Specs.pdf

REQUEST FOR QUOTATION

ARFQ 0512 2845 WEH2600000005

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014

SPECIFICATIONS

1. PURPOSE AND SCOPE: The West Virginia Office of Shared Administration (WVOSA), Purchasing Division is soliciting bids on behalf of The Department of Health Facilities, Welch Community Hospital (Agency) to establish an open-end contract for providing a service support agreement for biomedical equipment inspection, maintenance, parts, and repair for medical equipment at Welch Community Hospital.

NOTE: This request is covered in part or in whole by federal funds. All bidders will be required to acknowledge and adhere to the attached Federal Funds Addendum.

NOTE: The DoHS OSA has developed an EEOP Utilization Report, and it is available at:

https://dhhr.wv.gov/office-of-drug-control-policy/news/Documents/EEO%20Uitlization%20Report%20Completed%20Form%201-29- 21-final-PDF%20review%20for%20approval%20to%20submit%20%283%29.pdf

NOTE: The Health Insurance Portability and Accountability Act of 1996 (hereafter, HIPAA) Business Associate Addendum (“Addendum”) is made a part of the Agreement by and between the West Virginia Department of Health Facilities (DHF), Bureau for Office of Health Facilities (OHF), Welch Community Hospital (Agency), and Business Associate (Vendor) and is effective as of the date of execution of the Addendum.

2. DEFINITIONS: The terms listed below shall have the meanings assigned to them below.

Additional definitions can be found in section 2 of the General Terms and Conditions.

2.1 “Contract Services” means biomedical equipment inspection, maintenance, parts, and repair services as more fully described in these specifications.

2.2 “Pricing Page” means the pages, contained wvOASIS or attached hereto as Exhibit A, upon which Vendor should list its proposed price for the Contract Services.

2.3 “Solicitation” means the official notice of an opportunity to supply the State with goods or services.

3. QUALIFICATIONS: Vendor or Vendor’s staff, if requirements are inherently limited to individuals rather than corporate entities, shall have the following minimum qualifications:

3.1 Biomedical department staffing requirements are as follows:

https://dhhr.wv.gov/office-of-drug-control-policy/news/Documents/EEO%20Uitlization%20Report%20Completed%20Form%201-29-21-final-PDF%20review%20for%20approval%20to%20submit%20%283%29.pdf https://dhhr.wv.gov/office-of-drug-control-policy/news/Documents/EEO%20Uitlization%20Report%20Completed%20Form%201-29-21-final-PDF%20review%20for%20approval%20to%20submit%20%283%29.pdf https://dhhr.wv.gov/office-of-drug-control-policy/news/Documents/EEO%20Uitlization%20Report%20Completed%20Form%201-29-21-final-PDF%20review%20for%20approval%20to%20submit%20%283%29.pdf

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014

3.1.1 Must have a minimum of an Associate’s degree in biomedical engineering technology or Bachelor of Science degree in biomedical engineering.

4. MANDATORY REQUIREMENTS:

4.1 Mandatory Contract Services Requirements and Deliverables: Contract Services must meet or exceed the mandatory requirements listed below.

4.1.1 Preventative Maintenance Services

4.1.1.1 Vendor will provide biomedical equipment inspections, repairs, parts, and scheduled preventative maintenance for all equipment contained in Exhibit B for an all-inclusive monthly rate.

4.1.1.2 Preventative maintenance services shall include providing one (1) Biomed Medical Engineering Technician as an on-site staffing employee for Monday through Friday 8:00 am to 4:00 pm coverage with 24/7 support as needed. The vendor shall provide emergency repair services outside of standard coverage by responding no more than four hours after receiving a service request. Emergency service costs will be covered by the standard contract and the Hospital shall not be charged for emergency repair services. Biomedical Department hours of operation and employee holidays shall consist of New Year’s Eve, New Year’s Day, Memorial Day, Independence Day, Labor Day, Veterans Day, Thanksgiving Day, Christmas Eve, Christmas Day.

