Anne Arundel Dermatology, Pa

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: CITATION ONE Based on a review of the submitted Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report Form CMS-209 (FORM CMS-209), a review of the laboratory's procedure manual, a review of personnel records, and staff interview, the histopathology laboratory failed to establish a written policy for competency assessment of testing personnel and failed to have competency assessments that included the six criteria required in Subpart M of the State Operations Manual (SOM) Appendix C for two of two testing personnel in 2025 and 2026. The findings include: 1. A review of the FORM CMS-209 listed two testing personnel (TP), TP3 and TP4, for high complexity testing, who performed gross examination of surgical pathology specimens. 2. A review of the histopathology laboratory's policy and procedure manual revealed no written policies and procedures for employee competency assessment. 3. A review of laboratory personnel records revealed the following testing personnel competency assessments that failed to include the six CLIA criteria: 1.) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing, 2.) Monitoring the recording and reporting of test results, 3.) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records, 4.) Direct observation of performance of instrument maintenance and function checks, 5.) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples, and 6.) Assessment of problem- solving skills, as required in Subpart M of the SOM Appendix C: -TP 3: 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 3 -- assessments dated 07.15.2025 and 08.04.2026 -TP 4: competency assessment dated 04.07.2026 4. An interview with the histopathology laboratory supervisor on 09.10.2026 at 11:30 a.m. confirmed the above survey findings. CITATION TWO Based on a review of the submitted Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report Form CMS-209 (FORM CMS-209), laboratory's policy, personnel records, and staff interview, revealed that the micrographically oriented histographic surgery (MOHS) laboratory failed to follow the established policy for competency assessment for one of two testing personnel (TP) who performed slide interpretation of tissue removed during MOHS procedures in 2025. The findings included: 1. A review of the submitted FORM CMS-209 form listed two TP, TP1 and TP2, for high complexity testing who performed slide interpretation of tissue removed during MOHS procedures. 2. A review of the MOHS laboratory's "Quality Assurance Program" policy revealed, "New laboratory personnel are evaluated with in the first 6 months, at the 1 year and then annually." 3. A review of laboratory personnel records revealed no documented annual competency assessment in 2025 for TP2 as listed on the FORM CMS-209. 4. An interview with the histopathology laboratory supervisor on 09.10.2026 at 11:30 a.m. confirmed the above survey findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: CITATION ONE Based on laboratory observations, a review of the laboratory's procedure manual, a review of micrographically oriented histographic surgery (MOHS) patient specimen slides, and staff interviews, the laboratory failed to follow the slide-labeling procedure for eight of eight cases, totaling 53 slides reviewed in 2025 and 2026. The findings include: 1. Observation of the MOHS laboratory on 09.10.2026 at 8:30 a.m. revealed equipment, glass slides, tissue marking dyes, and stains used to process tissue removed during MOHS procedures. 2. A review of the laboratory's procedure, "Histopathology MOHS Micrographic Surgery," revealed that "Slides are labeled either with a hand written label including case number, full patient name and date, site and stage of MOHS or the same information is written directly on the slide." 3. A review of eight MOHS cases revealed the following MOHS cases with specimen slides that failed to include the patient's full name: -MOHS Case: K-370, date of service(dos): 04.02.2025, 3 slides -MOHS Case: RGW25-501, dos: 04.03.2025, 8 slides -MOHS Case: K-1040, dos: 08.26.2025, 7 slides -MOHS Case: RGW25-1470, dos: 08.07.2025, 12 slides -MOHS Case: K-21, dos: 01.06.2026, 3 slides -MOHS Case: RGW26-58, dos: 01.15.2026, 6 slides -MOHS Case: K-1001, dos: 07.07.2026, 10 slides -MOHS Case: RGW26-963, dos: 07.28.2026, 4 slides 4. An interview with the histopathology laboratory supervisor and the MOHS lab processing technician on 09.10.2026 at 10:00 a.m. confirmed the above survey findings. CITATIONTWO Based on a review of the submitted Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report Form CMS-209 (FORM CMS-209), review of the laboratory's policies and procedures, records review, and a staff interview, the laboratory failed to follow its policy for biannual physician proficiency testing for one of two testing personnel (TP) in 2025. The findings -- 2 of 3 -- include: 1. A review of the submitted FORM CMS-209 form listed two TP, TP1 and TP2, for high complexity testing who performed slide interpretation of tissue removed during micrographically oriented histographic surgery (MOHS) procedures. 2. A review of the laboratory's policy titled "Physician Proficiency Testing" revealed the following statement "A review of the test results on each MOHS provider is performed bi-annually. This review is to insure the accuracy of each test result and quality of slides the laboratory is producing. One set of random patient slides are sent on each MOHS provider and checked by a Dermatopathologist or a different MOHS provider." 3. A review of the laboratory's records revealed no documentation that the laboratory performed "physician proficiency testing" biannually for TP2 in 2025. 4. An interview with the histopathology laboratory supervisor on 09.10.2026 at 11:30 a. m. confirmed the above survey findings. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on a review of the submitted Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report Form CMS-209 (FORM CMS-209), lack of records, staff interview, and electronic mail communication, the laboratory director failed to ensure testing personnel four (TP4) had received the appropriate training and demonstrated accuracy before performing gross examination of patient tissue removed during histopathology procedures, with approximately 7000 cases grossed since TP4 began testing patient testing on 10.27.2025 until the date of the survey on 09.10.2026. The findings include: 1. A review of the FORM CMS-209 listed two testing personnel (TP), TP3 and TP4, for high complexity testing, who performed gross examination of surgical pathology specimens. 