Diagnostic Pathology Services At Integris

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/15/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the quality assurance specialist during an exit conference performed at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the QA (Quality Assurance) specialist, the laboratory failed to follow their written policy to assess the competency of the clinical consultant and technical supervisor, based on the position responsibilities as listed in Subpart M, for two of seven persons serving as clinical consultant and technical supervisor during the review period of April 2022 through the current date. Findings include: (1) On 02/15/2024 a review of the competency assessment policy identified competencies for the clinical consultant and technical supervisor, based on the position responsibilities were to be performed at least every two years; (2) A review of the Form CMS-209 and personnel records for competency assessments performed during the review period of April 2022 through the current date identified competencies, based on job responsibilities, had not been performed as follows: (a) Clinical Consultant #2/Technical Supervisor #2 - not documented as performed between April 2022 and the current date; (b) Clinical Consultant #3/Technical Supervisor #3 - not documented as performed prior to 02/14 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 -- /2024. (3) The findings were reviewed with the QA specialist who stated on 02/15 /2024 at 10:45 am, the competencies had not been performed for the positions as shown above. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the QA (Quality Assurance) specialist, the laboratory failed to verify the accuracy of slide interpretations at least twice annually during the review period of April 2022 through the current date. Findings include: (1) On 02/15/2024 at 10:45 am, the QA specialist stated the laboratory performed microscopic slide interpretations of H&E (Hematoxylin and Eosin) stained slides from frozen tissues. The tissue would then be observed microscopically; (2) A review of records for testing performed from April 2022 through the current date revealed no evidence the accuracy of slide interpretations had been verified at least twice annually after 08/01/2022; (3) The records were reviewed with the QA specialist who stated on 02/15/2024 at 10:45 am, the slide interpretations had not been verified for accuracy twice annually as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/03/19. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the regional quality manager at the conclusion of the survey. 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 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 a review of records, written policy, and interview with the regional quality manager, the laboratory failed to follow their policy for performing maintenance on the cryostat. Findings include: (1) At the beginning of the survey, the regional quality manager stated the laboratory prepared frozen sections using the Thermoscientific Microm HM 550 Cryostat. The sections were then reviewed microscopically; (2) The surveyor reviewed the policy for performing maintenance on the cryostat which stated the following maintenance be performed on the day of use: (a) "Clean the instrument" (b) "Apply a drop of oil to the plastic coupling and the micrometer" (c) "Lubricate the specimen cylinder" (3) The surveyor reviewed records and identified the cryostat had been used 3 days in October and November 2019 (10/29/19, 11/04/19, and 11/11/19; (4) The surveyor then reviewed cryostat maintenance records. There was no 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 -- documentation it had been cleaned on 3 of the 3 days; (5) The surveyor reviewed the records with the regional quality manager who stated the cryostat maintenance had not been documented as performed for the 3 days. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the QA coordinator at the conclusion of the survey. 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with the QA coordinator, the laboratory failed to document the reaction of the control slide(s) stained with each group of patient slides. Findings include: (1) At the beginning of the survey, the QA coordinator stated the laboratory performed microscopic interpretations of histology specimens using special stains (e.g., AFB (Acid Fast Bacteria), Giemsa, Alcian Blue 2.5, PAS (Periodic Acid Schiff), Iron, etc); (2) Later during the survey, the QA coordinator stated a positive control was performed for each special stain, and with each group of patient slides; (3) The surveyors reviewed 4 patient records when patient slides, stained with special stains, had been microscopically reviewed. For 1 of the 4 patients, there was no evidence the positive control had been observed, and had stained appropriately. The findings were as follows: (a) 03/29/17 - The AFB, Mucicarmine, and PAS stains had been used. (4) The surveyors reviewed the records with the QA coordinator, who stated the control slides had been observed by the pathologist performing the microscopic interpretation, but 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 --