Ct Skin Health, Llp

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: A. Based on surveyor observation, record review and staff interview, the laboratory failed to establish and follow a step by step written policies and procedures to ensure correct specimen embedding of tissue specimens while utilizing the tamper embedding tools in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/28/2024 at 9:30 AM of the histology laboratory area revealed two 'Leica HistoCore Arcadia H Paraffin Embedding Stations' containing one tamper embedding tool within the holding compartment. 2. Record review on 08/28/2024 of the 'Embedding Center Use and Maintenance' procedure, effective 07/01/2016 revealed lack of documentation of a step-by-step procedure for the use of tamper embedding tools and proper procedure for cleaning to prevent cross contamination between tissue specimens. 3. Staff interview on 08/28/2024 at 10:30 AM with the histology laboratory supervisor confirmed the above findings. 4. The laboratory performs 35,000 tests annually in the subspecialty of histopathology. B. Based on surveyor observation, record review and staff interview, the laboratory failed to establish and follow a step by step written policies and procedures for the newly validated immunohistochemistry stains prior to patient testing in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/28/2024 at 9:45 AM of the histology laboratory area revealed the presence of a Leica Bon Max Immunohistochemistry (IHC) stainer in use. 2. Record review on 08/28/2024 of the laboratory's antibody validation binder revealed five antibodies (SOX10, AE1/AE3, CK 5/6, MELA , S100) that were approved between 03/22/2024 through 04/08/2024 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 -- by the laboratory director. 3. Record review on 08/28/2024 of the laboratory procedure manual revealed lack of documentation of a written procedure manual for the newly validated antibodies for the Immunohistochemistry antibody staining listed in B-2 above. 4. Staff interview on 08/28/2024 at 10:45 AM with the histology laboratory supervisor confirmed the above findings. 5. The laboratory performs 35,000 tests annually in the subspecialty of histopathology. 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 surveyor observation, record review and staff interview, the laboratory failed to provide an updated written procedure manual that is approved, signed and dated by the laboratory director (LD) before use in the subspecialty of histopathology. Findings include: 1. Surveyor observation on 08/28/2024 at 2:10 PM of the laboratory's Periodic Acid-Schiff (PAS) immunohistochemistry manual staining station revealed a PAS staining procedure posted on the wall that lack documentation of an approval by the laboratory director (LD). 2. Record review on 08/28/2024 of the laboratory's 'Staining Procedure for Manual Periodic Acid - Schiff Reaction' SOP# 8.00 with an approval date of 12/28/2016 by the LD revealed a discrepancy between the staining protocol versus the currently used staining protocol posted on the wall. 3. Staff interview on 08/28/2024 at 02:45 PM with the histology laboratory supervisor confirmed the above findings. 4. The laboratory performs 35,000 tests annually in the subspecialty of histopathology. 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 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. Record review on 08/28/2024 of the laboratory's maintenance records revealed lack of documentation of daily humidity levels and room temperature for the general histology laboratory area. 2. Record review on 08/28/2024 of the laboratory's standard operating procedure revealed lack of documentation of written policies and procedures defining the acceptable humidity and room temperature requirements. 3. Record review on 08/28 /2024 of the 'Sakura Tissue-Tek Film Automated Coverslipper' manual revealed the following humidity and temperature requirements: a. Relative humidity: 30 to 85% (non-condensing). b. Operating temperature range:10 to 40 degrees Celsius. 4. Record -- 2 of 3 -- review on 08/28/2024 of the 'Sakura Tissue-Tek DRS 2000 Automatic Slide Stainer' manual revealed the following humidity and temperature requirements: a. Relative humidity: 30% to 85% (non-condensing). b. Operating temperature range: 10 to 40 degrees Celsius. 