West Michigan 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 Medical Assistant Manager, the laboratory failed to establish policies to assess competency for its technical consultants and technical supervisors for 2 (Technical Consultant #1/Technical Supervisor and Technical Consultant #2) of 2 technical consultants and technical supervisors listed on Form CMS-209. Findings include: 1. A review of the laboratory's competency assessments on 6/22/22 revealed a lack of competency assessments for personnel filling the technical consultant and technical supervisor roles: a. Technical Consultant #1, also serving as the Technical Supervisor. b. Technical Consultant #2. 2. The surveyor requested the competency assessment documentation for Technical Supervisor and Technical Consultant #2 on 6/22/22 at 12: 40 pm and it was not made available. 3. An interview on 6/22/22 at 12:40 pm with the Medical Assistant Manager confirmed the Technical Consultant and Technical Supervisor competency assessment documentation was not available. 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 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 -- 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: . Based on record review and interviews, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to establish procedures for its histopathology testing. Refer to D5401. 2. The laboratory failed to perform media control procedures for its Dermatophyte Test Media (DTM). Refer to D5477. 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 the Medical Assistant Manager and Practice Administrator, the laboratory failed to establish procedures for its histopathology testing for 14 (April 2021 to June 2022) of 14 months reviewed. Findings include: 1. A review of the laboratory's procedure manual on 6/22/22 revealed a section titled "Procedure Manual" stating "Written procedures for the performance of all analytical methods used by the laboratory shall be maintained in a test procedure manual(s). Written procedures shall be available to testing personnel during the performance of their duties to act as a reference for the tests they perform." 2. The surveyor requested the laboratory's histopathology procedure on 6/22/22 at 12: 55 pm and it was not made available. 3. An interview on 6/22/22 at 1:55 pm with the Medical Assistant Manager and the Practice Administrator confirmed the laboratory did not have a histopathology testing procedure available. 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 deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Medical Assistant Manager, the laboratory failed to ensure the tissue marking dyes used in histopathology testing had not exceed their expiration dates for 2 (red and yellow) of 3 tissue marking dyes in use. Findings include: 1. The surveyor observed the laboratory's tissue marking dyes on the laboratory counter on 6/22/22 at 11:59 am. Two of the dyes had the following expiration dates: a. Cancer Diagnostics Inc, Yellow, Lot number 9199, expiration date 7/31/21. b. Cancer Diagnostics Inc, Red, Lot number 9203, expiration date 7/31/21. 2. A review of the laboratory's procedure manual revealed a section titled "Test Systems, Equipment, Instruments, Reagents, Materials, and Supplies" stating, "Reagents, solutions, culture media, control -- 2 of 3 -- materials, calibration materials and other supplies shall not be used when they have exceeded their expiration date, have deteriorated or are found to be of sub-standard quality." 3. An interview on 6/22/22 at 11:59 am with the Medical Assistant Manager confirmed the tissue marking dyes in use had exceeded the expiration dates. 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 interviews, the laboratory failed to perform media control procedures for its Dermatophyte Test Media (DTM) for 2 (D1425-0621 and D1338-0819) of 2 lots of media reviewed. Findings include: 1. A review of the laboratory's "MOHS LABORATORY TEST REQUISITIONS AND REPORT LOG- SUPPLY LIST" revealed two lots of DTM had been in use by the laboratory: a. Four boxes of DTM lot number D133-0819 with the expiration date of 8/2021 were received in the laboratory on 10/15/19. b. DTM lot number D1425-0621 with the expiration date of 6/29/23 was received on 8/13/21. 2. A review of the laboratory's photocopied "Laboratory Tests Log for DTM, Parasites, KOH or Tzanck" on 6/22/22 revealed a lack of a documentation for sterility control, positive dermatophyte growth control, positive yeast growth control, and an inhibition of growth control for lot number D1425-0621. It revealed a lack of sterility control and positive yeast growth control documentation for lot number D133-0819. 3. An interview on 6/22/22 at 1:22 pm with the Medical Assistant Manager revealed the "Laboratory Tests Log for DTM, Parasites, KOH or Tzanck" photocopied log noting the positive and inhibition of growth control results for lot number D133-0819 came from a separate laboratory. The laboratory received media and documentation of the media control procedures from a separate laboratory and had not performed media control procedures. 4. A review of the laboratory's procedure manual revealed a section titled, "Control Procedures" on 6/22/22 stating, "Before or concurrent with initial use the laboratory must: (a) check each batch of media for sterility if sterility is required for testing; (b) 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 (c) document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer." 5. A review of the laboratory's "Laboratory Test Log for DTM, Parasites, KOH or Tzanck" on 6/22/22 revealed 44 patients had received testing with DTM from the lot number D133-0819 from 3/12/20 to 9/7/21 and 30 patients had received testing from the lot number D1425-0621 from 8/31/21 to 6/21/22. 6. An interview on 6/22/22 at 1:55 pm with the Medical Assistant Manager and the Practice Administrator confirmed the laboratory had not performed media control procedures for the DTM lots listed above prior to testing patients. -- 3 of 3 --

