Attachment 1- Statement of Work PICIS Critical Care Manager SW-Healthcare Analytics Platform.docx

STATEMENT OF WORK FOR PICIS Critical Care Manager SW-Healthcare Analytics Platform Background In January 2018, PICIS Critical Care Manager Software was implemented in the Oklahoma City VA Healthcare System (VAHCS) Intensive Care Department. This software was purchased and implemented under a 2011 VISN 16 purchase agreement to transition Critical Care Services from paper documentation to computerized documentation in accordance with VHA Memorandum 7056680, National Standards in Implementation and Use of Intensive Care Unit and Anesthesia Record Keeping Clinical Information and the Analytics System.

In 2015, OKC VAHCS was reorganized into VISN 19 under the VHA VISN realignment and as such will no longer be covered under the VISN 16 contract for reporting services after FY2018, leaving Critical Care Manager as the only in-house electronic health record (EHR) without a reporting and data analytics component. Furthermore, VISN 19, OKC’s current VISN, utilizes a different ICU EHR (Clinicomp’s Essentris) and all of VISN 19’s ICU reporting and data analytics program is integrated into the Clinicomp application such that OKC PICIS cannot be grandfathered into VISN 19’s current ICU reporting and data analytics. Thus, the need exists to secure a data analytics and reporting system for OKC VAHCS PICIS application.

Objectives/Purpose The purpose of purchasing a PICIS Critical Care Manager reporting system is to provide Intensive Care Services, and ancillary quality departments (e.g. Infection Control, Office of Quality, Safety, and Value) at the Oklahoma City (OKC) VA Health Care System (VAHCS) with automated, on-demand, operational and clinical data analytics. Analytics dashboards will provide end users with macro and micro trends and patterns on key performance indicators, quality measures, care interventions, population health tracking, and more. Such measures are necessary for facilitating informed decision-making and measuring progress towards goals. Reporting services will support real-time, point-of-care clinical decision-making support to improve the quality and safety of care to individual patients as that care is occurring. Reporting services will also assist in improving charting errors of commission or omission to ensure compliance with standards, eliminate the need for labor-intensive manual data collection thereby increasing efficiency and reliability of data while simultaneously decreasing workload, and support population health and research programs.

The vendor will provide all the required equipment, software, training, builds, support, and accessories for use in the OKC VA Health Care system. The vendor will inspect all the equipment prior to delivery and installation – any damaged components will be replaced at no cost to the VA. The contractor shall furnish the items listed in the specifications and provide the assembly and installation of the items.

Selection Criteria / Scope of Work Envision Data Analysis and Reporting by PICIS – brand name or equal http://www.picis.com/2018/05/24/envision-by-picis/

Product Specifications for Envision Data Analysis and Reporting by PICIS The data analysis and reporting system must include the following:

· Direct connection to and compatibility with the PICIS database

· Current, real-time, high-level data trends and patterns with drill downs to micro data points (e.g. month, unit, day, provider/nurse, medical record number, etc) – ability to retrieve updated data every 12 hours (twice a day), minimally

· Flexibility on timeframes/datetime range parameters, facility, unit location, datetime range parameters, provider

· Query capability that includes the ability to save, export, or modify queries

· Exportable reports in CSV, Excel, PDF, or similar format

· Graphics functions (e.g. pie charts, line charts, area charts, etc)

· Supply, installation, and configuration of an appropriate server with a minimal warranty of three years for all mechanical and electrical components.

· Any technical and/or clinical support and training required for database, software, or hardware management and utilization

· Ongoing technical and clinical support for the duration of the license

· Must be compatible with VHA security and privacy regulations

· Contractor and reporting/data analytics system must meet security requirements for VHA, including VHA Form 6500

Information Technology Security Requirements:

· Pursuant to VA’s Security Requirements for Unclassified Information Technology Resources Contract Clause 839.201, 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.

Information Security/Privacy:

· The contractor/subcontractor will understand and implement the IT security requirements for system interconnection required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA).

· The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

· Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1)

· VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

· Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

· The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

· The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

· If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

· The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements.

· The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

· Information systems that are hosted, operated, maintained, used, designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program)

· All contractors/subcontractors must 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 on any systems of record (SOR) on individuals.

· In the event of violations of the Privacy Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR 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 SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) “Record” 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 contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) “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.

· The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

· The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above

· The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 days.

· When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days.

