Tulsa Medical Laboratory, Llc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/08/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with business administration #1 and business administration #2 during an exit conference performed at the conclusion of the survey. 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 records and interview with business administration #1 and business administration #2, the laboratory failed to document the reactivity of the H&E (Hematoxylin and Eosin) stain each day of testing for one of six days of patient testing. Findings include: (1) On 03/08/2024 at 10:58 am, business administration #1 and business administration #2 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) The surveyor reviewed six patient records where patient slides, stained with H&E, had been microscopically reviewed. For one of six patients (test date was 12/02/2022), there was no evidence the reactivity of the stain had been observed for acceptability; (3) The surveyor reviewed the records with business administration #1 and business administration #2 who stated on 03/08/2024 at 12:30 pm, the reactivity of the stain had been observed during 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 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/14/2022. The findings were reviewed with the laboratory director at the conclusion of the survey. The laboratory was found in compliance with a standard-level deficiency cited. 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 observation and interview with the laboratory director, the laboratory failed to ensure that staining procedures were not performed with expired staining materials. Findings include: (1) On 02/14/2022 at 12:00 pm, the laboratory director stated the laboratory performed microscopic interpretations of histology specimens that had been stained with H&E (Hematoxylin & Eosin) stain; (2) On 02/14/2022 at 12:05 pm, the surveyor observed one coplin jar of 95% Alcohol (lot# 03418) with an expiration date of 01/31/2022 available for use; (3) The surveyor showed the coplin jar to the laboratory director, who stated to the surveyor on 02/14/2022 at 12:10 pm, the 95% Alcohol was not expired but that the label on the coplin jar had not been updated. 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 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/10/2020. The findings were reviewed with the practice manager and business coordinator at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on a review of patient histology slides and interview with the practice manager and business coordinator, the laboratory failed to ensure that patient histology slides were available for review during the survey for 8 of 40 patients. Findings include: (1) At the beginning of the survey, the practice manager stated: (a) The laboratory prepared frozen sections using the Leica CM1800 Cryostat. The slides were stained with H&E (Hematoxylin & Eosin), then reviewed microscopically by a pathologist; (b) The laboratory prepared cytological samples using the Touch Prep technique. The slides were stained with Diff Quik staining materials. (2) The surveyor requested patient histology slides for 40 patients with microscopic interpretations performed in 2018 and 2019. Slides could not be retrieved for 8 of 40 patients. The specific dates of service were 03/29/18, 04/03/18, 05/31/18, 06/19/18, 09/20/18, 11/02/18, 12/04/18, 06 /25/19; (3) The surveyor asked the practice manager and business coordinator to explain why the 10 patient slides could not be retrieved. The practice manager and business coordinator stated the slides were stored off-site and were not available for the survey. 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 -- 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 and interview with the laboratory director, the laboratory failed to have a written competency policy for the clinical consultant based on the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed personnel records for competency assessments performed during 2018 and to date in 2019. There was no evidence competencies had been performed for the clinical consultant based on their job responsibilities; (2) The surveyor asked the practice manager if a written policy to evaluate the positions based on job responsibilities was available and if competencies had been performed during the review period. The practice manager stated a policy to evaluate the clinical consultant based on job responsibilities had not been written; and competencies had not been performed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on an observation and interview with the practice manager and business coordinatory, the laboratory failed to ensure containers of staining materials had been labeled with lot numbers and expiration dates. Findings include: (1) At the beginning of the survey, the practice manager stated: (a) The laboratory prepared frozen sections using the Leica CM1800 Cryostat. The slides were stained with H&E (Hematoxylin & Eosin), then reviewed microscopically by a pathologist; (b) The laboratory prepared cytological samples using the Touch Prep technique. The slides were stained with Diff Quik staining materials (3 bottles - Fixative, Solution I, and Solution II). (2) Later during the survey, the surveyor observed the current staining materials with the practice manager and business coordinator. The following was identified: (a) The bottle containing the Hematoxylin stain and the bottle containing the Eosin stain were not labeled with the manufacturer's lot numbers and expiration dates; (b) The bottles containing the Diff Quik staining materials were not labeled with the manufacturer's lot numbers and expiration dates. (3) The surveyor explained to the practice manager and business coordinator that the bottles must be labeled with the lot numbers and expiration dates of the materials. