Suzanne A. Celmer-Harter, MA, BS, MT(ASCP)€¦ · Web viewThis plan provides specific guidance...

Running head: SCDU LAB BUSINESS PLAN 1

Serious Communicable Disease Unit Laboratory Business Plan

Suzanne Celmer-Harter

LDR 609

Dr. John Fick, FACHE

A project submitted in partial fulfillment

of the requirement for the degree

Master of Arts

Siena Heights University

June 26, 2017

SCDU LAB BUSINESS PLAN 2

Table of Contents

Executive Summary-----------------------------------------------------------------------------------------3

Strategic Direction-------------------------------------------------------------------------------------------4

Environmental Scan-----------------------------------------------------------------------------------------5

External Factors-U.S. Preparedness Strategies----------------------------------------------------------5

Regional Factors-State of Michigan Tiered Response System----------------------------------------6

Internal Factors-Risk Assessment for Beaumont Wayne Laboratory--------------------------------7

Laboratory Preparedness Process-------------------------------------------------------------------------8

Facility Planning-------------------------------------------------------------------------------------------10

Financial Budget and Capital Resource Requirements-----------------------------------------------11

Implementation Plan--------------------------------------------------------------------------------------12

References--------------------------------------------------------------------------------------------------15

Appendix A Biosafety Risk Assessment Worksheet-------------------------------------------------17

Appendix B Renovation of Laboratory for Creation of SCDU Laboratory-----------------------25

Appendix C Financial Costs Associated with Creation of SCDU Laboratory--------------------26

Appendix D Serious Communicable Disease Unit/Laboratory Training Curriculum------------27


Serious Communicable Disease Unit Laboratory Business Plan

Executive Summary

Beaumont Wayne serves the Western Wayne County region in Michigan as a 215-bed

community hospital with a level III trauma center accredited by the American College of

Surgeons (ACS) (Beaumont Health, Beaumont Hospital, Wayne, 2017). Beaumont Wayne’s

emergency department is equipped with 47 beds, and the intensive care unit has 18 monitored

beds to provide critical care to its patients. The hospital is located four miles from Detroit

Metropolitan Airport (DTW) and has a long-term relationship with the airport for emergency

response and provision of care.

Beaumont Wayne is an active member of the Region 2 South Healthcare Coalition,

participating in emergency preparedness planning and drills ranging from mass casualty

incidents to rapid emerging serious communicable disease scenarios. As hospital most

proximal to the DTW international airport, Wayne has maintained a contract with the

CDC Quarantine Station since the SARS outbreak of 2005 as the primary referral facility

for evaluation of ill air travel passengers screened through the station. (J. Cargill,

personal communication, September 22, 2016)

This plan provides specific guidance for Beaumont Wayne’s laboratory response to Ebola

and other serious communicable diseases. Creation of a serious communicable disease

laboratory, which will allow early identification of the disease and diagnostic treatment, is

critical for infection control, providing medical care, and keeping staff safe from transmission of

the disease. The principles and specifics of this plan pertain to Beaumont Wayne and follow the

guidance and recommendations of the Centers for Disease Control and Prevention and the

Michigan Department of Health and Human Services.


Strategic Direction

Beaumont Health is committed to providing the highest quality of care to all patients,

which it serves regardless of the type of illness or disease.

Compassion is a fundamental attribute to be a Beaumont Health physician, employee or

volunteer. It is so critically important, compassion is reflected in our mission, vision and

values: Our mission-Compassionate, extraordinary care every day; Our vision-To be

the leading high-value health care network focused on extraordinary outcomes through

education, innovation and compassion. Our values:

Compassion

Respect

Integrity

Teamwork

Excellence. (Beaumont Health, About us: Mission, vision and values, 2017, para.

1-4)

An integral part of the mission, vision and values of Beaumont Health is providing

the highest level of readiness for public health events by providing a strategic and

operational framework, along with the resources to respond and protect patients, visitors,

staff, and communities in the event of a serious communicable disease threat. The goal of

Beaumont Health is to coordinate, communicate, and collaborate with hospitals within the

system, the airport, and local/state departments of health to meet the demands of a public

health emergency through mitigation, preparedness, response, and recovery. Beaumont

Health is committed to providing a safe environment for all that meets the CDC and

MDHHS recommendations and regulations for care.


