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Summary Statement of Deficiencies 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 direct observation of reagents and interview with the facility personnel, the laboratory used the reagent, Potassium Hydroxide (KOH), past the expiration date. Findings include: 1. The laboratory performs KOH testing on patient specimens under the subspecialty of Mycology, with an approximate annual test volume of 100. 2. During the survey conducted on May 22, 2023, direct inspection of the Potassium Hydroxide reagent used for patient testing (lot #8506-01) indicated an expiration date of 7/31/2020. 3. The number of patients tested using the expired reagent could not be determined at the time of the survey. 4. At approximately 10:25am on 5/22/2023, the facility personnel interviewed stated that the expired reagent indicated above was in use at the time of the survey. 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 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 direct observation of stain reagents and interview with the facility personnel, the laboratory used the stain reagent, Hematoxylin, past the expiration date. Findings include: 1. The laboratory performs the Hematoxylin and Eosin (H&E) stain on patient slides in conjunction with Mohs testing, with an approximate annual test volume of 3,707 tests. 2. During the survey conducted on October 29, 2020, direct inspection of the Hematoxylin reagent, lot #7575-00, indicated an expiration date of April 2019. 3. The facility personnel confirmed that the expired reagent indicated above was still in use on the day of the survey. The number of patients tested using the expired reagent could not be determined at the time of the survey. 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 Quality Assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to follow policies and procedures for 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 -- an ongoing mechanism to monitor, assess, and correct problems identified in the analytic systems. Findings include: 1. The laboratory's established policy titled, "Quality Assessment Program" states, "The Laboratory Director will review all Quality Control/H & E records that have not been reviewed previously." 2. The laboratory utilized a Quality Control log to document the H&E Stain Acceptability until February 2020. The laboratory stopped documenting the H&E stain acceptability on the log from 2/17/20 through the date of the survey on 10/29/20. During that time, the laboratory director was initialing the H&E Quality Control slide made each day of patient testing. Interview with the facility personnel indicated that the Laboratory Director's initials were being documented on the QC slide as evidence of the H&E stain acceptability for that day of testing. 3. No documentation was presented for review to indicate the laboratory director was following the established QA procedure by reviewing the Quality Control/H&E records (log) as indicated in the policy above. 4. No revised QA policy and procedure was presented for review to indicate the laboratory changed the documentation procedure for the H&E stain acceptability, as evidenced from February 2020 through October 2020. 5. The facility personnel confirmed that the laboratory failed to follow established QA policies and procedures as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's established Quality Assessment (QA) policies and interview with the facility personnel, the laboratory failed to establish policies for amending test reports related to discrepancies identified during the accuracy verification process for Dermatopathology testing performed by the laboratory. Findings include: 1. The laboratory performs testing on patient specimens under the sub-specialty of Histopathology, with an approximate annual test volume of 3,257. 2. The policy titled, "Slide Review for Histopathology (including Frozen Sections) & Histopathology for Mohs" reviewed during the survey states, "ADS send two cases annually, per physician/testing personnel, per test...to be reviewed by a local dermatopathologist. ...In the event of a conflicting diagnosis, including diagnosis terminology or possible treatment, the following steps will be taken: 1). The PT section on the