Pediatric Care Center

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to document investigation and

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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports (#153/#155) and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed two consecutive testing events for Hemoglobin [(Hgb) Hematology testing], resulting in an initial unsuccessful proficiency testing participation. This affected Event #3, 2020 and Event #1, 2021. The findings include: 1. A review of the CASPER reports on May 20, 2021 revealed the laboratory scored sixty percent (60 %) for Hgb for Event #3, 2020 and Event #1, 2021, two consecutive testing events. 2. The API proficiency testing evaluation confirmed the above noted findings. 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 -- 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports (#153/#155) and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully perform in two consecutive testing events for Hemoglobin [(Hgb) Hematology testing], Event #3, 2020 and Event #1, 2021. These failures resulted in an initial unsuccessful proficiency testing participation (Refer to D2016). The findings include: 1. A review of the CASPER reports on May 20, 2021 revealed the laboratory scored sixty percent (60 %) for Hgb for Event #3, 2020 and Event #1, 2021, two consecutive testing events. 2. The API proficiency testing evaluation confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the room temperature logs, a lack of humidity records, a review of environmental requirements for the Abbott Cell Dyn Emerald Hematology analyzer, and an interview with Technical Consultant, the surveyor determined the laboratory failed to: 1) establish acceptable room temperature ranges as per manufacturer's requirements, and 2) monitor and document room humidity in the area of operation since the previous survey on 7/13/2017. The findings include: 1. A review of the Abbott Cell Dyn Emerald Operator's Manual on page 2-4 revealed, "Installation Environment The following are environmental requirements: ... Temperature range: 64 - 90 degrees F (Fahrenheit) ... Maximum relative humidity 80% (percent) for temperatures up 90 degrees F". 2. A review of the 2017-2019 temperature logs revealed the testing personnel recorded room temperature at the bottom of a vaccine refrigerator temperature log each day of patient testing, however no acceptable ranges for room temperature were specified. The records did not include any documentation of room humidity in the room where the Emerald was operated from July 2017 thru July 2019. 3. During an interview on 7/23/2019 at 1:35 PM, the Technical Consultant confirmed the above noted findings, stating the testing personnel had failed to utilize the appropriate form to record environmental parameters. . 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 -- 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 reviews of the Hematology quality control (QC) records and the patient logs, and interviews with the Technical Consultant, the laboratory failed to ensure at least two levels of quality control were performed and acceptable, prior to analyzing patient specimens and reporting the results on two days in 2018. The findings include: 1. A review of the QC records for the Abbott Cell Dyn Emerald Hematology analyzer revealed the following: A) 3/07/2018: No Normal or High QC performed (The surveyor noted results in the Low QC file were actually patient results erroneously saved in the wrong file; this observation was confirmed by the Technical Consultant.) B) 9/26/2018: No Low QC performed and the Normal QC was outside acceptable ranges 2. A review of the patient logs revealed seven patient CBCs (Complete Blood Counts) were performed on 3/07/2018, and four CBCs were run on 9/26/2018. 3. During interviews on 7/23/2019 at 2:05 and 3:05 PM, the Technical Consultant reviewed and confirmed the above noted findings. SURVEYOR ID #32558 Licensure & Certification Surveyor -- 2 of 2 --