Uhealth Pathology At Mailman

Summary Statement of Deficiencies D0000 A recertification survey was conducted from 12/09/2024 to 12/11/2024. UHEALTH PATHOLOGY AT MAILMAN clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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: Based on random patient reports review and staff interview, the laboratory failed to ensure that the patient report listed the name and address of the laboratory that performed the technical component (TC) for the test to detect level of O6- methylguanine-DNA methyl-transferase (MGMT) Methylation Promoter for two out of two patients reviewed. Findings included: 1--Review of validation method for MGMT Methylation Promoter level test revealed that was signed by the Laboratory Director on 01/16/2024. 2-Review of two final patient reports: P#1(dated 04/04/2024), and P#2 (dated 11/22/2024), revealed that the reports of the MGMT Methylation Promoter test failed to list the name and address of the laboratory that performed the TC for the test of reference. 3-During an interview on 12/11/2024 at 01:30 PM, with the laboratory manager, he confirmed that the final reports reviewed did not include the name and address of the laboratory that performed the TC for MGMT Methylation Promoter test and that the laboratory had reported 75 tests since the test was validated. 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 D0000 A recertification survey was conducted on 02/22/2023 to 03/20/2023 at UHealth Pathology at Mailman. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at 1:45 PM on 03/20 /2023. The following Condition was not met: D5400 - Analytic System 493.1250 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 review of the procedure manual and quality control (QC) records, and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and identify problems from 04/16/21 to 02/22 /23. Findings Included: Based on review of the procedure manual and quality control (QC) records and interview, the laboratory failed to run a negative control each day testing was performed on the Beckman Coulter Navios EX Flow Cytometer from 04 /16/21 to 02/22/23. (Cross Reference D5475) 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 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 -- 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: Based on observation and interview, the laboratory failed to follow manufacturer instructions for storage temperature of seven out of seven Biomerieux products used in the ETESTfrom 02/01/2023 to 02/22/2023. Findings included: During the laboratory tour on 02/22/2023 at 10:30 AM, the surveyor found reagents stored in a minus 20 Celsius Degree freezer in the Microbiology Department. The following reagents were used for the Minimum Inhibitory Concentration test (ETEST) from Biomerioeux: One box of Vancomycin lot 1009755230, one box Ceftriaxone lot 1009598200, two boxes Imipemen lot 1009371780, one box Imipenem - relebactam MIC Test Strip lot 112222039, one box Ceftaroline lot 1009747600, eight boxes Levofloxacine lot 1009399100 and one box Linezolid lot 1008695870. Reviewed of the required storage temperatures as per manufacturer showed the following storage requirements: -Vancomycin, Ceftriaxone, Imipemen and Linezolid to be stored at -20 to +8 Celsius (C) Degrees. -Imipemem-relebactan and Ceftaroline to be stored at temperatures from -20 C and below. -Levofloxacine to be stored at +2 to +8 C. - Review of the temperature log revealed an acceptable temperature range of -10 to -30 C. -See below the temperatures documented: 02/01/2023: -22.7 C 02/02/2023: -24.4 C 02/03/2023: -25.2 C 02/04/2023: -16.9 C 02/05/2023: -16.8 C 02/06/2023: -23.7 C 02 /07/2023: -22.8 C 02/08/2023: -24.8 C 02/09/2023: -23.2 C 02/10/2023: -13.7 C 02/11 /2023: -23.0 C 02/12/2023: -22.6 C 02/13/2023: -22.0 C 02/14/2023: -22.0 C 02/15 /2023: -22.9 C 02/16/2023: -23.7 C 02/17/2023: -25.3 C 02/18/2023: -22.8 C 02/19 /2023: -23.3 C 02/20/2023: -23.2 C 02/21/2023: -18.3 C 02/22/2023: -25.3 C Review of the recorded temperatures revealed the following: -Vancomycin, Ceftriaxone, Imipemen and Linezolid the documented storage temperatures were outside of the acceptable range on: 02/01/2023, 02/02/2023, 02/03/2023, 02/06/2023, 02/07/2023, 02 /08/2023, 02/09/2023, 02/11/2023, 02/12/2023, 02/13/2023, 02/14/2023, 02/15/2023, 02/16/2023, 02/17/2023, 02/18/2023, 02/19/2023, 02/20/2023, 02/22/2023. - Imipemen-relebactan and Ceftaroline, the documented storage temperatures were outside of the acceptable range in the following dates: 02/04/2023, 02/05/2023, 02/10 /2023 and 02/21/2023. -Levofloxacine the documented storage temperatures were outside of the acceptable range from 02/01/2023 to 02/22/2023. During an interview on 02/24/2023 at 12:30 PM, the Microbiology Supervisor confirmed that the reagents listed above were stored outside of the acceptable range as per manufacturer instructions in the days of reference. 