Epiphany Dermatology

Summary Statement of Deficiencies 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 review of the laboratory's established quality assessment (QA) policies and procedures, review of the Quality Control Staining log and interview with the facility personnel, the laboratory's QA processes failed to monitor, identify and correct errors found in the analytic portion of histopathology testing which is performed by the laboratory. Findings include: 1. The laboratory processes and interprets dermatopathology slides from patient specimens for Mohs testing. The laboratory's approximate annual test volume is 464. 2. The laboratory utilizes a Quality Control Staining log to record the results of the Hematoxylin & Eosin (H&E) stain acceptability each day of patient testing. The log contains the date, case#, stain acceptability, and a corrections column which lists the initials of the individual documenting the form. 3. Review of the Quality Control Staining log for April 2022 indicated the form was completed on the following testing dates, in this order: 4/13 /22, 4/14/22, 4/18/22, 3/19/22, 3/20/22, 3/21/22, 4/26/22, and 4/27/22. 4. No QA documentation was presented for review during the survey to indicate the laboratory monitored, identified and corrected issues found with the date discrepancies recorded on the Quality Control Staining log for April 2022. 5. The facility personnel interviewed during the survey on August 22, 2022 at approximately 1:20pm confirmed that the laboratory failed to monitor, identify and correct errors found with documenting the correct date on the Quality Control Staining log indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required. Findings include: 1. The laboratory performs DTM testing using the Acu-DTM media under the sub-specialty of Mycology, with an approximate annual test volume of 7. 2. It is the policy of the laboratory to perform Quality Control testing on each new lot or shipment of DTM media. The QC process includes testing 4 vials with specific organisms that either support or inhibit growth as expected. 3. No documentation of Quality Control testing was provided for review during the survey conducted on October 23, 2019 to indicate the laboratory checked the lot of media currently used by the laboratory for patient testing, for its ability to support growth and inhibit specific organisms and produce a biochemical response. The lot of DTM media in use at the time of the survey was lot# D-1295-1018, exp. 10 /08/2020. The laboratory noted that it was received on 12/10/2018. 4. The facility personnel confirmed that the laboratory did not perform and document controls as required for the DTM lot in use at the time of the survey. 5. There were approximately 8 patients tested since the date in which the new lot was received by the laboratory. 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 -- 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 lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of staining materials used for testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 393. 2. No documentation of the Hematoxylin & Eosin (H & E) stain acceptability was presented for review for testing that occured on 07/31/2018. Approximately 5 patients were tested that day. 3. The facility personnel confirmed that the laboratory evaluated the H & E stain acceptability each day prior to testing patients but failed to document the stain acceptability on the date indicated above. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of Quality Control records for review, the laboratory director failed to ensure that quality control programs are maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5445 and D5473 for findings. -- 2 of 2 --