Pathology Services Of Texarkana

Summary Statement of Deficiencies D0000 An onsite survey conducted 10/25/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5621 CYTOLOGY CFR(s): 493.1274(c)(1) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (1) A review of slides from at least 10 percent of the gynecologic cases interpreted by individuals qualified under 493.1469 or 493.1483, to be negative for epithelial cell abnormalities and other malignant neoplasms (as defined in paragraph (e)(1) of this section). (c)(1)(i) The review must be performed by an individual who meets one of the following qualifications: (c)(1)(i)(A) A technical supervisor qualified under 493. 1449(b) or (k). (c)(1)(i)(B) A cytology general supervisor qualified under 493.1469. (c)(1)(i)(C) A cytotechnologist qualified under 493.1483 who has the experience specified in 493.1469(b)(2). (c)(1)(ii) Cases must be randomly selected from the total caseload and include negatives and those from patients or groups of patients that are identified as having a higher than average probability of developing cervical cancer based on available patient information. (c)(1)(iii) The review of those cases selected must be completed before reporting patient results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) personnel form 209, laboratory workload reports, laboratory documents, and confirmed in interview, the laboratory failed to include a 10% negative rescreen for one of two cytotechnologists performing gynecologic cytology interpretations from April to September 2022. The findings include: 1. Review of the CMS personnel form 209 had the following testing persons (TP) qualified to perform gynecologic cytology (CT) screenings: CT/TP 1 CT/TP 2 2. Review of the laboratory policy titled "Quality 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 -- Control Negative Case Review Procedure" stated the following: "Upon completion of a batch cases, the cytotechnologist will have a minimum of 10% of negative cases pulled." 3. Review of laboratory documents from April to September 2022 did not include a 10% negative review, before patient test results are released, for CT/TP 2. Surveyor queried on 10/25/2022 at 10:50 in the laboratory office for documentation of a negative rescreen review for CT/TP 2, and none was provided. 4. Review of workload reports for CT/TP 2 had the following 124 total negative cases read from April to September 2022: Month : Negative Cases April: 26 May: 15 June: 14 July: 42 August: 21 September: 6 5. In an interview on 10/25/2022 at 11:00, in the office, the laboratory manager and CT/TP1 confirmed that a 10% negative rescreen for CT/TP 2 had not been performed. -- 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 of facility personnel, the laboratory failed to ensure expired items were not available for testing. The findings included: 1. Surveyor observation made on November 30, 2021 at 09:30 hours during the initial tour of the laboratory found the following expired items: a. Hema-Diff Xanthene (1 bottle) Lot 098285 Expiration date: 10-31-2021 b. Isopropyl Alcohol (4 gallons) Lot 088926 Expiration date: 09-03-2021 c. Isopropyl Alcohol (1 gallon) Lot 067176 Expiration date: 06-30-2021 d. Methanol (3 gallons) Lot 54887 Expiration date: 10-31-2021 2. An interview with cytotechnologist 1 (as listed on Form CMS- 209) on November 30, 2021 at 10:20 hours in the laboratory confirmed the findings. She agreed the items were expired and said most of them were not in use. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory quality control records, review of patient reports, and confirmed in interview, the laboratory failed to document the stain quality of known positive and negative reactivity with each patient slide or group of patient slides when assessing the professional component of ten of ten immunohistochemical stains (IHC) reviewed: Ki-67 CKC S-100 SOX-10 CK7 P53 P504s P16 P63 CK 5/6 The findings included: 1. Random review of patient records from November 2021 found four of eleven reports with professional interpretation for the following special immunohistochemical stains (IHC): Ki-67 CKC S-100 SOX-10 CK7 P53 P504s P16 P63 CK 5/6 2. Review of the quality control records from November 1, 2021 to November 30, 2021 found no documentation of the stain quality of known negative reactivity of the above stains. 3. An interview with histotechnologist 1 (as listed on Form CMS-209) on November 30, 2021 at 11:15 hours in the office confirmed the findings. She confirmed that the laboratory only documents the positive control. -- 2 of 2 --

