Summary:
Summary Statement of Deficiencies D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on review of laboratory personnel records, the CMS-209 (Laboratory Personnel Report), lack of documentation, and interview with the laboratory director; the laboratory failed to have qualifying documentation for one of one delegated clinical consultant for the specialties of chemistry and hematology (see D6057). D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records, the CMS-209 (Laboratory Personnel Report), lack of documentation, and interview with the laboratory director (LD); the laboratory failed to have qualifying documentation for one of one delegated clinical consultant (CC) for the specialties of chemistry and hematology. Findings include: 1. Review of laboratory personnel records revealed one of one CC, identified on 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 -- CMS-209, failed to have qualifying documentation for the role of CC. 2. Interview with the LD on 06/24/2025, at 10:27 am, confirmed the laboratory failed to have qualifying documentation for one of one delegated CC for the specialties of chemistry and hematology. -- 2 of 2 --