Dermatology Clinic, The

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 surveyor review of the Procedure Manual (PM), lack of Biannual Assessment (BA) records and interview with the Onsite Dermatologist (OD), the laboratory failed to verify the accuracy and reliability of Histopathology testing twice a year from 1/13/24 to 57/2/25. The finding includes: 1. The last documented evidence that a BA was performed was 2/10/24. 2. The OD confirmed 7/2/25 at 1:10 pm, the laboratory did not verify the accuracy of Histopathology testing twice a year. 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: A) Based on surveyor observation of Histopathology reagents and interview with the Onsite Dermatologist (OD), the laboratory used expired Histopathology reagents from 3/26/24 to 7/2/25. The findings include: 1. Adventek Tissue marking dyes were expired as follows: a) Blue marking day lot # 083812 expired 6/1/2021 b) Black marking dye lot #092020 expired 12/31/2021 c) Red marking day lot # 083863 expired 6/1/2021 2. Approximately 330 patients were tested with expired reagent. 3. The OD confirmed on 7/2/25 at 1:30 pm that the laboratory used expired reagents. 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 -- Note: These are the same Marking Dyes cited for being expired 3/26/24. Same lot #'s and expiration dates. B) Based on surveyor observation of Histopathology reagents and interview with the OD, the laboratory used expired Histopathology reagents from 10/31/24 to the 7/2/25. The findings include: 1. High Def 1% Lot # 133297 Expired 10 /31/2024. 2. Gill 3 Hematoxylin Lot #180061 Expired 2/28/25. 3. Vintage Bluing Lot # 144960 Expired 3/31/25. 4. Approximately 330 patients were tested with expired reagent. 5. The OD confirmed on 7/2/25 at 1:30 pm that the laboratory used expired reagents. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment 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 survey review of the Biannual assessment (BA) records, Laboratory Reagents and interview with the Onsite Dermatologist (OD) the Laboratory Director (LD) failed to ensure the Quality Assurance (QA) program was maintained to assure the quality of laboratory services from 3/26/24 to 7/2/25. The finding includes: 1. The laboratory used expired marking dye which was cited on the previous survey 3/26/24. Cross refer D5417 2. The laboratory used expired Bluing agent, Hematoxylin, and High Diff 1%. Cross refer 5417 3. The Laboratory failed to perform BA in 2024 and 2025. D5217 4. The OD confirmed on 7/2/25 at 1:40 pm, the QA program was not maintained,. -- 2 of 2 --

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 surveyor observation of Histology reagents and interview with the Office Manager (OM), the laboratory failed to discard expired Histopathology reagent from 12/31/2021 to the date of survey. The findings include: 1. Adventek Tissue marking dyes were expired as follows: a) Blue marking day lot # 083812 expired 6/1/2021 b) Black marking dye lot #092020 expired 12/31/2021 c) Red marking day lot # 083863 expired 6/1/2021 2. Approximately 200 patients were tested with expired reagent. 3. The OM confirmed on 3/26/24 at 10:30 am that the laboratory used expired reagents. 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 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 surveyor review of the Procedure Manual, interview with the Testing Personnel (TP) via telephone, the laboratory failed to establish acceptable written procedures for Biannual Assessment (BA) from 8/24/17 to the date of survey. The findings include; 1) The BA did not state who the reviewing Pathologist was. 3) The BA did not state what was sent to the reviewing pathologist. 4) The BA did not have a policy for third party review of cases. 5) The TP confirmed on 8/6/19 at 10:30 am that a BA procedure was not acceptable. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with 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 2 -- Testing Personnel (TP) via telephone, the Laboratory Director failed to establish a Competency Assessment (CA) procedure with all the required elements for TP from 8 /24/17 to the date of survey. The TP confirmed on 8/6/19 at 10:30 am that a CA procedure was not established. -- 2 of 2 --