Statement of Work_NTX Mobile Lift Service_Draft.doc

STATEMENT OF WORK

Annual Inspections, Preventative Maintenance and Service of Mobile Powered Floor-Based lifts

A. SCOPE OF WORK:

1. Contractors shall provide maintenance services and perform required annual weight and function tests and service calls for up to 101 mobile lifts throughout the VA North Texas Health Care System, in accordance with VHA and manufacturer requirements, as enumerated in this document.

2. Service calls should be attended to in one business day, with prompt attention to repairing mobile lifts in timely manner. The number of lifts start at about 101 mobile floor-based lifts, which is expected to increase gradually in future years.

3. The contractor will provide all parts, equipment, material, labor, and service calls to perform the tests and correct any deficiencies identified by the tests.

4. Annual Inspections, preventative and corrective maintenance of mobile floor-based lifts and pool lifts must follow manufacturer recommendations. In addition to any manufacturer requirements, VHA has its own required preventive/corrective maintenance checklist which must be filled out when annual preventive maintenance is performed. Required elements for all lifts on wheels include visual inspection for structural integrity to include loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear; wheel and brake function; scale function if present; lifting and lowering at full capacity; and emergency stop and emergency down at full capacity. The Preventive Maintenance checklist may be changed by the VHA National Center for Patient Safety (NCPS), possibly including detailed instructions for testing the emergency stop, and will be provided to the Contractor any time it is changed. The current required checklist and its FAQ are attached here:

5. Note on timing: Lifts can be inspected in an order suitable to both the Contractor and the lift location. The previous lift testing schedule will be made available, and inspections should ordinarily happen during the month of previous testing or in the month before or after that month. The Contracting Officer Representative (COR) may ask for earlier inspection in specific areas if inspections have expired or lifts have a pattern of problems.

6. Note on quantity: Periodic renovation and purchases may change the number of lifts needing annual inspections each year. We do expect purchases as we grow, meaning that numbers of lifts maintained in option years may be larger than those in the initial year. Lifts that are newly bought but under warranty will require annual testing under this contract but have a warranty service supplied by the manufacturer.

7. The contractor shall provide all labor, supervision, travel, parts, and all other resources required to deliver the requirements stated herein, except as may otherwise be specified in this statement of work.

8. Scheduling will be arranged with the COR, and other Safety, Patient Administrative Service, Nursing, or other service personnel may at times be delegated to assist the contractor in locating rooms. Contractors do not need to be supervised BY VA employees but do need to check in with the designated person onsite at the beginning of each workday. COR will designate the person to check in with at each facility.

9. The contractor shall provide written documentation of tests and service performed on each lift. The service will be deemed received only when the documentation is supplied.

10. The contractor shall provide written documentation of any mobile floor-based power that is missing (from the location listed) on a weekly basis.

11. Locations include:

a. VA NTXHCS (4500 S Lancaster Rd, Dallas, TX 75216)

b. Sam Rayburn Memorial Veterans Center (1201 E. 9th Street, Bonham, TX 75418)

c. Fort Worth Outpatient Clinic (2201 SE Loop 820, Fort Worth, TX 76119)

d. Garland VA Medical Center (2300 Marie Curie Boulevard, Garland, TX 75042),

e. Tyler Broadway VA Clinic (7916 S. Broadway Ave., Tyler, TX 75703)

f. Plano VA Clinic (3804 W 15th St, Suite 175, Plano TX 75075)

g. Grand Prairie VA Clinic (2737 Sherman St, Grand Prairie TX 75051)

h. Greenville VA Clinic (8325 Jack Finney Blvd, Greenville TX 75402)

i. Sherman VA Clinic (1715 Texoma Pkwy, Sherman TX 75090)

j. Denton VA Clinic (2322 San Jacinto Blvd, Denton TX 76205)

k. Granbury VA Clinic (1210 Paluxy Medical Circle Granbury, TX 76048).

· All annual lift testing must be completed by September 30, 2026, and by Sept. 30 each option year. (Award date dependent)

12. Period of Performance: Base plus 4 option years

Base Year: TBD

Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Note - Lift Quantity: This list of lifts may change as stock is upgraded. The VA also expects to add more mobile Floor-Based powered lifts in future years as new patient care areas open.

Mobile Floor Based powered Lifts:

Pool Lift:

B. BACKGROUND:

1. VA North Texas Health Care System has mobile lifts bought between 2010 and 2025 that need testing and service, and a unified and fast service agreement is a benefit.

2. Any future lifts bought by VA North Texas Health Care System are expected to require the same annual weight and function tests, repairs, unlimited service calls, and option years may have minor quantity changes.

3. Floor-based lifts are acquired for a wide variety of patient care areas. Some will be available during the day when patients are out of the way, and some will only be available outside normal working hours. The COR will negotiate with services controlling the spaces for access. Lift systems and floor-based lifts are installed and bought VA NTXHCS (4500 S Lancaster Rd, Dallas, TX 75216), Sam Rayburn Memorial Veterans Center (1201 E. 9th Street, Bonham, TX 75418), Fort Worth Outpatient Clinic (2201 SE Loop 820, Fort Worth, TX 76119), Garland VA Medical Center (2300 Marie Curie Boulevard, Garland, TX 75042), Tyler Broadway VA Clinic (7916 S. Broadway Ave., Tyler, TX 75703), Plano VA Clinic 3804 W 15th St, Suite 175, Plano TX 75075, Greenville VA Clinic 8325 Jack Finney Blvd, Greenville TX 75402, Sherman VA Clinic 1715 Texoma Pkwy, Sherman TX 75090, Denton VA Clinic 2322 San Jacinto Blvd, Denton TX 76205, Granbury VA Clinic 1210 Paluxy Medical Circle Granbury, TX 76048.

C. GENERAL REQUIREMENTS:

1. Inspection must be completed by personnel who are approved by the manufacturer and qualified to inspect each type of lift system in question, as listed above.

2. Inspection must meet the VHA preventive maintenance checklist, which must be filled out by the inspector. A current version will be provided any time it changes.

3. Inspection for any portable lift must include visual inspection for structural integrity to include loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear; wheel and brake function; scale function if present; lifting and lowering at full capacity; and emergency stop and emergency down at full capacity.

4. Functional inspection must include all normal functions of the lift.

5. Each weight test must include a full lifting cycle at maximum rated load capacity, with the weights attached appropriately to the hanger bar or lift straps so that the entire lift is tested including soft start/stop and emergency lowering.

6. Scale function must be included in these tests if the lift has a scale.

7. The contractor is responsible for replacing any items damaged by the contractor, sub-contractor, their employees or equipment.

8. The contractor is responsible for cleaning up areas after each inspection is complete and always kept clean. Contractor shall not interrupt any utility service or fire alarm service during the process of this job.

9. No weight testing will occur in patient rooms where the patient is present. Contractor will coordinate with Nursing and other service staff to ensure that empty rooms are available for work.

10. The contractor must notify COR in advance of any operation that requires cutting or creating dust. Any operation of this type will be subject to Infection Control Risk Assessment requirements to be established at the kick-off meeting and clarified as necessary along the way.

11. Any part and/or service not covered by this service contract will not be installed without first receiving a formal purchase order from the VA North Texas Health Care System, Logistics Service, Dallas, TX.

12. Service must provide a response within one business day, and a quick response and repair will be preferred.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES:

1. Documentation of testing must include the date of inspection, the serial number and location of the lift system being tested, VHA’s inspection checklist, the manufacturer’s checklist, any observations of importance for the safety of the hoist, photos of the test, and any corrective actions taken.

2. Contractors must deliver certification records to COR no later than two weeks after certification of each system. Documentation will be required before tests are considered complete.

3. The contractor must notify COR immediately, separately from certification forms, of any damage that jeopardizes the safety of the hoist system and any corrective action required by VA North Texas Health Care System.

4. Contractor will provide parts, labor, shipping, etc. to correct any deficiencies identified by the tests.

5. Work will be insured and certified for no less than 12 months following the completion of the testing and maintenance.

6. Emergency service calls require a response within 24 hours.

E. CONTRACTOR CONDUCT REQUIREMENTS:

1. The contractor shall obtain all necessary licenses and/or permits required to perform this work. The contractor shall take all precautions necessary to protect people and property from damage during the performance of this contract. The contractor shall be responsible for any injury to himself or his employees, or others, as well as for any damage to personal property that occurs during the performance of this contract that is caused by him/her or his/her employee’s fault or negligence. The contractor shall maintain personal liability and property damage insurance prescribed by the laws of the Federal Government.

2. All employees and subcontractors must wear a visible name tag and company identification when onsite. When more than one person is onsite performing work under this contract, one must be designated as a supervisor and must be fully responsible for the work to be performed.

3. Employees and subcontractors working onsite must wear the VA Contractor badge that can be checked out and back in with Safety service in building TT49. In Bonham, this badge can be found in Engineering Service.

4. The Contractor shall provide all supplies, materials, equipment, qualified personnel, supervision, management, and transportation to perform all tasks as identified herein. All work is to be performed in accordance with the guidelines established by the Federal, , and local ordinances and The Joint Commission. The Contractor’s procedures and quality control procedures shall conform to these guidelines.

