Palmetto Digestive Disease, Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palmetto Digestive Health Specialists on 05/22/2024 by the South Carolina Department of Environmental Control (SCDHEC). The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The facility was found to be out of compliance with the standards of the CLIA program. The following STANDARD LEVEL DEFICIENCES were found to be out of compliance: 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: During an onsite recertification survey on 05/22/2024, based on testing personnel record review (CMS 209), and testing personnel interview, the laboratory failed to assess the competency of one of two testing personnel (TP) for 2023 and 2024. Findings included: 1. A review of CMS 209 laboratory personnel report form listed two testing personnel. 2. Review of testing personnel's files revealed that TP1 performs high complexity histology testing did not have competency evaluations performed for 2023 and 2024. 3. In an interview on 05/22/2024 at 11:30 am, with testing personnel in the office confirmed the above findings. 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 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 -- 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 direct observation, lack of documentation, and testing personnel interview, the laboratory failed to define, monitor, and document storage conditions including temperature for the storage room where reagents are kept. 3 of 3 gallons stored in storage room. Findings included: 1. During a tour of the storage room 05/22/2023 at 11:45 am, the surveyor observed that there was no thermometer in the storage room where additional reagents are kept. 2. A review of the manufacturer's instructions label on the jug revealed temperatures requirements of 15 C to 30 C. a. Tissue-Tek Genie Wash Buffer Solution Lot # 8874A33923 3. In an interview on 05/22/2023 at 11:45 am in the storage room, testing personnel confirmed no thermometer was in storage room. Key Celsius = C 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 instrument instruction manual review, instrument maintenance record review, and testing personnel interview, it was determined that the laboratory failed to document weekly and bi-annual maintenance on robotic cover slipper and automatic slide stainer for a random 4 of 4 weeks reviewed, January 2024. Findings included: 1. Reviewed instructions manual for the Lecia CV 5030, robotic cover slipper page (pg.) 33, cleaning maintenance, shows three actions need to be performed for weekly maintenance and one action bi-annually. 2. A review of Palmetto Digestive cleaning log, lack documentation of weekly and bi-annually maintenance for Lecia CV 5030, robotic cover slipper for 4 of 4 weeks for January 2024. 3. A review of Tissue-Tek DRS 2000 automatic slide stainer's operating manual, section 6, pg. 6.1, revealed bi- monthly and monthly maintenance are to be performed. 4. A review of environmental records titled "Palmetto Digestive processor: Leica", revealed lack of documentation for bi-monthly and monthly maintenance for automatic slide stainer. 4 out of 4 weeks for January 2024. 5. In an interview on 05/22/2024 at 11:30 am with testing personnel in the office, the above findings were confirmed. 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. (f) The laboratory must document all control procedures performed, as specified in this section. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of patient reports, review of policy and procedures, review of quality assurance records, and staff interview, the laboratory failed to document positive and negative reactivity for a random 2 of 2 patient's reports documenting special stained slides. Findings included: 1. During a review of records on 05/22/2024 at 11:30 am, the surveyor observed that special stains were reported on patients results: a. Patient, Accession #S24-02524, under microscopic description, "(A) Special Stain (Immunoperoxidase)" CD3 was performed. And Special Stain (Histochemical) Masson Trichrome for Collagen. There was no documentation of acceptable positive and negative reactivity. b. Patient, Accession #S24-02543, under microscopic description, (B) Special Stains (Histochemical) DIFFQUICK was performed. And (C) Special Stains (Histochemical) Alcian Blue-PAS. There was no documentation of acceptable positive and negative reactivity. 2. Review of the laboratory's quality assurance records revealed no documentation of reactions for the control slides for immunoperoxidase, nor histochemical special stains. 3. Review of the laboratory's policy and procedure titled "Immunohistochemical Stains" on 05/22/2024 under section IV. Quality Control, "1. A qualified trained technician, evaluates the slide for staining quality records the results prior to sending to the requesting pathologist." Policy and procedure do not state to record the reactivity. 4. Review of daily H&E, Special Stain and IHC Quality Assessment records revealed a check mark. There was no documentation of acceptable positive and negative reactivity for special stains for 13 out of 13 months reviewed. 5. During an interview on 05/22/2024 at 11:30 am, in the office, testing personnel confirmed the above findings. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on records review (CMS 209), and staff interviewed, the technical supervisor (TS) of the laboratory failed to evaluate the capabilities of the testing personnel. Refer to D5209 Findings included: 1. Review of the CMS 209 Laboratory Personnel Report revealed one technical supervisor listed. 2. Review of personnel records, revealed the following: a. TP 1 lack competency records for 2023 and 2024. b. TP 2 competency records a. Titled "Special Stain Procedures-Competency Testing" Dated January 17, 2024 Signed by TP1 b. Titled "Gross Specimen Processing Procedure-Competency Testing" Dated January 20th, 2024 Signed by TP1 c. "General laboratory Procedures- Competency Testing" Dated January 17th, 2024 Signed by TP1 3. In an interview 05 /22/2024 at 11:30 am in the office with TP 1, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 06/08/2023 and concluded on 06/08/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with one deficiency cited. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on interview and document review, it was determined the facility failed to ensure the name and address of the laboratory location where the test was performed was on the test report for 1 of 5 reports reviewed. Interviews revealed the specimens were sent to a pathologist at another laboratory for examination and that specimens may be sent to another laboratory if special stains were required. Review of the laboratory report revealed it did not reflect the actual name and address of the laboratory locations where these procedures were performed. Findings included: In an interview at 11:00 AM on 06/08/2023, Testing Personnel (TP) stated the slides she prepared were sent to a pathologist at another location to be read. If special stains were requested, the specimens were sent to another laboratory. In an interview with the Laboratory Director (LD) at 11:20 AM on 06/08/2023, he stated he performed the interpretation of the slides at another laboratory and if special stains were required, the specimens were sent to a second certified laboratory. Review of the laboratory report 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 -- format revealed special stains for immunohistochemistry were not performed at the laboratory; however, they were indicated as being performed at the facility on the laboratory report. The report also included a statement that the technical component and the interpretation were performed at the laboratory. Only the technical component of the test was performed at the laboratory. However, the interpretation was performed at another location. In an interview with the TP and the Office Manager (OM) on 06/08/2023 at 12:10 PM, they were shown the sample report. They stated that the facility was listed as the testing location for all tests on all reports issued by the laboratory, even though other testing sites were utilized. -- 2 of 2 --