Attachment 1 - SIMP Performance of Work.pdf

Performance Work Statement Surgical Instrument Maintenance Program

THE UNITED STATES AIR FORCE ACADEMY (USAFA)

PERFORMANCE WORK STATEMENT (PWS)

PM/FSM approves the PWS by signing and certifying the contents as written meet the needs of the requiring activity.

Lt Col Gloria J. Walski, Functional Service Manager (FSM/CC)

08 September 2020

WALSKI.GLORIA.JE Digitally signed by

X N.1159718448

WALSKI.GLORIA.JEN.1159718448

Date: 2020.09.08 15:52:55 -06'00'

PERFORMANCE WORK STATEMENT

FOR

SURGICAL INSTRUMENT MAINTENANCE PROGRAM

1. DESCRIPTION OF SERVICES.

1.1 Contractor will provide on-location chamber cleaning, instrument, case cart and container repair services at USAF Academy Clinic 10th Medical Group at USAFA. All surgical instrument, container, and case cart work will be performed in a mobile repair lab equipped with all the necessary tools, parts and supplies required to inspect, test, repair, and laser mark medical equipment in accordance with OEM and/or industry specifications. Contractor will allocate a minimum of two (2) repair technicians to perform the work under this contract. Contractor must possess the capabilities and equipment on the mobile repair lab required to reapply 2D laser data matrix codes on instruments for UDI and tracking system conformance that may have been removed during repair. Types of instruments to be serviced but are not limited to various types of clamps, hemostats, forceps, retractors, scissors, knife handles, mallets, picks, skin hooks, laparoscopic instruments, punches, gouges, osteotomes, curettes, elevators, needle holders, sheaths, bridges, obturators, micro instruments, specula, rongeurs, case carts and containers. Contractor responsible for inspection, maintenance, and repair of all surgical instruments from all surgical services including laparoscopic sets, orthopedic sets, neuro sets, general sets, plastic surgery sets, podiatry sets, rectal sets, pediatric sets, ophthalmology sets, gynecology sets, urology sets, thoracic sets, vascular sets, and minimally invasive surgery sets. Insulated surgical instruments including laparoscopic instruments, electrosurgical devices, cautery hooks, bipolar forceps, irrigating bipolar forceps and specula are to be repaired and maintained under this contract. Contractor will provide up to $1000 in quality, German grade replacement instruments for items deemed non-repairable, cracked, pitted, beyond repair, or unfit for service each repair visit. Case cart repair services will include repair and/or replacement of casters, latches, hinges, shelf brackets, handles, bumpers, locks, adhesive/label removal, and welding. Contractor will place all surgical instrument sets, containers, and case carts on a preventative maintenance schedule to ensure all items are inspected, tested, and repaired proactively.

Chamber cleaning will be performed by the contractor a minimum of two (2) times per year. All repair activities will be documented and reported to Operating Room and Sterile Processing leadership at the conclusion of every repair visit. Contractor to administer education during repair visits to promote clinical communication, improve instrument quality, and reduce the frequency and severity of repairs.

1.1.1. Inspection, preventive maintenance, and general repairs shall be performed in accordance with manufacturer requirements and industry best practices.

1.1.2. The contractor mobile repair lab utilized at USAFA will include digital magnification photography equipment, lumen inspection scopes, and laser marking equipment. Digital magnification and lumen inspection images captured during the repair process will be shared with Operating Room and Sterile Processing leadership for educational purposes. Laser marking equipment will be utilized to reapply 2D laser data matrix codes on surgical instruments for UDI and tracking system compliance that have been removed during the repair process.

1.1.3. The contractor will staff its mobile repair labs with a minimum of two (2) repair technicians.

1.1.4. Contractor repair technicians must possess ASQ CQI and IAHCSMM CCSVP certifications at the time of submission.

1.1.5. Each autoclave will be cleaned by the contractor two (2) times annually.

1.1.6. Contractor will provide up to $1000 in replacement instruments each repair visit for items deemed non-repairable or unfit for use. Replacement instruments will be German grade, operating room quality and approved by staff. All replacement instruments will come with a 2D laser matrix code and carry a lifetime warranty against defects, cracking, pitting, and corrosion.

