Mid-Atlantic Skin Surgery Institute

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory did not have procedures to ensure that MOHS surgery maps were scanned into patient charts as needed per laboratory protocol for backing up the maps. Findings: 1. During interview on December 12, 2024 at 10:00 am with the histotechnologist it was determined that medical assistants backup MOHS surgery maps by scanning the maps into the corresponding patient chart. 2. In an email request sent by the surveyor on December 12, 2024 to check that MOHS maps for 2023 and 2024 were scanned into charts, the histotechnologist responded back on December 16, 2024 that the maps from 2023 and 2024 had not been scanned into patients charts, but the histotechnologist will scan these maps into the charts. 3. It was observed that the written procedures did not describe how the laboratory checks and ensures that MOHS maps are backed up by scanning them into patient charts. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue 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 -- for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on observation and interview with the histotechnologist, the laboratory did not retain histopathology slides from MOHS surgery for at least ten years from the date of examination. Findings: 1. The laboratory was initially certified for histopathology testing for MOHS surgery in 2009, all histology slides prior to July 1, 2024 were mistakenly discarded when the laboratory space was being renovated, and determined to be unrecoverable. 2. The laboratory once again began saving histopathology slides beginning July 1, 2024 in a locked cabinet after approving procedures to secure the slides in July 2024. 3. This was confirmed with the histotechnologist on December 12, 2024 at 10:30 am. -- 2 of 2 --

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 procedure manual and quality assurance (QA) review and interview with the histotechnician, the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The procedure, "Proficiency Testing" states, "Annually, the tech or Risk Manager will send the original slides, label it with only the surgical case number, and send it out for a microscopic examination by a Board Certified Dermatopathologist." The procedure, "Quality Assurance Program" states, "Proficiency testing is required for this service provided by our physician. It is suggested to submit 2 cases every 6 months to an outside pathologist. The Pathology report is attached to and retained as a method for proficiency testing." 2. The form used for recording PT documents the "Date of Surgery," the "Date Sent," and the date that the "outside pathologist" reviewed the slides. 3. A review of PT records from 2021 through 2023 showed that two cases were sent out for PT on 01/29/2021. 4. Two cases were documented as being sent out for PT on 12/30/2021 and two cases were documented as being sent out for PT on 12/05/2022, however all four of these cases were reviewed by the "outside pathologist" on 01/24/2023. There was no documentation that a second set of cases was sent out for PT in 2022. 5. During an interview on 03/03/2023 at 11:40 AM, the histotechnician stated that all four cases were probably sent together on 12/05/2022 and confirmed that the laboratory did not ensure that PT was performed at least twice annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- 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 observation and interview with the histotechnician, the laboratory failed to ensure that tissue marking dyes used during Mohs surgery to mark patient tissue samples were not used after they exceeded their expiration dates. Findings: 1. During a tour of the laboratory at 10:15 AM, it was observed that 3 of 7 of the in-use "Avantik Tissue Marking Dyes" were expired. "Violet," lot # 107323 expired 09/30 /2022; "Orange," lot # 112727 expired 12/31/2022; and "Black," lot # 101208 expired 06/30/2022. 2. During an interview on 03/03/2023 at 10:15 AM, the histotechnician confirmed that the tissue marking dyes were expired and stated that they would order new ones. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on procedure manual and record review and interview with the histotechnician, the laboratory did not document performance of routine preventive maintenance checks on the cryostat used for processing tissue samples for Mohs surgery. Findings: 1. The procedure, "Quality Control Policies and Documentation" states, "Air filter is cleaned as part of the maintenance every 6 months" and "Preventive maintenance and grounding checks are done 6 months." 2. A review of the "Cryostat Maintenance Checklist" from the most recent preventative maintenance (PM) performed on 11/08 /2022 showed that cleaning the air filter and performing "grounding checks" was not included in the PM. 3. During an interview at 11:55 AM on the day of the survey the histotechnician stated that the laboratory staff did not perform the PM on the cryostat and confirmed that preventative maintenance was not documented. -- 2 of 2 --

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the remote recertification survey, the laboratory director did not fulfill laboratory director requirements and ensure that testing person #1 who performed tissue grossing (inking tissue during tissue grossing) for histology (MOHS surgery) met qualification requirements for performing high complexity testing in order to ink tissue. See D6171 for findings. 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) (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 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 -- 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 the remote survey, testing person #1 did not meet requirements for tissue grossing (tissue inking) as this activity is a high complexity test. Findings: 1. Testing Person #1 did not have college credit hours to qualify as a high complexity testing person and ink tissue during tissue grossing; 2. The laboratory reported that Testing Person #1 inked tissue for the MOHS surgeon during tissue grossing; 3. This was confirmed with the laboratory director during the exit of the remote survey. -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation in the Histology laboratory and interview with the histotech, the laboratory did not have an eyewash in the Histology laboratory where staining and slide preparation is being performed. Findings: 1. The laboratory is required to implement safety policies and procedures to ensure safety in the testing personnel. The Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) provide guidelines for laboratory safety. 2. The area where laboratory was staining and preparing slides was toured during the survey. Observation of the staining area showed that there was no eyewash attached to the sink to aid in flushing out the eyes of the histotech if they were to have been splashed with any stains or chemicals. 3. During the survey on 09/05/2018 at 1:15 PM the histotech confirmed that the an eyewash station was not in the area where the staining and slide preparation is being performed. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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: 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 -- A. Based on review of the quality assurance (QA) records and interview with the laboratory director, the laboratory director did not ensure that the information being documented on the "Monthly Quality Assurance Checklist" was a reflection of the activities performed in the laboratory. Findings: 1. The "Monthly Quality Assurance Checklist" requires the user to mark a Y for yes; N for no; and N/A for not applicable by each item on the checklist indicating that the status of the item. 2. Review of the "Monthly Quality Assurance Checklist" records for 2017 and 2018 showed that the answer to all the questions on the checklist were Yes (Y). 3. The section on the "Monthly Quality Assurance Checklist" labeled "Specimens were handled and collected according to protocol" was marked with a "Y". Review of the laboratory records showed that there were 6 reports during 2017 and 2018 showing that there were problems with protocol being followed but they were not identified on the checklist. 4. The section on the "Monthly Quality Assurance Checklist" labeled "All proficiency test results were evaluated" was marked with a Y. Review of the laboratory records showed that proficiency was only tested in August 2017 and July 2018. The checklist indicates that proficiency testing is reviewed every month of the year. 5. The section on the "Monthly Quality Assurance Checklist" labeled "All personnel who perform tests have documented training for these tests", "All personnel who perform tests have read the procedure manual for those tests" and "Personnel evaluations were performed as necessary" were all marked with Y. Evaluation records show that these tasks are performed annually and not each month. 6. The "Monthly Quality Assurance Checklist" includes "All quality control/ calibrators were performed and were within acceptable limits before test results were reported." The laboratory does not have an analyzer that needs to be calibrated. 7. During the survey on 09/05/18 at 1:15 PM the laboratory director and histotech confirmed that the information being documented on the "Monthly Quality Assurance Checklist" was a reflection of the activities performed in the laboratory. B. Based on review of the procedure manual and interview with the laboratory director and histotech, the laboratory director did not ensure that the preventative maintenance was being performed every six months per the instructions in the procedure manual. Findings: 1. According to the preventative maintenance section of the procedure manual the laboratory is required to perform and document preventative maintenance every six month on the cryostats, air filters, strainer, fume hood, microscope and all other equipment used in the histology laboratory. 2. The laboratory records show that preventative maintenance was being performed annually instead of every six month. 3. During the survey on 09/05/18 at 1:15 PM the laboratory director and histotech confirmed that the preventative maintenance was not being performed every six months as required by the procedure manual. -- 2 of 2 --