revoked and the reasons for the withdrawal or revocation.
  6. All appeals and hearing decisions.
  7. A list of laboratories against which CMS has brought suit under § 493.1846 and the reasons for those actions.
  8. A list of laboratories that have been excluded from participation in Medicare or Medicaid and the reasons for the exclusion.
File

CMS’s OSCAR database contains limited data on the quality of labs inspected by state survey agencies and, as a result, it is not possible to analyze changes in the quality of lab testing over time. In January 2004, CMS implemented revised CLIA survey requirements and modified the existing OSCAR data—state survey agency findings—to reflect the changes.29 The revisions affected approximately two-thirds of the CLIA condition-level requirements.30 As a result of the data modifications, the findings for surveys conducted prior to 2004 no longer reflect all key condition-level requirements in effect at the time of those surveys[111]

Inspection

[142][143]

Accrediting Organizations (AO)
Federal Entities
CLIA Automated Survey Process Environment (ASPEN) system.[144]
PT

External quality assessments (EA) CDC Clinical Standardization Programs[145], CDC Environmental Legionella Isolation Techniques Evaluation (ELITE) Program[146], CDC Laboratory Quality Assurance Programs, AIHA Proficiency Testing Programs[147]

A 1989 HHS OIG report found that 90% of survey staff believed that laboratories handled proficiency testing samples differently than regular samples including: (1) having the laboratory s best analyst handle the specimen, (2) spending more time and effort analyzing the sample, (3) reviewing the same sample two or more times (4) discussing sample test results with workers in other laboratories or (5) sending the sample to an outside laboratory for an independent reading.[148] Test scores for PT samples which do not evidence normal statistical variation offer further evidence that a laboratory has given special attention to the sample.[148] Some laboratories destroy required records showing when a PT specimen is run who ran it and how often it was run.[148] State survey staff indicated that laboratories have strong incentives to make PT results as accurate as possible. One surveyor explained "As long as PT is used as a regulatory system, laboratories will have to handle PT samples differently. Common sense tells us that a laboratory wil put its best foot forward."[148]

Cri

A 1989 HHS OIG report found a number of issues: there was an insufficient budget to perform on-site inspections, proficiency testing was not standardized, improper handling of proficiency testing surveys, a lack of sanction authority for surveyors, insufficient regulations for PAP and AIDs testing, that few labs were terminated, and that terminated labs continued to receive Medicare payments.[148]

Enf

A 1989 HHS OIG report found that enforcement was subject to excessive delays and that the emphasis was on giving laboratories multiple opportunities to come into compliance, rather than decertifying them.[148] Sometimes the State will make a follow-up visit to the laboratory to verify compliance, but but due to limited resources, the State may not follow-up until the next scheduled inspection, which could be 1 to 2 years later.[148] Submission of an acceptable plan effectively removes the finding of a deficiency at least until the next on-site inspection.[148] One State certification director noted "In order to decertify a laboratory, we have to move cautiously and carefully. After we cite a deficiency, the back and forth can go on for years."[148] One State surveyor commented "HCFA usually sits on cases we have referred to them or they tell us to go back and resurvey the laboratory. Many of our cases just die on the vine." [148]

A 1989 HHS OIG report, surveyors noted that the survey process was concerned with paperwork rather than with substantive review.[148] A state surveyor noted that "Paperwork reviews can't tell you everything, and day-to-day practices can't be reviewed on an annual basis".[148] These surveyors feel that many of the deficiencies cited during on-site inspections are minor problems or "paper compliance issues."[148]

A 1989 HHS OIG report found that laboratories who had their CLIA certificates terminated fraudulently continued to receive payments.[148] When a laboratory CLIA certification is terminated, HCFA sent the medicare carriers copy of the termination letter sent to the laboratory.[148] The carriers then had to decide from the letter what action to take, whether to stop payment for all laboratory Medicare services or for one or more specialties.[148] Carrier staff found the letters confusing and HCFA usually did not follow up with carriers when laboratory termination notices are issued and normally do not review carrier action on termnation notices when they evaluate carrier performance.[148]

In 2022, the Texas HHS OIG found that managed care organizations were not properly tracking CLIA certification status and were not denying claims for invalid certificates or tests outside the scope of their CLIA certificate.[149][150][151]

Under current regulations, the major sanction authority for Medicare laboratories is decertification leading to termnation from participation. Fines, civil money penalties or other intermediate sanctions have not been used as remedies for laboratory deficiencies. The Omnbus Budget Reconciliation Act of 1987 (OBRA) mandated HCFA to develop regulations for intermediate sanctions that could be used with laboratories and other categories of providers "in lieu of termnation." Regulations to implement these provisions are stil under development. The CLIA 1988 also contains a provision regarding intermediate sanctions[148]

excessive cyotechnologist workloads involving as many as 200 to 300 slides per day rather than the 80 per day as recommended by all national organizations of cytopathologists and cyotechnologists. This problem is exacerbated by cyotechnologist salaries which frequently are based on a per case rate. This causes some cyotechnologists to work a second shift in a different laboratory and thus to exceed the recommended limit on slides reviewed[148]

In recent years, budgetary constraints have limted the number of State surveyors available to monitor laboratories. Because of the reduced number of surveyors HCF A modified its requirements so that States could intensify their inspections of other providers such as nursing homes, which are considered to pose greater safety risks to patients. The HCF A now requires States to perform on-site inspections of only 68 percent of laboratories each year. Nevertheless, about 10 States continue to conduct on-site inspections of all laboratories at least once a year. Because of limited staff resources, surveyors in six States suggested targeted inspections based on prior survey results. Laboratories performing in a satisfactory manner would not be visited as often as laboratories with multple deficiencies. Current survey scheduling does not formally distinguish between laboratories that perform in a satisfactory manner and those that do not. [148]

"What is needed is a system in-between visiting a laboratory about one day a year or every other year and having a resident inspector at the laboratory."

CLIA Surveyor, HHS OIG Report (1989)[148]

PT Acceptable Limits[edit]

Several analytes were removed due to infrequent utilization.[152]

CDC has shown in a recent poster 10 that it is possible to design ALs based upon such accuracy goals, and it is possible to simulate the ability of a PT program to identify laboratories that cannot meet such goals, while minimizing the likelihood of misidentifying laboratories that are meeting analytical accuracy goals based upon biological variability.Therefore, we proposed to amend ALs for certain current analytes as well as establish ALs for analytes proposed for addition in §§ 493.927, 493.931, 493.933, 493.937, 493.941 and 493.959 based on analytical accuracy goals. [153] [154]

“Criteria for Acceptable Performance”, as that term is used in §§ 493.923, 493.927, 493.931, 493.933, 493.937, 493.941, and 493.959, is defined by the target value and acceptance limits. Criteria for acceptable performance is meant for PT scoring only and not intended to be used to set acceptability criteria for a laboratory's verification or establishment of performance specifications.

Acceptable Performance[edit]

CLIA '22 improves quality and accuracy of laboratory testing while considering the capabilities and constraints of current testing methods. It underscores the importance of continuous advancements in laboratory technologies and methodologies to further enhance precision and align ALs with biological variation for all analytes. pi

CLIA '22 assigned a new percentage-based acceptable limit (AL) for 53 analytes (new and existing), of which 34 analytes now have ALs tighter than or equal to biological variation (BV). For the remaining 19 analytes, the AL assigned are wider than biological variation, primarily due to limitations in current testing capabilities whose imprecision exceeds biological variation.[155] Where biological variability data is available, CLIA set the AL to get as close to, or below BV. The percentage-based acceptable limits were established using simulations that aimed to maintain a miss rate (the percentage of laboratories not meeting the criteria for acceptable performance per PT challenge) within the 1% to 2% range based on PT program data with CLIA '88 ALs. For several analytes, e.g. therapeutic drugs and white blood cell differentials, there is no biological variability data available. White blood cell differential is the only remaining analyte with ALs set in SD.[156]

CLIA '88 prescribed a variety of acceptable limits, including: a multiple of the SD of results from the mean of other participants in the peer group; fixed limit as a percentage of the assigned value; fixed limit in concentration units; and a mixture of percentage and concentration units, depending on the concentration of the analyte.[156] For CLIA '22, all non-microbiology analytes (except WBC differentials) were assigned fixed ALs, preferably as percentage limits rather than concentration units.[156]


CLIA 22 Changes
Section Analyte Addition Analyte Removal
General Immunology
  • Anti-HBs
  • Anti-HCV
  • C-reactive protein (high sensitivity)
Routine Chemistry
  • B-natriuretic peptide (BNP)
  • ProBNP
  • Cancer antigen (CA) 125
  • Carbon dioxide
  • Carcinoembryonic antigen
  • Cholesterol, low density lipoprotein, direct measurement
  • Ferritin
  • Gamma glutamyl transferase
  • Hemoglobin Ale
  • Phosphorus
  • Prostate specific antigen, total
  • Total iron binding capacity (TIBC), direct measurement
  • Troponin I
  • Troponin T
 LDH isoenzymes
Endocrinology
  • Estradiol
  • Folate, serum
  • Follicle stimulating hormone
  • Luteinizing hormone
  • Progesterone
  • Prolactin
  • Parathyroid hormone
  • Testosterone
  • VitaminB12
Toxicology
  • Acetaminophen, serum
  • Salicylate
  • Vancomycin
  • Ethosuximide
  • Quinidine,
  • N-acetyl procainamide (NAPA)
  • Primidone
  • Procainamide

General Immunology Proficiency Testing Criteria for Acceptable Performance [157]
Analyte / Test Abbr. CLIA '22 Acceptance Limit CLIA '88 Acceptance Limit Notes
Alpha-1 antitrypsin AAT Target value ± 20%.
Alpha-fetoprotein (tumor marker) AFP Target value ± 20%.
Antinuclear antibody ANA Target value ±2 dilutions or positive or negative.
Antistreptolysin O ASO Target value ±2 dilutions or positive or negative.
Human Immunodeficiency virus antibody anti-HIV Reactive (positive) or nonreactive (negative).
Complement C3 C3 Target value ±15%.
Complement C4 C4 Target value ±20% or ±5 mg/dL (greater).
C-reactive protein (high sensitivity) hsCRP Target value ±30% or ±1 mg/L (greater). Only applies to hsCRP, not CRP.[b]
Hepatitis B surface antigen HBsAg Reactive (positive) or nonreactive (negative).
hepatitis B core antigen antibody anti-HBc Reactive (positive) or nonreactive (negative).
Hepatitis B e antigen HBeAg Reactive (positive) or nonreactive (negative).
Hepatitis B surface antibody anti-HBs Reactive (positive) or nonreactive (negative).
hepatitis C virus antibody anti-HCV Reactive (positive) or nonreactive (negative).
Immunoglobulin A IgA Target value ±20%.
Immunoglobulin E IgE Target value ±20%.
Immunoglobulin G IgG Target value ±20%.
Immunoglobulin M IgM Target value ±20%.
Infectious mononucleosis Mono Target value ±2 dilutions or positive or negative.
Rheumatoid factor RF Target value ±2 dilutions or positive or negative.
Rubella antibodies RUB Target value ±2 dilutions or positive or negative or immune or nonimmune.

