Physicians To Children Llc

Summary Statement of Deficiencies D0000 A recertification survey conducted from 06/01/2022 to 06/09/2022 found the PHYSICIANS TO CHILDREN LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following condition was cited: - D3000 FACILITY ADMINISTRATION. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain copies of the testing results (instrument printouts) and attestation from the proficiency testing (PT) for one out of six events for the specialty of Hematology (2020-2022). Findings include: -Review of American Academy of Family Physicians (AAFP) PT records for Hematology specialty in 2020 (second and third event), 2021 (first, second and third event) and first event of 2022 revealed that: -The laboratory failed to have an attestation signed by testing personnel (TP) and laboratory director (LD) and failed to have the instrument printouts for the first event of 2022. During an interview on 06/01 /2022 at 01:30 PM, the LD confirmed that the laboratory failed to have the documents listed above for the event of reference. 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 -- D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on records review and interview with Laboratory Director (LD), the laboratory failed to report SARS-COV-2 Antigen test results as required to Florida Department of Health (FDOH) since testing began on 02/07/2021. Findings include: -Review of Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS- 116) signed by the Laboratory Director on 05/31/2022, revealed that the laboratory performed Status COVID-19 Antigen/Flu A/B test to detect SARS CoV-2 Antigen. -Review of SARS CoV Antigen testing records revealed that the laboratory started testing with Care Start COVID-19 Antigen test on 02/07/2021, Quidel QuickVue on 09/09/2021 and Status COVID-19 Antigen/Flu A/B test from 01/04 /2022. The laboratory performed 600 tests with 72 tests results positive from 02/07 /2021 to 06/01/2022 -The laboratory had no records of reporting test results to the FDOH. During an interview on 06/01/2022 at 1:30 PM, the LD confirmed the laboratory was not reporting results to FDOH for SARS CoV-2 test results from 02/07 /2021 to 06/01/2022 and the testing volume for this period was as listed above. 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 lack of records and testing personnel (TP) # B interview, the laboratory failed to document all required maintenance performed to the Sysmex XP-300 analyzer from 03/18/2020 to present. Findings include: Based on Sysmex XP-300 analyzer user manual, the laboratory had to perform daily, weekly, monthly and every three months maintenance actions. The laboratory had no records to document the maintenance actions required as per manufacturer instruction from 03/18/2020 to 06 /01/2022. During an interview on 06/01/2022 at 01:00 PM, the TP # B confirmed that there was no documentation of all required maintenance for the period of reference. 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 -- 2 of 3 -- test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with Laboratory Director /Technical Consultant revealed that he failed to perform initial competency evaluation for testing personnel (TP) # B. Findings include: - Review of the CMS-209 form Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 06 /01/2022 revealed that the laboratory had two TP (A and B). -TP B started in December 2021, the laboratory had no records of the initial competency evaluation completed for the staff. During an interview on 06/01/2022 at 12:30 PM, with LD, he confirmed that there was no initial competency evaluation for TP B. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 06/01/2022 to 06/09/2022 found the PHYSICIANS TO CHILDREN LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain copies of the testing results (instrument printouts) and attestation from the proficiency testing (PT) for one out of six events for the specialty of Hematology (2020-2022). Findings include: -Review of American Academy of Family Physicians (AAFP) PT records for Hematology specialty in 2020 (second and third event), 2021 (first, second and third event) and first event of 2022 revealed that: -The laboratory failed to have an attestation signed by testing personnel (TP) and laboratory director (LD) and failed to have the instrument printouts for the first event of 2022. During an interview on 06/01 /2022 at 01:30 PM, the LD confirmed that the laboratory failed to have the documents listed above for the event of reference. 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 -- D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on records review and interview with Laboratory Director (LD), the laboratory failed to report SARS-COV-2 Antigen test results as required to Florida Department of Health (FDOH) since testing began on 02/07/2021. Findings include: -Review of Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS- 116) signed by the Laboratory Director on 05/31/2022, revealed that the laboratory performed Status COVID-19 Antigen/Flu A/B test to detect SARS CoV-2 Antigen. -Review of SARS CoV Antigen testing records revealed that the laboratory started testing with Care Start COVID-19 Antigen test on 02/07/2021, Quidel QuickVue on 09/09/2021 and Status COVID-19 Antigen/Flu A/B test from 01/04 /2022. The laboratory performed 600 tests with 72 tests results positive from 02/07 /2021 to 06/01/2022 -The laboratory had no records of reporting test results to the FDOH. During an interview on 06/01/2022 at 1:30 PM, the LD confirmed the laboratory was not reporting results to FDOH for SARS CoV-2 test results from 02/07 /2021 to 06/01/2022 and the testing volume for this period was as listed above. 