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 the lack of proficiency test records and an interview with the Hawaii Health Center Manager on 07/03/2018 at 08:15 a.m., it was determined that the laboratory failed to maintain copies of all its proficiency testing records to include 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. The findings include: a. The laboratory's American Proficiency Institute (API) Rh proficiency testing records for 3 of 3 events in 2016 and 3 of 3 events in 2017 were not available for review. b. The laboratory's protocol titled "Proficiency Testing: Rh & Provider Performed Microscopy (PPM) Test" states: i. In the section titled "Testing Process-Health Centers, 2. API logs, documents: If present with kit, discard. DO NOT USE API FORMS OR SEND RESULTS TO API." Rh proficiency testing results are recorded and sent to the Assistant to the COO for electronic submission to API. ii. In the section titled "Reporting and Documentation of Proficiency Test Results" - "Final 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 -- results will be kept by the Assistant to the COO," and that "the following documents will be scanned and retained by the Assistant to the COO for each testing event: PPGNHI Rh Proficiency Test Log, API Submission Form, API Results Form." iii. The Health Center Manager stated that the manager who preceded him did not retain copies of the laboratory's API PT records. He was unable to locate a laboratory contact who could assist in retrieving these documents for review. c. The laboratory's protocol titled "Proficiency Testing: Rh & Provider Performed Microscopy (PPM) Test" states: i. In the section titled "Rh Proficiency Testing: Control results and proficiency test results must be logged on the Rh Patient test log just as patient tests are logged." ii. The Health Center Manager stated that API Rh proficiency testing results were not logged on to this test log. Results were recorded on the Planned Parenthood Rh PT Log and Attestation Statement form. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and an interview with the Health Center Manager on 07/03/2018 at 08:15 a.m., it was determined that the laboratory failed to ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. The findings include: a. 8 of 8 procedures reviewed were not approved and signed by the Hawaii Laboratory Director. These procedures included: i. Laboratory Policies and Patient Test Management, 09/16 ii. Lab Specimen Collection and Processing, 09/16 iii. Laboratory Quality Assurance Plan, 09/16 iv. Proficiency Testing: Rh & Provider Performed Microscopy (PPM) Tests, 09/16 v. Laboratory Quality Control Procedures, 04/17 vi. Required Laboratory Quality Control and Documentation Logs, 11/17 vii. Rh Testing- Annual Laboratory Competency, 09/16 viii. Rh Testing with Eldon Log, 09/16 b. The Health Center Manager stated that approved laboratory procedures were available on line. The Manager and testing personnel were unable to locate these procedures during the survey. c. NOTE: THIS DEFICIENT PRACTICE WAS PREVIOUSLY CITED AT THE LABORATORY'S 03/31/2016 CLIA SURVEY. The laboratory's 04 /21/2016