Littleton Pediatric Medical Center

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on May 7, 2026, deficiencies were cited for Littleton Pediatric Medical Center in Highlands Ranch, Colorado. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on surveyor review of College of American Pathologists (CAP) laboratory proficiency testing (PT) records and an interview with the technical consultant (TC), the laboratory failed to ensure that Hematology Auto Differentials PT samples (Event 1, 2026) were tested in the same manner as patient specimens for 5 of 5 samples. The findings include: 1. Surveyor review of the laboratory PT records for Hematology Auto Differentials FH16 Event 1 revealed that testing personnel 1 (TP1) performed testing on samples 01-05 on January 26, 2026, and testing personnel 2 (TP2) performed testing on the same five samples on January 30, 2026. 2. During an interview on May 7, 2026, at 11:00 AM, the TC confirmed that the laboratory's regular procedure for patient specimens is to have only one staff member perform and report a hematology auto differential. 3. The TC further confirmed that by having both 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 -- TP1 and TP2 test the same set of PT samples prior to submitting the results, the laboratory failed to treat the PT samples in the same manner as they would have handled routine patient specimens D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (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 surveyor review of College of American Pathologists (CAP) laboratory proficiency testing (PT) records and an interview with the technical consultant (TC), the laboratory failed to ensure that Hematology Auto Differentials PT samples (Event 1, 2026) were tested the same number of times as routine patient specimens for 5 of 5 samples. The laboratory staff tested the PT samples three times (triplicate), while the routine laboratory procedure required patient specimens to be tested only two times (duplicate). The findings include: 1. Surveyor review of the laboratory PT records for the Hematology Auto Differentials Event 1 (2026) revealed that testing personnel 1 (TP1) and testing personnel 2 (TP2) performed testing on samples 01-05 three times each. 2. During an interview on May 7, 2026, at 11:30 AM, the TC confirmed that the laboratory's routine standard operating procedure for patient samples is to perform testing two times.The TC further confirmed that for the 2026 Hematology Auto Differentials Event 1 PT samples, TP1 and TP2 performed the testing three times, which did not follow the routine practice used for patient specimens. -- 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 review of the laboratory's competency records, proficiency testing (PT) records, and an interview with the laboratory's technical consultant (TC1), the laboratory failed to rotate the testing of PT samples in the microbiology, hematology, and urology subspecialties between the four testing personnel (TPs) competent to and regularly performing testing in theses subspecialties during all PT events from 2022 through 2024. The laboratory performs approximately 11,466 tests annually. Findings include: 1. A review of the laboratory's competency records showed that of the four TPs listed on form CMS-209, all four were competent to and regularly performed microbiology, hematology, and urology testing in the laboratory. 2. A review of the laboratory's PT attestations and records from 2022 through 2024 revealed that only one of four TPs competent to and regularly performing microbiology, hematology, and urology testing in the laboratory had participated in any events from 2022 through 2024. 3. An interview with TC1 on 07/01/2024 at approximately 11:00 A.M. confirmed that only one of the four TPs competent to and regularly performing microbiology, hematology, and urology testing in the laboratory had handled PT samples for these subspecialties from 2022 through 2024. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory's competency records and policies, and an interview with the laboratory's technical consultant (TC1), the laboratory failed to establish and follow written policies to assess the competency of three out of three technical consultants (TCs) and two out of two clinical consultants (CCs), since the last survey on 08/13/2021. The laboratory performs approximately 11,466 tests annually. Findings include: 1. A review of the laboratory's records showed that there were no recorded assessments of consultant competency, since the last survey on 08/13 /2021. 2. A review of the laboratory's policies and procedures revealed that there was no written policy for the assessment of consultant competency. 3. An interview with TC1 on 07/01/2024 at approximately 11:00 A.M. confirmed that the laboratory did not have a written policy to assess the competency of consultants and had not been doing so since the last survey on 08/13/2021. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records, and an interview with the laboratory's technical consultant (TC1), the laboratory failed to evaluate and document the evaluation of PT results received from the the College of American Pathologists (CAP), since the laboratory's last survey on 08/13/2021. The laboratory performs approximately 11,466 tests annually. Findings include: 1. A review of the laboratory's PT records showed that no evaluation or documentation of PT results review were recorded when the laboratory received a score of less than 100% for any analytes. 2. An interview with TC1 on 07/01/2024 at approximately 11: 00 A.M. confirmed that the laboratory did not document or perform any evaluation or