Pdp Az Dermatopathology Lab

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of histopathology quality control records on June 11, 2025 and interview with the facility personnel, the laboratory failed to retain stain acceptability records for the Hematoxylin & Eosin (H&E) stain from September 2024 through December 2024, and the laboratory failed to retain Immunohistochemical (IHC) stain acceptability records from 12/05/24. Findings include: 1. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 100,000. 2. The laboratory failed to provide evidence of H&E stain acceptability records from September 2024 through December 2024. The laboratory performed testing on approximately 81 days during that timeframe. 3. The facility personnel interviewed on 6/11/25 at 2:55 PM acknowledged that the laboratory could not locate the H&E stain acceptability documentation at the time of the survey for the dates indicated above. 4. The laboratory failed to provide documentation of IHC stain acceptability (for both positive and negative controls) for the following stain protocols performed on 12/05/24: SOX-10, PRAME250 and MART-1. 5. The facility personnel interviewed on 6/11/25 at 3:45 PM confirmed the laboratory failed to retain documentation of the IHC stain acceptability records from 12/05/24. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) 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 -- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of annual and semiannual competency evaluation documentation from 2024 and 2025 and interview with the facility personnel, the technical supervisor failed to evaluate and document the competency of four out of four testing personnel who perform testing in the subspecialty of Histopathology. Findings include: 1. The CMS-209, Laboratory Personnel Form presented for review during the survey listed 4 testing personnel (TP) who perform the gross examination of pathology specimens. 2. The 2024 annual competency documentation reviewed for TP-4 and TP-5 and the 2025 annual competency documentation reviewed for TP-6 and TP-7 revealed the competency evaluations were not performed and documented by the Technical Supervisor. 3. The 2025 semiannual competency documentation reviewed for TP-6 and TP-7 revealed the competency evaluations were not performed and documented by the Technical Supervisor. 4. The facility personnel interviewed on 6/11/2025 at 1: 45 PM confirmed that the competency evaluations indicated above were not performed and documented by the Technical Supervisor. 5. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 100,000. -- 2 of 2 --

Summary Statement of Deficiencies D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of positive and negative Quality Control (QC) documentation for Immunohistochemical (IHC) stains from 01/01/2022 through the date of the survey on 10/17/2023 and interview with the facility personnel, the laboratory failed to check immunohistochemical stains for positive and negative reactivity each time of use. Findings include: 1. The laboratory performs the microscopic interpretation of tissue specimens in the subspecialty of Histopathology, with a reported annual test volume of 63,000. 2. The laboratory performs IHC stains on certain tissues, if warranted and ordered by the physician who issues the diagnosis. 3. The laboratory failed to document positive and negative reactivity each time of use for each IHC stain performed by the laboratory from 01/01/2022 through 10/17/2023. 4. The number of patient specimens tested with IHC stains during the timeframe indicated above could not be determined at the time of the survey. 5. The facility personnel interviewed on 12 /06/2023 at 2:15 PM confirmed the laboratory failed to check each IHC stain for positive and negative reactivity each time of use during the timeframe indicated above. 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 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 dermatopathology testing, with an approximate annual test volume of 29,000 tests. 2. During the survey conducted on June 18, 2021, direct inspection of the Hematoxylin reagent, lot #060319, indicated an expiration date of 06/03/21. 3. The total number of patients tested using the expired reagent could not be determined at the time of the survey. 4. The facility personnel confirmed that the expired reagent indicated above was still in use on the day of the survey. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of the (A) Hematoxylin & Eosin (H & E) staining materials and (B) Periodic acid-Schiff (PAS) staining materials used for patient testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Histopathology, with an approximate annual test volume of 29,000. 2. The dermatopathology test report for patient D20-10952, reported by the laboratory on 09 /08/2020, was reviewed during the survey conducted on June 18, 2021. The laboratory performed the H & E and PAS stain on the patient's specimen in order to render the pathological diagnosis. A3. No documentation of the H & E stain acceptability was presented for review for testing that occurred on 09/08/2020 or for any other testing date during the month of September 2020. A4. Approximately 2,214 patient specimens were tested by the laboratory with the H & E stain during September 2020. B5. No documentation of the PAS stain acceptability was presented for review for testing that occurred on 09/08/2020 or for any other testing date during the month of September 2020. B6. Approximately 82 patient specimens were tested by the laboratory with the PAS stain during September 2020. 7. The facility personnel confirmed that the laboratory failed to document the H & E and PAS stain acceptability during September 2020. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory's QA processes failed to monitor and identify errors found in the analytic portion of histopathology testing which is performed by the laboratory. Findings include: 1. The laboratory processes and interprets dermatopathology slides from patient specimens. The laboratory's approximate annual test volume is 29,000. 2. The laboratory's established procedure for QA processes includes an monthly QA checklist to monitor the analytic portion of the testing, including but not limited to, QC performance. 3. No QA documentation was presented for review during the survey to indicate the laboratory identified and corrected issues found with the laboratory's failure to perform and document the H & E Stain and PAS stain acceptability during September 2020, see D5473 for findings. 4. No QA documentation was presented for review during the survey to indicate the laboratory established QA processes to monitor the expiration date of the stains used for patient testing. See D5417 for findings. 5. The facility personnel confirmed that the laboratory failed to monitor and identify errors found with a lack of QC performance and acknowledged that the laboratory's QA processes failed to monitor and identify errors found with expired reagents. -- 2 of 2 --

Summary Statement of Deficiencies 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 did not evaluate and document the performance of two 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 22,000. 2. No documentation of annual competency assessment for 2017 and 2018 was presented for review for two out of two 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 2017 and 2018. * This is a repeat deficiency from the survey conducted on 12/29/2016. 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 --