FUELING THE QUALITY ENGINE

FUELING THE QUALITY ENGINE: Small Details that Drive Big Impacts on Healthcare Outcomes

In this four-part report, we address patient safety gaps surrounding medical equipment management to better understand what’s increasing risk to your patients, and what should be done to protect your organization.

The Quality Engine: How the Vendors You Choose Impact Your Facility

Why “ISO-certified” Isn’t Enough: The Difference Between ISO 13485 and ISO 9001

Understanding ANSI: What New Standards Mean for Your Laser Operators

Evaluating Vendor Quality: Best Practices for Closing the Quality Gap

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CHAPTER 1: The Quality Engine

THE QUALITY ENGINE: HOW THE VENDORS YOU CHOOSE IMPACT YOUR FACILITY

Healthcare has always been detail-focused. It has to be. It’s one of those rare fields where

little things can make the difference between life and death — where “quality” and “safety”

are synonymous. But with the increasing demands of value-based care — and the rising

expectations of patients as consumers — the small factors that influence clinical quality and

patient safety now fuel a larger business-outcomes engine, driving critical outcomes ranging

from staff satisfaction and patient retention to profitability and growth.

In this new environment, there’s simply no room for risk; there’s no such thing as a harmless

shortcut. Yet several concerning quality gaps have emerged — and many are sitting right at

your patients’ bedsides and operating tables.

The Quality Engine Every aspect of a healthcare organization — from clinical decision-making to the condition

of hallway floors — is under increasing scrutiny. Whether due to the Affordable Care Act’s

broad-sweeping initiatives, or based on individual regulatory updates, the margin for error

is shrinking and the penalties are increasing. Hospitals need to be able to quickly adapt

to evolving regulatory standards and guidelines that govern clinical quality and patient

safety. A commitment to quality is no longer enough. Quality needs to be embedded into

the operations of the hospital, because business objectives are now tied back to it. In short,

clinical quality fuels the outcomes you care about most:

CLINICAL QUALITY& PATIENT SAFETY

PATIENTSATISFACTION

STAFFSATISFACTION

CLINICALOUTCOMES

PATIENTRETENTION/

VOLUME

STAFFRETENTION

OPERATIONALEFFICIENCY

REIMBURSEMENTOPTIMIZATION

PROFITABILITY& GROWTH

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THE QUALITY ENGINE: HOW THE VENDORS YOU CHOOSE IMPACT YOUR FACILITY

Quality Case Study: Medical Equipment Readiness

Imagine a nurse needs an infusion pump. If the nurse can quickly find a device that’s clean, patient-

ready and has been functionality tested, there’s no delay in care to the patient. Apply this across all your

moveable medical equipment and you can see the quality engine in motion: Smart workflows improve

medical equipment availability and prevent care delays. This not only reduces excess cost, it also enhances

patient experiences and improves staff satisfaction. This leads to improved clinical outcomes, which

maximize reimbursements and expand margins. Higher margins drive profitability and unlock growth

potential. All of these benefits can be gained by having a single infusion pump readily available for care.

However, those same small cogs, if interrupted, can also cause serious breakdowns in the quality engine.

If a device doesn’t work or is not available when needed, care is delayed — frustrating both patients and

staff. These delays decrease treatment efficiencies and require staff to spend time hunting for a patient-

ready device. Often, additional equipment is rented or purchased to patch this perceived gap in available

equipment — increasing costs and cutting into margins.

At the same time, patient and staff frustration drive rippling effects — decreased staff productivity, higher

turnover costs and lower patient retention stemming from a poor care experience. Not to mention the

biggest risk: that a care delay (or faulty equipment) will lead to a patient safety incident.


CARE DELAY/DISRUPTION

PATIENTFRUSTRATIONHIGHER

EQUIPMENTCOSTS

STAFFFRUSTRATION


Key Challenge: Building (and Maintaining) a Reliable Quality Engine

As the complexity of modern healthcare delivery rapidly increases — more technology, more

advanced care, and more demanding regulations — there are significantly more small cogs that play

a critical role in the quality engine. Even the most cutting-edge organizations struggle to consistently

manage all of these small factors. Additionally, attempting to manage all of this increasing complexity

isn’t in their financial or clinical best interests — it diverts attention and resources from the actual

hands-on delivery of exceptional patient care.

This leads more healthcare organizations to lean on third-party service partners to handle peripheral

aspects of the quality engine. For example, to address medical device challenges like the infusion

pump example described earlier, hospitals and health systems increasingly leverage medical device

rental and service vendors to ensure state-of-the-art, patient-ready equipment is available when and

where it’s needed.

As healthcare organizations lean more heavily on third-party

service partners, they need to be prepared to ask the right

questions on their quality and patient safety practices.

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The Hidden Risk Most Providers Miss

As health systems increasingly depend on vendors to provide essential medical equipment

rental and service, one concerning quality gap has emerged: medical equipment rental providers and service providers are not regulated by the FDA, nor are they required by law to adhere to OEM quality standards. This is true even for critical considerations like installing

OEM-approved replacement parts for integral components within a device, or ensuring the

technician servicing the equipment has received the appropriate training.

This means critical life-saving medical devices may not be maintained to the standards

that you expect — which could lead to poor performance or even equipment failures that

threaten patient safety. These quality shortcomings also create jams in the quality engine,

with problematic impacts down the line — from patient experience and staff satisfaction, to

operational efficiency, and profitability.

Imagine a rental vendor drops off a brand-new device that is covered under warranty. No

quality risk there, right? Wrong. Many vendors fail to communicate the service and support

plan that will follow the device across its useful life. Specifically, how will the device be

cleaned, tested and maintained on an ongoing basis to ensure it continues to operate at an

optimal, safe level for patients? Since there is no governance of third-party providers, vendors

can choose not to follow the most current standards for quality and patient safety, which can

introduce a higher level of risk to your patients and organization.


THE KEY QUESTION: How Do You Evaluate Vendor Quality?

As critical cogs in the quality engine fall in the hands of third-party vendors, the question becomes: how can your organization evaluate, monitor and ensure vendor quality?

In our next chapter we will dive into the differences in ISO certification standards — including the growing gap between the medical device specific ISO 13485:2016 and the generic ISO 9001:2015 — and why that difference could put your patients and bottom line at risk.


WHAT YOU CAN’T SEE CAN HURT YOU (AND YOUR PATIENTS): THE DIFFERENCE BETWEEN ISO 13485 AND ISO 9001

In the first chapter, we talked about a growing problem in many healthcare organizations:

How do you ensure all your vendors and service partners are committed to patient safety and

quality? In this chapter, we’re going to focus on the answer. It starts with how you evaluate your

vendor’s compliance to quality management system regulations such as those put forth by the

International Organization of Standardization (ISO).

What You Might Not Know about ISO

Globally, quality management systems in a variety of industries are based on ISO standards.

Some healthcare organizations don’t understand that there are different ISO standards

specific to different industries. The only ISO quality standard specific to medical devices is ISO

13485:2016. This standard is based on evaluating the risk to patient safety throughout the life

cycle of a medical device.

The troubling reality is that while a select few vendors now self-adhere to critical, risk-reducing

ISO 13485:2016 standards for their medical equipment management, most are either not certified

or are certified to a less stringent ISO 9001:2015. Understanding the difference between ISO

9001:2015 and ISO 13485:2016 is important for you as you select third-party service providers.

CHAPTER 2: Why “ISO-certified” Isn’t Enough

In other words, “We’re ISO-certified” might not provide the quality and patient safety

assurance you think it does when it comes to medical device service and rental providers.


What is ISO 13485?

ISO 13485 is a patient-focused and risk-based quality standard designed specifically for the

high-risk medical device industry. The ISO 13485 standard grew out of the more generic ISO

9001 standard — which provides a general framework to ensure quality and enhance customer

satisfaction across a wide range of industries.

CONTINUOUSIMPROVEMENT

Medical Industry: ISO 13485:2016A rigorous, patient-focused and risk-based quality management system to ensure those in the high-risk medical device industry are delivering the highest level of patient safety and quality.

