Gastroenterology Specialists Of Frederick

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the histopathology proficiency check was not performed as stated in the laboratorys written procedure. Findings: 1. The written procedure states that twice annually, proficiency checks will be performed by peer reviews. 2, The laboratory director did not complete the proficiency check peer review form for the second half of 2024. 3. This was confirmed during interview with the laboratory director on June 17, 2025 at 11:30 am. 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. This STANDARD is not met as evidenced by: Based on record review, observation and interview with the laboratory director, the laboratory did not follow written procedures for processing and labeling patient specimens for two of six cases reviewed. Findings: 1. The accession numbers on the slides for Case # 6 processed on December 18, 2023 and also for Case # 21 processed 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 -- on December 27, 2023 did not agree with the accession numbers on their respective final reports. It was observed that the slides for Case # 6 were labeled CEC23-06, but the final report was identified as CEC24-06 and the slides for Case #21 were labeled CEC23-21, but the final report was identified as CEC24-21. 2. This was confirmed with the laboratory director during interview on June 17, 2025 at 11:30 am. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director (LD), laboratory staff did not follow established safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. Findings: 1. During a tour of the laboratory at 9:45 AM, it was observed that the histotechnician had placed an open drink can on the counter near where they open biohazard bags containing tissue and biopsy specimens which are stored in jars of formalin preservative. This area also serves as secondary laboratory space and contained a stainer which is used to perform immunohistochemistry staining on tissue and biopsy specimens. 2. The laboratory is required to implement safety policies and procedures to ensure the safety of the testing personnel. The Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) provide guidelines for laboratory safety. Good laboratory practices state that there should be no eating, drinking, or application of cosmetics in the laboratory. 3. During an interview on 07/28/2023 at 3:30 PM, the LD confirmed that laboratory staff did not follow established safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) review and interview with the laboratory director (LD), the laboratory did not ensure that proficiency testing (PT) was performed at least twice annually. Findings: 1. The laboratory currently has 2 testing personnel (TP) listed on the "Laboratory Personnel Report" (CMS-209). One of one TP interprets stained histology slides. 2. The procedure, Section "6. Quality Assurance," "2.G. Pathologist Proficiency Testing" states that "Twice year these pathologist(s) will provide Peer Review and Consultation on a minimum of 5 cases per pathologist." 3. A review of QA records from 2022 and 2023 showed that the laboratory sent out 10 cases for secondary review from 2022 and five cases from 2023. Fifteen of fifteen cases were reviewed by the second pathologist on 06/25/2023. 4. During an interview on 07/28/2023 at 3:30 PM, the LD confirmed that PT slides were not sent out twice a year in 2022. 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 patient slide, laboratory records, and procedure review and interview with the laboratory director (LD) and testing person (TP), the laboratory failed to notify the practice when a patient specimen was missing. Findings: 1. Patient CEC22-00735 was 1 of 4 randomly chosen patients for review of laboratory records, physical slides, and final reports. 2. The patient had 8 biopsies labeled A-H that were collected on 09/21 /2022. 3. The laboratory documented the number of specimens received, the accession date, the grossing date, and the dates read and signed out by the pathologist on the "Specimen Flow Sheet" (flow sheet). 4. The flow sheet for 09/21/2022 showed that 8 specimens for CEC22-00735 were received from the practice. The specimens were not accessioned until 10/01/2023. 5. The slide for specimen E had "No Specimen" written on it by the TP. 6. The laboratory's procedure titled "Section 2. Specimen Handling & Reporting" stated that "For missing specimens, contact the submitting location." 7. There was no documentation that the laboratory contacted the practice to let them know that a specimen was missing. 8. The physician was notified on the final report that was issued on 11/18/2022, 58 days after specimen collection, that "Specimen E: Duodenum, Bulb NO SPECIMEN." 9. During the survey on 07/28 /2023 at 3:30 PM, the LD confirmed that they assumed the TP had notified the practice and the TP confirmed that they had not notified the practice that 1 of 8 specimens for patient CEC22-00735 was missing upon receipt. 