Careplus Reservoir Family Medicine

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 5/15/2024, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 3 and 2024-Event 1) resulting in unsuccessful participation for the specialty of HEMATOLOGY. Refer to D2131. 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 -- D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. 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 (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 5 /15/2024, the laboratory failed to participate in proficiency testing for the specialty of HEMATOLOGY for two of two 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 HEMATOLOGY: HEMATOLOGY: Year 2023-3rd Event 0% Year 2024-1st Event 0% 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 5 /15/2024, the laboratory has not successfully performed proficiency testing for the specialty of HEMATOLOGY in two of two 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 HEMATOLOGY: HEMATOLOGY: Year 2023- 3rd Event 0% Year 2024- 1st Event: 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 an interview with the technical consultant at 11:15 a.m. on 4/27/2023 and review of preventive maintenance logs for the CDS Medonic M-Series hematology analyzer from 10/21/2021 through 4/27/2023, the laboratory failed to perform and document maintenance as defined by the manufacturer with at least the frequency specified by the manufacturer for 12 of 18 months for monthly maintenance and 3 of 3 six-month periods for semi-annual maintenance. Findings include: 1) Review of preventive maintenance logs for the CDS Medonic M-series hematology analyzer from 10/21/2021 through 4/27/2023 revealed no documentation of the following maintenance procedures for the months listed: a) Monthly maintenance procedures "Monthly Cleaning" and "Clot Prevention" were not documented as performed for 12 of 18 months (March, April, May, June, July, August, September, October, November, December of 2022 and January and February of 2023). b) Six-month maintenance "Boule Cleaning Kit Procedure" was not documented as performed for 3 of 3 six-month periods between November of 2021 and February of 2023. 2) The technical consultant confirmed in an interview at 11:15 a.m. on 4/27/2023 the maintenance procedures were not documented as performed for the specified months. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the 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 -- manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the CDS Medonic M-Series Hematology Analyzer Procedure Manual, calibration records for the CDS Medonic hematology analyzer since the last survey on 10/21/2021, and interview with the technical consultant on 4/27/2023 at 12: 20 p.m., the laboratory failed to perform calibration at a minimum of every six months, as recommended by the manufacturer, from 4/29/2022 until 3/2/2023 for two of two six-month periods. Findings include: 1. Review of the CDS Medonic M-Series Hematology Analyzer Procedure Manual revealed the calibration procedure states, "Calibration must be performed upon setup of the instrument and then at a minimum of every six months." 2. Review of calibration records for the CDS Medonic hematology analyzer from 4/29/2022 through 3/2/2023 revealed calibration was not performed for twelve months, from 4/29/2022 until 3/2/2023. Calibration was not performed for two of two six-month periods reviewed. 3. The technical consultant confirmed in an interview on 4/27/2023 at 12:20 p.m. the calibration was not performed at a minimum of every six months as recommended by the manufacturer. -- 2 of 2 --