Nova Southeastern University - Inim Em Papper

Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Nova Southeastern University - Inim EM Papper Clinical Immunology Laboratory from 07/16/2024 to 07 /17/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: -D5400 Analytic Systems. CFR 493.1250 -D6168 Testing Personnel. CFR 493.1487 -D6076 Laboratory Director. CFR 493.1445 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the Testing Personnel (TP) failed to sign attestation for Proficiency Testing (PT) for Hematology specialty off cycle event in 2023, and the TP and Laboratory Director (LD) failed to sign attestations for Infectious Disease Serology 1st event in 2024. Findings included: 1- Review of the PT off cycle event dated October 10, 2023, from College of American Pathologist (CAP) Hematology Automated Differential Survey FH9-C 2023 revealed that the TP failed to sign attestation for the off cycle event performed on 09/20/2023. 2- LD and TP failed to sign attestation on April 02, 2024 from College of American Pathologist (CAP) VR3-A Infectious Disease Serology proficiency testing event. 3- Interview on 7 /16/2024 at 02:26 PM the Laboratory General Supervisor admitted there were no records of signatures. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of quality control (QC) records and interview, the laboratory failed to perform maintenance for Beckman Coulter Navios as specified by the manufacturer for three out of three years reviewed (2022, 2023 and 2024) (Refer to D5429), failed to run a positive and negative control each day testing on the Beckman Coulter Navios Flow Cytometer for two out of two years (2022 and 2023), and failed to run a negative control each testing day on the Beckman Coulter Navios Flow Cytometer for seven months (January to July 2024). Refer to D5475. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform maintenance for Beckman Coulter Navios as specified by the manufacturer for three out of three years reviewed (2022, 2023 and 2024). Findings included: 1- Filter replacement records for the Beckman Coulter Navios serial number AZ24273, were not provided for the years 2022, 2023 and 2024. 2- Review of the instrument manual PN A96247AD section 11 and laboratory procedure refer to Maintenance Log. Step 2. Filter cleaning a. Filter must be replaced every 6 months. 3- Interview on 07/16/2024 at 4:15 PM the Laboratory Office Manager stated that records would be sent via email 07/17/2024. Records for filter replaced every 6 months were not received 07/17/2024. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) records and interview, the laboratory failed to run a negative and positive control each day patient testing was performed on the Beckman Coulter Navios EX Flow Cytometer for 2 of 2 (2022 and 2023) years. Based on review of QC records and interview the laboratory failed to run a negative control each day patient testing was performed from 01/01/2024 to 07/15/2024 on the Beckman Coulter Navios EX Flow Cytometer. Findings included: 1-Review of the Navios Ex flow Cytometer records revealed that there was no positive and negative -- 2 of 6 -- control run for 2022 and 2023. 2-Review of the QC records from 01/01/2024 to 07/15 /2024 revealed that no negative control were ran during this period. 3-Review of Immuno-Trols records for February, May, June and July revealed that the Immuno- Trols cells (positive controls) were used on 02/13/2024, 05/13/2024, 06/26/2024 and 07/02/2024. 4-Results review of Patient(P)#1 (tested on 06/06/2024) on the Navios revealed that no positive or negative controls were used on the testing day. 5-Results review of P#2 (tested on 07/12/2024) on the Navios revealed that no positive or negative controls were used on the testing day. 6-A total of 932 patients were tested using the Beckman Coulter Navios EX Flow Cytometers during 2022 and 2023 with no positive and negative controls. A total of 257 patients were tested on 2024 using positive controls from 01/01/2024 to 07/16/2024 once per month instead of each day of testing. 7-The laboratory evaluated the following antibodies: -CD 2 (T cell lymphocytic marker). - CD3 (T cell lymphocytic marker). - CD4 (T cell lymphocytic marker). -CD8 (T cells marker). - CD19 (B cell marker). - CD3/CD4, CD3/CD8. - CD3-/CD56+ (Natural Killer cells). 8-Based on interview on 07/16/2024 at 02:30 PM, the Laboratory Office Manager stated that they only ran a Immuno-Trols positive control once for the last seven months. The Laboratory Office Manager also confirmed that the laboratory tested P#1 and P#2 without running a positive and negative control and that the laboratory did not have an IQCP (Individualized Quality Control Plan) to run controls monthly instead of each day of testing. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that three out of four Testing Personnel (TP) performing tests in the specialty of Hematology and subspecialty of General Immunology met the requirements specified in Section 493.1425 for moderate complexity testing, they failed to have Florida State Licensure (Refer to D6064) and failed to verify the foreign Diploma for one out of four TP (Refer to D6065). D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that two out of three Testing Personnel performing tests in the specialty of Hematology and subspecialty of General Immunology met the requirements specified in Section 493.1425 for moderate complexity testing. Findings included: 1-Review of Centers for Medicare and Medicaid Services FORM 209, Laboratory Personnel (CLIA), revealed that the Laboratory Director was also the Clinical Consultant and Technical Supervisor. The laboratory listed three Testing Personnel (TP) performing high complexity testing (TP#1, TP#2 and TP#3), and one TP (TP#4) performing only -- 3 of 6 -- moderate complexity testing. 2-Review of Testing Personnel records revealed that: - TP#2 had a PhD in Biology and Florida State Licensure for Microbiology but did not have Florida State Licensure for Hematology and Immunology. -TP#3 had a Bachelor of Science, but did not have Florida State Licensure. -TP#4 had a Bachelor of Science, but did not have Florida State Licensure. 3-Review of Daily Maintenance books for year 2023 and year 2024 revealed the following: TP#4, ran controls for XN- 430 in June, May, April of 2024. TP#2 ran controls for XN-430 in December 2023 and signed