PATIENT CARE RISK MITIGATION

THE OTHERIS FOR:

SERVICING VENTILATORS

General: ISO 9001:2015A generic framework to enhance customer satisfaction in a wide range of industries; not focused on the safety and e�cacy of medical devices.

FLORAL LOGISTICS

vs

PROFESSIONALCLEANING

CONSTRUCTION

ONE IS FOR:REPAIRING

LAWNMOWERS


Why choose ISO 13485:2016? The answer is simple: patient safety.


The Growing Gap Between ISO 9001:2015 and ISO 13485:2016

Healthcare has changed profoundly in the 20+ years since ISO 13485 diverged from the generic

ISO 9001. The gap between the two ISO standards has also grown. ISO 13485 is continually

updated to account for the evolving risks associated with medical devices. The latest iteration,

ISO 13485:2016, is already a mandate for medical device quality assurance. In fact, the FDA is

evaluating how to implement ISO 13485:2016 for the regulation of quality management systems

associated with medical devices. The updated standard includes additional requirements around

rigorous staff training, patient risk-based processes and protocols, service and maintenance.

Many of these standards are simply absent in ISO 9001:2015.

RISK-BASEDAPPROACH

CUSTOMERFEEDBACK

RECALLMANAGEMENT

Utilizing risk-based approaches, taking patient safety into

consideration through every step

Implementing a feedback system that

provides early warning of

quality problems

Controlling medical devices with regard to advisory notices, like

product recalls

CONTROL ENVIRONMENT

Controlling the work environment to prevent

contamination


1 https://www.iso.org/news/ref2318.html

In fact, there are more than 80 key differences between ISO 13485 and ISO 9001.

To dive into a few of these differences, check out this simple infographic.

The ISO 13485:2016 Difference

https://www.agilitihealth.com/wp-content/uploads/Agiliti_ISO-Infographic_022819.pdf

https://www.agilitihealth.com/wp-content/uploads/Agiliti_ISO-Infographic_022819.pdf



Would you let a landscaping company

repair your medical devices?

To apply the ISO standard simply, imagine this: Would

you trust a landscaping company to service your

essential medical equipment? How about a florist or

apparel retailer? Of course not. ISO 9001:2015 helps

landscapers, florists and retailers to build quality

practices and deliver consistent customer service, but

it does not pertain to medical devices, patient care or

risk mitigation. The point is, you want a vendor who is

qualified for the right thing in the right industry. That’s

why it’s critical to understand the sometimes-cryptic

ISO nomenclature, so you can properly evaluate vendors

and protect the performance of your quality engine.

Hold Your Vendors to the Highest Quality Standards

As we explained in the last chapter, small details around quality and patient safety fuel an

engine that positively drives every aspect of an organization — from staff satisfaction to

patient outcomes and even the bottom line. It’s critical to seek out third-party vendors that

demonstrate a commitment to the highest quality and patient safety standards — because

every input to the quality engine plays a role in keeping that engine running smoothly.

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THE ULTIMATE TAKEAWAY:

When a vendor tells you, “We’re ISO-certified,” or, “We follow ISO standards,” that doesn’t go far enough. To protect your patients and support the quality outcomes that drive your organization’s success, you need to confirm that vendors who work with medical devices are compliant with ISO 13485:2016 — and seek out vendors that self-adhere to these medical device, risk-reducing standards.


UNDERSTANDING ANSI: WHAT NEW STANDARDS MEAN FOR YOUR OPERATING ROOM

Growing demand for more precise, less-invasive treatments is turning medical lasers into

mainstream tools in the modern OR — a promising technology with rapidly expanding

applications. However, as healthcare facilities expand their use of medical lasers, new ANSI

safety standards and AORN guidelines will require many organizations to make major

changes in their laser operation protocol. These new requirements present significant staffing

challenges, as well as ongoing training and administrative burdens — which few ORs fully

understand or are prepared to handle.

Rising Regulatory Standards for Laser Safety

The increasing adoption and use of medical lasers have unsurprisingly brought a

corresponding increase in attention to developing best practices and safety standards.

OSHA, The Joint Commission and AORN now all play a role in adopting and enforcing

safety standards created by the American National Standards Institute (ANSI), the leading

independent organization that develops standards and recommended practices for the safe

use of many medical technologies, including medical lasers.