5. Record review on 08/28/2024 of the 'Leica HistoCore Arcadia C Cold Plate and HistoCore Arcadia H Paraffin Embedding Station' manual revealed the following humidity and temperature requirements: a. Relative humidity: 20% to 8% (non-condensing). b. Operating temperature range: 20 to 30 degrees Celsius. 6. Record review on 08/28/2024 of the 'Leica ASP300S Advanced Smart Processor Vacuum Tissue Processor' manual revealed the following humidity and temperature requirements: a. Relative humidity: 10% to 80% (non-condensing). b. Operating temperature range: 15 to 35 degrees Celsius. 7. Record review on 08/28/2024 of the 'Leica RM2125 Rotary Microtome' manual revealed the following humidity and temperature requirements: a. Relative humidity: Maximum 80% (non-condensing). b. Operating temperature range: 10 to 35 degrees Celsius. 8. Record review on 08/28 /2024 of the 'Leica Bond Max' Immunohistochemistry Stainer manual revealed the following humidity and temperature requirements: a. Relative humidity: 30 to 80% (non-condensing). b. Operating temperature range: 5 to 35 degrees Celsius. 9. Staff interview on 08/28/2024 at 2:30 PM with the histology laboratory supervisor confirmed the above findings. 10. The laboratory performs 35,000 tests annually in the subspecialty of histopathology. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to assess the competency of the laboratory's Clinical Consultants (CC), Technical Supervisor (TS) and General Supervisor(GS) in the subspecialty of Histopathology. Findings include: 1. Review of the laboratory's personnel competency records on 10/05/22 revealed the lack of documentation for the following personnel competency assessment in 2020 and 2021. a. 4 of 4 CC. b. 1 of 1 TS. c. 1 of 1 GS. 2. Record review on 10/05/22 of the laboratory's "Histopathology & Mohs Surgery" procedure manual (page 31) revealed "the laboratory director, clinical consultant, technical supervisor, and general supervisor must be reviewed once every year by another qualified staff member (the Mohs supervisor {BS &2+ years experience} or an MD)". 2. Staff interview with the laboratory supervisor on 10/05/22 at 10:10 AM confirmed the laboratory did not have competency assessment records for CC, TS and GS in 2020 and 2021. 3. The laboratory performs 21,120 tests in the sub-specialty of Histopathology. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result 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 -- reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform manufacturer recommended maintenance in its required frequency to ensure the proper functioning of the laboratory equipment. Findings include: 1. Record review of the laboratory's "Fume Hood Monthly Maintenance Log" on 10/05/22 revealed the laboratory failed to replace the fluorescent lamps biannually in 2020, 2021 and to-date in 2022. 2. Record review of the fume hood (Model# B1115484 and SN# P83313) operator's manual on 10/05/22 revealed to replace the fluorescent lamps biannually for the proper functioning of the equipment. 3. Staff interview on 09/29/2022 at 12:40 PM with the testing personnel #3 (TP#3) confirmed the above findings. TP#3 further commented he/she was not aware it is a required maintenance to be done semiannually.. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and staff interview the laboratory failed to document routine maintenance and function checks for laboratory equipment in the specialty of pathology. Findings include: 1. Record review of the laboratory's automated cover- slipper (model # 4764) maintenance records on 10/29/18 revealed weekly and monthly function checks were not documented since August 2017. 2. Staff interview with testing personnel # 2 on 10/29/18 at 11:30 AM confirmed the above findings. 3. The laboratory performs 10,450 tests annually in the specialty of pathology. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory director failed to ensure testing personnel (TP) were trained prior to testing patient samples. Findings include: 1. Record review of the laboratory's testing personnel report (CMS-209) dated 7/16/18 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 -- on 10/29/18 revealed the laboratory employed 1 new TP since last onsite survey. Record review of the laboratory's personnel records revealed the date of hire was 5/15 /17. Training records for the new TP were not available for review. 2. Staff interview with the general supervisor on 10/29/18 at 10:00 AM confirmed training records for the new TP were not available. -- 2 of 2 --