Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 15, 2019. 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: 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 on proficiency test (PT) document review and staff interview, the laboratory failed to enroll in a PT program that meets required CLIA criteria. Findings include: 1. American Proficiency Institute (API) PT document review revealed the laboratory was enrolled in only two Chemistry events per year for 2017 and 2018 which included only three PT samples each. 2. An interview with Staff #3 (CMS 209) in a medical office on 5/15/2019 at approximately 2:00 p.m. confirmed the lack of compliance with CLIA requirements for PT enrollment. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 test (PT) documents and staff interview, the laboratory failed to include all of the testing personnel (TP), who routinely perform the laboratory testing, in the examination of PT samples. ;; Findings include: 1. American Proficiency Institute (API) PT document review revealed Staff #3 (CMS 209) performed all PT testing for the second and third 2018 Chemistry events. 2. An interview with Staff #3 (CMS 209) in a medical office on 5/15/2019 at approximately 2 p.m. confirmed she performed all PT testing for the aforementioned PT events. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish a policy and procedure to assess testing personnel (TP) competency. Findings include: 1. SOP review revealed the laboratory did not include a policy and procedure to assess TP competency initially or semi- annually. 2. An interview with Staff #3 (CMS 209) in a medical office on 5/15/2019 at approximately 2:00 p.m. confirmed the lack of the aforementioned policies in their SOP. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP), proficiency test (PT) document review, and staff interview, the laboratory failed to include or to follow required policies and procedures. Findings include: 1. SOP review revealed the SOP did not include a record retention policy and procedure. 2. SOP review revealed laboratory failed to follow the established PT policy and procedure. 2. An interiew with Staff #3 (CMS 209) in a medical office on 5/15/2019 at approximately 2:00 p.m. confirmed there was not a record retention policy and procedure in their SOP and the laboratory was not following the PT procedure in their SOP. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 4 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)