Attachment A_Patient Safety Alert AL 14-04.pdf

Frequently Asked Questions (FAQs) for Patient Safety Alert AL14-07: Issues continue to occur due to improper ceiling mounted patient lift installation, maintenance and inspection

Link: http://vaww.ncps.med.va.gov/Guidelines/alerts/Docs/AL14- 07CeilingMountedPatientLifts.pdf

Date: September 3, 2014

Question 1: Is there a VA directive mandating that these actions must be completed (as opposed to the actions being more like guidelines)?

Answer 1: Yes, the actions in Patient Safety Alerts (PSA) must be completed. VHA Patient Safety Alerts are issued to VISNs and VA medical facilities by the Deputy Under Secretary for Health for Operations and Management (10N). VHA Patient Safety Alerts mandate specific actions to address actual or potential threats to life or health and may require clinician action. Patient Safety Alerts disseminate urgent notices that require specific, mandatory, and timely action on the part of the recipient(s). For more information regarding VHA Patient Safety Alerts and Advisories please see VHA Handbook 1050.01 and VHA Directive 1068.

Question 2: If the device, the supporting structure, and the maintenance procedures are accepted by the FDA, how can the VA mandate that procedures and practices that are not included in the original equipment manufacturers (OEM) scheduled maintenance requirements be part of the tests and verifications facilities must perform?

Answer 2: The VA can go above and beyond any manufacturer’s inspection requirements.

Question 3: Why do facilities need to complete the “Installation or Relocation Checklist for Ceiling Mounted Patient Lifts” and/or “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” in addition to manufacturer provided checklists prior to permitting the equipment to be used for patient movement?

Answer 3: AL14-07 requires the PSA checklists be completed by the facility in addition to any manufacturer’s checklist to ensure that all safety concerns are properly addressed. In reviewing checklists from manufacturers, it was noted that testing requirements were highly varied and did not address all safety concerns listed in AL14-

07. If a facility or manufacturer creates a single checklist that addresses all items in the PSA checklists and the manufacturers’ original checklist then it is acceptable to use.

Question 4: What is the governing document/standard that the Actions in AL14-07 are based on?

Answer 4: AL14-07 and the checklists provided with it are based on over 400 patient safety reports involving ceiling mounted patient lifts that have been submitted to NCPS by VHA facilities since the release of AL10-07 in March of 2010. In addition, ISO standard 10535:2006, FDA MAUDE reports, and ECRI Institute Hazard Reports were reviewed. After analyzing this information, the Patient Safety Alert and checklists were created by the National Center for Patient Safety (NCPS), the Healthcare Technology http://vaww.ncps.med.va.gov/Guidelines/alerts/Docs/AL14-07CeilingMountedPatientLifts.pdf http://vaww.ncps.med.va.gov/Guidelines/alerts/Docs/AL14-07CeilingMountedPatientLifts.pdf http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2389 http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=2389 http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3026

Management Program Office (10NA9) and the Center for Engineering and Occupational Safety & Health (CEOSH) (10NA11) to address the common root causes of the incidents.

Question 5: Which types of lifts should be included when completing the Actions in AL14-07?

Answer 5: AL14-07 is intended to cover all ceiling mounted patient lift systems used in facilities. Ceiling mounted patient lift systems are defined by ECRI Institute as: patient transfer lifts that consist of a permanently mounted overhead track supporting a suspended seat (sling or rigid). These lifts include the following: a track usually mounted on the ceiling…, a mounting system that attaches the track to the ceiling, a console containing the motor and pulleys, a suspension system including the seat, and a control box for lift movement regulation.

Question 6: Does AL14-07 affect lifts that are installed in patient homes?

Answer 6: No. AL14-07 pertains to ceiling mounted patient lift systems that are within VHA facilities including Community Based Outpatient Clinics (CBOCs). Actions do not need to be completed on lifts within patient homes; however, facilities may choose to develop educational material using this Alert to share with patients.

Question 7: AL14-07 does not include Actions regarding the frequency of preventive maintenance (PM), should facilities continue to follow manufacturers’ recommendations?

Answer 7: AL14-07 intentionally does not include a PM schedule for ceiling mounted patient lifts. The appropriate timeframe for preventive maintenance is a medical center decision based on manufacturers’ recommendations and/or a risk assessment completed by the facility. The Actions in AL14-07 are intended to bring attention to items that should be verified during PM procedures. Many medical centers have chosen to complete PMs semi-annually or annually.

Question 8: When should facilities start using the PSA checklists?

