Summary:
Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted for the the Obstetrical Associates Inc laboratory on 10/30/2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of unsuccessful proficiency testing performance for the hematology White Blood Cell Identification analyte (automated differential), the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 calendar year 2024 proficiency testing review (two testing events) of 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 -- American Proficiency Institute proficiency testing program the laboratory failed to attain a testing event score of at least 80 percent for hematology White Blood Cell (WBC) Identification (ID) analyte (automated differential) leading to unsatisfactory performance. The laboratory received an overall testing score for hematology WBC ID of 24 percent for the first testing event of 2024 and a score of 0 percent for the second testing event of 2024. Refer to D2128 and D2130 . D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: . Based on calendar year 2024 proficiency testing review (two testing events) of American Proficiency Institute proficiency testing program results, the laboratory failed to undertake remedial action in response to unsatisfactory proficiency testing events as evidenced by the following: White Blood Cell (WBC) Identification (ID) Analyte (automated differential): The laboratory achieved a WBC ID score of twenty- four (24) percent for the first testing event of 2024 and a score of zero (0) for the second testing event of 2024 resulting in unsatisfactory performance for each of the testing events and overall unsuccessful performance for the analyte (refer to D2130). Based on the second unsatisfactory testing event score there was no assurance that appropriate training had been undertaken, and technical assistance employed, to correct the problems associated with proficiency testing failures. . 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 calendar year 2024 proficiency testing review (two testing events) of American Proficiency Institute proficiency testing program results, the laboratory failed to achieve satisfactory performance for the same analyte for two consecutive proficiency testing events as evidenced by the following: The laboratory achieved a White Blood Cell Identification analyte (automated differential) score of twenty-four (24) percent for the first testing event of 2024 and a score of zero (0) for the second testing event of 2024 resulting in unsatisfactory performance for each of the testing events and overall unsuccessful performance for the analyte. -- 2 of 2 --