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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 desk review of the Center for Medicare and Medicaid Services CASPER Report 0155D (CMS 155) and the laboratory's College of American Pathologists (CAP) proficiency testing records, the laboratory failed to successfully participate in the specialty of Immunology for the Immunoglobulin E (IgE) and Immunoglobulin M (IgM) analytes for two out of three consecutive testing events, resulting in the initial unsuccessful proficiency testing (PT) occurrence. (Refer to D2084 and D2085). D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 satisfactory performance for the same analyte or test 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 a desk review survey of the CMS 155 and the laboratory's 2021 and 2022 CAP PT records, the laboratory failed to maintain satisfactory performance for the Immunoglobulin E (IgE) and Immunoglobulin M (IgM) analytes in the 2nd event of 2021 and 1st event of 2022, resulting in the initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory PT scores for the IgE and IgM analytes: 2021 Event two: IgE: 0% IgM: 60% 2022 Event one: IgE: 0% IgM: 0% 2. Review of the Laboratory's CAP PT performance evaluation records revealed the following unsatisfactory scores for the IgE and IgM analytes: 2021 Event two: IgE: 0% IgM: 60% 2022 Event one: IgE: 0% IgM: 0% D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) 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 desk review survey of the CMS 155 and the laboratory's 2021 and 2022 CAP PT records, the laboratory failed to achieve satisfactory performance for the overall specialty of Immunology in two out of three PT events in 2021 (event 2) and 2022 (event 1). The findings include: 1. Review of the CASPER CMS 155 report, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Immunology in two of three events: 2021 Event two: 65% 2022 Event one: 0% 2. Review of the Laboratory's College of American Pathologists (CAP) performance evaluation records revealed the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Immunology in two of three events: 2021 Event two: 65% 2022 Event one: 0% -- 2 of 2 --

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 review of the laboratory proficiency testing (PT) records and interview with the lead testing person, the testing personnel and/or laboratory director failed to sign attestation statements for ten of twenty five PT events in 2021 and 2022. The findings include: 1. Review of the laboratory's PT records revealed the following: Attestation statements not signed by the laboratory director for nine of twenty five events: - No laboratory director signature on the following attestation statements: 2021 hematology event one, 2021 celiac serology event two, 2021 general chemistry and therapeutic drugs event one - No laboatory director signature (testing person signed in lab director space) on the following attestation statements: 2021 hematology event two, 2021 diagnostic allergy events one and three, 2021 diagnostic immunology event three, and 2021 general chemistry and therapeutic drugs events two and three. Attestation statement not signed by testing personnel for one of twenty five events (2022 diagnostic allergy event one). 2. Interview with the lead testing person on October 12, 2022 at approximately 2:30 pm confirmed testing personnel and/or laboratory director failed to sign attestation statements for ten of twenty five events in 2021 and 2022. =================================== D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, 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 -- 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 review of laboratory records and interview with the lead testing person, the laboratory failed to retain the attestation statement for one of twenty five proficiency testing (PT) events in 2021 and 2022. The findings include: 1. Review of proficiency testing records revealed no retention of the attestation statement for 2021 hematology event three. 2. Interview with the lead testing person on October 12, 2022 at approximately 2:30 pm confirmed the survey findings. =================================== -- 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: =================================== The laboratory failed to maintain satisfactory participation in three out of four events for the following analytes: Cell ID or WBC Diff, hemoglobin (HGB), hematocrit (HCT), white blood cells (WBC), red blood cells (RBC) and platelets (PLT), resulting in non-initial unsuccessful participation in proficiency testing. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) 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 satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 155 (CMS 0155D) and College of American Pathologists (CAP) performance summary, the laboratory failed to maintain satisfactory performance in Cell ID or WBC Diff, Hemoglobin (HGB), Hematocrit (HCT), White Blood Cell (WBC), Red Blood Cell (RBC) and platelets (PLT) for the 1st and 3rd events 2021 and 1st event 2022, resulting in non-initial unsuccessful performance in proficiency testing. The findings include: 1. A review of the CMS 0155D report for 2021 revealed the Cell ID or WBC Diff, HGB, HCT, WBC, RBC and PLT scores for event one and event three= 0%. 2. A review of the CMS 0155D report for 2022 revealed the Cell ID or WBC Diff, HGB, HCT, WBC, RBC and PLT scores for event one=0%. 3. A review of the 2021 CAP PT Performance Summary for event one and event three revealed the Cell ID or WBC Diff, HGB, HCT, WBC, RBC and PLT analytes were graded as unsatisfactory with scores of 0%. 4. A review of the 2022 CAP PT Performance Summary for event one revealed the Cell ID or WBC Diff, HGB, HCT, WBC, RBC and PLT analytes were graded as unsatisfactory with scores of 0%, resulting in non-initial unsuccessful performance in proficiency testing performance. =================================== 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: =================================== The Laboratory Director failed to provide direction for successful Proficiency Testing (PT) Participation in three out of four events for Hematology in 2021 and 2022 resulting in non-initial unsuccessful proficiency testing participation. (Reference 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 review of the CMS 0155D -- 2 of 3 -- Report and the College of American Pathologists (CAP) PT Program Evaluation Report of the Unsatisfactory Scores for Hematology for three of four events for 2021 and 2022, determined the Laboratory Director failed to provide effective direction over Proficiency Testing for Cell ID or WBC Diff, Hemoglobin (HGB), Hematocrit (HCT), White Blood Cell (WBC), Red Blood Cell (RBC) and platelets (PLT) for the 1st and 3rd events 2021 and 1st event 2022, resulting in the non-initial unsuccessful participation in proficiency testing (PT)performance. (Refer to D2130) -- 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: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of three events for the Cell Identification (Cell I.D.), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), and Platelet (PLT) analytes resulting in the initial unsuccessful proficiency testing (PT) occurrence for Cell I.D., RBC, HCT, HGB, WBC, and PLT (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) 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 satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: =================================== Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2021 Proficiency Testing (PT) performance summary records from the College of American Pathologists (CAP) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Cell I.D., RBC, HCT, HGB, WBC, and PLT analytes in the 1st event 2021 and 3rd event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory Cell I.D., RBC, HCT, HGB, WBC, and PLT analyte scores of 0% for the 1st event of 2021 and the 3rd event of 2021. 2. A review of the laboratory's CAP Proficiency Testing records revealed unsatisfactory Cell I.D., RBC, HCT, HGB, WBC, and PLT analyte scores of 0% for the 1st event of 2021 and the 3rd event of 2021, resulting in the initial unsuccessful PT occurrence. =================================== -- 2 of 2 --