Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through observation, manufacturer's instrument instructions, review of lab environmental records for 2021 and 2022, and interview, it was determined that the room humidity, as required for the Cobas e-801 chemistry analyzer, the Sysmex XN- 550 hematology analyzer, and the MiniSed erythrocyte sedimentation rate instrument had not been monitored in 21 of 21 months in 2021 and 2022. Survey findings include: A) During an initial tour of the laboratory at 9:13 a.m. on 9/14/2022 the Cobas e-801 chemistry analyzer, the Sysmex XN-550 hematology analyzer, and the MiniSed erythrocyte sedimentation rate instrument were observed in the main laboratory room. B) Review of manufacturer's instrument instructions revealed an operating humidity range of 30% to 85% for the Cobas e-801, 20% to 85% for the Sysmex XN-550 and 15% to 85% for the MiniSed. C) Review of lab environmental records for 2021 and 2022 revealed that the room humidity had not been documented in 21 of 21 months reviewed. D) In an interview during the initial tour of the laboratory (9:13 a.m. on 9/14/2022), employee #2, as listed on the CMS-209, stated that laboratory humidity is not monitored. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory had Total PSA CalCheck and Vitamin B12 CalCheck available for use when it had exceeded it's expiration date. Survey findings include: A. During a tour of the laboratory at 2:33 p.m. on 9/14/2022, the surveyor observed one package of Total PSA CalCheck (lot # 45624101 expiration 6/30/2021) and one package of Vitamin B12 CalCheck (lot # 44019102 expiration 8/31/2022) in Refrigerator #2 in the main room of the laboratory. B. In an interview, at 2:33 p.m. on 9/14/2022, laboratory employee #2 (as listed on the form CMS-209), confirmed the expired CalCheck and stated that the expired CalChecks could be used for troubleshooting of the Cobas test system. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the Individualized Quality Control Plans (IQCP) for the microbiological media, and the IQCP for Meridian Revogene Clostridium difficile test system, and through interviews with laboratory staff, it was determined the laboratory failed to establish the number and type of control materials used for all test methods. Survey findings follow: A. A review of the IQCP binder revealed the laboratory had developed IQCP for the microbiological media and Meridian Revogene Clostridium difficile tests. During the review it was determined the Quality Control Plan failed to state the number and frequency of controls to be run or the specific type of control which would be used in two of two IQCP reviewed. B. In an interview at 2:20 on 9/14 /2022, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of specific type of control, number of controls and frequency of control in two of two Quality Control Plans reviewed. 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 -- 2 of 5 -- 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: . Through a review of the CMS-116, ALCOR SEDITROL package insert, Quality Control (QC) records, as well as interviews with laboratory staff, it was determined the laboratory failed to establish the criteria for acceptability of Erythrocyte Sedimentation Rate (ESR) control. Survey Findings Follow: A. The laboratory utilizes ALCOR Scientific MiniSED automatic analyzer to perform ESR assay with an annual test volume of 609 assays. A review of package insert for ALCOR SEDITROL for automated Sedimentation Rate states: "It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as a guide." B. A review of ESR quality control data for January-May 2022 revealed the mean and acceptable range in five of five months reviewed matched the expected range as listed on the ALCOR SEDITROL package insert: January- May 2022 Lot # C139 (expiration date 07/25/2022) range (1-17 mm/hr) and Lot # C239 (expiration date 07/25/2022) range (37-89 mm/hr): C. The surveyor requested documentation of established ranges for ESR quality controls. None was provided. D. In an interview on 09/14/2022 at 1438 laboratory employee #2 (as listed on CMS-209) confirmed that the laboratory had not established their own mean and range for ESR quality controls. The laboratory uses the manufactures ranges for the ESR control. D5783