Children's Medical Group Of Greenwich

Summary Statement of Deficiencies 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, surveyor observation and staff interview, the laboratory failed to check each new lot number and shipment of bacitracin discs for positive and negative reactivity in the subspecialty of bacteriology. Findings include: 1. Record review of the Bacitracin Disc Quality Control (QC) log sheets on 6/23/2022 revealed the following: a. The laboratory documents the Bacitracin Lot number and date received. b. S. pyogenes (positive control) and S. agalactiae (negative control) are the quality control organisms used. c. The last Bacitracin disc lot number documented was lot# 9156977 on 3/9/2020. d. Lack of QC documentation for shipments since April 2020. 2. Surveyor observation on 6/23/2022 at 1:30 PM of the laboratory area including the freezer and refrigerator revealed quality control organisms were not available in the laboratory. 3. Staff interview with the office manager on 6/23/2022 at 1:30 PM commented the former office manager said QC was not needed and therefore the laboratory stopped performing QC and he/she would need to order QC organisms. 4. The laboratory performs 1903 throat cultures annually in the subspecialty of bacteriology. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (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 laboratory director interview, the laboratory failed to check each lot number and shipment of Strep Select Agar (SSA) media for its ability to support growth, select or inhibit specific organisms, perform a visual inspection and check for sterility in the specialty of microbiology. Findings include: 1. Review of the Strep Select Agar Plates Quality Control log sheet on 6/23/2022 revealed the laboratory failed to document since April 2021 the following: a. The ability of the media to support growth, select or inhibit specific organisms for each lot number and shipment. b. A sterility test and visual physical characteristics of the SSA. 2. Staff interview with the laboratory director on June 23, 2022 at 12:00 PM confirmed the laboratory did not check each new lot number or shipment of SSA media for their ability to support growth, select or inhibit specific organisms, or check and document the sterility and physical characteristics. The LD commented the previous nurse manager stated that the laboratory does no longer need to perform the media QC. 3. The laboratory performs 1903 cultures annually in the specialty of microbiology. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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, testing personnel (TP) failed to test proficiency testing (PT) samples in the same manner as patient samples in the specialty of microbiology. Findings include: 1. Record review of the American Academy of Family Physicians (AAFP) PT records on 3/1/18 revealed TP had not tested PT samples for throat cultures (TC) in the same manner as patient samples for the following events: a) All PT samples were read by 5 TP for Event A in 2016 b) All PT samples were read by 2 TP for Event B in 2016 c) All PT samples were read by 5 TP for Event C in 2016 d) All PT samples were read by 2 TP for Event A in 2017 e) All PT samples were read by 3 TP for Event B in 2017 f) All PT samples were read by 5 TP for Event C in 2017 2. Record review of the laboratory's specimen log book on 3/1/18 revealed patient samples are tested and reported individually by TP. 3. Record review of the laboratory's AAFP PT attestation sheets on 3/1/18 revealed TP failed to sign for 2016 and 2017. 4. Interview with the TP#1 on 3/1/18 at 10:00 AM confirmed PT samples were not being examined in the same manner as patient samples for the events listed above. 5. The laboratory performs 3,345 TC tests 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 --