Rockford Dermatology Sc

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Repeat Condition Based on review of the laboratory's Allegation of Compliance (AoC) response regarding citations from the 03/07/2023 recertification survey, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD); in a repeated deficiency from 03/07/2023 recertification survey, the laboratory failed to perform bi-annual method accuracy evaluations (peer-reviewed slides/proficiency testing (PT) slides) for histopathology testing in 2023 through date of 08/25/2025. See D5217. 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: Repeat Deficiency Based on review of the laboratory's Allegation of Compliance (AoC) response regarding citations from the 03/07/2023 recertification survey, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD); in a repeated deficiency from 03/07/2023 recertification survey, the laboratory failed to perform bi-annual method accuracy evaluations (peer-reviewed slides/proficiency testing (PT) slides) for 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 2 -- testing in 2023 through date of 08/25/2025. Findings Include: 1. Repeat deficiency from 03/07/2023 recertification survey. 2. Review of the laboratory's AoC, submitted 03/27/2023 in response to deficiencies cited 03/07/2023 and signed by the LD on 03 /23/2023, stated, "Proficiency testing will be performed by ... [secondary dermatopathologist] and documented to meet this requirement biannually." 3. Review of laboratory policies and procedures revealed the procedure titled, "Procedure and Form", which stated, under "Quality Control Procedures", "Split samples for testing with another CLIA-certified laboratory ... biann[u]ally." 4. Review of laboratory records found the laboratory failed to perform biannual method accuracy evaluations (peer-reviewed slides/proficiency testing (PT) slides) for the years 2023 through 08/25 /2025 for histopathology testing. 5. Interview with the LD on 8/25/2025, at 12:10 pm, confirmed the laboratory failed to perform the bi-annual method accuracy evaluations for histopathology testing in 2023 through the date of survey, 08/25/2025. -- 2 of 2 --

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with Laboratory Director (LD); the laboratory failed to meet the condition level requirements for histopathology. Findings Include: 1. The laboratory failed to perform bi-annual method accuracy evaluations for histopathology testing in 2021 and 2022. See D5217. 2. The laboratory failed to ensure one out of ten patient test reports for Mohs testing was accurately transcribed into the electronic medical record. See D5801. 3. The laboratory failed to follow written policies and procedures to monitor, assess, and when indicated correct problems identified in the post-analytic systems specified in 493.1291. See D5891. 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 laboratory records, lack of documentation, and interview with Laboratory Director (LD); the laboratory failed to perform bi-annual method accuracy evaluations for histopathology testing in 2021 and 2022. Findings Include: 1. The laboratory's policy and procedure manual and proficiency testing records were 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 -- reviewed for 2021 through 2022. 2. Review of the laboratory's proficiency testing policy failed to include bi-annual method accuracy verifications for Moh's histopathology. 3. Review of proficiency testing documentation found only one Mohs case was sent out in 2021 and one case in 2022 to American Society for Mohs Surgery. 4. Interview with LD on 03-07-2023, at 1:45 pm, confirmed that the laboratory failed to perform bi-annual method accuracy verifications for Moh's histopathology testing in 2021 and 2022. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation and interview with the Laboratory Director (LD); the laboratory failed to ensure reagents used for histopathology testing were labeled to ensure accurate and reliable testing. Findings Include: 1. Direct observation of the laboratory facility on 03-07-2023 at 11:00 am identified unlabeled containers of marking ink used for histopathology testing. 2. Interview with the LD on 03-07-2023 at 11:00 am confirmed the containers of marking ink are used for histopathology testing. 3. On survey date 03-07-2023, at 1:45 pm, the LD confirmed the laboratory failed to label the marking ink with the following criteria: (1) Identity (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the Laboratory Director (LD); the laboratory failed to ensure one out of ten patient test reports for MOHs testing was accurately transcribed into the electronic medical record. Findings Include: 1. Review of one of ten patient test reports for Mohs testing found the laboratory failed to accurately transcribe the histopathology results in the laboratory's test report for patient seven (PT7), MRN: MM0000003628. a. The patient test report for the Mohs surgery indicated that margins were free of tumor at stage 1. No stage 2 documented. b. Mohs map indicated two stages were performed to clear the tumor. 2. On survey date 03-07-2023, at 12:45 pm, the LD confirmed the patient test report for -- 2 of 3 -- 08-23-2022 was incorrect for Stage I because there was residual tumor found according to the Mohs Map and corresponding slides. Stage II results should have been included on the patient test report based on the Mohs map and patient slides. 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 review of laboratory records, lack of documentation and interview with the Laboratory Director (LD); The laboratory failed to follow written policies and procedures to monitor, assess, and when indicated correct problems identified in the post-analytic systems specified in 493.1291. Findings include: 1. The facility's Quality Control on Documentation Protocol stated the following "quality control is performed on following logs every year by lab technician and medical director will review the log sheet; Mohs log..."Select three cases; Print out selected patient's chart; Check name, site and diagnosis to make sure information matches." 2. Review of quality assessment records found the laboratory failed to document review of three Mohs cases annually in 2021 and 2022. 3. Quality Assessment Procedures also stated "All QA records such as logs of test requisitions, test reports, and receipt and QA of reagents and culture media that have not been reviewed previously will be reviewed by the Laboratory Director or an appropriate, designated staff member every month. The Laboratory Director or an appropriate, designated staff member will conduct meetings with all relevant staff every month to communicate the results of