General Immunology Proficiency Testing Criteria for Acceptable Performance [159]
Analyte / Test Abbr. CLIA '22 Acceptable Limit CLIA '88 Acceptable Limit Notes
Cancer antigen (CA) 125 CA 125 Target value ±20%.
Carcinoembryonic antigen (CEA) CEA Target value ±15% or ±1 ng/dL (greater).
Cortisol Target value ±20%.
Estradiol Target value ±30%.
Folate, serum FOL Target value ±30% or ±1 ng/mL (greater).
Follicle stimulating hormone FSH Target value ±18% or ±2 IU/L (greater).
Free thyroxine FT4 Target value or ±15% or ±0.3 ng/dL (greater).
Human chorionic gonadotropin HCG Target value ±18% or ±3 mIU/mL (greater) or positive or negative. Excludes urine pregnancy tests done by visual color comparison categorized as waived tests.
Luteinizing hormone LH Target value ±20%.
Parathyroid hormone PTH Target value ±30%.
Progesterone PROG Target value ±25%.
Prolactin Target value ±20%.
Testosterone Target value ±30% or ±20 ng/dL (greater).
T3 uptake T3U Target value ±18%.
Triiodothyronine T3U Target value ±30%.
Thyroid-stimulating hormone TSH Target value ±20% or ±0.2 mIU/L (greater).
Thyroxine T4 Target value ±20% or ±1.0 mcg/dL (greater).
Vitamin B12 VB12 Target value ±25% or ±30 pg/mL (greater).
Routine Chemistry Proficiency Testing Criteria for Acceptable Performance [160]
Analyte Abbr. CLIA 2022 CLIA 1988 Notes
Alanine aminotransferase (ALT/SGPT) ALT Target value ±15% or ±6 U/L (greater).
Albumin ALB Target value ±8%.
Alkaline phosphatase ALP Target value ±20%.
Amylase AMY Target value ±20%.
Aspartate aminotransferase (AST/SGOT) AST Target value ±15% or ±6 U/L (greater).
Bilirubin, total TBIL Target value ±20% or ±0.4 mg/dL (greater).
Blood gas pCO2 pCO2 Target value ±8% or ±5 mm Hg (greater).
Blood gas pO2 pO2 Target value ±15% or ±15 mmHg (greater).
Blood gas pH pH Target value ±0.04.
B-natriuretic peptide BNP Target value ±30%.
Pro B-natriuretic peptide proBNP Target value ±30%.
Calcium, total CA Target value ±1.0 mg/dL.
Carbon dioxide CO2 Target value ±20%.
Chloride CL Target value ±5%.
Cholesterol, total CHOL Target value ±10%.
Cholesterol, high density lipoprotein HDL Target value ±20% or ±6 mg/dL (greater).
Cholesterol, low density lipoprotein LDL Target value ±20%. direct measurement
Creatine kinase CK Target value ±20%.
CK–MB isoenzymes CKMB Target value ± 25% or ±3 ng/mL (greater) or MB elevated (presence or absence).
Creatinine CREAT Target value ±10% or ±0.2 mg/dL (greater).
Ferritin FERR Target value ±20%.
Gamma glutamyl transferase GGT Target value ±15% or ±5 U/L (greater).
Glucose GLUC Target value ±8% or ±6 mg/dL (greater). (excluding measurements devices cleared by FDA for home use.)
Hemoglobin A1c HbA1c Target value ±8%.
Iron, total IRON Target value ±15%.
Lactate dehydrogenase LDH Target value ±15%.
Magnesium MG Target value ±15%.
Phosphorus PHOS Target value ± 10% or ±0.3 mg/dL (greater).
Potassium K Target value ±0.3 mmol/L.
Prostate Specific Antigen, total TPSA Target value ±20% or ±0.2 ng/mL (greater).
Sodium NA Target value ±4 mmol/L.
Total Iron Binding Capacity TIBC Target value ±20%. (Direct Measurement)
Total Protein TP Target value ±8%.
Triglycerides TRIG Target value ±15%.
Troponin I TNI Target value ± 30% or ±0.9 ng/mL (greater).
Troponin T TNT Target value ±30% or ±0.2 ng/mL (greater).
Urea nitrogen BUN Target value ±9% or ±2 mg/dL (greater).
Uric acid UA Target value ±10%.
Toxicology Proficiency Testing Criteria for Acceptable Performance [161]
Analyte Abbr. CLIA 22 CLIA 1988 Notes
Acetaminophen ACTM Target value ±15% or ±3 mcg/mL (greater).
Alcohol, blood ETOH Target Value ±20%.
Blood lead LEAD Target Value ±10% or ±2 mcg/dL (greater).
Carbamazepine, total CARB Target Value ±20% or ±1.0 mcg/mL (greater).
Digoxin, total DIG Target Value ±15% or ± 0.2 ng/mL (greater).
Gentamicin GENT Target Value ±25%.
Lithium LI Target Value ±15% or ±0.3 mmol/L (greater).
Phenobarbital PHENO Target Value ±15% or ±2 mcg/mL (greater).
Phenytoin total PHENY Target Value ±15% or ± 2 mcg/mL (greater).
Salicylate SAL Target Value ±15% or ±2 mcg/mL (greater).
Theophylline Target Value ±20%.
Tobramycin TOBRA Target Value ±20%.
Valproic Acid, total VALP Target Value ±20%.
Vancomycin VANC Target Value ±15% or ±2 mcg/mL (greater).
Hematology and Coagulation Proficiency Testing Criteria for Acceptable Performance [162]
Analyte Abbr. CLIA 22 CLIA 1988 Notes
Cell identification 80% or greater consensus on identification.
White blood cell differential DIFF Target ±3SD based on the percentage of different types of white blood cells in the samples.
Erythrocyte count ESR Target ±4%.
Hematocrit HCT Target ±4%. (Excluding spun hematocrit)
Hemoglobin HGB Target ±4%.
Leukocyte count WBC Target ±10%.
Platelet count PLT Target ±25%.
Fibrinogen FIB Target ±20%.
Partial thromboplastin time PTT Target ±15%.
Prothrombin time (seconds or INR) PT/INR Target ±15%. If a laboratory reports a prothrombin time in both INR and seconds, the INR should be reported to the PT provider program.
Immunohematology Proficiency Testing Criteria for Acceptable Performance [163]
Analyte Abbr. CLIA 22 CLIA 1988 Notes
ABO group ABO 100% accuracy.
D (Rho) typing RH 100% accuracy.
Unexpected antibody detection SCREEN 100% accuracy.
Compatibility testing XM 100% accuracy.
Antibody identification ABID 80%+ accuracy.

PT[edit]

External videos
video icon CLIA PT Final Rule, CMS-3355-F, OneLab Reach

During implementation of CLIA '88, CMS stated their goal was to have 95% of CLIA laboratories enrolled in PT with 90% of the total scores to contain no failures by the year 2000.[164] 

This goal commits CMS to continued improvement in the accuracy of diagnostic laboratory tests regulated under the Clinical Laboratory Improvement Amendments (CLIA) as demonstrated by improved PT performance. Specifically, further improvements are expected in laboratory scores on proficiency (accuracy) testing (PT) while the rate of compliance with PT enrollment requirements in CLIA also increases. It is important to measure progress on both enrollment and PT scores so that eventually all laboratories subject to PT under the CLIA rules are both participating in a PT testing program and performing well on those PT challenges. PT, along with the other CLIA quality requirements, offers each laboratory performing non-waived testing and CMS a means of measuring a laboratory's performance. It also increases patient and physician confidence in a particular laboratory by producing a snapshot of the laboratory's ability to perform tests accurately according to objective standards. Increased laboratory test accuracy reduces the need or inclination for repetitive laboratory testing and thereby reduces overall costs of medical care related to diagnostic testing. Typically, a laboratory that performs well on PT tends to provide more accurate testing results to clinicians, which aids in rapid and appropriate patient diagnoses and contributes to effective treatment. There is a well documented educational value for the laboratory staff from PT performance and evaluation of PT results.[164]

PT involves sending samples with results unknown to the laboratory, three times per year to evaluate whether the laboratory's results compared to its peers. The CLIA regulation requires that the PT samples be tested in the same manner and by the same individuals as those performing patient testing. The PT samples are provided by private non-profit organizations, Federal or State agencies. The PT programs that provide the samples undergo an annual and ongoing review process coordinated by CMS and CDC.[164]

Under CLIA all entities providing laboratory testing are certified. Laboratories performing non-waived tests are required by law to perform PT. CLIA defines laboratory testing as "the examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings." There are currently 86 tests or analytes for which laboratories must perform PT under CLIA. This list of 86 analytes is largely made up of diagnostic tests which are commonly performed and whose results are important to health care treatment decisions. Each laboratory performs PT on the regulated analytes that are a part of its specific test menu. There are other tests performed by laboratories, regulated under CLIA, for which there is no required PT under CLIA regulations. Tests for which PT is required may be added as the CLIA regulations are updated by CDC and CMS. Some laboratories voluntarily participate in any PT which is available, even if not yet required under CLIA regulations. If there is no PT available for a test, a laboratory must, at least two times each year, demonstrate the accuracy of any test performed.[164]

