Watertown Regional Medical Center

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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) federal report and the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Specialty of Hematology for events 2019-2 and 2019-3. See D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) report and the Wisconsin State Laboratory of Hygiene (WSLH) PT records, the laboratory failed to achieve satisfactory performance in PT for all regulated analytes within the Specialty of Hematology for events 2019-2 and 2019-3. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for the Specialty of Hematology- Event 2019-2, score 0% and Event 2019-3, score 0%. 2. Surveyor review of the WSLH PT evaluation reports on November 25, 2019 confirmed the failed 2019 PT scores for all regulated analytes within the Hematology Specialty. This results in a failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the Technical Consultant, the laboratory does not have a written procedure for evaluating testing personnel competency that includes all required elements. Findings include: 1. Review of the laboratory "Clinic Quality Plan" procedure states states "Competency must include at least 2 of the following competency methods for each test annually: a. Direct Observation b. Written Examination c. Record Review d. Blind Sample Testing e. Evaluation of Problem Solving Skills" 2. This laboratory procedure does not include all required competency assessment methods. It also states that competency will be assessed in at least two methods annually when competency must be assessed for all required competency assessment methods. 3. Interview with the Technical Consultant on May 1, 2018 at 10:00 AM confirmed a written policy for evaluation of competency of testing personnel does not include all required elements. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the Technical Consultant, the laboratory does not have procedures available for all testing performed. Findings include: 1. Review of laboratory procedures show that step-by- step procedures are not available for performing Pinworm testing. 2. Interview with the Technical Consultant on May 1, 2018 at 11:30AM confirmed that the laboratory does not have a written procedure for Pinworm testing. This is a repeat deficiency previously cited April 5, 2016. 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. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and records, performance verification records for the Sysmex Pochi hematology analyzer, and interview with the Technical Consultant, the laboratory did not verify the reference intervals (normal values) before reporting patient results. Findings include: 1. Review of the "Sysmex PocH-100i" laboratory procedure states the following for the hematology reference intervals: "Expected Values--Refer to Appendix 1-Ranges pocH 100i." 2. Review of the reference interval (normal values) in the Electronic Medical Record (EMR) for patient reports do not match the reference intervals in Appendix 1 for the Sysmex Pochi 100i hematology analyzer. The male and female reference intervals in the EMR versus the manufacturer's reference intervals do not match for the White Blood Cell, Red Blood Cell, Hemoglobin, Hematocrit, Mean Cell Volume, Mean Cell Hemoglobin, Mean Cell Hemoglobin Concentration, and Platelet analytes. 3. Review of laboratory performance verification records from October 2014 for the Sysmex Pochi hematology analyzer show that the laboratory did not perform reference interval (normal values) studies. 4. Interview with the Technical Consultant on May 1, 2018 at 12:00 PM confirms the reference intervals (normal values) for the Sysmex Pochi hematology analyzer were not verified prior to use for patient testing on October 23, 2014. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of performance verification records for the Sysmex Pochi hematology analyzer,