Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 9, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (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. This STANDARD is not met as evidenced by: Based on Proficiency Test(PT) record review and staff interview, the laboratory failed to maintain copies of all records for proficiency testing. The Findings include: 1. PT record review revealed that copies of all PT records were not maintained for Chemistry Event #2 in 2021. The attestation document was not present during the time of the survey. 2. During an interview with the TP #1(CMS 209) on December 9, 2021 at approximately 1:40 PM, in the conference room, confirmed that copies of the Chemistry Event #2 in 2021 was not present during the time of the survey. D3011 FACILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the laboratory record review and an interview with the testing personnel (TP), the laboratory failed to establish a written procedure for eyewash maintenance. Findings include: 1. Laboratory record review revealed that the laboratory failed to establish a written procedure for eyewash maintenance. 2. During an interview with the TP#1 (CMS 209 form) on December 9, 2021, in the conference room, at approximately 1:45 PM, confirmed that the laboratory did not establish a written procedure for eyewash maintenance. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on Proficiency Test(PT) records and staff interview, the laboratory failed to document