Calendar years 1993 and 1994 were phase-in years for PT enrollment and performance under CLIA for previously unregulated laboratories, such as those in physicians' offices. Calendar year 1995 represents the first year for which there is complete PT data. This data indicates that 69.4% of the total scores reported from all laboratories enrolled in PT demonstrated no failures. The data also indicate that 89.6%of the laboratories that were required to be enrolled in PT were actually enrolled. This represents the baseline from which to improve. The following year, 87.4% of the scores from enrolled laboratories demonstrated no failures on any PT challenges and the percentage of regulated labs actually enrolled was 93.2%. These figures indicate increases in both performance (accuracy) rates and enrollment rates from 1995 to 1996, consistent with the start-up of PT testing. As the PT program becomes a routine part of laboratory operations, further more modest gains are expected in both measures.[164]

CLIA PT Brochure Do's & Don'ts

Medicare conditions of coverage require all independent laboratories to participate successfully in a PT program in all applicable specialties and subspecialties for which an approved PT program is available. Each PT program must be approved by the Secretary of HHS. The HCFA guidelines require State surveyors to determine that (a) the specimens are tested by employees who are regularly assigned to testing in the applicable specialty, (b) the laboratory uses its routine methods and (c) the laboratory actually tests the PT specimens in-house. Laboratories that do not meet these specifications are not in compliance with Medicare s conditions of coverage. [148]

Most independent laboratories participate in PT programs offered by their State licensing and certification agency, CAP or the American Association of Bioanalysts. Only a few States offer extensive PT through their State laboratories.[148]

Specimens are mailed by the PT organization to each laboratory on a periodic basis usually quarterly. The laboratory tests each specimen and returns the analysis for grading. Laboratories must maintain records showing the action taken for each shipment of PT specimens. The PT organization scores the laboratory PT analysis and sends the results to the laboratory and State agency. The State licensing and certification agency determnes if the results are satisfactory, marginal or unsatisfactory.[148]

Unsuccessful PT scores in three consecutive quarters or three out of four quarters should result in a specialty or subspecialty decertification recommendation from the State to HCFA. Before taking action to terminate, however, HCF A staff must document whether there are mitigating factors. A decertified laboratory may be reinstated only after achieving satisfactory PT performance for two consecutive quarters or being judged satisfactory in testing specimens onsite during two separate visits by State surveyors.[148]

In December 1987, CDC issued a proposal for departmental consideration to establish a uniform PT program for laboratories regulated under Medicare and CLIA.[148] The purpose of the proposed PT standards is "to identify laboratories whose level of performance constitutes a threat to public health and not to provide educational benefits or to establish an optimum in laboratory performance."[148] Private sector PT organzations would continue to conduct the tests for laboratories in accordance with the new CDC standards and test grading criteria. Laboratories would need to maintain an 80 percent score in the specialty or subspecialty in order to pass. [148]

The major reason for the low number of Medicare terminations is that HCF A and many State agencies view termination as the last resort, to be used only when efforts to bring a laboratory into compliance have failed. Very often, States are able to achieve compliance without recommending decertification. Either the laboratory will come into compliance on its own, or it will voluntarily drop a test or specialty area where unsatisfactory performance has been noted. In one region, where there have been no decertifications for several years, the HCF A laboratory specialist explained Laboratories will do anything to avoid decertification. They will voluntarily stop performing a particular test or will contract with another laboratory for it. Because of this voluntary action by the laboratories, there is seldom a need for formal Federal compliance measures." In another region, the HCFA laboratory specialist explained The value of monitoring is to establish an ongoing dialogue between the State and the laboratory rather than the action taken against a laboratory if the laboratory fails. [148]

Though “non-regulated analytes” do not require PT, CLIA does require that laboratories verify the accuracy and reliability of analytes twice a year. [165]

PT samples must be tested in the same manner as patient specimens, e.g. testing the PT samples the same number of times as patient specimens, at the same time as patient specimens, by the same personnel that routinely test the patient specimens, and using the same test system, including analyzer and reagents, that is routinely used for the patient specimens.[166] PT samples should be rotated among all applicable testing personnel[166] PT samples may require sample preparation before testing (depending on the matrix), but after preparation, PT samples must be treated in the same manner as patient specimens.[166] PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event and should not be run on multiple systems for the same analyte.[166] A CLIA laboratory should only test the PT sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing.[166] PT samples should never be sent out to a laboratory with a different CLIA certificate, known as a PT referral, which is a violation of CLIA.[166]

Laboratories are prohibited from engaging in inter-laboratory communications regarding PT test results and laboratories which receive samples suspected to be PT samples from another laboratory for testing are required to notify CMS.[166][167]

Hospitals and health systems that operate multiple laboratories with different CLIA certificates have additional PT referral compliance issues.[167] For PT purposes, the laboratories are considered separate entities, each with their own CLIA certificate, even if they occupy the same department.[167] If PT samples are delivered to a hospital laboratory that are for a laboratory under a different CLIA certificate, CMS may construe that as prohibited PT referral.[167] Similarly, if PT samples are rotated amongst laboratories with different CLIA certificates for testing, as if they were part of a single laboratory, this would likely be considered a prohibited PT referral by CMS.[167] Laboratories operating under different CLIA certificates should purchase separate PT samples for each CLIA certificate, and to the extent possible from different PT vendors for each laboratory thus eliminating any possibility of sharing PT test results.[167] Where possible, individuals involved with PT testing at one laboratory should have restricted electronic access to PT results of another laboratory with a different CLIA certificate.[167] Individuals involved in PT testing should not perform the same survey at laboratories with different CLIA certificates. If there are multiple sites under one certificate, survey events should be rotated through all of the sites until all of the sites have participated.[166] However, PT events should never be shared between sites (e.g., each PT event should not be given to all of the sites to be tested and produce results which are then compared or averaged for submission to the PT program).[166]

If CMS determines that a laboratory has “intentionally” referred its PT samples to another laboratory for analysis, it may impose sanctions including revocation of the laboratory’s CLIA certificate and a prohibition against the laboratory’s operator or owner (including its laboratory director) from owning or operating another laboratory for one year.[167] CMS considers a referral of PT samples “intentional” if there is a “general intent to act—that is to send a PT sample to another laboratory for analysis.” [167] The penalty depends on whether the PT referral was “repeat” violation, the laboratory reported another laboratory’s PT test results, whether the lab received the PT results of another laboratory before the PT event close date, and whether the referral was "improper" (reflex/distributive/confirmatory) or "intentional."[167] CMS has usually been successful in asserting that the reason for referring another laboratory to test a PT sample is irrelevant.[167] In 2011, a CLIA laboratory in Mexico, Missouri had performed PT testing, and then sent unused portions of its PT samples to its parent hospital, Audrain Medical Center for storage, but the hospital in turn used the samples to check it's own equipment.[168][167] This PT referral was found to be in compliance with CLIA.[169][168][167]

CLIA PT referral regulations sanctions, effective May 2014[166]
Category Conditions
Category 1 For the most egregious violations, encompassing cases of repeat PT referral, regardless of circumstances revolving around the violation, and cases where a laboratory reports another laboratory’s PT results as its own to the PT program on or before the PT event close date.
Category 2 When a laboratory refers its PT samples to another laboratory for analysis and obtains test results for the PT samples from the other laboratory on or before the cut-off date for the PT event, but reports its own PT sample results to the PT program.
Category 3 Cases of PT referral where the laboratory refers its PT samples to another laboratory for analysis and obtains test results for the PT samples from the other laboratory after the cut-off date for the PT event. This category also includes the carve-out for confirmatory, distributive, and reflex testing
  • Confirmatory testing refers to testing performed by a second analytical procedure that could be used to substantiate or bring into question the result of an initial laboratory test, i.e. Pos HIV screen or Pos Lyme → Western Blot
  • Distributive testing refers to laboratory testing performed on the same specimen, or an aliquot of it, that requires sharing it between two or more laboratories to obtain all data required to complete an interpretation or calculation necessary to provide a final reportable result for the originally ordered test. When such testing occurs under different CLIA certificates, it is considered distributive testing, i.e. Protein Electrophoresis – Lab A does electrophoresis, Lab B does Total Protein
  • Reflex testing refers to confirmatory or additional laboratory testing that is automatically requested by a laboratory under its standard operating procedures for patient specimens when the laboratory’s findings indicate test results that are abnormal, are outside a predetermined range, or meet other pre-established criteria for additional testing, i.e. Pos Hep A screen → Total vs IgM, Pos E.coli → serotyping
If a laboratory has been sanctioned for any category of PT referral in the prior two survey cycles, the second, or "repeat" referral will be considered a Category 1.

Taking Essential Steps for Testing (TEST) Act of 2012[edit]

Under CLIA 1988,the revocation of a CLIA certificate and two years of probation for the owner and laboratory director were the automatic penalties for PT referrals regardless of the circumstance.[170][171] In some cases, the penalties were for new laboratory employees who in following standard operating procedures for patients, sent out PT specimens for confirmatory or reflex testing.[171]

There have been several cases where laboratories referred out PT HIV specimens for confirmatory workups because that was their procedures for patient samples.[169] These laboratories subsequently had their CLIA certificates revoked due to PT referral.[169] As the number of inadvertent PT referrals grew, there was a negative impact on laboratories and healthcare systems.[171] From 2009 to 2011, 16 CLIA laboratories had their certificates revoke due to improper PT referrals. Of the 18 intentional PT referral appeals lodged with HHS between 1994 and 2011, only a single case was overturned.[169]

In September 2010, CLIAC recommended updating the PT referral regulations to distinguish acceptable PT referral from unacceptable PT referral with the “intent to defraud” allowing CMS more flexibility in imposing sanctions on laboratories.[172] CLIAC also recommended that acceptable PT referral would allow laboratories to treat PT exactly as patient samples and perform reflex or referral testing when it is included in their standard procedure for patients.[172] The recommendation suggested there should be documentation to the referral laboratory on the nature of the referral and that referral laboratories should not be penalized.[172]

Ohio State University Wexner Medical Center Proficiency Testing Referral[edit]

On the evening of Feb. 15, 2012, a medical technology student at Ohio State University Wexner Medical Center(OSUWMC) inadvertently reflexed a positive Lyme disease proficiency testing (PT) sample to the Mayo Clinic reference lab for Western Blot confirmation.[173] The student had not yet been educated on PT and had only received limited verbal information in new-employee orientation.[173] The following morning, Mayo Clinic notified OSUWMC that an the improper PT referral was made.[173] OSUWMC conducted an internal investigation and found five other proficiency-test samples, routine blood culture specimens, had also been improperly routed to another OSU CLIA lab between 2009 and 2011.[173] Many laboratory staff members didn’t know that the two OSU laboratories were distinct CLIA laboratories with their own CLIA numbers and should not refer proficiency tests to each other.[169] OSUWMC proceeded to self-report the six improper testing referrals to its CLIA accreditation organization, the College of American Pathologists (CAP), and the Ohio Department of Health(ODH), the state agency responsible for enforcing CLIA.[169][174]

One of the critical takeaways here is the absolute importance in making sure that what we do with proficiency testing is fully communicated to our employees.

