Summary:
Summary Statement of Deficiencies D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on review of patient test records, observation of laboratory area and interview with the technical consultant; the laboratory failed to ensure confidentiality of patient information throughout all phases of the testing process. Findings: 1. During a tour of the laboratory on December 16, 2019 at 10:00 AM, it was observed that the laboratory area was a combination of 2 adjoining rooms with free access to both, blood gas and radiology lab. 2. The technical consultant explained that access to the adjoining laboratory room was through a key-code and that both blood gas and radiology personnel had access. 3. Review of blood gas test results revealed that patients' test reports are stored in binders left out on the counter top. 4. During survey date on December 16, 2019 at 10:30 AM, the technical consultant confirmed the surveyor's observations. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the technical consultant; the laboratory failed to have qualified personnel performing blood gas testing. Findings: 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 -- 1. Review of personnel records revealed that there was no documentation of the highest level of education for 3 of 17 testing personnel. See D6065 2. During survey date on December 16, 2019 at 11:00 AM, the technical consultant confirmed the surveyor's findings. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of laboratory personnel qualifications and interview with the technical consultant; the laboratory failed to have testing personnel with the educational requirements for performing moderate complexity testing. Findings: 1. Review of the laboratory's testing menu revealed that the laboratory performs blood gas moderate complexity testing. 2. Review of Laboratory Personnel Report - CLIA (Form CMS 209) revealed that 3 out of 17 testing personnel failed to have documentation to show an evaluation of their foreign degree to determine the equivalency of education in the United States 3. During survey date on December 16, 2019 at 11:00 AM, the technical consultant confirmed the surveyor's findings. -- 2 of 2 --