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 lack of records and testing personnel (TP) # B interview, the laboratory failed to document all required maintenance performed to the Sysmex XP-300 analyzer from 03/18/2020 to present. Findings include: Based on Sysmex XP-300 analyzer user manual, the laboratory had to perform daily, weekly, monthly and every three months maintenance actions. The laboratory had no records to document the maintenance actions required as per manufacturer instruction from 03/18/2020 to 06 /01/2022. During an interview on 06/01/2022 at 01:00 PM, the TP # B confirmed that there was no documentation of all required maintenance for the period of reference. 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 -- 2 of 3 -- test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with Laboratory Director /Technical Consultant revealed that he failed to perform initial competency evaluation for testing personnel (TP) # B. Findings include: - Review of the CMS-209 form Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 06 /01/2022 revealed that the laboratory had two TP (A and B). -TP B started in December 2021, the laboratory had no records of the initial competency evaluation completed for the staff. During an interview on 06/01/2022 at 12:30 PM, with LD, he confirmed that there was no initial competency evaluation for TP B. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on May 12, 2021 for Physicians to Children. The Physicians to Children laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 review of the laboratory's proficiency testing records for 2020 and 2021, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of 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 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 12, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, ABO/Rh blood typing for two out of three testing events in 2020 and 2021. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of routine chemistry. Findings include: On May 12, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, ABO/Rh blood typing, as shown below. Event #2, 2020 ABO/Rh-0% Event #1, 2021 ABO/Rh-0% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of immunohemoatology. Findings include: On May 12, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, ABO/Rh blood typing, in the specialty of immunohematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2162. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialtly of immunohematology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on May 12, 2021, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #2, 2020 ABO /Rh-0% Event #1, 2021 ABO/Rh-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Physician to Children LLC on 03/17/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 Analytic Systems 493.1250 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Testing Person, the laboratory failed to use positive and negative controls each day of use for ABO Group and Rh testing and Throat culture testing for 2 (2018-2020) out of 2 years reviewed (See D5449). D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Testing Person, the laboratory failed to use positive and negative controls each day of use for ABO Group and Rh testing and Throat culture testing for 2 (2018-2020) out of 2 years reviewed. Findings Included: 1. Review of the manufacturer's instruction for ABO Group and Rh manual slide testing controls revealed that "It is recommended that these reagents be tested on each day of use with appropriate positive and negative controls. Positive control-redblood cells known to possess the antigen toward which the reagent is directed. Group A, B red blood cells are considered an appropriate control. Negative control-red blood cells known to lack the antigen toward which the reagent is directed." The policy (last signed by the Laboratory Director on 03/03/20) stated that each day of testing "Personnel with known blood type/Rh will be used as fresh controls." Each day of testing only 1 Personnel's blood was used for controls, this does not meet the requirement of a positive and negative each day of testing as each Personnel only has 1 type of blood (for example A negative, A positive, O negative, etc.). Review of Patient logs from 08/31/18 revealed that each day of patient testing only 1 Personnel's blood was used for controls. Interview on 03/17/19 at 1:00 PM the Testing Person confirmed that 2 levels of control were not performed each day of patient testing. The laboratory does 25 patient test a year. 2. Review of the manufacturer's instruction for Throat cultures revealed that "Recommended organism strain for User Quality Control" is to plate 1 plate with "Streptococcus pyogens" and it will have heavy growth, and "Staphylococcus aureus" which will have complete inhibition. Review of Quality Control records revealed no positive or negative controls done for the plates used for Throat cultures. Interview on 03/17/20 at 2:45 PM the Testing Person revealed that they did not do a positive and negative control each day of testing and no IQCP had been performed. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on Hematology analyzer Sysmex XP-300 user manual review and interview with Testing Personnel (TP), the laboratory failed to document room temperature and humidity requirement to assure optimal operation of the analyzer during 2016, 2017, 2018. Findings include: Review of the Sysmex XP-300 manual indicates that the operation temperature range is 15 to 30 C and humidity range 30 to 85 %. There was no log available for documenting the temperature and humidity of the laboratory room. During an interview on 8/29/2018 at 10:30 a.m., the TPA confirmed that there was no documentation of room and humidity control check. 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 --