Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 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. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) data system for proficiency testing, the laboratory's proficiency testing (PT) records since the last survey on 7-5-17, and interview on 7-25-19 at 1:30 p.m. with Testing Personnel #1, listed on the CMS 209 personnel form, the laboratory failed to enroll in an HHS approved proficiency testing program for the subspecialty of bacteriology since patient testing for Neisseria gonorrhoeae and Chlamydia trachomatis began on 2- 12-19. Findings include: Review of the CMS data system for proficiency testing and the laboratory's PT records since the last survey on 7-5-17 revealed no documentation of the performance of proficiency testing for Neisseria gonorrhoeae and Chlamydia trachomatis in the subspecialty of bacteriology. In an interview on 7-25-19 at 1:30 p. m., Testing Personnel #1 confirmed the laboratory was not enrolled in PT for bacteriology. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)