Answer 8:

• For the Installation or Relocation Checklist:

AL14-07 Addendum Action 2b states that by close of business December 5, 2014, the “Installation or Relocation Checklist for Ceiling Mounted Patient Lifts” shall be completed prior to permitting the equipment to be used for patient movement.

• For the Corrective and Preventive Maintenance Checklist:

AL14-07 Addendum Action 3 states that by close of business December 12, 2014, the entire “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” shall be completed after:

• Modifications to or replacement of the lift unit

• Replacement of the lift strap

• Modifications to the track/rail structure

• Other major corrective maintenance procedures that may not be identified above

For minor corrective maintenance procedures that do not fall into the above categories, the manager of the service responsible for maintaining ceiling mounted patient lifts (or designee) shall determine the relevant sections of the “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” to be completed. Results shall be documented in the VistA AEMS/MERS system.

Question 9: What if a third party contractor/vendor is currently in the middle of completing PMs on the ceiling mounted patient lifts in a facility? Is it the expectation that the facility stop the inspections that are currently taking place and have the contractor start over on the PMs with the new checklist?

Answer 9: No. If there is a manufacturer or vendor on site currently performing inspections on ceiling mounted patient lifts, the facility may allow the contractor/vendor to complete the PMs that are in progress and work with them to include the new checklist requirements in the next cycle of PMs that the facility will perform. It is understood that the checklist changes will take time working with the contractor/vendor to implement and that it is not realistic or in the best interest of patient safety to stop PMs that are currently in progress.

Question 10: Are facilities required to complete every section of the “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” with every preventive maintenance procedure?

Answer 10: Yes. AL14-07 Action 3 explicitly states that the entire “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” shall be completed prior to permitting equipment to be used for patient movement. Results shall be documented in the VistA AEMS/MERS system.

Question 11: Are facilities required to complete the entire “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” if maintenance is being documented in VistA AEMS/MERS?

Answer 11: Yes. The “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” must still be completed as detailed in AL14-07 Action 3 to ensure that all items noted are properly addressed and then the results must be documented in the VistA AEMS/MERS system.

Question 12: Are facilities required to complete every section of the “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” with every corrective maintenance procedure?

Answer 12: AL14-07 Action 3 states:

For corrective maintenance (CM) procedures, the entire “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” shall be completed after:

‐ Modifications to or replacement of the lift unit ‐ Replacement of the lift strap ‐ Modifications to the track/rail structure ‐ Other major corrective maintenance procedures that may not be identified above

For minor corrective maintenance procedures that do not fall into the above categories, the manager of the service responsible for maintaining ceiling mounted patient lifts (or designee) shall determine the relevant sections of the “Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts” to be completed. Results shall be documented in the VistA AEMS/MERS system.

Question 13: For ceiling mounted patient lifts installed in a Department of Defense (DOD) facility, is there a mechanism for the Patient Safety Alert to be communicated through DOD channels?

Answer 13: NCPS has a procedure in place to notify the DOD of Patient Safety Alerts or Advisories, when appropriate.

Questions specific to the content of the PSA checklists:

Installation/Structure

Question 14: What if additional staff or contractors are needed for verification of all structural elements that tie into the buildings deck and its bracing and connective components?

Completing this verification with every PM may add additional cost that facilities did not account for when the lifts were originally installed.

Answer 14: All items in the checklists are important to ensuring continued safe use of ceiling mounted patient lift systems and prevention of harm. Facilities should distribute resources appropriately and account for any additional resources in future budget planning.

Question 15: How should VA staff verify “proper structural component sizing and physical installation…”?

Answer 15:

• When completing the “Installation or Relocation Checklist”, VA staff shall work with the manufacturer or vendor to ensure that the ceiling mounted lift is installed using the proper components.

• When completing the “Corrective and Preventive Maintenance Checklist”, the intent of this checklist item is to ensure a visual inspection is completed to verify that the structural components are not damaged and have not been modified in a way that will be detrimental to the functioning of the lift.

Rails/Tracks and End Stops

Question 16: How should VA staff verify “that all fasteners and set screws are properly tightened on the trollies and rails/tracks”?

Answer 16: Verification can include physically checking the fasteners or observing the contractor/vendor while work on the lift system is performed.

Lift Unit and Straps

Question 17: Do facilities need to replace a lift strap at the recommended timeframe from the manufacturer if the PM inspection reveals it is in good condition?

Answer 17: The timeframe to replace lift straps is a medical center decision based on manufacturer's recommendations and/or an appropriate risk assessment. It should be noted that in some cases the straps may not show outward signs of wear, but could still need to be replaced.

Load Testing

Question 18: Why is load testing required during PM procedures if many manufacturers do not have any recommendations for load testing after initial installation?

Answer 18: Load testing was identified for inclusion in the checklists after reviewing the patient safety reports submitted to NCPS. There have been reported incidents of lifts failing under loads that are below the maximum rating provided by the manufacturer.

There have also been a number of FDA recalls recently where manufacturers have revised their maximum rated load to a lower value than what was previously published.

While manufacturers may not require it, lifts should be load tested to ensure that the system is safe to use at the manufacturer specified rating. As stated in the response to Question 2, The VA can go above and beyond any manufacturer’s inspection

Question 19: Why is load testing required after replacement of a strap in a ceiling lift motor?

Answer 19: After replacement, the new strap should be load tested to ensure that it is installed properly and rated for the maximum load of the lift system. Incidents have been reported where the lift strap was not properly installed and patient falls have occurred due to this.

Question 20: How should VA staff verify “any “soft start” or “soft stop” features and that lifting speed does not exceed 2.5 inches per second with “zero” load” and “any “soft start” and “soft stop” features and that lifting speed does not exceed 1.5 inches per second under maximum rated lift capacity”?

Answer 20: The intent of inclusion of these items in the checklist is to ensure that the lift does not cause abrupt movement that could cause injury to the patient when it starts or stops. Testing should focus on ensuring that the lift does not accelerate or decelerate too quickly. One potential test method would be to use a stop watch to time movements and then measure the distance traveled. This information can then be used to determine the speed expressed in inches per second.

Question 21: Why are three stages (“a 100 lb. load, then 50% of maximum rated lift capacity, then 100% of maximum rated lift capacity”) required for “Verification of load testing and deflection testing…”?

Answer 21: The intent of this testing was to gradually test the lift to avoid potential catastrophic failure if the lift was not installed properly. However, based on recent feedback to CEOSH and concerns regarding potential staff injuries because of requirements to physically move significant weight multiple times, this checklist item will be amended to only require testing at the maximum rated load.

Question 22: Why is deflection testing required during installation and PM procedures if many manufacturers do not have any recommendations regarding this?

Answer 22: There have been reported incidents of tracks bowing inappropriately while under significant load and at the manufacturer specified rating. As stated in the response to Question 2, the VA can go above and beyond any manufacturer’s inspection

VA Representative

Question 23: What is the responsibility/liability of the VA Representative clearing these lifts for use with the signature block in the current checklists?

Answer 23: The signature of a VA Representative that the lift has been inspected and passed or failed a PM is no different than a VA staff member entering a work order in the VistA AEMS/MERS system stating the lift has been inspected, passed or failed a PM, and is released for use again.

Question 24: Who needs to sign off on the “Corrective and Preventive Maintenance” checklist?

Answer 24:

• If the PM is contracted out, the contractor/vendor, a VA representative, and the manager of the service using the ceiling lifts need to sign off on the checklist.

• If the PM is performed in house, a VA representative and the manager of the service using the ceiling lifts need to sign off on the checklist.

Manager of the Service Using the Ceiling Mounted Lifts

Question 25: Does the “Manager of the Service Using the Ceiling Lift” need to sign off on all the “Corrective and Preventive Maintenance” checklists?

Answer 25: Yes, the manager of the service using the ceiling lifts needs to be notified that work has been completed on lifts and that the lifts have been released into service.

The signature on the checklist confirms this notification.

Question 26: What is the intent of including the training of clinical staff in the preventive maintenance checklist (“Verify and confirm that VA clinical staff have been trained to operate the ceiling mounted patient lift, as required in the Training section.”)?

Answer 26: A lack of training has been identified as a root cause of incidents involving ceiling mounted patient lifts. The intent of this checklist item is to ensure that the “Manager of the Service Using the Ceiling Mounted Lift” is aware that the lift has been released back into service and that there is an on-going focus on staff training to ensure proper use of ceiling mounted patient lifts.

Question 27: On annual PMs, can facilities make a separate sign off sheet for the “Managers of the services using the ceiling lifts” stating that their staff is trained on the ceiling mounted lifts?

Answer 27: This is an acceptable practice. The intent of this checklist item is to ensure that there is an on-going focus on staff training to ensure proper use of ceiling mounted patient lifts.

General

Question 28: How will facilities be notified of changes to the Patient Safety Alert checklists?

Answer 28: Facilities will be notified of changes made to the Patient Safety Alert checklists via an NCPS Patient Safety Log entry, notifications on the CEOSH website, and emails to the various stakeholder mail groups (Facilities Engineering, Biomedical Engineers, Biomedical Technicians, Safe Patient Handling Coordinators, and Patient Safety Managers).