Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Administrative/Office Aspects
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Linde spirit ("green tree") mission / vision statement posted in location. NO OTHER MISSION STATEMENTS SHOULD BE POSTED.
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LifeGas general organizational chart and local "Center" organizational chart are current with employee titles listed, posted
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All permits, licenses and registrations are posted and current for all states(s) in which location does business (local, state, federal; business registrations; staff aware that current FDA registration information can be found on line; DOT/HazMat registrations are available and current, etc.)
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Location has OSHA 300A logs available for previous 5 years (posted Feb. 1st through April 30th each year, then filed)
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Emergency exit signs are posted above exit doors
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Evacuation/escape routes are posted in office, warehouse, etc.
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Employee "right to know" information is posted in employee common area (usually Federal labor posters and any State-required information)
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No unrestrained cylinders are being stored in office areas (must have signage, proper storage, etc.)
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No unbagged/untagged equipment or patient supplies being stored in office areas (must be identified with bag, tag and proper signage for storage areas).
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No smoking signage posted in office area.
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No protected health information in office (confidential patient information) is readily viewable by public (patient records, computer screens, white board, etc.)
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Protected health information is not released without patient approval
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Applicable personnel aware of local HSE support person.
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Front door and gate are not left unlocked when office area is unattended. Visitor sign-in sheets and visitor badges being utilized.
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Applicable personnel can immediately access Med-01-99 "navigator" for MED manual and accreditation-related policies
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Applicable personnel are familiar with the notification process for HQAA surveys and general inspections (per "Handling Regulatory and Third Party Inspections" IMS-17-16-GAM)
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Personnel are aware that surveyors are to be admitted for on-site reviews after verifying presence of HQAA photo identification, and understand need to follow "who to call" listing/notification procedures, as well as what is permitted to be reviewed (personnel and patient records can be reviewed, etc.)
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Are employees familiar with name of Linde US Healthcare compliance officer (David Welty) and compliance policy/plan in LIMSS (HOME-19-22-USA)
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Are applicable personnel at the location familiar with local sub-contract requirements (e.g., responsibilities of LifeGas for local O2 Shield agreements - initial set-up or not, etc.)
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Do applicable personnel know how many O2 Shield customers are being serviced? Any responsibility for concentrators or other biomed equipment maintenance at patient residences or nursing homes, etc.?
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Personnel using on-call/after hours log to document after-hours call situations?<br>AFTER-HOURS LOGS TO BE MAINTAINED FOR MINIMUM OF 7 YEARS. CALLS MUST BE RETURNED WITHIN 30 MINUTES PER INTERNAL POLICY (HOME-01-04)
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Quality/Performance Improvement Program - are KPI charts posted in LifeGas location with current information? Are staff aware that KPI's serve as the "OI/PI" program for LifeGas purposes? Does management at the location share information with personnel? Are KPI charts posted in locations?<br><br>REFER TO POLICY HOME-01-07:LIFEGAS/LINDE RSS QUALITY IMPROVEMENT PROGRAM
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Personnel understand conflicts of interest and what to do if they become aware of a conflict? <br><br>VPP-00-01-GROUP CODE OF ETHICS p. 33-35, CONFLICTS OF INTEREST POLICY
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Do personnel understand that there is a Board of Directors for "LifeGas" and that there is no advisory committee for LifeGas?<br><br>REFER TO POLICY HOME-01-05.
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Are personnel able to state method to report ethical situations, and familiar with abuse/neglect procedures, including Abuse/Neglect reporting form?<br><br>ABUSE/NEGLECT TRAINING PRESENTATION-HOME-07-08 AND ELDER ABUSE ACT POLICY HOME-19-20
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Annual Fire Drill documented and available for current and previous 3 years minimum
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Annual Mock Disaster/Emergency Drill documented and available for current and previous 3 years miniumum
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Current, complete patient listing available for emergency/disaster purposes?<br><br>REFER TO COORDINATION WITH HME CUSTOMER-DISASTER PLANNING (LIFEGAS) IN MED-01-99. (IMS-25-51)
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Current, complete HME customer listing available for emergency/disaster pruposes?<br><br>REFER TO COORDINATION WITH HME CUSTOMER-DISASTER PLANNING (LIFEGAS) IN MED-01-99. (IMS-25-51)
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Are personnel familiar with local emergency/disaster planning procedures, and have access to location-specific emergency/disaster plan?
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Do advertising/marketing materials correctly reflect the products/services currently offered by the location?<br><br>ENSURE NO "ROGUE" ADVERTISING IS BEING USED - MUST UTILIZE WHAT IS RELEASED BY THE CORPORATE OFFICE.
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Are location managers aware that annual budgeting/financial processes are controlled by "corporate leadership" and do they understand their role in the process?<br><br>REVIEW OF BUDGET/FINANCIALS PERFORMED DURING HQAA CORPORATE SURVEY, AND NOT USUALLY PART OF LOCATION SURVEYS.
