65– Sources Sought – Seeking Service Provider for the Sorin 3T Heater/Cooler Cleaning System at the San Francisco VA Medical Center
Notice Type: Sources Sought Notice
Posted Date:
Office Address:
Subject: 65-- Sources Sought - Seeking Service Provider for the Sorin 3T Heater/Cooler Cleaning System at the
Classification Code: 65 - Medical, dental & veterinary equipment & supplies
Solicitation Number: VA26117N1244
Contact: [email protected] mailto:[email protected]
Setaside: N/AN/A
Place of Performance (address):
Place of Performance (zipcode): 94121-1545
Place of Performance Country:
Description:
If capable of performing the service in
Company
DUNS Number
Capabilities Statement
PERFORMANCE WORK STATEMENT
SORIN 3T CLEANING SERVICES
1. GENERAL
1.1. SERVICES REQUIRED:
Under the authority of 38 U.S.C. Section 8153 and Veterans Affairs Acquisition Regulation (VAAR) Part 873 Contractor shall be considered for a one year purchase order/contract to provide cleaning services to the Sorin 3T Heater-Cooler device at the
The Stockert 3T Heater-Cooler System (3T), manufactured by
In
Per national directive and manufacturer's instructions, the Sorin 3T heater/cooler requires weekly water changes and a disinfection procedure every 14 days. This requires a qualified technician perform maintenance services every week per manufacturer's instructions. The maintenance procedures will take place in a designated room in the surgical area of the SFVAMC.
1.2. PLACE OF PERFORMANCE:
1.3. AUTHORITY/POLICY/HANDBOOKS: 1. APPLICABLE PUBLICATIONS:
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The Contractor shall adhere to the publications list that follows. The publications are maintained by the Government and are available through the COR. At any time, these publications are subject to change, made in the form of supplements or amendments issued at any organizational level and may affect contract performance.
a. STATION MEMORANDA Use Most Current Dated Publication:
NUMBER TITLE
00-08 Patient's Rights and responsibilities
00-09 Improving Organizational Performance
136-34 Medical Records Content and Documentation
136-17 Privacy Act of 1994
136-40 Electronics Signature and Computer-based Medical Records
b. OTHER REFERENCES
JC Standards for: Ambulatory Care (2014) and Hospital (2014).
2. QUALIFICATIONS:
2.1 Staff/Facility
Maintenance technicians must possess one or more attributes from each of the following
areas:
Must have significant experience cleaning the Stockert 3T Heater-Cooler System (3T). Per manufacturer's instructions: The heater-cooler may only be used by trained and qualified perfusionists and may only be maintained by trained and qualified personnel.
Licensure:
N/A
Maintenance technicians must possess all of the following:
Valid TB Test
Hepatitis B Immunization
Valid BLS Card
Operate biomedical computer equipment and software.
Malpractice insurance shall be provided by the contractor.
2.2 Prior to providing any services under this contract all Contractor personnel must receive and acknowledge receipt (as outlined in paragraph 4) of,
2.3 The qualifications of Contractor personnel shall be subject to review by the Chief of Staff and approval of the Director,
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2.4
3. Hours of Operation:
Contractor personnel shall be available to furnish required services every week at a designated
time
3.1 OVERTIME AND HOLIDAY PAY:
Any overtime and/or holiday pay that may be entitled to the Contractor's employees shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.
3.2 NATIONAL HOLIDAYS: Listed below are the ten (10) national holidays.
Third Monday in January Third Monday in February Last Monday in May
First Monday in September Second Monday in October
Fourth Thursday in November
When one of the holidays falls on a Sunday, the following Monday will be observed as a national holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a national holiday by
3.3 PAY:
Contracted personnel will be paid by a flat fee labor charge of
4. CONTRACTOR RESPONSIBILITIES
4.1. KNOWLEDGE, SKILLS AND ABILITIES:
a) Contractor shall provide one maintenance technician to come on a weekly basis to perform the Sorin 3T disinfection process.
b) In the event one technician is not able to perform these duties the contractor will have a backup technician available.
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c) Contractor personnel shall perform maintenance services, which include, but are not limited to the following:
o Week 1 and Week 3: Water change only (1 hour if water change only) The water in the water circuits must be changed every 7 days. In order to prevent microbial growth, 150 ml (5 US fl. oz.) of medical grade 3% hydrogen peroxide solution is added to the tank contents. The hydrogen peroxide concentration in the water can be measured senniquantitatively during the draining procedure by the use of a test strip. The hydrogen peroxide concentration will decrease over the 7-day-period until the next water change, but should not drop below 100 ppm. If concentrations fall below 100 ppm, the disinfection procedure must be completed.
o Week 2 and Week 4: Water change and Disinfection of tank/circuits (2 hours) Prior to operating the heater-cooler for the first time, when placing the system in storage and during regular operation, the water circuits must be disinfected at intervals of 14 days. The Heater-Cooler 3T water circuits include the pump, heating and cooling tanks, fittings and all interconnecting tubing. Technicians must follow all manufacturer's instructions when disinfecting equipment.
