36C25719Q0652-004.pdf

Statement of Work

SPS Water Testing to AAMI TIR34: 2014R17 Standard

13 May 2019

OBJECTIVE:

The Central Texas Veterans Health Care System (CTVHCS) Sterile Processing Service (SPS) is establishing a contracted water quality testing program on a monthly testing cycle in accordance with AAMI TIR34:2014R17 and requirements for Steris equipment operation

Instructions for Use (IFU).

The purpose of this contract is to procure Laboratory Analysis of water samples for AAMI compliance with water quality in accordance with VHA Directive 1116(2) dated March 23, 2016; Reference guidance in current 2017 AAMI TIR34 and various equipment IFU and

Steris equipment IFU.

Contractor must provide for the use of secure password protected web-based reporting with history of reports maintained on vendor database and exportable as excel and pdf documents.

CTVHCS intends to make this water testing for two physical locations that each have two internal locations in one contract and to make requirement “turn key” to the fullest extent possible.

REQUIREMENTS:

1. Water testing will be conducted monthly. Vendor will come to CTVHSC Temple and Austin

SPS locations to take water samples in secured areas of the CTVHSC SPS areas. Utility and

Critical water will be tested. Reports will be supplied electronically and hard copy.

a. Olin E. Teague Veterans’ Medical Center; 1901 Veterans Memorial Drive, Temple, TX 76504

b. Austin Outpatient Clinic; 7901 Metropolis Drive, Austin, TX 78744

2. CTVHSC-SPS requires water testing to occur in AM (morning) of day to ensure water testing does not interfere with SPS work flow or risk of work flow causing contaminated sample.

Water samples should be performed using same criteria as AAMI TIR34R17.

3. Sampling locations for SPS Water as listed in below chart.

4. A total of 19 samples per month will be collected each month for the testing described above:

Location CTVHCS-Temple CTVHCS-Austin

Decon (includes DI still) 3 Critical, 4 Utility= 7 3 Critical, 1 Utility = 4

Medivator 4 Critical, 1 Utility= 5 2 Critical, 1 Utility = 3

Total samples = 19 12 7

Attachment 1 36C25719Q0652 Page 1 of 9

5. SCHEDULE OF SUPPLIES:

a. Contractor shall supply all sampling supplies, containers and shipping labels.

Contractor will supply training as needed for emergency samples to be collected and shipped. Contractor shall pay postage and shipping on any samples requiring re-testing.

b. AAMI compliance with water quality Water Testing Requirements:

c. General Procedures for AAMI compliance with water quality:

i. The contractor shall furnish all sample collection bottles and return shipping labels, all transportation costs, and resources necessary to perform for AAMI compliance with water quality testing. Containers must be sterile, appropriate for the analysis, properly preserved, and ready for prompt transportation to the laboratory under strict chain of custody procedures. Contractor required to provide trained staff to perform sample collections.

ii. VA requires monthly, quarterly and annual source water samples for analysis plus 28 emergency samples if necessary.

6. Sample/specimen Analysis and Reporting:

a. The testing laboratory processing the water samples for AAMI compliance with water quality must be proficient at performing water quality AAMI compliance cultures from environmental samples.

i. The full 250 ml volume of potable water (utility) must be concentrated for routine quarterly testing. The testing laboratory must retain samples that test positive for AAMI compliance with water quality for 30 calendar days and must release them to the healthcare system if requested.

ii. Endotoxin testing must be in compliance with use of Limulus Amoebocyte

Lysate testing as listed in AAMI TIR34R17.

Attachment 1 36C25719Q0652 Page 2 of 9

Per Association for the Advancement of Medical Instrumentation (AAMI)

TIR34:2014R17

2.25 endotoxin: High-molecular-weight complex that is associated with the cell wall of Gram-negative bacteria, is pyrogenic in humans and specifically interacts with

Limulus amoebocyte lysate (LAL). See also bacterial endotoxins test (BET) and pyrogen.

2.26 endotoxin unit (EU): Standard unit of measure for endotoxin activity initially established relative to the activity contained in 0.2 nanograms of the U.S. Reference

Standard Endotoxin Lot EC-2 (United States Pharmacopeia [USP] standard reference material).

NOTE—FDA’s reference endotoxin EC-6, USP Lot G, and the World Health

Organization’s primary international endotoxin standard (IS) are sublots of the same endotoxin preparation, making the EU and IU (International Unit) equal (Poole, et al., 1997).

b. The laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body, such as EMLAP, NELAP, etc. Proof of certification must be provided before acceptance of contract.

c. Contractor required to provide all sample analysis reports via e-mail to identified

COR and Central Texas Veterans Health Care System Point of Contact.

d. Contractor required shall provide water testing services no less than once per month and more frequent if necessary. Successive stops between testing shall not exceed 35 calendar days.

e. Contractor required to make notification of any positive sampling results and notification will be made within 24 hours or 1 working day of making this determination. Confirmation of notification from CTVHCS required complete notification process.

f. Contractor Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations and conditions, including the specific outlet temperature of water at the time the sample was collected, pH, biocide residual levels, method detection limits, and a description of test methodology. Sample reports need to be provided in a format that can be copied into the CTVHCS SPS

AAMI water quality sampling results reporting form. Sample analysis reports must be provided within 7 calendar days of the lab receiving the samples. If the

7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day.

Attachment 1 36C25719Q0652 Page 3 of 9

g. Requirement- The contractor shall have qualified technical support staff for consultation relative to proper water sample collection, testing, and interpretation of results.

h. Required- collection of samples will be performed in full compliance with facility

PPE practice and policy. Collection team will be escorted into SPS restricted access areas.

i. Required- unscheduled event related collections may be required to be collected on weekends and federal holidays.

j. Reports must include reference material and include previous test results to note trend of water quality with visual aids /graphs. Reports and materials need to be both electronic and hard copy/paper. POCs will be provided for electronic access. Electronic access training of VA POCs required.

k. Required- Assistance with interpretation of reports and creating effective plan of action consultation required.

7. Contractor shall provide water testing equipment – contractor shall provide submittals of water testing equipment or lab certification that they intend on using to carry out the requirements of this contract. Submittals will then be evaluated to ensure that equipment is appropriate and certified.

8. REQUIRED-Sampling for SPS water quality of Utility and Critical water:

a. Laboratory and Chemical Analysis:

i. Requirements for testing per AAMI TIR34

TIR34 2014R2017 A.5.3 Quality Characteristics

a) Bacterial content

b) Endotoxin content

c) Total organic carbon

d) pH

e) Water hardness

f) Resistivity

g) Total dissolved solids

h) Ionic contaminants

i) Color

(Appendix A has complete breakdown of labs and parameters)

ii. Requirements and Procedures for Sampling of SPS water lines for CFU and Endotoxin: The contractor must be certified by the Environmental

Protection Agency or a State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic). The contractor shall utilize the Standard

Attachment 1 36C25719Q0652 Page 4 of 9

Spread Plate Method 9215C using R2A agar. The contractor will provide an outline of their actual testing procedures. Proof of certification and outline of actual testing procedures must be provided before acceptance of the contract. Sampling results will report the number of colony forming units of heterotrophic water bacteria per milliliter of water (cfu/ml).

iii. Bacteria in water readings of less than 1CFU may be recorded as <1CFU.

Critical water quality readings greater than <9 cfu/ml or greater are required to be immediately (<24 hours notified by both telephone and email to identified CTVHCS staff.

iv. Requirement -Utility water with bacteria in water findings of <195 or greater will require immediate (<24 hours) notification by both telephone and email.

v. All readings greater than 1CFU/ML should be quantified in whole numbers...or greater than 500 may be recorded as <10 cfu/ml or > 500 cfu/ml.

vi. REQUIRED- Sampling will be tested for presence of Endotoxin and response of results expected in less than 24 hours. Testing should be conducted and resulted in less than 7 days. Parameters for LAL testing as listed in AAMI TIR34R17.

1. Weekend and Holidays are included in the timed suspense as the

CTVHS is in continuous operation.

b. Contractor shall provide all sample analysis reports via e-mail to the COR and the assigned Points of Contact within the CTVHCS -SPS service within 7 calendar days including weekends and holidays of receiving the sample. If the 7th day falls on a weekend or federally observed holiday, the reports shall be provided no later than the next normal business day. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology.

c. The contractor shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

d. The Contractor shall provide expertise to formulate effective plans of action to correct the water to a safe condition, within parameters established.

9. REQUIRED- Contractor takes all responsibility of their staff while on CTVHCS property.

Contractor staff will be escorted in all restricted areas of SPS. All Contractor staff will be required to wear full PPE supplied by the CTVHCS SPS, no exceptions. The Contractor’s field service employee will wear visible identification issued by the VA Police Service.

10. The Certification & Accreditation requirements do not apply, and a Security Accreditation

Package is not required.

Attachment 1 36C25719Q0652 Page 5 of 9

11. Qualifications:

a. The Contractor services shall be performed by trained and qualified personnel and performed in accordance with manufacturer’s guidelines.

b. The laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body, such as EMLAP, NELAP, etc.

c. The testing laboratory processing the water samples for AAMI compliance with water quality must be proficient at performing water quality AAMI compliance cultures from environmental samples.

d. The contractor must be certified by the Environmental Protection Agency or a

State environmental protection agency to perform environmental sampling that includes heterotrophic bacterial testing (Aerobic).

12. Contractor Furnished Material:

a. The Contractor shall furnish all supplies, labor, materials and equipment necessary for this service. No Government property will be provided.

b. Contractor responsible for clean-up and removal of all trash and debris created during testing.

c. Contractor shall be responsible for any damage to property whether personal, private or government owned during performance of these services. Contractor shall be responsible for the actions of their workers.

d. Contractor shall provide all safety equipment and personal protective equipment for their employees outside of the CTVHCS-SPS areas.

13. Work Hours: The following terms have the following meanings and are applicable to this contract:

Normal hours of coverage are Monday through Saturday from 7:00 am to 6:30 pm, excluding holidays. All services will be performed during normal hours unless requested or approved by COR or his designee. CTVHCS Infection Prevention and Safety will provide a Risk

Assessment and guidance for working in hospital areas that is required to be followed.

Federal Holidays observed by Veterans Health Administration are:

i. New Years' Day Labor Day

ii. Martin Luther King Day Columbus Day

iii. Presidents' Day Veterans' Day

iv. Memorial Day Thanksgiving

v. Independence Day Christmas Day

Attachment 1 36C25719Q0652 Page 6 of 9

14. Identification, Parking, Smoking and VA Regulations:

It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Service. The

CTVHCS will not validate or make reimbursements for parking violations to the

Contractor under any conditions. Smoking is prohibited inside any buildings at the

CTVHCS.

15. Possession of weapons, illegal drugs & alcohol is prohibited.

16. Enclosed containers, including tool kits, shall be subject to search.

17. Points of Contact:

i. CTVHCS-SPS: Christopher Gould (Temple)

(Christopher.gould1@va.gov) 254-743-0285

ii. AOPC CTVHCS-SPS: Rodney Chiles (Austin)

(Rodney.Chiles@va.gov) 512-823-4532

18. Additional Notes:

a. Information System Officer, Information Protection: The contractor will not have access to VA Desktop computers. They will not have access to online resources belonging to the VA or the U.S. government.

b. Privacy Officer: The Contractor will not have access to protected Patient Health

Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

Records Manager:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C.

552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the

U.S. Government for which the Government Agency shall have unlimited rights

Attachment 1 36C25719Q0652 Page 7 of 9 mailto:Christopher.gould1@va.gov mailto:Rodney.Chiles@va.gov to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government

Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of

Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

j. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

19. See Appendix A below.

Attachment 1 36C25719Q0652 Page 8 of 9

C h ar ac te ri st ic

Ty p e o f Te st in g Sa m p le S it e

Sa m p le s ta ke n a n d a n al yz e d b y:

Su gg e st e d F re q u e n cy o f

Te st in g

U ti li ty

W at e r

P ar am e te rs

C ri ti ca l W at e r

P ar am e te rs

C o n d u ct iv it y/ R e si st iv it y

M e te r m g/ l = p p m

R e si st o m e te r R e p ro ce ss in g A re a

M ai n t.

P e rs o n n e l ( re p ro ce ss in g p e rs o n n e l i f p o in t-o f-u se w at e r tr e at m e n t is u se d

D ai ly <5 u

S/ cm

<1

C o lo r an d

T u rb it y V is u al In sp e ct io n R e p ro ce ss in g ar e a st o ra ge t an k M ai n t.

P e rs o n n e l D ai ly

C le ar C le ar

B ac te ri a (c fu /m

l) H e te ro tr o p h ic

P la te C o u n t

(H P

C

R e p ro ce ss in g ar e a st o ra ge t an k

M ai n t.

P e rs o n n e l

M o n th ly <1

<1 p H p H p H

M e te r

C o lo ri m e tr ic d ip st ic ks

M ai n t.

P e rs o n n e l

R e p ro ce ss in g

P e rs o n n e l

M o n th ly

M o n th ly

6-

5-

To ta l O rg an ic

C ar b o n

TO

C

TO

C t e st

R e p ro ce ss in g ar e a M ai n t.

P e rs o n n e l M o n th ly o r

Q u ar te rl y

<1 .0 m g/ m L

<1 .0 m g/ m L

W at e r h ar d n e ss

D e te rm in at io n o f p p m C aC O

C o lo ri m e tr ic

D ip st ic ks

A ll m ai n w at e r fe e d li n e s in to t h e f ac il it y

R e p ro ce ss in g

A re a

M ai n t.

P e rs o n n e l

R e p ro ce ss in g

P e rs o n n e l

A n n u al ly

A n n u al ly

<1

En d o to xi n s Eu

/m L

LA

L te st

R e p ro ce ss in g ar e a st o ra ge t an k

M ai n t.

P e rs o n n e l

O n in st al la ti o n , m o d if ic at io n , o r re p ai r o r w h e n p e rs is ta n t m ic ro b ia l l e ve ls ar e d e te ct e d b y

H P

C , A

TP

o r

TO

C

<2

<1

Io n ic C o n ta m in an ts Sp e ci fi c te st s fo r C h lo ri d e , I ro n

C o p p e r an d m an ga n e se

A ll m ai n w at e r fe e d li n e s in to t h e f ac il it y

M ai n t.

P e rs o n n e l

A n n u al ly

A n n u al ly

C h lo ri d e s m g/ l la b v al u e s R e p ro ce ss in g ar e a

M ai n t.

P e rs o n n e l

R e p ro ce ss in g

P e rs o n n e l

M o n th ly o r Q u ar te rl y si n k

<2 a u to m at e d w as h e rs go al <1

To ta l D is o ve d S o li d s la b v al u e s R e p ro ce ss in g ar e a

M ai n t.

P e rs o n n e l

R e p ro ce ss in g

P e rs o n n e l

M o n th ly o r Q u ar te rl y la b v al u e

Te m p e ra tu re Th e rm o m e te r o r p ro b e

R e p ro ce ss in g ar e a

W as h e r D is in fe ct o r

Te m p o f h o t an d c o ld w at e r so u rc e a n d a ll s ta ge s o f w as h a n d r in se

U lt ra so n ic

C le an e r:

t ar ge t Te m p o f e n zy m at ic c le an e r m an u al s o ak : t ar ge t te m p f o r d e te rg e n t an d a ll s o lu ti o n s u se d

R e p ro ce ss in g

P e rs o n n e l

D ai ly

Fi lt e rs

P re ss u re a cr o ss m e m b ra n e

(t c h e ck f o r p re ss u re in cr e as e s to a c ri ti ca l l e ve l a n d a b ru p t p re ss u re d e cr e as e s)

R e p ro ce ss in g

A re a, o n e q u ip m e n t th at h as in te rn al f il te rs

A

ER

o r P

O U w at e r tr e at m e n t e q u ip m e n t

R e p ro ce ss in g

P e rs o n n e l

(m ay b e d o n e in c o n ju n ct io n w it h m ai n t.

P e rs o n n e l)

D ai ly

A

ER

E q u ip m e n t to b

M o n it o re d

W h at is t o b

M n it o re d N o rm al In te rv al s

Sp e ci fi ca ti o n

C o m m e n ts

A

ER

A u to m at d

En d o sc o p

R p ro ce ss o r)

M o n it o r in si d e c h am b e r w al ls o f A

ER

D ai ly

M o n it o r in si d e c h am b e r w al ls o f A

ER

D ai ly

SP

S st af f

A

ER

In co m in g w at e r q u al it y

(p H

, h ar d n e ss

, t e m p

(s e e

B .3

W e e kl y

P e rf o rm s im p le d e p ar tm e n ta l;

te st s co lo ri m e tr ic

, d ip st ic k, t h e rm o m e te r

D ai ly U ti li ty w at e r

A

ER

P u re W at e r Q u al it y b e fo re e n te rs

A

ER

P o st f il te r w at e r q u al it y

A p p e n d ix A

T st in g an d p ar am e te rs

Attachment 1 36C25719Q0652 Page 9 of 9