STATEMENT OF WORK - DataRay 09-30-2024-UPDATED.docx

STATEMENT OF WORK

FOR CONTRACT THERMAL LABEL PRINTERS, SOFTWARE AND TECHNICAL SUPPORT FOR THE ROSEBUD IHS HOSPITAL, SD (09/30/2024)

A. PURPOSE OF CONTRACT:

The Rosebud HIS Hospital seeks to purchase Thermal Label Printers, Software and Technical support from DataRay for labeling of IV medications, blood collection and wristbands to enhance patient care and safety. Data Ray will supply hardware, provide maintenance services, resources, and tools to support successful implementation of a hosted application to enable the hospital accomplish its goals through annual licensing.

This procurement will enable the Rosebud IHS Hospital meet its National Patient Safety Goals and accrediting body safe medication practice standards.

B. SPECIFICATIONS OF SERVICES:

DataRay Shall:

1. Through its Thermal Printing System Solution for Healthcare utilizing its Communications Adapter (D3) in conjunction with thermal label/wristband printers provide thermal printing capabilities to the Rosebud IHS Hospital.

2. Install an operable Thermal Printing System using D3 Interface devices to connect hospital printers through interface with the IHS Resource Patient Management System (RPMS).

3. Employ labeling measures and industry standards designed to enhance patient safety and maintain patient confidentiality

8. At hospital's request provide custom formatting services including addition or revision of barcodes, print material field position, field font changes, and other format enhancements.

13. Provide licensing, service and support including preventive maintenance, and equipment upgrades agreed upon for hospital operational needs.

C. GOVERNMENT FURNISHED EQUIPMENT, FACILITIES AND PROPERTY:

The contractor will be authorized use of facility equipment for training and support services. The same restrictions apply to the contractors as other IHS personnel in the use of equipment and material for official business activities only.

D. CONTRACTOR FURNISHED EQUIPMENT, FACILITIES, AND PROPERTY:

The contractor is expected to ship DataRay D3 interface equipment. Also, DataRay is expected to ship other hardware such as printers and barcode scanners. The contractor will inform and communicate with the service unit, the exact timelines when the goods will be shipped and tentative arrival time.

E. WORK SCHEDULE/PAYMENT SCHEDULE:

The contract is for the DataRay Thermal Printing System Solution for Healthcare utilizing a Communications Adapter (D3) working in conjunction with thermal label/wristband printers including barcode readers to provide thermal printing capabilities to Rosebud IHS Hospital. Work shall be provided remotely and at the hospital facility.

User licensing, service and support including preventive maintenance, and equipment upgrades when agreed upon will be contracted on a yearly basis.

F. QUALITY ASSURANCE:

The Service Unit shall provide an ongoing method of monitoring and evaluating the quality and appropriateness products and services provided. Deficiencies in the quality of services performed will be identified and appropriate corrective measures sought before the level of performance becomes unacceptable.

QAPI Measures will include monitoring any mislabeling of blood specimen or IV Medication.

RCA will be implemented to trace the cause and fix the process or workflow.

Performance Surveillance Plan

Performance surveillance monitors will be established to comply with regulatory guidelines and to monitor contract performance. The performance surveillance plan has been developed to describe the Indian Health Service’s general plan in providing effective and systematic surveillance and reporting of all aspects of contract performance. This plan recognizes the responsibility of the contractor to carry out its own quality control obligations in the performance of this contract.

Surveillance will be accomplished via insight into the contractor’s performance against requirements listed in the work statement and performance standards listed in this plan. Performance-based incentives are consistent with the intent and purpose of the contract and are outlined on the following grid: Upon completion of the contract, the Government will complete and keep on record the Contractor’s performance evaluation form, see (Section J).

METHOD/MEASURES

CONTRACTOR

INCENTIVE

PERFORMANCE OBJECTIVE 1

THE CONTRACTOR SHALL SUPPLY AND INSTALL THERMAL PRINTING SYSTEM SOLUTION USING DATARAY’S D3 INTERFACE DEVICE TO CONNECT PRINTERS

ROSEBUD SERVICE UNIT WILL PROVIDE A POSITIVE PERFORMANCE REPORT ON DATARAY THERMAL PRINTING SYSTEM SOLUTION SERVICES

METHOD/MEASURES

CONTRACTOR

INCENTIVE

PERFORMANCE OBJECTIVE 2

DATARAY MAINTENACE STAFF SERVICES

DATARAY SUPPORT STAFF, RESPONSIVE TO CALLS FOR SUPPORT IN A TIMELY MANNER

AN OCCASIONAL DELAY IS RESPONSE BUT NOT MORE THAN TWICE IN A MONTH IN RESPONDING TO REQUEST FOR SUPPORT. RESPONSE FOR SUPPORT SHOULB BE WITHIN 24-48 HRS

THE CONTRACTOR SHALL RESPOND TO THE CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR) IN WRITING. WHENEVER, THEY RECEIVE NOTICE OF MORE THAN ONE COMPLAINT AGAINST ADDRESSING A REQUEST FOR SUPPORT IN A TIMELY MANNER

ROSEBUD SERVICE UNIT WILL PROVIDE A POSITIVE PERFORMANCE REPORT ON DATARAY THERMAL PRINTING SYSTEM SOLUTION SERVICES FOR RAPID RESPONSE TO REQUEST FOR SUPPORT

PERFORMANCE OBJECTIVE 3

DATARAY WILL COORDINATE WARRANTY SERVICE OF EQUIPMENT UNDER WARRANTY AND DAMAGED PARTS WILL BE SHIPPED AND REPLACED IN A TIMELY MANNER

RAPID RESPONSE TO REPORTS OF DAMAGED HARDWARE THAT ARE STILL UNDER WARRANTY

IF DAMAGED PARTS OR DATARAY EQUIPMENT IS NOT UNDER WARRANTY. EFFORT WILL BE MADE TO SUPPORT ROSEBUD IN ACQUIRING THE PART AND HAVE IT INVOICED

DATARAY WILL CONTINUALLY SERVCE EQUIPMENT TO ENSURE THAT THEY REMAIN IN GOOD WORKING CONDITION DURING THE DURATION OF THE CONTRACT

ROSEBUD SERVICE UNIT WILL PROVIDE A POSITIVE PERFORMANCE REPORT ON DATARAY THERMAL PRINTING SYSTEM SOLUTION SERVICES FOR RAPID RESPONSE TO REQUEST FOR SUPPORT

PERFORMANCY OBJECTIVE 4

DATARAY ENSURES THE EFFICENCY OF EQUIPMENT

DATARAY EQUIPMENT WILL WORK EFFICENTLY

DATARAY WILL PROVIDE SUPPORT AND SERVICE IN A TIMELY MANNER

BUISNESS OFFICE, PHARMACY AND OTHER DEPARTMENT HEADS HOUSING DATARAY HARWARE WILL MONITOR RESPONSE TIME FOR SERVICE CALLS

ROSEBUD SERVICE UNIT WILL PROVIDE A POSITIVE PERFORMANCE REPORT ON DATARAY THERMAL PRINTING SYSTEM SOLUTION SERVICES FOR RAPID RESPONSE TO REQUEST FOR SUPPORT

G. REPORTING REQUIREMENTS:

Contractor is required to provide timely service. Contractor must wear the appropriate IHS badge at all time while working in the IHS facility.

A detailed invoice must be submitted to the IHS designee with proper signature authority to initiate payment.

The Government reserves the right to accept or reject services if the level of work is unsatisfactory

H. PROFESSIONAL QUALIFICATIONS CRITERIA:

Contract staff shall be qualified by trade or basic qualifying regulatory body to perform work

All required certifications in this statement of work remain current during the life of this contract

The contract staff shall not have any work or health restrictions, which interfere with the performance of services.

I. CHARACTER INVESTIGATION FOR CONTRACTORS WHO WILL HAVE CONTACT WITH INDIAN CHILDREN:

Individuals providing services on personal or non-personal services contract (the duties and responsibilities of which involve regular contract with, or control over Indian children) are subject to a character investigation. IHS Personnel Office will conduct these investigations following awards of personal or non-personal service contract unless in the judgment of the Contracting Officer, investigation may be waived based on prior investigations on file. Until the character investigation has been completed and the Contracting Officer notified, such individuals shall not have unsupervised contact with Indian children.