Environmental Scan

In 1976, Ebola appeared in “two simultaneous outbreaks in Sudan and the Democratic

Republic of the Congo. Ebola disease is named for the Ebola River, located in a village in the

Congo” (World Health Organization, 2017, para. 1). Ebola is a virus that is transmitted through

blood and body fluids. According to the WHO (2017), Ebola patients are contagious only when

the disease has progressed, and the patient becomes symptomatic. Symptoms appear 2 to 21

days after exposure and include fever, muscle pain, headache, fatigue, diarrhea, vomiting,

abdominal pain, and hemorrhaging. The primary treatment for Ebola patients is supportive care

with electrolyte replacement, blood pressure control, and respiratory support (Guarner, 2014).

External Factors-U.S. Preparedness Strategies

In 2014, the largest to date Ebola epidemic occurred, which affected multiple countries in

West Africa. The overall risk of Ebola in the United States was and currently remains low. The

United States implemented safeguards against Ebola by requiring travelers from the three

primary affected countries to fly into one of five major airports, which conducted intensive

screening for the virus. Travelers were required to have their temperatures checked for signs of

fever, which may have indicated symptoms of the Ebola virus. Upon absence of fever, travelers

were entered into a public health registry as a Person Under Investigation (PUI) and were

monitored daily by their local health department. Any change in a person’s status regarding

symptoms within 21 days after arrival from the West African countries resulted in a public health

alert, and the traveler admitted to a local hospital that was set up to accept potential Ebola

patients. Patients assessed as having a high risk of Ebola were admitted to an isolation unit at the

hospital, and evaluated by infection control specialists, the local and state health departments,

and the CDC. If a diagnosis of Ebola was being considered, laboratory confirmation of the


Ebola virus was required (U.S. Department of Health and Human Services Centers for Disease

Control and Prevention, 2016).

Regional Factors-State of Michigan Tiered Response System

It was an unrealistic expectation that all potential Ebola patients coming from outside of

the United States would have been diverted to one of the five selected airports for screening and

evaluation and remained close to the airport location for up to three weeks after arrival. The

CDC distributed contact information about screened passengers to state health departments based

on the traveler’s residence. The Michigan Department of Health and Human Services (MDHHS)

assessed individuals arriving in Michigan after travel to an affected country for risk of

development of Ebola for up to 21 days. In addition, all patients that presented to hospitals for

treatment needed to be screened for recent travel history utilizing CDC and MDHHS algorithms.

Once a potential Ebola patient was identified, the hospital should have initiate an internal

response protocol.

MDHHS, in collaboration with the Centers for Disease Control and Prevention (CDC),

has created a tiered system to designate the response capabilities of hospitals. There are four

tiers established, each with different requirement needs to provide treatment, transfer or receive

patients. Local and state public health departments, hospitals, and emergency responders are

aware of the tier designation for each facility in its region to ensure patients are transported to the

correct location every time. Tier 1 and Tier 2 hospitals are required to treat patients. Tier 1

facilities will accept transfers from all other facilities in the region. Tier 2 facilities will only

accept transfers from facilities within the same hospital system. Tier 3 and Tier 4 facilities are

required to isolate and hold patients for up to 24 – 96 hours and then transfer patients to a Tier 1

or Tier 2 treatment center (Michigan Department of Health and Human Services, 2017).


As previously stated, in 2014, Beaumont Wayne was designated as Beaumont Health

system’s Tier 2 hospital for evaluation and treatment of patients with serious communicable

diseases. This designation required Beaumont Wayne to provide the capability to intake, isolate,

screen, test, and treat the serious communicable disease patient for the duration of their care and

recovery (Michigan Department of Health and Human Services, 2017). Beaumont Wayne was

selected for this designation because of the close proximity to the airport, and the physical

features that permitted effective patient intake and isolation, including direct access to the ED

and ICU negative pressure isolation rooms from the exterior of the facility. Tier 2 capability

requires the ongoing dedication and commitment of significant planning, financial, equipment,

personnel, training, and physical structure resources according to CDC guidelines.

Internal Factors-Risk Assessment for Beaumont Wayne Laboratory

The risk of acquiring Ebola through laboratory testing is low but not zero. “Biosafety

practices should be adhered to in all laboratories that receive potentially infectious material in

order to ensure laboratory personnel, public and environmental safety” (Association of Public

Health Laboratories, 2015, p. 1). Laboratories considering performing serious communicable

disease testing are required to perform a risk assessment to mitigate hazards. This assessment

represents the precautions that have been taken at Beaumont Wayne laboratory to safely handle

specimens from persons under investigation for serious communicable diseases. Analysis of

equipment, procedures, and processes was accomplished by evaluating engineering controls,

administrative practices, and process pathways (see Appendix A Biosafety Risk Assessment).

