Dermatology And Cosmetic Physicians, Sc

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) records and laboratory procedures and interview with the laboratory director, the laboratory did not document the quality evaluation of the H&E (Hematoxylin and Eosin) stain used in the last six of six months, the laboratory documented the last quality control record for the H&E stain on January 10, 2024. Findings include: 1. Review of H&E QC records showed the laboratory last documented their stain quality evaluation on January 10, 2024. 2. Review of the "Mohs Surgery Laboratory Compliance Manual", page 33, showed step 6.1.5 was marked off and a modified version entered. The original 6.1.5 stated, "A control slide will be made and evaluated each day that a frozen section is prepared. A record of the control slide will be maintained". The modified version stated, "No control slide will be prepared. Each slide is its own control. Adjustments are made if any slide has deficiency". The laboratory director initialed the modification, no date is present with the modification. 3. Interview with the laboratory director on July 9, 2024, at 10:00 AM revealed the laboratory changed their process and the laboratory had not documented H&E stain quality control results since January 10, 2024. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes 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 2 -- following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with staff, the histotechnicians did not record the time the laboratory received additional specimens for six of six Mohs cases with multiple levels performed on June 5, 2024. Findings include: 1. Review of the Mohs patient log showed six of the ten cases on June 5, 2024, required multiple levels during the Mohs procedures. Review of Mohs maps for the six cases with multiple levels showed the histotechnician did not document the time of specimen receipt for any of the additional specimens. The maps included a labeled space for recording the time and initials of the histotechnician for each level. 2. Review of the procedure manual revealed the histotechnician was responsible for recording the time of receipt for each specimen and their initials on the Mohs map. 3. Interview with Staff A on July 9, 2024, at 9:30 AM confirmed the laboratory did not record the received time for each additional layer required during Mohs procedures. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory director, the director did not ensure the laboratory developed and maintained a quality assessment program to assure the accuracy and quality of laboratory reports for one of four random Mohs cases reviewed. Findings include: 1. Review of four randomly chosen Mohs patient reports from the electronic medical record (EMR) revealed the laboratory reported the tumor type as Basal Cell Carcinoma (BCC) for the sample from the left lateral forehead of patient 1. Review of the corresponding map and log showed the recorded tumor type as Squamous Cell Carcinoma (SCC). Review of the pathology report from the Department of Veteran Affairs in Madison, Wisconsin, showed the diagnosis of tissue from the left lateral forehead site as SCC. 2. Interview with the laboratory director on July 9, 2024, at 10:00 AM confirmed the tumor type reported in the EMR was not consistent with the tumor type identified in the pathology report, the map, and the patient log and that the laboratory did not have a quality assessment program to assure the accuracy of reports. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of laboratory records and interview with the laboratory director, the laboratory did not verify the accuracy of Mohs interpretations in 2022. Findings include: 1. Review of laboratory records showed the laboratory sent three Mohs cases to a second laboratory for accuracy verification on January 19, 2023. Further review showed no documentation of accuracy verification for Mohs interpretations in 2022. 2. Interview with the laboratory director on April 20, 2022, at 11:35 AM confirmed the laboratory began patient testing in June 2022 and did not verify the accuracy of Mohs interpretations in 2022. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of laboratory records and patient logs and interview with a technical consultant, staff A, the laboratory did not document quality control (QC) for Mohs stain acceptability with patient testing for two of two days in August 2022. Findings include: 1. Review of the temperature log for the cryostat revealed Mohs surgery performed on August 5, 2022, and August 31, 2022. 2. Review of patient logs showed testing performed on patients 2-8 on August 5, 2022 and patients 9-16 on August 31, 2022. 3. Review of "Laboratory Quality Control for Hematoxylin and Eosin" log showed no documentation the laboratory performed QC testing on August 5, 2022, or August 31, 2022. 4. Interview with the laboratory director on April 26, 2023, at 9:50 AM confirmed the laboratory did not document QC for Mohs stain quality acceptability on two of two testing day in August 2022. 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 surveyor review of the "Mohs Patient Log", patient records and interview with the laboratory director, the laboratory did not establish an ongoing mechanism to monitor, assess and correct problems when identified in one of four cases reviewed. Findings include: 1. Review of the "Mohs Patient Log" revealed patient 1, case 129, had a Mohs site of Left Zygomatic cheek on March 15, 2023. 2. Review of the Mohs map for patient 1 revealed a location of left cheek zygomatic for case 129. Further review of the map showed a diagram indicating the location for Mohs surgery was the forehead. 3. Review of the patient report for patient 1 revealed the location was "Forehead-Medial" on March 15, 2023. 4. Interview with the laboratory director on April 26, 2023, at 9:50 AM, confirmed the laboratory did not establish an ongoing mechanism to monitor, assess and correct problems when patient information is inaccurate. -- 2 of 2 --