James P D'Apolito Md Pediatrics Inc

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 record review and an interview with the Office Manager (OM), the laboratory failed to enroll with a proficiency testing (PT) provider for the Group A Streptococcus (Strep) throat culture (cx) tests performed in the subspecialty of Bacteriology. This deficient practice had the potential to affect 93 out of 93 patient Group A Strep throat cx tests performed in this laboratory from 01/02/2024 through 05 /14/2024. Findings Include: 1. Review of the laboratory's "Throat Culture Quality Control" policy and procedure, approved by the Laboratory Director on 04/10/2018 and provided on the date of the inspection, found the following statements: "Every Quarter We have enrolled in a quality control program through the C.A.P...to test our proficiency with throat cultures... When office receives our C.A.P. kit; it is immediately refigerated. The kit is opened and checked for due date...we perform testing on the "unknowns" according to the enclosed instructions... ....cultures are performed just as we would on a patient." CAP; College of American Pathologists 2. Review of the laboratory's CAP PT documentation provided on the date of the inspection did not find any PT records for 2024. 3. The Inspector requested the laboratory's 2024 PT documentation from the OM. The OM was unable to locate any PT documentation for 2024 at the time of the inspection on 05/14/2024 at 9:50 AM 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 -- and later confirmed via electronic mail (email) on 05/14/2024 at 10:33 AM "I called CAP and we unfortunately did not enroll in proficiency testing for 2024." D6097 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(7) The laboratory director must ensure that patient test results are reported only when the system is functioning properly. This STANDARD is not met as evidenced by: Based on record review and an interview with the Office Manager (OM), the Laboratory Director failed to ensure that patient Group A Streptococcus (Strep) throat culture (cx) test results were only reported when the incubator temperatures were monitored and documented according to the manufacturer's specifications and laboratory's policy and procedure. This deficient practice had the potential to affect nine out of nine patient Group A Strep throat cx test results performed on three days of patient testing when the incubator temperatures were out of the acceptable range between 12/14/2023 through 01/25/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, signed by the Laboratory Director on 05/14/2024, found the Laboratory Director was listed as the sole testing personnel. 2. Review of the "BD BBL Taxo A Discs for Differentiation of Group A Streptococci" manufacturer's package insert revealed the following instructions: "2. Incubate plate(s) in ambient air (or in an atmosphere enriched with 5 to 10% CO2) at 35 to 37 C for 18 to 24 hours." 3. Review of the laboratory's "Selective Streptococcus Agar (SSA)/Throat Swab" policy and procedure, approved by the Laboratory Director on 02/11/2016 and provided on the date of the inspection found the following statement: "8. Invert the plate and place it in the incubator at 35C +/- 2 in CO2 for 18 - 24 hours." 4. Review of the laboratory's "CLIA Management Sheet" revealed a chart with the columns labeled and documentation indicated as follows on days of patient Group A Strep throat cx testing: Date Time Incubator Temp 12/14/23 8:41 40 01/18/24 8:30 34 01/25/24 3:02 34 5. Further review of the laboratory's "CLIA Management Sheet" found the following statement: "Incubator temps must stay between 35-37 degrees Fahrenheit... revised 1/20" 6. Review of the laboratory's Selective Streptococcus Agar with Bacitracin QC and Patient Log" worksheet found the following patient Group A Strep throat cx testing conducted on days when the incubator temperatures were out of the acceptable limits. Patient Date Date CX Plated Read Result #1 12/14/23 12/15/23 negative #2 12/14/23 12/15/23 negative #3 12/14/23 12/15/23 negative #4 12/14/23 12 /15/23 negative #5 01/18/24 01/19/24 negative #6 01/18/24 01/19/24 negative #7 01 /25/24 01/26/24 negative #8 01/25/24 01/26/24 negative #9 01/25/24 01/26/24 negative 7. Review of the laboratory's "Throat Culture Quality Assessment" policy and procedure, approved by the Laboratory Director via signature and date on 04/10 /2018 and provided on the date of the inspection, found two (2) patient throat cx cases were reviewed each quarter in 2022, 2023 and the first quarter in 2024 per the laboratory's protocol with no incubator temperature errors identified for

