Az Orthopedic Specialty Hospital

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records for review from 2021 and 2022 and interview with the testing personnel, the laboratory failed to maintain a copy of all PT records for a minimum of 2 years from the date of the proficiency testing event. Findings include: 1. The laboratory performs patient testing in the specialties of chemistry and hematology, with an approximate annual test volume of 5,004. The laboratory performs the Chem8+ test on the i-Stat analyzer and participates in 3 Proficiency Testing events annually. 2. During the survey conducted on September 30, 2022, the laboratory failed to produce evidence of the following PT documentation from each testing event of 2021 and the first and second testing events of 2022: - Attestation statements signed by the Laboratory Director and testing personnel - Copies of the instrument printouts - Copies of the PT program report forms used by the laboratory to record PT results 3. The testing personnel interviewed on 09/30/22 at 10:45am confirmed that the PT records indicated above could not be located during the survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of test requisitions for review and interview with the testing personnel, the laboratory failed to retain test requisitions and test authorizations for at least two years. Findings include: 1. The laboratory began patient testing on 04/09/2020 in the specialties of Chemistry and Hematology, with an approximate annual test volume of 5,004. The laboratory performs the Chem8+ test on the i-Stat analyzer. It is the practice of the laboratory to maintain test requisitions in the patient's Electronic Health Record (EHR). 2. The laboratory failed to provide evidence of the test requisition for patient ID#00909718 from testing performed on 11/23/2021. 3. The testing personnel interviewed on 9/30/22 at 11:24am acknowledged that the test requisition indicated above was no longer accessible in the EHR. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records for review from 2021 and 2022 and interview with the testing personnel, the laboratory failed to retain PT records for at least 2 years. Findings include: 1. The laboratory performs patient testing in the specialties of chemistry and hematology, with an approximate annual test volume of 5,004. The laboratory performs the Chem8+ test on the i-Stat analyzer and participates in 3 Proficiency Testing events annually. 2. The laboratory failed to produce evidence of PT records from each testing event of 2021 and the first and second testing event of 2022. See D2015 for specific findings. 3. The testing personnel interviewed on 09/30/22 at 10:45am confirmed that the PT records referenced above could not be located during the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance policy and interview with the facility personnel, the laboratory failed to follow established policies and procedures to assess employee competency. Findings include: 1. The laboratory began patient testing on 04/09/2020 in the specialties of Chemistry and Hematology, with an approximate annual test volume of 5,004. 2. The laboratory policy reviewed during the survey titled, "Quality Assurance Plan" states, "Initial training - When a new -- 2 of 10 -- employee is trained in the Arizona Orthopedic Surgical Hospital Lab, they complete a standard skills checklist to ensure that each employee is trained in a consistent manner and that they can demonstrate competency before they can verify patient test results. 6 Month Competency - After 6 months of testing each trained employee is given the skills checklist to ensure they understand all aspects of the laboratory testing. Annual Skills Checklists - As a part of every employee's annual evaluation, they are once again given the skills checklists, this time as a self-assessment to ensure that they understand all aspects of the laboratory testing. Competency Assessment - Throughout the year, all testing personnel are given the opportunity to demonstrate competency through a series of assessments, which may include written tests, running QC specimens, direct observation, etc". 3. The laboratory failed to follow the established policy indicated above to assess employee competency. See D6053 and D6054 for specific findings. 4. The facility personnel interviewed during the survey at 10:30am on 09/30/2022 confirmed the laboratory failed to follow established personnel competency policies to assess employee competency. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2021 and 2022 and interview with the testing personnel, the laboratory failed to provide a documented review of the PT results for testing events in the specialty of Chemistry and Hematology. Findings include: 1. The laboratory performs patient testing in the specialties of chemistry and hematology, with an approximate annual test volume of 5,004. The laboratory performs the Chem8+ test on the i-Stat analyzer and participates in 3 Proficiency Testing events annually. 2. No evidence, either by written comment or signature, was presented during the survey conducted on 9/30/22 to indicate the laboratory director or other facility personnel reviewed the PT results for each testing event of 2021 and the first and second testing events of 2022. 3. The facility personnel interviewed on 9/30/22 at 10:45am confirmed that the PT results indicated above were not reviewed by laboratory personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records, lack of established policies and procedures and interview with the testing personnel, (A) the laboratory failed to establish policies and procedures related to the retention of PT records; and (B) the laboratory failed to follow established Quality Assessment (QA) policies and procedures to monitor, assess, and when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. -- 3 of 10 -- Findings include: A1. 1. The laboratory performs patient testing in the specialties of chemistry and hematology, with an approximate annual test volume of 5,004. The laboratory performs the Chem8+ test on the i-Stat analyzer and participates in 3 Proficiency Testing events annually. A2. No documentation was presented for review during the survey conducted on 9/30/22 to indicate the laboratory established written policies and procedures related to the retention of PT records for a minimum of 2 years from the testing date. See D2015 for specific findings. A3. The testing personnel interviewed on 9/30/22 at 10:50am confirmed the laboratory failed to establish a policy and procedure for the retention of PT records for a minimum of 2 years from the testing date. B1. The laboratory's established QA policy titled, "Quality Assurance Plan (reference# 3103)" reviewed during the survey failed to include information on how the laboratory will monitor, assess, and when indicated, correct problems identified with Proficiency Testing and Personnel competency, including but not limited to, the frequency of QA review, how the laboratory will document the QA review, and the