Arizona Desert Dermatology And Surgery, Pc

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation of histopathology stain reagents and interview with the facility personnel, the laboratory used the stain reagent, Hematoxylin, past the expiration date. Findings include: 1. The laboratory performs the Hematoxylin and Eosin (H&E) stain on patient slides in conjunction with the Mohs procedure, with an approximate annual test volume of 373. 2. During the survey conducted on May 30, 2024, direct inspection of the Hematoxylin reagent, lot #159183, indicated an expiration date of 4/30/24. 3. The laboratory used the expired stain reagent for one day of patient testing conducted on 5/13/24. A total of 12 patients were tested using the expired reagent. 4. At approximately 11:45 AM on 5/30/24, the facility personnel interviewed stated that the expired reagent indicated above was in use at the time of 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 1 --

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 review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2020 and 2021. Findings include: 1. The laboratory performs frozen biopsy testing under the sub-specialty of Histopathology, with an approximate annual test volume of 3. 2. No documentation was presented for review during the survey conducted on December 29, 2021 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of frozen biopsy specimens at least twice annually during 2020. Approximately 3 patients had frozen biopsy testing performed by the laboratory during 2020. 3. No documentation was presented for review during the survey conducted on December 29, 2021 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of frozen biopsy specimens at least twice annually during 2021. Approximately 3 patients had frozen biopsy testing performed by the laboratory during 2021. 4. The facility personnel confirmed that the laboratory failed to verify the accuracy of frozen biopsy testing at least twice annually during 2020 and 2021. 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 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 -- 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) 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: (A) Based on review of the laboratory's test reports for Frozen Biopsy testing from 2020 and 2021 and interview with the facility personnel, the laboratory failed to include the gross description on two out of two test reports reviewed during the survey; and (B) based on review of Mohs test reports and interview with the facility personnel, the laboratory failed to include the final test result for Mohs testing for one out of three patient records reviewed. Findings include: A1. The laboratory performs Frozen Biopsy testing under the sub-specialty of Histopathology, with an approximate annual test volume of 3. The laboratory utilizes an Electronic Medical Record (EMR) to document the test result. A2. Two out of two Frozen Biopsy test reports reviewed during the survey [MR# 117426, from 11/09/20 and MR# 107897, from 4/12/21] failed to include the gross description for the Frozen Biospy. A3. Each electronic test report indicated above stated, "The specimen was submitted for frozen section as 1 block. The tissue specimen was frozen in the cryostat, sectioned and stained." A4. No documentation was presented for review during the survey to indicate the test reports referenced above contained the gross description, which may include but is not limited to, the measurement of the specimen, specimen description, specimen color, and specimen orientation. A5. The facility personnel confirmed that the frozen section test reports indicated above failed to include the gross description. B1. The laboratory performs Mohs testing under the sub-specialty of Histopathology with an approximate annual test volume of 313. It is the practice of the laboratory to document the final Mohs test result in the EMR. B2. One of out three Mohs test reports (MR# 6390, from 8/11/21) reviewed during the survey failed to include the final test result for Mohs. The EMR test information indicated the patient had Mohs testing, with 1 Stage performed. B3. The facility personnel confirmed that the test report documented in the EMR for the patient indicated above failed to include the final test result for Mohs testing. -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient test records, patient slides and interview with the facility personnel, the laboratory (A) failed to indicate the correct testing date on the Mohs map used for dermatopathology testing and (B) failed to indicate the identity of the personnel who performed the gross description of tissue biopsies sent to another laboratory for testing. Findings include: A1. The laboratory performs patient testing under the sub-specialty of histopathology, with an approximate annual test volume of 11,200. The laboratory utilizes a Mohs map and electronic test report to document the results of the Mohs procedure. A2. Review of the Mohs map for case# MH18-054 from testing performed on 04/09/18 indicated the testing was performed on 04/04/18. The patient slides, Mohs patient log and the Mohs operative report viewed in the electronic medical record (EMR) for this patient during the survey confirmed the testing was performed on 04/09/18, not 04/04/18. A3. The facility personnel confirmed that the Mohs map from the case indicated above was labeled with the incorrect testing date. B1. The laboratory performs the gross description of dermatopathology specimens that are sent to another CLIA-certified laboratory for reading and interpretation. B2. No documentation was presented for review to indicate the laboratory maintained a record system that included the identity of the personnel who performed the gross description. B3. The facility personnel confirmed that the 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 -- identity of the personnel who performed the gross description of biopsy specimens was not indicated on the final dermatopathology test report or any other record in the laboratory. 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) 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 dermatopathology test reports and interview with the facility personnel, the dermatopathology test report failed to include the name and address of the laboratory where the grossing of tissue specimens was performed. Findings include: 1. The laboratory performs the gross description of tissue specimens under the sub-specialty of histopathology with an approximate annual test volume of 11,200. The laboratory performs the gross description of dermatopathology specimens that are sent to another CLIA-certified laboratory for reading and interpretation. 2. Pathology report (A19-3735, patient ID# 102368) presented for review during the survey failed to include the laboratory name and address where the grossing of the specimen occurred. 3. The facility personnel acknowledged that the laboratory name and address were missing from the pathology test reports. -- 2 of 2 --