Attachment_6_Requirements.pdf

PERFORMANCE-BASED WORK STATEMENT (PWS)

FOR

AUTOMATED CHEMISTRY TESTING PLATFORM

AT

88TH MEDICAL GROUP (MDG)

WRIGHT-PATTERSON AIR FORCE BASE, OH

PERFORMANCE-BASED WORK STATEMENT

TABLE OF CONTENTS

Section Page

I. GENERAL REQUIREMENTS 3

II. INSTRUMENT TRAINING AND SUPPORT 7

III. INSTRUMENT REPAIR AND MAINTENANCE 8

IV. MINIMUM REAGENT REQUIREMENTS 10

V. UPGRADE OF EQUIPMENT 11

VI. CONTRACTOR PERSONELL 11

VII. CONSERVATION OF UTILITIES 11

VIII. INSTRUMENTATION AUTOMATION 12

IX. MIDDLEWARE SOFTWARE 12

X. DEFICIENCIES IDENTIFIED 14

XI. SERVICES SUMMARY 15

I. GENERAL REQUIREMENTS:

A. The Wright Patterson Air Force Base (WPAFB) Medical Laboratory is seeking two fully automated, walk away, fully-integrated, random access platforms, hereafter referred to as platform, capable of high throughput. WPAFB Med Lab is seeking a three-year (base year plus two option years) cost per reportable

Time and Materials (T&M) contract for instrumentation, instrument automation, middleware software, reagents, consumables and support to perform, on a single platform, the following clinical tests:

1. Acetaminophen

2. Alanine Amino Transferase (ALT)

3. Albumin (ALB)

4. Alkaline Phosphatase (ALKP)

5. Amylase (AMY)

6. Ammonia

7. Amphetamines

8. Aspartate Amino Transferase (AST)

9. Vitamin B12

10. Barbiturates

11. Benzodiazepine

12. Blood Urea Nitrogen (BUN)

13. N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) or Brain

Natriuretic Peptide (BNP)

a. The Contractor shall provide testing capability for only one of the analytes listed above

14. Calcium (CA)

15. Carbamazepine

16. Carbon Dioxide (CO2)

17. Cerebrospinal Fluid (CSF) Glucose

18. Chloride (CL)

19. Cholesterol (CHOL)

20. Cocaine

21. Cortisol

22. C-Reactive Protein (CRP)

23. C-Reactive Protein High Sensitivity (CRP HS)

24. Creatinine (CREA) enzymatic

25. Creatinine Kinase (CK)

26. Creatinine Kinase MB (CK-MB)

27. Digoxin

28. Direct Bilirubin (DBIL)

29. Estradiol

30. Ethanol

31. Ferritin

32. Folate

33. Free Thyroxine (FT4)

34. Gamma-Glutamyl Transpeptidase (GGT)

35. Gentamicin

36. Glucose (GLU)

37. Hemoglobin A1C

38. High Density Lipoprotein (HDL) Cholesterol

39. Human Chorionic Gonadotropin (HCG)

40. Iron (FE)

41. Iron Binding Capacity (TIBC)

42. Lactate Dehydrogenase (LD)

43. Low Density Lipoprotein (LDL) Cholesterol

44. Lactic Acid (LA)

45. Lipase

46. Lithium (LI)

47. Magnesium (MG)

48. Microalbumin (urine)

49. Opiates

50. Parathyroid Hormone (PTH)

51. Phencyclidine (PCP)

52. Phenobarbitol

53. Phenytoin

54. Phosphorus (PHOS)

55. Potassium (K)

56. Progesterone (PROG)

57. Prostate Specific Antigen (PSA)

58. Salicylate

59. Sodium (NA)

60. Tetrahydrocannabinol (THC)

61. Theophylline

62. Thyroid Stimulating Hormone (TSH)

63. Total Bilirubin (TBIL)

64. Total Protein (TP)

65. Triglycerides (TRIG)

66. Troponin

67. Urine/CSF Protein

68. Uric Acid

69. Valproate

70. Vancomycin

B. Each platform must be capable for throughput of at least 100 tests per hour.

The Contractor shallprovide enough instrumentation, reagent and consumables to complete an average daily test load, 1800 tests, within a 24 hour window. A guaranteed minimum of 97% uptime is required for all instruments.

C. With the use of additional middleware which meets the requirements of Section

IX of this PWS, the platform must indicate to the user when quality control (QC) values exceed the acceptable range set by the user on each specific analyte, and must block the user from performing patient testing on said analyte until such a time where QC is performed and values are within range.

