Attachment_1_-_PWS_-_Surgical_Instruments_Repair_(REVISED_12_Sept_16).pdf

PERFORMANCE WORK STATEMENT

FOR

SURGICAL INSTRUMENT REPAIR SERVICE

YOKOTA AIR BASE, JAPAN

374 SGCS/SGCSB

12 September 2016

PERFORMANCE WORK STATEMENT

SURGICAL INSTRUMENT REPAIR SERVICE

1. DESCRIPTION OF SERVICE/GENERAL INFORMATION.

Instrument sharpening and repair service is the care and servicing of surgical instrumentation for the purpose of retaining instrumentation in a serviceable condition safe for patient use. The contractor shall have the ability to replace broken common stock instrumentation on-site; all instruments deemed non-repairable/life worn or pose a patient safety risk on location with quality replacement German surgical grade instruments upon consultation and with staff approval.

Contractor shall provide an on-site Satellite Surgical Instrument Repair Service with certified Instrument Repair Technicians.

A sharpening and repair service for the broken and dull instrumentation shall be on an annual basis.

1.2. SCOPE OF WORK.

The Contractor shall provide surgical instrument repair, inspection, replacement and/or cleaning for all types of surgical instrumentation regardless of manufacturer. The Contractor shall provide all personnel, lodging, equipment, tools, materials, supervision, technical literature, manufacturer repair requirements and manuals, transportation and other items and services necessary to provide a Surgical Instrument Maintenance Program (SIMP) as defined in this PWS. The Contractor shall track the frequency of repair for all surgical instruments in order to report repair trends to the Medical Treatment Facility (MTF). The Contractor shall provide support consistent with the policies and standards of the customer and its governing authority (e.g. Department of Defense, Department of the Air Force, 374th Airlift Wing, 374th Medical Group, The Joint Commission (TJC), American Association of Medical Instrumentation (AAMI), and AORN Perioperative Standards and Recommended Practices. The Contractor shall provide support in the following areas:

1) On-site Maintenance Services

2) Comprehensive Training Program

1.2.1. Repair service shall be scheduled as follows:

ITEM ESTIMATED QTY FREQUENCY DUE

Operating Room and 10 clinics Approx. 150 sets & 1.5K items Once a year CY Aug-Oct

1.2.2. Contractor shall coordinate repair service 90-120 calendar days in advance. If there is a scheduling problem and the Government is at fault, the Contractor must notify the Contracting Officer’s Representative (COR) immediately. The Contractor shall provide documentation of this notification, including names, dates and times, if scheduled maintenance is not completed within the time parameters of this PWS. Instrument repair service shall be performed during normal duty hours; (normal duty hours are 0700 to 1700, five days per week, Monday through Friday coverage, excluding U.S. Holidays).

Failure to accomplish service during specified time shall be resolved in accordance with FAR 52.212-4

1.3. QUALIFICATIONS.

1.3.1. Contractor must be certified for quality repair service (International Organization for Standardization (ISO) 9001:2008, specifically 13485 for medical devices.

1.3.2. All Contractor personnel must be certified in blood borne pathogens and operating room protocol.

1.4. TRAINING. The Contractor shall provide comprehensive, real-time, focused training resulting from the maintenance services of the on-site visit at no additional charge. 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. Modules must incorporate the use of visual mediums, such as digital mapping or other technology that allow trainees to view microscopic defects leading to required maintenance.

Training must include the following subjects, at a minimum:

1) Care and handling of surgical instruments

2) Rigid scope care and reprocessing

3) Flexible scope care

4) Reprocessing Power handpieces and attachments

5) Laparoscopic instrument care and handling including insulation testing

6) Clinical approach to instrument repair process

7) Hands-on labs establishing quality testing standards for instrumentation

1.5. ADMINISTRATIVE CONTROL.

1.5.1. Contractor's service personnel shall report with repair equipment to the Medical Equipment Repair Center (MERC), Building 4408, Room 118, Yokota AB, Japan prior to reporting to the work-site for an electrical safety check.

1.5.2. Upon completion of instrument repairs, the contractor will provide daily reports documenting work performed, overall condition of the instruments report and a recommendation of better care and handling as it pertains to patient care. The contractor will provide a complete list (daily report) of all instrumentation cleaned, inspected, repaired, and refurbished for each day Contractor’s Technicians are at the facility. The complete list will include the cost of each item repaired/refurbished.

