Pediatrics East, Inc Germantown

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 two out of three proficiency testing (PT) events for the hematocrit analyte, resulting in the first unsuccessful PT occurrence for the hematocrit analyte. (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. 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 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2020 and 2021 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the hematocrit analyte in two out of three PT events, resulting in the first unsuccessful PT occurrence for the hematocrit analyte. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the hematocrit analyte: 2020 event three: 60% 2021 event two: 60% 2) Review of the laboratory's proficiency testing records revealed the following: 2020 event three: Sample numbers HD-12 and HD-13 scored as unacceptable, resulting in an overall score of 60% for the hematocrit analyte. 2021 event two: Sample numbers HD-7 and HD-10 scored as unacceptable, resulting in an overall score of 60% for the hematocrit analyte, and the first unsuccessful PT occurrence for the hematocrit analyte. -- 2 of 2 --

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 laboratory's policy for testing personnel, the form used for recording testing personnel competency assessments, and interview with the laboratory coordinator, the laboratory failed to follow testing personnel policy for competency assessment in 2018. The findings include: 1. Review of the laboratory's policy for testing personnel revealed that competency assessments would be performed using direct observation of patient testing, monitoring recording and reporting of test results, review of intermediate test results or worksheets, direct observation of instrument maintenance and function checks, blind testing and problem solving skills. 2. Review of the form used for recording testing personnel competency assessment revealed that direct observations and blind testing was not included as part of the competency assessment for complete blood count, urine colony count, urine microscopy, and pinworm prep. 3. Interview with the laboratory coordinator on August 28, 2018 at 4:00 pm confirmed the laboratory failed to follow testing personnel policy for competency assessment when it did not include direct observations and blind testing as part of competency assessment in 2018. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 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 -- through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment plan, the manufacturer package insert for quality control (QC) lot number L8127, the laboratory QC report for lot number L8127, the July 2018 quality assessment (QA) monitoring form, the January 2017 Cell-dyn Emerald maintenance log and patient number eleven test report, the January 2017 QA monitoring form, and interview with the laboratory coordinator, the laboratory's quality assessment plan was ineffective when it failed to detect problems with QC target entry in 2018 and untrained testing personnel in 2017. 1. Review of the laboratory's quality assessment plan revealed the following definition: To monitor and evaluate the ongoing and overall quality of the total testing process by evaluating all established policies and procedures for their effectiveness, identifying and correcting problems, assuring accurate, reliable and prompt test reports and assuring adequacy and competency of the staff. This includes the entire testing process from patient preparation and specimen collection, test analysis and reporting of test results. To qualify as testing personnel a high school diploma and documented training is required. 2. Review of the manufacturer package insert for quality control lot number L8127 revealed an acceptable target value of 51.1% for lymphocyte %. 3. Review of the laboratory quality control report for lot number L8127 revealed a target value of 49.9% in use for the lymphocyte %. 4. Review of the July 2018 QA monitoring form revealed signatures of both the laboratory coordinator and the laboratory director/technical consultant with no documentation of