Advanced Dermatology Of Michigan

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Office Manager, the laboratory failed to ensure reagents were labeled with the expiration date for 1 bottle of 100% alcohol observed. Findings include: 1. During a tour of the laboratory on 9/13 /21 at 12:07 pm, the surveyor observed a small plastic bottle with a "100% Alcohol" label. The bottle did not contain the expiration date of the reagent. 2. A review of the laboratory's "Histopathology for Mohs Micrographic Surgery" procedure revealed a section titled "Reagent Labeling" stating, "The manufacturer labels commercially prepared reagents. All containers used in the staining process must contain the name of the reagent as well as the lot number and expiration date. Dilutions or transfers of volatile materials will be performed under a ventilated hood. Original labels must include name of reagent, warning if reagent is hazardous, expiration date, strength, concentration, or dilution of reagent, preparation date and storage requirements" 3. An interview on 9/13/21 at 12:12 pm with the Office Manager confirmed the bottle did not have an expiration date. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the Office Manager, the laboratory failed to ensure tissue marking dyes used in tissue specimen grossing were not expired for 4 of 7 tissue marking dyes observed. Findings include: 1. During a tour of the laboratory on 9/13/21 at 12:07 pm, the surveyor observed 4 expired tissue marking dyes with the expiration date of 2/1/21. 2. An interview on 9/13/21 at 12:11 am with the Office Manager confirmed the tissue marking dyes used were expired. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the Laboratory Director failed to approve the procedure manual of the laboratory's testing process for 7 (March 2021 to September 2021) of 7 months since the current Laboratory Director was instated. Findings include: 1. A review of the laboratory's procedure manual revealed a lack of documentation of the Laboratory Director approving the laboratory's testing procedures. 2. An interview on 9/13/21 at 12:44 pm with the Office Manager confirmed the current Laboratory Director had not approved the laboratory's testing procedures since becoming the Laboratory Director on 2/26/21. -- 2 of 2 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM) and the Mohs' Technician (MT), the laboratory failed to retain a scanned copy for 10 years of the original Mohs' map for 9 (November 2018 to present date) of 10 months with the installation of a new Laboratory Information System (LIS). Findings include: 1. Record review for the chart audit revealed for 9 of 10 months the laboratory was not consistently scanning in the entire Mohs' map into the LIS system, only a captured picture shot that did not contain all the pertinent information for the final report. 2. When queried on September 25, 2019 at approximately 12:19 pm, the OM and MT stated that if a picture was captured then the map was not scanned into the LIS. 3. During the interview on September 25, 2019 at 12:19 pm, the OM and MT acknowledged the Mohs' map was not consistently scanned into the LIS, therefore not kept for 10 years from the date of reporting. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- . Based on record review and interview with the Office Manager (OM) and the Mohs' technician (MT), the laboratory failed to verify the accuracy of testing for the mycology potassium hydroxide (KOH) at least twice annually for 2 (1st and 2nd 2019) of 7 events reviewed. Findings include: 1. Record review of the final graded proficiency testing reports from the American Proficiency Institute (API) revealed the laboratory failed the 1st and 2nd events for 2019 as follows. a. 1st event 2019 - 50% b. 2nd event 2019 -50 % 2. When queried on September 25, 2019 at approximately 10: 00 am if the laboratory completed further testing or did chart reviews, the surveyor was instructed that no further action was taken. 3. During the interview on September 25, 2019 at approximately 10:00 am, the OM and the MT acknowledged that verification of accuracy was not acceptable for the 1st and 2nd events of 2019 and no further action was taken. 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 lack of documentation and interview with the Office Manager (OM) and the Mohs' Technician (MT), the laboratory failed to provide a test request for the potassium hydroxide (KOH) testing for 1 (#3) of 22 charts reviewed. Findings include: 1. Lack of documentation in the patient's chart failed to show a written request to perform the KOH testing performed on February 5, 2018 for 1 (#3) of 22 charts reviewed. 2. During the interview on September 25, 2019 at 12:00 pm, the OM and MT acknowledged the patient's chart did not contain an order for the KOH testing. ***Repeat Deficiency from the April 13, 2017 survey*** 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 lack of documentation and interview with the Office Manager (OM) and the Mohs' Technician (MT), the laboratory failed to have the final mycology potassium hydroxide (KOH) result maintained as part of the patient's chart or medical record for 1 (#3) of 22 patient charts audited. Findings include: 1. Lack of documentation for 1 (#3) of 22 patient charts audited revealed the final test report for the KOH testing was not maintained in the patient's chart or medical record. 2. During the interview on September 25, 2019 at approximately 12:00 pm, the OM and MT acknowledged the final KOH result was not present in the patient's chart or medical record. ***Repeat Deficiency from the April 13, 2019 survey*** D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and -- 2 of 3 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM) and the Mohs' Technician (MT), the laboratory failed to ensure 1) the date of testing, the site, and the tumor type were maintained as part of the final Mohs' map for 4 (#18, #20, #21, and #22) of 22 charts audited and 2) the time of receipt into the laboratory of the tissue specimen was not recorded for 13 (#10 - #22) of 22 patient charts audited. Findings include: 1. Record review for 4 (#18, #20, #21, and #22) of 22 charts audited revealed the final Mohs' map was missing the date of the surgery, the site, and the tumor type. 2. Record review for 13 (#10 - #22) of 22 charts audited revealed the specimen receipt time into the laboratory was not recorded on the Mohs' map. 3. During the interview on September 25, 2019 at 12:45 pm, the OM and MT acknowledged the missing information from the Mohs' map. -- 3 of 3 --