Adverse_Event_Reporting_PWS_-_draft.pdf

Adverse Event Reporting System:

Performance Work Statement

This is a request for a commercial-off-the-shelf (COTS) database driven, web-based incident reporting and investigation system that will support facility and field operations IHS-system-wide. The COTS product should address patient-care related and non-patient-care related safety incidents. The COTS product will be modified as described in section 4. The system will be available for all federal, Tribal, and Urban Indian Health Programs IHS employees 24/7 to report incidents and will be utilized at the national, regional, and local levels by approximately 800 patient-care related safety account holders and 400 non patient-care related safety account holders to investigate incidents. The contractor should have technical experience or competency in the fields of patient safety, medication errors, occupational safety, physical security, and risk management.

1. Patient-Care Related Incident and user types

a. A patient-care related incident shall be defined as one of the below and followed by the Agency for

Healthcare Research and Quality (AHRQ) Common Formats in a layered scheme:

i. errors or adverse events that have had or are expected to have a clinical effect on the patient. The effect is perceptible to either the patient or the health care team;

ii. errors or adverse events that necessitate a change in the patient’s care;

iii. errors or adverse events that cause temporary harm to the patient;

iv. errors or adverse events with a known risk of serious future health consequences, even if the likelihood of that risk is extremely small;

v. errors or adverse events that require providing treatment or procedure without the patient’s consent;

vi. errors or adverse events that may have contributed to or resulted in permanent harm to the patient;

vii. errors or adverse events that required intervention to sustain life;

viii. errors or adverse events that may have contributed to or resulted in the patient’s death; and

ix. near misses in which an error or adverse events nearly reaches the patient but is identified and mitigated prior to reaching the patient.

b. System use will occur on five levels - users, account holders, regional account holder, regional account managers, and system account managers. The system access will be authenticated to each user type as prescribed below:

i. Users will be able to access the reporting functions without the need for a user account;

ii. Account Holders, for a facility or subset of facilities, will be able to review, edit, and insert investigation data for incident reports as well as trend, analyze & export incident report data;

iii. Regional Account Holders, for facilities within their region, will have the same capabilities as

Account Holders;

iv. Regional Account Managers will have the same capabilities as Regional Account Holders, and will be able to add/edit/delete account holders or account holder permissions for facilities that fall within their region; and

v. System Account Managers will have the same capabilities as Regional Account Managers, and will be able to add/edit/delete account holders, regional account holders/managers, and establishments within their region(s).

c. Medication related safety incident

i. A medication related safety incident shall be defines as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.

ii. Medication error entry shall pull drug information from a database (accessible for modification by an IHS system account manager) that contains a complete list of available drugs, dosage forms, route of administration, dosage strength, generic name, trade name, therapeutic class, and container type.

iii. System shall classify medication errors based on the NCC MERP index for categorizing medication error algorithm. System users will have the ability to record a dissention of the auto-classification and justification of the dissent.

iv. System shall identify where in the process the error occurred including ordering/prescribing, transcribing and verifying, dispensing and delivering, administering, and monitoring and reporting.

v. The system shall allow querying/reporting medication errors by generic name, trade name, therapeutic class, medication error category, and process where error occurred; or data shall be reported in a tabular format that allows data to be filtered and sorting based on those categories.

2. Non Patient-Care Related Safety Incident and user types

a. A non-patient-care related safety incident shall be defined as one or more of the following:

i. Hazardous condition

ii. Physical security breach

iii. Near miss event (non-medical in nature)

iv. Damage to property

v. Exposure to hazard (biological, chemical, environmental, ergonomic, physical, and/or psychosocial) resulting in illness or injury to:

1. employees, contractors, students, and volunteers

2. visitors

3. patients- not related to patient-care

b. System use will occur on five levels - users, account holders, regional account holder, regional account managers, and system account managers. The system access will be authenticated to each user type as prescribed below:

i. Users will be able to access the reporting functions without the need for a user account;

ii. Account Holders, for a facility or subset of facilities, will be able to review, edit, and insert investigation data for incident reports as well as trend, analyze & export incident report data;

iii. Regional Account Holders, for facilities within their region, will have same capabilities as Account

Holders;

iv. Regional Account Managers will be able to add/edit/delete account holders or account holder permissions for facilities that fall within their region; and

v. System Account Managers will be able to add/edit/delete account holders, regional account holders/managers, and establishments within their region(s).

