Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 27, 2019. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. An Immediate Jeopardy was identified due to the laboratory's inability to have a qualified Laboratory Director and Technical Consultant for a moderate complexity laboratory. The following deficiencies were cited: 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 laboratory's proficiency testing records, lack of quality assessment activity, and staff interview the laboratory failed to monitor and evaluate the overall quality of the laboratory. Identified problems were not corrected by laboratory staff. (Refer to: D5209, D5211, D5217, D5291 and D5293) 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 procedure manual and interview with the testing personnel (TP), the laboratory failed to establish a written policy to determine employee competency for all test performed in the laboratory from May 2017 through February 2019. The findings include: 1. A review of testing personnel records revealed that the laboratory failed to perform a competency assessment with the six criteria required by CMS for the specialties of Chemistry and Toxicology from May 2017 through February 2019. 2. The laboratory failed to have a written policy and procedure to assess competency based on the position responsibilities on an initial, semi-annual, and annual basis. 3. The laboratory did not have a written policy for assessing employee competency for the tests performed in the laboratory. 4. An interview with TP #1 (CMS 209), in the laboratory, on February 27, 2019, at 11:30 AM confirmed that the laboratory did not perform a competency assessment on TP #1. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with the testing personnel (TP), the laboratory failed to review and evaluate the results of the American Proficiency Institute (API) proficiency test for the specialty of Chemistry from December 2017 through February 2019. The findings include: 1. A review of PT records for API revealed that attestation and performance review statements for Chemistry were not signed and reviewed by the Laboratory Director from December 2017 through February 2019. 2. The Laboratory Director and testing personnel must attest that PT samples were performed according to the guidelines set forth by the PT provider. 3. TP #1 confirmed on 02/27/19, at 10:30 AM, in the laboratory, that the Laboratory Director failed to review and sign the PT attestation and performance review statements for the specialty of Chemistry. 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 testing personnel, the laboratory failed to ensure that at least twice annually the laboratory verified the accuracy of Medica EasyRA toxicology drug screen test. The findings include: 1. Review of the laboratory's records revealed that there was no documentation of peer review or proficiency testing results for Medica EasyRA toxicology drug screen panel from June 2018 through February 2019. 2. Testing personnel #1 confirmed on 02/27/19, at 10:45 AM, in the laboratory that the laboratory failed to verify accuracy of their Toxicology drug screen test. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT -- 2 of 11 -- 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: Based on review of laboratory records and interview with the office manager, the laboratory failed to follow their written quality assessment (QA) to monitor, assess, and correct problems in the general laboratory system for quality assessment from May 2017 through February 2019. 1. The laboratory's current written quality assessment policy does not encompass all facets of the laboratory's technical and non- technical functions. The laboratory failed to follow their own QA policy regarding proficiency test review, competency assessment review, and overall QA of the laboratory. 2. The laboratory failed to have a QA policy addressing patient confidentially, specimen accept/reject criteria, sample identification, complaints, and