Kearny County Hospital

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) documentation and lack of QC data for an unsubstantiated Individualized Quality Control Plans (IQCP)s, the Rupture of Membrane (ROM) test, Gene Xpert Chlamydia trachomatis and Neisseria gonorrhoeae (CTNG) test, Gene Xpert Clostridioides difficile (C.diff) test, Gene Xpert Group B test, Gene Xpert Trichomonas vaginalis (TV), Gene Xpert methicillin- resistant Staphylococcus aureus (MRSA) test, QuickVue+ Infectious mononucleosis (mono) test and BD Affirm vaginitis panel for patient testing, and interview, the laboratory failed to have acceptable QC data for IQCP documentation to allow QC to be performed at the manufacturer's number and frequency or monthly and failed to perform a negative and positive control on each day of patient testing at time of survey. Findings: 1. Review of the facility's IQCP documents of the Rupture of Membrane (ROM) test revealed the laboratory performed QC new lot or new shipment. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Only 20 days of QC data was performed and no risk assessment could be presented. Two levels of QC were not performed every day of patient testing from 9/18/2019 to date of survey. 2. Review of the facility's IQCP documents of the Gene Xpert Chlamydia trachomatis and Neisseria gonorrhoeae (CTNG) test revealed the laboratory performed QC new lot or new shipment or every thirty (30) days. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Two levels of QC were not performed every day of patient 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 -- testing from 2/2/2018 to date of survey. 3. Review of the facility's IQCP documents of the Gene Xpert Clostridioides difficile (C.diff) test revealed the laboratory performed QC new lot or new shipment or every thirty (30) days. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Only 20 days of QC data could be presented. Two levels of QC were not performed every day of patient testing from 2/2/2018 to date of survey. 4. Review of the facility's IQCP documents of the Gene Xpert Group B test test revealed the laboratory performed QC new lot or new shipment or every thirty (30) days. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Two levels of QC were not performed every day of patient testing from 2/2/2018 to date of survey. 5. Review of the facility's IQCP documents of the Gene Xpert Trichomonas vaginalis (TV) test revealed the laboratory performed QC new lot or new shipment or every thirty (30) days. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Only 10 days of QC data could be presented. Two levels of QC were not performed every day of patient testing from 2/2/2018 to date of survey. 6. Review of the facility's IQCP documents of the Gene Xpert methicillin-resistant Staphylococcus aureus (MRSA) test revealed the laboratory performed QC new lot or new shipment or every thirty (30) days. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Only 20 days of QC data could be presented. Two levels of QC were not performed every day of patient testing from 2/2/2018 to date of survey. 7. Review of the facility's IQCP documents of the QuickVue+ Infectious mononucleosis (mono) test revealed the laboratory performed QC new lot or new shipment. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Only 10 days of QC data could be presented. Two levels of QC were not performed every day of patient testing from 2/2/2018 to date of survey. 8. Review of the facility's IQCP documents of theBD Affirm vaginitis panel revealed the laboratory performed QC new lot or new shipment. No substantiated QC data of new lot or new shipment interval was presented for the IQCP. Two levels of QC were not performed every day of patient testing from 4/8/2020 to date of survey. 8. Interview with technical consultant #4 on 9/25/2024 at 1:30 p.m. confirmed the laboratory failed to have acceptable QC data for IQCP documentation to allow QC to be performed at the manufacturer's number, frequency or monthly and failed to perform a negative and positive control on each day of patient testing at time of survey. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Review of eight (8) Individual Quality Control Plans (IQCP)s, and interview with the technical consultant #4 (TC#4), the laboratory director (LD) failed to ensure reviewing of quality control (QC) for analytical performance on eight (8) of eight (8) IQCPs. Findings: 1. Review of IQCPs performed from 2/2/2018 to time of survey revealed no documentation of review was performed at the time of survey. 2. The following IQCPs have not be reviewed for QC analytical performance at any time: a. Rupture of Membranes test b. BD Affirm Vaginitis Panel (includes Candida (C.) albicans, C. tropicalis, C. galbrata, C. kefyr, C. krusei, C. parapsilosis, Gardnerella vaginalis and Trichomonas vaginalis) c. QuickVue+ Infectious Mononucleosus test d. Gene Xpert methicillin-resistant Staphylococcus aureus (MRSA) test e. Gene Xpert -- 2 of 3 -- Clostridioides difficile (C. diff) test f. Gene Xpert Trichomonas vaginalis (TV) test g. Gene Xpert Group B test h. Gene Xpert Chlamydia trachomatis and Neisseria gonorrhoeae (CTNG) test 3. Interview with the technical consultant #4 (TC#4) on 9/25 /2024 at 1:30 p.m. confirmed, the laboratory director failed to ensure reviewing of QC for analytical performance on eight (8) of eight (8) IQCPs. -- 3 of 3 --