CHAPTER 3: Understanding ANSI

Approximately 70% of hospital laser programs we assess do not

meet new ANSI laser operator certification standards.

ANSI has continually updated its standards for the safe use of medical lasers over the past

30 years, but the last few years have seen changes that every healthcare organization should

know about. These changes can be broken into three distinct elements:

Laser Safety Program and Laser Safety Officer (LSO) requirements

Dedicated & Fully Trained Laser Operators

Third-Party Laser Use

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https://www.ansi.org/default


What It Says

Every facility that uses a medical or aesthetic laser must establish a formal Laser Safety

Program that is documented and managed by an appointed designated Laser Safety Officer (LSO). The standard applies to all patient care cases in which a laser is used, regardless of

whether the laser system is owned, borrowed, or rented.

What You Need to Know

• Each facility must establish and maintain a Laser Safety Program and designate an in-house

LSO, and if deemed necessary, additional personnel such as a Deputy LSO (DLSO).

• A third-party provider of laser and operator services does not serve as a facility’s LSO by virtue

of being the provider of laser rental services. Oversight and operation are two separate tasks.

• The LSO is responsible for ensuring that appropriate laser safety education and training is

provided and documented.

To be compliant with the American National Standards Institute (ANSI) Z136.3 Standard for

“Safe Use of Lasers in Health Care,” every facility that uses a medical or aesthetic laser must

establish a formal Laser Safety Program that is documented and managed by an appointed

Laser Safety Officer (LSO). Here are the key points you need to know:


THE LSO REQUIREMENTSANSI Z136.3: Laser Safety Officer 1.3 and Administration 5.1

What It Says

The LSO has the training and experience to administer a laser safety program. LSO education

and preparation should include, but not be limited to, completion of a formal medical laser safety

course, completion of a formal MLSO course, and certification as a MLSO (recommended).


• In-house LSO should now also be trained and certified as a Medical Laser Safety Officer

• Certification is attained from the Board of Laser Safety (BLS)

• Approved training courses are offered through the Laser Institute of America

MEDICAL LASER SAFETY OFFICER (MLSO) REQUIREMENTANSI Z136.3: Personnel 5.2.1

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We’ve collected an overview of primary MLSO responsibilities in this one-page brochure.

LASER SAFETY PROGRAM AND LASER SAFETY OFFICER (LSO) REQUIREMENTS

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https://www.agilitihealth.com/wp-content/uploads/Agiliti_Facility_Laser_Safety_Officer_Responsibilities.pdf

https://www.agilitihealth.com/wp-content/uploads/Agiliti_Facility_Laser_Safety_Officer_Responsibilities.pdf


What It Says

Procedural Controls include “Assigning a dedicated person to operate the controls, if

applicable, when appropriate for the procedure and practice setting. The laser operator should not have competing responsibilities that would require leaving the laser unattended during

potential operation.”


• Many facilities assign laser operator duties to the circulating nurse that also has other patient-

care responsibilities.

• This common approach is non-compliant with the latest standards. The split responsibilities

of the circulator being the laser operator can pull attention away from safe use standards

designed to protect both staff and the patient.


DEDICATED LASER OPERATORSANSI Z136.3: Administrative & Procedural Controls 4.2.5

What It Says

Laser safety training programs shall provide a thorough understanding of all procedures

required for establishing and maintaining a safe environment during the use of a health care

laser system (HCLS). Training shall be specific to the HCLS in use and the procedures to be performed.


• Laser operators need to hold certification of training on both the laser system and the

procedure being applied.

• Many facilities do provide training on the technology, but not the specific procedures. For

example, training on a Holmium laser does not differentiate between using the technology

for a Bronchoscopy and a Ureteroscopy. As a result, approximately 70% of hospital laser

programs we assess do not meet the updated standards.

FULLY CERTIFIED TRAINED LASER OPERATORSANSI Z136.3: Training Programs 5.2.2

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Because medical lasers are still an emerging specialty technology, most healthcare facilities have

taken an organic or ad hoc approach to meeting OR staffing needs for operating medical lasers.

