Laboratory sanctions for proficiency testing sample referral and result communication: a review of actions from 1993-2006.
Context.--The Clinical Laboratory Improvement Amendments of 1988
(CLIA) regulations for proficiency testing (PT) include prohibitions
against intentional PT sample referral or result communication, and
specify sanctions against laboratories that violate these regulations.
There has been little published analysis of sanctions against clinical
laboratories because of PT violations.
Objective.--To examine the application of principal sanctions as reported by the Centers for Medicare and Medicaid Services annually in the Laboratory Registry and to examine relevant aspects of judicial hearings and appeals in these cases.
Design.--The Laboratory Registry was examined for all available years (1993-2006) to determine the incidence of application of principal sanctions for PT violations. In addition, the decisions from the US Department of Health and Human Services hearings and appeals were reviewed to better understand the judicial disposition of these cases.
Results.--During the 14-year period examined, 78 laboratories received a principal sanction for a PT violation involving sample referral or result communication. During the same period, the number of laboratories in nonexempt states that would be expected to have participated in PT averaged 45983. The interpretive meaning of the key terms intentional and referral, and the implications for sanctioned laboratories and their owners and operators are discussed.
Conclusions.--Applications of a principal sanction for a PT violation were rare during the period of this study. However, the consequences of the imposition of such a sanction are severe. Suggestions are offered on policies and practices to minimize the risk of a PT sample referral or result communication.
(Laws, regulations and rules)
Medical laboratories (Laws, regulations and rules)
Medical referral (Laws, regulations and rules)
|Author:||Killeen, Anthony A.|
|Publication:||Name: Archives of Pathology & Laboratory Medicine Publisher: College of American Pathologists Audience: Academic; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 College of American Pathologists ISSN: 1543-2165|
|Issue:||Date: June, 2009 Source Volume: 133 Source Issue: 6|
|Topic:||Temporal Scope: 1993 AD Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation|
|Product:||Product Code: 7397030 Biomedical Testing Labs NAICS Code: 54138 Testing Laboratories SIC Code: 8071 Medical laboratories; 8731 Commercial physical research|
|Organization:||Government Agency: United States. Centers for Medicare and Medicaid Services|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
|Legal:||Statute: Clinical Laboratory Improvement Amendments of 1988|
Participation in approved external proficiency testing (PT)
programs is required for clinical laboratories that hold certificates
for nonwaived testing under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) regulations (42 CFR, pt 493). Laboratories are
required to enroll in these programs for all analytes listed in subpart
I of the regulations (the "regulated" analytes). If a
laboratory is testing analytes for which no PT program exists, it must
verify the accuracy of its results by other approved methods at least
twice a year. Some accrediting organizations require that laboratories
participate in approved PT programs that cover both the regulated
analytes and certain additional non-regulated analytes.
Proficiency testing is widely regarded as an important measure of a laboratory's performance and was considered in a 1988 Congressional report to be "arguably the most important measure, since it reviews actual test results rather than merely gauging the potential for good results." (1) Under the CLIA implementing law (42 USC 263a) and its regulations, PT is one of the most extensively regulated aspects of laboratory practice. Existing requirements demand that PT samples be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory and by using the laboratory's routine methods ([section]493.801[b]2). There must be no communication of PT results between laboratories (even if owned by the same organization) before the deadline for submission of results to the PT program ([section]493.801[b]3). In addition, a laboratory must not refer a PT sample to another laboratory for testing if it is certified to perform such testing itself ([section]493.801[b]4).
The Centers for Medicare and Medicaid Services (CMS) are responsible for enforcement of the provisions of the CLIA regulations and may impose a variety of sanctions on laboratories that are found to be out of compliance. The most severe sanctions against laboratories are principal sanctions. These are suspension, limitation, or revocation of a CLIA certificate, or cancellation of a laboratory's approval to receive Medicare payment for its services ([section]493.2). The equivalent sanction that can be applied by an accrediting organization is denial or withdrawal of a certificate of accreditation. Under the CLIA regulations, a finding of intentional referral of a PT sample to another laboratory for analysis expressly requires revocation of the CLIA certificate for at least 1 year and a possible civil monetary penalty ([section]493.1840[b]). Furthermore, if a CLIA certificate is revoked for any reason, the owner and operator of the laboratory are effectively prohibited from owning or operating a clinical laboratory for a 2-year period ([section]493.1840[a]). Laboratories may ask for a hearing to contest certain CMS-imposed sanctions before an administrative law judge and may appeal a judge's decision to the Department of Health and Human Services (DHHS) Departmental Appeals Board ([section]493.1844). Further appeals may be made to the US Court of Appeals for the district in which a laboratory has its principal place of business.
