Center For Dermatology, Pllc

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 patient test results maintained in the Electronic Health Record (EHR) and interview with the facility personnel, the laboratory failed to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (entered manually) to the final report destination, in a timely manner during 2024. Findings include: 1. Patient-specific data and the final test result information for Mohs and Frozen Biopsy testing is manually transcribed by laboratory personnel into the patient's EHR. 2. No documentation was presented for review during the survey conducted on 6/6/25 to indicate the laboratory had ensured test results and other patient-specific data were accurately and reliably sent from the point of data entry (entered manually) to the final report destination, in a timely manner during 2024. 3. The testing personnel interviewed on 6/6/25 at 8:30 AM confirmed the laboratory failed to verify the accuracy of patient-specific data and patient test results that are manually entered into the EMR during 2024. 4. The laboratory performs testing under the specialty of Histopathology with a reported annual test volume of 1,050. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1299(a) (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 a lack of (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the postanalytic systems specified in 493.1291. Findings include: 1. The laboratory failed to establish policies and procedures to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (entered manually) to final report destination, in a timely manner. 2. The facility personnel interviewed on 6/6/2025 at 8:30 AM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified with the postanalytic systems. 3. The laboratory performs patient testing in the subspecialty of Histopathology with a reported annual test volume of 1,050. -- 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 laboratory's Mohs records and interview with the facility personnel, the laboratory failed to follow policies and procedures that ensure positive identification of patient's dermatopathology specimens from the time of collection through completion of testing and reporting of test results. Findings include: 1. The laboratory performs Mohs interpretations and Frozen Biopsy testing under the subspecialty of Histopathology, with an annual test volume of 1,024. 2. One of out two patient slides for case# YCM23-550 was labeled with the incorrect specimen site (Right Superior Forehead). The correct site as noted in the EMR, on the Mohs map, on the laboratory Mohs log and on the patient's remaining slide was 'Left Superior Forehead'. 3. The facility personnel interviewed on 12/13/23 at 1:00 PM acknowledged the laboratory failed to ensure positive identification of the patient's specimens from the time of collection through completion of testing and reporting of results, as evidenced by the specimen identification error on the slide indicated above. 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. 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 Assessment (QA) documentation and interview with the facility personnel, the laboratory failed to follow established policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems. Findings include: 1. Patient-specific data and the final test result information for Mohs interpretations and Frozen Biopsy testing is manually transcribed by laboratory personnel into the patient's Electronic Health Record (EHR). 2. The laboratory's Quality Assessment policy states, "Biannually, 5 cases will be reviewed and randomly selected. All frozen sections will be pulled for review. If any issues noted they will be documented, and