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 -- 2 of 8 -- examining specimens. This STANDARD is not met as evidenced by: Based on standard operating procedure manual (SOPM) and record review and interview with the histotechnician, office staff, and the laboratory director (LD), the laboratory failed to have an up-to-date written procedure manual for the specific practices performed in the laboratory. Findings: 1. The laboratory's procedure titled "Section 2. Specimen Handling & Reporting" states that "For missing specimens, contact the submitting location." The laboratory failed to notify the practice when a patient specimen was missing. Cross-refer to D5311 for findings. 2. Section "4. Staining" "1. Hematoxylin and Eosin [H&E] Staining" states to "follow Laboratory H&E Stain Line Quality Control Guidelines located on the Quality Control Sheet." During an interview at 11:15 AM, the histotechnician stated that they filter the hematoxylin stain every 2 weeks. A review of the "Quality Control Sheet" for H&E staining showed that there are no "guidelines" listed on the log and no procedure for this in the SOPM. 3. Section "5. Immunohistochemistry" "1. Manual IHC Procedure" states, "When the Histotech receives a new antibody, the tech must grossly inspect the antibody and complete the Immunohistochemistry Stain Lot Number Quality Control Log [IHC Stain QC Log], prior to using." Record review showed that there were no IHC Stain QC Logs present at the time of the survey. During an interview at 2:30 PM the histotechnician confirmed that the lab did not use the IHC Stain QC Log and that the validation of new lot numbers of antibody were not documented. 4. Section "5. Immunohistochemistry" "2. New Antibody Validation" states, "Prior to staining tissue for diagnosis, any new antibody must be validated with appropriate documentation. This is also true for new lots of the same antibody. The detection system must also be validated when new lots of detection arrive, this validation consists of running a series of six (6) known negatives with appropriate controls." During an interview, the histotechnician stated that they would stain a slide with the old lot number of stain and the new lot number of stain and compare them to validate a new lot number of antibody. Neither the LD nor the histotechnician could explain what "new lots of detection" referred to. 5. Section "6. Quality Assurance" "1. General QA Plan" states that monthly the laboratory will complete a "Monthly Quality Assessment Report (MQAR)" which includes nine quality assurance (QA) topics. QA record review showed that there were no MQAR available at the time of the survey. 6. The QA procedure also states that "Procedure manual reviews will be performed annually or more frequently as needed." The SOPM was signed and approved by the LD on 03/01 /2019. During an interview at 1:10 PM the LD stated that they don't review the SOPM annually and aren't "aware" of all of the procedures in the SOPM. 7. The "Physician Quality Assurance" section of the QA procedure states, "At least twice a year, the lab will send out 2-4 slides for a second opinion (at least 6 months apart)." The laboratory did not ensure that proficiency testing was performed at least twice annually. Cross- refer to D5217 for findings. 8. Section "2.E. Personnel Competency" of the QA procedure states that the competency assessment of the histotechnician will include a "Histology Practical" where the employee will "prepare a practical slide set," cutting slides from "old or sample tissue blocks" "to prepare all the necessary stains (i.e. H&E Stain, Immunostains, and Special Stains)." During an interview at 1:50 PM the histotechnician stated that their competency assessment did not include a "histology practical." This was confirmed by the LD. 9. Section "2.G. Pathologist Proficiency Testing" of the QA procedure refers to the name of the laboratory as the "Center of Digestive Health & Nutrition." This is not the name of the laboratory being surveyed. During an interview at 2:30 PM the histotechnician stated that the SOPM was "borrowed" from another laboratory. 10. Section "7. Computers" "3. Data Integrity" -- 3 of 8 -- provides a procedure for checking 10 patient laboratory reports from the "Data Back- Up File" to "ensure the integrity of data, i.e. patient reports, is maintained during transmission, storage, back-up and retrieval." The procedure states that this is to be performed annually. During an interview at 3:00 PM the office staff stated that this was not performed. 11. During an interview on 07/28/2023 at 3:30 PM, the LD confirmed that the laboratory's SOPM was not updated to reflect the current practice of the laboratory. 