Summary:
Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratories Individualized Quality Control Plan (IQCP) for Routine Chemistry performed on the iStat analyzer and interview with the Technical Supervisor (TS), the laboratory failed to monitor, assess, and when indicated, correct problems identified in the preanalytic system in the calendar year 2022 the finding includes. 1. There was no documented evidence that the IQCP log "Virtua - Moorestwon Cancer Center "Quality Assessment" i-stat (chem8+)" which included review of the preanalytic system was completed in the calendar year 2022 2. The TS confirmed on 7/18/23 at 12:00 PM that the laboratory failed to monitor, assess, and when indicated, correct problems identified in the preanalytic system . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Procedure Manual (PM), Final Report (FR) and interview with the Techincal Supervisor (TS) the laboratory failed to have a procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for calculating estimated Glomerular Filtration Rate (eGFR) testing on the date of survey. The TS confirmed on 7/19/23 at 10:30 am that the laboratory procedure for calculating eGFR. b) Based on surveyor review of the PM, lack of Quality Control Verification (QVC) records and interview with the Techincal Supervisor (TS) the laboratory failed to have a procedure for QVC for routine chemistry testing on the date of survey. The TS confirmed on 7/19/23 at 10:30 am that the laboratory procedure for calculating eGFR. 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 surveyor review of Quality Control (QC) records and interview with the Techincal Supervisor (TS), the laboratory failed to verify commercial QC material with each new lot and/or shipment of QC used for Routine chemistry tests performed on iStat analyzer on the date of survey. The finding includes: 1. There was no documented evidence that QC was verified before being put into use. 2. The TS confirmed on 7/19/23 at 12:20 pm that the QC material was not verified before putting in use. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of