Children's Clinic Of Oxford Pa

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 11/15 /2022, the laboratory failed to maintain satisfactory performance in four of four testing events (2021 - Events 2 & 3 and 2022 - Events 1 & 2) resulting in unsuccessful 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 -- participation in Hematology for the analyte White Blood Cell Differential (WBC Diff). Refer to D2130. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 11/15 /2022, the laboratory has not successfully performed proficiency testing for WBC Diff in four of four testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D /0155D revealed the laboratory scored the following for WBC Diff: Year 2021 - 2nd Event: 73% Year 2021 - 3rd Event: 0% Year 2022 - 1st Event: 0% Year 2022 - 2nd Event: 73% 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 11/15 /2022, the laboratory director failed to provide overall management and direction for ensuring Hematology proficiency testing was tested for four out of four events as required under Subpart H. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 11/15 /2022, the laboratory director failed to ensure Hematology proficiency testing was -- 2 of 3 -- tested as required under Subpart H. The laboratory failed to maintain satisfactory performance in four of four testing events (2021 - Events 2 & 3 and 2022 - Events 1 & 2) resulting in the subsequent unsuccessful performance for WBC Diff. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for the Abbott Cell-Dyn Emerald hematology analyzer from 5/2/2022 through 8/19/2022, manufacturer's acceptable ranges for Abbott Cell-Dyn 18 Plus hematology controls, Lot #2094, and the Lab Accession Log, results of at least two of three levels of control failed to meet the manufacturer's criteria for acceptability for four days during this time frame, when a total of 26 patient complete blood count (CBC) tests were performed and reported. Findings include: Review of QC records for the Abbott Cell-Dyn Emerald hematology analyzer from 5/2/22 through 8/19/22, manufacturer's acceptable ranges for Abbott Cell-Dyn 18 Plus hematology controls, Lot #2094, and the Lab Accession Log revealed on the following days the normal and high controls, of three levels of hematology control, were outside the manufacturer's acceptable ranges for red blood cell count (RBC) when the patient CBC tests listed below were performed and reported: 6/7/2022 - Patients #33563, #47479, #47316, #47312, #43151, #42547, #42246, #43609, #32223. 6/16/2022 - Patients #24291, #40868, #48301, #40609. 6/17 /2022 - Patients #46757, #47393, #48400, #39469, #44408, #23703, #23783. 6/21 /2022 - Patients #29059, #47501, #29285, #28314, #44338, #17434. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, personnel records since the last survey on 3/25/2021, and the Lab Accession Log from 2/7/2022 through 10/13/2022, the laboratory director failed to ensure Testing Personnel #3, listed on the CMS 209 personnel form, received the appropriate training for performing complete blood count (CBC) testing on the Abbott Cell-Dyn Emerald hematology analyzer, prior to testing 63 patient CBC specimens between 2/7/2022 and 10/13/2022. Findings include: Review of personnel records since the last survey on 3/25/2021 revealed no documentation of training for Testing Personnel #3, listed on the CMS 209 personnel form. Review of the Lab Accession Log from 2/7/2022 through 10/13/2022 revealed Testing Personnel #3 had performed CBC testing on 63 patient specimens since 2/7/2022. 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 review of the CMS 209 personnel form, personnel records since the last survey on 3/25/2021, and the Lab Accession Log from 2/7/2022 through 10/13/2022, the technical consultant failed to evaluate and document the performance of Testing Personnel #3, listed on the CMS 209 personnel form, at least semiannually during the first year this individual tested patient CBC specimens. Findings include: Review of the Lab Accession Log from 2/7/2022 through 10/13/2022 revealed Testing Personnel #3 began performing CBC testing on patient specimens on 2/7/2022. Review of personnel records since the last survey on 3/25/2021 revealed the technical consultant failed to evaluate and document the performance of Testing Personnel #3 at least semiannually since 2/7/2022. -- 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: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 1/26/2022, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2021 2nd Event 73% Year 2021 3rd Event 0% Scores less than 80% for this analyte or parameter 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 -- indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 1/26/2022, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2021 2nd Event 73% Year 2021 3rd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --