Summary:
Summary Statement of Deficiencies D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( 2017-2018) and laboratory testing personnel interview on March 14, 2019 at 9:30 A.M., it was determined that the laboratory failed to report the proficiency testing results within the time frame established by the program. The findings include: 1. Puerto Rico Proficiency Testing Program records were review from year 2017 to 2018. 2. The records showed that the laboratory obtained a score of 0 % in the first testing event of syphilis Serology perform in May 2018 2015, due return the testing results out of the time frame specified by the Puerto Rico Proficiency Testing Program . 3. The ProficiencyTesting Program mailing date was May 7, 2018 and report deadline was May 25, 2018. 4. The laboratory testing personnel confirmed on March 14, 2019 at 9: 30 A.M, that the laboratory return the testing results out of the time frame specified by the Puerto Rico Proficiency Testing Program . D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency testing records review (2017-2018) and laboratory 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 -- testing personnel interview on March 14, 2019 at 10:00 A.M., it was determined that the laboratory failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. The finding includes: 1. The laboratory failed to report the proficiency testing results within the time frame established by the program. Refer to D2071. -- 2 of 2 --