Green Clinics Laboratory

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on February 24, 2026 at approximately 9:30 AM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified as follows: D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on facility policy/procedure review, facility document review, record review, and interview, the facility failed to document the reactions of histopathology quality control (QC) slides for immunohistochemical (IHC) and special stains each day of use for 19 of 19 patient reports reviewed. Findings included: A facility policy/procedure titled, "Standard Operating Procedure (SOP) IHC Staining Protocol," dated 04/26 /2016, revealed, "Section 4.8 Quality Control" revealed there was no procedure for documenting the reactions of the QC slides for IHC stains each day of use. A facility policy/procedure titled, "Standard Operating Procedure (SOP) Alcian Blue and PAS [Periodic Acid Schiff; a stain used to detect acid and neutral mucins] Staining Protocol," dated 04/18/2016, revealed there was no procedure for documenting the reactions of the QC slides for those stains for each day of use. A facility policy /procedure titled, "Standard Operating Procedure (SOP) Trichrome [a stain that uses three different dyes to detect muscle, collagen fibers, and cell nuclei] Staining Protocol for Connective Tissues," dated 04/19/2016, revealed there was no procedure for documenting the reactions of the QC slides for those stains for each day of use. A 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 -- facility policy/procedure titled, "Standard Operating Procedure (SOP) GMS [Grocott's Methenamine Silver; a special stain used to detect fungi] Staining Protocol," dated 04 /25/2016, revealed there was no procedure for documenting the reactions of the QC slides for those stains for each day of use. "Quality Control: Special Stains" documentation logs for "Grocott's Methenamine Silver," "Trichrome," and "Alcian Blue PAS [AB/PAS]" stains revealed the reactions of the QC slides were not being documented for each day of use. The documentation revealed a page for each stain with entries for "1/2026" and "2/2026." Patient reports special stains and/or IHC stains were used to render a diagnosis on the dates indicated, but there was no QC documentation for the day of use slides for the following: - Patient #1- Reported 05/05 /2025- IHC - Patient #2- Reported 05/12/2025- IHC, AB/PAS, Trichrome - Patient #3- Reported 06/10/2025- IHC, AB/PAS - Patient #4- Reported 06/10/2025- IHC - Patient #5- Reported 07/03/2025- IHC - Patient #6- Reported 07/13/2025- IHC, AB /PAS - Patient #7- Reported 08/10/2025- IHC, Trichrome - Patient #8- Reported 08/27 /2025- IHC - Patient #9- Reported 09/16/2025- IHC, AB/PAS - Patient #10- Reported 09/17/2025- GMS - Patient #11- Reported 09/23/2025- IHC - Patient #12- Reported 10 /06/2025- IHC, AB/PAS - Patient #17- Reported 10/28/2025- GMS - Patient #13- Reported 11/06/2025- GMS - Patient #14- Reported 11/11/2025- IHC - Patient #15- Reported 12/04/2025- IHC - Patient #16- Reported 12/08/2025-GMS - Patient #19- Reported 01/13/2026- GMS - Patient #18- Reported 02/17/2026- IHC, AB/PAS During an interview on 02/24/2026 at 11:10 AM, Technical Supervisor (TS) #1 stated that in the past, the reactions for the QC slides were documented each day of use, but currently, only an entry made to indicate the QC slides were acceptable for the entire month. TS #1 further stated that if a special stain was ordered, there was a QC slide prepared, and she read it first to assess the stain quality and then initialed the slide to indicate the slide was reviewed and found to be acceptable. She stated that the Laboratory Director (LD) then reviewed the QC slide and initialed the slide to indicate the stain was acceptable. In regard to the process for documenting the review of the QC slides for the IHC stains, TS #1 stated that a positive and negative control was ran each day of use for IHC stains, and she and the LD documented their acceptance of the stain quality by initialing the slides. TS #1 stated that a documentation log was not kept of the reactions of the IHC stains for each day. During an interview on 02/24/2026 at 2:20 PM, the LD stated that daily documentation in a log was not being completed for each day of use and stated that he thought initialing the slides was an acceptable form of documentation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on April 16, 2025, at approximately 10:00 AM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified as follows: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on interview and document and policy review, the laboratory did not enroll in a CLIA-approved proficiency testing (PT) program in the areas of Mycology and Bacteriology. This was noted for 2 of 4 areas of molecular tests reviewed. Findings included: A laboratory standard policy and procedures titled, "Verification of Performance Specifications," dated 01/17/2018, revealed the following statement regarding proficiency testing enrollment: "If the test(s) are new to the laboratory test menu and are listed as regulated by CLIA, the laboratory must enroll in an approved proficiency testing program." A "Nail Fungal Validation Report" revealed the laboratory validated a molecular assay for the detection and identification of fungus in nail specimens under the area of Mycology on 10/26/2023. A "UTI [urinary tract infection] Validation Report" revealed the laboratory validated a molecular assay for the detection and identification of organisms in urine specimens causing UTI in the 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 -- areas of Bacteriology and Mycology on 12/05/2023. A CMS-116 form and CMS-116 attachments, signed by the Laboratory Director (LD) on 04/16/2025, revealed Nail Fungus and UTI Panels were used for patient testing. During an interview on 04/16 /2025 at 2:20 PM, Technical Supervisor #5 confirmed the laboratory was not enrolled in PT for nail fungus testing (Mycology) or UTI panel (Bacteriology) and she could not find an appropriate PT. During an interview on 04/16/2025 at 2:50 PM, the LD confirmed the laboratory was not enrolled in a CLIA-approved PT for the Nail Fungus or UTI Panel assays. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of 20 laboratory policies and procedures and interviews with the Laboratory Director/Technical Supervisor, the laboratory failed to ensure that 20 of 20 written procedures were approved, signed and dated by the Laboratory Director. Findings include: 1. The Laboratory Director failed to sign and date 20 of 20 laboratory procedures. Procedures include: - Instructions for Submitting Fine Needle Aspiration Cytology Specimens - Instructions for Submitting Urologic Cytology Specimens - Specimen Acceptance and Rejection - Quick/Full Accessioning Protocol - Reference Lab Protocol - FNA Adequacy Protocol - ThinPrep 2000 Non-Gyn - Cytology Slides and Blocks Retention - Papanicolaou Stain - Centrifuge Operation /Cleaning and Maintenance - Cytology Records and Reports - Cytology Workload - Pathologist - Post Analytic Quality Assurance - Pre-Analytic Daily QA - Verification of Performance Specifications - Procedure of Creation, Review and Approval of Standard Operation Procedures - Quality Assurance and Quality Management - Quarterly Statistical Laboratory Evaluation - Standard Operating Procedure (SOP) CellSolutions F50 Non-Gyn Protocol 2. During interviews on February 5, 2024 at 10: 45 AM and 1:00 PM, these findings were confirmed by the Laboratory Director /Technical Supervisor. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. 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 --