Policy Standardization Across a 16-Hospital Health System

Large health systems achieve and maintain success by providing consistent quality care across the continuum. Like a brand promise, patients expect the same level of care from a health system’s 200-bed hospital they expect from the 2000-bed facility. Potential for variability is increased within large health systems; setting standardized work practices across the organization is key in providing consistent customer experience and quality of service. One step toward setting those standards and achieving a brand promise is to provide employees with transparent expectations. A clearly defined policy and procedure manual sets forth defined processes that are intended to meet quality standards set by the organization.

It is critical for hospital pharmacy departments to have robust policies and procedures which define standardized expectations, meet regulatory requirements, improve safety, and lead to consistent quality care. For example, to ensure cleaning of sterile compounding areas meets United States Pharmacopeia (USP) requirements, a facility should develop clear and concise instructions for how to clean and the appropriate use of cleaning products within their policies and standard operating procedures (SOPs). This article will focus on the Pharmacy department’s journey to consolidate 16 single facility’s policy and procedure libraries into a shared library. It will detail the approach to the large-scale initial assessment; discuss aligning standards across hospitals of differing sizes, operational practices, and needs; and break down how decisions were made when existing policies did not align.

Background

The organization is on a long-term journey to align and consolidate standards and operational practices. Policy consolidation is part of that journey and is a major step toward standardizing operational and regulatory processes. Three regions, consisting of 16 hospitals in the same geographical area, merged to one division and toward organizational standardization. Consolidation of the multiple facility libraries required a planning phase, implementation phase, and planning for future directions. An overview of the process and timeline is provided in Figure 1. Each phase is subsequently described in detail below noting the positive changes resulting from consolidation, and lessons learned from this journey.

Figure 1.

Policy standardization process and timeline.

Planning Phase

Policy library reviews

Initial reviews were led by the Pharmacy’s Program Director of Policy and Quality (PPDPQ) and Post Graduate Year Two Medication-Use Safety and Policy (MUSP) Pharmacy Resident. Pharmacy policies were obtained from each campus’ document library and compiled into one file. Documents included: policies, SOPs, work instructions (WI), compounding recipes, pharmacy forms, scope of service documents, and other pharmacy work related documents. The term documents will be used interchangeably for the list of above document types throughout the remainder of this article. To ensure all documents were included, the pharmacy director for each facility was asked to review and validate the list of documents, provide missing documents, and give direction for any inaccuracies.

Next, an initial review of each document was conducted by the PPDPQ and the MUSP pharmacy resident. This included a read through of each document and assignment of a keyword that best fit the overall concept of a document. A total of 167 keywords were assigned to 1170 documents. Keywords were then utilized to group the documents by topic. The documents and keywords were re-reviewed to determine the potential applicability across all 16 campuses and assigned based on the main topic of the document. For consistency, the MUSP resident completed the initial review, then the PPDPQ performed a secondary review for further consolidation or delineation for like topics. For example, the original keyword “compounding” required further subcategorization (eg, cleaning, environmental monitoring, and equipment) due to the amount of detail required to describe compounding requirements and the potential length of each document. If the document needed a second or clarifying keyword, this was added for ease of comparing documents. For example, if the original assigned keyword to a document was Automated Dispensing Cabinets (ADC) but the PPDPQ identified one policy related to ADC processes and one related to ADC overrides, the subsequent secondary keyword was assigned to the corresponding document. A total of 519 documents grouped by 57 assigned keywords were identified for consolidation. See Figure 2 for a full list of keywords.

Figure 2.

Keywords assigned to documents.

Policies were scheduled for review by subject across a 22-week period based on similarity of topic area, regulatory requirements, and estimated ease of transition. Documents not chosen for consolidation were assigned back to the respective pharmacy director for review with one of the following outcomes: delete from the facility document library or maintain the document in the facility library with no change or minor revisions. Figure 3 details the algorithm which guided the policy consolidation consideration process.

Figure 3.

Algorithm for policy consolidation decisions.

Subject matter expert group selection and preparation

The work group was led by the PPDPQ and consisted of campus pharmacy directors, pharmacy managers, the Executive Director of Pharmacy for the merged division, and the MUSP resident. Subject matter experts were added to the group on an ad hoc basis when external expertise or guidance was required. Members initially met for a 60-minute block of time each week for 22 weeks.

A shared document site and 22-week agenda were created prior to the first meeting. Documents were loaded into electronic folders and organized by meeting date. Folders contained a working document for active editing which had information comparing similar verbiage found in the facility documents. An introductory session was held with the group to discuss the organization’s vision for policy consolidation, work group expectations, review the schedule and shared document site, define differences between policies, SOPs, and WI, and introduce the organization’s new templates. The organization defines policies as documents that define rules for compliance and decision making, SOPs as documents that describe consistent ways to carry out a process, and WI as documents that provide details for carrying out a job duty in a consistent manner. Due to the significant number of documents requiring review, the team prioritized policy consolidation, followed by SOPs, WI, then other documents.

