Wayne Health Dearborn

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 Laboratory Director (LD) and laboratory liaison (LL), the laboratory failed to retain a copy of the original histopathology Mohs' map at least ten years for 1 (D16-1) of 11 patient charts reviewed. Findings include: 1. Record review revealed a lack of documentation for the Mohs' map in the patient's electronic medical record (EMR) for 1 of 11 patient charts reviewed. 2. When queried on 10/18/2022 at 10:50 am, the LD and LL were unable to provide the surveyor a scanned or a paper copy of the Mohs' map. 3. An interview on 10/18/2022 at 12:45 pm, the LD and LL confirmed the Mohs' map was not retained for at least 10 years from the date of reporting in the patient's EMR. ***Repeat Deficiency from 12/17/2018 survey *** 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) and laboratory liaison (LL), the laboratory failed to have a documented electronic request 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 -- for patient testing from an authorized person for 1 (patient 699075) of 4 patient charts reviewed. Findings include: 1. A record review of patient charts revealed for 1 (patient 699075) of 4 patient charts reviewed there was no electronic order for the potassium hydroxide (KOH) testing performed and resulted on 8/05/2021 in the patients electronic medical record (EMR). 2. An interview on 10/18/2022 at 12:45 pm, the LD and LL confirmed there were no orders documented in the patients EMR for the KOH test performed and resulted on 8/05/2021. 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 Director (LD) and laboratory liaison (LL), the laboratory failed to provide test reports maintained as part of the patients' chart for 1 (D22-024) of 11 patient test reports reviewed. Findings include: 1. A record review revealed for 1 (D22-024) of 11 patient charts reviewed, the laboratory did not provide a copy of the Pathology Report which brought the patient to this laboratory for further testing (Mohs'). 2. When queried on 10/18/2022 at 11:45 am, the LL was not able to provide the surveyor the document requested. 3. An interview on 10/18/2022 at 12:45 pm, the LD and LL confirmed the laboratory did not maintain a copy of the Pathology Report in the patient's EMR. 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 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: A. Based on record review and interview with the Laboratory Director (LD) and the laboratory liaison (LL), the laboratory failed to indicate the surgical site on the Mohs' map as part of the test report for 2 (D21-042 and D21-070) of 11 patient test records reviewed. Findings include: 1. Record review revealed for 2 of 11 patient test reports the surgical site was not recorded on the Mohs' map as part of the test report. 2. An interview on 10/18/2022 at 12:45 pm, the LD and LL confirmed the laboratory did not indicate the surgical site on the Mohs' maps for the patients listed above. B. Based on record review and interview with the Laboratory Director (LD) and the laboratory liaison (LL), the laboratory failed to correctly label the surgical site on the Mohs' log for 1 (D21-055) of 11 patient test records reviewed. Findings include: 1. A record review performed on 10/18/2022 at 10:57 am revealed the "Dermatopathology Report", the Mohs' map, and the "Mohs' micrographic surgery" notation in the patients electronic medical record (EMR) labeled the surgical site as "right medial -- 2 of 3 -- cheek" while the Mohs' log labeled the surgical site as "right cheek." 2. An interview on 10/18/2022 at 12:45 pm, the LD and LL confirmed the surgical site on the Mohs' log was not consistent with the "Dermatopathology Report", the Mohs' map, and the Mohs' notation in the patients EMR. C. Based on record review and interview with the Laboratory Director (LD) and the laboratory liaison (LL), the laboratory failed to establish a system to ensure the transcribed Mohs' surgical site was accurately transcribed onto the Mohs' map, Mohs' log and, in the patient's electronic medical record (EMR) visit note for 1 of (D22-048) of 11 patient test records reviewed. Findings include: 1. A record review revealed for 1 of 11 Mohs' cases reviewed, the surgical site on the patient's Mohs' map and the visit note in the EMR system was not transcribed accurately as follows: D22-048 i. Pathology report and Mohs' log - right upper cheek ii. Mohs' map and the visit note in EMR - right lower eyelid 2. An interview on 10/18/2022 at 12:45 pm, the LD and LL confirmed the surgical site locations was not transcribed accurately. -- 3 of 3 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Office Manager (OM), the laboratory failed to provide safety procedures for proper protection and disposable of biohazardous materials in the Mohs' laboratory for 2 (March 2019 to March 2021) of 2 years in use. Findings include: 1. During a tour of the laboratory on 3/29/2021 at 9:34 am, the surveyor observed XS-3 Xylene Substitute made by StatLab used for Mohs' staining stored in the flammable cabinet. 2. A record review of the "Mohs Procedure Manual" states in Section 4.3 "Storage used and Handling (See MSDS forms)" subsection 4.3.6 "Reagents are disposed of according to federal, state, and local laws." The surveyor did not observe any biohazardous waste containers available in the laboratory. 3. A phone interview on 4/5/2021 at 9:45 am with the OM, confirmed there were no procedures for protection and/or disposable of biohazardous waste in the laboratory. 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. 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 -- This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Laboratory Director (LD), the laboratory failed to label the histopathology marking inks that were poured off from the original container with the lot number, storage requirements, and expiration dates for 5 (yellow, red, black, blue, and green) of 5 ink containers observed. Findings include: 1. During a tour of the laboratory on 3/29/2021 at 9:34 am the surveyor observed 5 (yellow, red, black, blue, and green) of 5 marking inks that had been poured off into small containers without the lot number, storage requirements, and expirations dates recorded on the containers. 