The COTS System shall:

a. Provide an application with a consistent style for navigation and presentation features for any participating federal, Tribal, or Urban Indian Health Programs IHS employee (User), to report an incident on a 24/7 basis. The acceptable availability shall be at least 99 percent.

b. Provide a common start page for all user types listed in item 1b and 2b of this performance work statement.

c. Provide electronic incident reporting capability using a mobile-friendly, web browser-based application compatible with the IHS-specified and most major web browsers that meets the following system specifications & capabilities:

i. at a minimum, COTS shall provide individual and inter-related electronic incident reporting ability for each sub-type of patient-care related and non-patient-care related safety incident;

ii. capability to report patient-care related safety incidents, and non-patient-care related safety incidents.

Patient injury incidents shall allow reporter to choose to remain anonymous;

iii. provide functionality that allows for “enter once and populate forward” data entry;

iv. simple, intuitive user-interface allowing the user to navigate and submit the minimally-required elements of patient-care related safety incidents within 2-4 minutes;

v. maximized allowability of mineable discrete data fields balanced with optional free text fields;

vi. provide functionality that allows Users to initiate, enter data, save data and exit, and at later time return to complete, amend or update report;

vii. utilize intelligent pathways to minimize fields not applicable to user defined incident characteristics;

viii. provide mouse over tips and definitions, along with page-specific help, to assist users with reporting process and to improve data accuracy for critical elements;

ix. occupational injury/illness reporting shall include at least the minimum data elements required for and allow management of reports in compliance with Occupational Safety and Health Administration (OSHA) recordkeeping requirements and consistent with the OSHA Incident report sample forms 1 & 2, and the Bureau of Labor Statistics Survey of Occupational Injuries and Illnesses - Injury and Illness Case form. Occupational injury/illness reporting shall be consistent with the data elements listed on form HHS 841;

x. occupational injury reporting shall capture all required elements to comply with OSHA Bloodborne Pathogen Standard and Needlestick Prevention Standard consistent with the Model Plans and Programs for the OSHA Bloodborne Pathogens and Hazard Communications Standards;

xi. occupational injury reporting will capture at least the defined standard data elements utilized by, and provide an export format compatible with, the National Institute for Occupational Safety and Health (NIOSH) Occupational Health Safety Network (OHSN);

xii. the property damage entries shall capture data elements consistent with GSA Form 3620 and SF 91;

xiii. hazardous condition reporting shall capture at least the data elements consistent with DHHS form 834

- Report of an Unsafe Unhealthy Work Condition, Practice, or Hazard;

xiv. user and account holders shall be allowed to attach pictures, PDFs, and other common electronic files to any incident report;

xv. incident report forms shall be allowed to be printed in the same general layout as presented in the web browser-based application;

xvi. for OSHA recordable incidents, at the time of report submission, provide users a crosswalk of reported data and a link to use in completing separate report within the Department of Labor Electronic Compensation Operations and Management Portal;

xvii. patient safety incident reporting shall include at least the minimum data elements required for AHRQ Patient Safety Indicator PSI dashboard compliance; and

xviii. incorporate AHRQ Common Formats, a standardized taxonomy (no-cost, publicly available taxonomy), and systematic method for reporting adverse events, near misses, and unsafe conditions, and harm from all causes.

xix. data elements for Individual Case Safety Reports to the FDA Adverse Events Reporting System and Forms FDA 3500, 3500A and 3419 for Medical Device Reporting.

