Summary:
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 and staff interview, the laboratory failed to successfully participate in proficiency testing in two consecutive events for analyte D(RHO) and overall testing ABO/RHO in 2024. Refer to D2153, D2154, D2162, and D2163. 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 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 -- testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to attain an analyte test score of 100% for D(RHO) blood typing in proficiency testing (PT) events 1 and 2 in 2024 resulting in unsatisfactory performance. Findings include: 1. Review on 10/3/2024 of CASPER Report 0155D revealed the lab obtained an 60% PT score for D(RHO) in event 1 of 2024, and obtained a 40% PT score for D(RHO) in event 2 of 2024. 2. Interview on 10/3/2024 at 10:00 a.m. with the Office Manager confirmed the lab's above scores. 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 record review and staff interview, the laboratory (lab) failed to attain an overall test event score of 100% for ABO/RHO blood typing in proficiency testing (PT) events 1 and 2 in 2024. Findings include: 1. Review on 10/3/2024 of CASPER Report 0155D revealed the lab obtained an 80% PT score for ABO/RHO in event 1 of 2024, and obtained a 70% PT score for ABO/RHO in event 2 of 2024. 2. Interview on 10/3/2024 at 10:45 a.m. with the Office Manager confirmed the lab's overall scores. 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 record review and staff interview, the laboratory (lab) failed to achieve successful performance for D(RHO) blood type proficiency testing (PT) for two consecutive events in 2024. Findings include: 1. Record review on 10/3/2024 of CASPER Report 0155D revealed the lab achieved unsatisfactory performance for D (RHO) blood typing in events 1 and 2 of 2024. Refer to D2153. 2. Interview on 10/3 /2024 at 10:00 a.m. with the Office Manager confirmed the unsatisfactory performance scores for D(RHO). Refer to D2153. 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: -- 2 of 3 -- Based on record review and staff interview, the laboratory (lab) failed to achieve successful performance for overall testing event scores for ABO/RHO proficiency testing (PT) for two consecutive events in 2024. Findings include: 1. Record review on 10/3/2024 of CASPER Report 0155D revealed the lab achieved unsatisfactory performance for ABO/RHO blood typing in events 1 and 2 of 2024. Refer to D2154. 2. Interview on 10/3/2024 at 10:45 a.m. with the Office Manager confirmed the unsatisfactory performance scores for ABO/RHO. Refer to D2154. -- 3 of 3 --