Grosse Pointe Dermatology

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Coordinator 1 (LC1), the laboratory failed to follow written polices to assess employee competency assessment for 3 (TP1, TP2, TP3) of 3 personnel performing tissue examination and Potassium Hydroxide (KOH) preparation. Findings include: A. Laboratory failed to assess staff problem solving skills for 3 of 3 testing personnel for tissue examination: 1. Review of competency assessments for TP1, TP2, and TP3 revealed problem solving skills were not addressed. 2. Review of "Competency Assessment Policy / Procedure" letter F states "Assessment of problem-solving skills." 3. Interview with LC1 confirmed that problem solving skills were not assessed observed by Technical Consultant had not been conducted. B. Laboratory failed to conduct competency assessments for 3 of 3 testing personnel for Potassium Hydroxide testing: 1. Review of personnel competency assessments revealed that observation of Potassium Hydroxide preparation had not been conducted. 2. Review of the laboratory's "Competency Assessment Policy / Procedure" states that "Direct observation of routine patient performance ....and testing" should be conducted. 3. Interview on 9/22/2024 at 11:36 am with Laboratory Coordinator 1 (LC1) and Laboratory Coordinator in Training 2 (LCT2) confirmed that direct observation of KOH testing had not been performed 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with Laboratory Coordinator 1 (LC1) the laboratory failed to verify the accuracy of Potassium Hydroxide (KOH) preparation at least twice annually for 2 (January 2023 to September 2024) of 2 years reviewed. Findings include: 1. Review of the laboratory's twice annual verification data revealed that testing was not performed for KOH preparations. 2. An interview on 09/22/2024 at 11:36 am with LC1 confirmed the laboratory did not verify accuracy at least twice annually for KOH testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with Laboratory Coordinator (LC1), the Laboratory failed to establish a written procedure for Potassium Hydroxide (KOH) testing for for 2 (January 2023 to September 2024) of 2 years reviewed. Findings include: 1. Review of the laboratory's procedure manual revealed that the laboratory had not established a testing procedure for Potassium Hydroxide (KOH) testing. 2. Review of 2 of 10 patient records reviewed (01/27/2023 and 2/08/2024) revealed KOH testing was performed. 3. Interview with LC1 on 09/22/2024 at 11:36 am revealed that a procedure was not established. -- 2 of 2 --

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 record review and interview with the laboratory liaison (LL), the laboratory failed to evaluate hematoxylin and eosin (H&E) staining materials for intended reactivity each day of use for 6 (LB21-0976, LB22-0111, LB22-0234, LB22- 0378, LB22-0440, and LB22-0491) of 10 patient reports reviewed. Findings include: 1. A review of patient test reports revealed for 6 of 10 patient dermatopathology reports the reports lacked documentation of the hematoxylin and eosin stain quality for the slides reviewed as follows: a. LB21-0976 performed on 12/21/2021 b. LB22- 0111 performed on 2/17/2022 c. LB22 - 0234 (A) and (B) performed on 4/11/2022 d. LB22-0378 (A) and (B) performed on 6/13/2022 e. LB22-0440 performed on 7/08 /2022 f. LB22-0491 (A) and (B) performed on 8/01/2022 2. An interview on 8/23 /2022 at 10:30 am, the LL confirmed the H&E staining quality was not performed and documented since the new computer system went into place. 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 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 -- 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 record review and interview with the laboratory liaison (LL), the laboratory failed to establish a system to ensure the transcribed anatomic site was accurately transcribed for 1 (LB21-622) of 10 patient dermatopathology reports reviewed. Findings include: 1. A record review revealed for 1 of 10 dermatopathology reports reviewed, the anatomical site on the "Dermatopthology Report" was transcribed onto the worksheet inaccurately as follows: a. LB21-622 i. Pathology requisition and Visit note - left inferior central malar cheek ii. "Dermatopathology report" - left malar cheek 2. An interview on 8/23/2022 at 10:24 am, the LL confirmed the transcribed anatomical site was not accurately written on the "Dermatopathology Report" worksheet. -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory liaison (LL), the laboratory failed to have a request for patient testing for 1 (patient #17) of 23 patient results reviewed. Findings include: 1. A review of "GPDA Laboratory Test Requisition and Report Log" revealed for 1 (#17) of 23 patient charts reviewed the patient received potassium hydroxide (KOH) testing on 11/11/2019 with a negative result. 2. A review of the electronic medical record (EMR) for patient #17 revealed lack of a test request for KOH. 3. An interview on 4/01/2021 at 11:39 am with the LL confirmed a test request was not available for patient #17 for KOH testing. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory liaison (LL), the laboratory failed to have the final potassium hydroxide (KOH) report maintained as part of the patient's electronic medical record (EMR) for 1 (#17) of 23 patient charts reviewed. Findings include: 1. A record review for 1 (#17) of 23 patient charts reviewed revealed a lack of documentation in the EMR system for the KOH test result run on 11/11/2019 and recorded on the "GPDA Laboratory Test Requisition 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 -- Log" 2. During the interview on 4/01/2021 at 11:39 am, the LL confirmed the final KOH test result was not included in the patient's electronic medical record. 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 record review and interview with the laboratory liaison (LL), the laboratory failed to detect an incorrect laboratory test result reported out in the electronic medical record (EMR) for 2 (#1 and #5) of 23 patient charts reviewed. Findings include: 1. Record review for 2 of 23 patient charts reviewed revealed the final dermatophyte test medium (DTM) result in the EMR was incorrect as follows: a. Patient #1 - the specimen source is incorrect on the final report, the "GPDA Laboratory Test Requisition and Report Log" left hand was recorded and the final report states right hand. b. Patient #5 - DTM for the left foot was reported as negative, the "GPDA Laboratory Test Requisition and Report Log" revealed the result was positive. 2. During the interview on 4/01/2021 at 11:39 am, the LL confirmed the final laboratory test report in the patient's EMR record did not match the result recorded on the "GPDA Laboratory Test Requisition and Report Log." -- 2 of 2 --