Denver Recovery Group Labs

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on July 30, 2026, deficiencies were cited for Denver Recovery Group Labs in Littleton, Colorado. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of laboratory's College of American Pathologists (CAP) Urine Toxicology proficiency testing (PT) documents and an interview with the laboratory manager (not included in the CMS Form 209), the laboratory failed to enroll in the 2026 event 1 Urine Toxicology program. Findings include: 1. A review of the laboratory PT documents reveal that the laboratory did not enroll in the CAP Urine Toxicology PT event 1 in 2026. 2. An interview with the laboratory manager (not included in the CMS Form 209) at approximately 1:30 PM confirmed that the laboratory did not enroll in the CAP Urine Toxicology PT event 1 in 2026. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 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 -- the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of laboratory's American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing (PT) documents and an interview with the laboratory manager (not included in the CMS Form 209), the individual testing the PT samples and the laboratory director (LD) failed to attest to the routine integration of the samples into the patient workload using laboratory's routine methods. Findings include: 1. A review of laboratory's CAP Urine Toxicology PT documents revealed that the individual testing the PT samples and the LD failed to sign the attestation forms for Urine Toxicology PT event 1 in 2025 and event 2 in 2025. 2. A review of laboratory's API Miscellaneous Chemistry PT documents revealed that the individual testing the PT samples and the LD failed to sign the attestation forms for PT event 1 in 2025, event 2 in 2025 and event 1 in 2026. 3. An interview with the laboratory manager (not included in the CMS Form 209) at approximately 11:00 AM confirmed that the individual testing the PT samples and the LD did not sign the proficiency attestation forms in 2025 and 2026. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of laboratory's American Proficiency Institute (API) miscellaneous chemistry proficiency testing (PT) documents and an interview with the laboratory manager (not included in the CMS Form 209), the laboratory failed to review and evaluate the results obtained on the miscellaneous chemistry proficiency testing performed. Findings include: 1. A review of laboratory's API Miscellaneous Chemistry PT documents revealed that the laboratory obtained 0% for all analytes of event 2 of 2025. There was no documentation to show that laboratory reviewed or investigated this PT failure. 2. An interview with the laboratory manager (not included in the CMS Form 209) at approximately 11:30 AM confirmed that the laboratory obtained 0% for all analytes of API miscellaneous chemistry event 2 of 2025. There was no documentation to show that laboratory reviewed or investigated this PT failure. -- 2 of 2 --

Summary Statement of Deficiencies 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 office manager (not listed on CMS-209 form), the laboratory failed to evaluate and document the evaluation of PT results received from the PT provider, since the laboratory ' s last survey on 02/15/2022. The laboratory performs approximately 2,124,000 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 an analyte. 2. An interview with the laboratory's office manager (not on CMS-209 form) on 06/02/2024 at approximately 4:00 P.M. confirmed that the laboratory did not document any evaluation or