Pediatric Associates

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Associates of Tampa Bay LLC on 06/17/22. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6033 - 42 CFR 493.1409: Laboratories performing moderate complexity testing; technical consultant 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 record review and interview with Testing Personnel #D, the laboratory failed to have documentation of competency assessments for one (#D) out of three (#B, #C, and #D) Testing Personnel for two out of two years reviewed (2020-2022). Findings Included: Review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 06/17/22 revealed three Testing Personnel (#B, #C, and #D). Review of the policy titled "LAB 101 Laboratory Director's Responsibilities/Job Description/Delegation signed by the Laboratory Director on 10/15/21 revealed "11. Monitoring personnel in all phases (pre-analytic, analytic and post-analytic) of testing to assure the ongoing competency of all individuals who perform testing, including completed 6 month competency and annul [sic] competency documents." Review of Testing Personnel #D's file revealed no competency records were present. On 06/17 /22 at 12:50 PM, Testing Personnel #D stated she performed testing when the laboratory was short staffed. Testing Personnel #D confirmed the laboratory had not performed competency assessments on her. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY 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 -- CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have a qualified Technical Consultant in the Specialty of Hematology and Subspecialties of Bacteriology and Routine Chemistry from 09/24/21 to 06/17/22 with an annual estimated test volume of 2,750 (See D6034). D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a qualified Technical Consultant to provide technical oversight of the testing process from 09/24 /21 to 06/17/22. Findings Included: Record review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 06/17/2022 revealed the Laboratory Director also functioned as the Technical Consultant for moderate complexity testing in the Specialty of Hematology and Subspecialties of Bacteriology and Routine Chemistry. Review of the CMS-116, Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, signed by the Laboratory Director on 6/17/22 revealed the estimated annual test volume for Hematology was 2400, Bacteriology was 150, and Routine Chemistry was 200 for a total estimated test volume of 2,750. Review of Laboratory Director's personnel records revealed she became the Laboratory Director on 9/24/21. Review of the Laboratory Director's Curriculum Vitae (CV) and additional education/training records revealed no evidence of 1 year of laboratory training. Record review of the laboratory's policy titled "LAB 101 Laboratory Director's Responsibilities/Job Description/Delegation" revised 12/16/19 revealed "The Laboratory Director is responsible for the overall operation and administration of the laboratory...The Lab Director is also the Technical Consultant..." On 06/17/22 at 12:45 PM, the Diagnostics Services Director stated she did not know that the Laboratory Director needed 1 year of laboratory training to become the Technical Consultant. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Associates of Tampa Bay LLC from 12/03/2019 - 12/05/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6168 - 493.1487 Condition: Laboratories performing high complexity testing; testing personnel 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 record review and interview with the Laboratory Manager, the laboratory failed to have testing personnel that qualified to perform High complexity testing for modified Group A Selective Strep Agar with 5% Sheep Blood with Taxo A discs from 01/23/2018 through 12/03/19. (see 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 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 -- 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 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 record review and interview with the Laboratory Manager the laboratory failed to ensure 3 (#B, #C, and #D) out of 3 Testing Personnel were qualified to perform high complexity testing for a modified Group A Selective Strep Agar with 5% Sheep Blood with Taxo A discs from 01/23/2018 through 12/03/2019. Findings Included: Record review revealed the laboratory had modified the Group A Selective Strep Agar with 5% Sheep Blood with Taxo A discs procedure by adding a 2nd read at 48 hours. Record review of the Testing Personnels' level of education showed that -- 2 of 3 -- Testing Person #B and #C had high school diplomas and Medical Assistant diplomas. Testing Person #D had a high school transcript. Review of employee competencies for the modified Group A Selective Strep Agar with 5% Sheep Blood with Taxo A disc testing showed that Testing Person #B had competency evaluations performed 12 /2018 and 9/2019, Testing Person #C had competency evaluations performed 11/2018 and 11/2019 , and Testing Person #D had initial training 04/2019 and 6 month competency evaluation 10/2019. The competencies revealed that they were deemed competent and signed off to perform the modified Group A Selective Strep Agar with 5% Sheep Blood with Taxo discs. Interview on 12/05/2019 via telephone at 10:20 AM with the Laboratory Manager confirmed the education levels for Testing Personnel #B, #C, and #D and confirmed that they all performed the high complexity testing. -- 3 of 3 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing and interview with the Technical Consultant, the laboratory failed to score at least 80% for White Blood Cell Diff in the specialty of Hematology in 1 (2nd testing event of 2016) out of 6 testing events (1st, 2nd, and 3rd testing events in 2016 and 2017) reviewed. Findings Included: Review of API proficiency testing revealed that the laboratory scored a 40% for White Blood Cell Diff in the 2nd testing event of 2016. During an interview on 01/22/18 at 11:00 AM the Technical Consultant confirmed the proficiency testing failure. 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 --