2016. Things to consider when relocating a clinical laboratory

3/10/2016 Things to consider when relocating a clinical laboratory MAJ John W. Paap MS, MLS(ASCP)CM SFC(P) Maria A. Bowser, MLT(ASCP) Overview • Cli...
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3/10/2016

Things to consider when relocating a clinical laboratory MAJ John W. Paap MS, MLS(ASCP)CM SFC(P) Maria A. Bowser, MLT(ASCP)

Overview • Clinical Laboratories may experience a relocation due to several reasons including a renovation to the existing space and permanent transition to a new space. • Given that laboratories are the most regulated component of any hospital, relocations are significant events that may take months of planning and preparation before execution. • Collaboration and Teamwork are essential to the success of the relocation project. • It is critical to maintain regulatory compliance while instituting new compliance measures throughout the movement period. • Provision of services must remain uninterrupted

Disclaimer • This presentation is predominantly aligned to the relocation of a laboratory which entails the movement of existing equipment for continued use. Some information, however, may also be used for establishing clinical laboratory operations within a new facility or workspace. An example of this would be the construction of a new hospital.

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Project Planning – The outcome is only as good as the plan • The relocation of a clinical laboratory requires deliberate, careful, and documented steps which must be addressed in a method that ensures a continuance of mission capability. A typical laboratory relocation can take months of planning, so keep in mind that the best execution is a culmination of the plan. If the planning phase and plan are weak, lacking adequate substance, and does not account for all the moving pieces, the execution phase will fail.

Project Planning – The outcome is only as good as the plan • The relocation plan should be made based upon the organizational scope of practice. What I mean by scope is what the laboratory supports for the organization. Does it support 24/7 operations? Is there an operational requirement for continual instrument operability to meet the demands of inpatient wards and the Emergency Department? If so, how much capability is needed to fulfill the needs of the service throughout the transition period? What are the organizational requirements for the provision of blood bank services? What about anatomic pathology and microbiology? Answering these questions, and others, will go a long way toward discerning what is incorporated within the plan.

Project Planning – The outcome is only as good as the plan • All instrumentation needs to be inventoried and decisions made about what to move versus what to retire or store and how to best deploy instrumentation. Verification Protocols must be developed well in advance and followed for decommissioning and re-commissioning of all instrumentation. New processes must be planned for and instituted to secure sample delivery and recovery within the prescribed time constraints for testing within actionable criteria acceptable by the submitting clinics, wards, and departments. As you can see, this is a far reaching project where outreach and laboratory extension is essential. Select your planning and execution team carefully. The quality of the plan and the success of the project depend on it.

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Project Planning – The outcome is only as good as the plan • Deliberate, proven processes are key in any lab relocation. Research is as fundamental as identifying in-house assets destined to be relocated. Corralling the multitude of details — including instruments, contacts, and samples as well as meetings and timelines should be streamlined.

Project Planning – The outcome is only as good as the plan • Below is a list of processes that should be considered. • • • • • • • • • • • •

Planning, scheduling, and coordinating Preparing the inventory Identifying each instrument and its parts Preparing regulatory documentation (calibration, qualifying, validating) Decontamination Timeline preparation – Vendor movement of equipment Ensuring the safe handling of all chemicals and lab samples Managing transportation or disposal of all hazardous materials Handling all packing and moving Re-installing all lab instruments and holistic testing Performing any qualifications /validations/verifications, as needed, post-move Addressing any obstacles in a move, such as moving oversized equipment and refrigeration requirements

Project Planning – The outcome is only as good as the plan • Items to include accomplish: • Instrument inventory – pre and post move. (FLIPL, Statement of Charges avoidance) • Purge unutilized/under utilized supplies, documents, books, etc. • Regular strategy meetings • Labeling/tagging equipment • Labeling/tagging computer ports and phone locations • Document creation – validation protocols • Equipment relocation timelines (with move and install dates) • Chemical movement provisions • Address sample handling and transport (hospital wide too!) • Post-calibration • Repair • Qualification • Supply management • Union Notification

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Project Planning – The outcome is only as good as the plan • The relocation plan should explain the tools employed to efficiently manage and schedule a relocation project as well as the processes employed that will verify accuracy when completing tasks such as a comprehensive inventory audit and asset labeling. The relocation plan should also incorporate the project management process to accommodate the inevitable changes to tasks, relocation needs, and timing. The timeline and process should proactively address potential hurdles, such as the special needs of moving oversized equipment. Once in the new location, project tracking should continue through reinstallation and subsequent verification studies performed prior to patient testing.

Project Planning – The outcome is only as good as the plan • Highlight: Now would be a good time to also address the following: • • • •

Future efficiency improvement needs (LSS, RIE) Staff realignment and utilization Purge Acquisition of new/desired equipment – You will receive a budget for new equipment. (IO Funds) You will need to determine how you will spend these funds. This is a great opportunity to outfit your new lab with the latest and greatest. These funds are not CEEP – THIS IS YOUR MONEY!

Collaboration and Teamwork • As with any large and complex project, collaboration between your relocation partners and your internal team is a critical success factor. An effective model is to establish a corporate team including the project manager and representatives from facilities, engineering, lab quality assurance and compliance, along with the construction manager. I’d strongly consider incorporating the clinics and wards on occasion. As the Lab Manager, you should then structure lines of communication and timelines including any subcontractors (instrument manufacturers too!) handling the physical move and any other specialized logistical support.

