Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(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 This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) documents provided for review during survey and discussion with the Technical Consultant (TC), the laboratory failed to ensure PT samples were rotated among testing personnel (TP). Findings include: 1. Upon review of the PT documentation for all three (3) events in 2020, the laboratory failed to rotate the PT events with different TP. 2. One TP out of seven (7) performed all three (3) PT events in 2020. 3. An interview with the TC on 10/12/20 at approximately 1200 confirmed this. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) documents for 2018, 2019, and 2020, the laboratory failed to ensure the attestation form was signed by the Laboratory Director (LD) each time PT was performed and submitted. Findings include: 1. Seven (7) PT events were examined during survey, three (3) for 2020, three (3) for 2019 and one (1) for 2018. Three (3) out of seven (7) had no attestation form signed and available for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- review during survey 10/12/2020. 2. An interview with the TC on 10/12/20 at approximately 1200 confirmed this. D3011 FACILITIES 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 review of safety records and interview with one Testing Personnel (TP), the laboratory failed to ensure the eyewash equipment was tested weekly according to laboratory policy. Findings include: 1. Upon review of the written records for checking the eye wash weekly, it was noted that the eye wash had not been checked by TP since the first week of September 2020, creating a possible safety hazard if it was inoperable. 2. The one TP interviewed during survey 10/12/2020 confirmed it had not been done. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the quarterly Quality Assurance (QA) policy and QA records available for review during survey, the Technical Consultant (TC) failed to follow the laboratory's policy for quarterly QA review. Findings include: 1. The written policy for performing quarterly QA assessment submitted as a part of their