Shriners Hospital For Children Philadelphia

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the Siemens Rapid Point 500 analyzer records and interview with the laboratory director (LD) and technical consultant (TC), the laboratory failed to evaluate the relationship between 2 of 2 Siemens Rapid Point 500 blood gases analyzers in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 06/25 /2020, the laboratory could not provide comparison studies performed on 2 of 2 Siemens Rapid Point 500 analyzers used for blood gases analysis in 2018, 2019 and 2020. 2. From 08/24/2018 to 12/31/2018, 431 patient specimens were analyzed on the Siemens Rapid Point 500 blood gases analyzers. 3. From 01/01/2019 to 12/31/2019, 1196 patient specimens were analyzed on the Siemens Rapid Point 500 blood gases analyzers. 4. From 01/01/2020 to 06/25/2020, patient specimens were analyzed on the Siemens Rapid Point 500 blood gases analyzers. 5. The LD and TC confirmed the findings above on 06/25/2020 around 10:00 am. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 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 -- director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance (QA) policy, American Proficiency Institute (API) proficiency testing (PT) record, and interview with the laboratory technical consultant (TC) #1, the laboratory failed to look into blood gases (BG) PT participations among laboratory testing personnel (TP) in 2018. Findings include: 1. The laboratory QA policy, the laboratory director signed on 09/21/2016, states "Proficiency testing samples is periodically rotated among users and analyzers." 2. The laboratory PT Attestation Statement reads as follows: API BG 2018 2nd Event Person Sample Performing Test* Sets Tested Date TC #1^ BG-06, BG-07 06/08/2018 BG-08, BG-09 BG-10 *Total 12 TP routinely test patient BG. ^TC #1 (a non-TP) does not test patient BG. 3. Of these 5 BG PT sample sets, the TC #1 tested them all (5 of 5). 4. Of the other TPs, none (12 of 12) tested any (5 of 5) BG PT sample sets. 5. The laboratory did not have any follow-ups. 6. The TC #1 confirmed above findings on 08/24/2018 at 11:30 AM. ====================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --