Forefront Dermatology S C

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 review of laboratory policies and procedures, direct observation of laboratory testing supplies, and interview with the laboratory representative; the laboratory failed to ensure five of five margin marking dye vials and one of one mounting media vial were not used when they had exceeded their expiration dates. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Quality Control Policies and Documentation", which stated, under "Reagents", "This office will practice the following policies .... 2. All outdates/ expired [reagents] will be disposed of properly." 2. Upon a tour of the laboratory on 01/23/2025, at 9:47 am, direct observation of laboratory testing supplies found five of five margin marking dyes, used for demonstrating tissue margins in the grossing process of histopathology, and one of one mounting media vial, used for attaching the sample to the slide for microscopic evaluation, to be expired. Margin Marker Dye: Lot #: Expiration: Green, 2 oz 21245 09/30/2023 Red, 2 oz 21238 08/31/2023 Black, 2 oz 125196 05/31/2023 Blue, 2 oz 21235 08/31/2023 Yellow, 2 oz 125197 04/30/2024 Mounting Media: Lot #: Expiration: epredia | REF: 4112 110544 09/2023 3. Interview with the laboratory representative on 01/23/2025, at 10:53 am, confirmed the laboratory failed to ensure five of five marking dye vials and one of one mounting media vial were not used when they had exceeded their expiration dates. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, CMS-209 (Laboratory Personnel Report), lack of documentation, and interview the laboratory representative; the technical consultant failed to ensure competency evaluations were performed annually for one of two testing personnel (TP) performing Provider- Performed Microscopy (PPM) testing at the laboratory in the year of 2024. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Personnel Competency Testing", which stated, under "Procedure", "All testing personnel must have an annual review stating that they have reviewed all three phases of testing (pre analytic, analytic & post analytic) that are required for monitoring and testing competency ...." 2. Review of the CMS-209 revealed two TP performing PPM testing of Potassium Hydroxide (KOH) and Scabies. 3. Review of laboratory competency evaluation records revealed that one of two TP (TP #2) performing PPM testing lacked documentation of competency evaluation performed at the testing laboratory in 2024. 4. Interview with the laboratory representative on 01/23/2025, at 10:53 am, confirmed the technical consultant failed to ensure competency evaluations were performed annually for one of two TP performing PPM testing. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of laboratory policies and records and interview, the laboratory failed to verify the accuracy of its Potassium Hydroxide (KOH) and Histopathology procedures. Repeat deficiency. (Repeat Deficiency) Findings include: 1. Review of the laboratory policies and procedures revealed that personnel were instructed as follows: "Quarterly, the tech or Regional Clinic Manager will send three cases containing the original slides, label it with only the surgical case number, and send it out for microscopic examination by a Board Certified Pathologist/Mohs surgeon. NO differential diagnosis will be offered with the specimen..... Upon receipt of the pathology report form the Pathologist /Mohs surgeon, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician." 2. The "KOH QA/QC" states, "A minimum of 3 cases to be reviewed quarterly. Complete an Error Form for any fails. 3. Review laboratory records revealed the following: a. Verification of Histopathology procedures was only performed once in 2018 (on 11/27/18) for the following cases: 18-007; 18-0019; 18-009; 18-0025; 18-0030; and 18-0034. There was no outside diagnosis report available for comparison, as stated in the procedures. b. There was no documentation to show verification procedures for KOH testing was not performed twice in 2018. 4. At 10:00 AM on 12/03/18, the Regional Clinic Manager confirmed the surveyor's findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially 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 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures manual and records and interview, the laboratory failed to perform and document maintenance and function checks as specified. (Repeat Deficiency) Findings include: 1. The laboratory's procedures manual instructed personnel on maintenance of equipment as follows: a. Fume Hood Policy - Replace filter annually or as needed and document on log. b. Microscope- Change bulbs as needed and have regular service contracts performed. Document daily, monthly care. c. Room Temp/Humidity - The room temperature and humidity will be checked at the beginning of each day. Any