Dr. Daniel Sedmak, OSUWMC lab medical director (2011)[173]

The Ohio Department of Health and CMS conducted a complaint survey on March 12, 2011.[169] On June 11, 2011, CMS sent OSUWMC a deficiency notice that it intended to revoke it CLIA certificate due to non-compliance on PT referrals.[169][175] OSUWMC sent a response of over 100 pages to CMS that it had addressed the issue.[169] On July 12, 2011 CMS notified OSUWMC that's its CLIA certificate would be revoked effective August 10, 2011 if it did not appeal.[169] OSUWMC filed an appeal to stay the revocation.[169] The impacted laboratory performed over 7 million out of the 9 million annual tests in the Ohio State's medical laboratory network.[176] In response, OSUWMC lobbied the Ohio congressional delegation, who sent a bipartisan letter to the United States Secretary of Health and Human Services, Kathleen Sebelius, expressing their concerns about the CMS decision stating "is an extreme interpretation of the applicable statutory provision—it is a punishment that exceeds the nature of the offense".[174] On Dec 4, 2011 the Taking Essential Steps for Testing (TEST) Act of 2012 (Pub. L. 112-202) law was enacted granting CLIA more leeway in imposing sanctions instead of certificate revocation. [177][169][176] On Jan 16, 2013, a settlement between CMS and OSUWMC was announced requiring a new laboratory medical director, a fine of US$268,000 (equivalent to $350,544 in 2023), and additional staff training in PT.[177]The previous laboratory director was reassigned within the department.[178] A government mandated analysis of OSUWMC PT referral mishap that was conducted by Vanderbilt University and it was found that the successful appeal has cost it almost a US$1,000,000 (equivalent to $1,354,438 in 2023) — $646,551 in legal fees, a $268,000 fine and $9,925 for the analysis of what went wrong in addition to the internal costs such as subsequent staff retraining.[173] OSUWMC now includes proficiency-test training as part of its orientation, requires all laboratory employees to complete an annual computer course on proficiency testing, and have modified their laboratory information system (LIS) so that positive proficiency tests no longer automatically show up on a send-out list.[173] The CMS OSUWMC settlement is not a legal precedent and CMS retains discretion on imposing a sanction or revocation for improper PT referral.[176]

=Bill[edit]

The bill softened the CLIA statutory language from mandating that a lab's CLIA license "shall be suspended" to "may be suspended" and gave CMS the latitude to substitute intermediate sanctions where appropriate, including a directed plan of correction, civil money penalties, and costs or on-site monitoring or any combination thereof.[169] The bill was supported by American Association for Clinical Chemistry (AACC), College of American Pathologists (CAP), the American Clinical Laboratory Association (ACLA), and American Medical Technologists (AMT).[174] CLIA officials welcomed the enforcement discretion noting the rule allows for a better fit between the nature and extent of an intentional PT referral violation and the penalties that are imposed.[169][170]

On May 2, 2014, CMS published the regulations (CMS–1443–FC) outlining the alternative sanctions for PT referrals per the TEST Act that would be effective July 1, 2014. [171][170]

Unintentional reflex and confirmatory testing PT referrals may arise from a literal interpretation of the PT regulations, that that the PT specimen must be tested in the same manner as specimens.[169] For a patient specimen, a pathologist may review an abnormal smear that has been flagged by a medical laboratory scientist, but on a PT specimen, the pathologist review must be completed in the same CLIA lab.[169] If the pathologist completes the review at a CLIA laboratory with a different CLIA identifier than the ordering laboratory, even if completed within the same hospital, this would be construed as a PT referral.[169] Likewise, any reflex testing on the specimen must be completed by the laboratory with the same CLIA identifier, even if there are co-located laboratories sharing the same floor or building. In highly automated laboratories, PT samples may require different handling than patient samples to prevent reflexing.

PT is a major component of the CLIA regulations and plays an integral role in the overall quality assurance of a laboratory. We emphasize that there is no on-site, external proctor for PT in laboratories, and the testing relies in large part on an honor system. The PT program places heavy reliance on each laboratory and laboratory director to self-police their analysis of PT samples to ensure that the testing is performed in accordance with the CLIA requirements. [179]

2024


(Public Law 100-578)

State surveyors and CMS studies indicate that there may be widespread problems at waived and provider-performed microscopy laboratories. Colorado and Ohio surveyors found that about half of waived and provider-performed microscopy laboratories were not following manufacturers’ instructions, did not have manufacturers’ instructions onsite, or were conducting tests they were not authorized to perform. Colorado State surveyors found 90 percent of provider-performed microscopy laboratories lacked written procedures or could not demonstrate the accuracy of the test method or the competency of testing personnel. These findings have led CMS to initiate a pilot project in eight other States to survey a sample of waived and provider-performed microscopy laboratories. [182]

Because waived and provider-performed microscopy laboratories are not routinely surveyed, surveyors do not have the opportunity to educate staff, or identify and correct problems. Nearly all of our State agency respondents believe that the lack of onsite visits of waived and provider-performed microscopy laboratories is a vulnerability. A majority of State respondents report that they have found these laboratories performing moderate or high complexity tests. We found that 13 percent of waived laboratories and 11 percent of provider-performed microscopy laboratories in our sample were denied Medicare payment for tests they were not authorized to perform. [182]

In 1999, Colorado and Ohio State surveyors received permission from CMS to conduct random inspections of about 100 waived and provider-performed microscopy laboratories in their respective States. After reviewing these State studies, CMS concluded that, “significant quality and certification problems were identified in over 50 percent of these laboratories.” Consequently, CMS has begun similar pilot projects in eight additional States to determine whether problems found in Colorado and Ohio exist elsewhere. The number of waived laboratories and waived tests has increased significantly since the beginning of the CLIA program. In 1992, waived laboratories accounted for about 20 percent of all CLIA-certified laboratories. Today, 53 percent of all laboratories are waived. In 1992, the waived category covered nine tests such as urine pregnancy, glucose and urine dipstick or tablet analysis. Currently there are about 40 tests in the waived category. Test systems are created by manufacturers and given brand names, resulting in multiple test systems for each type of test. There were 250 waived test systems in 1995, which increased to approximately 840 test systems by September 2000. Waived laboratories are exempted from routine site visits in CLIA law and regulations,5 although States are not prohibited from requiring site visits to waived laboratories. The main reason these laboratories are not site visited is because waived tests are those that are simple, accurate and unlikely to pose harm to the patient if performed incorrectly. For laboratories conducting these simple tests, waived (and later provider-performed microscopy) categories minimized regulatory and financial burdens. Without the cost of surveys, CMS was able to set CLIA fees for waived and provider-performed microscopy laboratories very low. [182]

A1c ±6% to 10%.[183]

The National Cholesterol Education Program (NCEP) guidelines list the cholesterol testing performance as having a cv and bias of less than <3%, whereas CLIA '88 accepts true value ±10%.[184] Though CLIA proficiency standards may be be sufficient for the medical needs of clinicians, it was characterized as insufficient for assessing potential drug efficacy.[c]

For proficiency testing, CLIA requires outlier removal using a 3 SD limit that is not recommended by ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison.[d]

Comment: One commenter suggested that we should specify the N-terminal region of pro-B-natriuretic peptide (BNP), which was included as a required analyte in the proposed rule because this is the epitope usually detected by antibodies used in most test methods. Response: We agree with the commenter that the N-terminal region of pro-B-natriuretic peptide (BNP) is the part of the peptide that is usually measured, but we did not want to restrict the requirement for PT. Therefore, in this rule we are finalizing the name as proposed: proBNP. 41214

CLIA does not specify whether laboratories are required to participate in PT based on whether it is commutable or noncommutable. The same AL apply regardless of the PT samples’ commutability 41215

Commenters stated that rather than using the proposed AL of 20 percent for LDL cholesterol, we should require an AL of 12 percent, which is the accuracy target used by the National Cholesterol Education Program. Response: Because the commenters suggested an AL tighter than was proposed, we requested PT programs to simulate the impact of using that limit. Based upon reanalysis of new data shared by PT programs, we confirmed that the proposed AL of 20 percent is appropriate for scoring PT for LDL cholesterol, and we are finalizing that limit in this rule. 41215

We appreciate the commenters’ concerns, however, one outcome of more stringent ALs may be that laboratories switch to test methods that are more accurate across the range of testing and better able to meet clinical needs. We believe that manufacturers of analytical platforms that may fail to achieve consensus, or otherwise perform poorly, will improve their accuracy during the phase-in period. To address concerns regarding unintended consequences that may increase health disparities, we will monitor changes in PT participation for all analytes after this rule becomes effective as this is required as part of PT oversight under CLIA. This includes the methods used for testing each PT analyte required by CLIA 41215 

CLIA ALs have been used in ways

other than their intended purpose of identifying laboratories with unacceptable performance. One commenter noted that ALs have been used as goals for ideal performance, for example, setting quality control acceptable limits. Another commenter pointed out that ALs have been used for verifying analytical performance, for example, accuracy. We agree with the comments and reemphasize that ALs must not be used as the criteria to establish performance goals in clinical laboratories. Goals for accuracy and precision must be based upon clinical needs and manufacturer’s FDAapproved or -cleared labeling; PT performance is not the best assessment of these. Proficiency testing is intended to identify laboratories that are not performing with acceptable analytic accuracy; it is not intended, nor suited, to provide goals for analytical accuracy or clinical performance. 41214

After laboratories were found to be modifying their online PT data based on the results improperly received from other laboratories, CLIA proposed limiting PT programs participants’ online submission of PT data to a single submission and instituting an electronic audit log for tracking changes to submitted results.[e] However, the proposal was dropped after being deemed too burdensome and expensive.[188] Currently, none of the PT programs with online reporting implement an audit trail for changes to submitted results.[e]

