Department Of Dermatology

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: Based on surveyor observation, record review and staff interview the laboratory failed to provide and follow an updated procedure manual for the tissue processing program in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08 /20/2025 at 11:50 AM of the 'Leica ASP300S Advanced Smart Processor' tissue processing program revealed the following : a. Routine overnight tissue processing program: i. Step 1: Formalin; Duration: 30 minutes. ii. Step 2: Formalin; Duration: 30 minutes. iii. Step 3: 60% Ethanol; Duration: 45 minutes. iv. Step 4: 95% Ethanol; Duration: 45 minutes. v. Step 5: 100% Ethanol; Duration: 45 minutes. vi. Step 6: 100% Ethanol; Duration: 45 minutes. vii. Step 7: 50/50 Xylene/100%; Duration: 30 minutes. viii. Step 8: 50/50 Xylene/100%; Duration: 30 minutes. ix. Step 9: Xylene; Duration: 45 minutes x. Step 10: Xylene; Duration: 45 minutes xi. Step 11: Paraffin Wax; Duration: 30 minutes xii. Step 12: Paraffin Wax; Duration: 30 minutes xiii. Step 13: Paraffin Wax; Duration: 30 minutes b. Rush tissue processing program: i. Step 1: Formalin; Duration: 1 minutes. ii. Step 2: Formalin; Duration: 15 minutes. iii. Step 3: 60% Ethanol; Duration: 15 minutes. iv. Step 4: 95% Ethanol; Duration: 15 minutes. v. Step 5: 100% Ethanol; Duration: 15 minutes. vi. Step 6: 100% Ethanol; Duration: 15 minutes. vii. Step 7: 50/50 Xylene/100%; Duration: 15 minutes. viii. Step 8: 50/50 Xylene/100%; Duration: 5 minutes. ix. Step 9: Xylene; Duration: 15 minutes x. Step 10: Xylene; Duration: 15 minutes xi. Step 11: Paraffin Wax; Duration: 20 minutes xii. Step 12: Paraffin Wax; Duration: 20 minutes xiii. Step 13: Paraffin Wax; Duration: 20 minutes 2. Record review on 08/20/2025 of laboratory's established "ASP 300 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 5 -- Processor" standard operating procedure revealed the following tissue processing programs: a. Routine overnight tissue processing program: i. Step 1: 10% NBF; Duration: 30 minutes. ii. Step 2: 10% NBF; Duration: 30 minutes. iii. Step 3: 70% Ethanol; Duration: 45 minutes. iv. Step 4: 95% Ethanol; Duration: 45 minutes. v. Step 5: 100% Ethanol; Duration: 45 minutes. vi. Step 6: 100% Ethanol; Duration: 45 minutes. vii. Step 7: 50/50 Xylene/100%; Duration: 30 minutes. viii. Step 8: 50/50 Xylene/100%; Duration: 30 minutes. ix. Step 9: Xylene; Duration: 45 minutes x. Step 10: Xylene; Duration: 45 minutes xi. Step 11: Paraffin Wax; Duration: 30 minutes xii. Step 12: Paraffin Wax; Duration: 30 minutes xiii. Step 13: Paraffin Wax; Duration: 30 minutes b. Rush tissue processing program: i. Step 1: 10% NBF; Duration: 1 minutes. ii. Step 2: 10% NBF; Duration: 15 minutes. iii. Step 3: 70% Ethanol; Duration: 15 minutes. iv. Step 4: 95% Ethanol; Duration: 1 minutes. v. Step 5 100% Ethanol; Duration: 15 minutes. vi. Step 6: 100% Ethanol; Duration: 15 minutes. vii. Step 7: 50 /50 Xylene/100%; Duration: 15 minutes. viii. Step 8: 50/50 Xylene/100%; Duration: 5 minutes. ix. Step 9: Xylene; Duration: 15 minutes x. Step 10: Xylene; Duration: 15 minutes xi. Step 11: Paraffin Wax; Duration: 20 minutes xii. Step 12: Paraffin Wax; Duration: 20 minutes xiii. Step 13: Paraffin Wax; Duration: 20 minutes 3. Record review on 08/20/2025 of the "ASP 300 Tissue Processor" standard operating procedure revealed discrepancies in step 3 of the 'routine overnight tissue processing program' and step 3 and 4 in the 'rush tissue processing program'. 4. Staff interview on 08/20/2025 at 12:00 PM with the laboratory testing personnel #1 confirmed the findings in 3 above. 5. The laboratory performs 47,194 tests annually in the subspecialty of histopathology. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to follow manufacturer instructions for proper storage of special stain reagent in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/20 /2025 at 09:15 AM of the laboratory general working area revealed a refrigerator in use to store special stain reagents. 2. Surveyor observation on 08/20/2025 at 09:16 AM of the refrigerator contents revealed the following special stain reagents stored at 2 to 8 degrees Celsius: a. 'Alcian Blue pH 2.5 Stain Kit (AB 2.5), 1/3, Artisan Link Mix' b. 'Alcian Blue pH 2.5 Stain Kit (AB 2.5), 2/3, Artisan Link Mix' c. 'Alcian Blue pH 2.5 Stain Kit (AB 2.5), 3/3, Artisan Link Mix' d. 'Grocott's Methenamine Silver Stain Kit (GMS), 3/8, Artisan Link Mix' e. 'Grocott's Methenamine Silver Stain Kit (GMS), 6/8, Artisan Link Mix' f. 'Grocott's Methenamine Silver Stain Kit (GMS), 8/8, Artisan Link Mix' g. 'Elastic Stain Kit, 1/4, Artisan Link Mix' h. 