Jfk Medical Center Satellite Emergency

Summary Statement of Deficiencies 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), and interview with the General Supervisor (GS), the laboratory failed to have a procedure for a bi-annual method comparison between i-Stat analyzers for Routine Chemistry from 10/6/22 to the date of survey. The GS confirmed on 10/9/24 at 12:30 pm that the laboratory failed to have the above mentioned procedure. b) Based on surveyor review of the PM and interview with the GS, the laboratory failed to have a complete Quality Control Verification (QVC) procedures for Hematology testing from 10/6/22 to the date of survey. The findings include: 1) The procedure "G. new Lot crossover or parallel studies" does not specify the the amount of times the Quality Control (QC) material is to be run before being put into use. 2) The procedure "G. new Lot crossover or parallel studies" does no have procedure to compare QVC results with the values on the Manufactures assay sheet. 3) The GS confirmed on 10/9/24 at 12:30 pm that the laboratory failed to follow the have the aforementioned procedures. 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 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 -- 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 the lack of an Individualized Quality Control Plan (IQCP) and interview with the General Supervisor (GS) the Laboratory failed to have an approved Risk Assesment (RA), Quality Control Plan (QCP) and Quality Assessment (QA) plan for Routine Chemistry performed on the i-Stat and Alere Triage analyzers from 10/6/22 to the date of survey. The findings include: 1) The GS stated the laboratory followed the IQCP plan for Routine Chemistry performed on the i-Stat and Alere Triage analyzers. 2) There was no documented evidence that an IQCP was completed for Routine Chemistry performed on the i-Stat and Alere Triage analyzers 3) The GS confirmed on 10/9/24 at 11:00 am the laboratory failed to have an approved Quality Control Plan (QCP) for Routine Chemistry. 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 the lack of Quality Control Verification (QCV) records and interview with the General Supervisor (GS), the laboratory failed to verify QC material before use for routine chemistry and Hematology tests performed on the Sysmex XN-430, i-Stat, and Alere Triage from 10/6/2022 to the date of survey. The findings include: 1) There was no documented evidence that QCV was performed on the aforementioned analyzers. 2) The GS confirmed 10/9/2024 at 1:15 pm there was no documented evidence that QC material was verified before putting in use. 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: -- 2 of 4 -- Based on the lack of laboratory's Individualized Quality Control Plan (IQCP) and interview with the General Supervisor (GS) the laboratory failed to have documentation of data used to support their Risk Assessment (RA) for testing on the Stat and Alere Triage before reporting patient results from 10/6/22 to the date of the survey. The GS confirmed at 12:30 PM on 10/9/24 the laboratory did not have documentation of controls used to support their RA. 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 surveyor review of the Procedure Manual and interview with General Supervisor (GS) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 10/6/22 to the date of survey. The findings include: 1. The Laboratory failed to have a

Summary Statement of Deficiencies 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 the lack of Quality Control Verification (QCV) records and interview with the General Supervisor (GS), the laboratory failed to verify QC material before use for Lactate tests performed on the Nova Statstrip on the date of survey. The GS confirmed 10/6/22 at 1:15 pm that QC material was not verified before putting in use. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel 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 -- who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), Test Report (TR) and interview with the General supervisor (GS), the laboratory failed to maintain an accurate information system for Hematology, Endocrinology and routine Chemistry tests from 2/25/20 to the date of the survey. The findings include: 1. Review of the AL and revealed: a. Three out of eight AL entries had no collection time, date or tests ordered. b. Eight out of eight TR had collection times dates and test results. 2. The GS confirmed at 2:45 pm on 10/6/22 the laboratory did not main an accurate information system. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Test Report (TR) and interview with the General Supervisor (GS)), the laboratory failed to report Covid 19 testing accurately on the date of survey. The finding includes: 1. The laboratory performed COVID 19 non Food and Drug Administration (FDA) cleared tests. 2. A review of three out of three Covid 19 TR revealed that the The FDA COVID EUA statement appeared in the EMR but did not appear on the TR when printed. 3. The GS confirmed on 10/6/22 at 3: 00 pm that COVID 19 tests were not reported accurately. . -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the General Supervisor (GS), the laboratory failed to establish a procedure for verifying manually entered results from 3/22/18 to the date of survey. The GS confirmed on 2/25 /20 at 12:10 pm that the laboratory did not have the procedure mentioned above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 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 surveyor review of Performance Specifications (PS) records and interview with the General Supervisor (GS), the laboratory failed to verify accuracy for Human Chorionic Gonadotropin tests performed on the Abbott I-Stat analyzer before reporting patient test results from February 2018 to the date of survey. The GS confirmed on 3/22/18 at 3:30 pm the PS was not done. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Test Report (TR) and interview with the General Supervisor (GS) the laboratory failed to have all the required information on the TR from February 2018 to the date of survey. The findings include: 1. Lactate test did not have a reference range. 2. The name and address of the laboratory performing the test was not on the TR. 3. The GS confirmed on 3/22/18 at 2:35 pm that the TR did not have all the required information. -- 2 of 2 --