Histopath Inc

Summary Statement of Deficiencies 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 upon review of the policies and procedures, review of personnel files and interview of facility personnel, the laboratory failed to have a written policy to assess the competency of the five testing personnel performing Histopathology procedures in 2023 and 2024. The findings included: 1. Review of the policies and procedures found in the purple notebook found no policy for assessing the competency of testing personnel performing histopathology procedures. 2. Review of personnel files found no documentation of competency assessments performed in 2023 or 2024 for the five testing personnel performing histopathology procedures. 3. During interview of the practice manager conducted on December 12, 2024 at 12:37 PM, she confirmed there were no competency assessments available for review for the five pathologists performing histopathology procedures. 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 upon review of policies and procedures and interview of facility personnel, the laboratory failed to ensure 13 of 13 policies and procedures were approved, signed 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 -- and dated by the current laboratory director. The findings included: 1. Review of the 13 policies and procedures included in the purple notebook found 13 procedures. Review of these procedures found no documentation available that the current laboratory director had approved these procedures for use. 2. During interview of the Histotechnologist conducted December 12, 2024 at 9:36 AM, she confirmed the laboratory director had not approved, signed and dated the procedures in use since becoming the laboratory director on October 1, 2024. 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 upon review of patient reports and interview of facility personnel the laboratory failed to include the location of the laboratory where tests were performed in five of five histopathology final reports reviewed. The findings included: 1. Review of five final patient reports found the laboratory used a post office box as the address with no location of the laboratory where testing was performed. 2. During interview of the practice manager conducted December 12, 2024 at 1:13 PM, she confirmed that the laboratory did not include the location of the laboratory where testing was performed on the final reports. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation and confirmed in interview with laboratory personnel, the laboratory failed to ensure 1 of 7 expired inks used for grossing was not available for patient use on December 12, 2022, the day of the inspection. The findings included: 1. Surveyor observation in the Pathology Frozen Room in the cabinet above the microscope on December 12, 2022 at 10:30 hours found the following expired ink was available for use in specimen grossing: Tissue Marking Dye (Violet) Lot Number: 9205 Expiration Date: 07-31-2021 (499 days past its expiration date) 2. Interview with testing personnel #2 (as listed on Form CMS 209) at 10:30 hours in the Pathology Frozen Room confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policies, review of patient records, and confirmed in interview of laboratory personnel, the laboratory failed to follow its own policy to ensure 7 of 15 frozen section results reviewed from October 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 -- 2021, November 2021, and December 2022 were documented on the requisition slip. The findings included: 1. Surveyor observation on December 12, 2022 in the conference room found 8 frozen section requisitions from December 2022 that had hand written grossing results on the back of the requisitions. 2. Review of the laboratory's "Frozen Section" policy approved by the laboratory director under, "Additional Information," it stated, "...Frozen section diagnosis are made a permanent record in the surgical pathology report and it is documented on the requisition slip." 3. Random review of patient records from October 2021, November 2021, and December 2022 found no record of a frozen section requisition that had frozen section results written on the back. Further, the backs of the requisitions were not scanned electronically into the patient record. The following patient cases had no documentation of frozen section diagnoses on a requisition slip: October 2021: ST-21- 03573 ST-21-03601 ST-21-03607 ST-21-03615 November 2021: ST-21-03741 ST-21- 03805 ST-21-03905 4. The findings were confirmed in interview with the Practice Manager and Testing Personnel #2 (as listed on Form CMS 209) on December 12, 2022 at 13:30 hours in the conference room. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --