Primary Care Center Of Newport, The

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 Centers for Medicare and Medicaid CASPER Report 155 (CMS 155) and the laboratory's 2023 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events, resulting in initial unsuccessful participation for the white blood count (WBC) analyte in 2023. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 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 desk review of the CMS 155 and the laboratory's 2023 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the white blood cell count (WBC) analyte resulting in initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC scores: - 2023 Event two: 40% - 2023 Event three: 40% 2. Review of the laboratory's API PT evaluation reports revealed the following unsatisfactory WBC scores: - 2023 Event two: 40% - 2023 Event three: 40% -- 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 observation of the laboratory, review of manufacturers' instructions, lack of documentation, and interview with the lead testing person, determined the laboratory failed to monitor and document room temperature and humidity in the area where the Abbott Cell Dyn instrument was in use for Complete Blood Count (CBC) patient testing from January 2022 through the survey date of 06.16.2023. Findings include: 1. Observation of the laboratory at approximately 10:00 a.m. on 06.16.2023 revealed an Abbott Cell Dyn instrument on the laboratory counter in use for performing CBC patient testing. No devices for monitoring temperature or humidity were noted in the laboratory. 2. Review of the laboratory's Abbott Cell Dyn System Operational Specifications stated, "Laboratory Temperature: 18-30 degrees Celsius (C) (64-86 degrees Fahrenheit (F)). Relative humidity: 10%-85%, RHNC" 3. Interview with the lead testing person at approximately 11:00 a.m. on 06.16.2023 confirmed the laboratory failed to monitor and document room temperature and humidity in the area where the Abbott Cell Dyn instrument was in use for Complete Blood Count (CBC) patient testing since January 2022 through the survey date of 06.16.2023. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: ================================== Based on a review of the laboratory's procedure manual and upon interview with the Lab Director and Lead Testing Personnel, determined the laboratory procedures were not approved by the Lab Director during 2020 and 2021. The findings include: 1. A review of the laboratory's procedure manual revealed no signature by the Lab Director approving procedures. 2. An interview at approximately 12:30 p.m. on February 1, 2020 with the Lab Director and Lead Testing personnel confirmed that the procedures had not been signed by the Lab Director during 2020 and 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 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 Complete Blood Count (CBC) Quality Control (QC) data not found for January 2nd through January 19th, 2018 and May 1st through May 25th, 2018 and interview with the Laboratory Supervisor, determined the laboratory failed to retain CBC Quality Control data for January and May of 2018. The finding include: 1. CBC quality control data was not available for review for dates January 2nd - January 19th, 2018 and May 1st-May 25th, 2018. 2. An interview with the Laboratory Supervisor at approximately 12:00 p. m. October 15th, 2018 confirmed the CBC quality control data for January and May of 2018 was not available for review due to instrument malfunctions and QC had not been able to be retained. ==================================== D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. 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 review of patient CBC test audit which lacked Complete Blood Count (CBC) Quality Control documentation for 6 /09/2018 and 8/25/2018 and interview with the Laboratory Supervisor, determined the laboratory failed to perform daily CBC Quality Control (QC) prior to patient testing. The findings include: 1. Review of patient CBC test audit revealed daily CBC QC was not performed 6/09/18 and 8/25/18 on the Hematology Abbott Celldyn 1800 prior to testing and reporting 2 patient results. 2. Interview at approximately 12:00 p.m. October 15, 2018 with the Laboratory Supervisor confirmed the laboratory failed to perform daily CBC QC testing 6/09/18 and 8/25/18 prior to testing and reporting patient CBC results. =================================== -- 2 of 2 --