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Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory written procedure and interview with the laboratory director (LD), the LD failed to ensure that the lab was enrolled in a proficiency testing (PT) for performing diagnostic death testing when reviewing patient tissue on prepared slides. The LD confirmed on the day of the survey July 10, 2025, at 1:00 PM that PT was not performed for diagnostic death testing when reviewing patient tissue on prepared slides. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. 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 review of laboratory written procedure, patient slides, tissue cassettes, a sample jar, and interview with the lab director (LD) who is the testing person, the LD failed to document all pertinent information required for specimen identification and integrity and failed to document the slide acceptability nor slide rejection once slides were received in the lab. Findings: 1. Review of 65 patient slides prepared during the year 2025, 65 tissue cassettes, and a specimen container on July 10, 2025, at 12 Noon showed that the slides, cassette, and container were labeled with a case number and the patient initials. 2. The LD stated on the day of the survey July 10, 2025, at 12 Noon that he uses two identifiers when labelling the tissue cassettes and specimen containers. When prepared slides are returned to the lab, the slides are labelled with the same identifiers. 3. The "Autopsy Procedure Standard Operating Procedure" states "using a permanent marker label specimen containers on the lid of the container and the front of the container with the decedent's case number and initials". The "Autopsy Procedure Standard Operating Procedure" states to "label cassettes twice on the top and side with the case number and the decedent's initials". 4. The "Specimen Receipt and Labeling Requirement" procedure states "The requisition and the specimens are assigned a unique identification number" 5. The LD failed to document the slide and stain appearance of slides when received in the lab, which includes the slide acceptability or rejection. 6. The "Specimen Rejection" procedure states "the policy lists the specimen rejection criteria and handling of specimens that are received in suboptimal condition" 7. The LD confirmed on the day of the survey July 10, 2025, at 12 Noon, that the lab failed to document all pertinent information required for specimen identification and integrity and failed to document the slide acceptability nor slide rejection once slides were received in the lab. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) (e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on review of the laboratory written procedure and interview with the laboratory director (LD), the LD failed to discontinue procedures for testing that were no longer performed in the lab. Finding: 1. The LD stated on the day of the survey July 10, 2025, at 11:30 AM that tissue processing was no longer performed in the lab. 2. The LD failed to discontinue the "Cryostat Maintenance and Decontamination" and the "Embedding Center" procedures. 3. The LD confirmed on the day of the survey July 10, 2025, at 11:30 AM that the lab failed to discontinued procedures for testing that was no longer being performed in the lab. 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 -- 2 of 5 -- interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory written procedure, observation of the lab and mobile van on July 10, 2025, at 2:30 PM, and interview with the laboratory director (LD), the LD failed to monitor exposure, store, and label lab reagents used during tissue collection according to the written procedure and the manufacturer's instructions. Findings: 1. The lab uses Formalin Formaldehyde solution for fixation and preservation of human tissue for transport and storage. 2. Observation of the lab on July 10, 2025, at 2:30 PM showed the lab had a fireproof cabinet that did not have the Formalin Formaldehyde solution stored inside. 3. The LD stated on the day of the survey July 10, 2025, at 2:30 PM that the Formalin Formaldehyde solution was in his van that is used for transporting deceased human bodies that require autopsy. 4. The Formalin Formaldehyde solution was in the original container inside a non labeled plastic blue tub covered with a lid inside the back of the van. 5. The "Formaldehyde Policy" states that "Formaldehyde is stored in closed containers in well ventilated areas." 6. The "Formaldehyde Policy" states "that all designated areas where formaldehyde and formalin solutions are stored will have a sign posted that states danger and hazardous." 7. The "Formaldehyde Policy" states that persons who handles Formaldehyde must have exposure monitoring conducted biannually and the level must not exceed 0.5 ppm. 8. The LD confirmed on the day of the survey July 10, 2025, at 2:30 PM that the lab failed to monitor exposure, store, and label lab reagents used during tissue collection according to the written procedure and the manufacturer's instructions. D5787 TEST RECORDS CFR(s): 493.1283(a) (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 review of the laboratory written procedure, patient records, and interview with the lab director (LD) who is the testing person, the LD failed to maintain all pertinent specimen records and information once specimens were received in the lab. Findings: 1. The lab reviews slides prepared and stained by a local hospital to determine the cause of death. 2. The lab had one gray slide box containing 12 patient slides, one gray slide box containing 43 patient slides, one white box containing 10 patient slides, and 28 loose slides on a slide holder on a shelf near the microscope. The LD stated that all the slides were different patient cases. 3. The LD stated on the day of the survey July 10, 2025, at 11:30 AM that each gray box contained slides from five different patient cases from the year 2025 that he is still working on. They were incomplete with no diagnosis, and he received the prepared slides from the hospital two weeks ago. 4. The LD stated on the day of the survey July 10, 2025, at 11:30 AM that the white box contained a case from 2024 and that the case was completed and was not filed. 