Community Care Of Channing Way

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 lack of laboratory humidity records and an interview with the laboratory director on 8/26/2025, the laboratory failed to establish and monitor the humidity for the Sysmex XN-L 430 complete blood count (CBC) testing since its installation for patient testing in November 2024. The findings include: 1. A lack of the laboratory humidity records identified the laboratory failed to establish and monitor humidity for CBC testing per the Sysmex XN-L 430 manufacturer requirements. 2. An interview with the laboratory director on 8/26/2025 at 2:30 pm confirmed that the laboratory failed to monitor humidity since November 2024. 3. The laboratory reports performing 7242 hematology tests on the Sysmex XN-L 430 annually. 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 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 a review of Sysmex XP300 maintenance logs and an interview with the technical consultant (TC) on 8/17/2023, the laboratory failed to perform and document maintenance with the frequency defined by the manufacturer. The findings include: 1. A review of Sysmex XP300 maintenance logs from 2022 and 2023 identified the laboratory failed to perform and document maintenance as required by the instrument manufacturer: Weekly maintenance was not documented two of four weeks in October 2023, one of four weeks in January, February, May and July of 2023. Monthly maintenance: cleaning the waste chamber was not documented in January 2022, February 2022, May 2022, August 2022, October 2022, January 2023, March 2023, May 2023, June 2023. Monthly maintenance: cleaning the RBC and WBC transducer was not documented in July 2022, September 2022, December 2022, and April 2023. Quarterly maintenance was not documented for four of four quarters in 2022 and one quarter in 2023. 2. An interview with the TC on 8/17/2023 at 10:04 am confirmed the above findings. 3. The laboratory reports performing 6,570 patient tests on the Sysmex XP300 annually. 4. This is a repeat deficiency from the previous survey on 9/23/2021. 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 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 Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the specialty of hematology. See D2123, D2131 D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and a telephone interview with the technical consultant on 3/14/2022, the laboratory failed to participate in two (2) of three (3) testing events in 2021 for the specialty of hematology. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to participate in testing for events one (1) and three (3) in 2021 for the specialty of hematology for the analytes white blood cell differential, erythrocyte count, hematocrit, hemoglobin, leucocytes count, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), platelet count, and red cell distribution width (RDW) resulting in scores of zero (0). 2. A telephone interview with the technical consultant on 3/14/2022 at 12:30 pm confirmed the above findings. 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and telephone interview with the technical consultant on 3 /14/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the specialty of hematology. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve overall satisfactory scores for events one (1) and three (3) in 2021 for the specialty of hematology. Specialty Year Event Score hematology 2021 1 0% hematology 2021 3 0% 2. A telephone interview with the technical consultant on 3/14/2022 at 12:30 pm confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the American Proficiency Institute (API), the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory technical consultant (TC) on 9/23/2021, the laboratory failed to test PT samples with the regular patient workload by personnel regularly testing complete blood count (CBC) testing. The findings include. 1. A review of PT records from API for Hematology for 2020 events one, two and three and 2021 events one and two identified that one (1) of six (6) testing personnel listed on the CMS 209 performed all Hematology PT events for 2020 and event 1 for 2021. The laboratory failed to have five(5) of six (6) personnel who regularly perform CBC testing perform Hematology PT testing for 2020 and the first event for 2021. 2. An interview with the TC on 9/23/21 at 1:40 pm confirmed that one (1) of six (6) testing personnel performing CBC testing performed all the CBC PT testing for 2020 and the first event of 2021. 3. The laboratory reports performing 730 CBC tests annually. 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. 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 review of training documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory technical consultant (TC) on 9/23/2021, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F.R. 493.1413(b)(7)(8) for 2019 and 2020. The findings include: 1. A review of training and competency assessment records identified one (1) of six (6) testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 493.1413(b)(8) for 2019. 2. A review of training and competency assessment records identified four (4) of six (6) testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 493.1413(b)(8) for 2020. 3. An interview with the TC on 9/23/2021 at 1:35 pm confirmed the above findings. 4. The laboratory reports performing 730 CBC tests annually. 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 a record review of maintenance logs and an interview with the technical consultant (TC) on 9/23/2021, the laboratory failed to perform and document daily, weekly and monthly maintenance for the Sysmex XP-300 hematology analyzer as required by the manufacturer. The findings include: 1. 1. A review of the Sysmex XP- 300 maintenance logs for March 2021-August 2021 identified the laboratory failed to perform and document maintenance as required by instrument manufacturer. Daily maintenance was not documented six (6) of 31 days in March, four (4) of 30 days in April, eight (8) of 31 days in May, five (5) of 30 days in June, one (1) of 31 days in July and three of 31 days in August. Weekly maintenance was not documented three (3) of five (5) weeks in March, two (2) of four (4) weeks in April, three (3) of four (4) weeks in May, five (5) of five (5) weeks in June and three (3) of four (4) weeks in August. Monthly maintenance was not documented in April, May and June. 2. An interview with the TC on 9/23/2021 at 2:37 pm confirmed the above findings. 3. The laboratory reports performing 730 complete blood count tests on the Sysmex XP-300 annually. -- 2 of 2 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical consultant, the laboratory failed to document daily, weekly and monthly maintenance activities for the Sysmex XP-300 hematology analyzer as required by the manufacturer. Findings: 1. A record review of the maintenance logs from January 2019 through August 2019 revealed that the laboratory failed to document weekly and monthly maintenance activities for the Sysmex XP-300. There was no documentation of weekly maintenance for 16 of 32 weeks reviewed and no documentation of monthly maintenance for 7 of the 8 months reviewed. 2. An interview on September 10, 2019 at approximately 2:50 PM with the technical consultant confirmed the laboratory failed to document maintenance activities for the Sysmex XP-300 analyzer. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. 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 record review of final patient reports for complete blood counts (CBC) and an interview with the technical consultant, the laboratory failed to establish and follow a written procedure to monitor and assess the accuracy of reference ranges on the final reports generated through the laboratory's computer interface. Findings: 1. A review of three (3) final patient test reports revealed that the laboratory was using different reference ranges on their final reports than what the laboratory had established for male, female and pediatric patients. 2. An interview on September 10, 2019 at 1:10 PM with the technical consultant, confirmed the laboratory did not have a mechanism in place to verify the accuracy of results generated through the laboratory's computer interface. -- 2 of 2 --