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, review of laboratory records and interview it was determined that the laboratory failed to ensure adequate ventilation of the cytology laboratory. Findings include: 1. During the course of the survey the Survey Team detected a strong chemical odor in the laboratory. 2. On 01/06/2020 the Survey Team observed the cytology preparation technician using open containers of xylene and permount to coverslip cytology slide preparations with no equipment to properly ventilate the area. 3. On 01/06/2020 the Survey Team observed cytology slides being stained on the Sakura automated stainer machine. a. The laboratory "SAFETY MANUAL" stated that the Sakura automated stainer machine activated charcoal filter used to remove hazardous fumes, which are generated from the reagents in the staining unit, is to be "changed every three months." b. The survey team requested the Sakura automated stainer machine records indicating the changing of the charcoal filter. c. During an interview on 01/06/2020 at 2:30 PM the histotechnician stated that there "were no records to indicate the filter had been changed" in 2018, 2019 or to the date of the survey in 2020. 4. During an interview on 01/08/2020 at 9:15 AM the Laboratory Director/Technical Supervisor confirmed these findings. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on interview and review of laboratory records it was determined that the laboratory failed to observe the safety procedures established to ensure protection from chemical fume hazards. Cross Refer to D3001 Findings Include: 1. During an interview on 01/07/2020 at 10:15 AM the histotechnician stated that "the laboratory performed xylene and formaldehyde vapor exposure badge tests." a. The laboratory procedure titled 'FORMALDEHYDE PRECAUTIONS' stated when "Occupational Safety and Health Administration (OSHA) permissible exposure limits , 0.75 parts per million (ppm) during an 8 hour period, and short term exposure limits, 2.0 ppm in a 15 minute period, are exceeded, monitoring will be conducted at a 6 month and annual basis." b. The Survey Team reviewed the formaldehyde vapor exposure badge test results from 2018 for the histotechnician. Formaldehyde test badge results for the histotechnician from 07/22/2018 indicated a 15 minute period result of 2.2 ppm. This result exceeded the permissible exposure limit for formaldehyde of 2.0 ppm. c. The Survey Team reviewed the xylene vapor exposure badge test results from 2018 for the histotechnician. Xylene test badge results for the histotechnician from 07/06/2018 indicated a 15 minute period result of "> 300 ppm". This result exceeded the permissible exposure limit for xylene (National Institute for Occupational Health and Safety 15 minute permissible exposure limit for xylene is 150 ppm). 2. The Survey Team requested xylene and formaldehyde vapor badge test results subsequent to the 2018 results. a. During an interview on 01/07/2020 at 3:15 PM the Laboratory Director /Technical Supervisor stated "there was no testing performed following the 2018 testing period." D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, specimen slides and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that the number of slides prepared was accurately reported. The laboratory failed to document the number of specimen slides for three of three random gynecologic specimens diagnosed as unsatisfactory for diagnosis between June 17, 2019 and July 3, 2019. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that the total number of slides prepared was accurately documented for each specimen. 2. The Survey Team reviewed three of three gynecologic final test reports with a diagnosis of unsatisfactory for interpretation and the corresponding slides between June 17, 2019 and July 3, 2019. The Survey Team observed that the final reports provided by the laboratory failed to document the actual number of slides prepared. Case reports include: -19-003432-PP Final Report: NUMBER OF SLIDES: 1 Actual Number of slides: 2 -19-003393-PP Final Report: NUMBER OF SLIDES: 1 Actual Number of slides: 2 -19-003793-PP Final Report: NUMBER OF SLIDES: 1 Actual Number of slides: 2 3. During and interview on 01/08/2020 at 9:15 AM the Laboratory Director/Technical Supervisor confirmed these findings. -- 2 of 5 -- D5625 CYTOLOGY CFR(s): 493.1274(c)(3) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and review of gynecologic specimen slides it was determined that the laboratory failed to follow written policies and procedures to identify more significant lesions on prior negative specimens from new specimens with High-Grade Intraepithelial Lesions (HSIL). The laboratory failed to identify two of twelve prior negative specimens as having a more significant lesion than initially reported. Findings include: 1. The laboratory failed to follow the procedure "QC REVIEW OF PRIOR NEGATIVE CASES", which stated: "Each patient diagnosed with a new high grade intraepithelial lesion or cancer has all negative gynecologic slides received by the laboratory within the previous 5 years reviewed if available in the laboratory. Documentation of the fact that the review occurred is made using the form entitled QA Review of Prior Negative Cases. Specific discrepancies are documented on this form and it is signed by all reviewers." 2. The Survey Team reviewed twelve prior negative specimens from nine new HSIL's from October 2016 through November 2019. a. The Laboratory Director/Technical Supervisor confirmed on 01/18/2020 that the laboratory did not identify two of twelve prior negative specimens as having a more significant lesion than was originally reported. Prior Negative Cases Include: -18-5607-PP -17-4493-PP D5631 CYTOLOGY CFR(s): 493.1274(c)(6) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation, and, if appropriate,