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Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory's quality assessment procedures failed to correct problems identified with hematology control testing on 10 /30/2019. Findings include: 1) Review on 12/11/2019 of complete blood count (CBC) control testing from September through December 11, 2019 revealed on 10/30/2019, 2 (level 2 and level 3) of 3 CBC control results failed acceptability criteria. 2) Review on 12/11/2019 of patient CBC records revealed one patient CBC results were reported on 10/30/2019. 3) Review on 12/11/2019 of the laboratory weekly CBC control review revealed documentation that the CBC control failure had occurred and a patient impact assessment had been performed. The laboratory failed to document as part of its quality assessment procedures, that the laboratory corrected the problem through re-education, training, or other method to ensure testing personnel followed CBC control procedures. 4) Interview on 12/11/2019 at 11:45 a.m. with the laboratory director confirmed the above findings. 5) This is a repeat deficiency from the recertification survey completed on 10/11/2017. Tag D5791 was cited on the 10/11 /2017 survey for failures in identifying and correcting problems with CBC control testing. 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 record review and staff interview, the laboratory failed to successfully participate in a proficiency testing (PT) program for hematology testing in 2018 and 2019. Findings include: 1) The laboratory failed to attain a satisfactory performance score for white blood cell (WBC) differential in the 2nd PT event in 2018 and 1st PT event in 2019. Refer to tag D2121. 2) The laboratory failed to successfully participate in 2 out of the last 3 PT events for WBC differential in 2018 and 2019. Refer to tag D2130. D2121 HEMATOLOGY 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 -- CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory received unsatisfactory white blood cell (WBC) differential performance in the second proficiency testing (PT) event in 2018 and and the first PT event in 2019. Findings include: 1) Review of CASPER Report 0155D on 6/4/2019 revealed the laboratory obtained scores for WBC differential of 47% and and 0% for the 2nd American Proficiency Institute (API) PT event in 2018 and 1st API PT event in 2019 respectively. 2) Review on 6/4/2019 of the API performance summary for the "2018 Hematology / Coagulation - 2nd Event" revealed the laboratory reported unacceptable results (percent) for 4 out of 5 PT specimens for "Granulocytes" and 4 out of 5 PT specimens for "Monocytes/Mids." obtaining an overall score of 47% for WBC differential. Review on 6/4/2019 of the API performance summary for the "2019 Hematology / Coagulation - 1st Event" revealed the laboratory reported unacceptable results for 5 of 5 PT specimens for "Neut/Gran," 5 of 5 PT specimens for "Monocytes/Mids," and 5 of 5 PT specimens for "Lymphocytes" obtaining an overall score of 0% for WBC differential. 3) Phone interview on 6/4/2019 at 10:00 a.m. with both the director of quality assurance and compliance and the laboratory director confirmed the unsatisfactory scores for WBC differential obtained for the 2nd PT event in 2018 and the 1st PT event in 2019. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 record review and staff interview, the laboratory failed successfully participate in 2 out of the last 3 proficiency testing (PT) events for white blood cell (WBC) differential in 2018 and 2019. Findings include: 1) Review of CASPER Report 0155D on 6/4/2019 revealed the laboratory obtained scores for WBC differential of 47% and and 0% for the second American Proficiency Institute (API) PT event in 2018 and first API PT event in 2019 respectively. 2) Review on 6/4/2019 of the API performance summaries for the "2018 Hematology / Coagulation - 2nd Event" and the "2019 Hematology / Coagulation - 1st Event" revealed the laboratory obtained unsatisfactory scores (47% and 0% respectively) for WBC differential. 3) Phone interview on 6/4/2019 at 10:00 a.m. with both the director of quality assurance and compliance and the laboratory director confirmed the unsatisfactory scores for WBC differential obtained for the 2nd PT event in 2018 and the 1st PT event in 2019. -- 2 of 2 --