Summary:
Summary Statement of Deficiencies 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 quality assessment (QA) written policies records (years 2016 to 2018) review and interview with the laboratory director on August 8, 2018 at 11:15 AM, it was determined that the laboratory failed to have a procedure to verify the accuracy twice annually of the cytology non gynecology smears examination (tests not regulated for the proficiency testing program Subpart I) from August 8, 2016 to August 8, 2018 . The findings include: 1. On August 8, 2018 at 11:15 AM, the QA written policies showed that the laboratory did not have procedures to verify the accuracy twice annually of the cytology non gynecology smears examination (tests not regulated for the proficiency testing program Subpart I) from August 8, 2016 to August 8, 2018. 2. The laboratory director confirmed on August 8, 2018 at 11:15 AM, that the laboratory did not have the written procedure of the general laboratory systems requirements . 3. The laboratory examined 111 cases of cytology non gynecology from January , 2018 to August 6, 2018 and the annual cytology volume records showed that the laboratory examined 953 of cytology non gynecology cases during the year 2017. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- 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)