CENTER FOR PATIENT SAFETY PSO PRIMARY CONTACT HANDBOOK
CENTER FOR PATIENT SAFETY
PSO PRIMARY CONTACT HANDBOOK
INTRODUCTION
The Patient Safety and Quality Improvement Act of 2005 (PSQIA) and its implementing regulations, 42 CFR, Part 3, establishes a framework for healthcare providers to voluntarily report information regarding medical errors to a federally listed Patient Safety Organization (PSO). Such reporting is privileged and confidential, for the aggregation and analysis of patient safety events. Information shared within the PSO that is defined as Patient Safety Work Product (PSWP), with limited exceptions, is not subject to subpoena, discovery or admission into evidence in federal, state or local civil, criminal or administrative proceedings, including disciplinary proceedings against a Provider.
Information becomes PSWP when the Provider develops or assembles the information as part of a Patient Safety Evaluation System (PSES), and the information is either reported to a PSO or identifies or constitutes the deliberations or analysis of the PSES. Clear identification of what information is considered PSWP and when such information becomes PSWP is an essential step in creating an environment to maintain the privilege and confidentiality requirements intended by the PSQIA. Defining and documenting a PSES, although not required by the PSQIA and accompanying Rule, is encouraged by the Department of Health and Human Services and the Center for Patient Safety (CPS) as a best practice to support the identification and protection for PSWP.
A PSES defines the processes or systems within an organization for the collection, management and reporting of PSWP to a PSO. It can likely be established as a component of an organization’s current risk management, patient safety and/or quality improvement program. Under the PSQIA, a PSO may also establish a PSES to define processes for collection, management, and reporting of data and information submitted to the PSO. The CPS has established a PSES.
Step 1:
Assign an individual as the PSO Primary Contact to review the PSQIA and its Final Rule. This individual should be familiar with your organization’s:
· Safety reporting system
· Peer review review/credentialing processes
· HIPAA
· Quality, patient safety and risk management processes
· Claims activities (including reporting and disclosure practices)
Step 2:
Define your Patient Safety Evaluation System (PSES)
The PSES is the means or mechanisms your organization uses to collect, manage, analyze and communicate information for reporting to the PSO. Within these systems you may have information about events, errors, near-misses, quality improvement data, and other patient safety data and information that is developed, investigated, examined, and analyzed by and for the PSES workgroup. (See Step 5 for additional information about defining a PSES workgroup)
How to define your PSES?
1. Identify and assess your current reporting systems and information flow for patient safety and quality improvement activities and events, considering:
a. Your incident reporting system, including how patient safety events are currently identified, reported and managed through risk management/patient safety/quality improvement/customer services/credentialing processes
b. How this data is shared, processed and documented (consider developing a flowchart of your processes)
c. Your committee structure where patient safety and quality data and information are discussed/shared
2. Based on your analysis, determine what components of these activities and events will and will not be included in your PSES
3. Identify and define the scope and function of your PSES in your PSO policy (consider using the template provided by CPS, customizing to meet your needs).
Step 3:
Define your Patient Safety Work Product (PSWP)
Accurately defining PSWP is one of the most important requirements to obtain the available privilege and confidentiality protections when working with a PSO.
PSWP is the documents and information that is privileged and confidential as defined within the PSQIA and Final Rule. It is the documents that reflect the deliberations and analysis surrounding patient safety and quality improvement activities that are performed within your PSES.
PSWP may be data, reports, records, memoranda, deliberations, analysis, written or oral statements or other information collected, maintained, developed or assembled by your organization for the purpose of reporting to a PSO. There are two types of PSWP:
· Identifiable Patient Safety Work Product: Documents/information that includes identification of any provider that is a subject of the work, or any providers that participate in activities that are a subject of the work. It may also be considered identifiable because it contains patient-identification information which would invoke the HIPAA confidentiality regulations, or that identifies the individual who reported information in good faith.
