Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780. 493. 801 Condition: Proficiency Testing; Enrollment 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 upon review of proficiency testing records and interview of facility personnel, the laboratory failed to enroll in a proficiency testing program for Virology pathogens tested using the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel for the calendar year 2023. The findings included: 1. Review of proficiency testing records found no evidence of the laboratory participating in a proficiency testing program in 2023 for Influenza A and B . 2. During interview of the Technical Supervisor listed on the CMS report 209 Laboratory Personnel Report conducted July 25,2023 at 11:33 AM, she confirmed that she had not enrolled in a proficiency testing program for Influenza A and B for 2023. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists(CAP) proficiency testing records from 2022, and staff interview, the laboratory failed to document the review and