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 Office Manager, the laboratory failed to retain analytic system records of cryostat maintenance for 1 (2019) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of documentation for the performance of maintenance for the laboratory's two cryostats in 2019. 2. An interview on 4/7/21 at 10:44 am with the Office Manager confirmed the laboratory did not retain documentation of cryostat maintenance in 2019. 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 Office Manager, the laboratory failed to follow policies to assess competency for 2 (Testing Personnel #2 and #3) of 10 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel competency records revealed a lack of documentation of competency for two testing personnel performing mohs micrographic surgery 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 -- histopathology testing in 2019: a. Testing Personnel #2 b. Testing Personnel #3 2. A review of the laboratory's "Personnel Competency Policy and Procedure" revealed a section stating, "Testing personnel will be reviewed prior to testing patients' specimens to ensure that all personnel have the appropriate education and experience, have received that appropriate training for the type and complexity of services offered, and have demonstrated that they can perform all testing operations reliably, and can provide and report accurate results. Testing personnel must be reviewed every six months during the first year of testing and annually thereafter." 3. An interview on 4/7/21 at 11:15 am with the Office Manager confirmed the testing personnel listed above did not have documented competency assessments in 2019 for histopathology testing. 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 Office Manager, the laboratory failed to verify the accuracy of its histopathology testing at least twice annually for 1 (2019) of 2 years reviewed. Findings include: 1. A review of the laboratory's records revealed a lack of documentation of histopathology verification of accuracy testing in 2019. 2. A review of the laboratory's "Proficiency Testing Procedures" revealed a section stating, "It is up to each testing personnel to have another testing personnel confirm TWO readings per year for each test you do. You will need to complete one PT for each test before June. When they have all been completed and turned in, you will get your second set -round two- which needs to be done before December." 3. An interview on 4/7/21 at 11:15 am with the Office Manager confirmed the laboratory did not have documentation of histopathology verification of accuracy testing for 2019. ***This is a repeated deficiency previously cited during the 7/18/16 recertification survey*** -- 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, the laboratory failed to retain a copy of the original histopathology Mohs' map for one (#5) of 20 patient charts reviewed for at least 10 years. Findings include: 1. On December 13, 2018 at 12:30 PM, record review of the histopathology Mohs' maps revealed the laboratory did not keep the original map for as least 10 years from the date of reporting. 2. On December 13, 2018 at 12:30 PM when queried, a member of the office staff was unable to provide the surveyor with a copy of the final Mohs' map requested. 3. During the interview on December 13, 2018 at 12:30 PM, a member of the office staff confirmed the final Mohs' map was not retained for at least 10 years from the date of reporting. 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). 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to record the time in/out of specimen receipt into the laboratory for the Mohs' tissue and the frozen section specimens for nine (#1, #3-#4, #13 - #14, and #16 - #19) of 20 patient charts audited. Findings include: 1. On December 13, 2018 at 12:30 PM, record review of patients charts revealed the laboratory did not record the in/out time of specimen receipt for the Mohs' tissue and the frozen section onto the Mohs' map as follows: a. specimen #1 - no in time for 2nd stage b. specimen #3 - #4 - no in/out time recorded for two stages c. specimen #13 - no in/out time recorded for 2nd stage d. specimen #14 - no out time recorded for 1st stage e. #16 - #19 - no in/out time recorded on the Mohs' map for all stages 2. During the interview on December 13, 2018 at 12:30 PM, a member of the office staff confirmed the in/out times of the Mohs' specimen were not consistently recorded on the map. -- 2 of 2 --