Mcdaniel Dermatology And Skin Surgery Institute

Summary Statement of Deficiencies D0000 A Recertification survey was performed at McDaniel Dermatology and Skin Surgery Institute, CLIA ID 19D2197164, on May 12, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, patient records, and interview with personnel, the laboratory failed to establish complete quality assessment procedures to identify issues within the pre-analytic system. Findings: 1. Review of the laboratory's policies and patient records revealed the laboratory utilized a "Monthly Patient Quality Assurance Checklist" that included a review of one (1) randomly selected patient case each month. The following items were monitored: a) "Pre-Analytical: Specimens were logged in correctly: Lab requisitions and maps contain correct information, specimens were handled and collected according to protocol and specimens were labeled legible prior to receipt in the laboratory." b) "Analytical: Specimen was logged and accession number given, dye markings were handled properly, Proper embedding was followed correctly, cryostat sectioning was done properly, any necessary remedial action was performed and documented, and quality control stain results were examined for possible problems." c) "Post Analytical: Slides were reviewed by surgeon and map/slides were properly reported by surgeon." 2. Review of randomly selected patient records revealed two (2) of eight (8) patients had the following incorrect information documented on the "Moh's map:" a) April 24, 2024: Patient MD24-220: Incorrect address of the facility submitting the specimen b) 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 -- February 4, 2025: Patient MD24-37: Incorrect Moh's accession number assigned. Surveyor's review of the Moh's case log book, patient slides, and electronic patient notes (final report) revealed the Moh's accession number was documented as MD25- 37, which differed from the "Moh's Map." 3. In interview on May 12, 2025 at 2:18 pm, Assistant 1 stated the laboratory moved and operated from its current location on April 1, 2024. Assistant 1 stated the address on the "Moh's map" for Patient MD24- 220 was the facility's old address and should have been updated to their current address. 4. In interview on May 12, 2025 at 2:29 pm, Assistant 1 and 2 stated the Moh's accession number for Patient MD24-37 was listed incorrectly on the "Moh's Map." Assistant 1 and 2 stated for the identified patient, the Moh's accession number should have been MD25-37, not MD24-37. 5. In further interview on May 12, 2025 at 2:29 pm, Assistant 1 stated the laboratory reviews one (1) randomly selected patient each month. Assistant 1 stated the selected patient's case information documented in the log book, "Moh's Map" form, slides and patient notes (final report) are compared and reviewed each month for accuracy. 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 record review and interview with personnel, the Laboratory Director failed to ensure the quality assessment programs were established to assure the quality of laboratory testing. Refer to D5391. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on June 15, 2023 at McDaniel Dermatology and Skin Surgery Institute, CLIA ID # 19D2197164. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of policies, records, and interview with personnel, the laboratory failed to retain quality assurance and twice a year verification records for at least two (2) years as required. Findings: 1. Review of the laboratory's "Proficiency Testing" policy stated "Results of each Proficiency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent records." 2. Review of the laboratory's records revealed the laboratory did not retain the following: a) "Monthly Patient Quality Assurance Checklist" for January 2022 b) Twice year verification records (laboratory refers to as proficiency testing) for the first half of 2022 3. In interview on June 15, 2023 at 11:32 am, the Office Manager confirmed the laboratory did not retain the identified documents for at least two (2) years. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, personnel records, and interview with personnel, the laboratory failed to follow established competency assessment policies for one (1) physician performing potassium hydroxide (KOH) prep testing. Findings: 1. In interview on June 15, 2023 at 10:02 am the Office Manager and Laboratory Director stated Testing Personnel 1 performed KOH prep testing. 2. Review of the laboratory's "Competency and CLIA competency assessment" policy revealed "Evaluation and documenting competency of personnel responsible for testing is required at least semi-annually during the first year the individual sees patient specimens. After the first year, competency must be performed at least annually. The following procedures are requirements for assessment of competency for all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills." " Competency assessment, which includes the procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. Results of each Competency Test will be entered in a log and kept in the laboratory management manual, as part of its permanent records." 3. Review of personnel records for Testing Personnel 1 revealed the laboratory did not have documentation of a competency assessment performed for KOH testing for 2022. 4. In interview on June 15, 2023 at , the Laboratory Director confirmed a 2022 competency assessment was not performed on Testing Personnel 1 for KOH testing . 