Laboratory Preparedness

As previously stated, Beaumont Wayne was designated to be a Tier 2 hospital. Initial

preparation was done to set up a Serious Communicable Disease Unit (SCDU) lab. Equipment


and instruments were purchased and validated. Laboratory volunteers were selected, but no

drilling was performed for specimen collection, transportation, analysis, waste containment and

donning/doffing of PPE. The Ebola outbreak was contained, and the laboratory was dismantled

in January 2016. In September 2016, MDHHS performed an unannounced drill to determine the

site’s preparation for communicable diseases. No departments were ready, and leaders were

given the directive to reinitiate SCDU units and provisions for care. The first step was to do a

SWOT analysis.

Strengths Executive confirmation for Beaumont

Health to have a SCDU program to

align with our mission to provide

compassionate care every day

At system level, large clinical staff to

recruit resources

Wealth of research now published

related to SCD Units including

templates, processes, and procedures

Most instrumentation is currently in

place in the laboratory

Weaknesses Leadership at executive level-corporate

steering committee was not formed

Lab team was formed in 2014 from

volunteers but never drilled -No training for

donning and doffing PPE

Facility without renovations does not

support program

BSC was moved offsite. Will need to bring

back and recertify prior to use

Costs excessive to maintain SCDU, which

may never be used for patient care

Opportunities

Creation of steering committee

New policies allow for core instruments

to be used

Re-frame program to create additional

benefit to Beaumont for emerging

diseases, research and funding

Threats

Inadequate training could cause harm to

staff

Poor public image/financial impact if

hospital is perceived to be unprepared

Negative impact on employee retention if

they feel unsafe


In addition to the SWOT analysis, a preparedness evaluation for the current state of

Beaumont Wayne was conducted in conjunction with laboratory, infection control, nursing,

environmental services (EVS), employee health, and emergency/trauma services.

People Who would be in charge and direct the

SCDU

How would volunteers be recruited

Would have to prepare for 96-hour

staffing rooster

Train all personnel in PPE

Drill in all activities: Intake, care, lab,

imaging, procedures, waste handling,

body management

Process ED intake and identification

Isolation, selection, and preparation of

treatment area

Transfer of patient from ED to SCDU

Treatment area processes: patient care,

laboratory, imaging, cleaning, waste

management, equipment protection and

reprocessing

Post care HCW monitoring

Environment

SCD area: OBS A versus ICU, window

needed by state requirements to view

outside

How to handle visqueen wall placement

to separate SCD patients from ICU

population

SCD area mapping, steps to prepare and

drilling

Clean to dirty HCW flow

Isolation integrity prevention

maintenance

Lab specimen collection, handling,

processing, transport and testing flow

Waste collection, storage, disposal

Terminal clean of areas

Equipment

PPE, on-hand and replenishing supplies

No PAPRS currently purchased

Disposable bedside equipment

Identification of non-disposable equipment,

contamination mitigation, and

decontamination in terminal process

AV patient and staff monitoring including

communication equipment needed

Patient internet and phone communication

needed

Evaluation of utilization of lab point of care

instrumentation versus core analyzers

Recertification of BSC

How do you handle need for radiography

procedures i.e. CT, MRI, IR


Since the unannounced drill transpired in September 2016, monthly meetings of

Beaumont Wayne’s SCDU planning committee have occurred. Members have been charged

with preparing their departments for initiation of a SCDU event. The drill made it painfully

apparent that Beaumont Wayne was far from being able to sustain a SCD Unit and laboratory. In

the laboratory, reestablishment of point of care instrumentation, manual kit testing, and policies

and procedures have been developed or reevaluated for current established practices in the

diagnosis and treatment of diseases caused by special pathogens. Preparation is ongoing. The

ultimate goal is to be able to support Beaumont Health’s mission, vision and values as well as

providing staff a safe workplace that is free from personal harm or danger.

Facility Planning

The former glass washroom adjacent to the main lab where the deionized water system is

currently located was selected as the area to configure for the Serious Communicable Disease

Unit Laboratory. Renovations will require the room to be gutted, and the deionized water system

that serves the chemistry analyzers relocated. The room will need it be divided into three

sections. The largest section, which will be referred to, as the (red zone), will be against the back

wall where the deionized water was located. A stainless steel counter will need to be constructed

that runs parallel to the wall. The biological safety cabinet will be placed on the counter. A sink

with an eyewash station is required in the room. A refrigerator, packaging area, and supply

shelves will need to be located in the area. The front section of the divided room closest to the

door will have to be subdivided into two small rooms: one for donning and one for doffing. All

traffic must flow in a circle from clean/donning (green zone) to BSC room (red zone) to doffing

room (yellow zone). It was also suggested to make the room negative pressure to accommodate

potential contamination from doffing and in consideration of future pathogens. The ceiling will


have to be constructed of a solid material without separate acoustical tiles. The walls dividing

the rooms will have to have glass windows. Because rooms are small, traditional doors that open

inward are not a possibility. The SCDU lab will need glass doors that would slide open with a

push pad (operated by an uncontaminated elbow) for all three rooms. A shower and eyewash

station is also required in the doffing area (yellow zone), along with space for biohazard waste

bins. Finally, the donning room (green zone) will need to have storage spaces for clean PPE.

All dimensions must follow the CDC guidelines for the creation of Biological Safety

Laboratories (see Appendix B Renovation of Laboratory for Creation of SCDU Laboratory).

The operational impact of not creating a separate Serious Communicable Disease

Laboratory would be severe to Beaumont Health System and affect the diagnostic testing that we

could perform for critical patients. This construction is required to provide the SCDU level of

laboratory services needed for Beaumont Wayne as the Tier 2 for Beaumont Health system. If

the SCDU laboratory renovation is not approved, the laboratory will not be able to support the

system initiative of providing care for these potentially highly contagious patients.

Financial Budget and Capital Resource Requirements

During the initial pandemonium of the 2014 Ebola presence in the U.S., hospitals and

laboratories rushed to set up SCD units without much forethought about costs and sustainability.

A survey done in 2015 showed, “45 of the US hospitals spent a cumulative total of $53.9 million

(nearly $1.2 million per facility) to stand up their specialized isolation units” (Herstein, et al.,

2017, p. 965). At Beaumont Wayne, there was a proposal done in 2014 to build a new addition

to the hospital to house the SCDU (patient care and laboratory) at the cost of over $3 million

dollars (J. Cargill, personal communication, May 19, 2017). Funding and project approval was

never obtained, and the hysteria of Ebola preparedness died down by the end of 2015. “Without


the impending threat of Ebola virus disease (EVD) or another highly infectious disease (HID) on

the immediate horizon, public attention on HID preparedness tends to waver, and governments

tend to prioritize and shift funding elsewhere” (Herstein, et al., 2017, p. 967).

However, hospitals must remain vigilant for current or new threats to public health.

Healthcare organizations must be in a state of continual readiness to manage public health events

including the new emergence of pathogens that are not yet on anyone’s radar. In regards to

Ebola and many other pathogenic diseases, “early diagnosis and treatment are essential to initiate

supportive treatment before irreversible shock occurs to prevent further spreading of the disease”

(Cao, Senn, Castaneda, Humphries, & Karger, 2017, p. 189). If an healthcare system is to

remain dedicated to this type of patient care, it will require the ability to commit organizationally

and financially to the project. A report of all of the costs that have been spent by the laboratory

to establish a SCDU laboratory along with the projected future costs is attached (see Appendix C

Financial Costs Associated with Creation of SCDU Laboratory). A dedicated and supported

SCDU laboratory will not be limited to care of Ebola patients but could be used for other serious

communicable disease including multi-drug resistant TB, Botulism, Tularemia, Anthrax, SARS,

MERS, Avian Influenza, Monkeypox, Smallpox, and Plague.

Implementation Plan

Providing effective testing and diagnostic care for a serious communicable patient in a

safe environment for laboratorians is the prime focus of this plan and our organization.

Education of healthcare workers and prevention of exposure is crucial. It is imperative that

laboratory staff receive the most current specialized training and is confident in their

comprehension of policies, procedures, and protocols. Creating a team of dedicated


laboratorians is the first step in the implementation of the Serious Communicable Disease Unit

Laboratory.

Education about infection control and correct utilization of personal protective equipment

(PPE) is required. Healthcare workers must understand and have the knowledge of how to

protect themselves by donning and doffing PPE in a methodical manner, so they do not

accidentally contaminate themselves with blood or body fluids from patient samples. In

addition, staff must be able to perform testing while garbed in PPE. Initial donning and doffing

training will be done in a three-day hospital workshop with facilitators who will take each team

member accurately and precisely through each step (see Appendix D Serious Communicable

Disease Unit/Laboratory Training Curriculum). One day will be dedicated to the performance of

testing, including utilizing the biological safety cabinet and packaging specimens for internal and

external transport while in PPE. Continual preparedness will be accomplished through quarterly

refresher training days, as well as, unannounced emergency responder drills.