Proficiency Testing Providers[edit]

2024 CMS CLIA Approved Proficiency Testing Programs[189]
Company Location Notes
Accutest, Inc. / One World Accuracy
American Association of Bioanalysts – Medical Laboratory Evaluation (AAB-MLE)
American Proficiency Institute (API) Traverse City, Ml
College of American Pathologists' Surveys, College of American Pathologists (CAP) Northfield, IL
Commonwealth of Pennsylvania, Department of Health, Bureau of Laboratories Exton, PA
Wisconsin State Laboratory of Hygiene (WSLH) Madison, Wl
Historical CLIA Approved Proficiency Testing Programs[190]
Company Location Start End Notes
Accutest Westford, MA
American Academy of Family Physicians (AAFP) Kansas City, MO
American Academy of Pediatrics (AAP) Elk Grove Village, IL
American Association of Bioanalysts (AAB) Proficiency Testing Service Brownsville, TX
American Proficiency Institute (API) Traverse City, Ml
American Thoracic Society (ATS) New York, NY
California Thoracic Society (CTS) Tustin, CA
College of American Pathologists' Surveys, College of American Pathologists (CAP) Northfield, IL
External Comparative Evaluation for Laboratories (EXCEL), College of American Pathologists (CAP) Northfield, IL
Idaho Bureau of Laboratories, Proficiency Testing Program Boise, ID
State of Maryland, Office of Licensing and Certification Programs, Division of Laboratory Licensure Baltimore, MD Cytology Proficiency Testing Program
Medical Laboratory Evaluation (MLE) Washington, DC
New Jersey Department of Health, Proficiency Testing Program, Trenton, NJ
New York State Department of Health, State of New York, Department of Health Albany, NY
Ohio Department of Health Columbus, OH
Pacific Biometrics Seattle, WA
Commonwealth of Pennsylvania, Department of Health, Bureau of Laboratories Exton, PA
Puerto Rico Department of Health, Laboratory Services Program, Department of Health of Puerto Rico San Juan, PR
Solomon Park Research Institute Kirkland, WA
Wisconsin State Laboratory of Hygiene (WSLH) Madison, Wl
references: [191]

Other non-CLIA proficiency providers include: University of Washington Northwest Lipid Research Laboratories Reference Lipoprotein Analysis Basic Survey (ReLabs)[190].

Others include: Bio-Rad External Quality Assurance Services (EQAS), Randox International Quality Assurance Scheme (RIQAS)

Genetic Testing[edit]


Fees[edit]

New York[edit]

In effect, the [department] turned the clinical lab reference system special revenue account into an unauthorized and unsupervised revenue stream that is limited only by the bounds of the defendant's creativity.

Edward Sheridan, New York Supreme Court Justice, (2008)[192]

In the 1980s, American Association of Bioanalysts (AAB) successfully challenged the New York State Department of Health (NYDOH) Clinical Laboratory Evaluation Program (CLEP) inspection and permit fees for being anticompetitive due to lacking volume based Sliding scale fees, charging small community laboratories nearly the same as the largest publicly traded laboratories.[28][193]

In the 1990s, NYDOH laboratory inspection and reference fees nearly tripled without explanation.[28] In 1999, AABB, on behalf of 35 laboratories, sued the NYDOH challenging the legitimacy of the fees.[28] In 2008, trial testimony showed that lab fees were "arbitrary and capricious" and that the department's "bald estimates" did not reflect costs, but were instead used to subsidize unrelated expenditures including excursions to California and Europe, cars for the New York health commissioner, and baked goods for departmental meetings to which the lab was not party to.[194][192][195][196][197] On February 17, 2011, after a dozen years of litigation, NYDOH exhausted it's last appeal, and was ordered to refund 78% of the fees from 1998 and 2006, totaling US$5,041,377 (equivalent to $6,828,232 in 2023) to the litigant laboratories.[196][198]

In 2009, following the trial testimony of the 1999 complaint, AAB, along with over 200 laboratories, again sued the NYDOH for excess laboratory fees being used to subsidize non-regulatory activities as their accounting and billing practices remained unchanged. [199] In March 2013, NYDOH settled ahead of trial, agreeing to pay a US$18,000,000 (equivalent to $23,544,000 in 2023) to the laboratories, covering the fees paid from 2007 to 2011.[199][28]

California[edit]

A 2008 California State Auditor report found that CDPH LFS had raised its fees improperly one year and failed to impose two subsequent fee increases the budget act called for, thus not collecting more than $1 million in fees from clinical laboratories.[200]In three instances since fiscal year 2003–04, Laboratory Services incorrectly adjusted the fees it charged to clinical laboratories, resulting in more than $1 million in lost revenue.[200] According to state law, Laboratory Services must adjust its fees annually by a percentage published in the budget act.[200] From fiscal years 2003–04 through 2007–08, the budget acts included two fee increases: an increase of 22.5 percent effective July 1 of fiscal year 2006–07 and an increase of 7.61 percent effective July 1 of fiscal year 2007–08.[200] However, Laboratory Services raised fees by 1.51 percent effective July 1 of fiscal year 2003–04, when it was not authorized to do so, and failed to raise fees effective July 1 of fiscal years 2006–07 and 2007–08, when it should have done so.[200]

In September 2015, a follow-up California State Auditor report found that LFS made an unauthorized fee increase in January 2014 that has resulted in labs overpaying it more than $1 million in fees, and since 2008 it has collected more than $12 million in lab fees that it has not spent.[201]State law requires Laboratory Services to adjust its license and registration fees by percentages specified in the State’s annual budget act; however, the Legislature created a sliding schedule for license fees in 2009, which raised the fees, and since then license fees have been excluded from the annual budget act adjustment. We identified three errors Laboratory Services made since our 2008 audit.[201] Laboratory Services’ most egregious error occurred in January 2014 when it implemented an unauthorized license fee increase of more than 13 percent.[201] We estimate this error resulted in labs collectively overpaying the State more than $1 million in fees. Further, since posting the increased license fee in January 2014, Laboratory Services has continued to charge labs these erroneous fee amounts.[201] We determined that Laboratory Services did not realize that the percentage increase did not apply to license fees, as specifically stated in the annual budget act.[201]

The 2015 report also found that LFS oversight efforts largely duplicated CMS federal oversight with no meaningful benefit to consumers, and recommended repealing LFS state licensure requirements.[201] A bill to repeal CPDH LFS laboratory licensure requirements was introduced but did not pass.[202]

On September 28, 2017, a bill (AB 658) was passed to suspend the annual clinical laboratory license renewal fees for two years, 2018 and 2019 due to an excess of $22 million in reserves, as CDPH did not have the authority to suspend or refund the fees.[203][204]


[205]

[206]

Most Common Conditions and Deficiencies[edit]

[207]

Certificate Revocation[edit]

CMS may initiate adverse action to suspend, limit or revoke any CLIA certificate if CMS finds that a laboratory's owner or operator or one of its employees has:[208]

  1. Been guilty of misrepresentation in obtaining a CLIA certificate;[208]
  2. Performed, or represented the laboratory as entitled to perform, a laboratory examination or other procedure that is not within a category of laboratory examinations or other procedures authorized by its CLIA certificate; [208]
  3. Failed to comply with the certificate requirements and performance standards;[208]
  4. Failed to comply with reasonable requests by CMS for any information or work on materials that CMS concludes is necessary to determine the laboratory's continued eligibility for its CLIA certificate or continued compliance with performance standards set by CMS;[208]
  5. Refused a reasonable request by CMS or its agent for permission to inspect the laboratory and its operation and pertinent records during the hours that the laboratory is in operation;[208]
  6. Violated or aided and abetted in the violation of any provisions of CLIA and its implementing regulations;[208]
  7. Failed to comply with an alternative sanction imposed under this subpart;[208] or
  8. Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.[208][209] This provision applies only to the owner and laboratory medical director, not to all of the laboratory's employees.[208] This includes laboratories that cease all operations and surrender their CLIA certificate prior to the date when CMS revokes it.[f]

Failure by a laboratory to comply with even a single condition in an area of testing offered by that laboratory may be grounds for suspension or revocation of a laboratory's CLIA certificate.[211] If standard level deficiencies are sufficiently egregious, they will constitute a failure by a laboratory to comply with the overall condition of which the standards are subparts. [212] A laboratory is responsible for the acts of its employees, even when it is unaware of the employees’ actions.[213]

Improper PT referral

Wade is like the student who protests that he did not cheat on his exam because he did not hand in someone else’s work but merely checked his answers against those of another student. But peering over the shoulder of another student in the middle of an exam to check one’s answer is as much cheating as handing in someone else's work.

Wade Pediatrics v. CMS (2009)[214][215]

CMS may also suspend or revoke a CLIA certificate for improper referrals in proficiency testing if a laboratory has intentionally referred its proficiency testing samples to another laboratory for analysis.[208] An unlawful referral of a testing sample to another laboratory may occur without the actual physical transport of the sample from one laboratory to another laboratory.[213] The improper referral applies to a constructive referral and the improper exchange of information between laboratories regarding proficiency testing sample results akin to cheating.[216]

The laboratory has the ultimate burden of rebutting, by a preponderance of evidence on the record as a whole that it is in substantial compliance with relevant statutory and regulatory provisions, any prima facie case of noncompliance that is established by CMS.[217]

If the OIG excludes a laboratory from participation in Medicare, CMS suspends the laboratory's CLIA certificate for the period during which the laboratory is excluded.[208]

Medicare Termination[edit]

CMS always cancels a laboratory's approval to receive Medicare payment for its services if CMS suspends or revokes the laboratory's CLIA certificate.[218] CMS may also cancel a laboratory's approval to receive Medicare payment for being out of compliance with a condition level requirement, failing to submit a plan of correction satisfactory to CMS, or failing to correct all its deficiencies within the time frames specified in the plan of correction. [218] Cancellation of Medicare approval terminates any Medicare payment sanctions regardless of the time frames originally specified.[218]

The effective date of the cancellation of a laboratory's approval to receive Medicare payment for its services is not delayed because the laboratory has appealed and the hearing or hearing decision is pending.[219]

Appeals[edit]

A laboratory owner or director has a right to a hearing to challenge revocation of a laboratory’s CLIA certificate.[220] Appeals can be made to the United States Department of Health and Human Services(HHS) Departmental Appeals Board (DAB) Administrative Law Judges (ALJ).[219] Further appeals involve requesting a review from the HHS DAB and a petition for judicial review by the U.S. Court of Appeals of the circuit in which the laboratory has its principal place of business.[219]

The suspension, limitation, or revocation of a CLIA certificate is not effective until after a hearing decision by an ALJ is issued unless laboratory pose immediate jeopardy, the laboratory has refused a reasonable request for information (including but not limited to billing information), or for work on materials, or has refused permission for CMS or a CMS agent to inspect the laboratory or its operation.[219] The CMS decision to declare immediate jeopardy is not subject to appeal.[221]

CLIA related Medicare payment disputes can be appealed to the Office of Medicare Hearings and Appeals (OMHA), the Medicare Appeals Council, and finally a judicial review in federal court.[219][222]

Communcation[edit]

Ms. Chaitram clarified that there are no specific requirements in the CLIA laboratory test communication regulations. She noted that there is a CLIA requirement for the laboratory to have procedures for entering results in the patient record, and there is a CLIA requirement that the laboratory must have a system in place to ensure test results and other patient data are accurately and reliably sent from the point of entry to the final point of destination.

