PWS Nova Bio.pdf

Performance Work Statement (PWS)

For Point of Care

Glucometer and Test Strip/Reagent Supplies Medical Treatment Facility, David Grant Medical Center

Travis AFB

16 Mar 15

Table of Contents

SECTION NO. AND TITLE PAGE NO.

I. Description of Service 3

II. Service Summary 3

III. General Information 4

IV. Appendices 10

A. Applicable Publications and Forms 10 B. Statement of Need 11

PERFORMANCE WORK STAEMENT (PWS)

Glucometer and Test Strip/Reagent Supplies

Medical Treatment Facility, David Grant Medical Center

Travis AFB

I. Description of Services

1. The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described appendix B for the Lab Point of Care located at David Grant Medical Center Travis AFB. Services include instrument use, maintenance including 24/7 service and online phone support and calibration services at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised.

All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

1.1 Pre-Market Approval. Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device.

This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

1.2 Service Reporting. Contractor shall furnish a legible service report to the MERC personnel, signed off by the department, including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition.

II. Services Summary:

Performance Objective PWS Para Performance Threshold

Surveillance Method

Analyzer meets characteristics of performance for precision and accuracy defined by 1988 CLIA and CLSI.

Appendix B 100% Quality Control Materials (chemicals) and Metrics

Preventive maintenance and tech support meet requirements for availability and response.

Para 1 and Appendix B

One defect per performance period.

Correction can be accomplished with phone call or next visit on a one time basis.

Surveillance of service reports

Records management Para 1 100% of the time Review reports ensuring accurate data is being maintained.

All supplies and materials available

Appendix B 95% Customer complaint

HIPAA Complaint

Para 5 100% Customer complaint

(Published operating specifications are too detailed and lengthy to be included in this document, but are available in the operating sections, the MERC, and are matter of public record)

1. Procedures. The contractor’s standard quality control practices are expected to ensure services are performed in accordance with commonly accepted commercial practices, and include procedures to identify, prevent, and ensure non-performance and continual repeat of defective service does not occur. Procedures as set forth in the FAR 52.212-4 (a), Contract Terms and Conditions - Commercial Items, Inspection/Acceptance, will be used to remedy all deficiencies.

III. General Information

1. Government Furnished Property

The government will provide the following equipment, supplies and services listed below:

1.1. Utilities: For the purpose of this contract, the government will furnish all required utilities such as water, telephone, electricity, etc.). Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only.

1.2. Housekeeping: Housekeeping services will be provided by the MTF.

1.3. Security Forces and Fire Protection: Phone numbers: Non-Emergency Fire Department: 424- 3683; Non-Emergency Security Police: 424-3293. Emergencies (call) 911.

2. Operator Training. Contractor shall provide instructions and training to DGMC equipment operators on the daily, weekly and monthly cleaning requirements when required or requested by the COR. Must also be able to train on processing samples and other basic troubleshooting as needed.

3. Initial Inspection. All contractor owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contact COR to schedule inspection.

4. Removal of Equipment. Should the equipment or any component listed herein require repair at the contractor’s plant, contractor shall obtain a signed authorization from the COR authorizing removal of government equipment. Contractor shall not remove any equipment until loaner/replacement installed on-site. Contractor shall be responsible for damage or loss of equipment while in contractor’s possession.

APPENDIX A

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 to the extent specified (that is, the specific procedure in a paragraph, section, chapter or volume) 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 Contractor 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.

Publications Code:

AFI--Air Force Instruction AMC-Air Mobility Command DoDI-DoD Instruction MDGI -60th Medical Group Instruction

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

Number Title of Directive

DoDI 3020.37 Continuation of Essential DOD

Contractor Services During Crises

DoDI 5400.7-R DoD Freedom of Information Act Para, C.4.2.1, C.4.4C3.2.1.2 - C3.2-1.9

Air Force Sup DoD Freedom of Information Act

DoDI 5500.7-R Joint Ethics Regulation (JER)

DoDR 6025.18-R Health Information Privacy Regulation

AFI 33-129 Transmission of Information Via the

AMC Sup 1 Transmission of Information Via the Internet

AFI 33-201 Communications Security (COMSEC)

AFI 33-332 Air Force Privacy Act Information

AMC Sup 1 Air Force Privacy Act Information http://www.e-publishing.af.mil/pubs

Travis Air Force Base Environmental Management Policy for Contractors available at <http://www.travis.af.mil/pages/60cons/ReadingRoom.htm>.

Records Disposition Schedule WebRIMSs website at <https://webrims.amc.af.mil/login.cfm>

Privacy Act Systems of Records Notice(s) at <http://www.defenselink.mil/privacy/notices/usaf>

Health Insurance Portability and Accountability Act (HIPAA) http://www.travis.af.mil/pages/60cons/ReadingRoom.htm https://webrims.amc.af.mil/login.cfm http://www.defenselink.mil/privacy/notices/usaf

Appendix B Point of Care Instrumentation

Statement of Need

Objectives:

1. Must provide a handheld instrument for bedside Glucose testing.

2. Must be well integrated with data management software.

3. Request a contract with 1 base year and 1 option year to begin 1 Jun 2015.

Dimensions required:

4. Analyzer size must not exceed:

a. Size: 5.8in X 3.1in X 1.18in29 in

b. Weight: 0.49 lbs

5. Must be a handheld model.

Service Requirements:

6. Test time must be 6 seconds or less

7. Sample volume must be 1.2 microliters or less

8. Linear range must be 10-600 mg/dl

9. Glucose result must have no interference due to the following substances

(up to the indicated levels (mg/dl)) Acetaminophen 20 Acetoacetate 30 Ascorbic acid 10 Beta-hydroxy butyrate 30 Bilirubin 15 Cholesterol 500 Creatinine 6 Dopamine 10 Ephedrine 0.9 Galactose 350 Ibuprofen 48 L-dopa 100 Maltose monohydrate 240 Maltotetraose 240 Maltotetriose 240 Methyl-dopa 1 N-Acetylcysteine (NAC) 20 Salicylate 30 Tetracycline 30 Tolazamide 15 Tolbutamide 45 Triglycerides 750 Uric acid 20 Varying oxygen content

10. Hct range must be 20%–65% with no limitations over the full glucose measurement range of 10–600 mg/dl (0.5–33.3 mmol/L)

11. Strips must require no calibration code and have no user calibration requirements

12. Manufacturer must be able to guarantee strips for an up to 12 month sequester period

13. Strip shelf life must be 30 months from date of manufacture

14. Open vial stability must be 6 months and not subject to immediate use open opening

15. Test must be reimbursable under CPT 82947 (Hospitals using StatStrip can bill at a 67% higher reimbursement rate for increased outpatient revenue and improved cost accounting for inpatient testing).

16. System must be FDA cleared for use throughout all hospital and all professional healthcare settings, including intensive care settings

17. Required operating range:

Temp .......................................... 15-40 °C Altitude ...................................... up to 15,000 ft.

Humidity .................................... 10 - 90%

18. Required display type: color, touch screen

19. Must be capable of reading both 1D and 2D barcodes

20. Must be able to send message to meters

21. Operator lockout required

22. QC lockout required

23. Ability to enter user free text comments required

24. Ability to flag TGC results required

25. Must have ability to enter at least 30 other test / manual test entry items

26. Must have an automatic strip ejector to minimize post sampling exposure to biohazards

27. Must support multiple, flexible connectivity options (direct to Ethernet, Ethernet to USB, wireless)

28. Must have 2-year standard warranty

29. Vendor must be able to provide a companion self-test glucose meter for non-hospital use

30. Must have data storage to meet or exceed:

a. Patient Tests: 1,000 tests

b. QC Tests: 200 tests

c. Users: 4,000 users

31. Must have connectivity:

a. Meter Data Output: RJ-45 Ethernet Port

b. Protocol: TCP/IP Ethernet 10 Mbit

c. Standard: POCT1-A Compliant

d. Setup Program: NovaNet Web-Based Instrument Manager Software

32. Battery Information:

a. Type: 3.7V Li Polymer Rechargeable Battery

b. Feature: Rechargeable/Replaceable battery

c. Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby.

33. Docking Station:

a. Desk or wall mount charging station with RJ-45 Ethernet jack 3 led indicator lights showing connection status, transmit/receive data, and charging status. Extra battery slot included for recharging and storage of spare battery.

