Medicare Conditions of Participation
Laboratory Requirements

7.) Laboratory Requirements

        a.) General

A laboratory must have a current certificate of waiver, registration certificate, certificate of compliance, certificate for Provider Performed Microscopy (PPM) procedures performed by the laboratory or be exempt.149

        b.) Registration certificate, certificate for provider-performed microscopy procedures, and certificate of compliance

Laboratories performing only waived tests, provider performed microscopy (PPM) procedures, or any combination of these tests is not required to obtain a registration certificate.150 A registration certificate is required initially for all laboratories performing test procedures of moderate complexity or high complexity. HHS may suspend or revoke a laboratory’s registration certificate for failure to comply with regulatory requirements.

Laboratories issued a certificate of compliance must notify HHS of any changes in ownership, name, location, director or technical supervisor.151 The laboratory must also notify HHS if it performs any test that is not included in the laboratory’s certificate of compliance.

        c.) Facility administration for nonwaived testing

Each laboratory that performs nonwaived testing must meet the following requirements unless HHS approves a procedure that provides equivalent quality testing.152

• A laboratory must be constructed, arranged and maintained to comply with federal, state, and local laboratory requirements.153
• A facility that provides transfusion services must meet all regulatory requirements and document transfusion-related activities.154
• A laboratory must retain its records and its slides, blocks, and tissues.155

        d.) Quality system for nonwaived testing

Each laboratory that performs nonwaived testing must establish written policies and procedures that implement and monitor a quality system for all phases of the total testing process and general laboratory systems.156 The laboratory’s quality systems must include a quality assessment component.

Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements unless HHS approves a procedure that provides equivalent quality testing.157

• A laboratory must ensure confidentiality of patient information.158
• The laboratory must establish written policies and procedures that ensure positive identification and optimum integrity of a patient’s specimen from the time of receipt of the specimen through completion of testing and reporting of results.159
• A laboratory must have a system in place to ensure that it documents all complaints and problems reports to the laboratory.160 It must conduct investigations of complaints when appropriate.
• A laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results.161
• The laboratory must establish written policies and procedures to assess employee and consultant competency.
• A laboratory must review and evaluate the results obtained on proficiency testing performed.162 All proficiency testing evaluation and verification activities must be documented.
• A written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to and followed by laboratory personnel.163
• Testing must be performed following the manufacturer’s instructions and in a manner that provides test results within the laboratory’s stated performance specifications for each test system.164

For each test system, a laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process, bacteriology tests, mycobacteriology tests, mycology tests, parasitology tests, virology tests, routine chemistry tests, hematology tests, immunohematology tests, histopathology tests, cytology tests, clinical cytogenetics, and histocompatibility tests .165

Corrective action policies and procedures must be followed to maintain the laboratory’s operation for testing patient specimens in a manner that ensures accurate and reliable patient test results and reports.166 The laboratory must document all corrective actions taken.

The laboratory must maintain an information or record system.167 Records of patient testing must be retained.

        e.) Enforcement procedures

CMS’ decision to impose sanctions is based on deficiencies found by CMS in the conduct of inspections or through review of materials submitted by the laboratory and unsuccessful participation in proficiency testing.168

• CMS may impose one or more sanctions on a laboratory that is out of compliance with one or more CLIA conditions.169
• CMS may suspend, limit or revoke a CLIA certificate.170 When CMS suspends or revokes any type of CLIA certificate, CMS must concurrently cancel the laboratory’s approval to receive Medicare payment for its services.171
• CMS may also impose alternative sanctions: directed plan of correction; state onsite monitoring; and civil money penalty.172

CMS must cancel a laboratory’s approval to receive Medicare payment for its services if CMS suspends or revoke its CLIA certificate.173 It may also cancel the laboratory’s approval if the laboratory is out of compliance with a condition level requirement, the laboratory fails to submit a satisfactory plan of correction, or the laboratory fails to correct all of its deficiencies within the time frames specified in the plan of correction.

If CMS identifies condition level noncompliance in a laboratory, CMS must provide the laboratory written notice and an opportunity to respond.174 A laboratory may request a hearing with an administrative law judge or file a lawsuit in district court if it is dissatisfied with a CMS determination.175

If CMS has reason to believe that a laboratory’s activities constitute a significant hazard to public health, CMS may bring suit in district court to stop the laboratory from continuing the activities.176

CMS must annually provide physicians and the general public information that is useful in evaluating the performance of laboratories.177