[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.801]



[Page 1010-1011]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 493_LABORATORY REQUIREMENTS--Table of Contents

 

    Subpart H_Participation in Proficiency Testing for Laboratories 

                      Performing Nonwaived Testing

 

Sec.  493.801  Condition: Enrollment and testing of samples.



    Source: 57 FR 7146, Feb. 28, 1992, unless otherwise noted.





    Each laboratory must enroll in a proficiency testing (PT) program 

that meets the criteria in subpart I of this part and is approved by 

HHS. The laboratory must enroll in an approved program or programs for 

each of the specialties and subspecialties for which it seeks 

certification. The laboratory must test the samples in the same manner 

as patients' specimens. For laboratories subject to 42 CFR part 493 

published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the 

rules of this subpart are effective on September 1, 1992. For all other 

laboratories, the rules of this subpart are effective January 1, 1994.

    (a) Standard; Enrollment. The laboratory must--

    (1) Notify HHS of the approved program or programs in which it 

chooses to participate to meet proficiency testing requirements of this 

subpart.

    (2)(i) Designate the program(s) to be used for each specialty, 

subspecialty, and analyte or test to determine compliance with this 

subpart if the laboratory participates in more than one proficiency 

testing program approved by CMS; and

    (ii) For those tests performed by the laboratory that are not 

included in subpart I of this part, a laboratory must establish and 

maintain the accuracy of its testing procedures, in accordance with 

Sec.  493.1236(c)(1).

    (3) For each specialty, subspecialty and analyte or test, 

participate in one approved proficiency testing program or programs, for 

one year before designating a different program and must notify CMS 

before any change in designation; and

    (4) Authorize the proficiency testing program to release to HHS all 

data required to--

    (i) Determine the laboratory's compliance with this subpart; and

    (ii) Make PT results available to the public as required in section 

353(f)(3)(F) of the Public Health Service Act.

    (b) Standard; Testing of proficiency testing samples. The laboratory 

must examine or test, as applicable, the proficiency testing samples it 

receives from the proficiency testing program in the same manner as it 

tests patient specimens.

    (1) The samples must be examined or tested with the laboratory's 

regular patient workload by personnel who routinely perform the testing 

in the laboratory, using the laboratory's routine methods. The 

individual testing or examining the samples and the laboratory director 

must attest to the routine integration of the samples into the patient 

workload using the laboratory's routine methods.

    (2) The laboratory must test samples the same number of times that 

it routinely tests patient samples.

    (3) Laboratories that perform tests on proficiency testing samples 

must not engage in any inter-laboratory communications pertaining to the 

results of proficiency testing sample(s) until after the date by which 

the laboratory must report proficiency testing results to the program 

for the testing event in which the samples were sent. Laboratories with 

multiple testing sites or separate locations must not participate in any 

communications or discussions across sites/locations concerning 

proficiency testing sample results until after the date by which the 

laboratory must report proficiency testing results to the program.

    (4) The laboratory must not send PT samples or portions of samples 

to another laboratory for any analysis which it is certified to perform 

in its own laboratory. Any laboratory that CMS determines intentionally 

referred its proficiency testing samples to another laboratory for 

analysis will have its certification revoked for at least



[[Page 1011]]



one year. Any laboratory that receives proficiency testing samples from 

another laboratory for testing must notify CMS of the receipt of those 

samples.

    (5) The laboratory must document the handling, preparation, 

processing, examination, and each step in the testing and reporting of 

results for all proficiency testing samples. The laboratory must 

maintain a copy of all records, including a copy of the proficiency 

testing program report forms used by the laboratory to record 

proficiency testing results including the attestation statement provided 

by the PT program, signed by the analyst and the laboratory director, 

documenting that proficiency testing samples were tested in the same 

manner as patient specimens, for a minimum of two years from the date of 

the proficiency testing event.

    (6) PT is required for only the test system, assay, or examination 

used as the primary method for patient testing during the PT event.



[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 68 

FR 3702, Jan. 24, 2003]