d. Provide user permission levels based on geographic locations and role as either account holder or account manager. All accounts will adhere to IHS/HHS user account security and maintenance standards. The account settings shall meet the requirements below:

i. provide account holders the ability to review the names and account permissions of account holders and account managers for facilities for which they have permissions;

ii. notify users upon report submission regarding account holder(s) with permissions to review and investigate the report;

iii. notify individual incident reporting user upon completion of incident investigation, and provide feedback on results of investigation;

https://www.osha.gov/

iv. generate email notifications regarding initial incident report submissions to account holders and account managers based on permissions and choice of notifications;

v. allow account managers to modify email notification choices for themselves and the account holders in their region.

vi. provide an online account request process for new accounts or modifications, and generate automatic emails to account holders specifying changes to their account permissions;

vii. allow account holders with appropriate permissions to access incidents, verify or amend incident reports, and include investigation information;

viii. provide account holders the ability to search for individual incident reports;

ix. require that OSHA recordkeeping data elements must be completed before incident investigation process is complete;

x. allow account holders to select, monitor, trend, and report data by date range and/or facility/regional location(s);

xi. provide account holders a tracking system for all reported incidents and their status in real-time; and

xii. provide comprehensive data export functionality with parameters defined by the account holder and using plain language terminology.

3. System Performance

a. Shall meet Federal IT/Security/Accessibility requirements.

b. Data redundancy and backup shall include the capabilities listed below:

i. a unique identification number shall be generated for each incident;

ii. provide means to store and retrieve incident reports for a minimum of 30 years from the date of the incident.

c. Provide feedback submission capability for process improvement and change requests.

d. Performance level:

i. page to page changes - 3 to 8 seconds; and

ii. pre-defined basic table/chart reports - 3 to 30 seconds.

e. To the maximum extent possible system software components are developed as self-contained modules that facilitate change or replacement.

f. Allow the maximum number of non-login users to enter incidents without degradation to the operation.

g. Allow the maximum number of login users to perform review and analysis on submitted incidents, produce reports, and/or create exports without degradation to the operation.

4. The contractor shall modify the system to include these requirements:

a. Importation to the maximum extent possible of all existing IHS Incident Reporting system data related to the incident types listed in item 1a and 2a of this performance work statement.

b. Provide updates to required data elements based on revisions to relevant OSHA, DOL, DHHS, GSA requirements as provided by IHS.

c. Establishments shall be identified using codes from the IHS coding system for Area, Service Unit, Tribe, Reservation, and Community. The IHS Standard Code Book may be viewed at http://www.ihs.gov/scb/index.cfm?module=disp_tablesSCB&newquery=1 Other IHS codes may be required and will be provided by IHS.

http://www.ihs.gov/scb/index.cfm?module=disp_tablesSCB&newquery=1

d. The Vendor will provide a defined process for managing Change Control Board (CCB) activities including the methodologies that will be used when executing and implementing approved changes. The Vendor will be responsible for:

i. organizing and maintaining accurate records of change requests and CCB decisions;

ii. organizing and conducting CCB meetings;

iii. notifying the IHS stakeholders, contracting representatives and software sponsor of meetings;

and

iv. providing IHS with detailed cost and time estimates for CCB approved Change Requests.

5. The system shall have the following reporting capabilities:

a. OSHA 300 Log of Work-Related Injuries and Illnesses

b. OSHA 300a Summary of Work-Related Injuries and Illnesses (complete with establishment information)

c. Sharps Injury Log

d. AHRQ PSI dashboard

e. Pre-defined aggregated informational reports.

f. Summary reports based on user selected parameters

g. Line listings (e.g. OSHA Line Listings)

h. Export to format compatible with submission to NIOSH OHSN.

i. Comprehensive Incident Record Auditing logs for all stages of input, review, and account management

j. Elective electronic submission of Individual Case Safety Reports to the FDA Adverse Events Reporting

System and Forms FDA 3500, 3500A and 3419 for Medical Device Reporting. In the event such reporting is not feasible, the system will generate a report configured similarly to the FDA forms that will facilitate manual reporting by the system user.

