Integrated Dermatology Of Yuma

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper 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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 room temperature records from October 6, 2023 through November 8, 2024 and interview with the facility personnel, the laboratory failed to monitor and document the room temperature where dermatopathology reagents and equipment are utilized and stored on each day of patient testing. Findings include: 1. The laboratory processes specimens and interprets dermatopathology slides in conjunction with Mohs surgery, with an approximate annual test volume of 250. 2. The laboratory failed to monitor and document the temperature of the room where dermatopathology reagents and equipment are utilized each day of testing on 26 out of 26 testing dates between October 6, 2023 through November 8, 2024. 3. Mohs records (including patient logs) reviewed during the survey indicate 250 patients were tested during the timeframe indicated above. 4. The facility personnel interviewed on 2/13/25 at 11:25 AM confirmed that the laboratory failed to monitor and document the room temperature of the laboratory from October 6, 2023 through November 8, 2024. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance policy and interview with the facility personnel, the laboratory failed to perform and document the annual and bi-monthly maintenance of the microscope used for patient testing during 2021, 2022 and 2023. Findings include: 1. The laboratory's established maintenance protocol for the microscope used to read patient slides indicates the stage and oculars are cleaned bi-monthly (every 2 months) and a grounding and cleaning is performed yearly. 2. The laboratory failed to provide evidence of annual maintenance activities for the microscope from 2021 and 2022. 3. The laboratory failed to provide evidence of bi-monthly maintenance performance for the microscope from February 3, 2021 though the date of the survey performed on 10/03/2023. 4. The facility personnel interviewed on October 03, 2023 at 12:55 PM confirmed the laboratory failed to provide documentation of annual and bi-monthly maintenance for the microscope used by the laboratory to read patient slides during the timeframes indicated above. 5. The laboratory's reported annual test volume in the subspecialty of Histopathology is 500. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) 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 -- (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 test report 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 500. 2. One out of three Mohs test reports (22-316) reviewed in the Electronic Health Record (EHR) failed to include the electronic signature of the individual who performed the examination and made the diagnosis. 3. The facility personnel interviewed on October 03, 2023 at 12:55 PM confirmed the tissue pathology report indicated above was not signed by the individual who performed the examination and made the diagnosis. -- 2 of 2 --

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 the patient' Mohs map, review of patient slides, review of the electronic test report and interview with the facility personnel, the laboratory failed to follow established procedures to ensure positive identification of patient's dermatopathology specimens throughout the test reporting process. Findings include: 1. The laboratory performs Mohs testing under the sub-specialty of histopathology, with an approximate annual test volume of 500. It is the practice of the laboratory to assign a unique case number to each patient's Mohs specimen. The unique case number is included on the Mohs map, the patient slide(s) and the patient's electronic test report. 2. Review of the electronic test report for patient C.T. from 11/13/20 indicated the Mohs case number as "JG20-527". The Mohs map and Mohs slides for this patient indicated the Mohs case number as "JG20-550". 3. The facility personnel confirmed that the electronic test report indicated above contained the incorrect case number. The facility personnel acknowledged that the unique case number for this patient, tested on 11/13/20 was JG20-550. 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 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 -- through 493.1236. This STANDARD is not met as evidenced by: Based on lack of established Quality Assessment (QA) policies and procedures for review and interview with the facility personnel, 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 500. 2. 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. 3. 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 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory manual presented during the survey and interview with the facility personnel, the laboratory failed to have a procedure manual that was approved, signed, and dated by the current laboratory director. Findings include: 1. The laboratory's procedure manual presented for review during the survey conducted on November 14, 2018 failed to include the approval, signature and date of the laboratory director. 2. The facility personnel acknowledged that the procedure manual was not signed and dated by the laboratory director at the time of the survey. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on lack of a microscope maintenance policy and interview with the facility personnel, the laboratory failed to have a microscope maintenance policy that 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 -- indicates specific routine maintenance procedures as well as scheduled preventative maintenance procedures. Findings include: 1. The policy and procedure manual presented for review during the survey did not contain any policies with regards to microscope maintenance. 2. The facility personnel acknowledged that there were no microscope maintenance policies contained in the manual. 3. The laboratory's annual test volume under the sub-specialty of Histopathology is approximately 500. -- 2 of 2 --