Little information is available in the literature on the frequency or types of sanctions for PT sample referral or result communication that are imposed under the CLIA regulations. A review of all sanctions applied between 1993 and 2001 found that most sanctions were applied because of regulatory noncompliance, with fraud being a relatively infrequent reason, but PT violations were not specifically discussed. (2) A US Government Accountability Office report that called for strengthening of clinical laboratory oversight noted that only 1 of a total of 4 accredited laboratories that had been found by their accrediting organization to have engaged in improper PT referral had been sanctioned. (3)
The purpose of this study was to survey the frequency of actions by CMS and the accrediting organizations for this type of violation and to examine the judicial review of cases in Departmental hearings and appeals.
Data on sanctions imposed on clinical laboratories by CMS or by the accrediting organizations are published in the annual Laboratory Registry (LR). (4) As required by the CLIA regulations, CMS includes in the LR a listing of laboratories that were sanctioned by CMS or by an accrediting organization in the preceding year and the reasons for imposing these sanctions. The decisions of all appeals and hearings are also published in the LR. The LR was reviewed for the 14 years from its inception in 1993 to the most recently available report, which covers 2006. For each year, data on the application of a principal sanction or denial of accreditation because of PT sample referral or interlaboratory communication were obtained from the LR. For the purpose of this analysis, these sanctions were considered to have been applied during the year in which they were first recorded in the LR even if an appeal decision was delivered in a later year. During the period of this study, CMS or its predecessor, the Health Care Financing Administration (HCFA), prevailed in all appeals. Laboratories that lost their CLIA certification because they were under common ownership or operation with a laboratory that had had its CLIA certificate revoked for a PT violation were not included in the data set. Additional information was obtained by review of cases decided by administrative law judges in the Civil Remedies Division of DHHS and by the Departmental Appeals Board.
Data on the annual numbers and types of CLIA certificate from 1993 to 2006 were obtained from the CMS CLIA database. (5)
From 1993 to 2006 the annual LR reports list 78 laboratories that received a principal sanction by CMS or were denied accreditation by an accrediting organization because of PT sample referral or result communication. Of the 78 cases, 8 were denials of accreditation by an accrediting organization; the remainder of cases involved CMS (or HCFA) actions. The distribution by year is shown in the Figure. Data on the number of CLIA certified laboratories (other than those holding a certificate of waiver or provider-performed microscopy) are shown in Table 1. During this period, the number of laboratories in nonexempt states with a certificate of compliance or accreditation averaged 45983 and the number of additional laboratories of all types in exempt states averaged 6 175. (5)
There were more than 30 hearings and appeals before administrative law judges or the Departmental Appeals Board related to PT referral or result communication. The Centers for Medicare and Medicaid Services (or HCFA) prevailed in all cases. Relevant findings from these cases are discussed below.
During the first 14 years in which sanctions were documented in the LR, 78 laboratories are recorded as having received a principal sanction or denial of accreditation because of PT sample referral or communication. Given the much larger number of certified laboratories that were performing PT during this time, it is apparent that application of principal sanctions or denials of accreditation for PT violations was rare. There was an increase in the number of sanctions imposed from 1999 through 2000 arising in part from a related cluster of cases in one state. With the exception of the increase during those years, the number of applications of principal sanctions has been relatively stable during the 14-year period.