D. The desired instrumentation shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

E. With the use of additional middleware which meets the requirements of Section

IX of this PWS, the platform must indicate to the user when QC has expired (it has been more than twenty-four (24) hours since the last acceptable QC value) for each specific analyte, and must block the user from performing patient testing on said analyte until such a time where QC is performed and values are within range.

F. The platform shall come equipped to perform statistical analysis of QC data including QC lot numbers, means, ranges, standard deviation, and coefficient of variation percentages.

G. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.

H. The QC software shall provide the capability to write user defined Westgard QC

Rules.

I. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

J. The platform shall include a data management system for control of the operation of the platform, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the platform’s data management system.

K. The platform must have a bidirectional computer interface that is compatible with

Composite Health Care Platform (CHCS).

L. The platform must sample directly from primary patient tube.

M. The platform must have the capability of on-the-fly sample, reagent, and supply loading without interruption of sample processing.

N. The platform must detect if primary patient sample has adequate volume for required testing.

O. The platform must automatically dilute patient sample for a minimum of 75% of the tests listed in Section I, Paragraph (Par) A of this PWS if initial testing is outside the analytical measurement range.

P. The platform must have automatic clot detection.

Q. The platform must have continuous specimen loading capability.

R. The platform must have automatic test reflex capability that is programmable by the user.

S. The platform must indicate the turbidity, hemolysis, icterus, and lipemia level in plasma and/or serum samples as part of a pre-analytical specimen check included on every analyte listed in Section I, Par A of this PWS.

T. Each platform shall come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each platform, to include the data management platform, for a minimum of 15 minutes.

U. The Contractor shall provide Safety Data Sheets (SDS) for each item delivered under this cost per reportable agreement that is considered to be HAZARDOUS

MATERIAL by the United States or the Contractor’s representative. The SDS shall contain information on the hazards associated with each specific chemical or material.

V. If the platform requires a water source, the maintenance and service will be covered under this contract.

W. If the platform requires a water source, the water system will containing at a minimum the following components:

1. An automated system capable of utilizing reverse osmosis to purify and deionize water

2. No less than two (2) mix bed sorbent tanks

3. No less than one (1) reverse osmosis polish tank

4. A component capable of removing CO2 gas from the water

II. INSTRUMENT TRAINING AND SUPPORT:

A. The Contractor shall provide instrument transportation, delivery, and installation, to include calibration and test and system validation support, within 90 calendar days after the contract award.

B. The Contractor shall provide initial on-site operator training to all instrument operators prior to initiation and use of the instrument for patient testing.

C. The Contractor shall perform, at a minimum, the following initial instrument validation studies for each analyte listed in Section I, Par A of this PWS:

1. Simple Precision

2. Accuracy

3. Method Comparison

4. Instrument Correlation

5. Reference Range

6. Reportable Range

D. The Contractor shall provide supplemental operating training to Government personnel, without additional charge to the Government, upon installation of any upgrade in equipment hardware or operating platform software connected with the operation of an instrument already furnished under this contract.

III. INSTRUMENT REPAIR AND MAINTENANCE:

At a minimum, the Contractor shall provide the following maintenance and repair services:

A. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures guidelines, to include preventive maintenance.

B. Must provide all required tools, parts and labor as necessary to keep the instrument operational.

C. Must provide over the phone, instrument technical support during all duty hours

(24 hours a day, 7 days a week).

D. In the event of an instrument failure, the Contractor shall provide onsite emergency repair service within twenty-four (24) hours of the time of notification of the malfunction. The Contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online.

E. In the case of both instruments simultaneously failing, the Contractor shall provide onsite emergency repair within 8 hours of the time of notification of the malfunction. The Contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring at least one instrument back online within 24 hours of the time of notification of the malfunction.

F. Scheduled routine services shall be performed between 0730-1630 Monday-

Friday, except Federal holidays or, when the government facility is closed due to local or national emergencies, administrative closings, or similar government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. On occasion, an employee will be required to work on weekends and

Federal holidays. The government will notify the contractor within 24 hours of such occurrence.

G. Emergency services, to include onsite emergency repair, shall be performed twenty-four (24) hours a day, seven (7) days a week, to include Contractor and federal holidays.

H. During any period when both platforms are inoperable, the Contractor shall provide an alternate method of testing (including coverage of ISTAT cartridges) and deliver hard-copy patient results, for as long as both platforms remain inoperable.

I. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

J. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the platform failure at no additional cost to the Government.