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. This STANDARD is not met as evidenced by: I. Based on observation, record review, and interview with the laboratory director (LD), the laboratory failed to define and monitor the environmental conditions for histopathology specimen processing and slide preparation. Findings: 1. The laboratory processed histopathology specimens and prepared slides in a room that was not monitored for temperature or humidity. 2. There was no procedure or log that defined the acceptable temperature and humidity requirements for histopathology specimen processing and slide preparation. 3. During the survey on 07/28/2023 at 3:30 PM, the LD confirmed that the laboratory did not have defined acceptability requirements and was not monitoring temperature and humidity for histopathology specimen processing and slide preparation. II. Based on instrument operating manual and temperature log record review and interview with the laboratory director (LD), the laboratory failed to establish a room temperature range for the laboratory which was consistent with the histology slide stainer's manufacturer's instructions. Findings: 1. The laboratory monitored the temperature where they perform immunohistochemistry staining using the StatLab Quantum HDx Slide Stainer. The operating manual for the StatLab Quantum HDx Slide Stainer, under "3.1 Installation Requirements" states, "The work area must be in an environment with an ambient temperature between 18C-26C (64F- 79F)." 2. A review of the laboratory's "Daily Room Temp and Humidity Chart" showed that the "Allowable temp range" was "10C to 30C." 3. During an interview on 07/28/2023 at 3:30 PM, the LD confirmed that the laboratory's acceptable room temperature range was not consistent with the manufacturer's instructions. 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. -- 4 of 8 -- This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director (LD), the laboratory did not ensure that the in-use histology stain reagents were labeled with the date that they were opened. Findings: 1. During a tour of the laboratory at 2:30 PM, it was observed that three bottles of reagents were stored on the floor of the laboratory, under the fume hood. 2. Three of three bottles were opened and in-use: 100% Reagent Alcohol (lot # 174545, expiration date 05/31/2025), 95% Reagent Alcohol (lot # 173684, expiration date 05/31/2025), and xylene (lot # 171623, expiration date 04/30 /2025). 3. None of the opened and in-use bottles of reagents were labeled with the date that they were opened and put in to use. 4. During an interview on 07/28/2023 at 3:30 PM, the LD confirmed that the in-use histology stain reagents were not labeled with the date that they were opened. 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 staining reagent log, staining reagent instructions for use (IFU), and Stain Quality Assurance Log and interview with the testing person (TP), the laboratory failed to ensure that staining reagents were not used beyond their expiration date. Findings: 1. The laboratory performed immunohistochemistry (IHC) staining on patient histopathology slides using the Quantum HDx automated staining platform to identify Helicobacter pylori (HPY) and CD3 protein. 2. The reagent kit "Quantum HDx 3 Step HRP Detection Kit" (detection kit) was used for the laboratory's IHC staining. The IFU for this reagent kit stated "Do not use after expiration date printed on vial." 3. The laboratory recorded the lot number, date in use, and expiration date of all staining reagents on the "Lot Numbers" log. 4. The "Lot Numbers" log showed that lot number 211011 of the detection kit expired on 09/30 /2022 and the next lot number, lot 230602, was put into use on 12/12/2022. 5. The Stain Quality Assurance Log documented all slides stained and the dates of staining and showed that 34 slides were stained for HPY on 10/06/2022, 34 slides were stained for HPY on 10/13/2022, 10 slides were stained for HPY on 10/26/2022, 23 slides were stained for HPY on 10/30/2022, and 2 slides were stained for CD3 on 10/30 /2022. 6. During the survey on 07/28/2023 at 3:30 PM, the TP confirmed that the "Lot Numbers" log showed that the IHC reagent detection kit was used beyond its expiration date. 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: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 01/06/2022 for not performing and documenting instrument and equipment -- 5 of 8 -- maintenance as specified by the manufacturer. The