1.5.3. The Contractor’s service technician shall submit a copy of the report to Medical Logistics Customer Service.

1.6. SPECIFIC TASKS.

1.6.1. Contractor shall provide on-site repair/sharpening services. See attached excel spreadsheet for a list of items to be repaired/sharpened.

1.6.2. Contractor shall be prepared to service the complete inventory. The Operating Room personnel may prioritize instruments and sets based on Operating Room needs and scheduled surgical procedures.

1.6.3. Contractor shall send personnel qualified to inspect and repair instrumentation for a maximum of 7 consecutive days of service.

1.6.4. Contractor shall provide surgical instrument replacements while instrument is being repaired. The product should be of equal quality to the instrument being repaired and have a lifetime warranty.

1.6.5. Upon completion of on-site surgical instrument maintenance, the Contractor shall provide a summary after action report documenting work performed. Report shall include:

1) A digital picture with minimum 50x magnification detailing their findings of the damage, wear, tear, and overall condition of the instrument to identify micro-fractures in the instrumentation and determine safety of continued use.

2) Projected cost savings realized.

3) Recommendations for process improvement and improving patient safety.

4) Based on the results of the on-site inspection, the Contractor shall provide advice by power point presentation to the MTF on ways to improve processes, reduce maintenance costs and provide a recommended maintenance schedule. The contractor will also provide a printed report of the presentation and will send to customer.

1.6.6. Maintenance of surgical instruments shall be performed in accordance with manufacturer requirements.

1.6.7. The Contractor shall be responsible for initial set up and then, upon completion of services, is responsible for clean-up of any and all areas where repair and sharpening services have been performed.

1.6.8. The Contractor shall provide comprehensive, real-time, focused training resulting from the maintenance services of the 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. Modules must incorporate the use of visual mediums, such as digital mapping or other technology that allow trainees to view microscopic defects leading to required maintenance. Training shall be developed and approved IAW continuing education requirements so training will result in Continuing Education Units (CEUs) for nursing.

1.6.9. Contractor shall inspect, mark, remove, and repair all unserviceable surgical instruments. Every instrument that is defective shall be clearly marked with a description of the problem and be removed from service to avoid any potential injury. The Sterile Processing Department Non-Commissioned Officer in Charge will determine if permanent removal of the instrument is necessary based on instrument inspection and Contractor recommendation.

1.6.10. When required and supplied by the MTF, wear special protective clothing and shoe covers.

When duties will be performed in specified areas, a disposable protective hood shall be worn to ensure infection control standards are met. These items shall remain the property of the Government and shall not be removed from the MTF. After use, protective clothing shall be turned in or destroyed as directed by the Element Chief.

1.6.11. Participate in Quality Inspection and Risk Management activities to the extent required by Section 2, AFI44-119 and the MDGI44-138, Patient Safety Program.

1.6.12. Release of Information

1.6.12.1 Only release medical information obtained during the course of this contract to MTF staff involved in the care and treatment of that individual patient

1.6.12.2. Lists and/or names of patients shall not be disclosed or revealed in any way for any use outside the MTF without prior written permission by the Chief of the Medical Staff.

1.6.13. Maintain open and professional communication with members of the MTF staff.

1.6.13.1. Complaints validated by Medical Logistics Flight Commander and Chief of the Medical Staff, shall be referred to the Contracting Officer for further action to include implementation of any legal remedies for failure to perform.

1.6.13.2. Any contractor issues arising from the performance of this contract shall be addressed to the Contracting Officer (cc to the Medical Logistics Flight Commander) via COR for resolution.

1.6.14. The contractor shall perform work on an-annual basis starting between August and October.

1.6.15. Services Summary (SS):

SS # Performance Objectives

PWS Para # Performance Threshold Method of Assessment

SS #1: On-site, in the Hospital, where the surgical instruments located

1.6.1. 100% compliance Must be on-site repair service.

SS #2: Service complete inventory 1.6.2. 100% compliance Completed inventory cross checked with OR master list.

SS #3: Provide equal or greater quality replacement common stock instruments (kelly forceps, mayo scissors, carbide needle holder)

1.6.4. Up to $10K worth

inventory

Line by line replacement item documented and presented to OR element chief.

SS #4: After-action report

1.6.5. 100% compliance

Report given to OR element chief after completion of service.

SS #5: Follow manufacturer guidelines 1.6.6. 100% compliance

IAW specific instrumentation guidelines and recommendations.

