Dyersburg Family Walk In Clinic

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: The laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for White Blood Cell (WBC) analyte in 2021 event two and 2022 event one, resulting in the first unsuccessful proficiency testing (PT) occurrence for the WBC analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the White Blood Cell (WBC) analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC scores: a. 2021 event two 60%. b. 2022 event one 60%. 2. Review of the 2021 PT event two evaluation report revealed unacceptable scores for sample numbers XE-09 and XE-10, resulting in an overall score of 60% for the WBC analyte. 3. Review of the 2022 PT event one evaluation report revealed unacceptable scores for sample numbers XE-02 and XE-04, resulting in an overall score of 60% for the WBC analyte and the first unsuccessful PT occurrence. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the 2018 and 2019 complete blood count proficiency testing (PT) records and interview with testing personnel number one, the laboratory failed to perform the PT samples in the same manner as patient testing. The findings include: 1) Review of the 2018 and 2019 PT records revealed in the 2018 events two, three, 2019 event one, the PT samples were performed twice in the same day. 2) Interview on July 10, 2019 at 11:00 a.m. with testing personnel number one confirmed the PT samples are performed twice and patient samples are performed once. 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: The laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for hematology specialty resulting in the first unsuccessful proficiency testing (PT) occurrence for the hematology specialty. (Refer to D2122) D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 desk review of the Centers for Medicare and Medicaid Oscar Report 155 (CMS 155) and the laboratory's 2017 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the hematology specialty. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory hematology scores: 2017 event one 0%, 2017 event three 0%. 2. Review of the 2017 PT event one evaluation report revealed an event score of 0% for failure to participate. 3. Review of the 2017 PT event three evaluation report revealed an event score of 0% for failure to participate. -- 2 of 2 --