Summary:
Summary Statement of Deficiencies D0000 QSO-18-20-CLIA Multiple laboratories may operate at the same physical location (e. g., same building or suite, as applicable) with separate CLIA numbers, as long as each laboratory can demonstrate that it is operating as a separate and distinct entity. In addition, multiple laboratories that operate at the same physical location must meet the following conditions: a) All records (e.g., quality control, procedure manuals, personnel competency) must be kept separate and distinct for each laboratory and must clearly show that each laboratory is operating independently. b) The hours of operation must be specified for each laboratory. c) The hours of operation for each laboratory must be separate and distinct. The times of testing cannot overlap and cannot be simultaneous. Based on surveyor observation, record review and testing person interview, the laboratory did not have separate and distinct documents and records and was performing testing during the same times and at the same location as Interpath Laboratory Anchorage CLIA # 02D2130734. Findings: 1. Two laboratories are operating simultaneously at 188 W Northern Lights Blvd, Suite 600 in Anchorage, AK 99503. 2. The laboratory did not maintain separate temperature and instrument maintenance logs. 3. The testing person's training documents were from other laboratories. 4. The written procedures for Prostate Specific Antigen (PSA), Testosterone, and Thyroid Stimulating Hormone (TSH), were not specific for this laboratory, and included references to an instrument not in use in this laboratory. 6. The laboratory performs approximately 5,000 patient tests annually. 7. The testing person confirmed these findings 11/5/18 at 12:00 pm. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and testing person interview, the laboratory did not monitor and evaluate the overall quality of the analytic systems for testing performed by the laboratory. See D5403, D5423, and D5441 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)