Laboratory Accreditation and Inspection

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Clinical laboratories perform diagnostic testing in a highly regulated environment in which federal, state, and private accreditation agencies monitor the quality of testing processes. These agencies vary in the focus and stringency of their requirements, and differences exist among states. Continued accreditation requires regular inspection to assure quality of test results for physicians, insurers, and, ultimately, the patients being tested. Preparation for inspection requires understanding of the unique accreditation requirements for each institution, establishment of quality assurance and quality improvement oversight, and communication of each staff member's role in delivering quality test results for patient care.

Section snippets

Background

The Clinical Laboratory Improvement Act of 1967 began the federal regulation of the activities of large, independent clinical laboratories participating in the federal Medicare program that also were engaged in interstate commerce. The Final Rule for this legislation, enacted in 1978, included new standards for quality control, proficiency testing, and personnel competency in laboratories; however, this effort was insufficient to protect patients from the serious consequences of inaccurate

Roles of federal agencies

The Centers for Medicare and Medicaid Services (CMS), a division of DHHS, administers the CLIA program in conjunction with the FDA and the Centers for Disease Control and Prevention (CDC) [3]. By law, the CLIA program is self-funded through fees paid by its participants. Although the program is overseen by CMS, CLIA oversight extends to cover testing on patients who are not beneficiaries of Medicare or Medicaid programs [4]. CMS is charged with the implementation of CLIA, including laboratory

Certification by Centers for Medicare and Medicaid Services/Department of Health and Human Services

The Public Health Service Act (PHSA) mandates that laboratories performing tests on human specimens meet DHHS requirements [5]. Furthermore, the Social Security Act [6] mandates that laboratories meet the requirements of the PHSA if they want to be paid for services rendered on behalf of Medicare beneficiaries. Regulations implementing section 353 of the PHSA are contained in 42 CFR Part 493 [7]. Laboratories must have a valid CLIA certificate to legally test human specimens or to be eligible

Accreditation

Laboratories must undergo routine periodic inspection to assess whether they are in continued compliance with all requirements of CLIA. Laboratories can choose to be surveyed (inspected) directly by CMS through state inspectors or inspected by a private agency/organization that has been granted “deemed” status by CMS. That is, CMS has the authority (via section 353(e)(2) of the PHSA) to approve a private, nonprofit organization as an accreditation organization for clinical laboratories under

Inspections

The DHHS through CMS state inspectors or a deemed accreditation organization conducts inspections of laboratories performing moderate- and high-complexity testing for clinical patient care at least every 2 years. During an inspection, the laboratory must allow access to all physical areas of the facility, allow observation and interviews of employees performing testing or undertaking any other activities, and allow written records to be reviewed. Inspectors must review the laboratory's policies

Exceptions to the Clinical Laboratory Improvement Amendments of 1988

CLIA'88 regulates testing performed by a laboratory, defined as a facility for the biologic, microbiologic, serologic, chemical, immunohematologic, hematologic, biophysical, cytologic, pathologic, 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 [13]. These examinations also include procedures to determine, measure,

Role of the Clinical Laboratory Improvement Advisory Committee

CLIAC was established to advise the CDC, CMS, and the FDA on the implementation of CLIA'88 regulations. The committee was established by Congress, appointed by the US President through a federal officer, and governed by the Federal Advisory Committee Act of 1972. The committee consists of 20 individuals who represent a broad spectrum of expertise and viewpoints on clinical laboratory matters. CLIAC provides a forum for discussion of clinical laboratory initiatives and concerns. In implementing

Current areas of concern

A prevailing concern at recent CLIAC meetings is the highly variable–quality waived testing as presently delivered. There has been an increasing fraction of laboratories that offer only waived testing, usually as physician office laboratories (POLs). These facilities are not subject to routine inspections and only occasionally may be chosen as part of a sample for purposes of auditing. Inspections of POLs in eight states have found issues that raised concern over the quality of test results

Impact of Clinical Laboratory Improvement Amendments of 1988

Data in surveys by CMS demonstrated that the CLIA regulations have improved laboratory quality. Since CLIA was implemented in 1992, quality deficiencies found in clinical laboratories have decreased significantly. The first onsite surveys of laboratories revealed that up to 35% had problems with quality. More recently, less than 7% of 12,000 labs surveyed by CMS in a year have had problems identified with quality [18].

According to testimony provided to the US House of Representatives, CMS

Enforcement of the Clinical Laboratory Improvement Amendments of 1988

Failure to comply with CLIA regulations or failure to pass proficiency testing and periodic inspections can result in a variety of actions by CMS against the laboratory. CMS has authority to impose sanctions that can range from onsite monitoring, fines, or loss of Medicare reimbursement, all the way to revocation of the laboratory's CLIA certificate, depending on the gravity and pervasiveness of the problem. Most laboratories correct their problems as a result of the education they receive

Additional regulatory issues

Although this article focused on accreditation and inspection of clinical laboratories, critical processes for demonstration of compliance with CLIA regulations, this does not represent the totality of regulatory compliance required in today's complex environment. A variety of federal and international agencies further mandate specific practices for clinical laboratories that promote worker safety (Occupational Safety and Health Administration), safe transportation of specimens (Department of

Summary

Certification by CMS or accreditation by an authority with deemed status is required by the federal government under the auspices of the CLIA'88 program for laboratories performing testing on human specimens for most clinical purposes. Maintenance of currency is verified by successful inspections by these agencies.

Accreditation ultimately serves to achieve many purposes: improves the quality of clinical laboratory test results, improves confidence of patients and clinicians in the quality of

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