2. A review of training documentation revealed no record of documented training or demonstration of accuracy of test performance for grossing of patient tissue samples removed during histopathology procedures for TP4 by the laboratory director before patient testing began on 10.27.2025. 3. An interview with the histopathology laboratory supervisor on 09.10.2026 at 11:30 a.m. confirmed the above survey findings. 4. Electronic mail communication on 09.15.2026 at 9:00 a. m. with the histopathology laboratory supervisor confirmed that TP4 started patient testing on 10.27.2025 with approximately 7000 cases grossed from 10.27.2025 through the date of the survey, 09.10.2026. -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of laboratory and staff interviews, the laboratory failed to label reagents used in the Histopathology tissue processing laboratory with information when transferred from the primary to the secondary container. The findings include: 1. Observation of the Histology laboratory on 02.11.2025 at 9:00 a.m. revealed a secondary container used for processing samples for Histopathology procedures that was not labeled with identity, lot number, and expiration date when transferred from the original container to the secondary container. The reagent was verbally identified as Nail Prep (Item #NP-500) by histology laboratory supervisor. 2. An interview with the histology laboratory supervisor on 02.11.2025 at 09:00 a.m. confirmed the survey findings. 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: 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 -- Citation One: Based on observation of the Histology laboratory and staff interview, the laboratory failed to ensure that tissue marking dyes and hematoxylin used for inking and staining had not expired on the date of the survey (02.11.2025). The findings include: 1. Observation of the Histology laboratory on 02.11.2025 at 9:00 am revealed the following expired dyes and stains in use. -Mercedes Scientific Tissue Marking Dye Red (2 bottles), lot number 23004, expiration date 01.31.2025 - Modified Mayers Hematoxylin (1 bottle), lot number 181170, expiration date 10.31.2024. 2. An interview with the Histology laboratory supervisor on 02.11.2025 at 09:03 a.m. confirmed the above findings. Citation Two: Based on observation of the MOHS processing room and staff interview, the laboratory failed to ensure it did not use tissue marking dyes for MOHS Histopathology tissue processing past their expiration date on the survey date (02.11.2025). The finding include: 1. Observation of the MOHS processing room on 02.11.2025 at 9:39 a.m. revealed the following tisse marking dyes in use. -Cancer Diagnostic, Inc. Tissue Marking Dyes (2 bottles) Orange, lot number 21111, expiration date 04.30.2023. Green, lot number 21130, expiration date 05.31.2023. 2. Interview with the MOHS technician on 02.11.2025 at 9:39 a.m. confirmed the above findings. Work Key: MOHS: micrographically oriented histography surgery -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Intakes: TN00073355 Based on observation of the laboratory, a review of the laboratory procedure manual, and an interview with the histology laboratory supervisor, it was determined that the laboratory failed to follow the Standard Operating Procedure Manual for labeling chemical reagents. The findings include: 1. Observation of the laboratory on 02.11.2025 at 09:13 a.m. revealed a flammable cabinet with three containers of unlabeled substance, verbally identified as Xylene waste by histology laboratory supervisor. 2. A review of the laboratory's Standard Operating Procedure Manual under " Storage, use and handling" revealed the following: "All reagents are stored according to manufacturer's guidelines along with all state and federal Guidelines and are kept in a flammable cabinet. If chemicals are expired they are not used and disposed of. All chemicals are labeled clearly on outside of all bottles. Material safety data sheets are in the back of binder for reference." 3. An interview with the histology laboratory supervisor on 02.11.2025 at 09:13 a.m. confirmed the findings. 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 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)

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 lack of twice a year accuracy verification for peer slide review and interview with the Lead Histotechnician, determined the laboratory failed to verify peer slide review accuracy twice a year in 2020 and 2021. The findings include: 1. A lack of twice a year accuracy verification for peer slide review for 2020 and 2021. 2. An interview with the Lead Histotechnician at approximately 12:30 pm on February 7, 2022 confirmed only one peer slide review accuracy verification had been documented for 2020 and one peer slide review for 2021. ================================== D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) 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 -- (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: ================================== Based on observation of the laboratory, interview with the Lead Histotechnician, and review of testing personnel education documents, testing personnel number four and five listed on the Center for Medicare and Medicaid Services Personnel Report (CMS-209) failed to meet the high complexity regulatory education requirements for performing grossing of tissue removed during Histopathology procedures in August 2021 through February 7, 2022. The findings include: 1. Observation of the laboratory on February 7, 2022 at 9:30 am revealed grossing stations in use for histopathology testing procedures. 2. Interview with Lead Histotechnician on February 7, 2022 at 11:30 am revealed that testing personnel number four and five perform grossing of tissue removed during -- 2 of 3 -- Histopathology procedures. 3. Review of education documents for testing personnel number four and five revealed that testing personnel number four and five did not meet the minimum education requirements for performing high complexity testing for performing grossing of tissue removed during Histopathology procedures in August 2021 through February 7, 2022. ================================== -- 3 of 3 --