National Jewish Health

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; 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 a routine desk review of the CMS-155 report for proficiency testing performance and email communication with the laboratory's quality manager, the 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 -- laboratory failed to achieve satisfactory performance scores for the College of American Pathologist's proficiency testing for RBC, and HCT (non-waived) for two consecutive proficiency testing events, (event 1 in 2025 and event 2 in 2025). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing (PT) performance, and email communication with the laboratory's quality manager, the laboratory failed to achieve a satisfactory score for two consecutive College of American Pathologist's (CAP) PT events for the analyte: RBC, and HCT (non- waived) for event 1 and event 2 in 2025. Findings include: 1. A review of the CMS- 155 report for PT performance on August 5, 2025, at 11:59 AM, revealed the CAP PT results for the analyte: RBC, was 40% for event 1, and 60% for event 2 in 2025. 2. A review of the CMS-155 report for PT performance on August 5, 2025, at 11:59 AM, revealed the CAP PT results for the analyte: HCT (non-waived), was 20% for event 1, and 60% for event 2 in 2025. 3. An email communication with the laboratory's quality manager, on August 5, 2025, at 3:41 PM, confirmed the laboratory failed to achieve satisfactory PT scores for the analytes RBC, and HCT (non-waived) for two consecutive testing events, event 1 and 2 in 2025. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a record review of proficiency testing (PT) records and an interview with the laboratory quality assurance manager, the laboratory failed to test the complete blood count (CBC) PT samples from the College of American Pathologists (CAP) by personnel who routinely test patient samples since the last survey on January 8, 2021. Findings include: 1. A review of the CAP PT documents from Event 3/2021, through Event 2/2023, revealed the laboratory failed to test the CBC PT samples by personnel who perform patient testing since the last survey. 2. An interview with the laboratory quality assurance manager on 11/2/2023, at approximately 11:30 AM, confirmed the laboratory testing personnel failed to follow the instructions for rotating the testing of PT samples with testing personnel who perform normal patient tests. 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 a record review of patient test reports and an interview with the laboratory technical consultant (TC), the laboratory failed to include the testing laboratory's name and address of where patient samples for complete blood counts (CBC) were performed since May 2023. Findings include: 1. A review of patient CBC test reports revealed the laboratory failed to ensure the name of the laboratory and the address was stated on the test reports. 2. The laboratory performed approximately 4300 CBC tests in 2023. 3. An interview on 11/2/2023, at 1:30 PM, with the TC, confirmed the laboratory name and the address was not included on the patient test reports. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing documentation, Complete Blood Count procedure, and interview with staff, the laboratory failed to test proficiency testing samples the same number of times it routinely tests patient samples for five of six proficiency testing events from 2016 through 2018, Findings include: 1. Review of proficiency testing documents revealed all proficiency testing samples from the American Proficiency Institute (API) Hematology/Coagulation module were run in duplicate for the following modules: 2016 Events 2 and 3, 2017 Events 1 and 2, and 2018 Event 1. 2. Review of the Complete Blood Count procedure stated "samples should be rerun if original results are flagged". 3. In an interview on 08/09/2018 at approximately 1030 AM, the primary testing technologist and quality management coordinator confirmed all proficiency testing samples from the API Hematology /Coagulation modules were run in duplicate which is not in accordance with the complete blood count 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 1 --