5. The Contractor must make all subcontractors aware of the requirements of this contract.

6. Contractor personnel must conduct their work so as not to interfere with the normal functioning of the facility and will stop work if asked by VA North Texas Healthcare System personnel. Hours of work may need to be limited to daytime on units where patients sleep and nighttime in areas where patients would be exposed to risk by daytime work.

7. The Contractor shall take all precautions necessary to protect the lives and health of occupants of the building.

8. The Contractor must follow procedures required by VA North Texas Healthcare System Infection Control personnel and the construction safety committee, to include any required dust control.

9. Contractors performing any Construction activities must have 10-hour OSHA construction cards and must coordinate with the VA North Texas Healthcare System Construction Safety Officer to make sure safety requirements are followed.

10. The Contractor must state what efforts will be made to minimize noise during testing of equipment.

11. The Contractor shall immediately correct any fire and safety deficiencies caused by his personnel. If the contractor fails or refuses to correct deficiencies promptly, the Contracting Officer may issue an order stopping all or any part of the work and may hold the contractor in default of the contract.

12. The Contractor shall comply with applicable Federal and local safety and fire regulations and codes which are in effect at the beginning of the contract period. The contractor shall keep abreast of any changes in these regulations and codes applicable to the contract.

13. All material and equipment will be removed from the facility or stored properly at the end of each workday and secured during the workday in the areas specified by the Contracting Officer’s Representative.

14. The Contractor is responsible for supplying, completing, and submitting all reports required or requested by Federal or local ordinances which pertain to any duties contained in the contract.

15. The Contractor will be required to furnish the VA North Texas Health Care System with material safety data sheets for all chemicals used during this work. This information is required by the VA for emergency treatment in the event of ingestion of and/or contact with the material by humans and is required by OSHA regulations.

16. The Contractor will be required to follow all OSHA General Industry regulations, or if construction activities are performed, Construction regulations.

17. No hot electrical work shall be performed. Any electrical work that is necessary must be coordinated with the facility electricians, and lockout/tagout provisions must be presented if electrical work is required.

18. The Contractor’s personnel shall follow applicable policies of the VA North Texas Health Care System, to include policies concerning fire and disaster preparedness programs.

19. The contractor shall furnish at his own expense all labor, materials, machinery, and appliances which may be necessary or appropriate in the performance of this contract.

20. Any accumulated rubbish is to be collected and placed in facility trash or dumpsters.

F. CONTRACTOR EXPERIENCE REQUIREMENTS:

1. The contractor must provide evidence of qualifications to inspect all mobile lifts listed.

2. At least one person who is certified by the manufacturer on the equipment to be tested must lead each test.

G. PARTS:

1. The Contractor shall furnish all parts as necessary to maintain the equipment, covered by this contract, in accordance with the Conformance Standards Section.

2. The Contractor stipulates that he/she has ready access to new standard parts (manufactured, supplied by the manufacturer, or equal thereto).

3. All parts supplied shall be of current manufacture and have full compatibility with existing equipment.

4. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request.

H. SCHEDULE FOR DELIVERABLES:

1. Schedules will be planned with the contractor and will flex to allow for room availability. Inpatient rooms will be prioritized first.

2. Testing shall be completed between the contract issue date and September 30, 2026. Room availability will be arranged by COR and Nursing or local service staff.

3. Contractor must deliver certification records to COR no later than one month after certification of each system.

4. The contractor must notify COR immediately, separately from certification forms, of any damage that jeopardizes the safety of the hoist system and any corrective action required by VA North Texas Health Care System.

5. If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to explain why in writing to the Contracting Officer (CO), including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations.

I. CHANGES TO STATEMENT OF WORK:

1. Any changes to this SOW shall be authorized and approved only through written correspondence from the COR/CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

J. CONFIDENTIALITY AND NONDISCLOSURE:

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the COR/CO at the conclusion of the task order.

2. The COR/CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the COR/CO in response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

4. Vendors are to adhere to federal privacy laws and to keep confidential any sensitive or personal information learned during the performance of this contract.

K. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS: No VA sensitive information is included in this contract.

L. NARA RECORDS MANAGEMENT LANGUAGE CLAUSE:

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VA NTXHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA NTXHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA NTXHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment are properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA NTXHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA NTXHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA NTXHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public VA NTXHCS information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. VA NTXHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA NTXHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

End Statement of Work

_1821345811.pdf

Revision 2.1 1 of 2 Serial #: ____________________

PASS FAIL

The commissioning for a patient ceiling lift system(s) shall include, but not be limited to, the following points as components of the commissioning procedures.