6. System Support and Maintenance:

a. The contractor shall annually provide resources on user reporting, account holder functions, and account manager functions as described below:

i. Tutorials – develop resources for users and account holders on essential system functions that incorporate adult learning principles;

ii. the contractor shall provide up to two live Webinars. Live webinars will be recorded, made 508 compliant, and made available to new account holders and account managers;

iii. where system changes make portions of the webinar or tutorial < 30% obsolete, a disclosure and errata notice will be posted in conjunction with the webinar or tutorial to alert users, account holders, and managers prior to viewing; and

iv. where system changes make portions of the webinar or tutorial > 30% obsolete, the content will be revised in its entirety for further use.

b. Ensure error resolution as follows:

i. issues that impact overall system usability shall be resolved within 8 hours of discovery; and

ii. issues that do not impact overall system usability but do impact system users shall be resolved within 72 hours of discovery.

c. System Restart, when needed, will take 5-10 minutes.

d. Database Recovery:

i. restarting the database, when needed, shall not take more than 10 minutes;

ii. recovering lost data, when needed, shall not take more than 8 hours; and

iii. restarting from a backup copy of the database, when needed, shall not take more than 8 hours.

e. Have routine evaluations for system and data quality assurance.

f. Have routine system maintenance (hardware and software) provided by the contractor.

g. Provide notice a minimum of 24 hours prior to any action that will result in the system being inaccessible.

An expected time of the system being back online will be included in the notice. Scheduled downtime will include routine software upgrades and routine system hardware or database maintenance.

h. Provide account holder and account manager support which includes the following items:

i. Manuals for managing and investigating incidents and accessing reporting options for account holders;

ii. Administrator Manuals for account managers;

i. The COTS shall offer an ability to broadcast emails to system users.

j. A help desk shall have a toll free number, email address, and instant chat; and be available 8 am to 8 pm Eastern Time, Monday through Friday.

7. Mandatory References:

a. IHS Standard Code Book - http://www.ihs.gov/scb/index.cfm?module=disp_tablesSCB&newquery=1

b. Occupational Safety and Health Standards - U.S. Department of Labor, Occupational Safety and Health

Administration CFR 1904 -https://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=1&p_ keyvalue=1904

c. Model Plans and Programs for the OSHA Bloodborne Pathogens and Hazard Communications Standards -https://www.osha.gov/Publications/osha3186.html

d. Agency for Healthcare Research and Quality – Patient Safety Indicators dashboard -http://www.qualityindicators.ahrq.gov/modules/psi_resources.aspx

e. General Services Administration – GSA Forms Library - http://www.gsa.gov/portal/forms/type/GSA

f. Centers for Disease Control and Prevention – National Institute for Occupational Safety and Health –

Occupational Health Safety Network (OHSN) - http://www.cdc.gov/niosh/topics/ohsn/

g. US Department of Labor, Bureau of Labor Statistics - Survey of Occupational Injuries and Illnesses -http://www.bls.gov/respondents/iif/

h. US Department of Health and Human Services – Form 834 Report of an Unsafe Unhealthy Work

Condition, Practice, or Hazard - http://intranet.hhs.gov/forms/hhs_forms.html http://www.ihs.gov/scb/index.cfm?module=disp_tablesSCB&newquery=1 https://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=1&p_keyvalue=1904 https://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=1&p_keyvalue=1904 https://www.osha.gov/Publications/osha3186.html http://www.qualityindicators.ahrq.gov/modules/psi_resources.aspx http://www.gsa.gov/portal/forms/type/GSA http://www.cdc.gov/niosh/topics/ohsn/ http://www.bls.gov/respondents/iif/ http://intranet.hhs.gov/forms/hhs_forms.html