1.2. The contractor will provide custom reporting and education during every repair visit at no additional charge.

1.2.1. Any items deemed non-repairable or unfit for use will be recorded and returned to Sterile Processing leadership for education and replacement purposes.

1.2.2. The contractor will provide repair findings bulletins and educational programs to Operating Room and Sterile Processing personnel during each surgical instrument maintenance and repair visit. The contractor shall provide training on the proper inspection, care and handling of surgical instruments, industry best practices, and critical factors pertinent to patient safety.

1.2.3. Routine problems found in the surgical trays will be reviewed with the Sterile Processing and Operating Room staff and teaching standards will be implemented. Contractor shall provide educational bulletins to illustrate repair findings and educate surgical instrument processing staff on proper inspection techniques and industry best practices.

1.2.4. Repair summary reports shall be provided by the contractor at the conclusion of every surgical instrument repair visit to illustrate repair performance statistics, instrument concerns, and identify opportunities for improvement. Repair summary reports shall include repair data, sets repaired, instruments serviced, digital magnification images, lumen inspection images, and process improvement suggestions.

1.2.5. Contractor will provide surgical instrument testing materials to support and augment education at no additional charge. Testing materials include scissor sharpness test materials and other instrument functionality testing materials.

2. DEFINITIONS. The following terms are defined as they are used in this PWS.

2.1 Customer. For the purpose of this document, the 10 MDG shall be known as the

“customer”. The official point of contact shall be the customer’s appointed Quality Assurance Personnel (QAP).

2.2 Contractor. The selected service provider and its staff shall be known as the

“contractor”.

2.3 Quality Assurance. A planned and systematic pattern of all actions necessary to provide confidence that adequate technical requirements are established; products and services conform to established technical requirements; and satisfactory performance is achieved. For purposes of this PWS, quality assurance refers to actions by the Government.

2.4 Quality Assurance Personnel. A functionally qualified person or persons who perform quality assurance functions for a contracted service.

2.5 Quality Control. Those actions taken by a contractor to control the quality of outputs to ensure that they conform to the contract requirements as defined by the PWS.

3. SCOPE OF WORK.

3.1 Contractor will furnish all personnel, labor, supervision, tools, equipment, parts, and transportation necessary to clean sterilizers and repair surgical instruments, containers, and case carts under this contract. Medical devices covered under this contract include but are not limited to surgical instruments from USAF Academy 10th Medical Group. All work will be performed on-location at the USAFA 10th Medical Group. The standards used to clean sterilizers and service instrumentation, containers and case carts should meet manufacturer specifications or performance parameters outlined by the International Association of Healthcare Central Service Material Management (IAHCSMM) and/or AAMI (Association for the Advancement of Medical Instrumentation) when applicable. Contractor will be responsible for cleanup of all areas where maintenance and repair services are performed. The contractor will provide maintenance and repair services three consecutive days per month for a total of 36 repair days annually. Contractor repair services will be available Monday through Friday between 7:00AM and 4:30PM with technical support available any time of day, seven days a week. No-cost additional repair visits may be scheduled as requested. Contractor must be ISO 13485: 2016 certified. Contractor repair technicians must possess ASQ CQI and IAHCSMM CCSVP certifications at the time of submission.

4. SERVICES REQUIRED. The following services have been identified as requirements:

4.1 On-site Maintenance Services.

4.1.1. On-site repair services and customer support should be available between the hours of 0730 to 1630, Monday – Friday, excluding federal holidays. The contractor is responsible for providing on-site visits to perform maintenance to include repair, sharpening and cleaning services of the surgical instruments and sterilizers. On-site visits shall be provided three (3) times per year for 10 MDG and two (2) times per year for Dental. Visits will occur approximately in January, May and September or as specified by the 10 MDG. All surgical/dental instrument maintenance services must be accomplished within the Monday-Friday work week. The contractor shall schedule all on-site Services through the Surgery Department at (719) 333-5139 or

(719) 333-0510.

