Queen City Gastroenterology And Hepatology, Pc

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based upon observation inside the laboratory's refrigerator on 6/5/24, review of storage requirements printed on reagent bottles and interview with TP (Testing Personnel) #2 on 6/5/24, the laboratory failed to store its Alcian Blue/PAS (Periodic acid-Schiff) Stain kit as required by the manufacturer. Findings: Surveyor observed an unopened Alcian Blue/PAS Stain kit in the laboratory's refrigerator at approximately 10:40 a.m. Review of the storage requirements printed on the reagent bottles revealed a storage temperature of 15-30 degrees Celsius. In interview at approximately 10:40 a. m., TP#2 stated that the laboratory has always stored its PAS stain in the refrigerator. 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 3 -- This STANDARD is not met as evidenced by: Based upon review of 2023 and 2024 maintenance logs, review of the Lab Pulse 3618 H&E (hematoxylin & eosin) Automatic Slide Stainer User Guide, review of the Lab Pulse 1550 Tissue Embedding Center User Guide and interview with TP (Testing Personnel) #2 on 6/5/24, the laboratory failed to document its humidity when operating equipment in the laboratory area. Findings: Review of 2023 and 2024 maintenance logs revealed the absence of documentation of the laboratory's humidity. Review of the Lab Pulse 3618 H&E Automatic Slide Stainer User Guide revealed in its Maintenance section: "... store in a well ventilated room with humidity levels under 80%." Review of the Lab Pulse 1550 Tissue Embedding Center User Guide revealed in its Maintenance section: "... store in a well ventilated room with humidity levels under 80%." In interview at approximately 10:25 a.m., TP#2 confirmed she does not document the humidity in the laboratory. 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 upon review of the Lab Pulse 3618 H&E (hematoxylin & eosin) Automatic Slide Stainer User Guide, review of the laboratory's 2023 and 2024 automatic stainer maintenance logs and interview with TP (Testing Personnel) #2 on 6/5/24, the laboratory failed to perform and document all instrument maintenance activities required by the manufacturer. Findings: Review of the Lab Pulse 3618 H&E Automatic Slide Stainer User Guide revealed in its Maintenance section: "Lubricate the container cover front hinge pins once a week and clean the stainer after each use." Review of 2023 and 2024 automatic stainer maintenance logs revealed the following: 1. No documentation of lubricating the container cover front hinge pins once a week. 2. No documentation of cleaning the stainer after each use. In interview at approximately 10:30 a.m., TP #2 stated the following: 1. She does not lubricate the stainer. 2. The stainer is cleaned regularly; however, this task is not documented. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based upon review of training and competency records and review of the Laboratory Director's Responsibilities and Duties policy, the Laboratory Director failed to ensure the performance of competency assessments of 2 of 2 grossing staff employed in the laboratory. Findings: Review of training and competency records revealed the following: 1. Documentation of the intial training of TP (Testing Personnel)#2 from -- 2 of 3 -- October 2022 was observed. 2. Documentation of the intial training of TP #3 from January 2022 was observed. 3. No documentation of the assessment of competency for either employee was observed. Review of the Laboratory Director's Responsibilities and Duties policy revealed the following in section: "Non-Delegated Responsibilities": "9. Oversee the laboratory personnel performance on competency including

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 review of laboratory's procedures, review of laboratory records and absence of documentation, and phone interview with the LD(laboratory director) 11/15/21, the laboratory failed to verify accuracy of testing for the tissue microscopic examination at least twice a year in 2019, 2020, and 2021. Findings: Review of the laboratory's Quality Assurance procedure revealed, " 3. Pre-analytic, Analytic, and Post Analytic Systems....3. the following areas are included under these policies and procedures for Post-analytic Systems. a. Peer Review- Quarterly a review will be conducted on 5 surgical cases. Any issues or discrepancies will be noted and sent to another pathologist. b. Consultation review- A review of all consultations for pathology cases will be conducted to verify diagnostic consistency and maintain the highest standard of reporting accuracy possible. In addition, this will serve as a feed-back mechanism for the pathologist to evaluate their diagnostic skills." Review of the laboratory's records revealed there was no documentation that the laboratory had sent out cases for verification of accuracy in 2019 and 2021. There were 2 cases that were sent out to other laboratories for consultation in August and October 2020, but no other records to indicate the laboratory had verified accuracy of testing twice a year since the laboratory opened in January 2019- a period of approximately 34 months. During phone interview with the LD at approximately 3:45pm on 11/15/21, the LD confirmed there was no record on file that verification of accuracy was performed twice a year. He stated that he had shared slides for a second pathologist to review during 1st of 2021, but there was no record of that review on file. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 TP #1(testing personnel)11/15/21, the laboratory failed to discard reagents when they had exceeded their expiration date. Findings: During tour of laboratory and storage area at approximately 3:15pm., the surveyor observed the following reagents that had expired: a. One bottle of Bluing Reagent- Lot # 511093, expiration date: 10/21- located in safety storage cabinet in laboratory, available for use; b. One bottle of Clear Rite 3- lot #511060, expiration date: 10/21- located in safety storage cabinet in laboratory and two bottles of Clear Rite 3 with same lot number located in safety storage cabinet in storage room, available for use; c. One opened box of 10% Neutral Buffered Formalin- lot #068220, expiration date: 8/1/21- located in safety storage cabinet in storage room, available for use; d. Six unopened boxes of 10% Neutral Buffered Formalin- lot# 1714303, expiration 5/30/19-located in safety storage cabinet in storage room, available for use; TP#1 confirmed at approximately 3:20pm. that the reagents were expired. 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 review of laboratory's procedures, review of the laboratory's quality control records and absence of documentation, and interview with TP#1(histology technologist) 11/15/21, the laboratory failed to document control procedures for each special stain performed in 2019, 2020, and 2021. Findings: The laboratory performs manual Giemsa and AB-PAS(Alcian blue/periodic acid- Schiff) special staining procedures. Review of the laboratory's procedures revealed "Section 4. Staining... Policy: 1. All special stains must be run with a known positive control...4. All special stains will be entered on the Special Stain Quality Assurance Log and reviewed by the Pathologist. a. The Histology Special Stain Quality Assurance log was designed to keep a record of all special stains done and a check for acceptability of results. b. The slide accession number, date, and stain are to be logged. c. If the stain needs to be repeated or is unacceptable, it will be noted on this log." Review of stain Quality control logs revealed absence of documentation for the control slides for each special stain performed in 2019, 2020, and 2021. At approximately 2 p.m., TP#1 confirmed the laboratory only began documenting the positive control for the special stains in August 2021-(a period of approximately 31 months from the time the laboratory began testing until August 2021 when documentation started). She stated before that, they were performed but were not documented. -- 2 of 7 -- D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, verification of accuracy records, Quality control and Quality Assessment records, and TP(testing personnel) training and competency records 11/15/21, the LD(laboratory director) failed to provide overall management and direction of the laboratory. Findings: 1. The LD failed to ensure responsibilities were delegated to personnel that met the qualifications to perform the responsibilities. See D6079. 2. The LD failed to ensure verification procedures for the tissue microscopic examination was adequate to determine the accuracy of the testing performed. See D6086. 3. The LD failed to ensure the QA program was maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D6096. 4. The LD failed to ensure that TP had documented training for the performance of the gross examination of patient specimens. See D6102. 5. The LD failed to ensure TP competency procedures were established. See D6103. 6. The LD failed to evaluate the competency of TP. See D6120. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory's procedures and personnel records, review of the Medical Director job description, and review of the Delegation of responsibility 11/15 /21, the LD(laboratory director) failed to ensure responsibilities were delegated to personnel that met the qualifications to perform the responsibilities. Findings: Review of the laboratory's procedures revealed the Medical Director's Job description signed by the laboratory director 4/1/19 that stated, "...Delegation: The Medical director need not perform all responsibilities personally, Technical duties may be delegated to qualified laboratory personnel. Administrative duties may be delegated to qualified laboratory personnel. The Medical Director, however, remains responsible for the overall operation and administration of the laboratory." Review of the "Laboratory Director Responsibilities Delegation/Non-delegation" revealed the laboratory director delegated some responsibilities to TP#1(histology technologist) on 4/1/19. Some of the delegated responsibilities are duties that would be performed by the Technical -- 3 of 7 -- Supervisor or General Supervisor in Histopathology. For example, the delegation stated, "Delegated Responsibilities: As Director, I delegate the following to the Histotechnologist: 1. Observation and review of monthly QC...3. Review of performance on Proficiency Testing results, including: recommendations on