Dolehide Dermatology At Silver Cross

Summary Statement of Deficiencies D0000 An recertification certification survey was completed on 01/15/2026. The following condition level deficiencies were dicovered: D5028 - 42 CFR 493.1219 - Condition: Histopathology D6076 - 42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director D6108 - 42 CFR 493.1447 - Condition: Laboratories performing high complexity testing; technical supervisor D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, manufacturer's instructions for use, laboratory records, lack of documentation, and interviews with testing personnel (TP) #2; the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed (see D5217a), failed to perform and document biannual method accuracy (proficiency testing/peer reviewed histopathology cases) for histopathology interpretations for four of four events (see D5217b), failed to evaluate results of bi-annual method accuracy (proficiency testing /peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events (see D5221), failed to follow written policies and procedures for monitoring, assessing, and correcting problems identified for 24 of 24 months (see D5291), failed to outline control procedures for two of three stains utilized for histopathology testing (see D5403), failed to perform and document maintenance as defined by the manufacturer (see D5429), failed to establish and document a preventative maintenance protocol that ensures equipment, instrument, and test system performance for accurate and reliable test results for eight of eight instruments and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- microscopes utilized for the histopathology testing (see D5433), failed to exam and document the quality control (intended reactivity) of Hematoxylin and Eosin staining material used for 4 of 11 histopathology interpretations reviewed (see D5473), and failed to document histopathology special stain known reactivity and immunohistochemical (IHC) stain positive and negative reactivity for 11 of 11 patients reviewed in the subspecialty of histopathology in 2024 and 2025 (see D5601). 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: a) Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed in 2024 and 2025 in the subspecialty of histopathology. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Proficiency Testing Policy", which stated, under "Procedures:", "Twice annually 4-5 patients will be randomly chosen from our Mohs cases for review by an outside lab/reviewer for accuracy." 2. Review of biannual method accuracy documentation for Mohs micrographic cases revealed the diagnostic interpretation of the carcinoma was peer- reviewed by an outside reviewer, not the accuracy of the Mohs micrographic carcinoma exclusion procedure. Year/Event: Date: Mohs Case #: Diagnosis: 2024/1st Event 01/08/2024 SM24-003 BCC* 2024/1st Event 04/10/2024 SM24-054 BCC 2024 /1st Event 04/10/2024 SM24-056 BCC 2024/1st Event 04/29/2024 SM24-063 BCC 2024/2nd Event 08/16/2024 SM24-138 BCC 2024/2nd Event 10/16/2024 SM24-174 BCC 2024/2nd Event 11/15/2024 SM24-205 BCC 2024/2nd Event 11/20/2024 SM24- 210 BCC 2025/1st Event 01/20/2025 SM25-012 BCC 2025/1st Event 02/17/2025 SM25-022 BCC 2025/1st Event 04/09/2025 SM25-051 BCC 2025/1st Event 05/05 /2025 SM25-069 BCC 2025/2nd Event 06/23/2025 SM25-106 BCC 2025/2nd Event 06/30/2025 SM25-113 BCC 2025/2nd Event 07/14/2025 SM25-122 BCC 2025/2nd Event 10/31/2025 SM25-195 BCC *BCC = Basal Cell Carcinoma 3. Review of biannual method accuracy documentation for Mohs micrographic cases revealed the laboratory sent slides out for peer review one time each year in 2024 and 2025. Year /Event: Date(s) of testing: Date of review: 2024/1st Event 01/08/2024 - 04/29/2024 01 /13/2025 2024/2nd Event 08/16/2024 - 11/20/2024 01/13/2025 2025/1st Event 01/20 /2025 - 05/05/2025 01/12/2026 2025/2nd Event 06/23/2025 - 10/31/2025 01/12/2026 4. Interview with TP #2 on 01/15/2026, at 11:29 am, confirmed the laboratory failed to perform biannual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed in 2024 and 2025 in the subspecialty of histopathology. b) Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to perform and document biannual method accuracy (proficiency testing/peer reviewed histopathology cases) for histopathology interpretations for four of four events in 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Dolehide Dermatology Laboratory Manual", which stated, under "Proficiency Testing", "Twice annually 4-5 cases will be randomly chosen for review by an outside lab/reviewer for accuracy." 2. Review of laboratory records revealed a lack of bi- -- 2 of 10 -- annual method accuracy documentation at least twice annually for histopathology interpretations. 3. Interview with TP #2 on 01/15/2026, at 11:29 am, confirmed the laboratory failed to document biannual method accuracy (proficiency testing/peer reviewed histopathology cases) for histopathology interpretations for four of four events in 2024 and 2025. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed in 2024 and 2025 in the subspecialty of histopathology. