Crozer Chester Med Ctr Operating Room

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 review of the CASPER 155 Report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for the routine chemistry analyte: PO2 Blood Gas. 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 review of the CASPER 155 Report and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), the laboratory failed to achieve an overall testing score of satisfactory performance for the routine chemistry analyte: PO2:Blood gas. The laboratory had unsatisfactory scores for the 1st and 2nd event of 2024. Findings include: Subspecialty Year Event Score PO2: Blood gas 2024 1 60% PO2: Blood gas 2024 2 60% -- 2 of 2 --

Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on quality control record review and interview of the Laboratory Director and Point of Care Coordinator, on the date of the the survey (10/04/2021), the laboratory failed to run two levels of control materials each 8 hours of operation when performing Activated Clotting Time testing using the Hemochron Signature Elite analyzer. Findings: 1. Each month or change of reagents, 2 levels of external controls are run on the Hemochron Signature Elite analyzer.for Activated Clotting Time. 2. The laboratory did not have a complete Individualized Quality Control Program. 3. During the survey, the Laboratory Director confirmed the above findings. 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 --

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 the Laboratory procedure manuals and interview with the laboratory director (LD), point of care testing (PoCT) coordinator and technical consultant (TC) #2, the laboratory failed to establish a procedure to assess the competency for all testing personnel TP who performed Activated clotting time (ACT), Blood Gases Analysis and 2 of 3 TCs from 07/28/2017 to the date of survey. Findings include: 1. On the day of survey, 04/25/2019, the laboratory could not provide a competency assessment policy. 2. The laboratory could not provide documentation of competency assessment for 2 of 3 TC from 07/28/2017 to 04/25 /2019. 3. The LD, PoCT coordinator and TC#2 confirmed the findings above on 04/25 /2019 around 09:45 am. 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 quality assessment (QA) documents and interview with 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 2 -- laboratory director (LD), point of care testing (PoCT) coordinator and technical consultant (TC) #2, the laboratory failed to establish a quality assurance policy from 07/28/2017 to the date of survey. Findings Include: 1. On the day of survey, 04/25 /2019, the laboratory could not provide a policy for monitoring its pre-analytical, analytical, and post analytic programs form 07/28/2019 to 04/25/2019. 2. On 04/25 /2019 around 11:00, the LD provided QA activities performed on a monthly basis from July of 2017 to March of 2019, but could not produce a policy describing how quality systems are assessed. -- 2 of 2 --