· Non-identifiable Patient Safety Work Product: Documents/information that is anonymous as to provider, de-identified as to protected health information, and contextually de-identified so that the provider, patient or reporter cannot be identified.
Some documents/information cannot be considered PSWP as defined within the PSQIA and Final Rule. These are:
o The patient’s medical record
o Billing and discharge information
o Other original patient or provider information
o Deliberations and analysis performed outside of the PSES
o Data and reports generated for submission to external agencies to meet mandatory or voluntary reporting requirements
o Improvements, process and policy changes, and Action Plans made as a result of work within the PSES or the PSO.
Non-PSWP –– PSO participating organizations have the option of defining certain documents/information as non-PSWP. These might include:
o Items that have not been reported to the PSO and are voluntarily removed from your PSES by a designated individual/committee
o Items clearly identified by policy or in writing on the documents as non-PSWP and submitted to the PSES for reporting to the PSO
Information that is non-PSWP, even if it resides in the PSES or has been reported to the PSO, is not protected.
How to define your PSWP:
1. Identify and assess your current patient safety related documents, data and information. These may include:
o Safety reports, quality reports, written and verbal reports
o Committee minutes, notes, checklists, tally sheets, transcripts, recordings, peer review documents, incident reports, root cause analyses
o Any discussions or documentation used for quality and patient safety improvement, including CUSP team meetings and associated documents and patient safety huddles
2. Determine how these documents and discussions are being used, documented and maintained within your organization. Consider:
§ Who collects, reviews and maintains the data and information
§ How, where and when the information is being filed
§ How the information is maintained
§ Whether the information is for activities that would not allow the information to be defined as PSWP
3. Determine what documents/information can and cannot be considered PSWP and how each type will be managed and separated within your PSES.
4. Remember that identifiable PSWP should only be accessible to members of your defined workforce as needed to perform their job functions.
Remember:
· Data and information that is designated as PSWP within the PSES cannot be removed from the PSES and re-designated as non-PSWP once deliberations and analyses have begun about the information or events it reflects, unless it can be removed without disclosing any of the deliberations and analysis. For example, if the PSES gathers information about a certain type of event, it could designate the collected data as non-PSWP, as long as it didn’t disclose specific deliberations about the underlying problem or the data itself.
· PSWP is accessible only to members of your workforce who need it to perform their job functions.
· Underlying factual information that is gathered and recorded for other purposes, such as medical record entries or administrative documents such as bills, cannot be PSWP and can always be removed or used for other purposes.
Step 4:
Define your Workforce
Identify the individuals involved in your patient safety activities. You may consider including all employees, designated department employees, employees designated by title, medical staff members, volunteers, trainees, contractors, attorneys, liability insurance representatives, or other persons whose conduct, in the performance of work for your organization, are under the direct control of the organization, whether or not the organization pays them. Your organization may determine how many of those individuals will be included in the workforce.
· Information about patient safety events is reported to the members of the workforce as necessary to meet the expectations for the risk management, quality and safety activities defined by you or another identified individual/committee.
· All workforce members shall sign a confidentiality agreement specific to PSWP as it relates to the protections and confidentiality defined within the PSQIA.
Step 5:
Define your PSES Workgroup
The PSES workgroup is the core individuals/committees who routinely perform your patient safety and quality analysis and improvement work. You should consider committees such as safety, QI, PI, medical staff committees, CUSP or department teams, safety huddles, etc. In addition, other individuals with special subject matter expertise as deemed necessary for work on specific events or issues may be included in the PSES workgroup activities.
All PSES workgroup members should be educated on the PSQIA provisions, specifically those pertaining to confidentiality of information and protections in addition to your organization’s defined PSES and PSWP. All PSES workgroup members should also sign a confidentiality agreement specific to PSWP to be maintained in your files. Members need sign only one form; but remember to have any new individuals to the PSES Workgroup sign a form. Educational templates are available in the PSO Toolkit on the Center’s website.
