Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, staff interview and record review, the safety procedures failed to ensure the laboratory (lab) environment was set up using non-porous materials to allow for disinfection and protection from biohazardous materials from July 2023 to October 2023. Findings include: 1. Observation of the lab on 10/19/2023 at 10:00 a.m. revealed the lab's flooring was completely carpeted and the 1 of 1 chair had cloth material. 2. Interview with Testing Personnel on 10/19/2023 at 10:00 a.m. confirmed the above finding and revealed specimen handling, processing and testing all take place within the carpeted lab. 3. Record review on 10/19/2023 of the CMS-116 form received by the State Agency on June 26, 2023 revealed the labs move to the current physical location was effective July 10, 2023. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and staff interview, the Technical Consultant failed to meet qualifications requirements. Refer to D6035. 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 -- D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant failed to meet qualification requirements. Findings include: 1. Record review on 10/19/2023 of the laboratory's (lab) personnel form (CMS-209) revealed the Lab Director (LD) listed as the Technical Consultant. 2. Record review on 10/19/2023 of the LD's qualifications revealed no documentation of training or experience performing testing in Toxicology and Routine Chemistry testing. 3. Record review on 10/19/23 of competency assessment records revealed the competency assessments were performed by a Lab Consultant. 4. Record review on 10/26/2023 of the Lab Consultant's qualifications revealed the Lab Consultant does not meet the educational qualification requirements to be the Technical Consultant. 5. Interview by email on 10/26/2023 at 8:32 a.m. with the Lab Consultant confirmed the above findings. -- 2 of 2 --