Rocky Mountain Infectious Diseases

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure a competency assessment had been completed for the technical consultant (TC) for 2 of 2 years (2021, 2022) reviewed. The findings were: 1. Review of the TC's personnel record showed no evidence a competency assessment had been completed in 2021 or 2022. 2. Review of the laboratory's Quality Assessment Policy under "6.0 Personnel, Training and Competency", effective 8/1/14, failed to include a procedure for assessing the competency of the TC. 3. Interview with the TC on 11/28/22 at 1:41 PM confirmed the competency assessments had not been completed. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of documentation, review of the UNICO Power Spin Centrifuge Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- operator's manual, review of the laboratory's policy, and staff interview, the laboratory failed to follow the manufacturer's instructions and the laboratory's policy to perform function checks on the UNICO centrifuge. The findings were: 1. Review of the laboratory's documentation showed no evidence the revolutions per minute (RPM) or the timer was checked as directed. 2. Review of the Miscellaneous Equipment policy under "1. General Purpose Centrifuges" showed i. "RPM-RPMs will be checked with a tachometer annually and after repairs...ii. Timer - If the centrifuge is equipped with a timer, it will be checked at least annually against a standard time source..." 3. Review of the UNICO Power Spin Centrifuge operator's manual showed "It is recommended that your centrifuge's RPM be calibrated at least every 6 months." 4. Interview with the laboratory manager on 11/28/22 at 2:48 PM confirmed the function checks had not been performed as required. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to verify the statistical parameters of quality control material prior to use for 1 of 2 test systems (hematology) reviewed. The findings were: 1. There was no documentation the laboratory had verified new lot numbers of quality control material prior to being used on the hematology analyzer. 2. Interview with the laboratory manager on 11/28/22 at 2:50 PM confirmed the statistical parameters of the quality control materials had not been verified. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to verify the reportable range for tests performed using the Au480 chemistry analyzer and the HMX complete cell counter (CBC) at least once every six months, twice in 2017 and once in 2018. The laboratory performed approximately 26 CBC's per week and 339 chemistry tests per week. Findings include: 1. The laboratory lacked documentation to verify Sodium, Potassium, Chloride, Creatinine, Glucose, Urea Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Nitrogen, Calcium, Carbon Dioxide, Total Protein, Albumin, Alanine transaminase, Alkaline Phosphatase, Aspartamine Transaminase, Creatine Kinase, C-Reactive Protein, and Vancomycin reportable ranges using at least a zero or minimal level value, a midlevel value, and a value at the upper level of the reportable range at least once every six months in 2017, and for the first six months of 2018. 2. The laboratory lacked documentation they followed Coulter HMX complete cell count instrument manufacturer's recommendations to verify calibration once every six months in 2017, and for the first six months of 2018. 3. In an interview with staff on 10/23/2018 at approximately 1:45 P.M., staff confirmed they did not verify the reportable ranges for tests performed on the Au480 instrument or perform calibration verification as recommended by the HMX manufacturer once every six months. 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 humidity records review, lack of documentation, laboratory daily environmental logs review, and interview with staff, the laboratory failed to document they followed their policy to monitor and when indicated correct the failure to monitor laboratory humidity percent each day of testing in January, February, and April of 2018. Findings include: 1. Humidity records reviewed failed to include documentation the laboratory monitored Humidity in January 2018, failed to record humidity on 01, 05, 06, 07, 08, 09, 12, 13, 14, 15, 16, 19, 20, 21, 22, 23, 26, and 27 of February 2018, and in April of 2018 failed to record humidity only on 02, 03, 04, 06, 09, 10, 13, 16, 18, 19, 20, 25, and 27. 2. In an interview with staff on10/23/2018 at approximately 2: 20 P.M., staff stated they did not realize the forms were missing or incomplete. -- 2 of 2 --