4.1.2. Both the contractor and the customer have the right to suggest a schedule shift based on the interests of either party, but both the contractor and customer must agree to the change and that there will be no additional cost to the Government before implementing the change. The Government reserves the right to establish specific days and times for performance of any work under this contract. To minimize disruption to end-users, occasional work may be required during non-core hours (mornings/evenings/weekends). When this is required, the customer shall coordinate with the contractor.

4.1.3. Holidays. The Government observes the following:

New Year’s Day Labor Day Martin Luther King Jr. Birthday Columbus Day Presidents Day Veterans Day Memorial Day Thanksgiving Independence Day Christmas

4.1.4. Service Requirements.

4.1.4.1. The Surgery and Dental Departments will indicate which surgical instruments and/or instrument sets, power and scope repairs will need to be done based on operating room and dental needs and scheduled surgical procedures for all on-site instrument maintenance. The contractor must be prepared to service the complete inventory as identified in Appendix A, On-Site Equipment List.

4.1.4.2. The contractor shall inspect, mark, remove or repair all unserviceable surgical instruments. Every instrument that is defective shall be clearly marked with description of problem and be removed from service to avoid any potential patient liability.

4.1.4.3. Upon completion of on-site surgical instrument maintenance, the contractor shall provide a summary report documenting work performed and results, to include digital pictures of at least 50x magnification, detailing their findings of the damage, wear, tear and overall condition of the instrument.

4.1.4.4. Instrument maintenance of surgical instruments shall be performed in accordance with manufacturer requirements.

4.1.4.5. The contractor shall respond to any dissatisfaction expressed by the Surgery staff within two hours. The contractor must resolve the situation as soon as possible.

4.1.4.6. The contractor shall be responsible for initial setup and then, after completion of services, is responsible for clean-up of any and all areas where repair and sharpening services have been performed.

4.1.4.7. Based on results of on-site inspection, the contractor will provide advice to the Government on ways to improve processes and reduce maintenance cost.

4.1.5. Performance of Services During Crisis Declared by the President/ Secretary of Defense/USAFA Base Commander. The service provider shall perform services during a crisis per the contractual requirements. If the service provider shall perform the contractual requirements on a modified schedule, the modified schedule will be provided by the Contracting officer. The service provider shall supply a list of employees including name, address and phone number to the contracting officer. All these services shall continue unless otherwise directed by the contracting officer.

4.2 Off-Site Maintenance Services. Outside of the scheduled on-site visits, surgical/dental instruments including power cords and orthopedic power drills and saws, endoscopic and arthroscopic scopes in need of repair will be shipped to the contractor on an as needed basis.

4.2.1. Each item to be repaired or replaced costing $2000.00 or less, shall be covered by the contractor as part of the fixed price maintenance service agreement. The replacement item must be the exact same item being replaced.

4.2.2. Each item to be repaired or replaced over the above dollar limit will require coordination with the Government Quality Assurance Personnel (QAP). The contractor will provide proposed cost to replace and/or repair the item. Based on these costs the Government will be responsible for determining if the item should be repaired or replaced. If the decision is to replace the item, the Government will be responsible for replacement. If the government decision is to proceed with repairing the item, the Government QAP will approve the repair and the contractor will be reimbursed the proposed cost.

4.2.3. Once repairs are completed, the surgical instrument shall be returned to the USAFA Surgical/Dental Department. If the item is replaced, both the new and old items shall be returned.

4.3 Loaner Program.

4.3.1 When an instrument is sent for off-site maintenance, a loaner shall be available within 24 to 72 hours as identified by the customer.

4.3.2. An extensive inventory of equipment equal to that found at the Surgery Department shall be available for loan and supplied by the contractor to the customer for use until the Government’s equipment can be returned (see Appendix B, Off-Site Equipment Loaner List).

4.4 Comprehensive Training Program.

The contractor shall provide comprehensive, real-time, focused training resulting from the maintenance services of each on-site visit. The purpose of the training is to educate the surgical staff about proper use of the surgical instruments to prevent or reduce the need for maintenance services. Training curriculum shall be developed from the findings of the on-site inspection.