K. The Contractor shall replace all reagents, calibrators, controls, and any other materials used by the Government in the process of troubleshooting instrument failure prior to the time of notification of the malfunction to the Contractor.

L. The Contractor shall furnish a malfunction incident report to the Government upon completion of each service call. The report shall include, at a minimum, date and time notified, date and time of arrival, serial number, type and model number(s) of platform(s), time spent for repair, description of malfunction and repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

M. When required, the Contractor shall comply with the Occupational Safety and

Health Administration lockout and tag-out procedures while performing maintenance on electrical equipment.

N. The Contractor shall provide all material to verify analytical measurement range.

O. If the platform requires a water source all repair of the water source will be covered by the Contractor IAW with the aforementioned repair timelines.

IV: MINIMUM REAGENT REQUIREMENTS:

At a minimum, the Contractor shall provide the following maintenance and repair services:

A. The Contractor shall provide the reagents, and shall confirm with the ordering officer exact quantities and shipment schedule prior to shipment.

B. The minimum shelf life of the reagents will be three (3) months after the date of delivery.

C. All reagent kits must be FDA approved and will exhibit at least 95% sensitivity and 95% specificity.

D. Upon request or when a mandatory reagent changeover is required by the

Contractor, a technical specialist and sufficient reagents shall be provided by the

Contractor for in-house validation of new reagents that are added to the platform during the term of this contract.

E. Following the validation performed in Section IV, Par D, each reagent shall exhibit at least 95% agreement with test reagents currently in use, or with outside laboratory where applicable, as in the case of a new test introduced on the platform.

F. The vendor shall be the sole manufacturer and distributor of the test kits with the exception of therapeutic drug monitoring (TDM) reagents.

G. The vendor shall comply with all FDA regulations and the current edition of the

College of American Pathologist (CAP) checklist.

H. All reagent kits must come from the specific manufacturer that produces the platform. The reagents will be platform specific, and not outsourced from other companies with the exception of Therapeutic Drug Monitoring (TDM). The TDM assays may be a manufacturer validated assay not made by the vendor.

V: UPGRADE OF EQUIPMENT

A. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available.

B. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the Contractor and the Government through a bilateral modification.

VI: CONTRACTOR PERSONNEL:

A. Contractor Employees. The Contractor shall not employ persons for work on this agreement if such employee is identified to the Contractor by the Contracting

Officer as a potential threat to the health, safety, security, general well- being or operational mission of the installations and their population.

B. Contractor employees shall present a neat appearance. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility.

C. Contractor employees shall have current and valid professional certifications and licenses required to perform the work in this PWS, prior to contract award. All certification and licensing requirements by Federal, State, and local agencies shall be complied with at the contractor's expense.

D. The contractor shall utilize employees possessing adequate training, skills, and knowledge to perform the requirements of this contract.

E. The Contractor shall not employ any person who is an employee of the

Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation”.

VII: CONSERVATION OF UTILITIES:

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

B. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning platforms.

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

D. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the platforms cannot be safely dumped into the facility’s drain platform, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

VIII: INSTRUMENT AUTOMATION:

A. The Contractor shall provide full line automation for the processing, sorting, testing, and filing of all test samples for all analytes listed in Section I, Par A of this PWS. The line automation shall be capable of being connected to both platforms requested under this PWS by a track system, and will include the following additional components:

1. Module where specimen entry, exit, sorting, and queuing occurs

2. Centrifuge

3. Module where specimen de-capping occurs

B. The Contractor shall provide a centralized workstation where full control of the instruments operating on the automated line is possible for the user.

C. The Contractor shall provide dedicated personnel capable of instituting auto-verification for all analytes listed in Section I, Par A of this PWS within fourteen

(14) days of installation of the instruments.

IX: MIDDLEWARE PRODUCT:

A. The Contractor shall provide a middleware product capable of interfacing with the instruments requested in this PWS and the Government’s laboratory information system (LIS) CHCS utilizing a serial connection.

B. The middleware product at no time will have or operate an IP address.

C. The Contractor shall provide all terminal servers, serial cables, and hardware capable of sustaining a stand-alone computer workstation with the middleware product pre-loaded.

D. The middleware product shall be capable of user-defined rules written by the on-site user, specimen tracking, and intelligent metrics used for quality control analysis and patient delta checks.

