Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on first quarter (Q1-2019) of the American Association of Bioanalysts (AAB) performance summary report for Sperm Count and interview with the TP, it was determined that the laboratory failed to at least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. The findings included: a. Q1-2019, AAB reported an unsatisfactory score of 50% for Sperm Count. b. For seven (7) out of seven (7) random patient test results reviewed covering period from April 15/2019 to 10/9/2019, three (3) had Sperm count ordered, analyzed and reported which the laboratory received the unsatisfactory score of 50% for Sperm Count. c. The TP confirmed (12/4/2019, 12:30) that the laboratory received the above proficiency testing score. 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 and lack of laboratory written policies and procedures, and interview with the testing personnel (TP), it was determined that the laboratory failed to 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 -- establish and follow written procedures for Sperm Count test. The findings included: a. On the day of the survey (12/4/2019, 1100) the laboratory failed to provide a written policy and procedure for Sperm Count. b. For seven (7) out of seven (7) random patient test results reviewed covering period from April 15/2019 to 10/9/2019, three (3) had Sperm count ordered, analyzed and reported which the laboratory had no policy and procedure established. c. The TP confirmed (12/4/2019, 12:30) that the laboratory lacked an established policy and procedure for Sperm Count. 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)