Division Of Consolidated Laboratory Services

Summary Statement of Deficiencies 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 lack of supervisory competency assessment records, review of the Division of Consolidated Laboratory Services (DCLS) Competency standard operating procedure (SOP) and interview with the Quality Safety manager, the laboratory failed to establish a competency policy to evaluate personnel that held supervisory position listed on the Laboratory Personnel Report (Form 209) of technical supervisors (TS), general supervisors (GS) and clinical consultant. Findings Include: 1. The DCLS SOP did not state competency guidelines for personnel listed in on the Form 209 as CC, TS and GS. 2. Laboratory Personnel Report (CLIA) Form 209 lists 1 CC, 66 TS and 34 GS. 3. On the day of survey, November 29, 2022, the laboratory was unable to provide competency assessment records for the above personnel that held supervisory position listed on CMS Form 209. 4. The Quality Safety manager confirmed the findings above on November 29, 2022 around 12:00 pm. 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. 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 -- (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 D0000 The Centers for Medicare and Medicaid Services (CMS) Philadelphia Regional Office CLIA Surveyors conducted an announced routine CLIA recertification survey at Virginia Division of Consolidated Laboratory Services (DCLS) on December 07,2020- December 09, 2020. The laboratory is on compliance with 42 CFR part 493 with standard level deficiencies cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) documentation,

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of the creatinine-corrected results obtained in the biomonitoring program testing. Findings include: 1. During interviews at 10:45 am and 3:00 pm on 7/12/2018, TS#2 and TS#3 explained that the urine metals and perchlorate participant results are corrected based on the participants' urine creatinine values using a spreadsheet entitled Biomonitoring Creatinine Data Entry Form (Qualtrax ID#19289). 2. Record review showed that that the Biomonitoring Creatinine Data Entry Form spreadsheet is programmed to perform a calculation using the measurements of the target analyte and creatinine to adjust for participant hydration status. 3. During interview at 3:00 pm on 7/12/2018 TS#3 stated that results reported to the proficiency testing programs for biomonitoring analytes are not corrected for creatinine. 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) 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 reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)