Pediatric Associates Of New Bedford

Summary Statement of Deficiencies D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(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 record review and confirmed through an interview with the technical consultant (TC), the TC failed to assess the competency of all testing personnel (TP) through testing previously analyzed specimens, internal blind testing samples or external proficiency testing (PT) samples in the specialty of Hematology. Findings include: 1. Record review on 5/3/2023 of the laboratory's 2021 and 2022 American Proficiency Institute PT attestation sheets revealed 1 of 3 moderate complexity TP did not have their competency assessed through testing previously analyzed specimens, internal blind samples or external PT samples in the specialty of Hematology. 2. Record review on 5/3/2023 of the laboratory's PT policy revealed, a. "It is essential that all personnel be involved in testing." b. "PT samples are tested with the lab's regular patient workload by personnel who routinely perform testing." 3. Record review on 5/3/2023 of the 2021 and 2022 competency assessment records for TP#1 revealed: a. Section d. Assessment of test performance through external PT was checked off as being performed. b. The competency records were signed by the TC. 4. Staff interview on 5/3/2023 at 10:26 AM with TP#2 confirmed TP#1 did not perform PT or test a previously analyzed or blind sample in 2021 and 2022 in the specialty of Hematology. TP#2 stated, "TP#1 is only here a few days a week." 5. Staff interview on 5/3/2023 at 10:28 AM with the TC confirmed TP#1 did not perform PT or test a previously analyzed or blind sample in 2021 and 2022 in the specialty of Hematology. The TC also confirmed the above indicated competency sheets were signed as completed for testing PT, previously analyzed or blind samples. 6. The laboratory performs 14,987 tests annually in the specialty of Hematology. 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 D0000 A CLIA recertification survey was conducted for the Pediatrics Associates of New Bedford laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to indicate on the final patient test report the name and address of the referring laboratory where the test was performed as evidenced by the following: Surveyors reviewed fourteen (14) final patient test reports between 11/30/17 and 3/18/19 in the Epic Electronic Medical Record (EMR). The review revealed the name of the referring laboratory on the final patient test reports in the Epic EMR was Southcoast. The referring laboratory's name and address is St Luke's Hospital, 101 Page Street, New Bedford, MA 02740. The laboratory transitioned EMR vendors from eClinical Works to Epic in 2017. The technical consultant and testing person 1 confirmed in an interview on 3/22/19 at 3:00 P.M. that the final patient test reports did not indicate the name and address of the referring laboratory where the test was performed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES 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): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: Surveyors reviewed the personnel competency records for calendar years 2017 and 2018 on 3/22/19. The review revealed that semiannual competency evaluations were not performed and documented for three (3) out of three (3) newly hired testing persons (TP) for calendar year 2018. The TC and TP1 confirmed in an interview on 3/22/19 at 10:08 A.M. that the TC failed to perform and document semiannual competency evaluations for the three new TP. -- 2 of 2 --