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 review of the procedure manual and quality control (QC) records and -- 2 of 4 -- interview, the laboratory failed to run a negative control each day patient testing was performed on the Beckman Coulter Navios EX Flow Cytometer for 2 of 2 (October 2021 and April 2022) months reviewed. Findings included: Review of the daily alignment check, detector standardization, color compensation and verification QC records for October 2021 and April 2022, revealed there was no negative control run. A total of 7,839 Leukemia/Lymphoma panels were tested using the Beckman Coulter Navios EX Flow Cytometers from 04/16/21 to 02/22/23. The laboratory used the all three Flow Cytometer to diagnose and monitor leukemia and lymphoma. The laboratory evaluated the following antibodies: CD 2 (T cell lymphocytic marker), CD3 (T cell lymphocytic marker), CD4 (T cell lymphocytic marker), CD5 (T cell lymphocytic marker), CD7 (T cell lymphocytic marker), CD8 (T cells marker), CD9 (leukocyte marker), CD10 (follicle center cells marker), CD11c (dendritic cell marker), CD13 (myeloid cells marker), CD14 (monocytes and macrophages marker), CD15 (myeloid cells marker), CD16 (granulocytes and natural killer cell marker), CD19 (B cell marker), CD20 (B cell marker), CD22 (B cell lymphocytic marker), CD27 (B cell lymphocytic marker), CD33 (monocytes and macrophages marker), CD34 (hematopoetic stem cells marker), CD38 (plasma cells and activated T and B cells marker), CD45 (leukocyte marker), CD56 (natural killer cells marker), CD58 (lymphocytic marker), CD64 (monocytes and macrophages marker), CD71 (erythroid marker), CD79a (B cell lymphocytic marker), CD81 (plasma cell marker), CD103 (alloantigen-induced regulatory T cells marker), CD117 (stem cell and plasma cells marker), CD123 (hematopoietic progenitor cell marker), CD 138 (plasma cell marker), CD200 (lymphocytic marker), CD229 (plasma cell marker), CD319 (lymphocytic marker), HLA-DR (Human Leukocyte Antigen - DR isotype T cell marker), Kappa (light chain B cell markers), and Lambda (light chain B cell markers), MPO (myeloperoxidase marker), and TdT (Terminal deoxynucleotidyl transferase marker). On 02/24/2023 at 11:02 AM, the Technical Supervisor A stated that they only ran a positive verify control for the last 23 months and that the laboratory did not have an IQCP (Individualized Quality Control Plan). D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation, review of the procedure manual and interview, the laboratory failed to have a step-by-step procedure that explained how they performed the instrument to instrument comparison and how they defined the acceptability between test results for the Beckman Coulter Navies Flow Cyclometer instrument to instrument comparisons from 11/18/2022 to 02/22/2023. Findings Included: A tour of the laboratory on 02/22/2023 at 9:45 AM revealed there were three flow cyclometers (serial numbers A50, BE 28603, BE 32611). Review of the flow cytometry procedure manuals showed there was no procedure for the performance of the instrument to instrument comparison for the flow cytometers. The last annual review of the flow cytometry procedures by the Laboratory Director was signed and dated on 11/18 /2022. The laboratory used all three Flow Cytometers to diagnose and monitor leukemia and lymphoma. The laboratory evaluated the following antibodies: CD 2 (T -- 3 of 4 -- cell lymphocytic marker), CD3 (T cell lymphocytic marker), CD4 (T cell lymphocytic marker), CD5 (T cell lymphocytic marker), CD7 (T cell lymphocytic marker), CD8 (T cells marker), CD9 (leukocyte marker), CD10 (follicle center cells marker), CD11c (dendritic cell marker), CD13 (myeloid cells marker), CD14 (monocytes and macrophages marker), CD15 (myeloid cells marker), CD16 (granulocytes and natural killer cell marker), CD19 (B cell marker), CD20 (B cell marker), CD22 (B cell lymphocytic marker), CD27 (B cell lymphocytic marker), CD33 (monocytes and macrophages marker), CD34 (hematopoetic stem cells marker), CD38 (plasma cells and activated T and B cells marker), CD45 (leukocyte marker), CD56 (natural killer cells marker), CD58 (lymphocytic marker), CD64 (monocytes and macrophages marker), CD71 (erythroid marker), CD79a (B cell lymphocytic marker), CD81 (plasma cell marker), CD103 (alloantigen-induced regulatory T cells marker), CD117 (stem cell and plasma cells marker), CD123 (hematopoietic progenitor cell marker), CD 138 (plasma cell marker), CD200 (lymphocytic marker), CD229 (plasma cell marker), CD319 (lymphocytic marker), HLA-DR (Human Leukocyte Antigen - DR isotype T cell marker), Kappa (light chain B cell markers), and Lambda (light chain B cell markers), MPO (myeloperoxidase marker), and TdT (Terminal deoxynucleotidyl transferase marker). On 02/23/2023 at 10:56 AM, Technical Supervisor A stated they did not have a policy for instrument to instrument comparison. