Franks Dermatology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of 2024 and 2025 temperature and humidity records, laboratory instrumentation manuals, and interview with laboratory staff, the laboratory failed to document daily humidity. Survey findings include: A. A review of laboratory instrumentation manuals revealed performance specifications of a maximum of 60% relative humidity for the Leica CM1520 Cryostat (Instructions for Use CM1520- Cryostat, V 1.5 RevG- 10/2016, English). B. Through a review of temperature and humidity records for 2024 and 2025 it was revealed the laboratory failed to document humidity for 24 months for 2024 and 2025. C. In an interview, at 10:37am on 1/23 /2026, the operation manger listed on entrance/exit interview form, confirmed the laboratory humidities were not documented on days the laboratory was in operation. 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. 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 observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 1/23/26 at 12:16 pm, one bottle Mercedes Scientific Subxero Freezing Medium Lot# 45148 expiration date 08/2025, four bottles Signature Series Epredia Mounting Medium Lot# 136298 expiration date 2025-10-29, and four bottles Signature Series Epredia Mounting Medium Lot# 124381 expiration date 10-2024 were observed in a the laboratory, available for use beyond the expiration date. B) In an interview on 1/23/26 at 12:33 pm the operation manger listed on entrance/exit interview form confirmed that the items, identified above, had exceeded their expiration dates and were available for use in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the lack of documentation and an interview with laboratory staff the laboratory failed to follow established written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic systems. Findings include: A. The "Quality Control Assessment" policy included: "The Laboratory Director reviews all quality control charts and logs on at least a monthly basis." B. The "Temperature Monitor Log - Refrigerator, Freezer, Cryostat" and the "Reagent Changes" log were not reviewed by the Laboratory Director for 3 of 3 months (January 2024, February 2024, and March 2024) examined. C. These findings were confirmed by Employee #1 (as noted on the entrance and exit Conference Attendance Sheet) during an interview at 10:07am on 4/22/24. 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 D0000 This is the initial CLIA certification survey of the laboratory. At the time of the survey the laboratory was not in compliance with the following conditions of participation: D5300 - Preanalytic Systems D5400 - Analytic Systems D6076 - Laboratory Director (High Complexity) 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: Through lack of documentation and interviews with laboratory staff, it was determined the laboratory failed to verify the accuracy of frozen sections at least twice annually. Survey findings include: A. The surveyor requested documentation of twice annual consultation or quality assurance records for frozen section examinations. None was provided by the laboratory. The laboratory has been in operation for 11 months (June 2017). B. In an interview, at 9:17 a.m. on 5/11/2018, laboratory employee #2 (as listed on the Personnel Identification Worksheet) stated that no consultation slides had been sent out since the laboratory started testing and no slides had been sent out for quality assurance review. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 overall quality of the preanalytic systems and correct identified problems as specified in 493. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through a review of the laboratory policies and procedures, a review of the patient log, a review of patient final reports, observations made during a tour of the laboratory, and interviews with laboratory staff, it was determined the laboratory did not meet preanalytic systems requirements as evidenced by: D5311 - The laboratory did not ensure specimen preservation until the time of testing D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Through a review of the laboratory policies and procedures, a review of the patient log, a review of patient final reports, observations made during a tour of the laboratory, and interviews with laboratory staff, it was determined the laboratory did not ensure specimen preservation until the time of testing which has the potential to affect all histopathology slides reviewed. Survey findings follow: A. The laboratory policies and procedures failed to include procedures for the use of fixative in patient samples to prevent autolysis (destruction) of the tissue sample. B. At 10:05 a.m. on 5 /11/2018 laboratory employee #2 (as listed on the Personnel Identification Worksheet) stated that tissue samples are stored refrigerated between qauze soaked in saline until the tissue can be processed. C. Final reports and the patient log for ten patients were reviewed. Nine of ten patients were not processed on the day of the surgical procedure. Pathology #18-1736 Procedure Date 4/25/2018, Process Date 4/30/2018 (processed five days after the sample was obtained); Pathology #18-1669 Procedure Date 4/19/2018, Process Date 4/23/2018 (processed four days after the sample was obtained); Pathology #18-1537 Procedure Date 4/12/2018, Process Date 4/16/2018 (processed four days after the sample was obtained); Pathology #18-1385 Procedure Date 4/4/2018, Process Date 4/9/2018 (processed five days after the sample was obtained); Pathology #18-1186 Procedure Date 3/22/2018, Process Date 3/26/2018 (processed four days after the sample was obtained); Pathology #18-1163 Procedure Date 3/21/2018, Process Date 3/26/2018 (processed five days after the sample was obtained); Pathology #18-0940 Procedure Date 3/8/2018, Process Date 3/8/2018 (the same day the sample was obtained); Pathology #18-0802 Procedure Date 2/28/2018, Process Date 3/5/2018 (processed five days after the sample was obtained); Pathology #18-0827 Procedure Date 3/1/2018, Process Date 3/5/2018 (processed four days after the sample was obtained); and Pathology #18-0564 Procedure Date 2/14/2018, Process Date 2/15/2018 (processed one day after the sample was obtained). D. During a tour of the laboratory, at 10:05 a.m. on 5/11/2018, the surveyor observed nine patient samples in the refrigerator. The samples were stored between pieces of gauze, in petri dishes. Samples observed were as follows: 18-1993A dated 5/10/2018; 18- -- 2 of 7 -- 1992 dated 5/10/2018; 18-1970 dated 5/9/2018; 18-1990 dated 5/10/2018; 18-1968-A dated 5/9/2018; 18-1980-A & B dated 5/10/2018; 18-1991 dated 5/10/2018; 18-1966- A dated 5/10/2018, and 18-1961-A dated 5/10/2018. 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 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: Through a review of laboratory procedures,a review of cryostat temperature log, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to meet analytic systems requirements as evidenced by: D5403 - the procedure manual failed to include procedures for specimen acceptability, specimen rejection, specimen labeling, or specimen storage D5407 - the laboratory director failed to approve, sign, and date the procedure manual. D5413 - the laboratory failed to monitor temperatures to ensure reliable test system operation D5473 - the laboratory failed to document the quality of the Hematoxylin and Eosin stain each day of use D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)