INJURY/INCIDENT REPORTING
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Personnel are aware that Synergi is to be used for documentation of incidents involving employee injuries, etc. and any incidents involving patients should be shared with HME customer (include supervisors/legal/others, as necessary in communication)
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Are proper guidelines being followed in cases of adverse and sentinel events? HQAA requires investigation within 24 hours of becoming aware of incident, infection or injury; investigate within 72 hours for all other incidents, infections, or injuries involving patients.
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Are personnel familiar with what the company considers an unsafe issue and process for reporting?
COMPLAINTS REPORTING AND HANDLING
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Personnel aware that LEMS to be used for documentation of customer/patient complaints for LifeGas.
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Staff are familiar with timeframes for complaints documentation, reporting and actions, (5 days to acknowledge complaints and 14 days for written response letters. Responses to be coordinated with HME provider, as applicable)
WAREHOUSE/INFECTION CONTROL/SAFETY/MEDICAL GAS STORAGE
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Warehouse and shelves are neat, clean, organized and aisles without clutter and clear walkways. No cardboard boxes directly on floor.
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First aid kit present, with no unpackaged or outdated (expired) items<br><br>FIRST AID LOGS SHOULD NOT BE POSTED IN LOCATIONS, AS THESE ARE OBSOLETE
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Eye wash stations, present (solution not expired) in warehouse.<br><br>EYE WASH SOLUTIONS MUST BE PRESENT IN DESIGNATED EQUIPMENT CLEANING AREA IN ADDITION TO ANY OTHER EYE WASH STATIONS.
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All fire extinguishers in office and warehouse are properly attached to wall with appropriate designation signage; are free from obstructions; are current (annual inspection) with backs of cards on the extinguisher checked montly. <br><br>REMEMBER TO CHECK FIRE EXTINGUISHERS ON TRUCK (20 LB - MAY OR MAY NOT BE NEEDED, BUT CANNOT BE EXPIRED)
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Are staff competencies available for those operating specialized equipment, such as forklift? Are forklift inspection reports completed properly?
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Safety/Infection control officer designated for location - personnel aware of name of this person, and job description signed/dated and placed in location personnel file.<br><br>SAFETY OFFICER JOB DESCRIPTION LOCATED IN ICS STANDARDS IN MED-01-99.
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Material Safety Data Sheets (MSDS) are available for cleaning products and gases used/handled at location<br><br>AT MINIMUM,, LOOK FOR MSDS FOR MADACIDE AND OXYGEN, COMPRESSED AND REFRIGITAED.
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Tools used for oxygen are labeled and kept separate from other tools.
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Oxygen storage tank area has at least one "no smoking" sign posted
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Is LOX storage tank gate locked when the office is unattended? Do employees know ho to handle presence of unauthorized individuals? LOX storage tank area is maintained in secure fashion-gate should not be open when unattended.
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Cleaning/disinfectant supplies and ALL bottles/containers in location are labeled and stored properly. <br><br>SHOULD BE NO UNLABELED SPRAY BOTTLES OR OTHER CONTAINERS IN TEH WAREHOUSE, FILL AREAS, CYLINDER PREP AREAS, VEHICLES, ETC.
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All equipment is properly bagged and tagged with status, and place in proper areas designated by correct signage:<br> <br>"Clean/patient ready" equipment designated with "blue" tape on warehouse floor and appropriate signage. All items used with oxygen are bagged and kept free from dust and other contaminants (flow meters, regulators, adapters, fill hoses, oxygen disposable supplies, etc.)<br><br>"Functional Check" area - designated with "yellow" tape on warehouse floor and appropriate signage<br><br>"Dirty Area" - designated with "red" tape and appropriate signage<br><br>"Quarantine" and "Obsolete" area - designated with signage
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Clean/patient-ready items are segregated from dirty or contaminated items.
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All regulators, flow meters, adapters, etc. are bagged and kept free from dust and other contaminants?
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Only CLEAR bags are used for equipment (clean, dirty and "waiting for repair"). No red "see-through" bags or other colored bags are to be used for equipment storage. Only time red biohazardous bags to be used is when suspected contamination with blood or other body fluids or when picking up equipment from residence with know patient/careiver infectious disease.