'Elastic Stain Kit, 2/4, Artisan Link Mix' i. 'Elastic Stain Kit, 3/4, Artisan Link Mix' j. 'Elastic Stain Kit, 4/4, Artisan Link Mix' 3. Record review on 08/20/2025 of the 'Alcian Blue pH 2.5 Stain Kit, Grocott's Methenamine Silver Stain Kit and the Elastic Stain Kit' manufacturers provided package inserts revealed a temperature storage requirement of 15 to 30 degree Celsius. 4. Staff interview on 08/20/2025 at 09:25 AM with the laboratory Testing Personnel #1 (TP#1) confirmed the above findings. TP#1 further commented that he/she was unaware of the 15 to 30 degrees Celsius storage requirement and have -- 2 of 5 -- been storing the above reagents between 2 to 8 degrees Celsius. 5. The laboratory performs 47,194 tests annually in the subspecialty of histopathology. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to define and provide evidence of monitoring and documenting humidity requirements and room temperature in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/20/2025 at 09:15 AM during the laboratory tour revealed the following instruments: a. Leica RM2235 Rotary Microtome b. Leica RM2255 Rotary Microtome c. Leica RM2125 RTS Rotary Microtome d. Leica HistoCore BIOCUT Rotary Microtome e. Artisan Link Pro f. Tissue-Tek Tissue Embedding Console System g. Leica HistoCore SPECTRA ST h. Leica HistoCore SPECTRA CV Coverslipper i. Leica HistoCore PEGASUS Tissue j. Leica ASP300S Advanced Smart k. Leica BOND III - Fully Automated IHC & ISH Staining System l. Leica CM1860 UV Cryostat m. Thermo Scientific Cryotome FE & FSE n. Thermo Scientific Cryostar NX70/NX50 2. Record review on 08/20/2025 of the laboratory's maintenance records revealed lack of documentation of humidity levels and room temperature as per manufacturers requirements for the instruments listed in 1 above. 3. Record review on 08/20/2025 of the 'UMG Dermatopathology Procedure Manual for Temperature Quality Control 'revealed lack of documentation to define humidity and room temperature requirements. 4. Record review on 08/20/2023 of the 'Leica RM2235 Rotary Microtome' operator guide revealed the following site requirements: a. Relative humidity: Maximum 80% (non-condensing). b.Operating temperature range: 10 to 35 degrees Celsius. 5. Record review on 08/20/2025 of the 'Leica RM2255 Rotary Microtome' operator guide revealed the following site requirements: a. Relative humidity: Maximum 80% (non-condensing). b. Operating temperature range: 10 to 35 degrees Celsius. 6. Record review on 08/20/2025 of the 'Leica RM2125 RTS Rotary Microtome' operator guide revealed the following site requirements: a. Relative humidity: Maximum 80% (non-condensing). b. Operating temperature range: 18 to 30 degrees Celsius. 7. Record review on 08/20/2025 of the 'Leica HistoCore BIOCUT Rotary Microtome' operator guide revealed the following site requirements: a. Relative humidity range: 20% to 80% (non-condensing). b. Operating temperature range: 18 to 30 degrees Celsius. 8. Record review on 08/20 /2025 of the 'Artisan Link Pro' operator guide revealed the following site requirements: a. Relative humidity range: 25% to 85% (non-condensing). b. Operating temperature range: 15 to 35 degrees Celsius. 9. Record review on 08/20/2025 of the 'Tissue-Tek Tissue Embedding Console System' operator guide revealed the following site requirements: a. Relative humidity range: 0% to 85% (non-condensing). b. Operating temperature range: 15 to 35 degrees Celsius. 10. Record review on 08/20 /2025 of the 'Leica HistoCore SPECTRA ST Stainer' operator guide revealed the -- 3 of 5 -- following site requirements: a. Relative humidity range: 20% to 80% (non- condensing). b. Operating temperature range: 18 to 30 degrees Celsius. 11. Record review on 08/20/2025 of the 'Leica HistoCore SPECTRA CV Coverslipper' operator guide revealed the following site requirements: a. Relative humidity range: 20% to 80% (non-condensing). b. Operating temperature range: 18 to 30 degrees Celsius. 12. Record review on 08/20/2025 of the 'Leica HistoCore PEGASUS Tissue Processor' operator guide revealed the following site requirements: a. Relative humidity range: 20% to 80% (non-condensing). b. Operating temperature range: 10 to 35 degrees Celsius. 13. Record review on 08/20/2025 of the 'Leica ASP300S Advanced Smart Processor' operator guide revealed the following site requirements: a. Relative humidity range: 10% to 80% (non-condensing). b. Operating temperature range: 15 to 35 degrees Celsius. 14. Record review on 08/20/2025 of the 'Leica BOND III - Fully Automated IHC & ISH Staining System' operator guide revealed the following site requirements: a. Relative humidity range: 30% to 80% (non-condensing). b. Operating temperature: Maximum 35 degrees Celsius. 