Gut Pathology Llc

Summary Statement of Deficiencies 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 reviews of the Sakura Tissue Tek DRS Autostainer manual, the humidity logs in the Pathology lab, the patient logs and an interview with the Laboratory Director (LD) and the General Supervisor (GS), the laboratory failed to ensure environmental parameters specified on the log aligned with the manufacturer's operational requirements in the room where the Sakura Tissue Tek DRS Autostainer was utilized for patient testing. The surveyor noted the humidity recorded were below the manufacturer's established limits of 30-85 percent for 40 days out of the 61 days reviewed in March 2024 and April 2025. The findings include: 1. A review of the Sakura Tissue Tek DRS Autostainer manual revealed on page 13 the operational humidity requirements of 30-85 percent. However, the laboratory's humidity logs specified an acceptable humidity range of 20-60 percent. 2. Due to an inaccurate acceptable range on the log, the Sakura Tissue Tek DRS Autostainer was utilized 18 days in March 2024 and 22 days in April 2025 when the humidity was below the manufacturer's required environmental specifications without documentation of

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records (Daily Accuracy of Histology Stain, Slide Labeling and Data Entry logs), a review of the policies and procedures, and an interview with the Laboratory Director (the only testing personnel for Histopathology), the surveyor determined the Laboratory Director (Testing Personnel) failed to ensure the reactions and characteristics (quality) of the pathology slides were documented each day of patient slide interpretations. This affected the survey review period, November 2017 - July 24, 2019. The findings include: 1. A review of the "Daily Accuracy of Histology Stain, Slide Labeling and Data Entry" (quality control) records for 2017, 2018 and 2019, revealed the testing personnel failed to document the reactions and characteristics of the pathology slides for the survey review period of November 2017 - July 2019. The form included columns for slide quality and stain; however the columns were left blank for the time-frame previously mentioned. 2. During an interview on July 29, 2019 at 11:23 AM, the surveyor asked the Laboratory Director if the slide and stain adequacy were monitored for the Histopathology slides. The Laboratory Director stated the accuracy of the slides was documented in the manual with the documents of daily accuracy of Histology. When the surveyor stated she was unable to see this documented, the Laboratory Director reviewed the manual and the logs, and confirmed the missing documentation, stating it appeared she failed to document the accuracy for quite some time. The Laboratory Director further stated she reviewed each slide daily, but failed to document the evaluations. 3. Further 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 -- review of the quality control logs revealed the Laboratory Director (Testing Personnel) did not document the slide/staining accuracy from November 2017 - July 24, 2019. 4. The surveyor inquired of the Laboratory Director the policy for the quality control of the slides. The Laboratory Director stated the policy was in the QA (Quality Assurance) Manual. The Laboratory Director reviewed the policy and stated the slide quality is evaluated daily by the reading pathologist. The policy further indicated the slide quality encompassed embedding, microtomy and staining of slides. . D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the "Accuracy and Quality of Final Diagnosis Performance Improvement Indicator" records for May 2017 - July 25, 2019, a review of the policy and procedure for pathologist competency, and an interview with the Laboratory Director [Testing Personnel (TP) #1] and TP #2, the surveyor determined the Laboratory Director failed to ensure quality assessments were done to effectively identify any problems in slide peer reviews to assure