However, recent standard recommendations place new requirements on laser operators:

DEDICATED & FULLY TRAINED LASER OPERATORS2


What It Says

If the user employs a third party to provide a health care laser system (HCLS) (often including

the operator and all accessory equipment), the laser safety officer or designee shall assess the rented or borrowed equipment for compliance with all federal, state and local requirements, as

well as compliance with all requirements listed in ANSI Z136.3.

The laser safety officer shall ensure that the terms of agreement between the third-party provider

and the health care facility include, but are not limited to:

• The credentials of the third-party laser operator meet the facility’s policy.

• The health care facility has received written validation of the maintenance, service, cleaning and

condition of the equipment.

• Data and elements of documentation collected by the third party are appropriate, meet the health care facility policy, and can be verified by facility health care provider.

• All health care providers expected to be in the room with the third-party laser provider have had adequate training on all equipment, in order to safely operate the equipment in the

absence of the third-party employee, thereby ensuring safe patient care at all times.


• Third-party providers need to retain and provide useful key performance indicators to

assist the facility’s LSO in program oversight and continuous improvement initiatives and

to comply with accreditation standards. But not all third-party providers present or allow

access to maintenance records for the lasers they bring into the facility or have sufficient

quality indicator data of their service provision on a quarterly basis.

• The laser safety officer or designee need to approve each laser and laser operator that

comes into the facility. That does not mean they need to approve each laser or operator

each time they come in, but they should sign off on the operator’s credentials, laser

condition and maintenance records prior to its use at the facility.

• Third-party providers should provide an annual in-service for any facility staff that work in or

around the laser so the facility can meet ANSI requirements.


THIRD-PARTY LASER SERVICESANSI Z136.3: Third Party Laser Use 1.4.2

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To manage dynamic case volume and rapidly evolving laser technologies, healthcare organizations

increasingly leverage third-party medical laser services. Best-in-class partners do everything from

delivering and servicing the medical laser platforms to providing certified technicians to operate

the devices. However, revised ANSI standards make it clear that the onus for third-party quality

assurance lies with the facility’s LSO:

THIRD-PARTY LASER USE3


Why it Matters: The Impacts of Non-Compliance on the Quality Engine

As agencies like OSHA and The Joint Commission begin enforcing the elevated ANSI laser safety

standards, non-compliance will become a real risk, both financially and from a brand reputation

standpoint. But the lack of a fully compliant Laser Safety Program in most hospitals presents a

much more immediate set of risks:


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Patient & staff safety incidents:

As medical technologies grow increasingly powerful, improper and/or unsafe use

can lead to serious safety incidents that impact both patients and OR staff. Along

with opening up the facility for lawsuits and litigation.

Malfunctions & case delays:

Even if a hospital dodges a safety incident, equipment malfunctions resulting from

improper use or inability to successfully troubleshoot system errors can lead to

costly and sometimes unnecessary repairs — and much more costly case delays.

The quality engine:

The Quality Engine we introduced in the first chapter is incredibly relevant here.

The OR is a major revenue center in most healthcare organizations — not to

mention a high-visibility area from a brand reputation standpoint. Beyond the

immediate costs of case delays or safety incidents, these events have cascading

impacts on the OR Quality Engine — damaging patient and staff satisfaction,

reducing reimbursements and operational efficiency, etc. — that impact

profitability and growth in complex and long-lasting ways.

INCREASEDCOSTS

INCREASEDRISKS


The Challenges of Trying to Maintain Compliance In-House

The risks and costs of non-compliance should lead all hospitals to take the new ANSI

standards seriously. But unfortunately, achieving compliance comes with its own set of

challenges and costs:

• Aligning Laser Operator Staffing with Fluctuating Case Demand: Case demand can

vary significantly on any given day. For example, on one day, an 11-hospital system (an

Agiliti customer organization) required seven (7) dedicated laser operators across 22

hours of the day to cover its medical laser case demand. The next day, that number was

zero. Many hospitals will find it difficult to adequately predict the staffing needed to

cover both the maximum case demand and low-demand days.