SS #6: Initial set-up and after services performed 1.6.7. No more than 2 discrepancies

Inspection prior to set-up and after services performed by OR element chief.

SS #7: Focused training

1.6.8. No less than 2

trainings/briefings

Training must be specific to Operating Room and Sterile Processing Dept.

SS #8: Inspection, marking, and repair unserviceable instrumentation unless defectiveness found

1.6.9. 100% compliance

OR element chief spot check repair service. All instrument sets will be inspected by contractor.

1.7. GENERAL INFORMATION.

1.7.1. CONTRACT MANAGER. The Contractor shall provide a Contract Manager (CM) who shall be responsible for the performance of the work performed under this PWS. When the CM is absent, an alternate(s) shall be designated. The name of CM and his/her alternate(s) shall be submitted to the Contracting Officer (KO).

1.7.2. The CM and alternate shall be capable of conversing and comprehending in English. The CM or alternate shall be on site at all times while the work is being performed to coordinate the work schedules and supervise the performance of work being accomplished under this PWS.

1.7.3. SECURITY REQUIREMENT. Only Contractor employees authorized by the 374 MDG authorities may be granted access to Yokota AB.

1.7.4. CERTIFICATION REQUIREMENT. Contractor shall provide written documentation that repair service personnel have been properly trained in accordance with Joint Commission guidelines which includes infection prevention, pathogens and bloodborne viruses, standard precautions and principles of asepsis.

1.7.5. CONTRACTING OFFICER’S REPRESENTATIVE . The names of the COR and personnel authorized to place calls shall be provided to the Contractor at the time of contract award.

1.7.6. TRANSPORTATION. Government transportation will be provided dependent on repair site location within Yokota AB for surgical instrumentation transfer. Accountable equipment shall not be removed from the 374th Medical Group without prior written approval of the KO or COR.

1.7.7. U.S. LEGAL HOLIDAYS. This base observes the following legal holidays:

New Year’s Day 01 January Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Independence Day 04 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran’s Day 11 November Thanksgiving Day Fourth Thursday in November Christmas Day 25 December

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday.

1.7.8. HIPAA COMPLIANCE. The Contractor agrees to abide by all the requirements of the Health Insurance Portability and Accountability Act (HIPAA) as codified at 45 CFR Part 160 and Part 164, subparts A and E, and implemented by DoD 6025.18-R regarding the privacy and confidentiality of health records and information being provided and shared under the resulting contract. The Contractor shall also comply with the Business Associate Agreement under Privacy of Protected Health Information.

HIPAA is comprised of several different sections, each to be implemented by the Dept. of Health and Human Services. The medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPPA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs. The specific implementation of HIPPA Privacy for DOD medical facility is set forth in DOD 6025.18-R, and for HIPAA Security, the requirements for AF MTF’s are contained in DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements for all AF MTF’s . DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. MTRs are responsible to insure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.

IAW these regulations the Contractor and its employees meet the definition of Business Associates.

Therefore, a Business Associate Agreement is required by law to comply with both the HIPAA Privacy and Security regulations. This clause serves as that agreement for each MTF, whereby the contractor and its employees agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DOD 6025-18-R, DOD 8520.02-R and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.

1.7.9. GOVERNMENT FURNISHED SERVICES. The Government shall furnish the Contractor an adequate work environment (approximately 10 feet by 20 feet room) to include work tables, proper heat, light, ventilation, electrical outlets and other utilities for use by Contractor Repair Technicians to perform the above service.

APPENDIX

General Use and Disclosure Provisions

Except as otherwise limited in this Agreement, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, DOD 6025.18-R, the HIPAA Security Rule, or DOD 8580.02-R if done by the Government.

Specific Use and Disclosure Provisions

(a) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.

(b) Except as otherwise limited in this Agreement, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).

(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).

Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, DOD 6025.18R, the HIPAA Security Rule, or DOD 8580.02-R, if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

Termination

(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below.

(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.

(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Clause to a section in DOD 6025.18-R, HIPAA Privacy Regulation or DOD 8580.02-R, HIPAA Security Regulation, or any CFR or AFI provision means the section as currently in effect or as amended, and for which compliance is required.

(b) Survival. The respective rights and obligations of Business Associate under the "Effect of Termination" provision of this Clause shall survive the termination of this Contract.

(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with DOD 6025.18-R, the CFR HIPAA Privacy Rule, DOD 8520.02-R, the CFR HIPAA Security Rule and AFI 41-217.