Pediatric Associates Of Fall River

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the College of American Pathologists (CAP) proficiency testing (PT) record review and confirmed through an interview with the Laboratory Supervisor (LS) and Laboratory Director (LD), the laboratory did not enroll in PT for complete blood count (CBC) testing in the specialty of Hematology. Findings include: 1. Record review on 8/7/2024 of the laboratory's CASPER Report 0096D, CLIA Application and Survey Summary Report revealed there were no scores reported to CMS in 2023 and 2024 to date for the regulated Hematology analytes white blood cell differential, red blood cell count, white blood cell count, hemoglobin, hematocrit and platelets. 2. Record review on 8/7/2024 of the laboratory's 2023 and 2024 to date PT records revealed the laboratory did not have PT records for the analytes in #1 above. 3. Record review on 8/7/2024 of the laboratory's CBC volume report revealed the laboratory was performing CBC testing until 3/12/2024. 4. Staff interview with the LS and LD on 8/7/2024 at 12:15 PM confirmed the laboratory was performing CBC testing in 2023 and up until 3/12/2024 and was not enrolled in PT. The LS stated, CBC testing was temporarily stopped as of 3/13/2024 because the laboratory has purchased a new CBC analyzer and the old analyzer is unreliable. 5. The laboratory performs 1,428 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 3 -- D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to test proficiency testing (PT) samples in the same manner as patient samples by testing personnel who routinely perform the testing in the subspecialty of Bacteriology. This is a repeat deficiency cited at the 11/15/2022 survey. Findings include: 1. Record review on 8/7 /2024 of the laboratory's College of American Pathologists (CAP) 2023 PT Bacteriology Survey D attestation sheets record revealed 4 of of 13 bacteriology TP who perform throat cultures did not participate in PT in 2023. 2. Staff interview on 8/7 /2024 at 12:15 PM with the laboratory supervisor and laboratory director confirmed the above findings. 3. The laboratory performs 2,577 throat cultures annually in the subspecialty of bacteriology. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as patient samples by testing personnel (TP) who routinely perform the testing in the subspecialty of Bacteriology. Findings include: 1. Record review on 11/15/2022 of the laboratory's College of American Pathologists (CAP) 2021 and 2022 Bacteriology Survey D attestation sheets revealed: a. 13 of 15 bacteriology TP who perform throat cultures did not participate in PT in 2021. b. 14 of 16 bacteriology TP who perform throat cultures did not participate in PT in 2022. 2. Staff interview with TP #1 on 11/15/2022 at 11:00 AM confirmed the above TP did not participate in PT. 3. The laboratory performs 4,556 throat cultures annually. 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 Pediatric Associates of Fall River laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with the Laboratory Director (LD) on 2/23/21, the laboratory failed to document and maintain a copy of all PT records as evidenced by the following: The surveyor reviewed College of American Pathologists (CAP) PT records for calendar years 2019 and 2020. The review revealed that attestation statements provided by the PT program were not signed by the LD and analyst for the following events: 1. FH2- A & C 2019 Hematology Auto Differentials Events 1 and 3 2. HC7-C 2019 Chlamydia/GC with DNA Survey Event 3 3. D1-A 2019 Throat Culture Event 1 4. CM-A 2020 Clinical Microscopy Event 1 5. D1-A 2020 Throat Culture Event 1 6. FH2- A & B 2020 Hematology Auto Differentials 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 -- Events 1 and 2 7. HC7-A & C 2020 Chlamydia/GC with DNA Survey Events 1 and 3 The LD confirmed in an interview on 2/23/21 at 2:15 PM that not all attestation statements were signed by the analyst and laboratory director. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (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 (LD) on 2/23/21, the laboratory failed to check each lot number and shipment of disks when opened for positive and negative reactivity as evidenced by the following: The laboratory performs throat culture screens for presumptive identification of Group A Streptococci (GAS) using Selective Strep Agar and Bacitracin disks. Quality control (QC) record review on 2/23/21 revealed that the laboratory did not check each lot and each shipment of Bacitracin disks with positive and negative organisms. There were no Bacitracin disk QC records available for the following lot numbers of Bacitracin disks: Lot Number: Expiration Date: 1. 8116687 11/30/19 2. 8150727 12/21/19 3. 429135 6/30/22 4. 429744 6/30/22 5. 431993 7/31/22 Interview with the LD on 2/23 /21 at 2:00 PM confirmed that the laboratory failed to check each lot and shipment of Bacitracin disks using GAS positive and negative organisms. -- 2 of 2 --