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 the laboratory's policies, test menu, records, and interview with personnel, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) prep testing at least twice annually in 2022. Findings: 1. Review of the laboratory's test menu revealed the laboratory performs KOH prep testing. 2. Review of the laboratory's policies and records revealed the laboratory did not have a policy and documentation of verification of the accuracy of KOH testing at least twice annually for 2022. 3. In interview on June 15, 2023 at 11:38 am, the Laboratory Director confirmed the laboratory did not verify the accuracy of KOH prep testing at least semi annually in 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks -- 2 of 9 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policies and interview with personnel, the laboratory failed to follow their established policy related to the review of the policy manual. Findings: 1. Review of the laboratory's "Formal Policy Statement" revealed "This procedure manual is reviewed by the Laboratory Director annually and at other times as required by major changes in procedure or other circumstances affecting laboratory performance of the test." 2. Review of the laboratory's policy manual revealed the Laboratory Director did not review the policies in 2022. 3. In interview on June 15, 2023 at 10:30 am, the office manager confirmed the Laboratory Director did not review/sign the policies annually per laboratory policy for 2022. II. Based on review of the laboratory's policies, manufacturer's instructions, and interview with personnel, the laboratory failed to have complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory failed to include the following: a) Twice year verification (referred to as proficiency testing by the laboratory): specific number of cases to send semi-annually to a Board Certified dermatopathologist b) Maintenance for cryostat: updated frequency of performance of maintenance tasks per manufacturer's requirements for current cryostat in use 2. Review of the laboratory's "Proficiency Testing" policy revealed "Semi-annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it our {sic} for a microscopic examination by a Board Certified Dermatopathologist." 3. Review of the laboratory's "Quality Assurance Program" policy, which differed from the "Proficiency Testing" policy, revealed "Proficiency testing is required for this service provided by our physician. It is suggested to submit 3 cases every 6 months to an outside Pathologist." 4. Review of the laboratory's cryostat log and policy revealed " The machines are wiped out daily with dry gauze, to collect waste material. Then wiped with gauze containing 100% isopropyl alcohol, to disinfect. Wiped again with a dry gauze and ready for the next day. According to manufacturer's instructions, lab personnel should oil weekly, grease monthly, and/or perform necessary maintenance. There is a service contract" 5. Review of the Leica 1950 cryostat manual revealed "The microtome is virtually maintenance-free. To ensure a smooth operation of the instrument over several years we recommend the following: at least once a year have the instrument inspected by a qualified service engineer authorized by Leica, enter into a service contract at the end of the warranty period, and clean the instrument daily." 6. In interview on June 15, 2023 at 10:47 am, the Office Manager stated the Leica 1950 cryostat is a loaner. The Office Manager confirmed the laboratory's cryostat maintenance policy and log were not updated to the manufacturer's requirements. 7. In further interview on June 15, 2023 at 11:38 am, the Office Manager stated the laboratory sends six to eight cases to another dermatopathologist for proficiency testing. The Office Manager confirmed the laboratory's policies for proficiency testing did not correspond with what was in practice. 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. -- 3 of 9 -- This STANDARD is not met as evidenced by: Based on observation by surveyor and interview with personnel, the laboratory failed to ensure supplies and reagents did not exceed expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on June 15, 2023 at 9:54 am revealed the following expired items: a) KOH 10% 50 mL solution, Lot 21286302, Expiration date: 2022-10-12, Quantity: one (1) bottle b) Tissue Marking Dye Red, Lot 110104, Expiration date: 2022-09-30, Quantity: one (1) bottle c) Tissue Marking Dye Yellow, Lot 125197, Expiration date: 2023-04-30, Quantity: one (1) bottle d) Tissue Marking Dye Black, Lot number was illegible, Expiration date: 2022-10-31, Quantity: one (1) bottle e) DermPath Diagnostics Buffered 10% Formalin, Lot 25118, Expiration date: 2023-06-01, Quantity: ten (10) bottles f) Michel's Solution, Lot 133061, Expiration date: 2023-01-31, Quantity: seven (7) bottles 2. In interview on June 15, 2023 at 10:02 am, the office manager confirmed the identified items were expired. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form, quality control records, and interview with personnel, the laboratory failed to ensure Testing Personnel documented the stain quality for Hematoxylin and Eosin (H&E) stains for 2022 eighteen (18) months reviewed. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director serves as the Testing Personnel for Mohs (Histopathology). 2. Review of the laboratory's quality control logs for 2022 and January 2023 through June 14, 2023 revealed the Testing Personnel (who also serves as the Laboratory Director) did not document her review of the slide stain quality. 3. In interview on June 15, 2023 at 10:47 am, the Office Manager confirmed the Laboratory Director did not document her review of the stain quality of slides for the identified months. D5785