It is instructive to review the hearings and appeals decisions in these cases. The CLIA regulations prohibit intentional PT sample referral and result communication. In this context, it has been repeatedly held that the meaning of the word intentional does not require that there be a finding of an intention to cheat on proficiency testing. (6) Any referral, other than one made inadvertently, of a PT sample to another laboratory is a violation of the regulation. Although [section]493.801(b)(4) (prohibiting referral) specifies revocation of a CLIA certificate as a sanction, whereas [section]493.801(b)(3) (prohibiting communication) does not, the 2 types of violations are considered by CMS as effectively the same and either can result in revocation of a CLIA certificate. Importantly, judicial decisions have determined that it is not necessary to find that physical transfer of a PT sample occurred to conclude that there was referral. (7-9) The DHHS Departmental Appeals Board in a decision concluded as follows:
"Limiting the concept of a referral to a physical transfer is inconsistent with the underlying purposes of the condition for certification. Adopting the values achieved in another laboratory (either with or without having done the tests in one's own laboratory) clearly undercuts the general concept that the sample be tested in the same way as regular patient specimens in the laboratory are tested so that the results truly measure the proficiency of the laboratory reporting the results." (9)
The application of principal sanctions, particularly revocation of a certificate, is specified by the CLIA and its regulations, and there seems to be little if any possibility of alternative sanctions being applied for these PT violations. Nevertheless, review of the LR does indicate a few cases in which a CLIA certificate was not revoked. This deviation from applying the expected sanction was also noted in a recent US Government Accountability Office report on oversight of clinical laboratories with the explanation that the laboratories had undertaken corrective action that satisfied their accrediting organization. (3)
The consequences for the laboratory owner and operator in cases of PT sample referral or result communication are considerable. By regulation, a CLIA certificate can be revoked for a laboratory owned or operated by a person who owned or operated another laboratory that had its CLIA certificate revoked for any reason during the preceding 2 years. (This regulation effectively amounts to a 2-year ban on the owner and operator). In an organization that owns multiple laboratories, there may therefore be a significant impact following revocation of a CLIA certificate, well beyond the impact on the laboratory that was directly implicated in a PT violation. As an illustration of this point, the CLIA certificates of at least 27 laboratories that had not participated in any PT impropriety were revoked because they were under common ownership with laboratories that had been found to have engaged in such activities. (10-12) It should also be emphasized that under the CLIA regulations, the laboratory director is an operator ([section]493.2), and therefore may be subject to the 2-year ban on directing a clinical laboratory after revocation of a certificate. Laboratories are held responsible for the actions of employees that engage in prohibited PT sample referral or result communication even if management was unaware of or had not authorized such actions. (9,13-15)
Proficiency testing sample referral and sample communication undermine the principle that PT, despite its limitations, remains an important measure of the ability of a laboratory to produce reliable test results. (16,17) It is, of course, not possible to use PT to gauge the reliability of a laboratory if its reported PT results are generated wholly or in part in a different laboratory operating under different management and using different testing personnel, instruments, and methods and following a different quality assurance program. For this reason, PT sample referral and result communication are treated as serious matters, which can incur severe sanctions.
In addition to negating the primary purpose of PT, it has also been argued that collaboration among PT participants that leads to submission of similar or identical results by a group of laboratories may affect the validity of the PT program for all participants. (8) For example, such an effect might be expected for those PT challenges in which the mean and standard deviation of participants' results form the basis for determining the allowable range of results to achieve a passing score for all participants. The magnitude of the effect of such collaboration would be expected to depend on the survey, its grading scheme, the number of collaborating participants, and the total number of participants. However, there appear to be no available published data on this topic from known cases of PT collaboration.
Laboratory owners, directors, and employees should be aware of the serious consequences that can result from intentional PT sample referral or result communication. A suggested list of dos and don'ts for handling PT samples is given in Table 2 and in a recent CMS communication to laboratory directors. (18)
(1.) HR Rep No. 100-899, reprinted in USCCAN at 3828 (1988).
(2.) Rivers PA, Dobalian A, Germinario FA. A review and analysis of the clinical laboratory improvement amendment of 1988: compliance plans and enforcement policy. Health Care Manage Rev. 2005;30:93-102.
(3.) United States Government Accountability Office. Clinical Lab Quality: CMS and Survey Organization Oversight Should be Strengthened. Washington, DC: United States Government Accountability Office; 2006. GAO-06-416.
(4.) Centers for Medicare and Medicaid Services. Laboratory registry 1993-2006. http://www.cms.hhs.gov/clia/18_laboratory_registry.asp. Accessed September 4, 2008.
(5.) Centers for Medicare and Medicaid Services. CLIA database information. http://www.cms.hhs.gov/CLIA/downloads/summary%20chart1 993%2 0to%202007.pdf. Accessed September 4, 2008.
(6.) Long Medical Laboratory v HCFA, CR 334 (1994).
