Center For Dermatology, Pllc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 temperature records for review and interview with the facility personnel, the laboratory failed to monitor and document the room temperature and humidity of the area where dermatopathology stain reagents are stored and used for patient testing and where the cryostat is utilized. Findings include: 1. Each day patient testing occurred during 2021, the laboratory failed to monitor and document the room temperature of the area where dermatopathology stain reagents are used and stored. 2. The laboratory's daily temperature log showed an acceptable room temperature range of 70 degrees Fahrenheit (F) to 74 degrees F. 3. Each day of patient testing during 2021 and 2022, the laboratory failed to monitor and document the humidity of the area where the cryostat is used. 4. The manufacturer's instructions for the cryostat reviewed during the survey listed an acceptable operating relative humidity range of 0 - 60%. 5. The laboratory's reported annual test volume is 1,500. 6. The facility personnel interviewed on July 10, 2023 at 11:03 AM confirmed the laboratory failed to monitor and document the room temperature and humidity as indicated above. 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 patient. Findings include: 1. The laboratory performs patient testing in the subspecialty of Histopathology, with an approximate annual test volume of 1,500. 2. One out of one Mohs test reports (YSM21-402) 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 July 10, 2023 at 10:30 AM confirmed the tissue pathology report indicated above was not signed by the individual who performed the examination and made the diagnosis. 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 pathology test reports and interview with the facility personnel, the laboratory failed to have a system in place to ensure test results are reliably sent to the patient's electronic health record (EHR). Findings include: 1. The laboratory performs patient testing in the subspecialty of Histopathology, with an approximate annual test volume of 1,500. Pathology reports are scanned into the patient's EHR by laboratory personnel. The EHR is the final report destination. 2. The laboratory failed to provide evidence of the pathology test report maintained in the patient's EHR for biopsy# PS23-FBX-05. 3. The laboratory failed to have a system in place to ensure patient test results are reliably sent to the patient's EHR. 4. The facility personnel interviewed on July 10, 2023 at 11:19 AM confirmed the laboratory failed to have a system in place to ensure patient test results are reliably sent to the patient's EHR. -- 2 of 2 --

Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of amended test reports for testing performed in the sub-specialty of Histopathology and interview with the facility personnel, the laboratory failed to maintain duplicates of the original report, as well as the corrected report. Findings include: 1. The laboratory performs testing in the sub-specialty of Histopathology with an approximate annual test volume of 1,526. 2. During the survey conducted on 12/15/20, review of patient test report (Accession# YSF19-0021, reported on 11/13 /19), indicated the test report was amended. The operative note contained in the electronic record for this patient contained a page titled "Frozen Path info correction" and stated, "Frozen Section Path info was entered in wrong. The Rt Superior Occipital Scalp diagnosis should be 'Well Differentiated SCC' and the clinical description was 'Islands of atypical squamous cells invading the dermis' ". 3. The final, amended test report for accession YSF19-0021 included a Final Diagnosis of "Squamous Cell Carcinoma, Well-differentiated" and the Clinical Description stated, "Islands of atypical squamous cells invading the dermis." 4. The laboratory failed to provide documentation of the original diagnosis on the test report indicated above. The patient's test report only contained the amended diagnosis, and did not include the original diagnosis reported prior to the correction. 5. The facility personnel confirmed that the laboratory failed to maintain copies of the original test report, as well as the corrected test report. 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 -- 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 patient test reports and interview with the facility personnel, (A) the laboratory failed to follow policies and procedures for signing off on pathology test reports in a timely manner and (B) the laboratory failed to establish a policy and /or procedure for amending pathology test reports. Findings include: 1. The laboratory performs Mohs testing on patient specimens under the sub-specialty of histopathology, with an approximate annual test volume of 1,526. The laboratory utilizes an electronic medical record (EMR) system to maintain patient records, including Mohs test reports which are electronically signed by the physician who made the diagnosis. A2. The laboratory's established policy titled, "Providers Chart Review" (policy# 100.003) states, " All physicians and Nurse Practitioners must review and sign off patients charts within 72 hours of patients being seen virtually or in person." A3. Review of Mohs test reports indicated the laboratory failed to follow the established policy and sign off on patients' test reports within 72 hours of the procedure as evidenced by the following cases reviewed during the survey: PSM19- 186 - Date of Service (DOS) 7/15/19 - electronically signed on 7/28/19; YSM19-0614 - DOS 11/19/19 - electronically signed on 12/01/19; YSM20-0098 - DOS 2/19/20 - electronically signed on 3/01/20; PSM20-086 - DOS 5/11/20 - electronically signed on 5/23/20. A4. The facility personnel confirmed that the Mohs test reports reviewed during the survey were not signed in a timely manner by the physician who made the diagnosis. B1. No evidence was presented for review to indicate the laboratory established a policy or procedure for amending pathology test reports. B2. The facility personnel failed to provide documentation of an established policy and/or procedure for amending pathology test reports. The laboratory's policies and procedures are maintained in an electronic format and the surveyor requested the policy but no policy was presented for review by laboratory staff. -- 2 of 2 --