15. Record review on 08/20/2025 of the 'Leica CM1860 UV Cryostat' operator guide revealed the following site requirements: a. Relative humidity range: 20% to 60% (non-condensing). b. Operating temperature range: 18 to 35 degrees Celsius. 16. Record review on 08/20/2025 of the 'Thermo Scientific Cryotome FE & FSE' operator guide revealed the following site requirements: a. Relative humidity: maximum 80% (non-condensing). b. Operating temperature range: 5 to 35 degrees Celsius. 17. Record review on 08/20/2025 of the 'Thermo Scientific Cryostar NX70/NX50' operator guide manual revealed the following site requirements: a. Relative humidity: maximum 80% (non-condensing). b. Operating temperature range: 15 to 35 degrees Celsius. 18. Staff interview on 08/20 /2025 at 11:00 AM with the laboratory Testing Personnel #1 (TP#1) confirmed the above findings. TP#1 further commented that he/she was unaware of the humidity and room temperature requirements. 19. The laboratory performs 47,194 tests annually in the subspecialty of histopathology. 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: Based on surveyor observation and staff interview, the laboratory failed to ensure mounting medium used for immunohistochemistry (IHC) staining procedures did not exceed the expiration date in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/20/2025 at 12:45 PM of the laboratory IHC room revealed 2 of 2 'Immu-Mount' mounting medium with a lot number of 145085 and an expiration date of 08/01/2025 in use. 2. Staff interview on 08/20/2025 at 12:50 PM with the laboratory Testing Personnel #2 confirmed the above findings. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. -- 4 of 5 -- Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to establish policies and procedures for proper function of ancillary equipment for accurate and reliable test results in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/20/2025 at 9:45 AM of the histopathology laboratory general working area revealed multiple timers in use as follows: a. Fisherbrand Mini-Alarm Timer/Stopwatch, serial number: 192231983 b. Fisherbrand Mini-Alarm Timer/Stopwatch, serial number: 192232003 c. Fisherbrand Mini-Alarm Timer/Stopwatch, serial number: 192232024 2. Record review on 08/20/2025 of the laboratory's 3 of 3 timers listed above revealed a calibration due date of 06/10/2021. 3. Staff interview on 08/20/2025 at 09:50 AM with the laboratory Testing Personnel #1 (TP#1) confirmed the above findings. TP#1 further commented that he/she was unaware the timer calibrations had expired. 4. The laboratory performs 47,194 tests annually in the subspecialty of histopathology. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to establish and follow competency assessment policies and procedures of the Testing Personnel (TP) to perform and report Potassium Hydroxide (KOH) testing in the subspecialty of Mycology. Findings include: 1. Record review on 8/202/025 of the laboratory 's 'Centers for Medicare and Medicaid Services (CMS) 209 - Laboratory Personnel Report (CLIA)' form revealed the laboratory employs 23 of 41 moderate complexity TP. 2. Record review on 08/20/2025 of the laboratory 's established policies and procedure revealed lack of documentation of an established policy to evaluate testing personnel and maintain the competencies to perform and report the KOH testing. 3. Record review on 8/20/2025 of the laboratory 's competency assessment records for 2024 and 2025 revealed lack of documentation of competency assessments for 23 of 23 TP's performing the KOH testing. 4. Staff interview on 8/20/2025 at 12:35 PM with the Testing Personnel #1 confirmed the above findings. 5. The laboratory performs 42 KOH tests annually in the subspecialty of Mycology. -- 5 of 5 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: Based on surveyor observation, record review and staff interview, the laboratory failed to provide a written laboratory procedure for the Automated Coverslipper currently in use in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 4/12/2022 at 11:20 AM of the current laboratory equipment revealed a Leica CV5030 coverslipper installed in 2015 and attached to the Leica Stainer. 2. Record review on 4/12/2022 of the laboratory procedure manual revealed: a. A coverslipper procedure for the 'HCM 6000 Automated Glass Coverslipper'. b. Lack of documentation of a procedure for the Leica CV5030 instrument currently in use. 3. Staff Interview on 4/12/2022 at 11:25 AM with Testing Personnel #2 (TP#2) confirmed the above findings. In addition, TP#2 remarked the serial number of the Leica CV5030 translates to the instrument being in service since 2015. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure laboratory 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 -- procedures were approved by the laboratory Director (LD) prior to patient use in the subspecialty of histopathology. Findings include: 1. Record review of the following laboratory procedure manuals on 4/12/2022 revealed the lack of documentation of the current LD approval prior to patient testing: a. Immuno Special Staining (IHC) procedure manual b. MOHS procedure manual 2. Record review on 4/12/2022 of the Dermatopathology procedure manual revealed the following procedures are marked as revised with no current laboratory director signature of approval: a. Temperature Quality Control b. Specimen Collection and Handling c. Specimen Grossing d. Embedding Guidelines e. Missing Specimen Procedure f. Automated Hematoxylin and Eosin Staining Procedure 3. Staff interview with testing personnel #2 (TP#2) on 4 /12/2022 at 12:30 PM confirmed the IHC manual had been reviewed by the IHC technical supervisor and TP#2 was unaware the LD needed to review and approve. 4. Staff interview with testing personnel #3 on 4/12/2022 at 1:40 PM confirmed the MOHS procedure manual was not signed and approved by the LD. 5. Staff interview on 4/12/2022 at 11:20 AM with the laboratory supervisor confirmed the procedures in 2 above were revised by a prior histology technologist with no signed approval by the LD. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to provide evidence of monitoring and documenting proper paraffin temperature requirements for the period of April 2020 until April 12 2022. Findings include: 1. Record review on 4/12/2022 of the maintenance logs for the 'ASP 300 processor: Paraffin Temperature' chart revealed: a. The acceptable paraffin temperature range was 59 to 63 degrees Celsius. b. Lack of documentation of daily paraffin temperatures for the period of April 2020 until April 12 2022. 2. Record review on 4/12/2022 of the maintenance logs for the 'ASP 300S processor: Paraffin Temperature' chart revealed: a. The acceptable paraffin temperature range was 59 to 63 degrees Celsius. b. Lack of documentation of daily paraffin temperatures for the period of April 2020 until April 12 2022 3. Record review on 4/12/2022 of the laboratory's 'Temperature Quality Control' procedure revealed "Temperatures of all instruments/equipment on the Daily Q.C. Log should be taken early in the day to allow for

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document function checks to ensure proper functioning prior to patient testing. Findings include: 1. Record review on 7/8/19 of the laboratory's annual function checks for the 4 laboratory hoods revealed the last function check for the hoods was March 2018. 2. Record review on 7/8/19 of the 2017, 2018 and 2019 Maintenance logs for the Leica Cryostat 1860 UV located in the dermatopathology laboratory revealed: a. Only temperatures are recorded daily. b. The required cleaning and disinfection is not documented. 3. Record review on 7/8/19 of the Leica Cryostat 1860 UV Instruction Manual, Section 9: Cleaning, Disinfection, Maintenance, revealed: a. "Remove frozen section waste from the cryostat with a cold brush every day." b. "The cryostat, including all components, has to be disinfected after each daily use." 4. Staff interview with the laboratory supervisor (LS) on 7/8/19 at 11:20 AM confirmed: a. The hoods have not been checked since March of 2018. The LS stated he/she put in to have the hoods inspected and checked, but they were not done. b. The daily cleaning and disinfection of the above cryostat is not documented. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually 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 -- after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and staff interview, the technical supervisor failed to document annual competency of testing personnel (TP) to assess the knowledge and skills necessary to perform high complexity laboratory testing. Findings include: 1. Competency record review on 7/8/19 revealed: a. The 'UCHC Competency Checklist, Annual Dermatopathology' form used to assess annual competency was for prep tech activities only and did not contain a section for grossing. b. Annual competency assessment was not documented for 7 of 7 Grossing TP in 2017 and 2018. 2. Staff Interview with the laboratory supervisor (LS) on 7/8/19 at 10:45 AM, confirmed the above findings. The LS stated he/she was unaware that grossing was not addressed on the competency form. -- 2 of 2 --