(7.) Blanding Urgent Care Center Laboratory v. HCFA, CR 438 (1996).
(8.) Oakland Medical Group, PC v HCFA, CR 688(2000).
(9.) Oakland Medical Group, PC v HCFA, DAB 1755(2000).
(10.) Evette Elsenety, MD v HCFA, CR 779 (2001).
(11.) Evette Elsenety, MD v HCFA, DAB1796 (2001).
(12.) Millenium Medical Group v CMS, CR 875 (2002).
(13.) Primary Care Medical Group v HCFA, CR 439 (1996).
(14.) Melvin C. Murphy, MD v HCFA, CR 590 (1999).
(15.) Southfield Medical Clinic v HCFA, CR 667 (2000).
(16.) Klee GG, Killeen AA. College of American Pathologists 2003 fresh frozen serum proficiency testing studies. Arch Pathol Lab Med. 2005;129:292-293.
(17.) Noble MA. Does external evaluation of laboratories improve patient safety? Clin Chem Lab Med. 2007;45:753-755.
(18.) Centers for Medicare and Medicaid Services. Important Information for Non-Waived Labs. http://www.dhss.delaware.gov/dph/lab/files/cliaptrequirements. txt. Accessed March 17, 2009.
Anthony A. Killeen, MD, PhD
Accepted for publication October 8, 2008.
From the Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis.
The author has no relevant financial interest in the products or companies described in this article.
Reprints: Anthony A. Killeen, MD, PhD, Department of Pathology and Laboratory Medicine, University of Minnesota, Mayo Mail Code 609, 420 Delaware St SE, Minneapolis, MN 55455 (e-mail: email@example.com).
Table 1. Number of Laboratories Holding Certificates of Compliance and Accreditation (Nonexempt States) and Number Receiving Principal Sanctions or Denials of Accreditation by Year Year 1993 1994 1995 1996 1997 Compliance 44 762 40 384 37 578 37 126 31 040 Accreditation 23 751 19 359 19 426 18 475 15 803 Total 68 513 59 743 57 004 55 601 46 843 Sanction 1 1 4 3 1 Year 1998 1999 2000 2001 2002 Compliance 30 546 26 045 25 068 22 757 21 809 Accreditation 17 495 17 000 16 992 16 892 16 312 Total 48 041 43 045 42 060 39 649 38 121 Sanction 2 20 17 7 8 Year 2003 2004 2005 2006 Compliance 20 832 20 758 20 480 20 026 Accreditation 15 811 15 667 15 607 15 957 Total 36 643 36 425 36 087 35 983 Sanction 6 3 3 2 Table 2. Suggested Dos and Don'ts to Comply with CLIA Requirements for Proficiency Testing (PT) Samples Dos 1. Handle PT samples like patient samples (but never send a PT sample out of the laboratory, even if patient samples are normally referred for additional, confirmatory, or reflex testing). 2. Keep records of PT testing (including any corrective actions following unsuccessful PT performance) for at least 2 years. 3. Be aware of all CLIA certificates and their respective laboratories within an institution. There must be no referral of PT samples or communication of results between laboratories that operate under different certificates, even if owned by the same institution. Results from multiple laboratories should be returned to the PT organization by different members of personnel. 4. Be aware of patient sample referral practices to other laboratories. Ensure that personnel who are responsible for referring patient samples know that PT samples must never be referred to another laboratory. 5. Notify the accrediting organization or CMS if the laboratory receives what appears to be a PT sample from another CLIA-certified laboratory. Do not test the sample. 6. Ensure that laboratory staff members regularly review and understand the rules for handling PT samples. Don'ts 1. Send a PT sample outside the laboratory for any reason. If a sample requires review or interpretation by an outside pathologist, the pathologist should perform that task in the laboratory that received the PT sample. 2. Discuss PT results with staff from another laboratory before the cutoff date for submission of results. This applies to results from either laboratory. Abbreviations: CLIA, Clinical Laboratory Improvement Amendments of 1988; CMS, Centers for Medicare and Medicaid Services. Distribution of principal sanctions or denials of accreditation for proficiency testing referrals or result communication by year. 1993 1 1994 1 1995 4 1996 3 1997 1 1998 2 1999 20 2000 17 2001 7 2002 8 2003 6 2004 3 2005 3 2006 2 Note: Table made from bar graph.
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