Advocare West Morris Pediatrics

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records. Procedure Manual and interview with the Technical Consultant (TC), the laboratory failed to follow its policies for assessing the competency of Testing Personnel (TP) from 5/24 /23 to 3/11/25. The findings include: 1. There was no documented evidence CA was performed on TP # 2 as listed on the CMS 209 form in calendar year 2023. 2. The TC confirmed on 3/11/25 at 10:45 am, the laboratory failed to follow its policies for assessing the competency of TP in calendar year 2023. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on the lack of Quality Assessment Records (QAR), surveyor review of the Procedure Manual and interview with the Technical Consultant (TC), the LD failed to ensure that a Quality Assessment (QA) program was established to assure the quality 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 -- of laboratory services provided from 5/24/23 to 3/11/25. The findings include: 1. There were no QAR or procedures for QA available for review. 2. The TC confirmed on 3/11/25 at 10:45 am, the LD did not ensure the QA program was established. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to maintine NJCLL for 2023. The Supervisor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 5/23/23 that the laboratory did not have a NJCLL license for 2023. 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 surveyor review of the Quality Control (QC) records and interview with the Techincal Supervisor (TS), the laboratory failed to check each lot number and shipment of BBL Bacitracin Discs for negative reactivity from 3/25/23 to the date of the survey. The findings include: 1. There was no evidence that the laboratory used a 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 -- beta-hemolytic streptococcal species belonging to groups B, C, D and/or G to demonstrate lack of zone formation for a negative control. 2. The TS confirmed on 5 /23/23 at 11:00 am that negative QC was not performed. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the laboratory failed to follow the CA procedure for all employees who perform Throat Culture testing from 6/12/18 to the date of the survey. The findings include: 1. The CA was not performed on two out of six TP in 2019. 2. The CA was not performed on one out of six TP in 2020. 3. The TP # 2 listed on CMS form 209 confirmed on 3/25/2021 at 11:00 am the laboratory did not perform a CA on all employees. 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 surveyor review of the Quality Control (QC) records and interview with the 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 -- Testing Personnel (TP), the laboratory failed to check each lot number and shipment of BBL Bacitracin Discs for positive and negative reactivity from 6/12/2018 to the date of the survey. The findings include: 1. There is no documentation provided to show a presence of a zone of growth inhibition for a positive control. 2. There is no documentation provided to show a lack of zone formation for a negative control. 3. Approximately 15 specimens per day from 6/12/18 to the date of the survey were affected by a lack of QC records. 4. The TP #2 listed on CMS form 209 confirmed on 03/25/2021 at 11:00 am that QC was not performed. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (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 the surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of Throat Culture media for sterility from 6/12/18 to the date of the survey. The TP #2 listed on CMS form 209 confirmed on 3/25/21 at 10:30 am the laboratory did not perform the above QC. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Test Reports (TR) and interview with the Testing Personnel (TP), the laboratory failed to have an accurate Reference Ranges (RR) for Throat Culture (TC) tests from 06/12/18 to the date of the survey. The findings include: 1. A review of the TR revealed the RR was listed as "Negative, Presumptive, Not Performed" 2. The TP #2 listed on CMS form 209 confirmed on 3/25/21 at 10:30 am that these TC tests did not have accurate RR on the TR. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA on six out of six TP in the calendar year 2017. The TP #2 listed on CMS form 209 confirmed on 6/12 /18 at 10:20 am that CA was not performed in 20017. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of the Work Records, Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that test results were accurately transcribed on the FR from 6/9/16 to the date of survey. The 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 3 -- include: 1. A review of the Throat Culture Log (TC) and FR revealed: a. On 4/2/18 patient KL had a negataive TC but the laboratory reported positive on the FR. b. Patient SP - 3124407 had a positive rapid strep but the laboratory reported negative on the FR. 2. The TP #2 listed on CMS form 209 confirmed on 6/12/18 at 11:30 am that the laboratory did not transcribe results accurately. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that the Test Report Date (TRD) was indicated on the FR for Throat Cultures from 6/9/16 to the date of survey. The TP #2 listed on CMS form 209 confirmed on 6/12/18 at 11:35 am that the TRD was not on the FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to have a procedure to verify manually entered results into electronic medical records for accuracy from 6/9/16 to the date of survey. The TP # 2 listed on CMS form 209 confirmed on 6/15/18 at 11:15 am that the laboratory did not have the procedure mentioned above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PT samples were tested for Throat Culture (TC) tests in 2017 and 1-2018. The TP #2 listed on CMS form 209 confirmed on 6/15/18 at 11:30 am that the LD did not ensure PT TC samples were tested. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director failed to have training documented for one out of one new TP from 6/9/16 to the date of the survey . The TC # 2 listed on the CMS form 209 confirmed on 6/12/18 at 10:10 am that all TP did not have training records. -- 3 of 3 --