Northeast Al Peds

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with the Laboratory Manager (LM), the laboratory failed to ensure PT results were submitted before the postmark due date. This was noted for one of three events reviewed in 2023. The findings include: 1. A review of the API PT records revealed a score of 0% and "Failure to participate" on 2024 Complete Blood Count (CBC) Hematology Event 3 with a deadline date of 11/20 /2024. 2. At 9:30 AM on 2/27/2024, The LM confirmed the above findings. 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 D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration and quality control (QC) records, the Medonic user manual, and an interview with Testing Personnel #1, the Laboratory failed to ensure: a) Calibrations on the Medonic Hematology analyzer were documented every six months as per the manufacturers instructions; The laboratory failed to document two of two calibrations due in 2022. b) QC was performed after calibration and before patient testing on 7/13/2023. The findings include: 1. A review of the Hematology calibration records revealed the Medonic was calibrated 8/20/2021 and then seventeen months later on 1/30/2023. There was no documentation of a calibration the first half and second half of 2022. 2. A review of the Hematology QC records revealed the laboratory failed to perform and document QC after a calibration and before patient testing on 7/13/2023, 1 patient Complete Blood Count (CBC) performed. 3. A further review of the Medonic user manual revealed on page 59 "It is recommended to calibrate the instrument every 6 months." 4. During an interview on 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 -- September 18, 2023, at 13:30 PM, Testing Personnel #1 confirmed the documentation for the calibrations performed in 2022 could not be located and no QC was performed prior to patient testing on 7/13/2023. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute Proficiency Testing Evaluations, the laboratory failed to successfully perform in proficiency testing for Bacteriology (Throat Cultures) for two of three consecutive testing events, Event #3, 2021 and Event #2, 2022. The findings include: Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(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 -- Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) Evaluations, the laboratory failed to satisfactorily perform in PT for Bacteriology (Throat Cultures) for two of three consecutive testing events, Event #3, 2021 and Event #2, 2022. These failures resulted in an initial unsuccessful participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following: Bacteriology, Event #3, 2021 0 percent Bacteriology, Event #2, 2022 40 percent 2. A review of the API PT evaluations confirmed the laboratory scored 0 % for Throat Cultures for Event #3, 2021, and 40 % for Event #2, 2022. -- 2 of 2 --

Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Microbiology - Throat Cultures testing for Event #2 2020 and Event #3 2021. The laboratory scored zero percent (0%) for these events, due to the failure to timely submit the results. This affected two of seven Microbiology PT events reviewed by the surveyor. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the Event #2 2020 was 07/06/2020. The API Performance Summary for Event #2 2020 revealed zero percent (0%) for Throat Culture failure to participate. 2. A review of the PT records revealed the due date to submit API proficiency testing results for the Event #3 2021 was 10/13/2021. The API Performance Summary for Event #3 2021 revealed zero percent (0%) for Throat Culture failure to participate. 3. During an interview on 02/03/2022 at 10:53 AM, Testing Personnel #1 confirmed Event #2 2020 due date was overlooked, and Event #3 2021 arrived while she was out sick. The two new employees did not see the PT in time to perform before the due date. Also, Testing Personnel #1 confirmed 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 -- patient testing was being performed during these time periods, when staff failed to perform proficiency testing. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Medonic M-series calibration records, Medonic M-series User's Manual, and interview with Testing Personnel #1, the laboratory failed to calibrate the Micro Pipette Adapter (MPA) on the Medonic M-series which is the mode patient testing was being performed. This was noted from previous survey (September 2019) to current survey (February 2022), and affected four calibrations. The findings include: 1. A review of the Medonic M-series calibration records revealed the laboratory performed calibration for the Open Tube mode on 3/10/2020, 09/17/2020, 2/08/2021, and 8/20/2021. The last calibration log on 08/20/2021 revealed the MPA was last calibrated on 09/06/2018. 2. A review of the Medonic M- series User's Manual revealed on page 62 "...To calibrate MPA follow Steps 1-17 above except select [CALIBRATION] and then choose [CAPILLARY DEVICE] instead of Whole Blood Calibration in Step 6 and use MPA mode for analysis." 3. During an interview on 02/03/2022 at 11:45 AM, Testing Personnel #1 confirmed all patient samples are run in the MPA mode and calibration was being done in the Open Tube Mode. 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 a review of the Bacteriology Quality Control (QC), and an interview with Testing Personnel #1, the laboratory failed to document acceptable quality control results for negative Bacitracin ("A" disc) QC. This was noted from 09/05/2021 to 01 /20/2022, the surveyor reviewed from 09/23/2019 to 01/20/2022. This is a repeat citation. The findings include: 1. A review of the Bacteriology records revealed from -- 2 of 3 -- 09/05/2021 to 01/20/2022 the QC for Bacitracin was performed six times. During these six times the Streptococcus Agalactiae (negative control) was documented as "no growth up to disk". 2. During an interview on 02/03/2022 at 2:00 PM, Testing Personnel #1 stated she documented incorrectly for the negative Bacitracin QC because she had to re-document due to coffee being spilled on the originals. The surveyor asked why the form submitted as

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the Bacteriology Quality Control (QC) records, and an interview with Testing Personnel (TP) #1, the laboratory failed obtain and retain the manufacturer's insert for BD BBL Taxo A discs (Bacitracin discs) as per