Crosbyton Clinic Hospital

Summary Statement of Deficiencies D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with records from American Association of Bioanalysts (AAB), the laboratory did not successfully participate in the specialty of Immunohematology for the analyte Antibody Identification in 3 of 4 events between 2017 and 2018. The findings included: 1. Based on review of the CMS-155 proficiency testing report and AAB records, the laboratory received the following unsatisfactory scores for Antibody Identification: 2017 - Third Event - 0 percent 2018 - Second event - 0 percent 2018 - Third event - 0 percent Score of less than 80 percent are unsatisfactory performance. Unsatisfactory performance on two (2) consecutive events or two out of three (2 out of 3) events is unsuccessful performance. 2. In an interview at 11:28 hours on 01/16/2019 in the laboratory, the Laboratory Manager stated the unsatisfactory scores were received in error. The 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 -- Laboratory Manager stated the laboratory did not perform Antibody Identification, only Antibody Screens. The Laboratory Manager stated that in the event a patient specimen had a positive antibody screen, the laboratory would refer the Antibody Identification out to a CLIA certified reference laboratory. The Laboratory Manager stated the unsatisfactory scores were the result of marking "Would Refer" to an Antibody Identification challenge. The Laboratory Manager stated he had contacted AAB and was told by a representative to leave the next challenge blank if the laboratory did not perform the test. The Lab Manager stated the lab received a second 0 percent score for not participating, and that because of the previous submission form error, AAB was expected a response and had graded the laboratory as if they did not participate. Regarding the third event of 2018, the Laboratory Manager stated an AAB representative had instructed the lab to report Antibody Identification in a specific way in order to discontinue the test. Based on review of the AAB score sheet for Antibody Identification for the third event of 2018, the laboratory was sent a score of "DC" for discontinued. The proficiency testing program reported a score to CMS of 0 percent for the third event of 2018. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.803 Condition: Successful participation 493.1215 Condition: Hematology 493.1441 Condition: Laboratories Performing High Complexity testing; Laboratory Director 493.1409 Condition: Laboratories Performing Moderate Complexity testing; Technical Consultant 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 review of the CMS-155 proficiency testing report, the American proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Institute (API) proficiency testing records for 2015, 2016 and 2017, and interview of facility personnel the laboratory failed to successfully participate in a proficiency testing program for antibody identification. (See D2188 and D2191) D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records (3 testing events per year) from 2017 and 2018, and interview facility personnel the laboratory failed to attain an overall compatibility testing event score of at least 100% which constitutes unsatisfactory performance. Findings included: 1. Review of proficiency testing records found that the laboratory attained a score of 60% in the American Association of Bioanalysts (AAB) 2017 Q2 testing event for compatibility testing. The laboratory submitted unacceptable responses for specimens two and three. 2. Interview of the general supervisor conducted on October 16, 2018 at 11:07 AM confirmed that the laboratory made a transcription error for compatibility testing specimen two, and the specimen one was repeated and the correct results were obtained. D2182 ANTIBODY IDENTIFICATION CFR(s): 493.865(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the CMS report 155, proficiency testing records and interview of facility personnel found that the laboratory failed to attain a satisfactory score (80% or higher) in two of three consecutive testing events for antibody identification. The findings included: 1. Review of the CMS report 155 found that the laboratory attained and unacceptable score of 0% for antibody identification in the third testing event of 2017 and the second testing event of 2018 . 2. Review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records found that the laboratory received a score of 0% for anybody identification in the third testing event of 2017 in the second testing event of 2018 with no documentation of