STANDARD OPERATING PROCEDURE FOR MAINTENANCE AND CLEANING OF PULMONARY FUNCTION LABORATORY AND EQUIPMENT SOP Number: PFL 200.03 Version Number & Date: 3 rd version; 01 Mar 2011 Superseded Version Number & Date (if applicable): Supersedes version 200.02 14 Oct 2009 Effective Date: Review Date: Revision Chronology: Version Number Version Date Reason for Change 200.01 05Jun2007 Initial Version 200.02 14Oct2009 Revision 200.03 01 Mar 2011 Review Printed Name Signature Date (dd/mmm/yyyy) Written By: Shayna McKay / / Reviewed By: Sandra Halko / / Approved By: Grace Parraga / / Page 1 of 5 01 Mar 2011
1. INTRODUCTION & PURPOSE This standard operating procedure (SOP) describes the procedure for maintaining and cleaning the Pulmonary Function Laboratory (PFL) and the equipment therein to ensure compliance with all applicable guidelines for all testing conducted at this site. 2. SCOPE This SOP applies to all the equipment associated with pulmonary and cardiopulmonary testing and the facilities in which the equipment is used. 3. APPLICABLE REGULATIONS AND GUIDELINES Health Canada: Laboratory Biosafety Guidelines: 2004 National WHMIS Compliance Policy: 3 January 2002 University of Western Ontario: Health Sciences Research Ethics Board for Research Involving Human Subjects Guidelines: July 2001 College of Physicians and Surgeons of Ontario Clinical Practice Parameters and Facility Standards 4. REFERENCES TO OTHER APPLICABLE SOPs This SOP is applicable to all PFL SOPs All SOPs on Good Clinical Practices are applicable to this SOP 5. ATTACHMENTS A. Equipment in current use in the pulmonary function laboratory 6. RESPONSIBILITY It is the responsibility of the principal investigator at this investigative site to approve all SOPs. The principal investigator assumes ultimate accountability for all SOPs. It is the responsibility of all personnel involved in supervising, managing or conducting testing in the pulmonary function laboratory to follow this SOP. Page 2 of 5 01 Mar 2011
7. DEFINITIONS The following definitions apply to this SOP: Universal Body Substance Precautions (BSP): A system that consistently interrupts the transmission of infections thus ensuring increased protection for both patients and health care providers. 8. PROCESS OVERVIEW A. Calibration and Quality Control of Equipment B. Maintenance of Equipment C. Cleaning of Equipment D. Cleaning of the Pulmonary Function Laboratory E. Infection Control 9. PROCEDURES A. Calibration and Quality Control of Equipment All calibration and quality control procedures must be carried out by certified personnel (see PFL SOP 201: Training and Certification). Calibration of all pulmonary testing equipment in the pulmonary function laboratory should be performed on days when testing is being performed or at least once a week, whichever is more often. Calibration is to be carried out according to the manufacturer s directions. In addition to calibration logs that may be maintained digitally by the equipment, a hard copy of the calibration report should be obtained, initialled and dated, and filed in the calibration log binder in the PFL as source documentation. Quality control should be performed on all applicable equipment (equipment for which quality control processes have been developed by the manufacturer) at least once a month or after equipment maintenance has been performed, whichever is more often. Quality control is to be carried out according to the manufacturer s directions. In addition to logs of quality control that may be maintained digitally by the equipment, a hard copy the quality control report should be obtained, initialled and dated, and filed in the quality control binder in the PFL as source documentation. Page 3 of 5 01 Mar 2011
B. Maintenance of Equipment All maintenance must be performed by certified personnel (see PFL SOP 201: Training and Certification) or by a service rep from the equipment s manufacturer and/or supplier. Equipment should be checked at least monthly to ensure that there are no visible signs of wear or damage. Any problems should be noted in the equipment maintenance record book, along with steps taken to remedy the problem. Any service work, whether performed by site personnel or equipment service reps, should also be recorded in the equipment maintenance record book. Gas tanks should be checked on a weekly basis. Pressure levels should be recorded in the logbook, and replacement tanks ordered as necessary. To extend the life of the equipment, gas tanks should be turned off when not in use, unless otherwise recommended by the manufacturer. C. Cleaning of Equipment All cleaning is to be carried out by certified personnel (see PFL SOP 201: Training and Certification). All equipment that comes into contact with test subjects must be treated appropriately as follows: Personnel must wear gloves at all times when handling equipment that will be/has been in contact with test subjects mouth or nose. Equipment that is designed for one time use must be disposed of appropriately after each subject (see PFL SOP 400: Health and Safety). Equipment designed for multiple uses must be cleaned according to the manufacturer s directions. Disinfecting solutions must be changed at least once a week, or more frequently if required by the number of tests being performed, unless otherwise indicated by the manufacturer Rinse solution must be changed each cleaning cycle, unless otherwise indicated by the manufacturer Equipment should be cleaned at least once a week, or more frequently if required by the number of tests being performed, unless otherwise indicated by the manufacturer Reusable equipment must be appropriately disposed of (see PFL SOP 400: Health and Safety) if it shows visible signs of wear or damage, or as indicated by the manufacturer. Many pieces of reusable equipment may only be disinfected and reused a prescribed number of times (see Attachment A for details). Large pieces of equipment should be wiped down with a clean cloth after each study subject. Disinfecting spray should be used weekly or each day there is a test subject, whichever is more often. Page 4 of 5 01 Mar 2011
D. Cleaning of the Pulmonary Function Laboratory Countertops should be wiped down with a clean cloth and disinfectant spray at least once a week or more often if required. Household waste is disposed of at the end of each day by facility housekeeping services. Study personnel are responsible for having biohazard waste removed. Full biohazard bag must be taped closed with autoclave tape and placed in a non-restricted area The room number and principal investigator s initials must be written on the autoclave tape An email is sent to services@robarts.ca requesting pickup of the biohazard bag and indicating its location Dirty linens are to be removed on Monday afternoon and taken to the Robarts Research Institute loading dock for pickup on Tuesday morning by linen services. E. Infection Control Nosocomial infections are a potential risk during pulmonary function testing. Body substance precautions (BSP) apply to all areas of the pulmonary function laboratory. Gloves must be used for handling reusable equipment and equipment that has been in contact with any bodily fluid Hands must be washed immediately and thoroughly before and after subject testing and after removing gloves Page 5 of 5 01 Mar 2011