All team members will be educated in how to use the laboratory equipment including set-

up, reagent loading, calibrations, performing and documenting daily quality control, performing

patient analysis, result entry, maintenance, and troubleshooting instrumentation. Per

accreditation regulations by College of American Pathologists (CAP), technologist (and nursing

staff that performs point of care testing at the patient’s bedside) will be assessed for competency

at the initial learning event, six months after initial learning, and annually for the remainder of

their tenure on the team. Additionally, technologists will be assessed for competency regarding

specimen procurement, handling, transport, packaging, and waste management. Checklists will

be created for staff to use to verify every step in a procedure or protocol for anything requiring

competency assessment. Any changes in protocols will be communicated to team members


verbally and through written communications via policy and procedural changes in document

control. Team members will have to sign off to verify they understand the changes and will

adhere to the updated policies and procedures.

Timelines for implementation is dependent on the organization’s ability to determine

financial support for the renovation of the SCDU and laboratory. If the financial support is

approved, it will be approximately three to six months for site construction to be completed. The

laboratory is currently able to perform testing for SCD patients on closed tube specimens on the

current automated instrumentation. Personnel can be trained on all instrumentation and PPE

within a month. All testing that requires opening specimen tubes will need to be sent to MDHHS

laboratory for testing until the laboratory can establish a permanent site for the biological safety

cabinet and staff are trained in donning and doffing of PPE.

Conclusion

As one can see from the frequency of medical headlines in the news to serious

preparation regulations directed by federal and state health agencies, preparation for future

critical pathogenic diseases is necessary. Facilities must take action to prepare themselves for

biological attacks made on our communities. It is a healthcare organization’s commitment to

public health that requires facilities to adopt measures to prepare for potential attacks and keep

our citizens and employees cared for and safe.


References

Association of Public Health Laboratories. (2015, April). A biosafety checklist: Developing a

culture of biosafety. Retrieved from Association of Public Health Laboratories:

https://www.aphl.org/aboutaphl/publications/documents/id_biosafetychecklist_42015.pdf

Beaumont Health. (2017). About us: Mission, vision and values. Retrieved from Beaumont

Health: https://www.beaumont.org/about-us/mission-vision-and-values

Beaumont Health. (2017). Beaumont Hospital, Wayne. Retrieved from Beaumont Health:

https://www.beaumont.org/locations/beaumont-hospital-wayne

Cao, J., Senn, C., Castaneda, P., Humphries, S., & Karger, A. B. (2017). Establishing a stand-

alone laboratory dedicated to the care of patients with ebola virus disease. Laboratory

Medicine, 48(2), 188-194. doi:10.1093/labmed/lmw072

Guarner, J. (2014). When the rubber meets the road: Dealing with a returning traveler from West

Africa during the ebola outbreak of 2014. American Journal for Clinical Pathology,

142(4), 428-430. doi:10.1309/AJCPEPQB4G3ECCOP

Herstein, J. J., Biddinger, P. D., Gibbs, S. G., Le, A. B., Jelden, K. C., Hewlett, A. L., & Lowe, J.

J. (2017). Sustainability of high-level isolation capabilities among US ebola treatment

centers. Emerging Infectious Diseases, 23(6), 965-967. doi:10.3201/eid2306.170062

Michigan Department of Health and Human Services. (2017). Four tiers of MI hospitals ebola

virus disease: Preparedness and response. Retrieved from Michigan Department of

Health and Human Services:

http://www.michigan.gov/documents/mdhhs/Hospital_Tiers_final_559431_7.pdf

U.S. Department of Health and Human Services. (2016, July 8). CDC’s response to the 2014–

2016 ebola epidemic West Africa and United States. CDC Morbidity and Mortality


Weekly Report, 65(3), 1-112. Retrieved from

https://www.cdc.gov/mmwr/volumes/65/su/pdfs/su6503.pdf

World Health Organization. (2017, May). Ebola virus disease. Retrieved from World Health

Organization: http://www.who.int/mediacentre/factsheets/fs103/en/


Appendix A: Biosafety Risk Assessment Worksheet

Beaumont Health WayneLaboratory Biosafety Risk Assessment Worksheet

CDC and MDHHS Recommendations (APHL Template)

Hospital Laboratory Name: Beaumont WayneDate of Assessment: June 17, 2017Name of Assessor: Suzanne Celmer-Harter, BS MT(ASCP)

Laboratory Director/ManagerBiosafety Level: BSL 2 LaboratoryName of Organism/Agent: Ebola Virus

Procedure Potential Hazard(s) Control Recommended Guidelines

Specimen Collection from potential SDU patient-Nursing to obtain specimen(s)

Needle stick injuries Only trained personnel allowed to perform specimen collection following universal precautions protocols.

