Patient First - Colonial Park

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor record review (Application for Exception to Section 5.22(f)) and interview with the Technical Consultant (TC)#1, the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests are being performed. Findings Include: 1. The PA regulations (5.23 (b)(1)) states: "A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2 . Review of the application for Exception to Section 5.22 (f) form signed by the laboratory director (LD) on 11/10/2022 states: " the laboratory director will appoint a qualified general supervisor for each laboratory who will be on-site to oversee laboratory operations during all hours in which testing is being performed and who will review quality control records on a weekly basis". 3. On the day of survey 05 /03/2023 at 9:30 am, during an interview, TC#1 stated that the laboratory did not have a qualified supervisor onsite for every hour of patient testing as required by the State of PA. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory Quality Control (QC) records and interview with the Technical Consultant (TC) #1 and #2, the laboratory failed to retain quality control and patient test records for KOH and Wet Preparation slide reading, for at least 2 years, from 02/28/2017 to the date of survey. Findings include: 1. On the day of survey, 10/11/2018, the laboratory was unable to provided daily visual KOH and Wet preparation slide reading QC records for 4 of 11 months ( April, May, June and July) in 2017. 2. TC #1 and #2 confirmed the finding above on 10/11/2018 around 10:30 am. * KOH = Potassium hydroxide 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 --