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Proficiency Testing Policy", which stated, under "Procedures:", "Twice annually 4-5 patients will be randomly chosen from our Mohs cases for review by an outside lab/reviewer for accuracy. The results of the proficiency testing (PT) will be forwarded to the laboratory director within one week of their return from the outsides reviewer. The director will carefully evaluate any unacceptable, unsatisfactory or unsuccessful proficiency testing results in an effort to identify the cause of the failure." 2. Review of laboratory policies and procedures revealed the policy titled "Competency /Evaluation Program", which stated, under "Laboratory Proficiency Testing", "Proficiency testing results are reviewed by the Lab Director." 3. Review of laboratory records revealed a lack of documentation of review by the laboratory director for four of four Mohs histopathology bi-annual method accuracy events performed in 2024 and 2025. 4. Interview with TP #2 on 01/15/2026, at 11:29 am, confirmed the laboratory failed to evaluate results of bi-annual method accuracy (proficiency testing/peer reviewed Mohs micrographic carcinoma exclusion results) for four of four Mohs events performed in 2024 and 2025 in the subspecialty of histopathology. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to follow written policies and procedures for monitoring, assessing, and correcting problems identified for 24 of 24 months in the subspecialty of histopathology in the years of 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Quality Assurance [QA] Policy", which stated, under "QA Checklist", "1. Using the Quality Assurance (QA) Monthly Checklist, pre- -- 3 of 10 -- analytic, analytic and post-analytic processes are monitored in order to identify problems, failures or unacceptable results in specimen processing or patient care." 2. Review of laboratory policies and procedures revealed the procedure titled "Quality Assessment Procedures", which stated, under "3. Ongoing Assessment:", "The Laboratory Director will review, monitor and sign the Monthly QA Checklist in order to assess and correct problem identified in the general laboratory systems." 3. Review of laboratory records revealed a lack of documentation of monthly quality assurance checks performed in laboratory for the previous 24 months reviewed. 4. Interview with TP #2 on 01/15/2026, at 10:31 am, confirmed the laboratory failed to follow written policies and procedures for monitoring, assessing, and correcting problems identified for 24 of 24 months in the subspecialty of histopathology in the years of 2024 and 2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 the surveyor's review of laboratory records, direct observation, and an interview with testing personnel (TP 2), the laboratory failed to ensure three of three tissue marking dyes were not used for histopathology testing after exceeding their expiration dates. Affecting two of two testing months (07/2023 and 08/2023). Findings Include: 1. Review of the "Mohs Laboratory Reagent Protocol" revealed the following: a. "PURPOSE: As part of the Mohs laboratory's quality control, the shelf- life of laboratory reagents is recorded upon receipt and monitored monthly. Expired reagents are identified and properly disposed." b. "PROCEDURES: 2. Each month the lab supplies and reagents are checked for expiration dates. 3. If the supplies or reagents are found to have become outdated, they are disposed of according to the recommended disposal method on the MSDS sheet for that reagent." 2. On 08/16 /2023 at 11:25 a.m., the surveyor's direct observation revealed exceeded expiration dates for three of three tissue marking dye reagents. a. "ReOrder #GR2056-GN (11- 9005-12) - EXP: 2023-07-31" b. "ReOrder #GR2056-GN (11-9005-12) - EXP: 2023- 07-31" c. "ReOrder #GR2056-R (11-9002-12) - EXP: 2023-06-30" 3. On 08/16/2023 at 11:30 a.m., TP 2 confirmed the above findings. 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's review of the manufacturer's maintenance schedule, laboratory records, lack of documentation, and an interview with testing personnel (TP 2), the laboratory failed to perform and document the maintenance for one of one biosafety cabinets for two of two testing years (2022 and 2023). Affecting a total of 207 Mohs surgeries. Findings Include: 1. Review of the laboratory's "Quality Control Policy" revealed the following: a. "Quality Control: Equipment Maintenance and Records 4.b. - Staff will perform and document the required routine and daily maintenance on instruments and equipment. 7. The laboratory must maintain documentation of daily function checks and/or maintenance checks for the preceding 2 years." 2. Review of the manufacturer's "Purair Basic Consumable Parts List" for one of one biosafety cabinets (Air Science biosafety cabinet - Serial # P7573) revealed the following: a. "Replace Pre-filters every 2 - 3 Months" b. "Replace Main Filter Every 12 Months" 3. Review of laboratory records and lack of documentation revealed the laboratory failed to perform and document the maintenance for one of one biosafety cabinets (Air Science biosafety cabinet - Serial # P75733) for two of two testing years (2022 and 2023). Affecting a total of 207 Mohs surgeries. 4. On 08 /16/2023, at 10:30 a.m., TP 2 confirmed the above findings. -- 2 of 2 --