4.1.1.3 Biomedical equipment inspections, repairs, and scheduled preventative maintenance are to be provided as suggested by the original equipment manufacturer (OEM) and must be clearly documented in an equipment log provided by the vendor, cost will be covered by the standard contract, and the Hospital shall not be charged additionally for this service. The log shall document all service calls, preventative and corrective maintenance, and related equipment service activities, and is to be submitted to hospital management and/or their designee(s). All data information logs that are created during the life of the service contract shall remain the property of Welch Community Hospital.

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014

4.1.1.4 Vendor will be required to maintain competencies and documentation of training for Vendor’s onsite staff to conform to WV OSA, and Welch Community Hospital policies. All employee training, education, performance evaluation and improvement plans must be clearly documented and available upon request by Hospital senior management.

4.1.1.5 Vendor’s on-site staff shall be required to complete facility provided orientation training as it pertains to hospital policy and procedures.

4.1.1.6 Vendor’s Biomed Medical Engineering Technician shall function in accordance with established Hospital management practices by actively participating in committees, meetings, and department projects as assigned without additional cost. Vendor shall cooperate and participate in Office of Health Facilities Licensure and Certification (OHFLAC) and/or Center for Medicare and Medicaid Services (CMS) surveys. Meetings are held during normal business hours, Monday through Friday, 8:00am to 4:00pm, and a maximum of two (2) hours per month. Vendor may be requested to provide reporting as to work performed (preventative maintenance and/or repairs) on covered equipment.

4.1.1.7 Vendor will be required to include biannual inspections and certification of Pharmacy clean room and hood. Vendor will include variable air sampling for both bacterial and fungal; cost will be covered by the standard contract and the Hospital shall not be charged additionally for this service.

4.1.1.8 Vendor must provide all parts; cost will be covered by the standard contract and the Hospital shall not be charged additionally for parts.

Vendor must provide all tools and test equipment required to repair and maintain Hospital biomedical equipment.

4.1.1.9 Vendor must demonstrate continuous compliance with all regulatory requirements at federal and state levels from organizations including CMS, Food and Drug Administration (FDA), OSHA and Environmental Protection Agency (EPA).

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014 https://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/downloads/R37SOMA.pdf http://www.fda.gov/MedicalDevices/default.htm https://www.osha.gov/ https://www.epa.gov/

4.1.1.10 The vendor will provide all replacement parts for the equipment listed in the attached schedules. All parts will be new or of equal quality and conform to the OEM requirements for safe and efficient operation. There shall be no extra charges for the vendor retrieving parts at rapid rates. It is the expectation that all parts needed to meet the required four-day (4-day) turnaround time will be inventoried on-site at the vendor’s expense.

4.1.1.11 If the vendor does not meet the required four-day (4-day) turnaround time on repairs the vendor will then be required to submit a corrective plan of action to hospital administration in that this event will not occur again. If the vendor is unable to perform repair/service in a four-day (4-day) turnaround time, the manufacturer of the equipment shall be contacted to complete the repair/service at the vendor’s expense.

4.1.1.12 It is the vendor’s responsibility to inventory each department to locate, identify, and test all biomedical equipment listed on Exhibit B and that which is listed in Sections 4.1.1.7 and 4.1.1.8 and implement appropriate communication and make inquiry as to devices not found.

4.1.1.13 Vendor will evaluate new equipment upon request, remain current with biomedical industry standards and safety regulations, prepare and manage departmental policies and procedures and provide consulting services for equipment space utilization and design. Other value added services will include providing in-service and training of Welch Community Hospital clinical staff in the proper usage and management of their biomedical equipment which will be included in the monthly set fee.

4.1.1.14 Welch Community Hospital reserves the right to audit, on a scheduled or random basis, the use and provision of services to ensure https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R37SOMA.pdf https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R37SOMA.pdf http://www.fda.gov/MedicalDevices/default.htm https://www.osha.gov/ https://www.epa.gov/

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014 compliance with the terms of this and any subsequent agreement.

Vendor will be given notice and must provide full cooperation with Welch Community Hospital in connection with any audit tasks including access to properties, records and personnel as requested.

Audits may include in their scope such details as service logs, invoices, contracts, management reports, correspondence and any other records or relevant information.

