PWS.pdf

PERFORMANCE WORK STATEMENT

1. GENERAL REQUIREMENTS: Contractor will provide FDA approved test kits, equipment, upgrades, and technical support to enable molecular testing of Neisseria Gonorrhoeae (GC), Chlamydia trachomatis (CT), Aptima HPV, HPV 16, 18/45 Genotyping, Bacterial Vaginitis, Vaginal Trichomonas and Yeast FDA approved Testing.

2. SPECIFIC TASKS

DESCRIPTION: The Contractor will provide all equipment, tools, materials, IT support, supervision and training necessary to provide instrumentation, assay kits and collection devices for the detection of Neisseria Gonorrhoeae (GC), Chlamydia trachomatis (CT), Aptima HPV, HPV 16, 18/45 Genotyping, Bacterial Vaginitis (BV), Vaginal Trichomonas and Yeast (CV/TV).

2.1 The system will be located at the Carl R Darnall Army Medical Center hospital at Fort

Hood building 36065, second floor Laboratory room #42-419.

2.2 Contractor’s proposed solution must fit into the designated space with adequate room for ergonomically correct technician movement and storage of supplies, reagents, and consumables sufficient for 4 weeks of operation. The space must comply with all relevant fire and safety codes.

2.3 Productivity and efficiency will include greater than 500 results in a 12 hour period and over 50,000 tests annually.

2.4 At a minimum the platform should have available FDA approved assays for the detection of CT/GC in urine, Endocervical/Vaginal swabs and male urethral swabs, HPV testing from thin prep PAP collections, and BV and CV/TV testing from Vaginal swabs.

2.5 No more than four collection device types will be required to cover the menu of testing above.

2.6 Following collection specimens should be stable in the collection device for not less than

30 days at room temperature.

2.7 Instrument maintenance must be minimal, day of use maintenance will not exceed 20 min, other maintenance will not require more than one hour per month of technician time.

2.8 System must have an active, either chemical or biological, decontamination system, contamination rates should be included in the proposal.

2.9 The majority of assay reagents must be stable at room temperature; refrigerated reagents must not require more than 233ft of storage for 10,000 tests.

2.10 System must have integrated software that performs all calculations required for the final patient result.

2.11 Technical support must be available by telephone during normal duty hours (0700-1800

CST, Mon-Fri), field service must be available next day.

2.12 The Contractor will provide all personnel, reagents and consumable items needed to conduct the instrument validation in accordance with the requirements of the College of

American Pathologists and the Medical Director of the Carl R. Darnall Army Medical Center Department of Pathology.

2.13 Validation of the instrument includes verification of bi-directional communication with CHCS the LIS in use by DoD laboratories.

2.14 Contractor will provide off site training for two staff members per year and unlimited on-site training to accommodate staff turnover.

2.15 Delivery of reagents will not exceed 7 days from the date of request.

3. CTGC ANALYZER SALIENT CHARACTERISTICS

3.1 FDA approved, assays for the following specimen types from asymptomatic and symptomatic patients age 14 and older.

• Male and/or female urine

• Female Endocervical Swabs

• Male Urethral Swabs

3.2 System must not require more than two types of collection devices to support the test menu

3.3 Simultaneous detection of Chlamydia trachomatis and Neisseria Gonorrhoeae from a single specimen.

3.4 Due to space constraints, and sharing of room with other established molecular systems, CT/GC system must be a closed system minimizing any potential aerosols. (Minimal specimen handling no manual specimen uncapping to avoid cross contamination.)

3.5 Able to result 500 specimens in a 12 hr. period

3.6 No more than 30 minutes required to put machine into operation on a daily basis

3.7 Operator maintenance, not related to start-up, should not exceed 1 hr. per month

3.8 Room temperature storage of reagents, cold storage (4°C) should require less than

23ft3 of storage for 10,000 tests.

3.9 System must have active decontamination that does not require large quantities (>1

Gal) of bleach or other hazmat for operation per run cycle (pre, during and post run).

3.10 All reagents must be ready for use

3.11 The system must fit into the allocated space

3.12 Minimum next business day technical support in the event of instrument failure to include weekend support under emergency conditions

3.13 System software must provide:

• Automated data reduction

• Qualitative result interpretations

• Notify user if quality controls or other system parameters would invalidate the test result

3.14 Specimen stability after collection, minimum 30 days at room temperature (25°C)

4. HPV AND HPV GENOTYPE SALIENT CHARACTERISTICS

4.1 Productivity and efficiency will include greater than 50 results in a 12 hour period and over 4,800 tests annually.

4.2 At a minimum the platform should have available FDA approved assays for the detection of HPV and HPV 16 18/45 in PreservCyt solution from cervical or vaginal specimens.

4.3 No more than two collection device types will be required to cover the menu of testing above.

4.4 Following collection specimens should be stable in the collection device for not less than 105 days at room temperature.

4.5 Instrument maintenance must be minimal, day of use maintenance will not exceed 20 min, other maintenance will not require more than one hour per month of technician time.

4.6 System must have an active, either chemical or biological, decontamination system, contamination rates should be included in the proposal.

4.7 The majority of assay reagents must be stable at room temperature; refrigerated reagents must not require more than 233ft of storage for 5,000 tests.

4.8 System must have integrated software that performs all calculations required for the final patient result.

5. TRICHOMONAS VAGINALIS/BACTERIAL VAGINALIS CANDIDA

5.1 A vaginitis panel that is able to simultaneously detect the three most common causes of infectious vaginitis: Bacterial Vaginosis, Candida Vaginitis and Trichomoniasis all from one collection using molecular nucleic acid amplification test (NAAT).

5.2 System must not require more than two types of collection devices to support the test menu

5.3 Due to space constraints, and sharing of room with other established molecular systems, CT/GC system must be a closed system minimizing any potential aerosols.

(Minimal specimen handling, no manual specimen uncapping to avoid cross contamination.)

5.4 Able to result 500 specimens in a 12 hr. period

5.5 No more than 30 minutes required to put machine into operation on a daily basis

5.6 Operator maintenance, not related to start-up, should not exceed 1 hr. per month

5.7 Room temperature storage of reagents, cold storage (4°C) should require less than 23 ft3of storage for 10,000 tests.

5.8 Room temperature storage of reagents, cold storage (4°C) should require less than 23 ft3 of storage for 10,000 tests.

5.9 System must have active decontamination that does not require large quantities (>1 Gal) of bleach or other hazmat for operation per run cycle (pre, during and post run).

5.10 All reagents must be ready for use

5.11 The system must fit into the allocated space

5.12 Minimum next business day technical support in the event of instrument failure to include weekend support under emergency conditions

5.13 System software must provide:

• Automated data reduction

• Qualitative result interpretations

• notify user if quality controls or other system parameters would invalidate the test result

5.14 Specimen stability after collection, minimum 30 days at room temperature (25°C)