5. The LD failed to maintain the "Reference Histology Work Request" -- 3 of 5 -- record that was contained in the gray box and the white box with the slides documenting the location where the slides were prepared, who prepared the slides, the type of stain used to prepare the slides, the number of slides contained in the box, embedding information, section information, block check, QC check, nor did the LD document the date and time that the sides were received in the lab. 6. The LD stated on the day of the survey July 10, 2025, at 11:30 AM that once the slides are received in the lab the "Reference Histology Work Request" record is thrown away. 7. Review of the "Autopsy Procedure Standard Operating Procedure" on July 10, 2025, at 11:30 AM states that "Specimens received from the hospital are checked for case file identifiers and placed in the pending case area. 8. The LD stated on July 10, 2025, at 11:30 AM that the 28 loose slides were from a historical brain case he completed on 2 /5/2023. They were mailed back to him from a hospital in Virginia two months ago. 9. The LD failed to maintain the record that came with the slides that showed the slide information, slide identification, nor did the LD document the date and time the slides were received in the lab. 10. The LD confirmed on the day of the survey July 10, 2025, at 11:30 AM that the lab failed to maintain all pertinent specimen records and information once specimens were received in the lab. D5805 TEST REPORT CFR(s): 493.1291(c) (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 on review of the written procedure manual, patient final reports, and interview with the laboratory director (LD), the LD failed to include the complete name and address where testing was performed. Findings: 1. Review of two patient final reports from the year 2025, two patient final reports from the year 2024, and two patient final reports from the year 2023 on the day of the survey July 10, 2025 at 1:00 PM showed that the final reports did not include the complete name and address where the slides diagnostic review was performed nor did the final reports include the complete name and address where the patient tissue technical component was performed. 2. The LD confirmed on the day of the survey July 10, 2025, at 1:00 PM that the lab failed to include the complete name and address where testing was performed. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory written procedure and interview with the laboratory director (LD), the LD failed to ensure that the lab was enrolled in a proficiency testing -- 4 of 5 -- program for performing diagnostic death testing when reviewing patient tissue on prepared slides. Findings: Refer to D2000 -- 5 of 5 --

Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of patient final reports and interview with the laboratory director (LD), The LD failed to ensure that patient reports were corrected in a timely manner prior to release of test results. Findings: 1.The laboratory performs Pathology reviews of patient slides to confirm diagnosis. 2.Review of six patient final reports showed that two of the six reports had errors that were not noticed until the day of the survey. 3.Review of Patient A final report showed that the specimen was received on July 14, 2021. The slide review was performed on 7/14/21 and test results were reported on 7 /19/21. Review of the patient electronic medical record showed that the patient's last name was spelled incorrect on the final report. 4.The LD stated that he was unaware that the last name was spelled incorrect on the report prior to the day of the survey. The LD performed a corrected report with the correct spelling of Patient A last name on the day of the survey. 5.Review of Patient B final report showed that the specimen was received on July 12, 2021. The slide review was performed on 7/ 6/2021 and the test results were reported on 7/6/2021. Review of the patient electronic medical record showed that the report date was 7/12/2021 and the receive date was 7/6/2021. 6.The LD stated that he was unaware that the receive and the report dates were incorrect on the report prior to the day of the survey. The LD performed a corrected report of the 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 -- receive date and the report date on Patient B final report on the day of the survey. 7. The LD confirmed that he failed to ensure that patient reports were corrected in a timely manner prior to release of test results on the day of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: A. Based on review of laboratory records and interview with the laboratory director (LD), the LD failed to maintain all required COVID-19 proficiency testing (PT) records when PT was performed. Findings: 1. The laboratory did not maintain all PT records including the reporting documents, worksheets, sample raw data, nor the signed attestation. 2. The LD confirmed that he did not have any PT documents nor PT records on the day of the survey. B. Based on observation and interview the laboratory did not maintain records for proficiency testing for histopathology. Findings: 1. The laboratory participates in a peer review for histopathology testing; 2. The laboratory did not have records of the results it obtained for proficiency testing and did not have the proficiency test providers review of their proficiency test results. In addition the laboratory did not have records of the report form submitted to the proficiency test provider for review; and 3. The laboratory director had a certificate of participation from the proficiency and the laboratory director confirmed, During interview conducted on the afternoon on the day of survey with the lab director, the lab director stated that a certificate he produced was evidence of successful Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- participation with the proficiency testing program and confirmed that the lab did not have proficiency testing records and reports. 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: A. Based on review of the written procedure manual, review of patient histopathology prepared slides, and interview with laboratory director (LD), the LD failed to have written policies and procedures for labeling and identification of patient stained slides for review. Findings: 1. The LD stated that he did not have written procedures for labeling patient slides. That he randomly generated identification numbers for patients. 2. Review of 5 patient cases that had slides prepared with hematoxylin and special Immunofluorescence stains showed that a case from 10/16/20 had three slides prepared. 3. The identification number written on all three slides were incomplete and different from each other with ED201292 CA, 1292-A2 CA, and 1292 CA. 4. A case from 7/23/20 showed on the final report the case number was ED20-130. The number 130 was the only identification number written on two prepared slides. 5. The LD stated he was labeling slides with a one identification method and then later switched to a two identification method. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: See D5441for Based on surveyor observation and staff interview, the laboratory failed to maintain records showing that the emperature of the warmer met the labs temperature requirements for patient testing (see D5413); failed to maintain records to ensure reagents and stains were not used past expiration or of substandard quality (see D5417); failed to have a written procedures for performing the validation on the BioRad IQ 5 analyzer used to test qPCR COVID-19 specimens (See D5421); failed to have preventive maintenance records for the equipment used for histopathology testing (see D5429); failed to ensure external quality control test results were performed and internal quality control test results were documented for patient testing for SARS- CoV-2 performed using the rapid BD Veritor test system (see D5441); failed to establish written