Decision meetings

Prior to the weekly group meeting, the PPDPQ and associated subject matter experts reviewed the scheduled documents with matching keywords and proposed a consolidated final draft document. The draft document was posted in the shared document site then reviewed by the group before the scheduled meeting. Sharing the documents in advance allowed time for comments and questions prior to the decision meetings. The shared documents followed a new standardized format including sections for the scope, purpose, qualified personnel, training, supplies and equipment, policies/procedure, definitions, exceptions, references, and related documents. At the weekly decision meeting, subject matter experts led the meeting with guidance by the PPDPQ. Typically, 2 to 3 consolidated draft documents were discussed each meeting and conversations were focused on questions and concerns escalated from the pre-meeting review. If edits were needed to the document after the live discussion, they were completed by the subject matter expert or PPDPQ and a final document was posted for approval at the following week’s meeting. Once the work group agreed, the final document was voted on for approval.

Many of the live meetings were used to determine language that would accommodate operational and workflow differences between locations of varying sizes. While the group was able to agree on workflow standardization for several of the documents, there were some items that did not allow for immediate operational changes due to the varying multidisciplinary practices and sizes of institutions. For example, it was easily decided for all campuses to transition to the same standard signature form for staff acknowledgment of risk when working with hazardous drugs. However, sterile compounding cleaning documents required further review due to physical build differences at campuses with different configurations from full clean room suites at some locations to segregated compounding areas at others. To accommodate differences and allow the department to maintain one policy for all sites, the documents were written with clearly defined scopes, detailed exceptions, and tables or graphs to further delineate location specific requirements. Examples of policies split into separate sections for clarity include the compounding areas and cleaning documents. These were separated into sections to accommodate the variability in room configuration mentioned above.

Implementation Phase

Outcomes

Through the consolidation process, the institution developed 72 shared policies across the division to guide standard pharmacy practice and deleted 372 of the 519 documents evaluated for consolidation. An additional 379 documents were deleted from the facility libraries after facility review due to duplication, relevance, or alternate location for storage. Reasons for deletion from the pharmacy document libraries included: compounding recipes which could be placed in compounding software applications, duplication of information from a corporate document, information that could be easily summarized and incorporated into a new or existing document, and/or the information was detailing expectations for a non-pharmacy department and required transfer into another department’s document library. The pharmacy department eliminated a total 751 documents from the pharmacy policy libraries, 343 documents were maintained specific to a campus with no change, 60 documents were revised and maintained at a campus, and 16 documents were placed on hold for later review.

Approval process and document library clean up

While the organization worked toward unification and consolidation, each facility still maintained a separate medical staff and executive approval process. Each pharmacy director was tasked with obtaining approval of the final consolidated documents from their region’s respective Pharmacy and Therapeutics (P&T) Committee. Once the P&T committees of each region approved the documents, the process for approval was transitioned back to the PPDPQ to obtain approval through each location’s Policy Management Committee (PMC) or their document approval team. These committees review the documents to ensure they are aligned with organization standards, are compliant with regulatory and accrediting body standards, and to ensure no duplication existed with corporate or other department policies. Additionally, the PMC and approvers helped guide standardization of language, remove old documents, and upload approved documents to the new shared division library. A guide was provided to the PMC to facilitate publication of the newly consolidated documents and ensure deletion of old or duplicate documents. The guide included the new document title, the author of each new document, which committees approved the document, the date of approval, the date of approval from the Executive Director of Pharmacy, and final directives for each document including deleting the old policy, maintaining the document in current state in the current library, or revising the document.

Education and roll out

Using the first building block of the Prosci ADKAR^® Model for change management, the department focused on staff awareness in advance of the go-live. ¹ Verbal communication was provided at the weekly pharmacy leadership meetings, and an introductory flyer with packet including all proposed policies was distributed in a weekly pharmacy newsletter approximately 2 months prior to the go-live. This flyer and packet included an explanation of the logic behind the change, a list of the changes, and a compressed file with all final policies that would be published. Additionally, campus directors and managers were asked to circulate this information with front line staff each week and be available or escalate questions as needed. Impacted departments were also notified of modifications to the pharmacy department document library.

Benefits

The consolidation process had many benefits for the pharmacy division:

• The standardization of policies across 16 facilities allowed for additional review and standardization of operational processes from multiple leaders with an outside perspective.

• Document review resulted in revisions to document language to ensure the most up-to-date and accurate information aligning with current literature and regulatory standards.

• Consolidating documents helped identify opportunities for shared oversight of software applications through region one’s pharmacy Informatics team and Operations and Compliance Coordinator. For example, because the organization standardized the compounding policies, pharmacy was required to update the compounding quality software to match pharmacy compounding tasks, education, and some recipes.

• Fewer documents in the library should result in decreased amount of time required during annual review by document owners.

• End user’s time will be optimized while searching the decreased available documents. Limiting the number of documents, should in theory result in obtaining the answer more quickly and efficiently.

• Increased communication and support from shared facilities, created open dialog to discuss new and existing work processes or equipment and maintain compliance with regulatory organizations.

Lessons Learned

Issue	Lessons learned and recommendations
Differences in clinical workflows	Where locations had different clinical practices such as IV to PO processes or therapeutic interchange lists, a general statement about pharmacy management of said process was placed in the shared document, then a further reference was made to the facilities’ site-specific document for additional detail. Since the initial standardization of pharmacy documents, the health system has transitioned to one electronic health record. This has been a positive change and has been an incentive to standardize operational and clinical workflows.
Policies included a wide array of regulatory or safety, clinical, and operational components	To ensure a complete review of each document, the meetings included review by a pharmacy operations expert from the campuses impacted, pharmacy policy and/or accreditation expert, medication safety expert, and a clinical subject matter expert where applicable.
Physical differences; pharmacy size and layout	Where practices could not match across all 16 locations the policies were written to exclude locations where items were not applicable or separate sections of the policies were created to detail how to handle the operation or process at that site.
Variation in accreditation agencies and standards	The health system’s 16 facilities were accredited by 2 different accrediting agencies. A full review and crosswalk of each agency’s accreditation standards was completed prior to document consolidation to ensure standards were addressed uniformly. Often, compliance was achieved by describing how to accomplish the end goal in policy vs using the exact language from the accrediting bodies standards.
Timeline	The timeline for review was short and, to avoid overwhelming the team the original meetings were set for 60 min. Sixty minutes weekly was not sufficient time to review the documents in question. It is difficult to determine the time needed to review these types of documents when you are encouraging open dialog. Instead of setting a specific time up front, we suggest making it clear that the times for each meeting may vary and block out more time than you anticipate needing for review.
Operational changes are needed more quickly than committee approval	An operational need for change in a document used to guide daily tasks may be needed immediately but committee approval can take several months resulting in a mismatch between operational processes and the written document. To fill this gap the team communicated the disparity with front line staff and the worked to escalate approval timelines where possible. The health system found it important to continue the communication about this disparity and expected timeline to leaders and frontline staff while working to decrease time to approval. The health system utilized in house messaging software and in person meetings to distribute this communication. For example, this happened when new contracted items were available, an item was on backorder or unavailable, or new products and instructions were introduced to the facilities. The project coordinators communicated often with pharmacy leaders, provided education sheets, and provided standard communication which was in turn communicated to frontline staff.
Facility hesitancy to delete documents	Open and honest discussions occurred to accommodate each facility’s needs. Operational and workflow processes and regulatory standards were always considered, but safety and regulatory requirements were promoted as a priority. Facilities were given the option to maintain their own documents in some cases, but global standardization and adoption of the shared document was highly encouraged. There were limited instances where all locations did not adopt the standardized document in full.

Plans for Future Direction

While the newly consolidated document library provided a new foundation for the merged division, it will be important to continue that work until all processes and documents align. Following the library publication, campuses were instructed to review their document libraries for any missing regulatory items, duplicates, or any items that could be consolidated within their own facility libraries. Currently, the PPDPQ and a recently implemented position of Operations and Compliance Coordinator continue work on document consolidation as operational processes and clinical workflows further align. To ensure the document libraries remain up to date and to maintain continued evaluation for standardization opportunities an annual review process for all controlled documents will take place. Each of the consolidated documents will be reviewed at least annually for accuracy, compliance with state and federal requirements, and additional opportunities for improvement. The health system utilizes a policy software system which maintains version histories and can track and trend historical edits of each document. This can be used for future revisions when questions around historical processes are presented.

Summary

The Institute for Safe Medication Practices (ISMP) identifies staff competency and education as one of ten key elements of medication use. Within this element they highlight staff education on policies and procedures around medication use as an important part of an organization’s error prevention strategy. ² Although ISMP recognizes the important role policies and procedures play in healthcare, and regulatory agencies require policies and procedures around their standards, there was limited published literature available to guide the creation of a policy and procedure manual or appropriate actions for consolidation when combining libraries or manuals. The goal in sharing this journey is to provide a road map for approaching this change to other institutions going through similar processes. In Figure 4 a checklist is provided for policy consolidation or policy manual creation. The institution achieved the goal of consolidating documents across multi-regional areas but accepts this will be a continuous process. In sharing this journey, the health system hopes others can implement similar processes and lessons to create a brand promise, maintain consistent documents, and meet accreditation standards throughout an organization.

Figure 4.

Checklist for policy manual creation or consolidation.