Summary:
Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to investigate an unacceptable Hematology proficiency testing (PT) result for 1 analyte in 2018. Findings are as follows: 1. The laboratory performed proficiency testing (PT) through the American Proficiency Institute (API) program. 2. The laboratory received an unacceptable PT result in the 2018 Hematology / Coagulation 3rd Event for Mean Platelet Volume (MPV) on sample HEM-15. 3. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 4. In an interview on 03/13/19 at 3:30 p.m., Testing Personnel 7 (TP7) confirmed the above finding. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- failed to verify the accuracy of Hematology proficiency testing (PT) scores when the PT program returned evaluations of 4 analytes as Not Graded in 2017. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 3/13/19 at 9:5 a.m. 2. The laboratory performed proficiency testing (PT) through the American Proficiency Institute (API) program. 3. The following PT results from 2017 were not graded by the PT provider. Survey: Hematology / Coagulation 3rd Event Sample ID: HEM-15 Tests: White Blood Cell Count Granulocytes Lymphocytes Monocytes 5. The API expected results data summaries were not present in laboratory records. Evaluations for accuracy of the non-graded results were not found during review of laboratory documents. The laboratory was unable to provide evaluations of non-graded results upon request. 6. In an interview on 03/13/19 at 3:30 p.m., Testing Personnel 7 (TP7) confirmed the above finding. . 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 document review and interview with laboratory personnel, the laboratory failed to 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. Findings are as follows: 1. The Laboratory Procedures Manual did not include a Proficiency Testing (PT) procedure by which to monitor, assess, and, when indicated, correct problems identified in the PT process. 2. The laboratory was unable to provide the above document upon request. 3. In an interview on 3/13/19 at 10:00 a.m., the General Supervisor confirmed the above findings. . 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)