Medstar Mohs Laboratory

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 proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory failed to ensure that PT was performed at least twice annually for the specialty of histopathology. Findings: 1. During an interview on 06/06 /2025 at 10:45 AM the LD stated that once a year the laboratory sends out patient slides from completed Mohs surgery cases to another dermatologist to review in order to meet the requirement for PT. 2. Record review showed that the laboratory recorded the case numbers of the slides which were sent out on a "Mohs Quality Improvement and Consensus Sheet" (Mohs QI form). 3. Two Mohs QI forms were reviewed. One sheet listed seven cases which were originally tested in 2022 (more than two years ago and outside the scope of this CLIA survey) and four cases tested in 2023 (M23-17, M23-24, M23-53, and M23-74). The second sheet listed six cases from 2024 (M24- 006, M24-013, M24-040, M24-046, M24-63, and M24-321) and six cases from 2025 (M25-05, M25-048, M25-067, M25-070, M25-082, and M25-093). 4. The sheets did not document the date that the slides were sent out for PT. 5. During an interview on 06/06/2025 at 11:00 AM, the LD confirmed that PT slides were not sent out twice a year. 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 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual and proficiency testing (PT) record review and interview with the laboratory director (LD), the laboratory failed to ensure that the written procedure manual included a procedure for performing PT. Findings: 1. The laboratory performs H&E staining procedures to evaluate histopathology slides for Mohs surgery patients. 2. During an interview on 06/06/2025 at 10:45 AM the LD stated that the laboratory sends out several patient cases and slides once a year to another dermatologist to evaluate. 3. Record review showed that the PT was documented on a "Mohs Quality Improvement and Consensus Sheet" (Mohs QI form) which had columns labeled, "Case ID," "Path Req (if applicable)," "Grossing (+/-)," "Staining (+/-)," "Diagnostic Consensus (+/-)," "Comments," and "Reviewer." 4. A review of the laboratory's procedure manual showed that it did not include a procedure for how the laboratory performs PT for the discipline of histopathology, including how many cases to send to the second dermatologist and how to interpret the results documented on the Mohs QI form. 5. During an interview on 06/06/2025 at 11:00 AM, the LD confirmed that the laboratory failed to include a procedure for performing PT in the laboratory's written procedure manual. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on quality control (QC) and patient log record review and interview with the laboratory director (LD), the laboratory failed to ensure that daily stain QC was consistently documented, recording the quality of the staining characteristics of the Hematoxylin and Eosin (H&E) stain each day of patient testing. Findings: 1. The laboratory performs H&E staining procedures to evaluate histopathology slides. Daily stain QC for the H&E stain is recorded on the "Hematoxylin and Eosin Staining Quality Control" log. 2. A review of daily stain QC logs from seven days of testing from 12/04/2023 to 12/20/2023 showed that on one of seven days (12/06/2023) the results of the stain QC was not documented on the "Hematoxylin and Eosin Staining Quality Control" log. 3. A review of patient logs showed that there were six patients tested on 12/06/2023 (case # M23-345 through case # M23-350); and 4. A review of daily stain QC logs from six days of testing from 09/11/2024 to 09/30/2024 showed that on one of six days (09/18/2024) the results of the stain QC was not documented on the "Hematoxylin and Eosin Staining Quality Control" log. 5. A review of patient logs showed that there were four patients tested on 09/18/2024 (case # M24-229 through case # M24-232). 6. During an interview on 06/06/2025 at 11:00 AM, the LD confirmed that daily stain QC was not consistently documented. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require -- 2 of 3 --

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 review of histopathology worksheets and interview with laboratory staff at 1 PM on the day of survey, the laboratory did not document the lot number and stain changes to ensure they were not substandard or expired. Findings: 1. The laboratory did not document the lot number of staining reagents used for patient testing. 2. The laboratory did not document the date when new lots of staining rreagents were placed in use. 3. The laboratory did not document the cleaning and replacement of stain reagents each week as described by the laboratory staff. 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 2 -- (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 review of records provided to credential the histotechnologist, the histotechnologist does not meet requirements for the inking of tissue to mark the tissue with dye(s) for orientation purposes. The inking of tissue is considered tissue grossing for CLIA and requires the person performing this activity to meet requirements for high complexity testing. -- 2 of 2 --