Fort Myers Dermatopathology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Fort Myers Dermatopathology PA on 4/09/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e)(3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure documentation of immunohistochemical stains for positive and negative reactivity each time of use for two of two years (2023-2025). Findings included: 1. The CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certifications signed 12/6/22 and 3/25/2025 both included immunohistochemical stains (IHC). 2. The Immuno Stain Process Quality Control log for 2/2025 and 6/2024 was signed monthly by Testing Personnel A (TP-A) who was the only testing personnel reading slides. The date of signing was not documented. There was no documentation available for review documented by TP-A of the IHC controls reactivity each time of use. 3. Testing Personnel B confirmed on 4/09/2025 at 12:10 PM there was no documentation by the Testing Personnel performing the IHC test (the reading of the slides) of the positive and negative reactivity each time of use, and the laboratory had never documented this before. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, 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 -- precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on documentation review and interview, the Laboratory Director failed to ensure the verification of the immunohistochemical (IHC) testing performed procedures were adequate to determine accuracy, precision, and other pertinent performance characteristics of the method from 1/10/2024 to 4/09/2025. Findings included: 1. The IHC processor, Intellipath, was installed 12/19/23 and the date of the first patient testing was 1/10/2024. The documentation of verification of operation for the newly installed Intelllipath failed to include review and approval of use by the Lab Director. 2. The laboratory Procedure and Policy Manual signed as approved by the Laboratory Director 9/22/2023 and 1/15/2024 included a list of the Laboratory Director's responsibilities. One of the listed responsibilities was to ensure "Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method." 3. Testing Personnel B on 4/09/2025 at 12:10 PM confirmed there was no documentation of the Lab Director ensuring the verification of the immunohistochemical (IHC) testing performed on the Intellipath from 1/10/2024 to 4/09/2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Fort Myers Dermatopathology PA on 12/12/22. Fort Myers Dermatopathology PA is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Requirements for Laboratories. The following is description of the Standard-level deficiency. 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 observation, record review, and staff interview, the laboratory failed to follow their procedure for equipment maintenance for two of two years (2020 - 2022) reviewed. The findings included: On 12/12/22 at 10:30 a.m., tour of the laboratory revealed two Olympus microscopes that had periodic maintenance stickers on them that the date was "12/2020". On 12/12/22 at 10:45 a.m., the histology technologist stated they had periodic maintenance performed on the microscopes every two years. A review of the laboratory's procedure manual signed by the laboratory director on 8 /31/22 revealed the "Equipment Maintenance" procedure that stated "Principle: To have in place a schedule for Preventative Maintenance on an annual basis. Equipment: All laboratory equipment that is in use in the laboratory". On 12/12/22 at 12:00 p.m., the Histology Technologist stated she was unaware that the laboratory's periodic maintenance schedule for the microscope did not agree with the laboratory's "Equipment Maintenance" procedure. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) 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 -- (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, and interview with the Laboratory Manager, the laboratory failed to ensure quality control (QC) results for hematoxylin and eosin (H&E) stains were documented by Testing Personnel #A and acceptable before reporting patient results from 10/02/20- 12/12/22. The findings included: Record review of the "Quality Control Chart" logs for hematoxylin and eosin stain revealed no documentation to indicate if the control slides were reviewed by the acceptable or not acceptable for 372 days (10/02/20, 10/05/20, 10/07/20, 10/09/20, 10/12/20 - 10/15/20, 10/19/20, 10/21 /20, 10/23/20, 10/26/20, 10/28/20, 10/30/20, 11/02/20, 11/04/20, 11/06/20, 11/10/20 - 11/13/20, 11/16/20, 11/18/20, 11/20/20, 11/23/20, 11/25/20, 12/02/20, 12/04/20, 12/09 /20, 12/11/20, 12/16/20, 12/18/20, 12/22/20, 12/23/20, 12/30/20, 01/06/21, 01/08/21, 01/11/21, 01/13/21, 01/15/21, 01/18/21, 01/20/21, 01/22/21, 01/25/21, 01/27/21, 01/29 /21, 02/01/21, 02/03/21, 02/05/21, 02/08/21, 02/10/21, 02/12/21, 02/15/21 - 02/17/21, 02/22/21, 02/24/21, 02/26/21, 03/03/21 - 03/05/21, 03/10/21 - 03/12/21, 03/15/21, 03 /17/21, 03/19.21, 03/22/21, 03/24/21 - 03/26/21, 03/29/21, 03/31/21, 04/01/21, 04/02 /21, 04/05/21, 04/07/21, 04/09/21, 04/12/21, 04/14/21, 04/16/21, 04/19/21, 04/21/21, 04/23/21, 04/26/21, 04/28/21, 04/30/21, 05/03/21 - 05/07/21, 05/10/21, 05/12/21 - 05 /14/21, 05/17/21, 05/19/21 - 05/21/21, 05/24/21 - 05/28/21, 06/01/21, 06/02/21, 06/04 /21, 06/07/21 - 06/11/21, 06/14/21, 06/16/21, 06/18/21, 06/22/21, 06/24/21, 06/29/21, {06/31/21} sic, 07/07/21, 07/13/21, 07/15/21, 07/16/21, 07/20/21, 07/22/21, 07/23/21, 07/27/21, 07/30/21, 08/04/21, 09/14/21 - 09/17/21, 09/20/21 - 09/24/21, 09/27/21, 09 /28/21, 10/01/21, 10/04/21 - 10/08/21, 10/12/21, 10/14/21, 10/18/21 - 10/22/21, 10/25 /21 - 10/29/21, 11/01/21 - 11/05/21, 11/08/21 - 11/12/21, 11/15/21 - 11/19/21, 11/22 /21 - 11/24/21, 11/29/21, 11/30/21, 01/06/22, 01/07/22, 01/10/22 - 01/14/22, 01/17/22 - 01/21/22, 01/24/22 - 01/28/22, 01/31/22, 02/01/22 - 02/04/22, 02/07/22 - 02/11/22, 02/14/22 - 02/18/22, 02/21/22 - 02/25/22, 02/28/22, 03/01/22 - 03/04/22, 03/07/22 - 03 /11/22, 03/14/22 - 03/18/22, 03/21/22 - 03/25/22, 03/28/22 - 03/31/22, 4/05/22 - 04/08 /22, 04/11/2022, 04/12/2022, 04/14/2022, 04/15/2022, 04/21/2022, 04/22/2022, 04/25 /2022 - 04/29/2022, 05/02/22 - 05/06/22, 05/09/22 - 05/13/22, 05/16/22 - 05/20/22, 05 /23/22 - 05/27/22, 05/31/22, 06/01/22 - 06/03/22, 06/06/22 - 06/10/22, 06/13/2022 - 06 /17/22, 06/20/22, 06/21/22, 06/23/22, 06/24/22, 06/28/22, 06/30/22, 07/06/22, 07/07 /22, 07/26/22, 08/02/22, 08/04/22, 08/08/22 - 08/10/22, 08/12/22, 08/16/22 - 08/19/22, 08/22/22 - 08/26/22, 08/29/22 - 08/31/22, 09/01/22, 09/02/22, 09/06/22 - 09/09/22, 09 /12/22 - 09/16/22, 09/19/22 - 09/23/22, 09/26/22, 09/27/22, 10/10/22, 10/12/22 - 10/14 /22, 10/17/22 - 10/20/22, 10/24/22 - 10/28/22, 10/31/22, 11/01/22 - 11/04/22, 11/07 /22 - 11/11/22, 11/16/22 - 11/18/22, 11/21/22 - 11/23/22, 11/28/22 - 11/30/22, 12/01 /22, 12/02/2022, 12/05/22 - 12/09/22. Review of the laboratory procedure "MOH'S" (micrographically oriented histographic surgery) H&E ( hematoxylin and eosin) QC (quality control)/QA(quality assurance) revealed "A quality control slide is run on the H&E manual stainer each morning by a technician and the staining is checked for stain adequacy ...The pathologist each day will initial the Moh's H&E Staining QC worksheet." On 12/12/22 at 11:45 a.m., the Histology Technologist stated she completed the QC worksheet and did not know she was to give the QC worksheet to the pathologist. -- 2 of 2 --

Summary Statement of Deficiencies 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 interview with the Laboratory Manager the laboratory failed to document the humidity of the laboratory for 2 out 2 years (2017-2018) reviewed. Findings Included: Review of manufactures instructions for the automated slide stainer revealed that the humidity should not be greater than 80%. There was no documentation of humidity provided. During an interview on 11/13/18 at 1:00 PM the Laboratory Manager confirmed that the humidity had not been documented. 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 --