Norton Immediate Care Center - Dupont

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 desk review of Hematology proficiency testing results from the American Academy of Family Physicians (AAFP) proficiency testing agency on 06/01/2020, the laboratory failed to successfully participate in the specialty of Hematology in two of three consecutive testing events. See D2122 and D2131 D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from the American Academy Family Physicians (AAFP) proficiency testing agency on 06/01/2020, the laboratory failed to attain an overall satisfactory score of at least 80 percent in two of three consecutive Hematology testing events. Findings include: 1. The laboratory scored seventy-five (75) percent in the second testing event of 2019. 2. The laboratory scored zero (0) percent in the first testing event of 2020. 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 desk review of proficiency testing results from American Academy of Family Physicians (AAFP) proficiency testing agency on 06/01/2020, the laboratory failed to achieve satisfactory overall scores in two of three consecutive testing events for the specialty of Hematology. Findings include: 1. The laboratory failed to achieve satisfactory performance with a score of seventy-five (75) percent in the second testing event of 2019. 2. The laboratory failed to achieve satisfactory performance with a score of zero (0) percent in the first testing event of 2020. -- 2 of 2 --

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 record review, review of the policy and procedure manual, and staff interview on 12/05/2018, the laboratory failed to ensure the policy for the performance of Complete Blood Cell counts performed on the AcT Diff 2 hematology analyzer was approved, signed, and dated by the laboratory director prior to patient testing and reporting results. Findings include: Review of records for the hematology analyzer revealed the instrument was initially used for patient testing and reporting 10 /19/2018. Review of the policy and procedure for the hematology analyzer failed to include the laboratory director's review and approval prior to 10/19/2018. Interview with staff at 12:45 PM on 12/05/2018, revealed the laboratory failed to have a policy in place to ensure all procedures were reviewed, approved, signed, and dated prior to patient testing and reporting. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 record review and staff interview on 12/05/2018, the laboratory failed to ensure the laboratory director/technical consultant review, approve, sign, and date the performance specifications for the AcT Diff 2 hematology analyzer prior to routine patient testing. Findings include: Record review revealed performance specifications (precision, accuracy, reportable range verification, reference range verification) were established for the AcT Diff 2 hematology analyzer 10/18/2018. There was no documentation of review by the laboratory director/technical consultant prior to patient testing on 10/19/2018. Interview with staff at 12:45 PM on 12/05/2018, revealed the laboratory failed to have a policy in place to ensure all performance specifications for each nonwaived unmodified test system were reviewed, approved, signed, and dated prior to reporting patient test results. -- 2 of 2 --