Atrium Wfbh Immunodiagnostics Laboratory

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of personnel records 7/18/22 and the deficiency cited at D6171, the laboratory failed to verify that 1 of 7 testing personnel (TP #7) met the minimum education requirements for performing high complexity testing. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory 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 -- training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the laboratory director 7/18 /22 and review of additional transcripts 8/4/22, the laboratory failed to ensure that 1 of 7 testing personnel (TP #7) met the minimum education requiremements for performing high complexity testing. Review of personnel records for TP #7 revealed a Bachelor of Science degree in Health Sciences. On 8/4/22, a review of additional transcripts provided after the survey on 7/18/22 and 8/2/22 revealed TP #7 did not have 24 semester hours of science courses that included 6 semester hours of chemistry, 6 semester hours of biology and 12 semester hours of chemistry, biology, or medical laboratory technology in any combination. During interview at approximately 11:15 a.m., the laboratory director stated they had reviewed TP #7's transcript and they thought TP #7 met the requirements. -- 2 of 2 --

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with TP (testing personnel) 7/22/19, the laboratory director failed to ensure that 1 of 5 testing personnel (TP #3) had documented training for the APOL1 test. The laboratory's General Policy 14 "New Employee Training" (effective 5/20/05) states "... training will be required for new test methodologies and/or instruments prior to a technologist reporting patient test results. ..." Review of personnel records records revealed there was no documentation of APOL1 training for TP #3. During interview at approximately 12:35 p.m., TP #1 stated that she trained TP #2, but all other training was done by the Ph.D. from the hospital that developed the test. She stated TP #3 was trained and had been performing the test, but she was unsure whether the training was documented or whether the records might have been misplaced. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to 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 -- process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with staff 7/22/19, the laboratory director failed to ensure that specific policies and procedures were established for evaluating the competency of testing personnel (TP) who perform the APOL1 test. Findings: 1. The laboratory's General Policy 14 "New Employee Training" (effective 5/20/05) states "... Reassessment of the new technologist will be required 6 months after completion of orientation/training and then yearly thereafter. ..." The policy did not include the criteria for acceptable performance, did not describe the steps to take in the event that performance criteria are not met, and did not indicate who was responsible for evaluating and documenting testing personnel competency. During interview at approximately 10:40 a.m., the general supervisor stated that the laboratory director has a "designee" perform the competency evaluation for each TP. He stated the laboratory did not have a written delegation of duties from the laboratory director to specific personnel qualified to perform competency evaluations. 2. Review of personnel records revealed the records did not include a competency evaluation specific for the APOL1 test which included the six elements of competency. During interview at approximately 12:30 p.m., TP #1 verified that they did not have a specific competency evaluation for APOL1 which included the required elements. -- 2 of 2 --