CLIA[edit]

Top 5 CLIA Deficiencies in 2021[223]
No. Regulatory Subpart Regulatory Cite Deficiency # all labs
with
deficiency		 % all labs
with
deficiency
1 Personnel Competency Assessment (D5209) STANDARD 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 726 18.96%
2 Analytic Systems (D5413) STANDARD 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented. 670 17.50%
3 General Lab Systems (D5217) STANDARD 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I or this part. 623 16.27%
4 Verification of Performance Specifications (D5421) STANDARD 493.1253(b)(1) Each laboratory that introduces an unmodified, FDAcleared or approved test system must demonstrate that it can obtain performance specifications comparable to those established by the manufacturer. 610 15.93%
5 Analytic Systems (D5403) STANDARD 493.1251(b) The procedure manual must include the requirements for specimen acceptability, microscopic examination, step-bystep performance of the procedure, preparation of materials for testing, etc. 560 14.63%
Top 5 CLIA Conditions in 2021[223]
Rank Regulatory Subpart Regulatory Cite Deficiency # all labs
with
condition		 % all labs
with
condition
1 Proficiency Testing (D2016) CONDITION 493.803 Each laboratory performing nonwaived testing must successfully participate in a PT program approved by CMS as described in subpart I of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. 875 22.85%
2 Laboratory Director - Moderate (D6000) 493.1403 The laboratory must have a director who meets the qualification requirements of § 493.1405 of this subpart and provides overall management and direction in accordance with § 493.1407 of this subpart. 697 18.20%
3 Analytic Systems (D5400) CONDITION 493.1250 Laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems.

375

9.79%
4 Personnel High Complexity (D6076) CONDITION 493.1441 The laboratory must have a director who meets the qualification requirements of 493.1443 and provides overall management and direction in accordance with 493.1445 366 9.56%
5 Facility Administration (D3000) CONDITION 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing 275 7.18%

A2LA[edit]

AABB[edit]

Top 5 AABB Nonconformances in 2022[224]
Rank Checklist % Description
1 BBTS 2.1.3 5.6% Evaluations of competence shall be performed before independent performance of assigned activities and at specified intervals.
2 BBTS 1.3 5.6% Quality and operational policies, processes, and procedures shall be developed and implemented to ensure that the requirements of these BB/TS Standards are satisfied. All such policies, processes, and procedures shall be in writing or captured electronically and shall be followed. Standard 5.1.1 applies.
3 CT 5.0 4.8% The facility shall identify, design, modify, and validate the policies, processes, and procedures that affect the quality of cellular therapy products, services, and patient care.
4 BBTS 5.0 4.3% The BB/TS shall have policies and validated processes and procedures that ensure the quality of the blood, blood

components, tissue, derivatives, and services. The BB/TS shall ensure that these policies, processes, and procedures are carried out under controlled conditions.

5 BBTS 3.5 3.3% The BB/TS shall have a process for scheduled monitoring and maintenance of equipment that at a minimum is in accordance with manufacturer’s written instructions. The process shall include frequency of checks, check methods, acceptance criteria, and actions to be taken for unsatisfactory results.


CAP[edit]

Top 5 CAP Deficiencies in 2016[225]
Rank Checklist # of all labs % of all labs Description
1 GEN.55500 1154 29.4% Competency Assessment of Testing Personnel
2 COM.01200 963 7.1% Activity Menu
3 COM.10000 760 5.3% Procedure Manual
4 COM.04250 674 4.8% Comparability of Instruments and Methods - Nonwaived Testing
5 COM.10100 606 4.2% Procedure Manual Review

COLA[edit]

Top 5 COLA Deficiencies in 2016[225]
Rank Checklist Description
1 PER 5 For lack of complete competency assessments as required.
2 LDR 5 For the Lab Director not fulfilling the QC and QA responsibilities of the position.
3 PT 16 Lack of review of PT results by the Lab Director and supervisory staff.
4 LDR 4 For the Lab Director not fulfilling the PT responsibilities of the position
5 WAV 2 For not performing or documenting QC on waived testing as required by the manufacturer

TJC[edit]

Top 5 TJC Deficiencies in 2016[225]
Rank Checklist % Of Citation Description
1 HR.01.06.01 48% Staff are competent to perform their responsibilities
2 QSA.02.08.01 32% The laboratory performs correlations to evaluate the results of the same test performed with different methodologies or instruments or at different locations.
3 DC.02.03.01 31% The laboratory report is complete and is in the patient’s clinical record.
4 QSA.01.03.01 31% The laboratory has a process for handling and testing proficiency testing samples.
5 LD.04.05.07 29% The laboratory director, technical consultant, and/or technical supervisor are responsible for maintaining

laboratory performance.


EL

CLIA[edit]

CLIA identification numbers are 10-digit alphanumeric unique identifiers issued by the CLIA data system to identify a CLIA laboratory.[226] This is assigned at the time of initial entry of the CLIA application and included with the mailing of the remittance fee coupon.[226]

10-digit alphanumeric CLIA identifier[226]
Positions Field description
1 and 2 Identify the State in which the laboratory was located when it initially applied for a CLIA certificate.
3 A capital letter “D” to identify the provider/supplier as a laboratory certified under CLIA.
4 to 10 The unique facility number identifiers.

An example CLIA ID no is: 21D0665373 which is the CLIA Certificate of Accreditation (CoA) for the National Institutes of Health(NIH) Department of Laboratory Medicine (DLM) located in Bethesda, Maryland.

Laboratories which are CLIA-exempt and those designated as VA laboratories do not have a CLIA certificate, but are assigned a CLIA identification number.[226] Once a laboratory is assigned a number, it retains this number even if it withdraws from CLIA, has its certificate revoked, changes its certificate type or ownership, location (i.e., relocates to another State), name, or operator.[226] A CLIA number will not be reassigned to another laboratory.[226] Although CLIA-exempt laboratories do not need a CLIA certificate to operate, they are assigned a CLIA identification number for Medicare and Medicaid payment purposes.[227]

Blood Establishment[edit]

A Hospital Blood Bank routinely collects or processes Whole Blood or blood components.[228] Processing includes irradiation, rejuvenation, or pre-storage leukocyte-reduction of any blood component, or freezing, deglycerolizing or washing Red Blood Cells.[228]

A Hospital Transfusion Service performs compatibility testing for blood or blood components but does NOT collect allergenic or autologous blood, or process Whole Blood or blood components (except Red Blood Cells and Recovered Plasma).[228] You must also answer Item 10.5a concerning Medicare program reimbursement.[228] Hospitals that solely prepare Red Blood Cells or Recovered Plasma, pool Platelets or Cryoprecipitated AHF for ease of transfusion, or issue bedside leukocyte-reduction filters with blood components are Hospital Transfusion Services. [228]

Blood Bank laboratories are required to enroll in the FDA electronic Blood Establishment Registration (eBER) for a FDA Establishment Identifier (FEI) based on a Data Universal Numbering System (DUNS) number. Central File Numbers (CFNs) up until September 30, 2001.[228]

Retention[edit]

1 2 3
User Fee Related Records - Bank Media N1-44CHJ1-04, Item lal Temporary, 6 years and3months
User Fee Related Records - canceled Payments Nl-441Hll-04, Item 1a2 Temporary, 6 years and 3months
User Fee Related Records - Refund Reports N1-441Hll-04, Item la3 Temporary, 6 years and 3months
User Fee Related Records· Admlnlslratlan Accounts Recondllatlon Flies Nl-440-01-04, ltem 1a4 Temporary, 6 years and 3months
Participant Testing Program Files-Annual Letters Nl-441Hll-04, ltem lbl Temporary, 5 ID 10 years
PT Participant Summary Reports Nl-441Hll-04, ltem le Temporary, 6 years
YaUdatlon Review FUes N1-441H11-D4, Item 1d Temporary, 3 years
abarataly personnel Report. Form CMS-114, used to collect data reprdlng the laboratory director and all other laboratory supervisory or consultant responslbllltles, or tests. Used In CLIA processes. Nl-440-96-01, Item 5 Temporary, 6 years

[229]

Compliance[edit]

Following Operation Lab Scam in the 1990s, which resulted in health care fraud settlements totaling over $800M from large laboratories, including Corning Clinical Laboratories, Damon Clinical Laboratories, LabCorp, Quest Diagnostics, and SmithKline Beecham Clinical Laboratories, the OIG issued "Compliance Program Guidance for Clinical Laboratories" in 1997 encouraging laboratories to setup compliance programs.[230][231]Cite error: The opening <ref> tag is malformed or has a bad name (see the help page).[167] As part of the fraud settlements, laboratories also had to enter into corporate integrity agreements.

Surveyor highlighting the outcome-oriented survey process (OOSP)[232]

Citations[edit]

CLIA citation decision algorithm.

