Summary:
Summary Statement of Deficiencies 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 a lack of proficiency testing records and reports, the laboratory failed to have complete documentation of American Proficiency Institute (API) Proficiency Testing (PT) records to include the attestation statement for a minimum of two years. Findings Include: It was confirmed with the laboratory testing person on July12, 2018 at approximately 12:20 pm that the laboratory failed to have documentation of handling, preparation, processing, examination and each step in the testing and reporting of results and the attestation for all PT samples for 2016 second & third events, 2017 all three events and the first event in 2018 along with the signed attestation statements. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's API PT score reports and confirmed in an interview with the laboratory testing person, the laboratory failed to satisfactorily participate in a CMS-approved PT program for Bacteriology. The following score was assigned: 2016 second event = 40% 2018 first event = 40% Both are considered unsatisfactory PT performance test 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 a surveyor's review of the laboratory policies/procedures, annual competency records and an interview with the laboratory testing person, the laboratory failed to have a complete policy and procedure for personnel competency and perform annual competency. Finding Include: 1) It was confirmed by the laboratory testing person on July 12, 2018, at approximately 12:00 pm that the laboratory failed to have a complete written procedure for annual competency to include direct observation for testing personnel number one for calendar year 2017 and 2018. 2) The laboratory failed to perform annual competency for testing personnel number two in the calendar years 2017 and 2018. 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 a review of API PT reports and an interview with the laboratory testing person, the laboratory did not evaluate, perform and document remedial action for the PT score that was less than 100% for the 1st event in 2017 for bacteriology testing. Findings Include: It was confirmed with the laboratory testing person on July 12, at approximately 12:20 pm that the laboratory failed to evaluate the results received for: 2017 first event Bacteriology = 80% D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on reviewing proficiency testing results from API the second event for 2016 and first event for 2018, and lack of documentation, the laboratory failed to document the evaluation of three of five unsatisfactory test results for the bacteriology samples. -- 2 of 7 -- 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)