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the laboratory practice manager, business coordinator, and clinical consultant #1 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 laboratory practice manager and the laboratory business coordinator, the laboratory failed to document the reaction of the staining control slides. Findings include: (1) At the beginning of the survey, the laboratory practice manager and the laboratory business coordinator stated to the surveyor the laboratory performed the following testing: (a) Microscopic interpretations of slides made from frozen tissue specimens - The tissue specimens were sectioned and the tissue placed on slides, fixed, stained with H & E (Hematoxylin and Eosin), dried, coverslipped, and examined microscopically for diagnosis; (b) Microscopic interpretations of slides made from touch prep specimens - Slides of touch preps from sentinel lymph nodes were fixed, stained with Diff Quik, dried, coverslipped and examined microscopically for a rapid assessment. (2) The laboratory practice manager and the laboratory business coordinator also stated to the surveyor a QC (Quality Control) slide was included in each batch of patient slides being stained, to monitor the acceptability of the staining process. At the time of the microscopic examination, the condition of the stain was documented on the patient test log by the pathologist who examined the slides as "S" for satisfactory or "U" if 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 -- unsatisfactory; (3) The surveyor then reviewed the patient testing log from 03/29/16 through 01/23/18. For 2 of the 21 patient specimens tested, there was no evidence the control slide had been observed and had stained appropriately: (a) Patient #11: Testing performed on 03/09/17 - Touch preps of 4 sentinel lymph nodes had been stained with Diff Quick. There was no indication on the log if the QC stain was satisfactory or unsatisfactory; (b) Patient #12: Testing performed on 03/16/17 - Touch preps of 4 sentinel lymph nodes had been stained with Diff Quick. There was no indication on the log if the QC stain was satisfactory or unsatisfactory. (4) The surveyor reviewed the records with the laboratory practice manager and the laboratory business coordinator, who agreed the pathologist performing the microscopic interpretation listed above had not documented the condition of the Diff Quick control slide. NOTE: D5601 was cited at the previous recertification survey performed on 02/05/16. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory practice manager and the laboratory business coordinator, the laboratory failed to ensure permanent testing records were maintained. Findings include: (1) At the beginning of the survey, the laboratory business coordinator stated to the surveyor the laboratory performed microscopic interpretations of slides made from surgical tissue specimens. The tissue specimens were frozen and sectioned using the Leica CM 1800 cryostat. The tissue was placed on slides, fixed, stained with H & E (Hematoxylin and Eosin), dried, coverslipped, and examined microscopically for diagnosis; (2) During the survey, the surveyor reviewed records for the cryostat from 04/01/16 through 01/23/18. The surveyor identified during 2 of the 22 months reviewed, the cryostat temperature and the laboratory humidity had been documented in pencil: (a) November 2016: Days 2 through 30 (b) December 2016: Days 1 through 30 (3) The surveyor reviewed the findings with the laboratory practice manager and the laboratory business coordinator who verified the records listed above included documentation made in pencil; (4) The surveyor explained to the laboratory practice manager and the laboratory business coordinator the use of pencil does not ensure permanence of documentation. The laboratory practice manager and the laboratory business coordinator agreed the laboratory failed to maintain permanent laboratory records when documentation was recorded in pencil. NOTE: The Interpretive Guidelines at 493.1283(a) states, "Corrections of laboratory results include the corrected result, incorrect result (noted as such), the date of the correction, and the initials of the person making the correction. Laboratory records should not be documented in pencil and the use of whiteout is not acceptable for making corrections." -- 2 of 2 --