Arizona Center For Hematology And Oncology

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of Mohs slides and interview with the facility personnel, the laboratory failed to ensure positive identification of one out of three patient specimens from the time of collection through completion of testing and reporting of test results. Findings include: 1. The laboratory performs Mohs testing under the subspecialty of Histopathology, with an annual test volume of 1,500. It is the practice of the laboratory to assign a unique accession number to each Mohs case which is manually recorded by laboratory personnel on the Mohs log, patient's Mohs Map, patient's slides and the final test report maintained in the patient's Electronic Medical Record (EMR). 2. The laboratory failed to ensure positive identification of a patient's specimen throughout the entire test process for one out of three Mohs cases reviewed during the survey, MS23-587 performed on 5/19/2023. The case number manually scribed on the patient's slides was illegible. 3. The facility personnel interviewed on 11 /16/2023 at 10:10 AM acknowledged that the laboratory failed to ensure positive identification of the patient's specimens from the time of collection through completion of testing and reporting of results, as evidenced by the illegible case number manually scribed on the slides indicated above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of humidity records for review from 2021, 2022 and 2023, review of the manufacturer's specifications for the cryostat, and interview with the facility personnel, the laboratory failed to monitor and document the humidity of the area where the cryostat is utilized. Findings include: 1. The laboratory uses the Leica CM1850 Cryostat to process patient samples for Mohs testing. The laboratory's reported annual test volume in the subspecialty of Histopathology is 1,500. 2. The manufacturer's specifications for the Leica CM1850 Cryostat reviewed during the survey listed an operating relative humidity range not to exceed 80%. 3. No documentation was provided for review during the survey to indicate the laboratory monitored and documented the humidity of the room where the cryostat is utilized for each day of patient testing during 2021, 2022 and 2023, through the date of the survey. 4. The facility personnel interviewed on 11/16/2023 at 10:20 AM confirmed the laboratory failed to monitor and document the humidity of the room where the cryostat is operated. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of tissue pathology reports and interview with the facility personnel, the qualified individual who performed the examination and made the diagnosis failed to sign the Mohs Map for one out of three patient test reports reviewed during the survey. Findings include: 1. The laboratory performs patient testing in the subspecialty of Histopathology, with an approximate annual test volume of 1,500. 2. One out of three Mohs maps (MS21-1273) reviewed in the Electronic Health Record (EHR) failed to include the signature of the individual who performed the examination and made the diagnosis. 3. The facility personnel interviewed on 11/16 /2023 at 09:30 AM confirmed the Mohs Map indicated above was not signed by the individual who performed the examination and made the diagnosis. -- 2 of 2 --

Summary Statement of Deficiencies 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 lack of competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess employee competency. Findings include: 1. The laboratory performs the grossing procedure on patient specimens under the sub-specialty of Histopathology, with an approximate annual test volume of 6,500. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of individuals who perform the gross evaluation on histopathology specimens. 3. The facility personnel confirmed that the laboratory did not have a policy established to assess the competency of testing personnel who perform the gross evaluation on histopathology specimens. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation and interview with the facility personnel, the laboratory failed to verify the accuracy of dermatopathology testing at least twice annually during 2016 and 2017. Findings include: 1. The 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 3 -- performs Mohs testing and biopsy interpretations under the sub-specialty of Histopathology, with an approximate annual test volume of 6,500. 2. It is the practice of the laboratory to perform accuracy verification every six months, by sending a minimum of 3 Mohs cases and 2 Biopsy cases to an outside facility for accuracy assessment. 3. On the date of the survey, October 30, 2018, the laboratory failed to present documentation of accuracy verification for Mohs cases and biopsy readings and interpretations that were performed by the laboratory in 2016 and 2017. The facility personnel stated that the laboratory performed the accuracy verification procedures during each respective year, however the original documenation was destroyed. 4. The facility personnel confirmed that the laboratory failed to produce evidence of accuracy verification for testing performed by the laboratory, as indicated above. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patients' electronic test reports and interview with the facility personnel, the laboratory failed to have one out of one pathology reports signed by the individual who performed the examination and made the diagnosis. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 6,500. The laboratory performs biopsy interpretations on patient specimens. It is the practice of the laboratory to record pathology reports in the Electronic Medical Record (EMR). 2. No documentation of a signed pathology report was presented for review in the EMR or elsewhere in the laboratory for a biopsy performed on patient M.W. on 04/02/2018. 3. The facility personnel confirmed that the laboratory failed to maintain a signed pathology report in the EMR for the biopsy case indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of testing personnel competency evaluation documentation and interview with the facility personnel, it was determined that the technical supervisor failed to evaluate and document the performance of one testing personnel at least annually. Findings include: 1. The laboratory performs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 6,500. 2. No documentation of annual competency assessment for 2016 and 2017 was presented for -- 2 of 3 -- review for one out of one testing personnel who performs the gross description on patient specimens. 3. The facility personnel confirmed that no annual competency evaluation was performed for the testing personnel indicated above during 2016 and 2017. -- 3 of 3 --