4.2 STANDARDS OF PRACTICE:
Contractor personnel shall perform services in accordance with ethical, professional, and technical standards of the healthcare industry consistent with
Contractor shall be responsible for meeting or exceeding
4.3 STANDARD OF CONDUCT:
The Government reserves the right to refuse acceptance of contract personnel whose personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other abuse, or other conduct resulting in formal complaints by patients or other staff members to designated Government Representatives. Standards for conduct shall mirror those prescribed by current Federal Personnel Regulations.
Complaints concerning contract personnel's conduct with Government employees or patients will be dealt with by the Contractor and Contracting Officer's Representative. The Contracting Officer is the final authority on validating complaints. In the event that contract personnel are involved and named in a validated complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of
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incidents involving physical or verbal abuse. The final arbiter on questions of acceptability is the Contracting Officer.
4.4 CONFLICT OF INTEREST:
The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the
4.5 CONTRACTOR LIAISON:
The Contractor shall designate one (1) employee who shall be responsible for the performance of the work under this contract. The liaison shall have full authority to act for the Contractor on all matters relating to the daily operation of this contract. The liaison may be a contract health care provider performing under this contract. An alternate may be designated, but the Contractor shall identify, in writing, those times when the alternate shall act as the liaison.
Contractor Liaison: Phone: Fax:
4.6 EMERGENCIES OR COMPLICATIONS:
Contract personnel will report any unusual incidents immediately to Chief OR Nurse or the
Chief of Surgical Service.
All accidents, malfunctions, injuries and deaths related to the delivery of services shall be reported verbally to the
4.7 ARRANGEMENT FOR REPLACEMENT STAFF:
The Contractor shall provide scheduled services throughout the contract period. In the event of the absence of Contractor's personnel for any reason, the Contractor shall coordinate an alternate with the Chief OR Nurse or his representative.
4.8 ALTERNATE SOURCES:
a. If routine services are disrupted for more than two (2) consecutive scheduled shifts or emergency response requests, the Government reserves the right to procure such services from an alternate source, until routine services are restored by the Contractor. When the Government exercises its right to procure these services from an alternate
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source, the Contractor shall reimburse the government for all charges in excess of the amount that would have normally been incurred by the contract.
b. A copy of the other source's time sheet or other verifiable documentation shall be used as the basis for any reimbursement.
4.9 CONTINUING MEDICAL EDUCATION (CME) REQUIREMENTS:
Contract personnel registered by national associations shall continue to meet the minimum standards for CME and SFVAMC Bylaws and Rules to remain current as prescribed by legal requirements. CME is the sole responsibility of the Contractor, shall be obtained at no additional cost to the Government, and shall be reported to the COR annually on the first normal duty day in January for the previous calendar year. Periodic CME may be conducted at the
4.10 EVIDENCE OF INSURANCE COVERAGE:
Before commencing work under this contract, the Contractor shall furnish certification to the Contracting Officer that the coverage required (General & Professional Liability as well as Workers Comp) has been obtained and such policy shall state, "This policy may not be changed or cancelled without written notice to the VA Contracting Officer. Said policy must bear an appropriate "loss payable clause" to
4.11 CONTRACTOR PERSONNEL POLICY:
The Contractor shall assume full responsibility for the protection of its personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following to the personnel:
Worker's compensation
Professional liability insurance
Health examinations
Income tax withholdings, and
Payment for any leave, including sick leave or vacation time is considered the sole responsibility of the Contractor. The Contractor shall comply with all existing local, state, federal and/or union laws, regulations relevant to fringe benefits, and premium pay for their employees. Such personnel shall not be considered SFVAMC employees for any purpose and shall be considered employees of the Contractor. There is no employer-employee relationship between the
4.12 PERSONAL HYGIENE AND CLOTHING:
Contract health care providers shall be neat, clean, well groomed and shall otherwise exercise good personal hygiene. Appropriate and professional operating room attire shall be worn at all times. A laboratory style coat must be worn over scrubs when the contract health care provider is not performing duties in a clinical examination area, operating or procedure rooms. Medical
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scrubs are not to be worn outside the facility. Protective clothing shall be provided by the SFVAMC and will remain the property of the SFVAMC.
4.13 HEALTH REQUIREMENTS:
a. Contract health care providers shall not perform services under this contract unless a pre-assignment medical examination has been performed within 30 calendar days of their first scheduled shift. Pre-assignment medical examinations shall be the responsibility of the Contractor at no cost to the Government.
b. As a condition of employment
c. Contract health providers having patient contact or exposure to biological or pathological specimens shall be immunized against, be granted an immunization waiver or have documented proof of immunity to: rubella, mumps, polio and Hepatitis B. In addition, contract health care providers shall be free of infectious diseases (to include but not limited to active Tuberculosis and Viral Hepatitis) that might reasonably be expected to place other workers, patients or the public at risk.
d. The Contractor shall provide the Government with all the information necessary to ensure that Government records are maintained correctly and in compliance with Joint Commission,
e. The Contractor shall provide the COR with certification that contract health care providers have completed the medical evaluation required above, a minimum of five (5) working days prior to performance of contract services. This certification shall state the date that the examination was completed, the doctor's name that performed the examination, a statement concerning the physical health of the individual and the following statement:
[
f. The Government may take nose and throat cultures from contract health care providers when required by Government Infection Control Committees (ICC).
g. When a health care provider has been found medically unfit for providing services required under this contract, they shall be required to discontinue working immediately. Contract health care providers will not return to work until given clearance by the appropriate physician.
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h. The Government will provide emergency health care for injuries sustained while on duty for contract health care providers. These services will be billed to the Contractor at the current full reimbursement rate.
4.14 IMMUNIZATION WAIVER/EXEMPTIONS:
Waivers and exemptions may be granted in accordance with
Bylaws.
1. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT
5.1 PATIENT SENSITIVITY:
a. Contract health care provider shall respect and maintain the basic rights of patients,
demonstrating concern for personal dignity and human relationships.
5.2 CONTRACT PERFORMANCE MONITORING:
a. Monitoring of Contractors time shall be demonstrated through clinical and administrative record reviews and through patient satisfaction survey. The COR will be responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures or by failure to supply required documentation shall be forwarded immediately to the Contracting Officer.
The Contractor shall maintain an adequate record system for recording services, listing servicing providers, charges, Comprehensive Procedure Tracing (CPT) codes applicable, patient identification, service dates and all other commonly accepted information elements for services rendered to patients pursuant to this contract (including, but not limited to, such records as are necessary for the evaluation of the quality, appropriateness, and timeliness of services performed under this contract).
5.3 MEDICAL RECORDS:
Clinical or other medical records of
5.4 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA):
Contractor shall take reasonable measures to ensure patient privacy and confidentiality. The contract service providers herein agree to take all reasonable precautions to safeguard patient information from unauthorized access or modification, in both electronic and hard-copy formats. This includes not only electronic security measures such as "strong" user passwords
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on computer systems, but also physical barriers to prevent unauthorized use of computer work-stations; that hard copy patient files are in secured lockable areas, that files are in lockable cabinets, that the cabinets can in fact be locked, i.e., keys are available, and the locking mechanisms work properly. This precaution also includes the proper transfer of patient information via electronic means, such as faxing or system-to-system transmission.
Contractor personnel shall make sure no patient information of any type is given to outside parties, agencies or organizations of any type without the expressed written consent of the patient and the
That the undersigned understands that all parties are bound by the requirements of the "Health Insurance Portability and Accountability Act of 1996" which provide guidance on the protection of patient privacy and confidentiality. This Act mandates that all government agencies and those bodies with whom they contract must be in compliance with the directives of the Act. Details of the Act are still under development by the
5.5 PERFORMANCE IMPROVEMENT (P1)/RISK MANAGEMENT:
Contract health care providers shall participate in PI/Risk Management activities to the extent required by SFVAMC Memoranda. Contract personnel specific data must be submitted by the Contractor to the COR upon request. The Government shall evaluate the contract personnel professional, as differentiated from administrative, performance under this contract using quality assurance standards specified in VA Regulations, Joint Commission Standards, and VA Station Memorandum.
5.6 QUALITY ASSURANCE AND PERFORMANCE MONITORING:
Contract personnel will be held to the same standard as
5.7 THE JOINT COMMISSION:
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Contractor's personnel shall be subject to the same quality assurance standards in meeting or exceeding current recognized National Standards as established by the Joint Commission. Copies of the quality assurance standards are on file in the
The Contractor is required to maintain records that document competence/performance level of Contractor employees working on this contract in accordance with the Joint Commission Accreditation and other regulatory body requirements. The Contractor will provide a current copy of the competence assessment checklist and annual performance evaluation to the COR at the time of contract award or upon request, for each Contractor employee working on this contract.
Where the contract does not require the Joint Commission Accreditation or other regulatory body requirements, the Contractor must perform the required work in accordance with the Joint Commission Accreditation standards. A copy of these standards may be obtained from the Joint Commission,
5.8 HHS/OIG REQUIREMENTS:
To ensure that the individuals providing services under this contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the
5.9 COMPUTER SECURITY:
In the performance of official duties, if the contract personnel has regular access to printed and electronic files containing sensitive data that must be protected under the provisions of the Privacy Act of 1974 and other applicable laws, federal regulations,
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regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in the access agreement which the contract personnel signs.
GOVERNMENT RESPONSIBILITIES
6.1 IDENTIFICATION PIV BADGE:
An identification (ID) badge will be issued by the
6.2 GOVERNMENT TRAINING AND ORIENTATION:
a. The
b. The Contractor shall ensure that all contract personnel attend and participate in
6.3 DRUG SCREENING:
Contract health care providers are subject to random drug testing. They are also subject to drug testing when there is a reasonable suspicion that they use or are impaired by illegal drugs while on duty. Reasonable suspicion of drug use or impairment includes, but is not limited, to the following:
a. Observable phenomena, such as direct observation of drug use, possession or the physical symptoms of being under the influence of a drug;
b. A pattern of abnormal conduct or erratic behavior;
c. Arrest or conviction for a drug-related offense or the identification of a contract health care provider as the focus of a criminal investigation into illegal drug possession, use, or trafficking;
d. Information provided either by reliable and credible sources or independently corroborated; or
e. Newly discovered evidence that the contract health care provider has tampered with a previous drug test.
7. SPECIAL CONTRACT REQUIREMENTS
7.1 BILLING FOR SERVICES:
The Contractor is responsible for submitting billing for services monthly.
7.2 PAYMENTS:
a. Contractor shall accept payment for services rendered under this contract as payment in full and will not bill the veteran or his/her third party insurer for any services covered under this contract or for additional services for which the
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7.3 INVOICE AND PAYMENT:
Payment is to be made monthly in arrears. Contractor shall submit invoices in original addressed to: VAFSC, P.O. Box 149971,
Any discrepancies found shall be brought to the attention of the Contractor and shall be resolved. A corrected invoice must then be submitted by the Contractor as instructed by the Government.
Patients shall not be invoiced for services. The invoice MUST be itemized to include the following information.
(1)
(2) Contractor's tax ID number
(3) Veteran's name and social security number (last four)
(4) Date of treatment(s)
(5) Medical conditions for which service was rendered
(6) Description of services rendered
(7) Appropriate CPT code(s)
(8) Fees being charged for services rendered
(9) Extended amount due;
(10) Invoice number, date; and Contract/Obligation number
Payment for services rendered by the Contractor shall be made monthly upon receipt of a proper invoice. When inadequate invoices are received (those lacking any of the essential items listed above), the vendor will be notified in writing within 7 calendar days of receipt of such bills that these bills cannot be processed for payment until a proper invoice is submitted. (Prompt Payment Act Public Law 97-177)
The itemized invoice shall be verified for certification of the services rendered during the billing period.
7.4 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:
Contractor and subcontractor personnel who require access to
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the
Should the contract require Contractor personnel to maintain
The cost for such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government on the basis of the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. At this time, the current estimated costs for such investigations are as follows:
LEVEL OF SENSITIVITY
BACKGROUND
INVESTIGATION LEVEL
APPROXIMATE COST
Low Risk
National Agency Check with Written Inquiries
Moderate Risk
Minimum Background Investigation
High Risk
Background Investigation
The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and social security number of Contractor personnel. The
7.5 POST-AWARD PERFORMANCE CONFERENCE:
The Contracting Officer may schedule a post-award performance conference with the
Contractor, if deemed necessary, for contract orientation purposes.
P
er 6500.6 Appendix C.
1. General
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as
2. Access to VA Information and VA Information Systems
a. A contractor/subcontractor shall request logical (technical) or physical access to
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information and
b. All contractors, subcontractors, and third-party servicers and associates working with
c. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a
3. VA Information Custodial Language
a. Information made available to the contractor or subcontractor by
b. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from
c. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of
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4. Security Incident Investigation
a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to
b. To the extent known by the contractor/subcontractor, the contractor/subcontractor's notice to
c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with
5. Liquidated Damages for Data Breach
a. Consistent with the requirements of 38 U.S.C. --5725, a contract may require access to sensitive personal information. If so, the contractor is liable to
b. The contractor/subcontractor shall provide notice to
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independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
(6) Amount of time the data has been out of
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
6. Training
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a. All contractor employees and subcontractor employees requiring access to
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
7. Security Requirements for Unclassified Information Technology Resources
The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.
8. Security Accreditation Package (C&A)
The C&A requirements do not apply and a Security Accreditation Package is not required.
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Link/URL: https://www.fbo.gov/spg/VA/VANCHCS/VANCHCS/VA26117N1244/listing.html
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