Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Validation survey was conducted at the Dickenson Community Hospital on February 12-14, 2019 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: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: A. Based on the review of policy and procedures (P&P), and an interview with the technical supervisor, the lab failed to retain the documentation of establishing the mean and standard deviation (SD) for the new lot number (L3186) of BioRad LiquiChek Unassayed Chemistry Controls at the dates of survey on February 12-14, 2019. Dates of record review included January 1, 2017 and up to February 14, 2019. Findings include: 1. The lab uses the BioRad LiquiChek Unassayed Chemistry Controls to perform daily quality control procedures on the Siemens Dimension EXL chemistry analyzer. Review of the P&P "Lab General Policy and Procedure", " 4.0 Quality Control", signed approved by the lab director on 10/04/18, revealed the following statements: "A minimum of 20 test values should be used to establish a Mean (x) and Standard Deviation (SD). The SD values determine quality control limits. Ideally 20 measurements should be ran over a 20 day period. The average and SD must be established each time there is a lot number change in QC materials in order to validate new lot." 2. The laboratory changed lot numbers from L3180 (exp date 06/30/18) to L31860 (06/30/19) during the month of June 2018. The inspector requested to review the documentation of the initial verification of the new lot number according to the above-specified policy. The documentation was not 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 6 -- review. 3. The technical supervisor confirmed in an interview at approximately 1:00 PM on February 13, 2019 that the requested documentation was not available. B. Based on the review of policy and procedures (P&P), available quality control (QC) records, manufacturer package inserts (PI), instrument test data, and an interview with the technical supervisor, the lab failed to retain the documentation of the daily QC procedures for six (6) of 9 Beckman Coulter "6C Cell Control" lot numbers used from January 1, 2018 through August 19, 2018. Findings include: 1. Review of the P&P "Quality Control Procedures and Review", "Hematology Quality Control" revealed the following statements: "3.0 Quality Control- When control results are reviewed, the results are checked against the +2 SD control ranges where applicable. Anytime a result correction is entered, a comment must be entered stating what the problem was and how it was corrected. 6.0 Notes- Controls are reviewed and acceptable prior to reporting patient results. QC statistics are viewed monthly by Lab Service Manager and pathologist." An interview with the technical supervisor at approximately 1:00 PM on February 14, 2019 revealed that the lab does not print out the daily QC records or end of the month statistics for review. She/he stated the hematology QC records were reviewed within the DxH 600 hematology analyzer's hard drive. Comments regarding QC