New Britain Pediatric Group

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to establish policy and procedures for proper function checks of ancillary equipment to ensure accurate and reliable test results are obtained in the subspecialty of bacteriology. Findings include: 1. Surveyor observation on 11/14/2024 at 10:00 AM of the bacteriology laboratory area revealed three thermometers in use lacking calibration date documentation. 2. Record review on 11/14/2024 of the laboratory's quality binders revealed: a.Lack of documentation of calibration being performed for 3 of 3 thermometers in use. b.Lack of documentation of an established policy and procedure for the proper function check of ancillary equipment. 3. Staff interview at 11 /14/2024 at 10:30 AM with the Laboratory Director (LD) confirmed the above findings. The LD further commented that he/she was not aware that the thermometers needed to be calibrated. 4. The laboratory performs 2,000 tests annually in the subspecialty of bacteriology. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) 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 -- (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to check each new lot number and shipment of media for sterility and the ability to support growth and, as appropriate, select for or inhibit specific organisms prior to patient testing in the subspecialty of bacteriology. Findings include: 1. Record review of the 'Uricult Testing' and 'Uricult Quality Control Log' on 11/14/2024 revealed the laboratory failed to check each new lot number and shipment for sterility and the ability to support growth, select or inhibit specific organisms prior to patient testing for 3 of 8 new reagent lots from 01/09/2023 to 11/12/2024. 2. Record review of the 'Bacteriology Media Control log' and 'Selective Strep Agar (SSA) Quality Control Log' on 11/14/2024 revealed the laboratory failed to check each new lot number and shipment for sterility and the ability to support growth, select or inhibit specific organisms prior to patient testing for 9 of 12 reagent lots from 05/09/2023 to 10/15 /2024. 3. Staff interview with the laboratory director on 11/14/2024 at 11:00 AM confirmed the laboratory did not check each new lot number or shipment of SSA or Uricult media prior to patient testing. 4. The laboratory performs 2,000 tests annually in the subspecialty of bacteriology. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to evaluate the competency assessment (CA) of testing personnel (TP) using the six required elements to perform and report accurate test results in the subspecialty of bacteriology. Findings include: 1. Record review on 11/14/2024 of the laboratory's CMS 209 form "Laboratory Personnel Report (CLIA)" revealed 6 of 6 TP performing moderate complexity testing. 2.Record review on 11/14/2024 of the laboratory's annual competency evaluation forms for the year 2023 and 2024 revealed lack of documentation for the six required CA criteria for 6 of 6 TP. 3.Staff interview on 11 /14/2024 at 11:30 AM with the technical consultant confirmed the above findings. 4. The laboratory performs 2000 tests annually in the subspecialty of bacteriology. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on record review and staff interview, proficiency testing (PT) samples were being used as internal blind samples for assessing competency of testing personnel (TP) prior to submitting the test results to the PT program due date in the specialty of microbiology. Findings include: 1. Record review of the College of American Pathologists (CAP) PT records on 9/4/18 revealed 5 of 6 TP tested the same PT samples as internal blind samples prior to the CAP PT program due date for the 2016, 2017 and 2018 throat culture surveys. 2. Record review of the laboratory's patient log book on 9/4/18 revealed 1 of 6 TP tested swab A, and 5 of 6 TP tested swab B prior to the PT due date for the above surveys. 3. Interview with the laboratory director (LD) on 9/4/18 at 9:15 AM confirmed 5 of 6 TP tested PT samples as internal blind samples prior to the CAP PT program due date for the above surveys. 4. The laboratory performs 1, 217 throat cultures annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test 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 2 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory did not verify accuracy bi- annually for Uricult testing. Findings include: 1. Record review of laboratory's proficiency testing records on 9/4/18, revealed the laboratory did not verify the accuracy of the Uricult test at least twice annually for 2016 and 2017. 2. Staff interview with laboratory director on 9/4/18 at 10:15 AM confirmed the laboratory did not have a system in place to verify the accuracy of Uricult testing bi-annually in 2016 and 2017. 3. The laboratory performs 275 Uricult tests annually. -- 2 of 2 --