J. REQUIRED MALPRACTICE INSURANCE:

Requires the contractor to maintain liability insurance, in the coverage amount acceptable to the contractor to maintain liability insurance, in the coverage amount acceptable to the contracting officer, which is not less than the amount normally prevailing within the local community for the specialty concerned which will be maintained throughout the duration of the contract.

K. COMPLIANCE WITH IHS RULES AND REGULATIONS:

1) The contractor shall generate and maintain proper medical record information in accordance with I.H.S. regulations. All medical record information generated in the performance of this contract will remain the property and subject to the exclusive control of the IHS.

2) The Contractor shall comply with all IHS facility infection control land safety procedures, practices and standards.

3) The contractor shall meet all regulatory standards during the performance of this contract

The duties of the Contractor through its staff shall be performed pursuant to the bylaws of the Service Unit. The regulations of the hospital, applicable provisions of law, other rules and regulations of any and all governmental authorities and pertinent to contract services must be followed.

Indemnification, Liability, Statute of Limitations: Any provisions in the TOS related to indemnification and filing deadlines are hereby waived, and shall not apply except to the extent expressly authorized by law. Liability for any breach of the TOS as modified by this Amendment, or any claim arising from the TOS as modified by this Amendment, shall be determined under the Federal Tort Claims Act, or other governing federal authority. Federal Statute of Limitations provisions shall apply to any breach or claim.

Governing law: Any arbitration, mediation or similar dispute resolution provision in the TOS is hereby deleted. The TOS and this Amendment shall be governed by and interpreted and enforced in accordance with the laws of the United States of America without reference to conflict of laws. To the extent permitted by federal law, the laws of the State of [Company to insert name of state if one is mentioned in its TOS] (excluding [Company's state] choice of law rules) will apply in the absence of applicable federal law.

The Contractor will be required to design, develop, or operate a system of records on individuals, to accomplish an agency function subject to the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties.

(a) The Contractor agrees to—

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies—

(i) The systems of records; and

(ii) The design, development, or operation work that the contractor is to perform;

(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a system of records on individuals that is subject to the Act; and

(3) Include this clause, including this paragraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a system of records.

(b) In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a system of records on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a system of records on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a system of records on individuals to accomplish an agency function, the Contractor is considered to be an employee of the agency.

(c)(1) “Operation of a system of records,” as used in this clause, means performance of any of the activities associated with maintaining the system of records, including the collection, use, and dissemination of records.

(2) “Record,” as used in this clause, means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and that contains the person’s name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint or voiceprint or a photograph.

(3) “System of records on individuals,” as used in this clause, means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

(a) The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

(b) To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

(c) If new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations.

The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement:

(a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and

(b) Specifies the disposition to be made of such records upon completion of contract performance.

48 CFR § 352.224-71 Confidential Information.

Confidential Information (December 18, 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: [INSERT RESTRICTED TYPES OF INFORMATION. If none, so state.]

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are: [STATE WHY THE PUBLIC OR GOVERNMENT INTEREST REQUIRES THE RESTRICTION OF EACH TYPE OF INFORMATION. ANY BASIS FOR NONDISCLOSURE WHICH WOULD BE VALID UNDER THE FREEDOM OF INFORMATION ACT IS SUFFICIENT UNDER THIS CLAUSE.]

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

L. ANY SPECIAL REQUIREMENTS:

Rosebud, South Dakota is a geographic area with wide temperature span. The winters can be very cold and windy. Contract providers should expect to drive in weather conditions they may not be accustomed. The sole authority to close the hospital or clinics rests with the CEO. This decision is based on National and regional weather reports. If the hospital remains open the contract provider shall be expected perform work requiring in-house service performance on time as all other hospital employees will be required.

M. CONTRACTING OFFICER REPRESENTATIVE (COR):

Name: Ms. Julie Willcuts Title: Patient Business Office Director Phone Number: (605) 747-0535 See Attached Certificate:

DATARAY SOW APRIL 24, 2024