Appropriate PPE is required.

Only plastic tubes can be used: no glass.

Dispose of sharps in approved designated container.

Doff hand PPE per protocol; immerse site of injury with 70% alcohol for 30 seconds, wash with soap and water.

Immediately seek medical evaluation.

Report and document incident per EHS protocol.



Handling of Specimen(s)-Nursing to package specimen(s) in patient room according to protocol-triple bagged wiping the specimen(s) and bags with bleach wipes and allowing drying between bags.)

Dropping or failure to tighten specimen container lid(s) resulting in specimen tube leakage or breakage

Ensure all specimen tubes collected are tightly sealed.

If cap has to be removed from tube to fill with specimen, make sure that it is put firmly back in place and wrapped with parafilm.

Follow protocol for biological spills notify management.

Decontaminate and collect waste according to protocol.

Don new PPE after cleanup.

Redraw or collect new specimen(s).

Leaking of specimen(s) in bag

Inspect each individual bag to ensure it is free of tears, rips, or holes before placing specimen(s) inside.

Individually bag specimen(s) collected and decontaminate each exterior.

Follow protocol for biological spills.

If leakage is within the first bag, but contained inside the second bag, discard specimen(s) according to protocol.

If leakage has occurred through all bags, follow protocol for disinfection of specimen(s)/bags and transport container.

Immediately notify nursing personnel of unacceptable specimen(s) and document on log sheet.

Transport of Dropping of Only trained Follow protocol



Specimens(s) specimen(s) collected causing tube(s) to break/leak

personnel in appropriate PPE are allowed to transport specimen(s).

Carefully handle all specimen(s) wearing PPE and place transport box on cart (never hand carry).

Do not use pneumatic tube system

Use less populate routes for intra-facility transport with security clearance.

for biological spills.

If leakage is within the first bag, but contained inside the second bag, discard specimen(s) according to protocol.

If leakage has occurred through all bags, follow protocol for disinfection of specimen(s)/bags and transport container.

Immediately notify nursing personnel of unacceptable specimen(s) and document on log sheet.

Breakage of specimen(s) in transportation box

Specimen(s) must be transported in a durable, leak-proof transport container.

Ensure specimen transport box is fully intact with no cracks or breakage before placing specimen(s) inside.

Don new PPE per protocol if integrity has been broken.

Place specimen(s) into new specimen transport box.

Immediately notify management.

Processing and Aerosolization, Wear If specimen(s)



Testing of Specimen(s)

Splash, or Splatter due to vortexing or centrifugation

appropriate PPE to prevent from contact with skin, eyes, and clothing.

Only perform vortexing or centrifugation in BSC with sash at appropriate level.

Limit traffic around BSC and minimize number of personnel in PPE handling specimen(s).

Make sure all lids on specimens are on tight before vortexing or centrifuging.

Use sealed rotor in centrifuge.

Follow all acceptable BSC practices.

Rapid/kit testing must be performed inside BSC.

break inside centrifuge, wait 60 minutes for aerosols to settle before opening lid and assessing spill.

Wash exposed skin with soap and water.

Utilize Eye wash according to protocol for exposure to eyes.

Remove contaminated clothing or shoes.

Follow Infection Control Protocols for exposure, which may include showering.

Specimen(s), equipment and all materials must be decontaminated before removing from BSC.


Transfer of Only trained Wipe all tube(s)



contaminated material from the BSC or contamination of BSC surfaces

personnel in PPE are allowed to perform testing.

Ensure personnel don appropriate PPE to be protected from exposures.

with disinfectant wipes. Place tube(s) into a bag (inspected for tears) along with a disinfectant wipe. Seal and wipe outside of bag with disinfectant wipe and place in second bag. Repeat with third bag and wipe outside of bag.

Discard specimen(s) in appropriate waste container.

Wipe inside of BSC with disinfectant.


Aerosolization, Splash, or Splatter due to analysis on instrumentation-no vents are present on instrumentation to allow potential exposure while instrument is running.

Always follow manufacturer’s recommendations for utilizing instruments.

Never operate instruments without protective covers or shields in place.

Wear appropriate PPE to prevent from contact with skin, eyes, and clothing.

Limit traffic

Wash exposed skin with soap and water.

Utilize Eye wash according to protocol for exposure to eyes.


Follow Infection Control Protocols for exposure, which may include showering.

Specimen(s),



around instrumentation and minimize number of personnel in PPE handling specimen(s).

Make sure all lids on specimens are on tight and not broken/cracked before placing specimen(s) on analyzers.

Do not remove caps from specimen(s) prior to placement on analyzer.

