Childrens Doctor Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on, September 8 2021. Condition and Standard level Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 the review of the College of American Pathology (CAP) Proficiency Testing (PT) provider, and staff interview, the laboratory failed to participate in the 1rst event of 2020 for Hematology. Findings: 1. Review of the CAP PT documents, the laboratory failed to submit the results for the 1rst event for 2020. 2. Interview with Staff #2 (CMS 209 form), on September 08. 2021, at approximately 1pm, in the exam room, confirmed the aforementioned statement. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of 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 -- 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 the review of the College of American Pathology (CAP) Proficiency Testing (PT) provider, and staff interview, the Laboratory Director (LD) failed to ensure the the 1rst event of 2020 for Hematology results were submitted for evaluation. Findings: 1. A review of the CAP PT documents confirmed that the LD failed to ensure that results for the 1rst event for Hematology 2020 were submitted by the deadline. 2. Interview with Staff #2 (CMS 209 form), on September 08, 202, at approximately 1pm, in the exam room, confirmed the aforementioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 27, 2019. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: A proficiency testing desk review was completed on January 14, 2019. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and 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 -- Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in three consecutive events (1st, 2nd and 3rd events of 2018), resulting in subsequent unsuccessful occurrence for Bacteriology. Findings include: Refer to D 2021 D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) report, the laboratory failed to participate in three consecutive PT events (events 1, 2 and 3 of 2018) which resulted in subsequent unsuccessful occurrence for Bacteriology. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed the subspecialty of Bacteriology # 0005 on events 1, 2 and 3 of 2018 with scores of 0% on all three events. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed Bacteriology on Events 1, 2 and 3 of 2018 and revealed the 0% scores were for failure to participate. This resulted in subsequent unsuccessful 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: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in three consecutive events (1st, 2nd and 3rd events of 2018) and failed to ensure the laboratory followed the approved allegation of compliance (AOC) for bacteriology, resulting in subsequent unsuccessful occurrence for bacteriology. Findings include: Refer to D 6019 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) -- 2 of 3 -- 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 26, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to test the PT samples with the laboratory's patient workload by personnel who routinely perform the laboratory testing as required. Findings include: 1. College of American Pathologists (CAP) PT document review revealed the laboratory failed to perform testing on the 2018 Bacteriology Third Event PT samples. 2. An interview with Staff #2 (CMS 209) on 3/26/2019 in exam room #5 at approximately 1:00 p.m. confirmed the laboratory did not perform testing on the aforementioned PT samples in 2018. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in three consecutive events (1st, 2nd and 3rd events of 2018), resulting in subsequent unsuccessful occurrence for Bacteriology. Findings include: Refer to D 2021 nd Unsuccessful PT performace The facility th D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) report, the laboratory failed to participate in three consecutive PT events (events 1, 2 and 3 of 2018) which resulted in subsequent unsuccessful occurrence for Bacteriology. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed the subspecialty of Bacteriology # 0005 on events 1, 2 and 3 of 2018 with scores of 0% on all three events. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed Bacteriology on Events 1, 2 and 3 of 2018 and revealed the 0% scores were for failure to participate. This resulted in subsequent unsuccessful performance. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 6, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st and 2nd events of 2018), resulting 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 -- in the first unsuccessful occurrence for Bacteriology, analyte #0005. Findings include: Refer to D2021 D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathology (CAP) proficiency testing (PT) report, the laboratory failed to participate in two consecutive PT events (events 1 and 2 of 2018) which resulted in the 1st unsuccessful occurrence for Bacteriology. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed the subspecialty of Bacteriology # 0005 on events 1 and 2 of 2018 with scores of 0% on both events. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed Bacteriology on Events 1 and 2 of 2018 and revealed the 0% scores were for failure to participate. This resulted in the first unsuccessful 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: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) report, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive testing events (events 1 and 2 of 2018) resulting in the first unsuccessful occurrence for Bacteriology, analyte # 0005. Refer to D 6016 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 -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Reports 153 (CMS 153) and 155 (CMS 155) and the laboratory's 2018 proficiency testing (PT) evaluation reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance for two of three consecutive proficiency testing events resulting in the first unsuccessful PT occurrence for Bacteriology, analyte # 0005. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed the subspecialty of Bacteriology # 0005 on events 1 and 2 of 2018 with scores of 0% on both events. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed Bacteriology on Events 1 and 2 of 2018 and revealed the 0% scores were for failure to participate. This resulted in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 30, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologist (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 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 -- 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for hemoglobin (HGB) # 795. Findings include: Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologist (CAP) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for hemoglobin (HGB) # 795. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 795 HGB on event 2 of 2017 with a score of 0% and event 1 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed HGB on event 2 of 2017 and event 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --