Tots N Teens Pediatrics, Pc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to ensure the previous Laboratory Director signed the attestation statements for three of eleven events in 2021. The findings include: 1. A review of the API PT records revealed the no signature by the previous Laboratory Director (or designee) on attestation statements for the following surveys: a) 2021 Hematology 1st Event. b) 2021 Hematology 2nd Event. c) 2021 Hematology 3rd Event. 2. During an interview on September 28, 2022, at 12:33 PM, Testing Personnel #1 confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Medonic M Series Complete Blood Count (CBC) Hematology analyzer maintenance records and an interview with Testing Personnel #1, the laboratory failed to document performance of monthly maintenance as defined 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 -- by the manufacturer's requirements. This was noted for six of 20 months reviewed in 2021 and 2022. The findings include: 1. A review of the Medonic M Series CBC Hematology analyzer revealed the following monthly maintenance was not documented: a) 2021: March, April, June, and July. b) 2022: July and August. 2. During an interview on September 28, 2022, at 12:26 PM, Testing Personnel #1 confirmed the above findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the validation records for the Medonic M Series Hematology analyzer, and an interview with Testing Personnel #1, the previous Laboratory Director failed to document review and approval of the installation procedures as verification of the manufacturer's performance specifications before patient testing began. This was noted on one of one new instruments performing moderate- complexity testing. The findings include: 1. A review of the validation records for the Medonic M Series Hematology analyzer revealed no documentation (signature and date) by the previous Laboratory Director to indicate review and approval of the procedures verifying the manufacturer's performance specifications. Patient CBC (Complete Blood Count) testing began July 29, 2021. 2. A review of the Medonic M Series Method Validation Evaluation revealed, "...#4. The Lab Director must sign and date to indicate all documents have been reviewed and accepted. ...". 3. During an interview on September 28, 2022, at 10:29 AM, Testing Personnel #1 confirmed the above findings. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with Testing Personnel #1, the Technical Consultant failed to ensure periodic training was provided for one of three testing personnel in 2022. The findings include: 1. A review of the personnel records revealed Testing Personnel #3 resigned in 2014 and was rehired in August 23, 2021. The records only included annual competencies performed August 23, 2021 and August 26, 2022. There was no documentation of training upon rehire. 2. During an -- 2 of 3 -- interview on September 28, 2022, at 10:26 AM, Testing Personnel #1 was unaware the laboratory should have retrained Testing Personnel #3, since it was seven years between her resignation and rehire. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate and document the semi-annual competency for one of three testing personnel in 2022. The findings include: 1. A review of the personnel records revealed Testing Personnel #3 resigned in 2014 and was rehired in August 23, 2021. The records only included annual competencies performed August 23, 2021 and August 26, 2022. There was no documentation of a semi-annual competency evaluation. 2. During an interview on September 28, 2022, at 10:26 AM, Testing Personnel #1 was unaware the laboratory should have retrained Testing Personnel #3, and performed a semi-annual competency, since it was seven years between her resignation and rehire. -- 3 of 3 --

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 CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed Throat Cultures (Bacteriology) for Events #1 and #2, 2021, and Event #1, 2022. These failures resulted in a non-initial unsuccessful participation for the laboratory. 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 3 -- 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 CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed Bacteriology (Throat Cultures) for Events #1 and #2, 2021, and Event #1, 2022. These failures resulted in a non-initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CMS Casper reports revealed the laboratory scored the following for Bacteriology (Throat Cultures): a) 60 % for Event #1, 2021. b) 60 % for Event #2 of 2021. c) 60 % for Event #1, 2022. These failures resulted in a non-initial unsuccessful participation. 2. A review of the API proficiency testing evaluations confirmed the above noted failures. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory director failed to ensure the testing personnel successfully participated in proficiency testing for Throat Cultures (Bacteriology). The laboratory failed Throat Cultures for Events #1 and #2, 2021, and Event #1, 2022. These failures resulted in a non-initial unsuccessful participation for the laboratory. The findings include: Refer to D6016. 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: Based on a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory director failed to ensure the testing personnel successfully participated in proficiency testing for Throat Cultures (Bacteriology). The laboratory failed Throat Cultures for Events #1 and #2, 2021, and Event #1, 2022. These failures resulted in a non-initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CMS Casper reports revealed the laboratory scored the following for Bacteriology (Throat Cultures): a) 60 % for Event #1, 2021. b) 60 % for Event #2 of -- 2 of 3 -- 2021. c) 60 % for Event #1, 2022. These failures resulted in a non-initial unsuccessful participation. 2. A review of the API proficiency testing evaluations confirmed the above noted failures. -- 3 of 3 --

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 CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed Throat Cultures (Bacteriology) for two consecutive testing events, Events #1 and #2, 2021. These failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CMS Casper reports revealed the laboratory scored sixty percent (60 %) for Events #1 and #2 of 2021. These two consecutive failures resulted in an initial unsuccessful participation. 2. A review of the API proficiency testing evaluations confirmed the above noted failures. 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 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the laboratory failed Bacteriology (Throat Cultures) for two consecutive testing events, Events #1 and #2, 2021. These failures resulted in an initial unsuccessful participation for the laboratory. Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) 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 a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #2, the surveyor determined the laboratory failed to submit results for 2019 3rd Event Hematology before the cutoff date. This was noted on one out of seventeen 2018-2020 API survey events reviewed. The findings include: 1. A review of the instrument printouts with the 2019 3rd Event Hematology survey revealed the laboratory tested the proficiency testing samples on 11/21/2019. However, the laboratory failed to submit the PT results to API by the cutoff date on 12/02/2019, and scored 0% for this survey. 2. During an interview conducted on 11/03/2020 at 12:30 PM, Testing Personnel #2 confirmed the above noted findings, stating she realized on 12/03/2019 that she had forgotten to submit the results. . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Bacteriology records, and an interview with Testing Personnel #2, the surveyor determined the laboratory failed to perform quality controls (QC) on the Taxo A discs every 30 days as per the IQCP (Individualized Quality Control Plan), and failed to document the actually QC results. The laboratory failed to perform Taxo A disc QC 29 months of the 34-month period (January 2018- Octoberb 2020) reviewed. The findings include:1. A review of the IQCP for the Taxo A discs revealed QC should be performed every 30 days using Strep pyogenes as the positive QC, and Strep agalactiae as the negative QC. The IQCP was reviewed annually, and signed most recently by the Laboratory Director on 1/28/2020 with the comment, "no changes needed". 2. A review of the Taxo A disc QC revealed testing personnel only performed QC on 2/14/2018, 6/14/2018, 3/19/2019, 6/12/2019, 8/30 /2019, 11/1/2019, and 2/2/2020. The surveyor further noted, the laboratory failed to document the lot numbers of the QC organisms, and the actual QC results. On all the above date (except 6/14/2018), testing personnel only documented "Controls passed", "QC passed", or "Controls" with a check mark, with no documentation of the organisms used, or the QC results. 3. In an interview on 11/3/2020 at 2:40 PM, Testing Personnel #2 reviewed the above noted findings, and confirmed the laboratory was not performing Taxo A disc QC every 30 days as per IQCP. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. 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 Testing Personnel #2, the Laboratory Director failed to ensure that results were submitted before the cutoff date, 12/02/2019. This affected one of seventeen API surveys (2018 - 2020) reviewed by the surveyor. The findings include: 1. A review of the instrument printouts for the 2019 3rd Hematology survey revealed the laboratory tested the proficiency testing samples on 11/21/2019. However, the Laboratory Director failed to ensure the PT results were submitted before the deadline, and scored 0% for this event. 2. During an interview conducted on 11/03/2020 at 12:30 PM, Testing Personnel #2 confirmed the above findings. 3. Also see D2123. -- 2 of 2 --