Summary:
Summary Statement of Deficiencies D0000 An Initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on January31, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 staff interview, the laboratory failed to rotate performance of proficiency testing samples among all personnel who test patient samples. Findings include: 1. Interview with the technical supervisor and testing personnel # 2 (see CMS 209) on January 31, 2018 at 12 pm revealed all proficiency testing samples were performed by testing personnel # 2. 2. No signed attestation statements or raw data showing testing personnel's identification were available for review. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Based on review of 2016 and 2017 proficiency testing (PT) records and staff interview, the testing personnel (TP) and laboratory director (LD) failed to sign attestation statements, attesting that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of 2016 and 2017 PT records revealed no signed attestation statements. 2. Interview with the technical supervisor and TP # 2 (see CMS 209) on January 31, 2018 at 12 pm confirmed attestation statements are not signed by the TP and LD. 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 review of 2016 and 2017 proficiency testing (PT) records, lack of records to review and staff interview, the laboratory failed to document each step of the testing process and failed to maintain a copy of all testing records. Finding include: 1. Review of PT records revealed no test records , raw data or documentation showing each step of the testing process including how specimens were tested, who tested the specimens, how many times specimens were tested and instrument printouts showing values obtained. 2. Interview with the technical supervisor and testing personnel # 2 (see CMS 209) on January 31, 2018 at 12 pm confirmed records are not available at the time of the survey. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and staff interview, the laboratory failed to meet the requirements for testing in the speciality of Hematology for testing Prothrombin time and activated clotting time. Findings include: Refer to: D 5211, D 5291, D 5403, D 5421, D 5463, D 5545,& D 5787 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. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on review to Proficiency testing (PT) records and staff interview, the laboratory failed to document review of PT scores. Findings include: 1. Review of PT records showing the laboratory's scores revealed no documentation of review by the laboratory staff or laboratory director. 2. Interview with the technical supervisor and testing personnel # 2 (see CMS 209) on January 31, 2018 at 12 pm confirmed PT scores are not signed indicating they were reviewed. 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: Based on review of the laboratory's on-line Quality Assurance (QA) policy and procedure, review of laboratory records and staff interview, the laboratory failed to follow their written QA plan. Findings include: 1. Review of on-line policy and procedures revealed a written QA policy and procedure as well as forms designed for use in the QA process. 2. Review of laboratory records revealed no evidence of QA activity. 3. Interview with the technical supervisor on January 31, 2018 at approximately 3 pm confirmed the laboratory has a QA policy but no documentation of QA activity is available. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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)