Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) complaint investigation and an inital certification survey were completed on November 4, 2020. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 surveyor observation and an interview with the Chief Operations Officer (COO), the laboratory failed to provide a shower station and eyewash for immediate emergency use within the laboratory area. The findings include: 1. The laboratory failed to have a shower station and eyewash available in the laboratory to ensure safety measures of any person's eyes or body that may be exposed to injurious corrosive materials, for quick drenching or flushing for immediate emergency use. A tour of the laboratory confirmed a shower station and eye wash was absent from the laboratory area. 2. The COO confirmed on 11/3/2020, at 11:30 AM, in the laboratory, that a shower station and eye wash has been absent from the laboratory since August 2020. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- This STANDARD is not met as evidenced by: Based on review of the P23 Labs, Quality Manual, Testing Personnel (TP) Training Checklist and interview with Chief Operating Officer (COO), the laboratory failed to list all mandatory competency assessment criteria on training checklist for TP assessment. The finding includes: 1. The laboratory started COVID-19 testing on September 21, 2020 and only had initial competency records available for review. Review of the P23 Labs, Quality Manual on November 3, 2020, revealed the laboratory failed to include language that addressed the semi-annual competency assessment requirement and testing evaluation process. The policy stated that personnel competency assessment is evaluated annually,but did not mention semi- annual evaluation. The manual did not include a copy of the training checklist or how to use. 2. A review of the TP competency assessment training checklist found the laboratory failed to include all 6 competency assessment criteria such as specimen handling, record reporting, proficiency testing, problem solving and a system for complaints. 3. A review found the laboratory failed to document the name of the person who performed the initial competency training on the checklist. The laboratory had a space for documenting the trainer's name on form that was left blank for all TP. The laboratory director failed to sign the initial competency assessment checklist for 3 of 3 TP. 4. An interview with the COO on November 3, 2020 at 11:00 AM confirmed the laboratory did not include all of the 6 competency assessment criteria on the training checklist or semi-annual competency assessment. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency test (PT) records and interview with the COO, the laboratory failed to ensure that at least twice annually the laboratory verified the accuracy of QuantStudio 5 Taq-Path COVID-19 assay and unregulated analytes. The findings include: 1. Review of the laboratory's records revealed that there was no documentation of peer review or internal proficiency testing (PT) performed twice annually for the QuantStudio 5 Taq-Path COVID-19 assay or unregulated analytes. 2. The laboratory does not have a policy indicating how PT for unregulated analytes is assessed. 3. The COO confirmed on 11/3/2020, at 1:30 PM, in the conference room, that the laboratory has not performed PT twice annually for the QuantStudio 5 Taq-Path COVID-19 assay or unregulated analytes. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: -- 2 of 11 -- Based on surveyor review of Quality Manual and interview with the COO, the laboratory failed to perform and document the quality assessment monitors for the laboratory. The findings include: 1. A review of the Quality Manual and laboratory procedure on page 1 of 29, revealed the laboratory did not provide specific guidance or instructions for P23 labs staff to follow for monitoring, assessing and correcting problems in the laboratory. 2. A review revealed the laboratory did not perform or list the names of monitors for their laboratory testing or laboratory information system. 4. An interview with the COO on November 3, 2020 at 2:00 PM confirmed the laboratory did not complete any quality assessment monitors for laboratory processes performed. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of