· All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

Reporting and Data Analytics System must have the capability to produce the following reports, minimally:

1. ICU Daily Census

a. Daily census - # ICU admissions by facility and location – parameter for facility currently admitted

b. Number of admissions (date and times of admission) report to be generate per day or any time frame- flexibility on timeframe is important for quality improvement projects- Datetime range parameter, facility and location. Count of admissions by day of week, with drilldown to details with grouping by day of week.

c. Number of discharges (date and times of discharge) report to be generated per day or any time frame- flexibility on timeframe is important for quality improvement projects - Datetime range parameter, facility and location. Count of admissions by day of week, with drilldown to details with grouping by day of week.

d. Length of stay in ICU (per patient, per group of patients), flexibility in timeframe - Datetime range parameter, facility and location. Count of LOS days admitted per patient, group of patients (location). LOS for current patients, LOS for historical patients.

e. Readmissions within 48 hrs of Unit Discharge (numeric value)

2. IPEC CAUTI Compliance Report (Catheter-associated Urinary Tract Infection)

a. CAUTI Insertion Summary

i. % rate of orders written with indication on day of insertion by provider

ii. % rate of hand washing by inserter

iii. % rate of sterile gloves, drape, sponges

iv. % rate of antiseptic or sterile solution for periureteral cleaning

v. % rate of single-use packet of lubricant jelly by inserter

vi. % rate of catheter being properly secured by inserter

3. CAUTI Insertion Detail

a. Event ICU Foley Insertion Bundle

i. Assessment of catheter necessity

ii. Patient informed/instructed regarding procedure

iii. Hand hygiene

iv. Sterile prep of meatus performed

v. Use a single-use packet of lubricant

vi. Aseptic insertion technique

vii. Foley catheter placed w/o difficulty

viii. Foley catheter placed w/ difficulty

ix. Sterile closed drainage system

x. Foley secured per protocol

xi. Urine returned in line

xii. Patient tolerated procedure well

xiii. Order written with indication on day of insertion by provider

4. CAUTI Maintenance Detail

a. CAUTI Maintenance Statistics for IPEC

i. Number of observations completed

ii. Drainage system was sterile and continuously closed

iii. Catheter properly secured

iv. Collection bag below the level of the bladder

v. Unobstructed urine flow

vi. Clinical indication written for continuance of indwelling catheter

vii. Daily hygiene care is documented or observed

5. IPEC CLABSI Central Line Compliance Report

a. CLABSI Insertion Statistics Summary for IPEC

i. % rate of hand hygiene completed

ii. % rate of cap worn by inserter

iii. % rate of mask worn by inserter

iv. % rate of sterile gloves worn by inserter

v. % rate of sterile gown worn by inserter

vi. % rate of full body drape (head to toe) on patient

vii. % rate of chlorhexidine used

viii. % rate of times femoral site used

ix. % rate of audits completed per lines inserted

6. IPEC CLABSI Central Line Detail

a. CLABSI Insertion Statistics for IPEC

i. Hand hygiene completed

ii. Cap worn by inserter

iii. Mask worn by inserter

iv. Sterile gloves worn by inserter

v. Sterile gown worn by inserter

vi. Full body drape (head to toe) on patient

vii. Chlorhexidine used

viii. Number of time femoral site used

ix. Number of central lines inserted

x. Date and time placed

xi. Date and time removed

xii. Date and time of admission to the unit

7. IPEC VAP Compliance Report

a. VAP Summary Compliance Report

i. % rate of HOB elevated > 30 degrees

ii. % rate of HOB Contraindications

iii. % rate of SUD prophylaxis

iv. % rate of DVT prophylaxis

v. % rate of oral care/lip care prophylaxis with chlorhexidine

vi. % rate of daily sedation vacation

vii. % rate of daily readiness to wean

viii. % rate of daily spontaneous breathing trial

ix. Bed days of care / Vent days

8. IPEC VAE Detail Report

a. VAE Summary Compliance Report

i. Temperature max, min and average

ii. Positive End-Expiratory Pressure max, min, and average (PEEP)

iii. Fraction of inspired oxygen (FIO2) max, min, and average

iv. Date/time of intubation

v. Date/time of extubation

9. Restraint Report

a. Documented restraint assessment of ICU patients

i. Datetime range parameter, facility and location parameters

ii. Order creation date and time

iii. Order extension

iv. Order discontinuation date and time

v. Order description

vi. Data documented / Dboid-level tracking of all assessment items:

1. Location

2. Type

a. Clinical – all options

b. Behavioral – all options

3. Behavior while restrained - all options

4. Safety – all options

5. Diet/Hydration – all options

6. Elimination – all options

7. Injury – all options

8. Discontinuation – all options

9. Plan of Care – all options

10. Family Notification

11. Alternative Interventions

12. Response to Alternatives

10. Moderate Sedation Report

a. Documented assessment protocol of ICU patients

i. Datetime range parameter, facility and location parameters

ii. ICU: Moderate Sedation Protocol

iii. Moderate Sedation: Event

iv. Dboid-level tracking of all assessment items

11. Pain -Agitation – Delirium Assessment Report

a. Documented data elements protocol of ICU, and PACU patients

b. Data element: Pain Presence

i. None

ii. Present

iii. CPOT Score

iv. UTA

v. Phantom

c. Data element: Pain #1 Scale Used

i. Numeric Scale

ii. Faces Scale

iii. Critical Care Pain Observation Tool

iv. Behavior descriptor

d. Data element: Critical Care Pain Observation Tool Score

i. 0 -10

e. Data element: Date and time of score > to total score of 1

f. Dboid-level tracking of all assessment items

g. RASS Score

h. GCS Score

i. CAM ICU Scoring Report

i. Documented data element using scoring protocol for ICU patient.

1. Level of consciousness: RASS

2. Level of consciousness: CAM-ICU

3. Acute onset or fluctuating course

4. Inattention

5. Altered level of consciousness

6. Disorganized thinking

12. Skin Report

a. Documented data elements using abnormal skin findings.

i. Intact

ii. Bruising

iii. Redness

iv. Swelling

v. Blisters

vi. Pressure areas

b. Site Assessments – all options

13. Braden Skin

a. Braden risk assessment scale for ICU patient

i. Data Elements:

1. Criteria: Moisture

a. Constantly moist, Points 1

b. Very moist, Points 2

c. Occasionally moist, Points 3

d. Rarely moist, Point 4

2. Criteria: Activity

a. Bedfast, Points 1

b. Chairfast, Points 2

c. Walks occasionally, Points 3

d. Walks frequently, Points 4

3. Criteria: Sensory Perception

a. Completely limited, Points 1

b. Very limited, Points 2

c. Slightly limited, Points 3

d. No impairment, Points 4

4. Criteria: Mobility

a. Completely immobile, Points 1

b. Very limited, Points 2

c. Limited, Points 3

d. No limitations, Points 4

5. Criteria: Nutrition

a. Very poor, Points 1

b. Probably inadequate, Points 2

c. Adequate, Points 3

d. Excellent, Points 4

6. Criteria: Friction and Shear

a. Frequently side down, Points 1

b. Occasionally slides down, Points 2

c. No apparent problems, Points 3

14. "ICU Recovery" Report

a. ICU Census summary of patients identifying daily volume of patients, where records contain the event “ICU Recovery”. Summary date to include calculated fields for number of cases, total times, and average times.

i. Location ID

ii. ICU Date

iii. ICU Admit time

iv. ICU Discharge

v. ICU Staff name

15. “Prophylaxis”

a. Venous Thromboembolism

i. Proportion of ICU patients who received/did not receive VTE prophylaxis:

1. Patient on anticoagulants

2. Patient not on anticoagulants

ii. Start date/time

iii. End date/time

iv. Type of VTE

b. Pneumatic Compression Device Status/Type/Location Length

i. Proportion of ICU patients who received/did not receive Pneumatic Compression Devices:

1. Presence/Absence of PCD

2. Start date/time

3. Stop date/time

4. Type

16. SIRS/Sepsis Report

a. Percentage of ICU population screening positive

b. Criteria: SIRS/qSOFA

i. Temperature

ii. WBC count

iii. Pulse / HR

iv. Respiration Rate

v. PaCO2

vi. Mental Status

vii. Antibiotics:

1. Presence

2. Name – Type

3. Start date/time

4. End date/time

viii. Blood cultures

1. Date/time drawn

2. Date/time resulted

17. Invasive Lines Report – Nasogastric Tubes/GI Tubes, Peripheral IVs, Esophageal Tamponade Tube, Fecal Management System, central venous catheters (all – to include HD caths, tunneled and non-tunneled, Swan-Ganz, etc), Drains, Arterial and Venous sheaths/catheters, Chest Tubes

a. Insertion-

i. Line # and Type

ii. Location

iii. Size

iv. Date/Time of Insertion

v. Dressing Type

vi. Stabilization/Securement

vii. Tubing Change Tracking

viii. Duration Tracking

ix. Cuff Inflated/Deflated/Checked (when applicable)

x. Balloon Inflated/Deflated/Checked (when applicable)

b. Care and Maintenance – to include but not limited to:

i. Line # and Type

ii. Dressing Change

iii. Stabilization/Securement

iv. Site Findings

v. Flush

vi. Status

vii. Site Treatment

viii. Duration Tracking

ix. Cuff Inflated/Deflated/Checked (when applicable)