E. The middleware product shall be capable of monitoring key analytes and provide quality assurance through real-time process monitoring, all in an effort to assess moving averages of assays that have inherent biological variation. Key analytes, defined as high volume assays which have minimal biological variation when analyzed, are the following:

1. Alkaline Phosphatase (ALKP)

2. Alanine Amino Transferase (ALT)

3. Aspartate Amino Transferase (AST)

4. Carbon Dioxide (CO2)

5. Total Bilirubin

6. Calcium

7. Creatinine (CREA) enzymatic

8. Glucose

9. Free Thyroxine (FT4)

10. Thyroid Stimulating Hormone (TSH)

11. Blood Urea Nitrogen (BUN)

F. The Contractor shall provide middleware or equivalent product capable of suspending auto-verification if moving averages exceed user-defined thresholds, and automatically rerouting samples to the alternate instrument on the automation line, until such a time that quality control correction has been achieved on the instrument with exceeded threshold.

G. The Contractor shall provide middleware or equivalent product capable of displaying the following real-time metrics to the user: test turnaround time, percent of auto-verification, test volume, most recent quality control value(s) for all analytes listed in this PWS, sample integrity, and sample indices (Hemolysis, Icterus, Lipemia).

H. The Contractor shall provide user training at Wright-Patterson Air Force Base, in the Medical Center Laboratory, on the middleware product to three (3) users within the first seven (7) days after product installation.

X. DEFICIENCIES IDENTIFIED:

A. Major findings are contract non-conformances which are considered critical or major. IAW FAR 46.101 a major nonconformance means a nonconformance, other than critical, that is likely to result in failure of the supplies, or to materially reduce the usability of the supplies or services for their intended purpose. A critical nonconformance means a nonconformance that is likely to result in a hazardous or unsafe condition for individuals using, maintaining, or depending upon the supplies or services; or is likely to prevent performance of a vital agency mission. If at any time Laboratory and/or the Contracting Officer Representative (COR) identifies a condition as having a significant adverse effect on the quality of the activity, such as those stated below, the COR shall document their findings and notify the Contracting Officer immediately in writing (email is acceptable).

1. Contractor failure to meet a Performance Threshold.

2. Failure to provide adequate corrective action to preclude reoccurrence of

Government identified findings.

3. Failure to provide corrective action to deficiencies identified by the contractor within a prescribed suspense period.

4. Any failure to adhere to security and/or safety regulations that results in a security or safety incident.

B. Minor Finding. IAW FAR 46.101 a minor nonconformance means a nonconformance, that is not likely to materially reduce the usability of the supplies or services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the supplies or services. When COR identifies a minor finding, the COR shall document the findings, but is not required to notify the Contracting Officer. However, if the same minor finding is repeatedly identified, it may be an indication that a major finding is occurring or has occurred because the Contractor has not taken proper steps to prevent recurrence. In this case, the COR shall notify the Contracting Officer in writing (email is acceptable).

XI. SERVICES SUMMARY:

A. The following table is the Services Summary for the Automated Chemistry Testing Platform.

Performance

Objective

PWS

para.

Performance Threshold Method of

Surveillance

Remedy

SS – 1 Instrument

Configuration and

Testing

I.A-C Configuration is correct and integrated platform can perform all tests listed in this paragraph.

100%

Surveillance

CAR

SS – 2 CLIA

Compliance

I.D Instrument is compliant with the 1988 Clinical

Laboratory Improvement

Act

100%

Surveillance

CAR

SS – 3 Quality

Control

Notification

I.E The system must notify users when QC values exceed defined ranges, and must halt 100% of all testing until QC correction occurs

Customer

Complaint

CCR

SS – 4 User

Interface

I.J-K Instrument must meet characteristics in the associated PWS paragraphs

SS – 5 FDA

Compliance

IV.D 100% of reagents must be

FDA approved for testing.

Instrument should be FDA approved for 100% of industry standard urine preservatives

CCR, CAR

SS – 6 Installation II.A Par A should be achieved in 90 days or less

SS – 7 Initial

Training within 7 days

II.B No fewer than 4 team members should be trained within the first 7 days of instrument go-live

Periodic

Surveillance

Reperformance

SS – 8 Off-Site

User Training

II.D-E 100% of PWS par C and D are met each year of the agreement

CCR,

SS – 9 Upgrade

Training

II.F No fewer than 4 team members should be trained within the first 7 days of any upgrade to the instrument

SS – 10 Technical

Support Over-the-

Phone

III.C Vendor must be able to be contacted 100% of the time over the phone for technical support

SS – 11 Emergency

Repair

III.E Emergency repair to bring instrument back to operational status occurs within 8 hours of customer service request

100%

CAR