Banner University Medical Center Tucson

Summary Statement of Deficiencies 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 for Frozen Biopsy testing, and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2023. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2023. 2. The facility personnel interviewed on 11/13/24 at 10:30 AM confirmed the laboratory failed to verify the accuracy of the testing listed above at least twice annually during 2023. 3. The laboratory reports the performance of 700 tests annually under the subspecialty of Histopathology. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 quality assessment (QA) policies and interview with the facility personnel, the laboratory failed to perform and document quality assessment activities as indicated in laboratory policy. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Histopathology with an approximate annual test volume of 700. 2. The laboratory's established policy, #4089, Version 2, states, "Pick and review two (2) patients randomly on a semi-annual basis. Document all findings of this review on Laboratory Specimen Management form. Keep QA forms under the month this review was conducted or place in the next month's section if a follow-up review is scheduled. Review all reports for appropriate procedures". 3. No QA documentation was presented for review to indicate the laboratory performed and documented QA reviews as outlined in laboratory policy during 2018 and 2019. 4. The facility personnel confirmed that the laboratory failed to perform and document the semi-annual QA review as stated in policy during 2018 and 2019. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) 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 -- Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's test reports for Mohs testing from 2018 and 2019, test records for Mohs testing and interview with the facility personnel, the laboratory failed to include the test result on two out of four test reports reviewed during the survey. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 700. The laboratory utilizes a Mohs Map as the test report. The Mohs Map contains an area for the physician to document whether or not the margins are clear. 2. Two out of four Mohs test reports reviewed during the survey (W19-113 and W18-077) failed to include the final test result for Mohs, including the number of stages performed. 3. The facility personnel confirmed that the Mohs Maps indicated above failed to include the final test result. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of policies for review, review of patient test reports and interview with the facility personnel, the laboratory failed to establish policies for documenting Mohs Maps and reporting and maintaining test reports in an electronic record system. Findings include: 1. The laboratory performs Mohs testing on patient specimens under the sub-specialty of histopathology, with an approximate annual test volume of 700. The laboratory utilizes a Mohs map as the test report, as well as documenting the results in an electronic medical record (EMR). 2. On the date of the survey, 01/17 /2020, no documentation was presented for review to indicate the laboratory had established policies and procedures in place to indicate the laboratory's process for documenting the Mohs map. 3. On the date of the survey, 01/17/2020, no documentation was presented for review to indicate the laboratory had established policies and procedures in place to indicate the laboratory's process for reporting and maintaining test reports in an electronic record system.. 4. The facility personnel confirmed that the laboratory failed to have established post-analytic policies in place related to Mohs map and test reports that are maintained electronically. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of accuracy verification documentation and interview with the facility personnel, the laboratory failed to verify the accuracy of dermatopathology testing at least twice annually in 2016 and 2017. Findings include: 1. The laboratory began patient testing under the sub-specialty of Histopathology in March 2016, with an approximate annual test volume of 720. 2. During the survey conducted on April 10, 2018, the laboratory presented documentation of accuracy verification for Mohs cases that were reported in 2016 and 2017 but were not reviewed by an outside dermatopathologist until March of 2018. There were no cases sent out for accuracy verification during 2016 and 2017. 3. The facility personnel acknowledged that no cases were sent out for review during 2016 and 2017. 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 the laboratory's established policies and interview with the facility personnel, (A) the laboratory failed to establish policies related to accuracy 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 -- verification for Dermatopathology testing performed by the laboratory and (B) the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated correct problems identified in the general laboratory systems. Findings include: 1. The laboratory performs Mohs testing on patient specimens under the sub-specialty of Histopathology, with an approximate annual test volume of 720. A2. No documentation was presented during the survey to indicate the laboratory had established policies related to the verification of accuracy process for the testing indicated above, including but not limited to, information specific to the frequency of the review, number of cases reviewed, individual or laboratory performing the review and a remedial action plan in the event of a noted discrepancy. A3. The facility personnel confirmed that the laboratory did not have an established policy in place at the time of the survey for the verification of accuracy process used for dermatopathology testing performed by the laboratory. B2. No documentation was presented for review to indicate the laboratory had established quality assessment policies and procedures for an ongoing mechanism to monitor, assess, and when indicated correct problems identified in the general laboratory systems. B3. The facility personnel confirmed that the laboratory did not have quality assessment policies and procedures in place at the time of the survey. -- 2 of 2 --