If standard-level noncompliance has been identified, cite the most specific standard available. Where there are underlying standards, condition-level deficiencies can only be cited when standard-level deficiencies have been identified. Remember to cite to standard level deficiencies when such deficiencies support a finding of condition-level deficiencies.[235]

Standard-level deficiencies written in one subpart cannot be the basis for a condition in another subpart. Deficiencies in Proficiency Testing or Personnel would not be the basis for the condition of Bacteriology to be out of compliance. It is not uncommon for a surveyor to identify issues that crossover between subparts of the regulations. Cite deficiencies at the appropriate area of the regulations that describes the problem. For example, failures in proficiency testing may be caused by an error in specimen identification, test system malfunction, or lack of training for staff. Consider citing the most appropriate citation for the laboratory to come into compliance. Avoid citing multiple citations for the same deficiency unless each citation focuses on a different aspect of the deficiency (instrument malfunction vs. staff training, or quality system vs. laboratory director responsibilities, as discussed above). The surveyor must consider the deficiencies cited when determining the conditions out of compliance, and also the potential enforcement actions should the laboratory not correct the deficiencies. The organization of the regulations and conditions allows the surveyor to write a condition out of compliance according to specialty/subspecialty or to theSystems of testing (General Laboratory Systems, Preanalytic Systems, Analytic Systems, or Postanalytic Systems). [236]

Annual Test and Volume Reporting[edit]

As part of the bi-annual CLIA renewal, the laboratory's test menu, methodology, and total annual test volume is reported by specialty and subspecialty.[237] Total annual volume for waived tests, and PPM procedures are reported separately, respectively as a whole.[237] Reporting test volume by test has been proposed, but was deemed too burdensome by CLIA, though some states may require it. Only tests that are ordered and reported should be included in the laboratory’s test volume(s).[237] Calculated parameters (e.g., A/G ratio, MCH, MCHC, HCT, etc), quality control tests, and proficiency testing assays should not be counted.[237] Measured components of profiles should be counted separately, (e.g., Lipid Panel consisting of a total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides equals 4 tests).[237]

COVID reporting[edit]

COLA

Partner organizations[edit]

Type Entity
Federal
State Departments Health departments in the United States
Professional Organizations
International World Health Organization (WHO)
Standards
Healthcare f
Vendors f
Other f

History2[edit]

Prior to CLIA '88, there was no federal regulatory framework applicable to all clinical laboratories, only a patchwork of state initiatives with limited authority and oversight.[238]

There was widespread fraud in falsely generated cytology reports for specimens that had not been examined ("dry lab" testing) and fictitious reports for clinical specimens that were poured down the drain instead of tested (sink testing)[110] CLIA institutes policies and procedures for preventing and detecting fraudulent results.[110]

[239]

What emerges is a picture of a Pap-screening industry kept afloat by over-worked, undersupervised, poorly paid technicians. It is an industry that often ignores what few laws protect women from slipshod testing.

Walt Bogdanich, Wall Street Journal (1987)[240]

Walt Bogdanich highlighted how high-volume, cut-rate laboratories across the US colloquially called Pap factories or Pap mills, had laboratory technicians, called cytotechnologists, analyze up to four times as many specimens per day as medical experts recommended for accuracy.[240] These laboratories would pay screeners on a piecework basis, as little as 45 cents per Pap test slide, which encouraged the screeners to rush the analysis.[240] The poor remuneration encouraged screeners to review slides rapidly if they are paid on a piecework basis or, if they are paid on salary, to hurry through quotas at one laboratory in order to take second and third jobs at other laboratories.[240] Technicians would often take the pap smears home and examine them there, without direct supervision, and often in the presence of family distractions.[240] Only one state, California, regulated the number of pap smears a technician could read in a single day, but the regulation was often ignored.[240] As a results of the rushed pap screenings due to the sweatshop labor conditions, a number of women received false negative readings and subsequently developed cervical cancers from which they died. The College of American Pathologists (CAP) and the American Society of Cytology (ASC) offered voluntary accreditation to laboratories that met their criteria, but most of the largest pap laboratories were not enrolled.[240] 

how incompetent management and greed impacted clinical laboratories.

Bogdanich had interviewed over 500 people for the stories.[241]

In response to the Pap-mill stories, the American College of Obstetricians and Gynecologists conducted several studies and found that the false negative rate of the Pap Smear could be as high as 80% depending on the laboratory.[242] The Health Care Financing Administration

Low salaries and exccessive workloads are causing cytotechnologists to leave the professsion and seek more finannicaly rewarding professions. Fewer individuals are entering the field because better working conditions and highere salaries can be obtained in other professions. The declining number of qualified cytotechnologists to review smears compounds the problem.[243]

We need systemic change; we need systemic regulation, and we need not only Government activity, but quite frankyly, physicians in this country have to speak out against greed and callousness within their own profession....We are being medically mugged by these laboratories, and I am just kind of tired of it.

Barbara Mikulski, US Senator, (1988)[244]


One South Jersey facility was performing so poorly on syphilis serology proficiency tests that its director was asked to attend training sessions at the state health department's laboratory in Trenton. At these workshops, according to the file, the director "was unable to follow what was being taught. In short, we feel that (the director), far from being qualified to direct a clinical laboratory, is incapable of functioning as a bench technician (the lowest level of lab worker).

S.1737 - Clinical Laboratories Improvement Act of 1975

Following the introduction of CLIA '88, the Hawaii Office of the Auditor recommended that the Hawaii Department of Health (DOH) discontinue the laboratory personnel licensure program, but the DOH declined, noting that licensure prevented unqualified persons from practicing.Cite error: A <ref> tag is missing the closing </ref> (see the help page).

Public Cholesterol Screening[edit]

...many express concern that “people are making big decisions about what they are going to do based on what may be a very lousy test result,” especially given an overly trusting public who “believes that the number coming out of a machine is carved in stone.”

Public Cholesterol Screening, (HHS OIG)(1990)[254]

In 1985, the National Cholesterol Education Program (NCEP) launched encouraging clinicians and the public to measure their cholesterol via the "Know your cholesterol" campaign by attending screening, counseling, and referral events (SCOREs) held throughout the community. [255]

A wide variety of public and private providers, with or without health care experience, conducted screenings at sites as diverse as shopping malls, pharmacies, health clubs and village halls.[256] Hospitals and other health care providers, public health departments, private agencies and organizations, employers, and businesses such as pharmacies and grocery stores all sponsored public cholesterol screenings.[256] While screening was sometimes provided as a public service, more often it served as a public relations tool, marketing ploy, or money-maker for the sponsor.[256] For-profit sponsors, such as retail stores, drew people in with storefront ads urging people to “Take the test that could save your life!” or warning “Cholesterol Kills!” while pharmacies offered screenings to contribute to their health care image and build traffic.[257]

There was rapid growth in the cholesterol testing market with estimates of over 100 million cholesterol tests being performed annually, representing nearly 2/3 of all US adults, generating over a $1 Billion in annual revenue in 1989.[256] In 1990, there were over 25 cholesterol measurement devices on the market, but three portable analyzers in were primarily used in public screenings: Abbott Vision, Boehringer-Mannheim Reflotron, and Kodak Ektachem DT60 Analyzer.[256][258] The development of portable, dry-chemistry analyzers made it feasible for cholesterol screening of large groups of individuals.[259][260] These analyzers offered results within minutes testing, required only a fingerstick, and had a low cost per test.[259][260] Equipment manufacturers aggressively marketed the devices to any entrepreneur that could buy them.[256]

Many respondents questioned the qualifications of staff at screenings: “I've seen ads in the paper for people to learn to do cholesterol screening where the main requirement seems to be that they own a car.”

Public Cholesterol Screening, (HHS OIG)(1990)[254]

Following the NCEP campaign, there were initiatives at the federal and state levels to incorporate national guidelines into regulations.[261] In July 1989 Maryland, was the first state to enact legislation separate from existing laboratory law, entitled Cholesterol Testing[g]that created a self-supporting program that to regulate cholesterol screening conducted outside of laboratories and physicians' offices requiring a license and defined minimum standards of quality assurance including personnel training, quality control, proficiency testing, counseling, and patient referral.[265] [261] In the few states states with existing laboratory regulations, such as Florida, oversight authority of off-site testing was limited and enforcement led to litigation.[264] Florida[266], and several other states subsequently followed Maryland's suit and enacted cholesterol screening licensure legislation.

In May 1990, the HHS OIG published a report critical of the state of public cholesterol screenings, often being performed at store, malls, and health fairs, noting how "sometimes the operations looked more like a sideshow at a carnival."[267][268] The report indicated that the majority of screening were not following NCEP recommendations.[269][267] The report found the screenings were often performed by untrained technicians, with improperly collected fingerstick capillary punctures that had been milked, a laxity of quality assurance and quality control, a disregard for basic hygiene, a lack of privacy, no hardcopy test report, being performed at unkempt sites that lacked proper biohazard storage, with no follow-up counseling nor physician referral. [268]CITEREFOversight_of_Implementation1991a}}[267] The OIG report described how for-profit providers could short-circuit quality control to minimize operating costs and maximize profits, or choose equipment based on cost and ease of operation rather than accuracy.[254] There were health concerns about the the implications of inaccurate test results; screenees would either be falsely reassured that they are not at risk or made unduly anxious paying for unnecessary doctors visits and re-testing.[270]

Following the OIG report, a senate hearing was held in November 1989. The HHS OIG Richard P. Kusserow described the fly-by-night screening outfits as crossing the line "from shoddy to criminal." Senator Ron Wyden (D-OR) likened the unregulated screening to "playing Russian roulette with safety testifying:"[271]

The evidence shows that public cholesterol testing is riddled with questionable health practices that are risky at bet. Much of public cholesterol screening is tainted by staggering sloppiness, frequent indifference to infection control, and widespread use of untrained personnel employing improperly maintained or poorly calibrated equipment. Much of the screening also ignores simple, good health practices...Compounding the serious quality control problems are a growing number of fast buck artists who have a keen sense of how to exploit the enormous public interest in cholesterol control for easy, huge profits.


[272] public health threat[273]

Report spurred states like California to pass regulation. [274]

[275] 

American Heart Association expressed concern about mass cholesterol screenings "that are not part of the medical care system."[276]

Staff members often had no medical training themselves, and included people 'drawn to cholesterol screening because of the money to be earned,' said HHS Inspector General Richard Kusserow.