Step 6:
Submission of Information to the PSES
Information collected for submission to the PSES is considered to be PSWP at the time it is collected or developed, unless specifically designated as non-PSWP by designated individuals/committees. The data/information is submitted to the PSES as part of the PSO reporting process. The PSES may also develop new information as part of its deliberations and analysis; any information developed within the PSES is PSWP.
Step 7: Submission of PSWP to the PSO
Designated individual(s)/committee(s) should review information contained within the PSES and determine what will be submitted to the PSO. Data and information submitted to the PSO, unless designated as non-PSWP before submission, must be treated as confidential PSWP.
Guidelines to help you determine what to submit:
· Any event, near miss or unsafe condition may be reported to the PSO database, according to your organization’s policy.
· In addition to events, consider:
o Root Cause Analysis, FMEA, Defect Analysis, or other Proactive Risk Assessments
o Learning from Defects documentation
o Notes from patient safety huddles or rounds, telephone calls, or hallway conversations
o Quality outcome reports such as blood utilization, complications, or Core Measure variances
o Committee minutes - Safety, Quality, Quality and Safety Committee of the Board, Medication, Blood, etc.(refer to CPS PSO Crosswalk)
Essential factual information, whether in medical records, other administrative records or the minds of staff, cannot be protected. It was generated for purposes other than patient safety activities. Compilations of that information (incident reports, infection reports, other variance reports) may or may not be submitted to the PSES. If they are submitted and become part of the PSES documentation, they can be “removed” (designated as non-PSWP) at any time before they are submitted to the PSO. Reports to the PSO in the common formats are protected (unless you designate them as non-PSWP) but many of the actual data points are not, as they were created and/or recorded for other purposes (e.g. patient age, results of a culture of suspected infection or a radiology report after a fall).
Deliberations and analysis that takes place within the PSES is protected, in any recorded or unrecorded form. That cannot be removed (or designated as non-PSWP). To keep deliberations and analysis available for sharing outside the workgroup, they must take place outside the PSES.
Consider this example:
The Infection Prevention Department receives a report of an infection that needs to be reported to the Missouri Department of Health and Senior Services report. This report is initially considered as PSES. The following options are available:
· The report itself can be left within the PSES, and someone can use original sources to re-generate the information for reporting to the state.
· The report can be removed from the PSES and be designated as non-PSWP if it has not been submitted in its current form to the PSO.
· If some data points on the report that exist in other sources have been included in a web-based report to the PSO, but not the report itself (i.e. it is not attached to the web-based event report), then the report form can still be removed from the PSES and designated as non-PSWP. These might include dates of surgery, dates of initial onset of infection, antibiotics used, etc. These facts would never be protected as they are part of the patient’s medical record. (See caveat below.)
· Caveat: Any document reflecting deliberations and analysis that take place inside the PSES (e.g. infection control committee discussions of root cause or of other similar events) is PSWP and cannot be designated as non-PSWP. If the organization wants to share the deliberations and analysis beyond permitted audiences per its policy, it needs to conduct the deliberations and analysis outside the PSES. Related data such as the original report (but not deliberations and analysis) that has not been disclosed can then be submitted to the PSO if the organization later wants to protect it.
This is complicated to understand. It is often advantages to talk with someone from the Center – feel free to send an e-mail or call any time.
Removal of PSWP from your PSES:
Develop a process to remove PSWP from your PSES prior to submission to the Center PSO, including:
· Maintenance of a log of PSWP that is removed from the PSES, including the date of removal and a statement that you no longer intend to report the information to a PSO
· Identify which personnel or categories of personnel are authorized to remove PSWP from your PSES.
· Removing it from your PSES is the technical way to remove federal confidentiality requirements.
· Delibrations and analysis that occur within the PSES as PSWP cannot be removed.
Process for Submission:
Define your process to report your PSWP to the PSO. Data and information reported to the CPS PSO will be entered into an electronic reporting system.