Summary Statement of Deficiencies 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 record review and interview with laboratory staff, the laboratory did not document maintenance performed for the Quantum stainer. Findings: 1. The manufacturer instructions for the Quantum slide stainer requires cleaning of the module, chamber, wash stations and tube inspections. These activities were not documented in 2021; and 2. This was confirmed during interview with the histotechnologist on the afternoon of the day of the survey. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory director acting as technical supervisor did not perform competency checks for the histotechnician performing tissue grossing (inking tissue). Findings: 1. The Histotechnician performs tissue grossing that is high complexity testing; 2. The Technical supervisor did not perform competency checks in 2021 for the histotechnician; and 3. This was confirmed during interview on the afternoon 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 -- day of survey when the histotechnician confirmed that competency check records were not available. -- 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: No deficiency details available. 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 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: I. Based on review of the patient slides and interview with the laboratory director (LD) and histology tech during the onsite revisit survey conducted on 12/10/19, the laboratory failed to ensure that patient slides were retained and available for the required 10 year period. Findings: 1. On 11/15/19 the "Stain Quality Assurance Log" showed that patient 893-A/B was reviewed and reported. The LD explained that 893-A /B indicated that there were two slides read, 893-A and 893-B. When the slides were pulled for review it was determined that slide 893-B was missing. 2. During the onsite revisit survey on 12/10/19 at 2:00 PM the LD and histology tech confirmed that patient slide 893-B was not available at the time of the survey. II. Based on review of the quality control (QC) slides and interview with the laboratory director and histology tech during the onsite revisit survey conducted on 12/10/19, the laboratory failed to ensure that QC slides were retained and available for the required 10 year period. Findings: 1. On 10/25/19 the "Stain Quality Assurance Log" showed that slides 1/3 and 3/3 for Helicobacter Pylori (HPY) had been reviewed and found acceptable. When the slides were pulled for review it was determined that the 2/3 HPY slide was missing. 2. On 11/13/19 and 11/15/19 the "Stain Quality Assurance Log" showed that slides for HPY had been reviewed and found acceptable. When the slides were pulled for review it was determined that there were 3 slides labeled 1/4, 2 /4 and 4/4. The slide labeled 3/4 was missing. 3. During the onsite revisit survey on 12 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 -- /10/19 at 2:00 PM the histology tech confirmed that the two of the QC slides were not available at the time 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 record review and interview with the laboratory director, the laboratory failed to ensure that written quality control (QC) policies were established to ensure accurate and reliable testing of patient specimens for histology. Findings: 1. During interview with the laboratory director on the afternoon on the day of survey, the director stated that in order to ensure a QC slide meets the laboratory's criteria of acceptability for staining characteristics or, if appropriate, positive reactivity, additional control slides are added to staining events to increase the chances that at least one control slide will stain as expected for each specific specialty or immunohistochemistry stain. 2. The laboratory did not have a written procedure for performing this method of QC analysis and evaluating and analyzing results of the quality control testing when multiple tissue was used to check the ability of each stain to produce expected patterns of reactivity and there were no references for the reliability of using multiple control slides to guard against control failure. 3. During the interview on 12/10/19 at 2:00 PM the laboratory director confirmed that the laboratory did not investigate and document the investigation when QC failures occurred if at least one tissue reacted as expected. -- 2 of 2 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Abbreviations- H&E = Haematoxylin and Eosin IHC = Immunohistochemistry Based on review of patient intermediate worksheets and interview with the laboratory director, the laboratory's record system failed to ensure that the intermediate worksheets were retrievable at the time of the survey. Findings: 1. The "H&E/IHC /Special Stain Quality Assurance Log" was reviewed for 2018 and 2019. On 10/22/18 and 10/24/18 the Helicobacter Pylori (HPY) stain was documented as unacceptable. 2. The surveyor asked to review the intermediate worksheets with the original interpretations of the slides reviewed. The laboratory director was not able to locate the intermediate worksheets with the original interpretations. 3. During an interview on 08/02/19 at 3:00 PM, the LD confirmed that the intermediate worksheets with the original interpretations of the slides were not available at the time of the survey. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 06/28/17 for not performing and documenting quality assurance (QA) activities to ensure that problems were identified, monitored, and corrected in the pre- analytic, analytic, and post-analytic phases of testing. The