Summary:
Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the approved reference ranges in the laboratory procedure manual, and interview with the technical consultant (TC) #1, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. One of the eleven chemistry parameters listed on the laboratory information system (LIS) report differed from those in the approved procedure manual. Findings: 1. Review of the patient report from the LIS system revealed one of the eleven parameters for chemistry testing failed to correctly match those reference ranges in the procedure manual. LIS patient report Procedure manual Glucose 70-99 mg/dl 70-130 mg/dl 2. Interview with the TC #1 on July 11, 2023 at 11:00 AM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. 3. The laboratory reports approximately 3000 chem 8 panels annually. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: 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 -- Based on review of 2021 and 2022 competency documentation, review of the procedure manual, and interview with the technical consultants (TC) #1, and #2, the technical consultants failed to perform 54 of 54 competencies for 2022. Findings: 1. Review of competency documentation showed no competency evaluations for 2022 for 54 testing personnel. 2. Review of the procedure for competency showed, "After an individual has performed his/her duties for one year, competency must be assessed at least annually." 3. Interview with TC #1 on July 11, 2023 at 11:00 AM confirmed, TC #1 and #2 failed to evaluate the competency of all testing personnel for 2022. 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 #1, the laboratory failed to have academic credentials required to qualify one of 54 testing personnel for the speciality of routine chemistry for moderate complexity testing (Refer to D6065). 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 personnel records and interview with the technical consultant (TC) #1, the laboratory failed to have documentation of academic credentials to qualify one of 54 testing personnel (TP) for moderate complexity testing. Findings: 1. Review of the personnel records for one of 54 testing personnel for the speciality of routine chemistry revealed the laboratory failed to have academic credentials to qualify TP #4. 2. Interview with TC #1 on July 11, 2023 at 11:30 AM confirmed, the laboratory failed to have the required documentation to qualify TP #4 for moderate complexity testing. 3. The laboratory reports approximately 3000 chem 8 panels annually. -- 2 of 2 --