Summary Statement of Deficiencies 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 plan (IQCP), and quality control documentation, the laboratory failed to ensure the quality control testing for the OPTI-CCA blood gas analyzer was performed according to the IQCP requirements at time of survey. Findings: 1. Review of the laboratory's IQCP documentation titled "AVL OPTI 1" included a section for two external quality control (QC) frequency as "Two levels of external controls (OPTI Check) shall be performed each day of use." 2. Review of the "ABG LOG SHEET QC LOG" included: a. QC performed on September 1, 2022, October 1, 2022, and October 31, 2022. b. Patient and Proficiency testing done without QC performed weekly as required occured on: September 8, 2022, September 15, 2022, September 22, 2022, October 3, 2022, October 10, 2022, October 17, 2022 and October 24, 2022. 3. Interview with the Chief Executive Officer (CEO) and Laboratory Director on November 30, 2022 at 3:00 p.m.confirmed, the laboratory failed to ensure the quality control testing for the OPTI-CCA blood gas analyzer was performed according to the IQCP requirements. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control documentation and interview, the technical consultant (TC) failed to ensure the quality control (QC) was reviewed regularly on fifty-one analytes for seven months for shifts, trends and outlyers to maintain consistancy of QC results on the Siemens Dimension EXL (s/n: DR252105) chemistry instrument at time of survey. Findings: 1. Reveiw of the October 2022 Unity World Wide Reports showed no evidence that the TC performed a review on any of the fifty-one analytes on the Siemens Dimension EXL chemistry analyzer. 2. Interview with an external consultant, Chief Executive Officer (CEO) and laboratory director (LD) could not verify or confirm the TC performed a review of any of the QC for the Dimension EXL chemisty analyzer for the months of April, May, June, July, August, September and October of 2022. 3. Interview with the Chief Executive Officer (CEO) and Laboratory Director on November 30, 2022 at 1:15 p.m.confirmed the technical consultant (TC) failed to ensure the quality control (QC) was reviewed regularly for shifts, trends and outlyers to maintain consistancy of QC results on the Siemens Dimension EXL chemistry instrument. D6073 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(4) Each individual performing moderate complexity testing must follow the laboratory's established

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's 2019 and 2020 American Proficiency Institute (API) proficiency testing (PT) documentation and interview, the laboratory failed to verify the accuracy of hematology analytes that were assigned a ungraded proficiency testing score for 3 of 5 events. Findings: 1. Review of the laboratory's 2019 and 2020 API PT documentation for hematology found the following ungraded results: 2019 Hematology/ Coagulation 2nd Event Received "Grade" of "Not Graded" Blood Cell Identification samples ECI-06,07,08,09 and 10 2020 Hematology/ Coagulation 1st Event Received "Grade" of "Not Graded" Blood Cell Identification samples DIF-01, ECI-01,02,03,04 and 05 2020 Hematology/ Coagulation 2nd Event Received "Grade" of "Not Graded" Blood Cell Identification samples ECI-06,07,08,09 and 10 2. Review of the laboratory's PT original evaluation forms failed to find any documentation demonstrating a self-assessment or self-grade of the "Not Graded" samples. 3. Interview with General Supervisor December 2, 2020 at 11:25 a.m. confirmed the laboratory failed to verify the accuracy of hematology analytes that were assigned a ungraded proficiency testing score for 3 of 5 events. 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 --