Comanche County Hospital

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of monthly coagulation quality control (QC) instrument printouts from 1/1/22 to 4/29/22, QC and patient test logs, and interview with Testing Personnel (TP) #1, the laboratory failed to ensure QC acceptability in the specialty of Hematology for prothrombin time and partial prothrombin time before reporting patient test results. Findings: 1. Review of the monthly coagulation QC instrument printouts from 1/1/22 to 4/29/22 revealed unacceptable QC results with no repeated QC with acceptable values for the following analytes, QC levels, and dates a. Prothrombin time- (1)-QC04: 1/13/22, 1/14/22, 1/15/22, 1/16/22, 2/11/22, 2/23/22, 3/2 /22, 3/3/22, 3/4/22, 3/21/22, 3/22/22, 4/19/22, 4/20/22. b. partial Prothrombin time- (1) QC04: 1/3/22, 1/11/22, 1/12/22, 1/13/22, 1/14/22, 1/16/22, 1/17/22, 1/19/22, 1/20 /22, 1/21,22, 1/24/22, 1/27/22, 1/28/22, 2/2/22, 2/9/22, 2/17/22, 2/21/22, 2/22/22, 2/23 /22, 3/7/22, 3/8/22, 3/11/22, 3/14/22, 3/16/22, 3/22/22, 3/23/22, 3/24/22, 3/28/22, 4/1 /22, 4/4/22, 4/5/22, 4/6/22, 4/8/22, 4/11/22, 4/12//22, 4/13/22, 4/14/22, 4/15/22, 4/18 /22, 4/19/22, 4/20/22, 4/21/22, 4/22/22, 4/25/22, 4/27/22, 4/28/22, 4/29/22. (2) QC05: 1/4/22, 1/7/22, 1/10/22, 1/12/22, 1/16/22, 1/17/22, 1/18/22, 1/20/22, 1/21/22, 1/24/22, 1/25/22, 2/8/22, 2/9/22, 2/26/22, 3/1/22, 3/3/22, 3/4/22, 3/5/22, 3/8/22, 3/10/22, 3/11 /22, 3/14/22, 3/16/22, 3/17/22, 3/18/22, 3/21/22, 3/22/22, 3/24/22, 3/28/22, 3/29/22, 3 /30/22, 4/1/22, 4/6/22, 4/7/22, 4/11/22, 4/12/22, 4/13/22, 4/14/22, 4/15/22, 4/18/22, 4 /19/22, 4/21/22, 4/22/22, 4/25/22, 4/27/22, 4/28/22, 4/29/22. 2. Review of QC logs found no

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 the review of proficiency testing (PT) records from American Proficiency Institute (API) and interview with the laboratory supervisor, the laboratory failed to successfully participate in PT for the analyte: Cell identification or White blood cell differential for two out of three consecutive proficiency testing events: 2021 Event 2 and 2021 Event 3 (refer to 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: A PT desk review and phone interview with the laboratory supervisor on 2/4/22 revealed the laboratory failed to successfully particiate in PT from API for the analyte: Cell identification or White blood cell differential. Findings: 1. Review of the 2021 API 2nd Event revealed a score of 36% for Cell identification or White blood cell differential. 2. Review of the 2021 API 3rd Event revealed a score of 0% for Cell identification or White blood cell differential. 3. Phone interview 2/4/22 at 9:30 a.m. with the laboratory supervisor confirmed, the laboratory failed to successfully particiate in PT from API for the analyte: Cell identification or White blood cell differential. -- 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 the lack of documentation and interview, the laboratory failed to assess the competency of Technical Consultant (TC) #3. Findings: 1. No competency documentation for TC #3 was available at the time of survey. 2. Interview with Testing Personnel (TP) #1 on July 15, 2020 at 11:55 a.m. confirmed, the laboratory failed to assess the competency of TC #3. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of