x. Balloon Inflated/Deflated/Checked (when applicable)

c. Discontinuation

i. Date/Time

ii. Sutures/staples removed

iii. Removed by

18. Vascular Procedure Report

a. Sheath Removal

b. Site Assessment

c. Site Care

d. Intake/Output

e. Physiological Variables - TBD

19. Airway Report

a. Airway Type

b. Respiratory Device

c. Oxygen FiO2/Humidity

d. Endotracheal Tubes

i. Intubation date/time

ii. Extubation date/time

iii. Care and Management

1. Securement

2. Oral/Lip Care

3. Tube Size

4. Tube Placement

a. Date of intubation

b. Reposition date

c. Site

d. Landmark Position

e. Landmark CM

5. Tube Suction

6. ET Tube Cuff

7. Sedation Vacation

8. Sedation/Analgesia/Paralytics

a. Start/hold/stop time

b. Drug Name

c. RASS Score

d. GCS Score

iv. Manner of Extubation

1. Self-Extubation

2. Extubation

e. Tracheal Tubes

i. Trach_Laryngectomy Tube Care

ii. Trach/Laryngectomy Tube Assessment

iii. Trach/Laryngectomy Stoma Assessment

20. Devices & Device Data– IABP, Impella, CRRT, Therapeutic Hypothermia, Pacemakers

21. Progressive Mobility

a. Date/Time

b. Data Elements:

i. Phase

ii. Phase 1 Interventions

iii. Phase 2 Interventions

iv. Phase 3 Interventions

v. Phase 4 Interventions

c. Ambulate

d. Up in Chair

e. Up to Bathroom

f. Turn and Reposition

22. C. Difficile Report

a. Admit Date

b. Isolation Precaution Type, Date and Time

c. Stool Data Elements

i. Date/Time of Stool

ii. Bowel Movement Assessment

1. Elimination Method

2. Stool Color

3. Stool Characteristics

iii. Bristol Stool Scale

d. Date/Time and Type of Enteral Feedings Administered

e. Date and time of C. Diff PCR Lab Ordered

f. Date and time of C. Diff PCR Lab Send

23. Care Plans

a. Problem

b. Interventions

c. Goal

d. Evaluation

24. Education

a. Date/Time Education Provided

b. Topic

c. Information provided to (Learner)

d. Learning Style/Preference

e. Readiness to Learn

f. Learning Barriers

g. Method

h. Goal

i. Outcome

25. Morse Fall Risk Assessment Score Report

a. Data Elements:

i. Date/Time Completed

ii. History of Falls

iii. Secondary Diagnosis

iv. Ambulatory Aid

v. IV/Heparin Lock

vi. Gait/Transferring

vii. Mental Status

viii. Fall Risk Score

26. Hygiene:

a. Bath complete assist

b. Bath partial assist

c. Bath self

27. Safety Report

a. Call Bell Within Reach / Call Light Status

b. Bed Low and Locked

c. ID + Allergy Band Verified

d. Side Rails

e. Alarms

f. Safety Measures

28. CABG Report – TBD

29. PCA Protocol Reports - TBD

30. Nursing Admission Assessment Report - TBD

31. Interward Transfer Report - TBD

32. Discharge Report - TBD

33. + 12 Data Reports TBD at a later date by OKC VAHCS

Deliverables and Timeline The contractor shall deliver the equipment via standard delivery with F.O.B. within 90 days of the date of the award.

On-site assembly, installation, configuration – including above listed report builds and dashboard configurations - and training will be provided by the contractor. The contractor will have 30 working days to complete the installation and configuration of any hardware. The contractor will have an additional 90 working days to complete the installation and configuration of software, to include report builds, dashboard configuration, and training.

Equipment should be delivered to the following address:

Deliverables and quality assurance will be monitored through a quality assurance inspection plan (QASP) that includes, but is not limited to, inspection upon receipt, testing, direct observation and review by OKC VAHCS Point of Contact (POC), Biomedical Engineering, and PICIS Coordinators, as well as through progress / milestone reviews, and contractor reports.

Place of Performance The place of performance will be the buildings on the grounds of the Oklahoma City VAHCS.

Period of Performance The contractor shall deliver the equipment via standard delivery with F.O.B. within 90 days of the date of the award. The contractor will have 30 working days to complete the installation and configuration of any hardware and an additional 90 days to complete any software installation and configuration – including report and dashboard builds- as well as training. The Analytics Solution and Custom Analytics will be on a One (1) Year Base Year with Four (4) 1 Year Option Years.