Women's Ob/Gyn, Pc

Summary Statement of Deficiencies 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)

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Quality Control Procedure (QCP) for the Affirm VPN analyzer, Affirm Quality Control (QC) results, and an interview with the laboratory director and testing person, the laboratory failed to follow the written QCP and perform external positive & negative controls to ensure the proper performance of Probe Analysis Card (PAC), Reagent Cassette (RC) and Processor from January 1, 2020 through survey date. FINDINGS: 1. The laboratory is using a positive Trivalent control swab to test the PAC & RC with each new lot and weekly on the Affirm VPN analyzer. a. The QCP states, " that QC is performed using both positive and negative Trivalent control swabs with each new lot of PAC & RC and weekly. b. Approximately 2,091 patient samples were tested and reported during this time period. 2. The laboratory director and testing person confirmed on July 28, 2022 at approximately 2:30 PM, the laboratory failed to follow QCP and perform a external negative control for the PAC & RC performed on the Affirm VPN from January 1, 2020 through survey date. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 a surveyor's review of the laboratory's Quality Assurance (QA) policy and confirmed in an interview with the laboratory manager and testing person, the laboratory failed to follow their established written QA policy and perform an annual QA review, as required by the laboratory's QA policy, for the calendar year 2018. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's QA policy and confirmed during the interview with the laboratory manager and testing person, the laboratory director failed to ensure that the laboratory's quality assessment (QA) policy/procedure was followed. Refer to: D5291 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --