Edgewood Center Pediatrics

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Clinical Supervisor, the laboratory failed to establish a system to ensure that patient specific data was accurately reported from point of entry to the final report for 1 (P5) of 10 patient records reviewed. Findings include: 1. A record review of the patient log dated 06/26/2023 revealed P5's date of birth (DOB) as 6/21/2020. Review of P5's test report dated 06/26/2023 revealed P5's DOB was documented as 03/22/2021. 2. The interview conducted with the Clinical Supervisor on 1/16/2025 at 12:09 pm confirmed the test report was inaccurate as the patient dob should have been documented as 6/21/2020. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Testing Personnel (TP) #2, the laboratory failed to follow written policies and procedures to perform the semi-annual quality assurance (QA) checklist for 2 (January and July of 2022) of 3 semi-annual checks reviewed in 2021 and 2022. Findings include: 1. Review of the "Quality Assessment Policy" states "The Quality Systems (QA) for Edgewood Center Pediatrics will be reviewed on an on-going basis (every six months) to monitor, assess and when indicated, corrected. Problems identified in the laboratory's quality systems". The quality systems include the general laboratory system, pre-analytic quality system, analytic quality system, and the post analytic quality systems. 2. When queried on 12/21/2022 at 12:06 pm, TP2 was unable to provide the surveyor documentation to show the QA checklist had been performed for 2 of 3 semi-annual checks for 2021 and 2022. 3. During the interview on 12/21/2022 at 12:06 pm, TP2 confirmed the QA checks had not been performed semi-annually in 2022 as written in the policy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 record review and interview with the Office Manager (OM) and Testing Personnel (TP) #2, the laboratory director failed to attest to the routine integration of the hematology proficiency testing samples into the patient workload for 4 (event 3 in 2019, event 1 and 2 in 2020, and event 1 in 2021) of 5 events reviewed. Findings include: 1. Record review of the American Proficiency Institute (API) testing documents, the Laboratory Director (LD) failed to sign the attestation statement sheet as follows: a. event 3 in 2019 - not signed by the LD a. event 1 in 2020 - not signed by the LD b. event 2 in 2020 - signed by the testing personnel c. event 1 in 2021 - not signed by the LD 2. During the interview on 7/14/2021 at 10:50 AM, the OM and TP2 confirmed the LD did not sign the attestation statement sheet for the events listed above. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: 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 -- . Based on lack of documentation and interview with the Office Manager (OM) and Testing Personnel (TP) #2, the laboratory failed to perform and document the function checks as required for the room temperature for 7 months (January - July 2021) of 2 years reviewed. Findings include: 1. A record review revealed lack of documentation of the room temperature for the proper operation of the laboratory instrumentation for 7 months (January - July 2021) of 2 years. 2. An interview on 7/14/2021 at 11:41 AM, the OM and TP2 were unable to provide the surveyor the documentation requested. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager (OM) and Testing Personnel (TP) #2, the Technical Consultant (TC) failed to evaluate the competency of testing personnel performing the hematology testing for 11 (TP1 - TP11) of 11 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of testing personnel competency assessments revealed testing personnel competencies were assessed by a "reviewer" TP1 and TP2 who are not qualified or credentialed as a Technical Consultant to perform this task as follows: a. TP1 assessed by TP2 - assessment dates of 8/16/2019 and 8/22/2020 b. TP2 assessed by TP1, assessment dates of 8/24/2019 and 8/14/2020 c. TP3 assessed by TP2, assessment dates of 7/30 /2020 due now d. TP4 assessed by TP2, assessment dates of 5/20/2019, 5/27/2020, and 6/9/2021 e. TP5 assessed by TP2, assessment dates of 9/09/2020 and 12/30/2020 f. TP6 assessed by TP2, assessment dates of 8/05/2019, 2/21/2021, and 2/02/2021 g. TP7 assessed by TP2, assessment dates of 9/28/2020 and 2/15/2021 h. TP8 assessed by TP2, assessment dates of 7/01/2021 i. TP9 assessed by TP2, assessment dates of 7 /01/2021 j. TP10 assessed by TP2, assessment dates of 7/01/2021 k. TP11 assessed by TP2, assessment dates of 5/04/2020 and 11/02/2020 2. An interview on 7/14/2021 at 9: 55 AM, the OM and TP2 confirmed the TC did not perform the competency assessments and the OM and TP2 were not qualified as a TC and not listed on the CMS-209 form as a TC. ***Repeat Deficiency from 11/17/2016 survey*** -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1 and #3 (TP1 and TP3), the laboratory failed to retain the hematology monthly maintenance log for 1 (August 2018) of 24 months reviewed. Findings include: 1. Record review of the monthly hematology "XP-300 Maintenance Log" revealed the laboratory did not retain August 2018 log for 2 years. 2. During the interview on May 23, 2019 at 10:30 AM, TP1 and TP3 confirmed the monthly maintenance log was not retained. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1 and #3 (TP1 and TP3), the laboratory failed to have a written request for patient testing for the routine bacteriology and hematology testing for 2 (#8 and #11) of 18 patient charts audited. Findings include: 1. Record review conducted on 18 patient charts audited revealed the laboratory did not have a written request or standing order for the routine testing as follows: a. #8 - 2/18/19 throat culture b. #11 - 2/21/18 complete blood cell count 2. During the interview on May 23, 2019 at 11:47 AM and 12:25 PM, TP1 and TP3 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 -- confirmed the patient chart did not contain a written and/or standing order for the laboratory testing performed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1 and #3 (TP1 and TP3), the laboratory failed to perform and document the required hematology instrument maintenance for 17 (2018 and 2019) of 24 months reviewed. Findings include: 1. The Sysmex "XP-300 Maintenance Log" listed weekly, monthly, and quarterly maintenance. There was no documentation to show the maintenance was performed as follows: a. weekly 1. three of four weeks in May and June 2018 2. three of four weeks in March and April 2019 b. monthly 1. April, July, and October in 2018 2. April 2019 c. quarterly (or every 4500 samples) - no documentation in 2018 and 2019 2. During the interview on May 23, 2019 at 10:30 AM, TP1 and TP3 confirmed the maintenance had not been documented as required. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: . Based on policy review, record review, and interview with testing personnel #1 and #3 (TP1 and TP3), the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as specified in 493.1251 through 493.1283 in the analytic laboratory systems for 4 (2017 and 2018) of 5 every six month assessment. Findings include: 1. Review of the "Quality Assessment Policy" revealed the lab was to review the quality assessment monitors every six month. 2. Record review revealed the laboratory did not perform and document patient chart reviews every six months in 2017 and 2018. 4. On May 23, 2019 at approximately 12:45 PM, TP1 and TP3 confirmed the quality assessment policy had not been followed. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1 and #3 (TP1 and -- 2 of 3 -- TP3), the laboratory failed to have the final bacteriology report maintained as part of the patient's chart or medical record for 1 (#8) of 18 patient charts audited. Findings include: 1. Record review revealed for 1 of 18 patient charts audited, the final bacteriology throat culture report was not maintained in the patient's paper chart. 2. On May 23, 2019 at 11:47 AM, TP1 and TP3 confirmed the final throat culture test result was not included in the patient's paper chart as part of their medical records. -- 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: . Based on review of the CMS database and review of the American Proficiency Institute (API) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the hematology analyte white blood cell differential (WBC Diff). Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of two proficiency testing events for the hematology analyte: WBC diff. Refer to D2130. D2130 HEMATOLOGY 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 -- 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 review of the CMS database and review of the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the hematology analyte white blood cell differential (WBC Diff) in two consecutive testing events. Findings include: Unsatisfactory performance for two consecutive PT events constituting unsuccessful performance for WBC diff: WBC Diff PT Event Score 3rd event 2017 0% 1st event 2018 33% -- 2 of 2 --