'We found numerous shortcomings that compromise the safety and effectiveness of public screenings across the country,' the report said. 'Screening staff may be placing themselves as well as screenees at risk due to marginal observation of the basic rules of hygiene.'

Medicare and private insurers do not cover the tests unless ordered by a doctor, and the study said increasing numbers of Americans are turning to mobile services, which charge about $6 to $7, for cholesterol screening.[277]

The OIG report indicated that that existing oversight was minimal with only 16 states having any regulatory controls over public cholesterol screening.[267][261] One of the strongest barriers to regulation was the lack of consensus regarding whether screening constitutes a clinical diagnostic test or primarily an informational service to the public.[278] In Michigan and Wisconsin, the State Attorney General has ruled that public cholesterol screening does not constitute a clinical laboratory test, since it is not ordered by doctors and providers are not involved in diagnosis and treatment.[278] In Tennessee, while a special task force unanimously agreed that screening should be fully licensed, legal opinion was split regarding whether screening constitutes a clinical chemistry diagnostic test under state law.[278] In Florida, the Office of Licensure and Certification sent cease and desist orders to unlicensed providers, followed by injunctions for non-compliance.[278] Other barriers to regulation was funding, lack of qualified staffing, and the burden of additional regulations to potential providers.[278] The Citizens for Public Action on Cholesterol and cholesterol testing equipment manufacturers advocated that screening regulations should be separate from clinical laboratory laws.[279] Even where state regulation existed, the mobile nature of the public screenings often made enforcement challenging.[h]

Prior to CLIA '88, screening was not federally regulated, and was not reimbursable under Medicare, although diagnostic tests for high blood cholesterol and coronary heart disease were covered.[260]. Furthermore, prior to CLIA '88, mobile laboratories were not federally regulated.[281] In 1990, the HCFA Administrator, in testimony before the Senate Committee on Labor and Human Resources and the Senate Subcommittees on Oversight of Government Management, indicated that public cholesterol screening would not be waived under CLIA 1988, thus laboratories or sponsors of public screenings must meet specific performance and other requirements before being certified to conduct public testing when they took effect in 1992. [282]





[283]

[284]

[285]

Quality[edit]

Division of Laboratory Systems logic model for evaluating laboratory practices[286]


Most laboratory quality control and quality programs focus on the laboratory itself and the accuracy its results, not clinical utilization, hence there is excess and inappropriate use of testing, including the use of obsolete tests.[i][j]

Gallery[edit]

Clinical Laboratory Improvement Amendments (CLIA) Brochure for updated 2003 regulations
CLIA Proficiency Testing brochure before the TEST Act.

Notes[edit]

  1. ^ This issue finally came to a head in the mid-1970s when AAB member James Prier, Ph.D., HCLD (ABB), then director of Pennsylvania’s Bureau of Laboratories, promulgated state clinical laboratory regulations that applied to all laboratories, including physician-directed laboratories. The Pennsylvania Medical Society filed suit, claiming that the regulations improperly encroached on the state’s Medical Practice Act. The Pennsylvania Medical Society won a trial court decision that struck down the regulations, but on appeal the Pennsylvania Supreme Court reversed the lower court’s decision, ruling in a landmark and precedent-setting decision that the provision of clinical laboratory testing does not constitute the practice of medicine. An interesting side note to the legal battle in Pennsylvania was that the rules put forth by Dr. Prier contained eight “simple” tests frequently performed by physicians that were exempt from regulation. According to Dr. Prier, his intent was to end the exemption after one year, which he felt was long enough for physicians to become accustomed to Pennsylvania’s regulations. These eight simple tests turned out to be the forerunners of the original “waived” tests in the CLIA ’88 statute, much to the chagrin of Dr. Prier.[28]
  2. ^ Comment: A few commenters requested clarification of what should be considered high sensitivity C-reactive protein, as opposed to traditional C-reactive protein, as included in the proposed rule. A related comment suggested that we should require PT for all assays for C-reactive protein. Response: Although traditional C-reactive protein has been used as a general marker of inflammation for many years, it did not meet the threshold for inclusion as a required PT analyte. In this rule we are finalizing the proposed PT requirement for high sensitivity C-reactive protein and we appreciate the need to define which test methods would be considered “high sensitivity” testing. High sensitivity C-reactive protein concerns testing related to cardiac ischemia, either for frank cardiac events or for risk stratification, which requires more sensitive test methods to detect lower concentrations. We are deferring to laboratories to know whether their assay is a high sensitivity method used to detect cardiac pathology, or the traditional, less sensitive C-reactive protein. PT programs must label their PT offerings accordingly.[158]
  3. ^ The problem lies in using clinical laboratories following routine protocols and QC performance criteria established for patient testing and making unwarranted assumptions about the level of quality. The solution lies in the design of alternative experimental protocols for drug trials carried out in clinical laboratories...The performance criteria selected to evaluate laboratory quality under these schemes implicitly consider the needs of clinicians when treating patients and, in some cases, the state-of-the-art performance in laboratories. They do not focus on the needs of drug manufacturers to measure drug efficacy in clinical trials. Consequently, laboratory data provided for routine patient care are not the same in terms of concept, quality, or intended use as those needed by drug manufacturers, and ultimately, the drug regulators.[185]
  4. ^ It is important that outliers be removed to set target values. Because a spurious PT result, including one due to a transcription error, could affect the peer group mean, especially when the peer group has relatively few laboratory participants, PT programs should continue to discard aberrant results when calculating the peer group target. At this time, we do not have sufficient information to provide additional or alternative options for outlier removal. However, we recognize the need for PT programs to have valid modern approaches for outlier removal. Therefore, we are retaining the requirement to remove outliers as described in the definition for target value, using a 3 SD criterion. Regarding the comment referencing ISO requirements, we note that ISO standards do not apply to CLIA. [186]
  5. ^ a b Section 493.901(c)(6): We proposed to add the requirement that PT programs limit the participants’ online submission of PT data to one submission or that a method be provided to track changes made to electronically reported results. Many PT programs currently allow laboratories an option to report PT results electronically, while some other PT programs only allow laboratories to report PT results electronically with no other option such as facsimile or mailed PT submission forms. However, at this time, the PT programs that do participate in the online reporting have no mechanism to review an audit trail for the submitted result. In some cases of PT referral, it has been discovered that laboratories have sent PT samples to another CLIA-certified laboratory for testing, received results from the other laboratory, and then changed their online reported results to the PT program since those results can be modified up until the PT event close date. In an effort to assist in PT referral investigations and determinations, an audit trail that includes all instances of reported results would aid in determining if a laboratory compared PT results obtained from another laboratory and changed their previously submitted results. [187]
  6. ^ CMS is not denied authority to revoke a laboratory’s CLIA certificate in the circumstance where the laboratory has previously gone out of business. CLIA could be rendered ineffective if a laboratory owner was able to avoid its enforcement provisions simply by closing the laboratory’s doors. Revocation of CLIA certifications is mandatory.[210]
  7. ^ Most legislators, the public, and many health care providers incorrectly viewed cholesterol "screening" as a simple analytical procedure that could be performed easily and properly by someone with little or no training. As part of the educational process needed to alter this belief, [[Maryland State Department of Health and Mental Hygiene]] (MSDHMH) chose to entitle the legislation "Cholesterol Testing" rather than "Cholesterol Screening" because neither the public nor most health care providers associate the same need for quality control and quality assurance with "screening" as they do with "testing. [262][263][264]
  8. ^ No matter what type of regulation, State respondents often described problems identifying providers in order to bring them into compliance: “By the time we hear about them, they’re gone.” Some likened themselves to detectives in trying to track down providers, relying on advertisements, word of mouth, complaints from other providers, or just plain “serendipity” to find them. [280]
  9. ^ "To date, most quality control and quality improvement efforts in outpatient clinical laboratory testing have focused on the laboratory itself and the accuracy of its test results. There is evidence of excessive and inappropriate use of clinical laboratory tests in the hospital inpatient setting, but there are no comparable studies of the use of laboratory tests in outpatient clinics and physicians’ offices. The extent of inappropriate outpatient testing is unknown. While laboratories may recognize orders that might be inappropriate and may offer expert advice or educational materials to the physician, the committee found little concerted effort to improve the appropriateness of test ordering in the context of patient care. Because laboratory payments do not represent a very large portion of the budget for Medicare, managed-care plans, third-party payers, or hospitals, these organizations have less incentive to focus on changing utilization patterns for laboratory tests than they do for other types of care."[287]
  10. ^ "Laboratorians and physicians should work together to conduct a systematic review of the full laboratory fee schedule to identify obsolete tests that no longer offer value and need never be used for any case. This would provide another opportunity for the various laboratory-related associations and physicians’ organizations to work together to update clinical practice. New tests and testing methods are supplanting old tests and raising the quality of care, but it is difficult for physicians to keep up with all the changes. As long as obsolete tests are coded and remain on the fee schedule, some physicians will order them and some laboratories will provide them."[288]

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CLIA 2[edit]

CLIA itself has not been the subject of much litigation.[1] Federal district courts have held that the CLIA did not create a private cause of action for individuals to sue laboratories that do not comply with its provisions.[1]


Attribution[edit]

Sources[edit]

Journal
Journal2


Optometry


Books
Regulatory
Congressional Hearings
  1. ^ a b Garrett & Mitchell (2018), p. 953.
  2. ^ Rohde, Rodney E.; Falleur, David M.; Ellis, Joanna R. (March 10, 2015). "Almost anyone can perform your medical laboratory tests – wait, what?: Your barber, realtor, electrician and massage therapist are all licensed, but only 12 states in the US license medical laboratorians". Elsevier Connect. Archived from the original on 2021-07-23. Retrieved 21 April 2024.
  3. ^ Hosek, Susan D.; Straus, Susan G. (2013). Patient privacy, consent, and identity management in health information exchange: issues for the military health system. Research Reports. Santa Monica, CA: RAND. doi:10.7249/RR112. ISBN 978-0-8330-7790-5. Document no. RR-112-A. Retrieved 21 April 2024.
  4. ^ Public cholesterol screening : are bad results putting millions at risk? : hearing before the Subcommittee on Regulation, Business Opportunities, and Energy of the Committee on Small Business, House of Representatives, One Hundred First Congress, first session, Washington, DC, November 27, 1989. Washington, DC: U.S. Government Printing Office. 1990.
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