4.4.1. Customized educational modules shall be developed to educate the operating room staff on how to better care, clean, and maintain instruments. Modules shall incorporate the use of visual mediums, such as digital mapping or other technology that allow trainees to view microscopic defects leading to required maintenance.

4.4.2. Training shall be accomplished within six weeks after the completion of the on-site visit. The contractor shall schedule all education training sessions through the Surgery Department at (719)333-5139 or (719)333-0510.

4.4.3. Training shall be developed and approved In accordance with (IAW) the State of Colorado continuing education requirements so training will result in Continuing Education Units (CEU) for nursing.

5. DELIVERABLES.

5.1. IAW PWS paragraph 3, the contractor shall provide Frequency of Repair report annually, in arrears, by 15 October of each year.

5.2. IAW PWS paragraph 4.1.4.3. The contractor shall provide a Summary Report documenting the work performed and results of on-site visit. The report will include digital pictures of at least 50x magnification and details of the findings of damage, wear, tear and overall condition of instruments.

5.3 IAW PWS paragraph 4.4.1. Customized education modules shall be provided to the Government no later than six weeks after the on-site visit.

5.4. IAW PWS paragraph 6.2. The contractor shall provide a Quality Control Plan (QCP) to the CO for acceptance no later than 30 days after contract start date.

6. SERVICES SUMMARY.

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service for each requirement. These thresholds are critical to mission success.

PERFORMANCE

OBJECTIVE

PWS PARAGRAPH PERFORMANCE

THRESHOLD

Repair, cleaning, and sharpening of surgical/dental instruments performed in accordance with manufacturer requirements.

4.1.4. No more than 2% failure per

on-site visit of equipment serviced.

Training is developed and provided IAW PWS.

4.4 100% of training is developed and provided within six weeks of the site visit.

Loaner equipment is provided within stated timeframes.

4.3 98% of all customer request are provided within the requested 24 to 72 hours per quarter.

Complete on-site service within 5 workdays.

4.1. On-site services are

completed within 5 working days 100% of the time.

6.1. Government Quality Assurance. The Government will evaluate the contractor’s performance under this contract. Government Personnel will record all surveillance observations. When an observation indicates defective performance, the QAP will require the contract manager or representative at the site to initial the observation.

The initialing of the observation does not necessarily constitute concurrence with the observation, only acknowledgement that he or she has been made aware of the defective performance. Government surveillance of tasks not listed in the services summary (such as items referenced in FAR 52.246-4 Inspection of Services clause) may occur during the performance period of this contract. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the contracting officer as a result of surveillance will be according to the terms of this contract. Contractor performance will be surveilled to determine if it meets the standards. A variety of surveillance methods may be used. When the performance requirement is not met, a Contract Discrepancy Report (CDR) will be issued to the contractor by the contracting officer. The contractor responses to the CDR shall be made to the contracting officer within 15 calendar days of receipt.

6.2. Quality Control Plan. The contractor shall provide a Quality Control Plan (QCP) to the CO for acceptance no later than 30 days after contract start date. The contracting officer will notify the contractor of acceptance or required modification to the plan.

The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. As a minimum, the contractor shall develop quality control procedures addressing the area identified in paragraph 5.

Services Summary. The record of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

7. GOVERNMENT FACILITIES AND SERVICES.

7.1. The Contractor will Perform all surgical instrument, container, and case cart work in a mobile repair lab equipped with all the necessary tools, parts and supplies required to inspect, test, repair, and laser mark medical equipment in accordance with OEM and/or industry specifications. The contractor shall be responsible for safeguarding all government property provided for contractor use.

7.2. Information Resources. The customer shall provide access to government staff and pertinent information for this contract. The customer shall be available to provide technical input, answer questions, review work and provide feedback. The customer shall provide the contractor copies of, or access to, all required directives, publications and documents for this task upon request. All documentation provided to the contractor shall remain the property of the customer and shall be returned upon completion of this task.