• Exponential Training Demands: The technology- and procedure-specific training

requirements of the new ANSI standards rapidly multiply the staffing burden. That

same 11-hospital system performs six different procedures, and while several hospitals

use the same type of laser, each of the 11 hospitals has a unique model. To ensure their

dedicated laser operators can cover peak case demand at any of its hospitals, each

laser operator must be properly trained and certified on 60+ devices and procedures —

including rarely performed procedures.

• Administration of Laser Operator Scheduling & Training: A hospital will also need

to dedicate staff for laser operator scheduling to maximize staffing efficiency and

minimize case delays. This can become a very complex process matching the certified

laser operator with the correct case. And to achieve full compliance with ANSI

standards, hospital administrators are also responsible for creating and maintaining

laser safety logs, safety documentation and ensuring ongoing compliance in practice

with all laser safety standards.

All of these factors contribute their own substantial headaches and costs. And as mentioned,

falling short on any of these can not only put a hospital at risk of non-compliance penalties

and embarrassments — it can actually put staff and patient safety at risk.

Is Your Laser Safety Program in Compliance?Get your 10-point laser safety audit here.


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https://resources.agilitihealth.com/medical-laser-safety-checklist/

https://resources.agilitihealth.com/medical-laser-safety-checklist/


Evaluating Vendor Quality

As you have seen through this report, the growing complexity in modern healthcare delivery

presents new and expanding quality and safety challenges. “The difference is in the details” has

never been more true, as healthcare organizations face the daunting challenge of managing

medical equipment across a multi-faceted healthcare delivery environment.

In the first three chapters, we highlighted how subtle and hidden quality variances in things like

medical device management and medical laser operation can impact an organization’s quality

engine. These variances can enhance or inhibit everything from operational efficiency, revenue,

and the bottom line, to clinical outcomes and patient safety and satisfaction. In this final chapter,

we will dive into why vendor quality matters and provide simple guidelines for evaluating and

selecting high-quality service partners.

The Ugly Truth: Not All Service Providers Follow the Same Standards

Healthcare organizations are increasingly turning to vendors and service partners for medical

equipment rental and service. However, what many healthcare organizations don’t know is

that these third-party service organizations are not governed or regulated by the FDA like

medical device manufacturers or healthcare providers — and thus are not mandated to have

full quality management systems in place. While most service providers take quality and

patient safety seriously, not all go to the same lengths. The pace of change in healthcare

continues to accelerate: technologies advance, regulations adapt, best practices evolve, and

new patient safety risks emerge. In this dynamic environment, staying at the leading edge of

patient safety practices requires a strong organizational commitment to quality.

CHAPTER 4: Evaluating Vendor Quality

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EVALUATING VENDOR QUALITY: BEST PRACTICES FOR CLOSING THE QUALITY GAP


Cutting Corners Up Front = Passing the Risk to Your Patients

Why would a vendor or service partner choose not to hold themselves to the highest quality

standards? One answer is cost. Achieving independent certification, meeting or exceeding

ANSI requirements, and implementing a quality management system requires more intensive

staff training, and more time- and resource-intensive risk-based protocols. The decision to cut

corners on quality allows vendors and service partners to “pass the savings along to you” in

the form of a lower line-item cost. However, by cutting corners in their internal operations and

standards, they’re also passing along additional risks to you, your staff and your patients. Ask

yourself, are the increased costs and risk across the organization worth a cent saved on a line-

item basis? Not when the impact is so great:

The Broad Impacts of Quality Gaps in Medical Device Rental and Service

• Care Delay/Disruption: Device malfunction/servicing issues can delay care and disrupt clinical

workflows

• Patient Frustration: Device malfunction and/or care delays damage patient experience

• Staff Frustration: Equipment issues frustrate clinical staff and contribute to burnout/turnover

• Higher Equipment Costs: Additional device repair and replacement costs

• Compliance Penalties: If a third party provides a non-compliant device or service, it is the

healthcare provider that bears responsibility

• Patient Safety Risks: Device malfunction/failure can directly lead to adverse outcomes

• Lost Revenue: Care delays decrease patient throughput; lower patient satisfaction (and lower

HCAHPS scores) can impact reimbursement rates and lead to patient volume leakage


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CARE DELAY/DISRUPTION PATIENT

FRUSTRATION

HIGHEREQUIPMENT

COSTS

STAFFFRUSTRATION

COMPLIANCEPENALTIES

LOSTREVENUE

PATIENTSAFETY RISKS


What Now?

