AMENDED SOW - HEMODIALYSIS WATER TESTING.docx

STATEMENT OF WORK

HEMODIALYSIS WATER TESTING SERVICE

I. Scope: The contract shall provide services for hemodialysis water testing for VA Long Beach Healthcare System (VALBHCS). This includes the following test types, Bacteria/Colony Count and LAL/Endotoxin. Service must include all sample collection supplies, consumables and equipment necessary to perform this service.

II. Period of Performance: The period of performance will start shortly after award for a one (1) Year Base Period with the Government having the option to exercise four (4) one-year option periods for a total of five (5) years.

III. Services to be Provided:

a. Ongoing Support Services:

STATEMENT OF WORK

HEMODIALYSIS WATER TESTING

· The contractor shall be responsible for performing hemodialysis water testing services.

· All services must meet the standards of Association for the Advancement of Medical Instruments Technical Information Report (AAMI TIR-34) standard defined for the test below;

1. Bacteria/Colony count – 48-hour Incubation: 63 tests per month

2. LAL/Endotoxin: 63 tests per month

· All services/tests must be performed on a weekly/monthly basis.

b. Documentation: Vendor will provide individual results in a service report which describe services performed (in sufficient detail to be acceptable to the field inspectors of The Joint Commission). The following information must be provided in each report:

1) Date of service

2) Sample ID and serial #

3) Test name

4) Environmental results

5) Reference range

6) Vendor comments

Note: The completed service report must be approved and signed by Biomedical Engineering personnel or their representative. A copy of each report must be sent to the Lead Medical Instrument Technician (MIT), or with a designee of the MIT, i.e., a supervising official, using the agreed upon method of communication(s).

c. Labor: The vendor will provide all labor associated with the hemodialysis water testing defined in section III “Services to be Provided” of the SOW.

· All testing errors must be corrected by the contractor at a mutually agreed upon time and at no additional cost to the VA.

d. Response Times:

· LAL Endotoxin results: Must be reported within 48 hours post testing service date.

· Bacteria/Colony Count: Must be reported within 3-4 days post testing service date. Colony count testing will be reported on Sundays, holidays, or any day that testing is completed.

· Test results must be report by email, website or fax. If a website is used, users must be provided 24/7 access to the results of test.

· Failures or other testing issues must be communicated via phone support or email immediately upon identification.

· Test results that are ready prior to the stated report times must, upon completion, be reported immediately.

· The Contractor will notify VALBHCS immediately when any results action level is above the Alert Limit.

· Water cultures:

· Max Level = 100 cfu/mL

· Action level = 50 cfu/mL

· Endotoxin LAL

· Max Level = 0.25 eu/mL

· Action level = 0.125 eu/mL

e. Parts:

· Sample Collection Supplies: All sample collection supplies defined as “Kit” must be included. The kit must include, shipping box, freezer pack, test tubes and bottles. These supplies are to be include in the pricing.

f. Qualifications: The contract must provide evidence of their most recent dialysis water testing service. This shall include evidence of bacterial, colony count and LAL/endotoxin testing service.

· Equipment: The contractor’s personnel must be capable of performing all hemodialysis water testing services on the equipment below.

· B-Braun Dialog+ Dialysis machine

· Phoenix 36X Gambro Dialysis machine

· Millenium HX Portable Reverse Osmosis machine

· Accreditation: The contractor’s laboratory must have the following accreditation;

· Perry Johnson Laboratory Accreditation (PJLA)

· ISO/IEC 17025

IV. Hours of Coverage:

a. Normal hours of testing will be Monday through Friday from 8am to 5pm EST.

b. All services will be performed during stipulated hours of coverage unless requested or approved by Biomedical Engineering.

· Hours: Normal duty hours are 7:30 a.m. through 5:00 p.m., Monday through Friday, not including federal holidays. Whenever contact with a facility is required outside of normal duty hours, the Contractor shall coordinate these times with the designated COR, POC or designee.

c. Federal Holidays: In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”