Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Virginia Women's Center on August 1, 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: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report Form (CMS 209), procedure and policy manual, personnel files, and an interview, the laboratory did not establish and follow a policy for one (1) technical consultant's competency assessment in calendar years 2016, 2017 and up to the date of the survey on August 1, 2018. Findings include: 1. Review of the CMS 209, revealed that Testing Personnel B serves as Technical Consultant (TC). (See Personnel Code Sheet) 2. Review of the laboratory procedure and policy manual revealed no protocol outlining documentation of the competency assessment of the TC. 3. Review of the personnel files revealed that the laboratory director failed to document competency assessments in calendar years 2016, 2017, and year to date 2018 for Testing Personnel B in the role of TC. 4. In an interview with the TC at approximately 12:00 PM, it was confirmed that laboratory did not establish and follow a policy for documenting competency assessment for the duties of the one (1) TC for the timeframe outlined above. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 -- The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the laboratory's Quality Assurance (QA) policies, Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, monthly QA reports and an interview, the laboratory director failed to: 1. ensure the laboratory followed their written QA policy to perform annual competency assessments for twenty-two (22) of twenty-two (22) testing personnel in 2017 (Cross reference D6021 Part A); 2. ensure the laboratory follow their written policy to perform and document monthly QA reviews for twenty (20) of twenty-four (24) months reviewed (Cross reference D6021 Part B, *REPEAT DEFICIENCY). 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: A. Based on a review of the procedures and policies, personnel records, quality assurance (QA) reports, and an interview, the laboratory did not follow their written QA policy to perform annual competency assessments for twenty-two (22) of twenty- two (22) testing personnel in 2017. Findings include: 1. Review of the laboratory's procedure manual revealed a QA policy for personnel competency assessment. The policy stated: "At least annually, the lab director and/or technical consultant will review the performance of each testing personnel to assure competency and the written review will be filed in the individual's personnel file". 2. Review of the laboratory's personnel files revealed no annual competency assessments for Testing Personnel A through V in calendar year 2017. (See Personnel Code Sheet) 3. Review of the available QA monthly reports revealed no