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 patient testing logs; Mohs maps, patients' test reports and interview with the laboratory director; the laboratory failed to establish and follow written policies and procedures that ensured positive identification and optimum integrity of a patient's specimen from the time of collection of receipt of the specimen through completion of testing and reporting of results. Findings: 1. On 09/12/19 at 10: 00 AM the surveyor reviewed the patient testing log. The following information is documented on the patient testing log: a. Date b. Accession # consisting of the letter "M" for Mohs; 2-digit year #; and chronologic 3-digit number. c. Patient's Name d. Site e. Level f. Physician's Last Name g. Tech Initials 2. The surveyor selected 5 patients names from the Patient Log, along with their corresponding Mohs map and test report. 3. 1 of 5 patients Mohs maps was not documented using the lab's established format for documenting the Accession #s for March 12, 2019. 4. Further review of the Patient Log and Mohs maps form 03/12/19 revealed that there were more patients tested that day. Mohs maps for all 4 was not documented using the lab's established format for documenting the Accession # / 5. On September 12, 2019 at 11: 30 AM, the laboratory director confirmed the surveyor's findings. 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 D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, review, and interview; the laboratory was not constructed, arranged and maintained to ensure the ventilation and utilities necessary for conducting all phases of the testing process. Findings: 1. Surveyor observation revealed that there was no fume hood in the room where tissue specimens were processed, cut, and stained. 2. Review of laboratory procedures manuals revealed that the laboratory's procedures manuals consisted of a written procedures manual, which was supplemented with 2 American Academy of Dermatology (AAD) CLIA Compliance Manuals. The AAD compliance manual had a section where the laboratory can fill in the blanks to describe its maintenance procedure for its fume hood. The laboratory did not complete the section for maintenance of its fume hood. 3. During survey date 04/24/18, the laboratory director confirmed the surveyor's findings. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory procedures manuals and patients test reports; 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 5 -- laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1273, and 493.1281 through 493.1299. Findings: 1. The laboratory failed to verify its histopathology procedures. See D5217 2. The laboratory failed to have an approved comprehensive procedures manual. See D5403 and D5407 3. The laboratory failed to include pertinent information on its patients' test reports. See D5607 and D5817 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 and interview, the laboratory failed to verify the accuracy of its histopathology procedures at least annually biannually. Findings: 1. Review of the laboratory's procedures manuals revealed that there were no procedures that described how the laboratory verifies its histopathology procedures. 2. Review of the laboratory's records revealed that there was no documentation to show that the laboratory performed proficiency testing or any other kind of verification procedures for its histopathology tests. 3. During survey date 04/24/18, the laboratory director confirmed the surveyor's findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)