Family Care Physicians

Summary Statement of Deficiencies 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 a lack of records and interview with the Technical Consultant (TC), the laboratory failed to report positive SARS-CoV-2 test results as required for 2 (testing on 12/16/2022 and 1/03/2023) of 25 patients tested since the laboratory started testing in December 2022. Findings include: 1. An interview on 2/09/2023 at 11:32 am with the TC revealed the laboratory started testing in December of 2022 and had a total of 25 patients tested with 2 positive tests for SARS-CoV-2. 2. The surveyor requested documentation of the laboratory's attempts to report positive SARS-CoV-2 results using its SARS-CoV-2 antigen test system to the health department on 2/09/2023 at 11:32 am and it was not made available. 3. An interview on 2/09/2023 at 11:32 am, the TC confirmed the laboratory had no documentation showing the 2 patients that had tested positive were reported to the health department. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification 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 -- requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure the office manager, performing the duties of a Technical Consultant, has met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure personnel performing the technical consultant duty of performing testing personnel competency assessments was qualified for 1 (office manager) of 2 personnel performing testing personnel competency assessments. Findings include: 1. A review of the laboratory's personnel competency records revealed the Technical -- 2 of 3 -- Consultant had a competency assessment performed on November 17, 2021, and November 4, 2022, by the office manager. 2. The surveyor requested the qualifications of the office manager on 2/09/2023 at 9:31 am and the documentation was not made available. 3. A interview on 2/09/2023 at 9:31 am, the TC confirmed the office manager did not have the qualifications to perform the duties of a technical consultant. -- 3 of 3 --

Summary Statement of Deficiencies 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 a lack of records and interview with the Technical Consultant (TC), the laboratory failed to report positive SARS-CoV-2 test results as required for 2 (testing on 12/16/2022 and 1/03/2023) of 25 patients tested since the laboratory started testing in December 2022. Findings include: 1. An interview on 2/09/2023 at 11:32 am with the TC revealed the laboratory started testing in December of 2022 and had a total of 25 patients tested with 2 positive tests for SARS-CoV-2. 2. The surveyor requested documentation of the laboratory's attempts to report positive SARS-CoV-2 results using its SARS-CoV-2 antigen test system to the health department on 2/09/2023 at 11:32 am and it was not made available. 3. An interview on 2/09/2023 at 11:32 am, the TC confirmed the laboratory had no documentation showing the 2 patients that had tested positive were reported to the health department. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification 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 -- requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure the office manager, performing the duties of a Technical Consultant, has met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure personnel performing the technical consultant duty of performing testing personnel competency assessments was qualified for 1 (office manager) of 2 personnel performing testing personnel competency assessments. Findings include: 1. A review of the laboratory's personnel competency records revealed the Technical -- 2 of 3 -- Consultant had a competency assessment performed on November 17, 2021, and November 4, 2022, by the office manager. 2. The surveyor requested the qualifications of the office manager on 2/09/2023 at 9:31 am and the documentation was not made available. 3. A interview on 2/09/2023 at 9:31 am, the TC confirmed the office manager did not have the qualifications to perform the duties of a technical consultant. -- 3 of 3 --

Summary Statement of Deficiencies 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 record review and interview with the Technical Consultant, the laboratory failed to correct positive patient identification between the test report and the patient's medical record for 1 (Patient 120) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's patient test records revealed Patient 120 had a date of birth, used for positive patient identification, with the year 1982 listed on the Complete blood Count test report from testing performed on 2/10/20. 2. A review of Patient 120's medical record revealed the patient's date of birth year was 1992. 3. An interview on 7/20/21 at 10:26 am with the Technical Consultant confirmed Patient 120 had an incorrect date of birth listed on the test report. 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 D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to have an electronic request for patient testing from an authorized person for one (#2) of ten patient charts audited in 2016 and 2017. Findings include: 1. On January 29, 2018 at 11:43 a.m., document review for one of ten patient charts audited did not have a electronic request for the hematology complete blood cell count by an authorized person. 2. During the interview on January 29, 2018 at 11:43 a.m., the technical consultant as listed on the CMS-209 confirmed an electronic request for laboratory testing was not available. 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 --