[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.801]

[Page 1001-1003]
 
                         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.

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    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 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

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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]