The question becomes, how do I evaluate the quality of different third-party vendors? Let’s

look at a few simple recommendations healthcare organizations can take when evaluating and

selecting high-quality service partners.

What to Look for in a Medical Equipment Rental Provider

Smart rental practices play an important role within a healthcare facility’s goal to optimize

inventory and reduce overall costs. But as we have demonstrated throughout this series, it

is imperative to take steps to ensure your medical equipment rental partner aligns with your

quality goals and that the rental equipment does not introduce risk to your facility. When

evaluating vendor quality, start here:

ARE THEY ISO 13485:2016 CERTIFIED AND COMPLIANT?

The first and most critical question to ask a medical device rental or service vendor is, “Do you

meet the ISO 13485:2016 standard?” The bottom line is that many vendors claim to be “ISO

certified,” but few self-adhere to this higher, healthcare-specific ISO standard, which focuses

on identifying and addressing the specific patient safety risks in a healthcare environment.

Do they provide complete transparency – data and analytics – around the service history of rental devices?

Do they follow OEM instructions and preventive maintenance schedules?

Are all service technicians fully certified on the latest standards?


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Download a Rental Provider Quality Evaluation7 critical questions you should be asking your equipment rental providers

https://resources.agilitihealth.com/critical-questions-surrounding-rental-equipment/

https://resources.agilitihealth.com/critical-questions-surrounding-rental-equipment/


What to Look for in a Surgical Laser Partner

The updated ANSI safety standards require healthcare organizations to make significant changes in

their laser safety programs, including that laser operators have no competing responsibilities and

maintain current certification on both the specific medical laser model and the particular procedure.

As organizations consider these complexities and the ongoing costs of managing the needed

certifications, most are looking to partner with a third-party provider of laser operation services.

Here are a few simple tips to help you evaluate and select a trusted surgical laser service partner:

Do they have their own medical laser safety officers (MLSOs) providing oversight of their laser operation service program?

What is their process for maintaining technician certifications?

Do they provide you with comprehensive, case-by-case laser logs and documentation for required ANSI reporting? Is this documentation and reporting easily accessible (e.g., online)?

Will they provide the necessary training for your facility staff that works around medical lasers?

Do they offer technician-only services that allow you to utilize your owned surgical lasers for procedures?


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KEY TAKEAWAY: Leading Vendors Recognize Higher Quality = Better Value

While adherence to higher quality and patient safety standards may not be required for vendors and service providers, forward-thinking vendors recognize the direct connection between quality and value. By self-enforcing the ISO 13485:2016 quality standard, or ensuring the latest laser operator safety certifications, service partners like Agiliti recognize that they‘re giving healthcare organizations critical fuel for the quality engine. Likewise, savvy healthcare organizations are seeking out expert partners that self-adhere to the highest quality and patient safety standards. They’re asking tough questions to uncover small-but-important factors that impact clinical and business outcomes. By ensuring the quality of every input to their quality engine, they’re supporting better patient experience, improving clinical outcomes, enhancing operational efficiency, and driving profitability and growth.

©2019 Agiliti Health, Inc.

About Agiliti

Agiliti helps hospitals reclaim millions of dollars in wasted medical equipment. The

company places equipment management experts and clinical engineers in more than

7,000 hospitals to ensure that the right equipment is in the right place at the right time.

Onsite services free nurses and other clinicians to spend more time caring for patients

and less time searching for the equipment they need. Agiliti also provides responsive

rental services for a full range of equipment, including respiratory systems, infusion

therapy devices, specialty beds and surgical lasers. A nationwide network allows the

company to serve all health systems and hospitals across the U.S. For more information,

visit agilitihealth.com.

CORPORATE OFFICE 6625 West 78th Street. Suite 300.

Minneapolis, MN. 55439

Toll Free: 800.847.7368

Phone: 952.893.3200

Fax: 952.893.0704


http://www.agilitihealth.com

http://www.agilitihealth.com

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FUELING THE QUALITY ENGINE