Associates In Pediatrics

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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with the American Association of Bioanalysts (AAB) PT program representative confirmed the laboratory's initial unsuccessful PT performance for the specialty of hematology (See D2131) and the following hematology analytes: cell identification /white blood cell differential, red blood cells, hematocrit, hemoglobin, and white blood cells (See D2130) for two consecutive PT events in 2023 (events one and two). 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 -- 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory failed to achieve satisfactory performance for the hematology analytes: cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, and white blood cells for two consecutive PT events in 2023 (events one and two) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 09-01-2023, and the AAB PT records the laboratory received the following unsatisfactory analyte scores: Cell Identification /White Blood Cell Differential EVENT 1, 2023 33% Unsatisfactory EVENT 2, 2023 0% Unsatisfactory Red Blood Cells EVENT 1, 2023 20% Unsatisfactory EVENT 2, 2023 0% Unsatisfactory Hematocrit EVENT 1, 2023 20% Unsatisfactory EVENT 2, 2023 0% Unsatisfactory Hemoglobin EVENT 1, 2023 20% Unsatisfactory EVENT 2, 2023 0% Unsatisfactory White Blood Cells EVENT 1, 2023 60% Unsatisfactory EVENT 2, 2023 0% Unsatisfactory 2. A phone interview with the AAB PT representative on 9-27-2023 at 10:28 AM, confirmed the initial unsuccessful PT performance for the hematology analytes: cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, and white blood cells for two consecutive PT events in 2023 (PT events one and two). D2131 HEMATOLOGY CFR(s): 493.851(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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with the American Association of Bioanalysts (AAB) PT program representative the laboratory failed to achieve satisfactory performance for the specialty of hematology for two consecutive PT events in 2023 (events one and two) resulting in the initial unsuccessful PT performance for the overall specialty of hematology. Findings include: 1. Review of the CASPER Report 0155D, generated on 09-01-2023, and AAB PT records, the laboratory received the following unsatisfactory scores for the specialty of hematology. HEMATOLOGY EVENT 1, 2023 42% Unsatisfactory EVENT 2, 2023 0% Unsatisfactory 2. A phone interview with the AAB PT representative on 09-27-2023 at 10:28 AM, confirmed the initial unsuccessful performance for the overall specialty of hematology. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with an AAB PT program representative the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialty of hematology (see D6016) resulting in the laboratory's initial unsuccessful PT performance for the overall specialty of hematology and the following hematology analytes: cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, and white blood cells for two consecutive PT events (event one and two) in 2023. 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, and interview with an AAB PT program representative the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the specialty of hematology (see D2130 and D2131) resulting in the laboratory's initial unsuccessful PT performance for the overall specialty of hematology and the following hematology analytes: cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, and white blood cells for two consecutive PT events (event one and two) in 2023. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the application for certification (CMS 116), policies and procedures manuals, laboratory personnel report - CLIA (CMS 209), personnel records and interview; the laboratory failed to establish and follow written policies and procedures to assess employee competency. Findings: 1. Review of the CMS 116 submitted during the laboratory's survey of April 18, 2018 revealed that the laboratory performed Urinalysis and Hematology procedures. 2. Review of the laboratory's procedures manual revealed that there were no procedures that described the laboratory's process for assessing the competency of the Technical Consultant and Clinical Consultant. However, there were instructions for performing and documenting the training and competency of testing personnel. 3. Review of the CMS 116 revealed that the following information: a. There was 1 person listed as the laboratory director who also fulfilled the positions of Clinical Consultant (CC), Technical Consultant (TC), and Testing Personnel (TP). b. There were 7 additional persons listed as CC. c. There were 25 additional persons listed as TP 4. Review of personnel records revealed that there was no documentation to show the competency assessments for 1 of 1 TC; 7 of 8 CCs and 3 of 26 TP. 5. During survey date 04/16/18, the Clinical Manager confirmed the surveyor's findings. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures manuals; Laboratory Personnel Report (CMS 209) and personnel records; the laboratory director failed to specify in writing the responsibilities and duties of each consultant and each person engaged in the testing process; and identify which examinations and procedures each individual is authorized to perform, and whether supervision and/or director review is required prior to reporting patient test results. Findings: 1. Review of the laboratory's policies and procedures manuals revealed the laboratory director did not specify which testing personnel performs the microscopic urinalysis procedures. 2. There were a total of 26 testing personnel listed on the CMS 209. 3. Review of personnel records revealed that there was no documentation to show which testing personnel were responsible for performing urinalysis testing for 26 of 26 testing personnel. 4. During survey date 04 /16/18, the Clinical Manager confirmed the surveyor's findings. -- 2 of 2 --