University Of Maryland Dermatologists Pa

Summary Statement of Deficiencies 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: Based on review of the patient slides, standard operating procedure (SOP), quality assessment (QA) documentation and interview with the histology tech (HT), the laboratory director (LD) did not ensure that the HT's were labeling the slides as defined in the SOP, the QA records were documented with the date of review, and that the HT's that substituted had been given updated orientation instructions prior to preparing Moh's slides. Findings: 1. Patient slides were reviewed to verify that they were labeled per the instructions in the SOP. The patient slide log showed that there had been 4 different HT's employed in the laboratory since the previous survey on 05 /23/2023. Review of the slides showed that two of the four HT's failed to include the first name of the patient and the site location on 12 sets of patient slides. 2. The quarterly QA reviews since the previous survey on 05/23/2023 were reviewed. The documentation showed that LD had initiated the worksheet but there were no dates for each review showing that the review had been performed in a timely manner. 3. The credentials and competency reviews for the four HT's that had been preparing slides since the previous survey on 05/23/2023 were reviewed. The records showed that two of the four had competencies documented in 2021 and one of the four did not have any competency records. The competency records were not current for three of the four HT's preparing slides for review. 4. During the survey on 09/23/2024 at 10:45 AM, the HT confirmed that the slides were not labeled correctly, quarterly QA reviews had not been documented with the date of review, and competencies were not current for three of four HT's. 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 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 procedure and laboratory records and interview with the testing person (TP), the laboratory failed to document the biannual accuracy /proficiency verification of the Mohs surgeon in 2021 and 2022. Findings: 1. The procedure titled "Diagnostic Proficiency Review" stated that "Each Mohs surgeon, including the Mohs laboratory director, will submit cases on a bi-annual basis for review to verify accuracy/proficiency of the diagnosis and testing procedure. The cases will be reviewed for stain quality, diagnosis, and completeness of tissue margins. This will be documented on the Mohs case review log. " 2. The procedure went on to state that if "the review must take place off-site" then the "accession number, number of slides, and patient MRN will be logged on the slide tracking log that is created for all slides not in the laboratory." 3. Review of laboratory records showed that there were no Mohs case review logs and no slide tracking log documenting biannual accuracy/proficiency verification. 4. During the survey on 05/24 /2023 at 12:00 PM, the TP confirmed that biannual accuracy/proficiency verification was not documented for the Mohs surgeon in 2021 and 2022. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper 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 -- use. This STANDARD is not met as evidenced by: Based on observation and interview with the testing person (TP), the staining containers located in the automated stainer were not labeled to indicate which staining reagent was contained within. Findings: 1. The laboratory used an automated slide stainer to apply the hematoxylin and eosin stain to patient slides. 2. The individual containers holding each staining reagent within the automated stainer were not labeled with the identity or expiration date of each staining reagent contained within. 3. During the survey on 05/24/2023 at 12:00 PM, the TP confirmed that the individual containers in the automated stainer were not labeled with the identity or expiration date of the staining reagents contained within. 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 staining reagent logs and interview with the testing person (TP), the laboratory did not ensure that staining reagents were not used beyond their expiration date. Findings: 1. The laboratory used a "Reagent Log" to document the name of the staining reagent, lot number, expiration date, opened date, and TP's initials. 2. The log showed that lot number 2002233 of Eosin expired on 01/27/2022. The next documented lot number for Eosin was L22515 with an expiration date of 09 /09/2023, but the opened date was not filled in. 3. The log showed that lot number 129138 of hematoxylin expired on 02/28/2023. The next documented lot number for hematoxylin was 160052 with an expiration date of 04/30/2024, but the opened date was not filled in. 4. The log showed that lot number 2104101 of Scott's bluing expired on 02/12/2022. The next documented lot number was L16021 which was opened on 06 /13/202,2 about 4 months after the previous lot number expired. 5. During the survey on 05/24/2023 at 12:00 PM, the TP confirmed that the "Reagent Log" showed that expired stains were used for patient testing. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the procedure and the hematoxylin and eosin (H & E) stain quality control (QC) log and interview with the testing person (TP), the laboratory failed to document slide staining quality each day patients were tested. Findings: 1. The procedure titled "Identification, Labeling and Storage of Mohs Surgery Slides" stated -- 2 of 3 -- "The daily quality control slide will be examined by the Mohs surgeon and the quality of the staining will be documented in the log that has been created for this purpose." 2. The H & E Quality Control Log stated "The Mohs surgeon will identify the QC slide as adequate (+) or inadequate (-). Slides that are marked inadequate (-) will have a comment identifying deficiencies" and included columns to record the date, the accession number of the slide used for QC, the "Slide Quality" results, and the Mohs surgeon's initials. 3. Review of the QC log from 05/19/2021 - 05/24/2023 showed that the "Slide Quality" was not documented or initialed by the Mohs surgeon from 06/28 /2021-12/27/2021 and from 10/17/2022-12/27/2022. 4. During the survey on 05/24 /2023 at 12:00 PM, the TP confirmed that the H & E stain quality was not consistently documented by the Mohs surgeon each day of patient testing. 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: Based on review of the procedure and the quarterly quality control (QC) log and interview with the testing person (TP), the laboratory director failed to maintain the established quality assessment (QA) procedure by not performing quarterly reviews. Findings: 1. The procedure titled "Quarterly Records" stated that "The quarterly record form documents that quality control forms, including Mohs maps, have been completed by the Mohs technician/surgery staff. The Mohs director signs off each quarter to verify this has been completed." 2. The "Mohs Director Quarterly Q.C. Log Check" (quarterly log) stated "The Mohs director will initial that records are complete for each quarter. Incomplete records or problems identified will be described below with the

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on remote review of final test reports and test records and email communication with the testing person (TP), the laboratory failed to ensure that the final test report contained the correct test report date and patient first name. Findings: 1. One of four remotely reviewed final test reports contained a test report date and a patient first name that did not match with the laboratory test records. 2. The date on the final test report was "February 25, 2019." The patient log, Mohs map, and slide labels indicated that the patient was treated on February 26, 2019. 3. The patient's first name on the patient log, Mohs map, and slide labels was different than the patient's first name on the final test report. 4. An email communication received from the TP on 04/12/2021 at 3:56 PM confirmed that the "name and date on the patient log, Mohs map and slides is the correct information." 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 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 interview with the practice operations director, the laboratory failed to retain the stained slides used for the interpretation of patients who have had Mohs surgery. Findings: 1. The surveyor reviewed the "Patient Log" and selected slides from M18- 017, initials AS for review. When Slide M18-017 was found for review the initials were JS. 2. When the rest of the "Patient Log" was reviewed it was determined that the numbers M18-001 through M18-019 had been used in January 2018 and then again in March 2018. 3. At the time of the survey the slides from January 2018, M18- 001 through M18-019, could not be located. 4. During the survey on 09/25/18 at 1:00 PM the practice operations director confirmed that the slides from January 2018, M18- 001 through M18-019, could not be located. The laboratory did not ensure that the slides used for the interpretation of patients who had Mohs surgery were not saved for the required 2 years. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: A. Based on review of the procedure manual and interview with the laboratory director, the laboratory did not follow the established policies and procedures for positive identification and integrity of the specimens that were analyzed. Findings: 1. The procedure manual shows an example of how to label the slides. The histotech is required to include the last two digits of the current year followed by the next sequence number for that year. 2. The laboratory director stated that the Mohs ID number should include an "M" for one doctor and a "S" for the other doctor in the practice. This letter should be listed prior to the last two digits of the current year. 3. The surveyor was reviewing the "Patient Log" for 2017 and 2018. From 11/03/17 through 01/26/18 Dr. "S" was listed as the physician. Dr. "S" performed the Mohs surgery and performed the interpretation of the slides labeled M17-267 through M18- 019. 4. On 03/05/18 Dr. "M" was listed as the physician. Dr. "M" performed the Mohs surgery and performed the interpretation of the slides labeled M18-001 until the date of the survey. 5. Mohs ID numbers M18-001 through M18-019 were used twice in the same calander year. 6. During the survey on 09/25/18 at 1:00 PM the laboratory director confirmed that there was no written procedure for identify Dr. "M" slides verses Dr. "S" slides and that the Mohs ID numbers M18-001 through M18-019 were used twice in the same calander year. 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 procedure manual and interview with the laboratory manager, the laboratory did not ensure that the written procedure describing the system used for verifying the accuracy and reliability of interpretation of the histopathology specimens for which proficiency samples are not available was not performed and documented for 2017 and 2018. Findings: 1. The procedure stated that proficiency testing evaluation would be performed twice a year to verify the accuracy of interpretation histopathology specimens. 2. During the survey on 09/25/2018 at 1:00 PM the laboratory manager confirmed that the records that were available did not include documentation of split samples being reviewed by a second Mohs surgeon at part of the proficiency testing program. 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)