Clarkston Dermatology

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with a Medical Assistant (MA), the laboratory failed to perform and document the refrigerator every 3 months maintenance for 1 (April 2023) of 6 checks from January 2022 to July 25, 2023. Findings include: 1. A review of the "Equipment Quality Control Refrigerator Maintenance Record" revealed the following tasks to be performed and documented every 3 months for the refrigerator: a. check door gasket seal b. defrost/clean. c. grounding 2. Record review of the "Equipment Quality Control Refrigerator Maintenance Record" log revealed a lack of documentation for the 3 months maintenance for 1 (April 2023) of 6 checks reviewed. 3. An interview on 7/25/2023 at 11:58 am, a MA confirmed the laboratory failed to perform and document the April 2023 refrigerator maintenance. 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 record review, lack of documentation, and interview with Medical 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 -- Assistant (MA), the laboratory failed to perform and document the quarterly patient chart review for the histopathology/Mohs' testing for 2 (March and June 2023) of 6 quarterly checks in 2022 and 2023. Findings include: 1. Record review of the "Quality Assurance Audit - Patient Chart Review" logs revealed no documentation for 2 (March and June 2023) of 6 quarterly checks in 2022 and 2023. 2. When queried on 7 /25/2023 at 12:05 pm, a MA was unable to provide the surveyor documentation to show the quarterly checks had been performed. 3. An interview on 7/25/2023 at 12:03 pm, a MA confirmed the quarterly patient chart reviews had not been performed for March and June in 2023. -- 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 Director (LD), the laboratory failed to have a electronic request for patient testing from an authorized person for 1 (#19) of 20 patient charts audited. Findings include: 1. Record review revealed for 1 (#19) of 20 patient charts audited the laboratory did not have an electronic request for laboratory testing by an authorized person for the dermatophyte test media (DTM) testing completed on 8/26/2021. 2. An interview on 12/21/2021 at 11:59 am, the LD confirmed the patient testing did not have an electronic request. 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 document review and interview with the Laboratory Director (LD), 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 -- laboratory failed to establish a system to ensure the transcribed Mohs' surgical site were accurately reported on the Mohs' map and in the laboratory information system (LIS) for 1 case (796) of 15 Mohs' cases reviewed from December 2019 to December 2021. Findings include: 1. Record review revealed for 1 case (796 performed on 12/30 /2019) of 15 Mohs' cases reviewed, the Mohs' surgical site on the Mohs' map and in the LIS system did not match the original Pathology report location. 2. An interview on 12/21/2021 at 12:14 pm, the LD confirmed the locations on the Mohs' map and in the LIS system were not consistent with the original Pathology report. 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, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to have the final dermatophyte test media (DTM) patient test report maintained as part of patients' electronic medical record (EMR) for 1 (#19) of 20 patient charts reviewed. Findings include: 1. On 12/21/2021 at approximately 12:00 pm, the surveyor requested 20 test orders and reports maintained in the patients' EMR system. 2. A record review revealed for 1 (#19) of 20 patient charts reviewed a lack of documentation in the patient's EMR for the DTM performed on 8/26/2021. 3. An interview on 12/21/2021 at 11:59 am, the LD confirmed the patient testing was not available in the patient's EMR and not made available to the surveyor. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the back staff manager (BSM), the laboratory failed to retain 3 (D1241-0817, D1288-0818, and D1312-0219) of 3 manufacturer's package insert for 2 years. Findings include: 1. Record review revealed the laboratory was using "ACU-DTM" Dermatophyte Test Medium (DTM), selective medium for the detection of dermatophytes. 2. Record review of the package inserts revealed the laboratory did not retain 3 of 3 manufacturer's package insert for 2 years as follows: a. D1241-0817 b. D1288-0818 c. D1312-0219 3. During the interview on 11/4/2019 at 10:45 am., the BSM acknowledged the manufacturer's package inserts were not retained for 2 years. 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 record review and interview with the back staff manager (BSM), the laboratory failed to perform verification of accuracy for the potassium hydroxide (KOH) and dermatophyte test medium (DTM) testing for 2 (November 2017 to November 2019) of 2 years. Findings include: 1. A record review revealed a lack of 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 -- documentation for the twice annual verification of accuracy for the KOH and DTM testing for 2 of 2 years. 2. During the interview on 11/4/2019 at 11:30 am, the BSM acknowledged the verification of accuracy for the KOH and DTM testing was not performed and documented. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (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 back staff manager (BSM), the laboratory failed to perform and document media checks for the "ACU-DTM Dermatophyte Test Medium (DTM)" with each new batch, lot, or shipment for sterility, physical characteristics, and the ability to support growth of yeast for 2 (November 2017 to November 2019) of 2 years. Findings include: 1. A record review of "ACU-DTM (Dermatophyte Test Medium) Directions for Use" in the package insert exposed a section stating, "CLIA requires the end user to perform a minimum of a positive and negative control on each new lot or batch purchased." The table indicated the microorganisms to use for quality control were, "Trichophyton mentagrophyte, E. coli, and Candida albicans." 2. A record review of the DTM section of the "KOH & DTM Log" book revealed a lack of documentation for the media checks for sterility, physical characteristics, and a control for the yeast (Candida albicans) for 2 of 2 years. 3. When requested by the surveyor on 11/4/2019 at approximately 10:35 am, the BSM was not able to provide records of performing the sterility, physical characteristics, and the yeast control on the DTM. 4. During the interview on 11/4/2019 at approximately 10:35 am., the BSM acknowledged the media checks for sterility, physical characteristics and the ability to support growth of yeast had not been performed. -- 2 of 2 --