Summary:
Summary Statement of Deficiencies D0000 The Laboratory Director and Technical Supervisor were at the entrance conference conducted 06/04/2019. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the Laboratory Director and Technical Supervisor on 06/06/2019. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of CMS 155 reports, the laboratory failed to attain a score of at least 80 percent for the hematocrit (HCT) Hematology analyte for 1 of 1 proficiency testing events in 2019 (Hematology-1st Event). Findings included: 1. Review of CMS 155 Dallas Nephrology Associates (45D0478993) report for proficiency testing 2019 (1st event) revealed the following unsatisfactory score: HCT 2019 1st Event 60% The laboratory failed to attain a score of at least 80% for HCT analyte. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on review of laboratory's quality control (QC) policy, BIO-RAD control material manufacturer's instructions, expected value sheets, Architect c4000 QC data, and in interview with staff, the laboratory failed to retain all data used for establishing statistical parameters (standard deviation [SD]) of control material put into use 04 /2017 on the Architect c4000. Findings included: 1. Review of the laboratory's DTILAB GENERAL QUALITY CONTROL PLAN pages 14-15 stated: "XI. ESTABLISHING QC PRODUCT DATA RANGES: (QC) Quality Control on all methods at DTILAB involves a standard process of evaluation of QC data prior to installation of a new QC lot. Assay/QC Verification Procedure ... 3. Verify all levels of the new control lot by initially running each level of control a minimum of, 3 times in its perspective file to ensure that the mean of all 3 runs are within the range shown on the original MFG assay sheet. 4. Run the new control levels a minimum of twice a day for 10 days. 5. Use the mean of, at least 20 runs, minimum to verify that the new lot yields means falling within the range specified by the manufacturer in the package insert. 6. If the calculated mean falls within the range specified on the assay sheet, use it in place of the manufacturer's stated mean. 7. If parallel testing for immunoassays is not possible, assayed controls are used and manufacturer limits are posted until the target mean and SD of the new assayed lot is obtained." The policy did not include instructions for unassayed control material used by the laboratory. 2. Review of BIO- RAD Liquid Unassayed Multiqual manufacturer's instructions (package insert) stated, "The values listed are approximate and are provided only for your convenience. The actual observed value will vary depending upon lot number, temperature, analyzer, reagent, method, and calibrator." During a telephone interview on 06/06/2019 at 11:50 am, the Biorad technical representative stated that for unassayed quality control material every laboratory should establish their own mean and SD. He also stated that statistically for every 20 data points there should be 1 outlier in a QC program. 3. Review of Biorad control material Level 1 (Lot #47941), Level 2 (Lot #47942), and Level 3 (Lot #47943) used on the Architect c4000 revealed the lot numbers were put into use 04/2017 (expiration date 10/31/2019). The laboratory provided spreadsheets of SD's and means for all analytes, which were consistent with what was entered in the QC program for ranges used for day-to-day acceptability. Data used to establish those SD's and means were not available. The ranges, which are determined by SD and mean calculation, did not detect immediate error (refer to D5441). 4. During an interview on 06/06/2019 at 11:50 am, when asked how the ranges and SD's were established the Technical Supervisor (TS) stated she changed the mean. The TS was asked again how the SD's were established and she stated she changed the mean. The surveyor explained to the TS that the SD's made the ranges wide and were unable to detect immediate error, the TS stated if she made the SD's any smaller there would be many QC issues. The laboratory was unable to provide the documentation for establishing the SD for the above lot number set. 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. -- 2 of 8 -- (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)