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 on record review and an interview with the Laboratory Director, the laboratory failed to follow the manufacturer's instructions for the incubation time of the Selective Streptococcus Agar (SSA) and Taxo A discs, utilized for throat Group A Streptococcus (strep) testing procedures. This deficient practice had the potential to affect three out of three patient throat cultures tested and reported on 12/05/2019. Findings Include: 1. Review of the BD BBL Taxo Discs for Differentiation of Group A Strep manufacturer's instructions revealed the following statements: BD BBL Taxo A discs "Test Procedure 1. ...place the Taxo A disc in the center of the inoculated area... 2. Incubate plate(s)...for 18 to 24 hours." 2. Review of the laboratory's 2018, 2019, and 2020 patient test records on the "Selective Streptococcus Agar with Bacitracin QC and Patient Log" worksheets revealed documentation when the throat cultures were plated as well as when the throat cultures were read (interpreted). 3. Review of three out of three of the laboratory's patient test records and test reports from 12/03/2019 revealed throat culture test results were not read (interpreted) and reported following the manufacturer's instructions of 18-24 hours of incubation with the use of the Taxo A disc as indicated below: Date Date Culture Culture Plated Read 12/03/19 12/05/19 12/03/19 12/05/19 12/03/19 12/05/19 4. The Laboratory Director confirmed, at 10:20 AM on 02/06/2020, that the laboratory's test records and final test reports for the Strep A throat culture tests utilizing SSA and Taxo A discs indicated 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 -- that the laboratory did not follow the BD BBL Taxo Disc manufacturer's requirement of 18-24 hours of incubation and the three patient throat cultures indicated above were read (interpreted) and reported beyond 24 hours of incubation. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and an interview with the Laboratory Director, the laboratory failed to document the handling, preparation, processing, examination and each step in the testing and reporting of proficiency testing (PT) results. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find any mention of PT policies and procedures. 2. The Surveyor requested the laboratory's PT policy and procedure from the Laboratory Director. The Laboratory Director confirmed the laboratory did not have an established PT policy and procedure. The interview occurred on 03/20/2018 at 9:12 AM. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or 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 -- examining specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the laboratory failed to follow their written throat culture reporting procedures according to the manufacturer's instructions. Findings Include: 1. Review of the Beckon Dickinson (BD) BBL Taxo A disc manufacturer's package instructions found the following reporting instructions: "...any zone of inhibition, regardless of diameter, be reported as "beta-hemolytic Streptococcus, presumptively group A by bacitracin. No zone of inhibition (growth up to the edge of the disc) is reported as "beta-hemolytic Streptococcus, presumptively not group A by bacitracin." 2. Review of the laboratory's "Selective Streptococcus Agar (SSA) / Throat Swab" policy and procedure found the following reporting instructions: "C. Positive result: ... Presumptive Group A Streptococcus by bacitracin. D. Negative result: ...Negative for Group A Streptococcus or Beta hemolytic streptococci not Group A by bacitracin. ... The absence of beta hemolytic colonies on the SSA plate should be reported as "No Group A Streptococcus isolated." 3. Review of 13 out of 13 of the laboratory's 2016, 2017 and 2018 throat culture test reports, provided on the date of the inspection, did not find that the laboratory reported throat culture results according to the manufacturer's and laboratory's instructions. The laboratory reported the 13 throat culture results reviewed in the following variety of ways: "threoat cx is negative" "throat cx isnegative" "throat cx is negative" 4. The Laboratory Director stated the laboratory's throat culture test reporting is a free text field in the patients' electronic medical record and confirmed the laboratory did not follow the manufacturer's or laboratory's throat culture reporting instructions. The interview occurred on 03/20 /2018 at 9:50 AM. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the Laboratory Director failed to ensure that a quality assessment program was established. Findings Include: 1. Review of the laboratory's policies and procedures, provided on the date of the inspection, did not find any mention of quality assessment policies and procedures. 2. The Surveyor requested the laboratory's quality assessment policy and procedure from the Laboratory Director. The Laboratory Director confirmed the laboratory did not have an established quality assessment policy and procedure. The interview occurred on 03/20/2018 at 9:19 AM. D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director, the Laboratory Director failed to ensure that all remedial actions were taken and documented whenever the incubator temperatures deviated from the manufacturer's and laboratory's established temperature criteria for the incubation temperature of the Selective Streptococcal Agar (SSA) and Becton Dickinson (BD) BBL Taxo A discs utilized for the throat culture testing procedures performed. Findings Include: 1. Review of the manufacturer's package instructions for the SSA found the following statement: "Incubate the plates...at 35-37C" 2. Review of the manufacturer's package instructions for the BD BBL Taxo A discs found the following statements: "Incubate... at 35 to 37 C" 3. Review of the laboratory's 2016, 2017 and 2018 incubator temperature logs where the SSA and Taxo A discs were incubated prior to interpretation revealed documented incubator temperatures that were outside of the manufacturer's incubation requirements without indication of any