Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at A Tidewater Women's Health Clinic on June 6, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of policies and procedures, a facility tour, patient test logs, and an interview, the laboratory director (LD) failed to document approval and review of the laboratory's modifications of the written procedure for patient Rh blood typing. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a procedure for Rh Blood Slide Test Typing that was approved by the LD on 6/2/14. The procedure stated in step number nine (9) and ten (10) "If no agglutination occurs initially, incubate the test for five minutes at 18-24 degrees Celsius. After incubation, immediately observe for agglutination. If the slide is smooth after that time, no agglutination, the result is negative and the patient is Rh negative. Record all results into the daily log and patient's chart". 2. During a tour of the facility, the inspector made an inquiry of where and what timing device is used when the testing personnel perform the incubation step for negative results of the Rho Blood Slide Test Typing. The primary testing personnel stated, "We do not perform the five minute incubation step. I was not trained to do that step." 3. Review of the laboratory's patient log documentation from July 2016 to the date of the survey on 6/6/18, a total of twenty- four (24) months, revealed no evidence of the laboratory performing the additional incubation step per the written protocol for negative results. The inspector requested to review documentation of the incubation step. No documentation was available for 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 -- review. 4. In an interview with the primary testing personnel at approximately 4:30 PM on 6/6/18, it was confirmed that the laboratory failed to follow the established policy for Rh Blood Slide Test Typing and that the LD failed to document approval and review of the laboratory's modifications of the written procedure for patient Rh blood typing during the twenty-four (24) months reviewed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of policies and procedures, patient test logs, quality assurance (QA) records, and an interview, the laboratory failed to ensure that the quality assurance (QA) policies were maintained during the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a written and approved QA policy that included a quarterly check list and monitors for compliance to be performed by the LD. The QA plan and check list included a Personnel Policies section that stated: "All personnel who perform tests have documented training for the tests and understand the protocol and procedures for the tests". The QA plan included a Compliance Monitor section that stated "Explanation of any "no" responses to the QA plan or