Do not perform dilutions. Accept > linearity range for results.

equipment and all materials must be decontaminated before removing from BSC.


Malfunction of instrument

Ensure all equipment works according to manufacturer’s instructions prior to specimen(s) arriving in lab.

Place specimen(s) in a secure area for storage (BSC or refrigerator in SCDU lab until instrument is operational.

Notify nursing that testing cannot be performed immediately.

Call technical



support hotline for troubleshooting instructions. Place service call for onsite support if needed.

Notify management immediately.

Accidental exposure to a piece of an instrument that was used for SCDU patient testing

Only trained personnel in appropriate PPE are allowed to operate instruments.

Limit number of individuals near instrument during and after analysis (prior to final decontamination).

Utilize appropriate PPE to prevent contact.

Wash exposed skin with soap and water immediately.

If exposure is an injury, which breaks the skin, carefully doff PPE, and wash in 70% alcohol for 30 seconds, wash with soap and water.


Immediately seek medical evaluation.

Report and document incident per EHS protocol.

Packaging of Specimen(s) for External Transport

Leaking package Inspect each individual bag to ensure it is free of tears, rips, or holes before placing specimen(s) inside.

Individually

Discard leaking package according to contaminated waste protocol.

Immediately notify nursing.




bag specimen(s) collected and decontaminate each exterior.

Pack specimen(s) according to Category A transport procedure.

Waste Collection External contamination of waste containers

Only trained personnel in appropriate PPE are allowed to collect waste for disposal.

Ensure personnel don appropriate PPE.

Only trained EVS employees can remove waste from lab and facility.

Waste containers must be disinfected before removal from BSC and lab.

If waste container is leaking, use appropriate PPE to contain spill.

Limit the number of people with access to the area.

Notify EVS to have trained personnel in appropriate PPE clean and disinfect area.

EVS will isolate the waste container and control spill.

Storing of Specimen(s) awaiting External Transport

Malfunction in designated refrigerator

Ensure storage units are functioning prior to specimen arrival (check temperature and alarm status).

Utilize a backup storage unit if available.

Pack in dry ice and leave at room temperature for up to four hours.

Appendix B: Renovation of Laboratory for Creation of SCDU Laboratory


Appendix C: Financial Costs/Budget Associated with Creation of SCDU Laboratory


Hospital NameEbola Treatment Center Activity Description Activity Time

PeriodApproximate/Estimated Cost

Current costs Assure Readiness of Ebola Treatment/Assessment Center activities

Beaumont Wayne Laboratory Equipment-Refrigerator 12/2014 $549.00Beaumont Wayne Laboratory Equipment-Statspin centrifuge 12/2014 $2,653.00Beaumont Wayne Laboratory Equipment-BSL 2 biosafety cabinet 12/2014 $12,615.00Beaumont Wayne Laboratory Equipment-Hemochron Elite coag analyzer 12/2014 $7,100.00Beaumont Wayne Laboratory Equipment-Hematology Drucker QBC star 12/2014 $6,950.00Beaumont Wayne Laboratory Equipment-Hematology Sysmex pocHi-lab 5/2017 $16,900.00Beaumont Wayne Laboratory Equipment-Chemistry Piccolo Express 12/2014 $10,800.00Beaumont Wayne Laboratory Equipment-Chemistry Abbott i-Stat 12/2014 $10,493.00Beaumont Wayne Laboratory Testing supplies; QC; cartridges, tubes,

calibrators, kits, verification samples12/14-5/17 $22,468.00

Beaumont Wayne Laboratory CAP proficiency surveys 2015-2017 $2,610.00Beaumont Wayne Laboratory Salary of technical personnel utilized

during lab setup10/16-5/17 $37,464.00

Total Current Costs: $130,602.00

Projected Future CostsBeaumont Wayne Laboratory Enhancements to physical infrastructure to

ensure infection control for Ebola/Special Pathogen preparedness and response activities: Lab-250 sq. ft., relocation and renovation of two additional sites-250 sq. ft. Renovation cost estimated to be $350 sq. ft. to include new HVAC for negative pressure and relocation of electrical panel for main laboratory

2017-2018 $175,000.00

Total 2017 Costs SCDU Lab Implementation:

$303,987.30

Beaumont Wayne Laboratory Maintenance and recertification of Biological Safety Cabinet