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 04/1/2021 to 4/16/2021 found the clinical laboratory UHEALTH PATHOLOGY AT MAILMAN was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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: Based on observation and staff interview, the laboratory failed to remove reagents from the laboratory that expired after February and March 2021. Findings include: During laboratory tour on 04/01/2021 at 10:00 am, the surveyor found: a) In a refrigerator on Microbiology room #6014, the following expired reagents were identified: -96 Well Spectral Calibration Plate with JUN Dye for Multiplex qPCR lot 2010087 expired on 3/24/21 -96 Well Spectral 0.2 ml Calibration Plate lot 2062075 expired on 3/3/21 -96 Well Spectral Calibration Plate lot 2002067 expired on 3/7/21 -96 Well Spectral 0.2 ml Calibration Plate lot 2002063 expired on 2/2/21 b) In the second Microbiology room Binwax Now Streptococus Control Swabs lot 107210 and 107833 was on a shelf expired on 3/28/21. c) In Cytogenetics room at 10:30 am Straight From TM Whole Blood CD138 Microbeads lot 5200906145 reagent was in a refrigerator expired on 3/19/21. During an interview on 4/1/2021 at 10:00 am with Microbiology Supervisor, she explained that the materials of reference were not currently in use. An interview with Cytogenetics Supervisor at 10:30 am,she explained that the laboratory was not using the reagent of reference. D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) 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 -- (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide documentation of COVID-19 validation instrument data printouts with serial numbers for the following instruments: ABI 7500 Fast (ABIF1), ABI 7500 fast (ABIF2), ABI 7500 (ABIS), QuantStudio 7 (QS7), ABI 7500 (ABIS2), QuantStudio 7-2 (QS7-2), QuantStudio 7-1 (QS7-1) and QuantStudio 7-3 (QS7-3). Findings include: Review of COVID-19 testing records revealed the following instruments in use : 1.ABIF1 used for CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC-EUA) starting on 4 /21/2020. 2.ABIF2 used for CDC-EUA starting on 4/28/2020. 3.ABIS used for PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PE-EUA) and Direct PCR for detection of SARS-COV2 (LDT) starting on 7/8/2020. 4.QS7 used for PE-EUA, CDC-EUA starting on 7/27/2020. 5.ABIS2 used for PE-EUA and LDT starting on 9 /14/2020. 6.QS7-2 used for PE-EUA, LDT starting on 10/2/2020. 7.QS7-1 used for LDT starting on 1/26/2021. 8.QS7-3 used for LDT starting on 2/12/2021. Review of COVID-19 validation instrument records revealed no documentation of instrument data printouts with serial numbers for ABI 7500 Fast, ABI 7500 fast, ABI 7500, QuantStudio 7, ABI 7500, QuantStudio 7-2 , QuantStudio 7-1 and QuantStudio 7-3. During an interview on 4/16/2021 at 12pm, the laboratory director confirmed no documentation of instrument data printouts was provided for ABI 7500 Fast, ABI 7500 fast, ABI 7500, QuantStudio 7, ABI 7500, QuantStudio 7-2, QuantStudio 7-1 and QuantStudio 7-3 in Covid-19 validations. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on December 21, 2020 for UHealth Pathology at Mailman. The laboratory, UHealth Pathology at Mailman, is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of Mycobacteriology. Refer to D2037. Findings include: Review of the Collage of American Pathologists (CAP) proficiency testing records and the review of 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 -- the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on December 21, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the subspecialty of mycobacteriology for two consecutive testing events in 2020. D2037 MYCOBACTERIOLOGY CFR(s): 493.825(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of mycobacteriology. Findings include: On December 21, 2020 on or about 10:00 AM the College of American Pathologists (CAP) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the subspecialty of mycobacteriology, as shown below. Event #1, 2020 Mycobacteriology-16% Event #2, 2020 Mycobacteriology- 16% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of mycobacteriology Findings include: On December 21, 2020, on or about 10:00 AM, the College of American Pathologists (CAP) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events in the subspecialty of mycobacteriology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2037. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a -- 2 of 3 -- manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of mycobacteriology Findings Include: The review of the College of American Pathologists (CAP) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on December 21, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2020 Mycobacteriology-16% Event #2, 2020 Mycobacteriology-16% -- 3 of 3 --