Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the Casper database and verified with the proficiency testing company, Medical Laboratory Evaluation (MLE). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program; 493.1403 laboratories performing moderate complexity testing; laboratory director 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 a desk review of proficiency testing records obtained from the Casper 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 -- database and verified with the proficiency testing company, Medical Laboratory Evaluation (MLE), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the analytes of ABO and D (Rho) Typing (refer to D2153). D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Casper 155 Report and Medical Laboratory Evaluation proficiency testing records found that the laboratory failed to attain a score of at least 100% acceptable responses for ABO Group and D (RHO) typing. Findings: 1. MLE 2020 (event 1) - laboratory received an unsatisfactory score of 80% for ABO. 2. MLE 2020 (event 2) - laboratory received an unsatisfactory score of 80% for ABO. 3. MLE 2020 (event 1) - laboratory received an unsatisfactory score of 80% for D (RHO). 4. MLE 2020 (event 2) - laboratory received an unsatisfactory score of 80% for D (RHO). D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) 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 proficiency testing desk review of Casper 115 Report and Medical Laboratory Evaluation (MLE) proficiency testing records found that the laboratory failed to attain an overall score of at least 100% for each testing event in the specialty of immunohematology ABO/RHO. Findings included: 1. MLE 2020 (event 1) - laboratory received an unsatisfactory event score of 80%. 2. MLE 2020 (event 2) - laboratory received an unsatisfactory event score of 80%. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (100% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of immunohematology for ABO Group. Two out of three unsatisfactory -- 2 of 3 -- scores results in unsuccessful PT performance. Findings include: 1. MLE 2020 (event 1) - laboratory received an unsatisfactory score of 80% for ABO. 2. MLE 2020 (event 2) - laboratory received an unsatisfactory score of 80% for ABO. 3. MLE 2020 (event 1) - laboratory received an unsatisfactory score of 80% for D (RHO). 4. MLE 2020 (event 2) - laboratory received an unsatisfactory score of 80% for D (RHO). 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 a proficiency testing desk review of Casper 155 Report and Medical Laboratory Evaluation (MLE) proficiency testing records found that the laboratory failed to attain satisfactory performance of 100% for each testing event in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance in the specialty of immunohematology ABO/RHO. Findings included: 1. MLE 2020 (event 1) - laboratory received an unsatisfactory event score of 80%. 2. MLE 2020 (event 2) - laboratory received an unsatisfactory event score of 80%. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services (refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (refer to D2153 and 2163). -- 3 of 3 --