Annapath, Inc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual, manufacturer's specifications, and maintenance record review and interview with the general supervisor (GS), the laboratory did not ensure that the procedure for performing function checks on the fume hoods was up to date and followed by the testing personnel (TP). Findings: 1. The procedure, "Safety Equipment," Section 3.3, "Quality Control and procedure" states, "Safety hoods are monitored daily and results are documented on the Temperatures and Safety Equipment Maintenance Log." Section 3.3.1, "Hemco ducted fume hood for coverslipping" states, "Ideal airflow should read 100 lfm (linear feet per minute)"; and 2. A review of the "UniFlow CE Specification" sheet for the Hemco fume hood showed that it is "Recommended that hoods be used with sash open with face velocity of 80-100 FPM" (feet per minute). 3. A review of the "Automatic Coverslipper" maintenance log from February 2024 showed that the "Ideal Velocity" of the automatic coverslipper (Hemco) fume hood was listed as "40-60" FPM, which does not match the manufacturer ' s acceptable range or the one written in the procedure manual. The "Velocity ft/min" for the Hemco fume hood was documented on the maintenance log as "60" on 21 of 21 days used in February 2024 which is outside the manufacturer ' s recommended acceptable range. 4. Section 3.3.2, "Misonix ductless fume hood workstation for grossing" and section 3.3.3, "Misonix ductless fume hood workstation for non-gyn" of the "Safety Equipment" procedure state that the "ideal airflow should read 50 lfm." During an interview on 04/17/2024 at 1:15 PM, the GS stated that the workstations are no longer "ductless" and that 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 3 -- procedure manual had not been updated. Maintenance record review showed that at the time of the survey there was no documentation that the Misonix fume hoods were checked daily for adequate airflow. The GS confirmed that the laboratory did not measure and document the airflow of the Misonix fume hoods. 5. During an interview on 04/17/2024 at 2:30 PM, the GS confirmed that the procedure for performing function checks on the fume hoods was not up to date and followed by the TP. 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 record review and interview with the general supervisor (GS), the laboratory failed to document the lot numbers and expiration dates of stains and reagents used for histology testing to ensure that they were not used when they had exceeded their expiration date, had deteriorated, or were of substandard quality. Findings: 1. A review of "Processing Station" and "Staining Station" maintenance logs from January through March 2024 showed that the laboratory documented the lot number and expiration date of the stains and reagents used for histology slide staining on the top right portion of the logs. 2. During an interview on 04/17/2024 at 12:30 PM, the GS stated that the electronic file used for documenting the lot numbers and expiration dates of histology stains and reagents before January 2024 was corrupted and that the information was no longer accessible. A review of maintenance logs from January 2023 showed that the lot numbers and expiration dates of 17 out of 19 stains and reagents used were not documented on the logs. 3. The lot number and expiration date of the distilled water used for staining was not documented on the maintenance logs from January 2023 through March 2024. During an interview on 04/17/2024 at 12:30 PM, the GS stated that the laboratory did not document the lot number and expiration date of the distilled water and confirmed that the laboratory did not ensure that the lot numbers and expiration dates of histology reagents were documented. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor observation, procedure manual review, and interview with the general supervisor (GS), the laboratory did not perform and document routine preventive maintenance checks on the fume hoods. Findings: 1. The procedure, "Facilities," section 3, "Ventilation", subsection 3.3, "Certification" states, "A licensed ventilation specialist will perform an annual testing and certification of the hood. The certification label is posted on the equipment." 2. The laboratory uses three "Misonix WS-6 Downflow Work Stations" (hood #191310-L1, #191310-L4, and #191310-L5) to perform the technical component (grossing) of the histopathology testing. 3. During a tour of the laboratory on 04/17/2024 at 1:20 PM it was observed that the fume hoods -- 2 of 3 -- at three of three "Misonix WS-6 Downflow Work Stations" were labeled with a sticker which stated that the maintenance had been performed October 2021. During an interview at the same time, the GS confirmed that maintenance had not been performed on the fume hoods since that date. -- 3 of 3 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the standard operating procedure manual (SOPM) and interview with the laboratory supervisor (LS), the laboratory failed to have a procedure for performing a specimen recut for microscopic slide examination for histopathology testing. Findings: 1. The laboratory performed both the technical (gross examination) and professional (microscopic examination) components of histopathology testing. 2. The technical and professional components shared a laboratory information system (LIS). 3. The LS stated that the pathologists (professional) requested recut specimens for microscopic examinations through the LIS. The request for a recut was then placed on the laboratory's (technical) daily workload list within the LIS. Once received, the laboratory personnel retrieved the stored patient block, performed the recut, and sent the new slides to the pathologist for microscopic examination. 4. During the survey on 09/26/2022 at 3:30 PM, the LS confirmed that the laboratory's SOPM did not have a procedure for the technical component of the laboratory to receive and perform a recut. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on review of personnel files and staff interviews, the laboratory failed to ensure that testing personnel performing gross examinations for histopathology were qualified to perform high complexity testing (refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and -- 2 of 3 -- verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of the personnel files and interview with the vice president (VP), one of the two testing personnel (TP) performing gross examinations was not qualified to perform high complexity testing. Findings: 1. The laboratory performed both the technical (gross examination) and professional (microscopic examination) components of histopathology testing. 2. The pathologists (professional) delegated the gross examination responsibilities (technical) to the TP and reviewed all gross descriptions within 24 hours. 3. One of two TP that performed the gross examinations did not meet the minimum qualifications for TP performing high complexity testing. 4. During the survey on 09/26/2022 at 3:30 PM, the VP confirmed that one of the two TP performing the gross examinations did not meet the minimum qualifications for high complexity TP. -- 3 of 3 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 on review of the written procedure manual and interview with the histologist, the laboratory did not update the immunohistochemistry (IHC) quality control (QC) procedure to reflect the change in the way QC is performed for patient testing. Finding: 1. The laboratory did not document the antigen retrieval steam bath temperature nor the pH of the buffer solution used to perform the patient test on the IHC analyzer. 2. The histologist stated that the manufacturer now have prediluted materials for testing and there is no mixing of reagents that require the antigen retrieval steam bath temperature and the pH of the buffer solution to be documented. 3. The histologist confirmed that the IHC QC procedure was not updated to reflect the change in the way QC is performed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 the written procedure manual and interview with the histologist, the laboratory did not document the temperature of the over flow refrigerator purchased during the year 2017. Findings: 1. The laboratory installed a new refrigerator at the end of the year 2017. 2. The histologist stated that the refrigerator was needed for over flow laboratory material. Observation of the refrigerator at 11:00 AM showed immunohistochemical reagents used for performing patient testing stored in the refrigerator. 3. The laboratory did not document the refrigerator temperature once it was put into place to store test reagents and supplies. 4. The histologist confirmed that temperatures were not documented on the over flow refrigerator. 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 review of the written procedure manual, laboratory stain material log, and interview with the histologist, the laboratory did not ensure that staining material needed to prepare patient slides for review did not exceed the intended expiration date. Findings: 1. The laboratory stain material log did not show the lot numbers and expiration dates of the material needed to prepare patient slides for review. 2. The histologist stated that when stain reagents are opened laboratory personnel pays attention to the expiration date, but the lot and expiration date of the material is not documented anywhere in the laboratory in the event of a recall or problem and when empty containers are discarded. 3. The histologist confirmed that stain material lot numbers and expiration dates were not documented. -- 2 of 2 --