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Collaboration and Teamwork • Joint meetings serve as a mitigation factor and are crucial to the success of any relocation project. You should ensure these forums occur on a regular basis. Success often requires that teams need to meet weekly or biweekly, particularly in the latter stages of relocation arrangement, in order to avoid miscommunication and maximize efficiency. These meetings should be attended by: • • • • •

Laboratory Leadership Facilities Management Nursing Safety Logistics

• • • •

Vendors Dep. Cdr. for Service IMD QMD

Regulatory Compliance and QA • Knowledge of regulatory compliance is crucial in any move involving regulated laboratories. • BLUF: the Laboratory’s regulatory status must be safeguarded. You should demonstrate knowledge of and practice compliance requirements and have (or access to) the technical expertise and resources to handle analytical instrument validation/verification/qualification across a range of technologies and manufacturers. Again, validation and verification plans are critical to this process and must be written and approved by your medical director well in advance of the movement.

Regulatory Compliance and QA • Ensure post-move adherence to the organization’s policies. This also includes adherence to the laboratory’s policies. Some of the policies and regulations that may need to be considered include the safety and chemical hygiene plans( New SAPs), the QMP, the Union Negotiated Agreement. Keep in mind that all Laboratory QA processes and policies should remain in effect throughout the move.

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Leadership Duties • Prepare your Staff. There really is no substitute for frank and open dialogue with your staff. Keep them updated on the progress early and often. Weekly lab staff huddles are a perfect venue to deliver updates and progress notes to your staff members. Again, the focus of this is to garner their support and to reassure them.

Leadership Duties • Plan. As with any project, large or small, planning is first and always. Back plan from the “Go-Live” date. Planning is continuous. Continually scan your field of fire. • Preposition your assets. Account for infrastructure needs such as power, water, drainage, and HVAC requirements. Also account for efficiency modeling and process flow needs. Preposition refrigeration assets and routine supplies for each section. Keep in mind that everything, including refrigeration, must be verified prior to use. Preposition phone, LAN and computer capability. Preposition supplies.

Leadership Duties • Site checks and determination. Check and recheck that everything is ready to go. Do the phones work? Do the computer programs work and able to connect as needed? Ensure a safe working environment for your staff. Check fire exits, extinguishers and evacuation plans. Establish a satellite accumulation point (SAP). Acquire a certificate of occupancy.

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Leadership Duties • Movement of redundant equipment. This equipment is the equipment designated in the planning phase to be utilized as the first-line capability on the go-live date. I would recommend some form of redundancy such as I-Stat for those critical tests essential to the efficacy of the service. Keep in mind that there will not be redundant capability for 2-4 weeks until remaining instruments are moved and validated according to your plan. Use this time wisely, outlining the expectations to the staff performing this work so that minimal downtime is experienced.

Leadership Duties • Movement of additional equipment and “Go-Live.” On this date, everything works, has been verified/validated according to the protocols, supplies are in place, phones and IT functions, and the entire staff has been assimilated together.

Summary and Lessons Learned • Moving analytical instrumentation is an intrinsically complex process that requires careful planning and execution to ensure that laboratory equipment, and precious samples arrive at their destination safely. It is also essential that the new laboratory meets all compliance requirements and is able to become productive as quickly as possible.

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Summary and Lessons Learned • Build your lab team! What is meant here is really two main points: • One Team, One Fight. Garner the support of your laboratory staff. Get out of your foxhole and be present. Get to know your staff. This will go a very long way in how they feel about and react towards the move. In most cases, they have been working the same way for many, many years and their whole working world will change significantly. Paint the positive picture and let them know that you are diligently working to support them. • Assemble your lab movement team and carefully delineate roles and responsibilities to your team members. Assigning roles and responsibilities will ensure that everything is accomplished. Don’t forget to follow through. Doers do, what checkers check.

Summary and Lessons Learned • When the contractors arrive to move your equipment and a few of the analyzers, assemble them and stress to them the fragility of your equipment. Some of the instrument vendors will arrive to move the larger equipment items, but most of the equipment will be moved by a contractor and your lab staff. Unfortunately, these contractors are the very same movers that move your household goods during a PCS. Monitor them throughout the process.

Summary and Lessons Learned • Don’t just invite the OICs and NCOICs of the various wards and clinics to the scheduled coordination meetings. Any move has second and third order affects upon their functions and processes within the facility. Explain to them that their attendance is vital to the overall healthcare mission of the organization. Explain and reassure to the providers through a routine lab bulletin what is happening and how the dislocation will affect the service.

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Summary and Lessons Learned • Keep the DCCS updated. Schedule and provide periodic updates and a walk through (or two) to keep him/her and the Commander apprised of the progress. Be prepared with a concise slide deck. Highlight the tremendous work of the staff.

Summary and Lessons Learned • Have fun and learn. You may never again be a part of another relocation project. This one was 37 years in the making. Here are a few pictures of the lab renovation and the temporary trailers we moved into. The only downside? We have to move back once the renovation is complete! • Questions?

Pictures - Before

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Pictures - Demolition

Pictures - Demolition

Pictures - Demolition

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Pictures - Demolition

Pictures - Trailers

Pictures - Trailers

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Pictures - Trailers

Pictures - Trailers

Pictures – New Space

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Pictures – New Space

Pictures – New Space

Pictures – New Space

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Pictures – New Space

Pictures – New Space

Pictures – New Space

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Pictures – New Space

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