Peak Clinical Diagnostics Llc

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 review of proficiency testing evaluation reports from the proficiency 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 -- testing provider, American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance scores for two consecutive events for RBC, HCT (non- waived), and HGB (non-waived) proficiency testing for event 1 in 2025 and event 2 in 2025, see D2130. Additionally, the laboratory failed to achieve an overall satisfactory performance score for Hematology for two consecutive events (event 1 in 2025 and event 2 in 2025), see D2131. 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 review of the CMS-155 Individual Laboratory Profile report for proficiency testing (PT) performance and a review of the proficiency testing evaluation report provided by the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance scores for RBC, HCT (non-waived), and HGB (non-waived) proficiency testing for event 1 in 2025 and Event 2 in 2025. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on 12/24 /2025 at 11:30 AM, revealed the RBC score for event 1 in 2025 was 60%, and the score for event 2 in 2025 was 60%; the HCT (non-waived) score for event 1 in 2025 was 60%, and the score for event 2 in 2025 was 60%, the HGB (non-waived) score for event 1 in 2025 was 60%, and the score for event 2 in 2025 was 60%. 2. A review of the PT evaluation report from the provider, API, on 12/24/2025 at 12:00 PM revealed the RBC score for event 1 in 2025 was 60%, and the score for event 2 in 2025 was 60%; the HCT (non-waived) score for event 1 in 2025 was 60%, and the score for event 2 in 2025 was 60%, the HGB (non-waived) score for event 1 in 2025 was 60%, and the score for event 2 in 2025 was 60%. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) 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 a review of the CMS-155 Individual Laboratory Profile report for proficiency testing (PT) performance and a review of the proficiency testing evaluation report provided by the American Proficiency Institute (API), the laboratory failed to achieve overall satisfactory performance scores for Hematology for event 1 in 2025 and Event 2 in 2025. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on 12/24/2025 at 11:30 AM, revealed the overall Hematology proficiency testing score for event 1 in 2025 was 79%, and the score for event 2 in 2025 was 62%. 2. A review of the PT evaluation report from the provider, API, on 12/24/2025 at 12:00 PM revealed the overall Hematology proficiency testing score for event 1 in 2025 was 79%, and the score for event 2 in 2025 was 62%. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site initial certification survey conducted on June 17, 2025, through June 23, 2025, the following condition level deficiencies were cited for Peak Clinical Dignostics, LLC in Aurora, Colorado: 493.1250 Condition: Analytic systems; and 493. 1459 Condition: Laboratories performing high complexity testing; general supervisor 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 a review of proficiency testing (PT) records, the laboratory's policies and procedures manual, an interview with the general supervisor (GS), and technical supervisor 2 (TS2), the laboratory failed to test their hematology PT specimens in the same manner it tests routine patient specimens. Findings include: 1. A review of the laboratory's Pentra XL hematology instrument printouts accompanying the American Proficiency Institute (API) PT records for event 1 of 2025 in the specialty of hematology revealed that the laboratory ran all 5 of the 2025 hematology event 1 PT specimens on both of the laboratory's Pentra XL instruments. 2. A review of the laboratory's PT policy stated that " ... proficiency testing specimens are to be handled and analyzed exactly as patient specimens ... these specimens should not be run multiple times or on multiple instruments." 3. An interview with the GS, on June 17, 2025, at approximately 11:00 AM, confirmed that the laboratory did not treat the 2025 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- hematology event 1 PT specimens like patient specimens by running all 5 of the 2025 hematology event 1 PT specimens on both of the laboratory's Pentra XL instruments, against the laboratory's PT policy stating: " ... proficiency testing specimens are to be handled and analyzed exactly as patient specimens ... these specimens should not be run multiple times or on multiple instruments." 4. An interview with TS2, on June 17, 2025, at approximately 11:05 AM, confirmed that the laboratory did not treat the 2025 hematology event 1 PT specimens like patient specimens by running all 5 of the 2025 hematology event 1 PT specimens on both of the laboratory's Pentra XL instruments, against the laboratory's PT policy stating: " ... proficiency testing specimens are to be handled and analyzed exactly as patient specimens ... these specimens should not be run multiple times or on multiple instruments." 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 the number of the deficiencies cited herein, the laboratory is not in compliance with the Condition: Analytic Systems. The laboratory failed to monitor the quality of the water produced by its water purification system; failed to monitor the temperature and humidity of each room where patient testing is performed; failed to calibrate its thermometers used in refrigerators and freezers annually (See D5413), the laboratory failed to verify the manufacturer's stated reference intervals (normal values) were appropriate for the laboratory's patient population (see D5421), failed to verify the acceptable ranges and means of liquid assayed chemistry quality control materials (see D5469), failed to establish a system to evaluate at least twice a year the relationship between test results from their Horiba Pentra XL hematology instruments (see D5775), failed to establish a system to identify and assess patient test results that are inconsistent with previous patient results or are inconsistent with other test parameters (see D5777), and failed to document the