2. A record review of the "Mohs Procedure Manual" states in "section 4.2 Preparation and Labeling" under 4.2.1 "Liquid reagents may be transferred to correctly labeled smaller containers for that particular reagent." 3. An interview on 3/29/2021 at 9:45 am with the LD confirmed the laboratory did not provide the labeling information on the histopathology marking ink poured off containers. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A. Based on observation, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to perform and document the traceable thermometer calibration checks as required by the manufacturer before the expiration for 8 (July 2020 to March 2021) of 24 months of operation. Findings include: 1. During a tour of the laboratory on 3/29/2021 at 9:34 am the surveyor observed a McKesson traceable thermometer in use that provides the room temperature and humidity readings being used past the expiration date of 7/12/2020. 2. A lack of documentation upon review of the laboratory records revealed the thermometer was not calibrated and/or replaced by the expiration of 7/12/2020. 3. When queried on 3/29 /2021 at 9:45 am, the LD was unable to provide the surveyor the requested calibration documents and/or proof of replacement of the thermometer. 4. A interview on 3/29 /2021 at 9:45 am, the LD confirmed the McKesson traceable thermometer was not calibrated and/or replaced by the 7/12/2020 expiration. B. Based on record review and interview with the Office Manager (OM), the laboratory failed to perform and document the weekly eyewash maintenance for 10 weeks (10/2019 week 3, 5/2020 week 4, 9/2020 weeks 3 and 4, 11/2020 weeks 1, 3 and 4, and 12/2020 weeks 2-4) of 2 years reviewed. Findings include: 1. A record review of the "WSU Dermatology Surgery Eyewash Maintenance Log" revealed for 10 weeks of 2 years reviewed lack of documentation the weekly maintenance was performed as follows: a. 10/2019 - no documentation for week 3 b. 5/2020 - no documentation for week 4 c. 9/2020 - no documentation for weeks 3 and 4 d. 11/2020 - no documentation for weeks 1, 3, and 4 e. 12/2020 - no documentation for weeks 2 - 4 2. When queried on 3/29/2020 at 1:12 pm, the OM was unable to provide the surveyor documentation for the missing preventive maintenance on the eyewash station. 3. A interview on 3/29/2021 at 1:12 pm, the OM confirmed the eyewash maintenance was not performed and documented weekly as required. -- 2 of 3 -- D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the 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 record review and interview with the Laboratory Director (LD), the laboratory failed to maintain a record system that included the time the specimen for each stage of Mohs' testing was received in the laboratory and processed for 7 (#2, #4- 8, and #10) of 12 Mohs' final map reports reviewed for 2 years. Findings include: 1. A record review for 7 (#2, #4-8, and #10) of 12 Mohs' cases reviewed revealed the laboratory did not have a record system in place that included the time each stage of the Mohs' testing was received in the laboratory and processed when multiple stages were collected. 2. A interview on 3/29/2021 at 1:45 pm, the LD confirmed the time received in the laboratory and processed for each stage of the Mohs' testing was not documented. ***Repeat Deficiency from 12/17/2018 survey*** D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Office Manager (OM), the Technical Supervisor (TS) failed to assess employee competency for 1( #5) of 1 testing personnel performing the high complexity Mohs grossing for 2 years. Findings include: 1. A review of the laboratory's competency records revealed a lack of documentation of competency assessments for 1 (#5) of 1 testing personnel performing the high complexity Mohs grossing in 2019 and 2020. 2. A interview on 3 /29/2021 at 10:55 am, the OM confirmed competency assessments were not available for testing personnel #5. -- 3 of 3 --

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, the laboratory failed to retain a copy of the original histopathology Mohs' map at least ten years for three (#1, #2, and #4) of 15 patient charts reviewed. Findings include: 1. On December 17, 2018 at 3:23 PM, patient chart review revealed the laboratory did not have the Mohs' map as part of the patients medical record and the laboratory did not retain the original map for as least 10 years from the date of reporting . 2. On December 17, 2018 at 3:23 PM when queried, the office staff member was unable to provide the surveyor the final copy of the Mohs' map requested. 3. During the interview on December 17, 2018 at 3:23 PM, the office manager confirmed the final Mohs' map was not retained for at least 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: . Based on record review and interview, the laboratory failed to at least twice annually verify the accuracy of testing for each provider using Michigan Dermatological Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Society "Physician Performed Microscopy/DTM Interpretation" and/or "Dermatopathology" examination for four (spring/fall 2017 and 2018) of four seasonal exams reviewed. Findings include: 1. On December 17, 2018 at 2:45 PM, record review of the "Physician Performed Microscopy/DTM Interpretation" exams revealed the testing personnel (TP) did not perform at least twice a year verification of accuracy as follows: a. TP #4 - no fall 2017 b. TP #1 and #2 - no spring and fall 2017 c. TP #4 - no spring 2018 d. TP #3 - no spring and fall 2018 2. On December 17, 2018 at 2:45 PM, record review of the "Dermatopathology" exams revealed the TP did not perform at least twice a year verification of accuracy as follows: a. TP#1 - no spring and fall 2017 b. TP #3 - no spring and fall 2018 3. During the interview on December 17, 2018 at approximately 4:30 PM, the office manager confirmed the spring and fall Michigan Dermatological Society examinations was not consistently completed and documented for each provider. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to document room temperature and humidity readings each day of operation. Refer to D5413. 2. The laboratory failed to was the Chlorazol Black E, Wright-Giesma stain, and CDI Tissue Marking Dyes before the manufacturer's expiration date. Refer to D5417. 3. The laboratory failed to perform and document the weekly eyewash maintenance. Refer to D5429. 4. The laboratory failed to document the