Pittsburgh Gastroenterology Associates, Ltd

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a lack of documentation and interview with the laboratory director (LD) and testing personnel #3 , the laboratory failed to follow a competency assessment procedure to assess the competency of 1 of 2 Clinical Consultant (CC) for their supervisory responsibilities in 2022 and 2023. Findings include: 1. On the day of the survey, 03/07/2024 at 10:15 am, the laboratory could not provide competency assessment documents for 1 of 2 CC (CMS 209 personnel #2) for their supervisory responsibilities in 2022 and 2023. 2. The LD and TP#3 confirmed the findings above on 03/07/2024 at 11:45 pm. *Repeated deficiency. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competency assessment records, and interview with the Laboratory Director (LD) and Testing Personnel #3, the Technical Supervisor (TS) failed to assess the competency for 2 of 4 TP through external proficiency testing samples or internal blind testing samples for grossing examinations 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 -- performed in histopathology in 2022 and 2023. Findings include: 1. On the day of survey, 03/07/2024 at 11:53 am, review of histopathology TP competency assessment records revealed annual competencies performed in 2022 and 2023 did not include the assessment of external proficiency testing samples or internal blind testing samples for 2 of 4 TP (CMS 209 TP #3 and #4) who performed grossing examinations in histopathology in 2022 and 2023. 2. The LD and TP#3 confirmed the findings above on 03/07/2024 at 12:00 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's Personnel Competency Procedure and interview with the Testing Personnel (TP) #3 , the laboratory failed to have a competency assessment (CA) policy for the 1 of 1 Clinical Consultant (CC) (CMS 209 personnel #2), and 1 of 2 Technical Supervisor (TS) (CMS 209 personnel #2) for their supervisory responsibilities in 2020. Findings include: 1. On the day of survey, 02/15/2022 at 09:14 a.m, the TP#3 could not provide a CA policy to assess the competency of 1 of 1 CC (CMS 209 personnel #2) and 1 of 2 TC (personnel #2) from 02/04/2020 to 12/31/2020. 2. The TP #3 confirmed the finding above on 02/15/2022 around 10:45 am. B. Based on review of the laboratory's Personnel Competency Procedure, record review, and interview with the Testing Personnel (TP) #3, the Laboratory failed to follow the Laboratory's written policies and procedures to assess the competency of 1 of 2 testing personnel (TP) (CMS 209 personnel #2) who performed histopathology slide reading and biopsies, and 3 of 5 Testing Personnel (CMS209 personnel #3, #4 and #5) who performed grossing and inking in 2020 and 2021 . Findings Include: 1. The laboratory's Personnel Competency Procedure states: "These Competency assessment will then be reassessed yearly" 2. On the day of survey 02/15/2022 at 09:14 a.m., review of the competency assessment records revealed the laboratory did not follow their Policy to evaluate yearly the following: - 1 of 2 TP (CMS 209 personnel #2) who performed histopathology slide reading and biopsies in 2021. - 3 of 5 TP (CMS209 personnel #3, #4 and #5) who performed grossing and inking in 2020. 3. The TP #3 confirmed the findings above on 2/15/2022 at 10:45 a.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the manager, the laboratory failed to have a general supervisor who meets the qualifcation under 493.1461(e)(1). Refer to D6143. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(1)(i) 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; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least -- 2 of 4 -- one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the Testing Personnel (TP) #3 , the laboratory failed to have a general supervisor (GS) who meets the qualification under 493.1461 (e) (1) from January 2022 to 02/15/2022. Findings Include: 1. On the day of the survey 02/15/2022 at 09:15 a.m, Interview with TP#3 stated: the TP#3 was made a general supervisor (GS) since January 2022. 2. Review of CMS209 revealed that TP#3 was assigned as (GS). 3. The document provided during the inspection indicated that TP#3 has a Bachelor of Science in Biology. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification 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 the CLIA ' s Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Testing Personnel (TP)#3, the laboratory failed to ensure that each individual performing High Complexity testing (1 of 5) is qualified. 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 -- 3 of 4 -- 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 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 CLIA's Laboratory Personnel Report (Form CMS-209), review of personnel qualification records, and interview with the Testing Personnel (TP)#4, the laboratory failed to ensure that each individual performing High Complexity testing (1 of 5 TP) had the minimum qualifications required for grossing and inking from 2/15/2020 to 2/15/2022. Findings Include: 1. On the date of survey 02 /15/2022 at 09:15 am, the surveyor reviewed the credentials of the testing personnel listed on the CMS 209 (TP #4) and discovered that 1 of 5 TP who performed grossing and inking for small biopsies examinations from 02/15/2020 through the day of survey, did not have the minimum qualifications. 2. The document provided during the inspection indicated that TP#4 has a High School diploma. 3. The TP#4 confirmed the finding above on 02/15/2021 at 10:45 a.m. -- 4 of 4 --

Summary Statement of Deficiencies No Tags 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 --