4.1.1.15 Vendor will perform clinical equipment inspections, repairs and scheduled preventative maintenance for all equipment contained in Exhibit B. Vendor will notify the facility in writing of the findings of equipment to be added to the equipment list and equipment that needs to be removed (not found). The “Per Each” pricing listed for the equipment contained in Exhibit A is not subject to change.

5. CONTRACT AWARD:

5.1 Contract Award: The Contract is intended to provide the Agency with a purchase price for the Contract Services. The Contract shall be awarded to the Vendor that provides the Contract Services meeting the required specifications for the lowest total annual cost as shown on the Pricing Pages.

5.2 Pricing Page: Vendor should complete the Pricing Page by completing Exhibit A. Vendor will provide pricing per each Item Description, then multiply the pricing per each by the quantity provided to get the Pricing per Month for each Line Item and then multiply the Pricing per Month by 12 to obtain total annual pricing per Line Item. Vendor will add the Monthly Pricing Line Items to obtain the Total Monthly Pricing. Vendor will add the Annual Pricing Line Items to obtain the Total Annual Pricing. Exhibit B (schedule of equipment) has been included to provide a more detailed description of each piece of equipment. Vendor should complete Exhibit A in full as failure to complete the document in its entirety may result in Vendor’s bid being disqualified.

NOTE: Examples of a properly completed Pricing Page are shown below and are for reference purposes only.

Pricing Per Each multiplied by Quantity = Monthly Pricing ($10.00 x 2 each = $20.00 per month x 12 months = $240.00 Monthly Pricing Total multiplied by 12 Months = Annual Pricing Add all lines of the Annual Pricing Column to get the Total Annual Cost

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014

6. PERFORMANCE: Vendor and Agency shall agree upon a schedule for performance of Contract Services and Contract Services Deliverables, unless such a schedule is already included herein by Agency. In the event that this Contract is designated as an open-end contract, Vendor shall perform in accordance with the release orders that may be issued against this Contract.

7. PAYMENT: Agency shall pay monthly flat fee as shown on the Pricing Pages, for all Contract Services performed and accepted under this Contract. Vendor shall accept payment in accordance with the payment procedures of the State of West Virginia.

8. TRAVEL: Vendor shall be responsible for all mileage and travel costs, including travel time, associated with performance of this Contract. Any anticipated mileage or travel costs may be included in the flat fee or hourly rate listed on Vendor’s bid, but such costs will not be paid by the Agency separately.

9. FACILITIES ACCESS: Performance of Contract Services may require access cards and/or keys to gain entrance to Agency’s facilities. In the event that access cards and/or keys are required:

9.1 Vendor must identify principal service personnel which will be issued access cards and/or keys to perform service.

9.2 Vendor will be responsible for controlling cards and keys and will pay replacement fee, if the cards or keys become lost or stolen.

9.3 Vendor shall notify the Agency immediately of any lost, stolen, or missing card or key.

9.4 Anyone performing under this Contract will be subject to Agency’s security protocol and procedures.

9.5 Vendor shall inform all staff of Agency’s security protocol and procedures.

10. VENDOR DEFAULT:

10.1 The following shall be considered a vendor default under this Contract:

Biomedical Equipment Inspection, Maintenance, Parts, and Repair Services

Revised 10/27/2014

10.1.1 Failure to perform Contract Services in accordance with the requirements contained herein.

10.1.2 Failure to comply with other specifications and requirements contained herein.

10.1.3 Failure to comply with any laws, rules, and ordinances applicable to the Contract Services provided under this Contract.

10.1.4 Failure to remedy deficient performance upon request.

10.2 The following remedies shall be available to the Agency upon default:

10.2.1 Immediate cancellation of the Contract.

10.2.2 Immediate cancellation of one or more release orders issued under this Contract.

10.2.3 Any other remedies available in law or equity.

11. MISCELLANEOUS:

11.1 Contract Manager: During its performance of this Contract, Vendor must designate and maintain a primary contract manager responsible for overseeing Vendor’s responsibilities under this Contract. The Contract manager must be available during normal business hours to address any customer service or other issues related to this Contract. Vendor should list its Contract manager and his or her contact information below.

Contract Manager: ______________________ Telephone Number: ________________________ Fax Number: ______________________________ Email Address: ___________________