Twice/year $1000.00

Beaumont Wayne Laboratory Reagents and supplies for testing (estimate)

annual $20,000.00

Beaumont Wayne Laboratory CAP proficiency surveys, CAP and CLIA license to perform testing

annual $3000.00

Beaumont Wayne Laboratory Vendor Service agreements for instrumentation (estimate)

annual $15,000.00

Beaumont Wayne Laboratory Labor costs for quarterly drilling/training/competency of 6-8 technologists

annual $10,000.00

Beaumont Wayne Laboratory Labor costs for 2 technologists on-call staffing 24h/d, 7d/wk

annual $52, 600.00

Beaumont Wayne Laboratory Administrative costs of SCDU technical specialist (0.5 FTE)

annual $35,000.00

Future Annual Budget Costs $136,600.00

Appendix D: Serious Communicable Disease Unit/Laboratory Training Curriculum


Beaumont Hospital WayneSerious Communicable Disease Unit/Laboratory Team

Training Curriculum

Team Member Name:_______________________________________________________

Employee ID:______________________________________________________________

Date(s) of Training:_________________________________________________________

Type of Training (initial or refresher):_________________________________________

Name of Preceptor(s):_______________________________________________________

Team Member Achieved Proficiency (Yes or No):________________________________

Proficiency Reassessment Dates (if needed):_____________________________________

(Initials indicate the student has been shown, understands and demonstrates proficiency)

Date: PreceptorInitials

StudentInitials

IntroductionPurpose of SCDU TeamMission & Values of BHS and SCDU TeamAssumptions/CommitmentRisk AssessmentSafetyTraining plan and Education

Employee HealthCare provider symptom questionnaireExposure and symptom monitoringMDHHS guidance for monitoring and movementImmunizations

Serious Communicable DiseasesReview of select serious communicable diseases, EbolaUniversal infection prevention strategies and practicesInfection Prevention Guidance Summary for HCP

Personal Protective Equipment (PPE)PPE Guidance Matrix for Serious Communicable DiseasesEmployee physical evaluation checklistPPE requirements including Fit Testing for N-95 maskPPE and Cleaning Supply ListTrained observer, Trained observer checklist


Donning procedurePPE donning checklistDoffing procedurePPE doffing checklistDonning and doffing PPE with N-95 maskDonning and doffing PPE with PAPRS (if needed in lab)Cleaning and disinfecting PAPR battery and tubing

BHS Patient Screening and IntakeIdentify Isolate, Inform Algorithm (Figure 2.1)ED Algorithm, ED Job action sheetsAmbulatory Sites Algorithm

CommunicationCommunication Plan ACommunication Plan BCommunications TimeLineHICS & Notification of MDHHS

Serious Communicable Disease Unit (SCDU)SCDU backgroundStandard Operating ProceduresPhysical characteristics, unit layoutActivation of the SCDU

Care of the SCDU Patient related to ancillary servicesSpecimen collection, blood draw for EVDI-Stat, misc. point of care testing (assisting nursing)Blood product administration in SCDUEthics recommendations for the care of the SCDU patientAutopsy and tissue policies

Obtaining and Processing Laboratory SpecimensGuidelines for laboratory precautions and safetyLaboratory notification and consultationPatient log sheets for processing and analysisSpecimen procurement and handlingSpecimen procurement and handling checklistTransporting specimens within the hospital to labTransport checklistPacking and shipping specimens to MDHHS or CDCPacking and shipping to an external facility checklistUtilization of Biological Safety CabinetCentrifugation safetyLaboratory test menu


Analysis of Laboratory SpecimensUtilization of Automated Instrumentation ProcedureDXH training and proficiencyTop 500 training and proficiencyDXC/DXI training and proficiencyPreparation for analysis and decontamination proceduresChecklist for decontamination of instruments

Point of Care TestingpocHi training and proficiencyHemochron Elite training and proficiencyPiccolo training and proficiencyi-Stat training and proficiencyAlere BinaxNow Malaria training and proficiencyFlu, Strep A, RSV kit testing training and proficiencyUrinalysis multistix dip testing training and proficiency

Blood BankProcedure for blood bank testingSelection and processing of blood products for transfusion

Environmental Infection ControlCleaning/Disinfection of BSC unit and SCDU laboratoryCleaning/ Disinfection/ Waste management checklistBiohazard waste removal-notification of EVSManagement of Contaminated Equipment Intended for Disposal/Repair/Maintenance

Refresher trainingDonning and doffing proceduresPAPRS (if needed by lab)

I have read all policies related to the above topics, have practiced the procedures, and understand the expectations and requirements to be a member of the SCDU team and perform testing.

Signature:______________________________________________ Date:_________________

Management Review:_____________________________________ Date:_________________

Suzanne A. Celmer-Harter, MA, BS, MT(ASCP)€¦ · Web viewThis plan provides specific guidance...

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