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Personnel aware of proper process for picking up "dirty" vs. "potentially contaminated" equipment. <br><br> Wears disposable gloves for all pick-ups.<br> If equipment does NOT appear to contain blood or other bodily fluids:<br> Bag and tag equipment. Use CLEAR bag only. <br> If desired, use Madacide to perform initial curbside cleaning, and ensure proper PPE use.<br> Document steps taken on status tag.<br> Place in designated "dirty" area in truck (or place "dirty area" signage on or near equipment, as possible).<br> Place equipment in designated "dirty" area back at location.<br><br> If equipment appears to contain blood or other bodily fluids or equipment that may be contaminated due to being removed from home of known patient/caregiver with infections disease:<br> May need to wear disposable gown in addition to disposable gloves if equipment is large and may touch clothing.<br> Use red biohazardous bag ONLY to bag this equipment. <br> May curbside clean with Madicide if desired, as described above<br> Place gloves/gown inside RED biohazardous bag with equipment and seal bag as much as possible.<br> Place potentially contaminated equipment in "dirty area" in truck.<br><br>
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Storage of biomedical waste should not be for an extended period of time . Example Florida rules - waste cannot be stored longer than 30 days on site. Contact local Hauler for quick pick-ups.<br><br>Properly using "Biomedical Waste Transport Log" and has these available on truck. <br><br>Location has "Transport Log - Non-Regular Pick-Ups" available for use (and maintaining monthly documentation properly)<br><br>Location has complete list of decontamination and disposal materials and where they are stored on "Bloodborne Pathogen Equipment List - Medical Sites"<br><br>Location aware of proper biomedical waste "spill handling" procedures per HOME-06-08 policy.<br><br>Other Requirements outlined in Policy Home-06-08:Bloodborne Pathogens Program for Home Healthcare:<br><br>Location has biomedical waste agreement in place with local hauler<br><br>After cleaning and processing any "red bagged" equipment, disposable gloves and used red bags placed into red waste receptacles (box, bin, etc.) at the Center provided by local biomedical waste hauler<br><br>All sealed biomedical waste bags/containers are labeled with Center's name and address prior to off-site transport. If sealed red bag placed into larger bag or container prior to transport by local waste hauler, placing Center's name/address only on exterior bag is sufficient<br><br>Outer containers such as red waste receptacle at Center, should be labeled with transporter's name, address, registration number (if applicable) and 24 hour phone number<br><br>No outside storage area being used for biomedical waste<br><br>Signage present that designate storage area for "employees only." Chosen storage area for "employees only." Chosen storage area has restricted access from general traffic flow patterns and is accessible and identifiable to only authorized personnel through signage "employees only."<br><br>Signage in storage area states "Biomedical Waste" or "Infectious Waste"<br><br>Storage area is constructed smooth, easily, cleanable, imperious materials - no carpeting, concrete should be sealed.
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Proper PPE available and used during equipment cleaning procedures - refer to manufacturer's guidelines and MSDS. Must wear disposable gloves and eye protection minimum.
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Applicable personnel familiar with manufacturers' "soak time" for disinfectant solutions. (NOTE: 10 MINUTE SOAK TIME FOR MADACIDE: 1 AND FD.
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Once equipment has received functional checks, is it then tagged and placed in clear bag, and put in blue/patient-ready/clean area?
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No expired items on shelves.<br><br>Look for any expired items on shelves in storage areas. Ensure stock rotation, and any normal saline or other solutions are being stored in temperature-controlled environment, if applicable.
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Food/drink items not stored near equipment or warehouse/filling areas.
CYLINDER STORAGE
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Proper storage and handling of oxygen and other cylinders:<br><br>Adequate and correct signage available to ensure no co-mingling-industrial and medical product segregated; full/empty segregated<br><br>No upside-down cylinders in racks or un-nested (freestanding) cylinders of any type (only cylinders in process may be unrestrained) - proper cylinder racks being used for size of cylinders<br><br>Separation of full/empty cylinders with appropriate signage<br><br>Segregation of "quarantined" cylinders with appropriate signage<br><br>Separation of oxygen cylinders from others containing flammable gases (20 ft or non-combustible wall minimum of 5 ft high with fire resistance rating of at least 30 minutes-e.g., propane for forklifts)<br><br>Cylinder valves protected from abnormal mechanical shocks that may damage cylinder, valve or safety device-proper use of valve protection caps, as applicable<br><br>Connections are not forced<br><br>No hydrocarbons used near oxygen cylinders<br><br>Oxygen cylinders/vessels are NOT stored near electrical outlets, fuse/circuit boxes, etc. No electrical cords should be draped over oxygen cylinders<br><br>No bungee cords being used to secure cylinders<br><br>Hand trucks for cryogenic home vessels have chain or strap (No bungee cords)
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LOX base units are stored properly with status tags
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Equipment in manufacturer's cartons NOT stored directly on floor? (Includes soft good supplies and other types of equipment - should be on shelves or pallets, if equipment not designated to sit directly on floor, such as concentrators)
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LifeGas-owned equipment contains equipment stickers (company name, phone number, etc.; and PM stickers)
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Are HEPA masks available on each truck and for delivery personnel (fit testing usually required)?
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Do personnel understand when to use HEPA mask? (When a patient has active or suspected Tuberculosis (TB), NOT Hepatitis B. If a patient is coughing, and it may not be known why, the employee may don his/her mask. Refer to Policy HOME-03-04-USA)
EQUIPMENT PM/CHECKS/TRACKING/RECALLS
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Are copies of features, warranties, instructions and PM requirements available for all types of equipment being handled by the location?
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