7.3. Utilities Conservation. The contractor shall make sure employees practice utilities conservation. The contractor shall be responsible for operating under conditions that prevent the waste of utilities to include:

7.3.1. Lights shall be used only in areas where work is actually being performed.

7.3.2. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

7.3.3. Water faucets or valves shall be turned off when not in use.

8. GENERAL INFORMATION.

8.1. Employees. The contractor shall not employ persons for work on this contract if such employee is identified to the contractor by the contracting officer as a potential threat to the health, safety, security, well-being or operational mission of the installation and its population.

8.2 Contractor personnel shall present a neat appearance and be easily recognized as a contracted employee. The contractor shall furnish an identifying badge, which shall include as a minimum the person’s name, the name of the contractor and the function.

Each employee shall wear the badge on the outer garments at all times.

8.3. Personnel Skills and Qualifications. The contractor shall provide staff with the knowledge, expertise, education and experience necessary to successfully complete all PWS requirements. Industry certifications, including but not limited to O.R.

Protocol and Bloodborne Pathogens certifications, are not required but are desirable.

Contractor personnel must be available on contract start date. The nature of the work may require close contact with government professionals at all levels of the organizations, and require working in a team environment. The contractor is expected to behave in a professional manner and provide courteous customer service at all times.

8.4. Security and Privacy Requirements. All personnel employed by the contractor in the performance of this contract, or any representative of the contractor entering the government installation, shall abide by all security regulations of the installation.

The Government reserves the right to direct the removal of an employee for misconduct or security reasons. This action does not relieve the contractor from total performance of the contract tasks specified herein.

8.5.1. Access to USAFA Ambulatory Surgical Center (ASC). The contractor will be issued a temporary visitor’s pass/badge to gain access to the ASC. The customer shall assist, as needed, in obtaining access badges.

8.5.2. The contractor shall ensure employees driving on USAFA Air Force Base have a valid automobile driver’s license.

8.5.3. Privacy. The contractor shall comply with the provisions of the Privacy Act of 1974, the Health Insurance Portability and Accountability Act of 1996 to protect personal health information the contractor may encounter while completing the tasks associated with this contract.

9. APPLICABLE INSTRUCTIONS, DIRECTIVES AND REGULATIONS

Publications and forms applicable to this Performance Work Statement (PWS) are listed below, and are mandatory. The contractor shall follow those publications coded as mandatory to the extent (that is, the specific procedure in a paragraph, section, chapter or volume) specified, to meet requirements in this PWS. Applicable publications are located at http://www.e-publishing.af.mil/pubs. The Government may issue supplements or amendments to listed publications from any organizational level during the life of the contract. The contractor shall keep all issued publications up-to-date. The contractor shall immediately implement those changes in publications that result in a decrease or no change in the contract price. Before implementing any such revision, supplement, or amendment that will result in an increase in contract price, the contractor shall submit to the contracting officer a price proposal for approval. Price proposals shall be submitted within 30 calendar days from the date the contractor receives notice of the revision, supplement, or amendment-giving rise to the increase in cost of performance. The Government and the contractor will negotiate the changes into the contract under provisions of the Changes clause. The Government will continue to supply the Government forms needed for daily operations. Upon completion of the contract, the contractor shall return to the Government all issued publications and unused forms.

http://www.e-publishing.af.mil/pubs

Publications Code:

AFI--Air Force Instruction AFMAN--Air Force Manual DoD--DoD Instruction

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS

Number

AFI 33-332

Title of Directive

Air Force Privacy Act Information

Mandatory

M Ch. 1, 3, 7, 9, and 10 (Para. 8.5.3.)

AFMAN 17-1201 User Responsibilities and Guidance M for Information Systems (Para. 3) DoD 5400.7-R Freedom of Information Act, Ch. 4 M Para. C.4.2.1, C.4.4, C3.2.1.2 - C3.2-19

DoD 6025.18-R Health Information Privacy Regulation M

(Para. 8.5.3.)

10. APPENDICES.

A. On-Site Equipment List

B. Off-Site Equipment Loaner List