Summit Women's Center

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with the laboratory liaison (LL), the laboratory failed to ensure the immunohematology Rh quality control was documented before patient testing for 8 days (8/17/2021 to 11/16/2022) of 18 months of testing reviewed. Findings include: 1. A record review for 8 days of 18 months of testing reviewed revealed a lack of documentation on the daily log for the positive and negative immunohematology Rh quality control testing result before patient testing as follows: a. 8/17/2021 - 8 patients tested b. 9/07/2021 - 3 patients tested c. 9/08/2021 - 3 patients tested d. 9/11/2021 - 5 patients tested e. 9/21/2022 - 10 patients tested f. 9/24/2022 - 10 patients tested g. 11/02/2022 - 8 patients tested h. 11 /04/22 - 11 patients tested 2. A record review of the "Quality Control Policy" states "We document the results of all controls and will take appropriate actions when the controls do not perform as expected." "All quality control testing is satisfactorily completed prior to patient testing." 3. A interview on 11/16/2022 at 10:25 am, the LL confirmed the Rh positive and negative control was not documented on the daily log for the above listed dates. ***Repeat Deficiency from the 11/09/2017 survey*** 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 of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of immunohematology. Findings include: A review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the specialty immunohematology. Refer to D2155 and D2163. D2155 ABO GROUP AND D(RHO) TYPING 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): 493.859(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate in a testing event for the specialty of immunohematology for 2 (3rd event 2019 and 2nd event 2020) of 3 testing events. Findings include: 1. A review of the CMS database and the API proficiency testing reports revealed the laboratory failed to participate in 2 out of 2 testing events in 2020 for the specialty immunohematology: Immunohematology Specialty PT Event Score 3rd event 2019 0% 2nd event 2020 0% D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for specialty of immunohematology for 2 (3rd event 2019 and 2nd event 2020) of 3 testing events in 2019. Findings include: 1. A review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieved a satisfactory overall testing event score for 2 out of 2 testing events: Immunohematology Specialty PT Event Score 3rd event 2019 0% 2nd event 2020 0% -- 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 procedure review, record review, and interview with the office manager, the laboratory failed to ensure written competency policies were established and implemented for seven (#1 - #7) of seven testing personnel (TP) performing moderately complex ABO Rh testing from April 2017 to April 2019. Findings include: 1. Procedure review revealed the laboratory competency policy did not contain one of the six minimum regulatory requirements: "Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples." 2. Record review revealed for seven of seven TP the competency assessments lacked documentation for the missing regulatory requirement from April 2017 to April 2019. 3. During the interview on March 28, 2019 at 9:17 AM, the office manager acknowledged the competency assessment did not contain all the minimum regulatory requirements. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to 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 -- identify any problems that require