Crozer Chester Medical Ctr - Poc

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for the analyte Creatinine. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 review of the CASPER 155 report and graded results from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing for the analyte: Creatinine, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 2nd event of 2020 and the 3rd event of 2020. Findings include: Analyte Year Event Score Creatinine 2020 2 0%. Creatinine 2020 3 0%. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals and interview with the point of care testing ( PoCT) coordinator and PoCT educator, the laboratory failed to establish a competency assessment procedure to assess the competency of 2 of 2 technical consultants from 2018 to the date of survey. Findings Include: 1. On the day of survey, 12/13/219, the laboratory could not provide a written procedure to assess the competency of 2 of 2 clinical consultants from 11/06/2019 to 12/13/2019. 2. The PoCT coordinator and PoCT educator confirmed the finding above on 12/13/2019 around 8:45 am. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the point of care testing (PoCT) coordinator and PoCT educator, the laboratory failed to provide a written or electronic request for patient creatinine testing performed in the MRI department in 2018 and 2019. Finding Include: 1. On the day of survey, 12/13/2019, review of patient records revealed, the laboratory did not have a written or electronic requests 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 -- for creatinine tests ordered in the MRI department in 2018 and 2019. 2. The PoCT coordinator interviewed at the time of survey said, "there was a standing order policy". 3. The "Administration of Gadolinium - Based Contrast Agents procedure manual provided to the surveyor (discontinued 7/1/2019) by the MRI department, was unclear regarding the laboratory's process for standing orders. 4. The procedure was not signed by the CLIA laboratory director. 5. The PoCT coordinator confirmed the findings above on 12/13/2019 around 10:00 am. **** MRI = Magnetic Resonance Imaging. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the point of care testing (PoCT) coordinator, the laboratory failed to establish and perform maintenance protocols for 3 of 3 thermometers used to monitor a mini refrigerator in the radiology department from 2017 to the date of survey. Findings Include: 1. On the day of survey, 12/13/2019, while on tour of the laboratory, observation of a mini refrigerator stored in the Radiology department, revealed 3 thermometers, were in use to monitor the refrigerator temperature. 2. The mini refrigerator stored quality control material for nova state senor, used to perform creatinine tests from 11/06/2017 to 12/13/2019. 3. The PoCT coordinator was unable to provide the calibration and maintenance records for the 3 of 3 thermometers. 4. The laboratory could not provide a maintenance protocol for the thermometers. 5. The PoCT coordinator confirmed the findings above on 12/13/2019 around 10:15 am. D5785