NOTE: Ceiling mounted patient lifts are not to be installed in treatment units with actively suicidal patients.

Lift Location:

VAMC Contact's Phone Number:

Installer:

VAMC Contact:

Manufacturer:

Model:

Facility: Work Order:

Serial Number: EE Number:

Installer's Phone Number:

Structure

Rails/Tracks and End Stops

NOTES:

Lift Unit and Straps

Perform a visual inspection to verify structural component sizing and physical installation to ensure that the correct structural system is in place and properly installed to support the lift.

Verification that all fasteners and set screws are properly tightened on the trollies and rails/tracks.

Ensure that the rail/track is free of gaps (unless required by design). If included in installation, verify rail turntable function, exchanger function, gate alignment, and safety block installation.

Confirm track is clean and clear of all debris. (Use manufacturer’s recommended cleaning materials to avoid damage to the motor case and other components.)

Verification that all manufacturer specified end stops or docking gates are properly installed.

Inspection of lift unit casing for cracks and alignment.

Inspection and activation of hand control for full operation (e.g., up, down, left, right) and “return to charge” function if applicable.

Corrective and Preventive Maintenance Checklist for Ceiling Mounted Patient Lifts

Mfgr Contact's Phone Number:

Date:

Mfgr Contact:

Confirm any and all lift unit indicator lights are functioning. (e.g., red service warning light, charging state light) Inspection and verification of all emergency functions of the lift unit.

Inspection of spreader bar and clips for cracks and for loose or missing rings or cotter pins.

Full extension and inspection of lift strap for loose threads or frays.

Complete

Verification that the lift unit charges properly.

Perform a visual inspection to verify proper connections of the lift's structural system to the building’s structure (including seismic bracing if applicable).

Perform a visual inspection to verify proper interface at the ceiling (hard deck or soft tile) and proper installation of all protective features around the support rods and rails/tracks.

Revision 2.1 2 of 2 Serial #: ____________________

After the activities listed in the above checklist and in the manufacturer's installation/operations/owner’s manual(s) have been completed, the inspector shall release the ceiling mounted lift installation to VA representative.

SIGNATURE:

After the activities listed in the above checklist and in the manufacturer's installation/operations/owner’s manual(s) have been completed, the manager of the service using the ceiling mounted lifts confirms that the current staff have received initial training on ceiling mounted lifts and that there is a process in place to provide ongoing training on the proper use of ceiling mounted lifts.

TITLE:

Manager of the Service Using the Ceiling Mounted Lifts COMPLETE

VA Representative After the activities listed in the above checklist and in the manufacturer's installation/operations/owner’s manual(s) have been completed, the VA representative shall review those items with the inspector prior to releasing the ceiling mounted lift back into service to ensure completion of all requirements.

COMPLETE

Inspector COMPLETE

DATE:

Verification of any “soft start” or “soft stop” features and that lifting speed does not exceed 2.5 inches per second with “zero” load.

Verification of load testing and deflection testing at the manufacturer's specified maximum rated lift capacity.

Verification of any “soft start” and “soft stop” features and that lifting speed does not exceed 1.5 inches per second under maximum rated lift capacity.

Verification of emergency lowering feature at maximum rated lift capacity.

Verification of function of emergency stop at maximum rated lift capacity.

Load Testing

Inspection

Facility:

Work Order:

Manufacturer:

Lift Location:

Model:

VAMC Contact:

Serial Number:

EE Number:

VAMC Contacts Phone Number:

Mfgr Contact:

Installer:

Mfgr Contacts Phone Number:

Installers Phone Number:

Date:

NOTES:

NOTES_2:

Serial:

NOTES_3:

NOTES_4:

DATE:

TITLE:

DATE_2:

TITLE_2:

DATE_3:

TITLE_3:

Serial_2:

Check Box1: Off

Check Box2: Off

Check Box3: Off

Check Box4: Off

Check Box5: Off

Check Box6: Off

Check Box7: Off

Check Box8: Off

Check Box9: Off

Check Box10: Off

Check Box11: Off

Check Box12: Off

Check Box13: Off

Check Box14: Off

Check Box15: Off

Check Box16: Off

Check Box17: Off

Check Box18: Off

Check Box19: Off

Check Box20: Off

Check Box21: Off

Check Box22: Off

Check Box23: Off

Check Box24: Off

Check Box25: Off

Check Box26: Off

Check Box27: Off

Check Box28: Off

Check Box29: Off

Check Box30: Off

Check Box31: Off

Check Box32: Off

Check Box33: Off

Check Box34: Off

Check Box35: Off

Check Box36: Off

Check Box37: Off

Check Box38: Off

_1821345816.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).