Veterans Memorial Hospital

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 review of Vitros verification of performance specification and calibration records, lack of calibration verification records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 2:30 pm on 1 /26/2023, the laboratory failed to perform calibration verification procedures every six months for the analytes, procalcitonin and beta-hydroxybutyrate for two out of three time periods from 6/1/2021 - 1/26/2023. The findings include: 1. The laboratory 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 -- verified the reportable range for the analytes, procalcitonin and beta-hydroxybutyrate using a minimum value, mid-point value and maximum value when they implemented the new Vitros chemistry analyzer in June 2021. 2. The calibrations performed for the analytes, procalcitonin and beta-hydroxybutyrate each used 2 calibrators. 3. At the time of the survey, the laboratory did not have documents indicating calibration verification procedures had been performed on the analytes, procalcitonin and beta- hydroxybutyrate since their implementation in June 2021. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and confirmed by laboratory personnel identifier #8 (refer to the Laboratory Personnel Report) at approximately 9:30 am on 01/12/2021, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty, bacteriology (Streptococcus agalactiae screen by PCR) for two out of two years from 2020- 2021. The findings include: 1. The Laboratory Test List & Annual volume form indicated that the laboratory performed bacteriology testing including Streptococcus agalactiae screens by PCR. 2. At the time of the survey, personnel identifier #8 confirmed that the laboratory did not enroll in an approved proficiency testing program for the subspecialty of bacteriology (Streptococcus agalactiae screen by PCR) from 2020- 2021. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance specification records and confirmed by Laboratory Personnel identifier #8 (refer to the Laboratory Personnel Report) at approximately 3: 15 pm on 04/13/2021, the laboratory failed to verify the performance specifications of precision and reportable range for the HemoCue WBC (white blood cell) test system. The findings include: 1. The laboratory implemented the HemoCue WBC test system in August 2020. 2. At the time of the survey, the laboratory did not have precision or reportable range performance specification records for the HemoCue WBC test system. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plans (IQCP) and confirmed by laboratory personnel identifier #8 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 04/13/2021, the laboratory failed to establish written quality control and quality assessment plans for the following test system IQCPs: FilmArray BioFire and Clearview PBP2a SA Culture Colony Test. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of coagulation (D-dimer) and erythrocyte sedimentation rate (ESR) quality control (QC) records and confirmed by laboratory personnel identifier #8 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 04/13/2021, the laboratory failed to ensure that results of control materials met the laboratory's and manufacturer's test system criteria for acceptability before reporting coagulation (D- dimer) patient test results for 2 out of 11 days of patient testing and ESR patient test results for seven out of 24 days of patient testing in September 2020. Refer to D5783 for findings. -- 2 of 3 -- D5783