34. Must have additional features:

a. Color touch screen

b. Built-in barcode scanner

c. Traditional QC with target values assigned to QC materials

d. Numeric or pass/fail QC

e. QC prompting or QC lock out

f. Abnormal and critical ranges flagged by color highlighting

g. Canned or free text user comments

h. Rejecting of results at meter (optional) for repeat testing

i. Accepting patient ID or accession number

j. Use of operator password (lockout)

k. Entry of offline tests

l. Entry of ICD-9 Diagnosis codes

m. Ordering physicians I.D.

n. On-screen training mode

o. Correlation mode

p. Slope and intercept adjustment

q. Web-based meter configuration by location

r. Custom meter configuration by medical unit

s. Connect to all LIS/EMR

t. POCT1-A data output

35. QC program must be flexible for optimum QC data interpretation and manipulation.

36. An expiration date tracking system is a must. It must have lot traceability for all QC material.

37. Must have FDA approval for testing designed critically ill patients.

38. A factory trained representative of the vendor will install, validate and correlate analyzers with results approved by Laboratory Medical Director before the current contract expires to ensure that there is no lapse in patient testing.

Contracting Service Requirements: (*Note: all calibration reagents, reagents, and quality control materiel must be approved by FDA)

39. Must be able to provide pricing for all tests as well as per patient listed on the attachment provided. This must include:

a. All reagents

b. All standards

c. All items that were consumed and disposed of.

d. All parts and accessories

e. All quality control materiel

f. All calibration material

Expenses for Operator training will be covered by vendor and include roundtrip airfare, all meals, lodging, training manuals, instructional videos and other appropriate course material. Training will take place at vendors training location.

40. Must be able to provide one training slot per year of the contract

41. Vendor provides a specialist to perform/oversee system installation, correlation, validation. Vendor also provides all validation reagent, calibrators, controls, and consumables needed to perform these tasks free of charge during the validation period.

Methods of Monitoring:

42. Must have an ease of maintenance

43. Easy to use and flexible software is one of the strong features for consideration.

44. Must have 24/7 365 available technical support.

45. The calibration frequency must always be monitored.

46. The analyzer must also alert the operator for sudden out of range quality control.

Standards of Performance:

47. The analyzer must meet the characteristics of performance for precision and accuracy defined by 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI)

Test Menu Test Annual Totals

Glucose 61,200

Appendix C Ordering Schedule

Supplies will be sent on a quarterly basis. Below is the ordering schedule to include all items and their quantities.

One Time Equipment Purchase - Items to be delivered upon Contract Award

Part Number Description QTY 53398 StatStrip Glucose

Meter 2D 7 ea

53400 Single Docking Station, POS Statstrip

Conn Mtr

7 ea

Annual Consumables

Part Number Description QTY 42214 StatStrip Glucose

Strips (1,800 test strips/cases)

160 Cs

41741 Control Solution 1, StatStrip (1 bottle per package)

80 Ea

41743 Control Solution 3, StatStrip (1 bottle per package)

80 Ea

42173 StatStrip Linearity Kit, (5 levels, 1 of each bottle)

8 Kits

1st Quarter – Items to be delivered the 1st Day of Each Quarter – 1st of September

42214 StatStrip Glucose

Strips (1,800 test strips/cases)

41741 Control Solution 1, StatStrip (1 bottle per package)

41743 Control Solution 3, StatStrip (1 bottle per package)

42173 StatStrip Linearity Kit, (5 levels, 1 of each

2nd Quarter – Items to be delivered the 1st Day of Each Quarter – 1st of December

42214 StatStrip Glucose

Strips (1,800 test strips/cases)

41741 Control Solution 1, StatStrip (1 bottle per package)

41743 Control Solution 3, StatStrip (1 bottle per package)

42173 StatStrip Linearity Kit, (5 levels, 1 of each

3rd Quarter – Items to be delivered the 1st Day of Each Quarter – 1st of March

42214 StatStrip Glucose

Strips (1,800 test strips/cases)

41741 Control Solution 1, StatStrip (1 bottle per package)

41743 Control Solution 3, StatStrip (1 bottle per package)

42173 StatStrip Linearity Kit, (5 levels, 1 of each

4th Quarter – Items to be delivered the 1st Day of Each Quarter – 1st of June

42214 StatStrip Glucose

Strips (1,800 test strips/cases)

41741 Control Solution 1, StatStrip (1 bottle per package)

41743 Control Solution 3, StatStrip (1 bottle per package)

42173 StatStrip Linearity Kit, (5 levels, 1 of each

APPENDIX A