Summary:
Summary Statement of Deficiencies D0000 Based on an initial certification survey conducted on March 05, 2025, deficiencies were cited for MD Pain in Englewood, Colorado. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, and an interview with the general supervisor (GS), the laboratory failed to establish a written policy or procedure for a quality assurance (QA) plan, establishing an ongoing mechanism to monitor, assess and correct problems when indicated concerning: complaint investigations, and communications for the laboratory since the laboratory began patient testing in October of 2024. The laboratory performs approximately 330,000 toxicology tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed the laboratory failed to have a written policy or procedure for a QA plan, establishing an ongoing mechanism to monitor, assess and correct problems when indicated concerning: complaint investigations, and communications for the laboratory. 2. An interview with the GS on March 05, 2025, at approximately 09:00 AM, confirmed that the laboratory failed to have a written policy or procedure for a QA plan, establishing an ongoing mechanism to monitor, assess and correct problems when indicated concerning: complaint investigations, and communications for the laboratory since the laboratory began testing October of 2024. 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 --