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9125-QE Managing Equipment in the Blood Bank Laboratory
10/9/2010
2:00 PM - 3:30 PM
Event Outline
Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory
Event Date: Saturday, October 09, 2010, 2:00 PM to 3:30 PM
Presenters: Theresa Downs, Sheri Goertzen, Nancy Shotas
Speaker Presentation
Theresa Downs
Sheri Goertzen Documentation Needed to Manage Your Equipment
Nancy Shotas Challenges in Documentation of Equipment Maintenance
Event Faculty List
Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010
Event Time: 2:00 PM to 3:30 PM
Director/Speaker Theresa Downs MT(ASCP)SBB, CQA(ASQ) UH2F225/Box 0054 1500 East Medical Center Drive Ann Arbor, Michigan, N/A, 48109 (734) 936-6862 [email protected] Disclosures: No
Speaker Sheri Goertzen MT(ASCP)BB, CLS(CA) 1779 E. Muncie Ave. Fresno, CA, 93720 (559) 353-6069 [email protected] Disclosures: No
Speaker Nancy Shotas BS MT(ASCP)BB CQA(ASQ) Laboratory - Blood Bank 2701 W. 68th Street Chicago, IL, 60629 (773) 884-4620 [email protected] Disclosures: No
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Managing Equipment in the Blood Bank Laboratory: Part 1
Equipment StandardsEquipment Standards
Theresa Downs, MT(ASCP)SBB, CQA(ASQ)
Selection
Qualification
UseWarming Devices
Computers
AABB Equipment Standards
Identification
Monitoring/Maintenance
Storage devices
Alarm systems
AABB Equipment Standards
Why Do We Do This?
Ensure The validity of data The safety, potency and purity of blood
productsproducts
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Equipment Qualification Timeline
Selection•Assess
il bl
Qualification• Install
Calibration/Maintenance
available equipment
•Decide on equipment
•Operate•Perform •Verify data
integrity•Maintain
equipment
Equipment Selection
Define selection criteria Why the equipment is needed Intended use Intended use What is available out there (pros and cons) Check manufacturer’s websites for
documentation QC, maintenance, cost
Which one will best meet needs Manufacturer track record
Equipment Qualification
Ensures the equipment works as intended
Uses IQ, OQ and PQ
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Installation Qualification
• Establishes the instrumentation was received as specified
• Documents the proper installation and operability according to manufacturer p y gstandards.
Local codes Safety Plugs Space Temperature Humidity
Operational Qualification
The process of demonstrating that an instrument will function according to the manufacturer’s operational specifications underoperational specifications under normal laboratory conditions. Does the equipment operate per
manufacturer’s instructions? Can maintenance/QC be performed per
instructions?
Performance Qualification
• A testing procedure designed to test the analytical instrument’s functional performance to factory published specifications. Performs per laboratory specifications Documents integrity of equipment Documents intended use
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Use of equipment
Follow manufacturer’s instructions!!!!
Unique identification
Traceability Maintenance/repair records QC records
ACME Laboratory
Monitoring and Maintenance
Use manufacturer’s instructions to determine Type of checks
F Frequency Acceptance criteria Actions for unsatisfactory results
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Calibration
Before use After repair At defined intervals Safeguards to Safeguards to
prevent adjustments to calibration
Investigation and Follow-Up
Assessment of blood products Quarantine until determination is made
Assessment of donor eligibility and d d ti t f tdonor and patient safety
Remove equipment from service Investigate the malfunction Re-qualify when repaired Reporting when indicated
Storage devices
Proper capacity for intended product Temperature monitored
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Alarm systems
Set to activate before unacceptable conditions
Initiates process for investigation d ti tiand corrective action
Blood warmers
Equipped with temperature sensing device
Detect malfunctions Prevent hemolysis and other
damage
Computer systems
Records Downtime processes Compliance Support of management of system Unauthorized access
AABB Meeting: 2010
Managing Equipment in the Blood Bank Laboratory : Part 2
Documentation Needed to Manage Your
Equipment
Sheri Goertzen, MT(ASCP)BB, CLS
Objective
Describe the documentation needed for management of equipment.
Will include: examples which will be shared and discussed.
Did you know…the 2nd most frequent CAP
deficiency for 2009 (11.05%) was GEN.20375 “Document Control”
Equipment Lifecycle
BirthPlan, Justification, Quotes, Purchase or Lease Agreement, Installation, Validation, Training
LifeQuality Control, Calibrations, Service Contracts, Maintenance, Corrective Actions, Repair Records
DeathDecontamination, Decommission, Disposal Records
Birth
PlanBudget JustificationQuotesAcquisition Records / Purchase OrderService Agreements / ContractsQualification:
Installation, Operational, Performance
Validation (if used in a process)Training
So where do we begin?How much is involved?
Depends on what kind of equipment.Does it perform a simple vs. complicated process?
Keep a file folder for each piece of equipment
Start with the acquisition documents and operator/user manuals.Add the qualification and validation documents.Continue to add service & repair records over the life of the equipment.Can be a paper file, an electronic file, or a combination of both.Records must be promptly accessible to the users of the equipment.
Example:
EQUIPMENT QUALIFICATION WORKSHEET
NEW EQUIPMENT REQUALIFICATION / MONITORING
Equipment Name/Model: ACME Plasma Freezer – XYZ/123
Vendor: ACME Date Received: 04/27/10 Asset #: 1033852
Description & Purpose of the Equipment: The ACME Plasma Freezer is a storage device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of storing frozen plasma products in the Transfusion Service.
Purpose of Qualification: Establish documented evidence that the ACME Plasma Freezer consistently, with a high degree of assurance, produces proper storage conditions.
EQUIPMENT QUALIFICATION WORKSHEET (cont.)
Qualification Activities:Installation Qualification (IQ)
Performed By: Plant Services/Engineering Date: 04/27/10Initial Electrical Check
Performed By: Biomed Date: 04/27/10Operational Qualification (OQ)
Performed By: Plant Services/Engineering Date: 04/27/10-04/28/10Performance Qualification (PQ)
Performed By: Tony Tech, MT(ASCP) Date: 04/27/10-05/02/10Risk Analysis
Performed By: Susie Supervisor Date: 04/28/10Safety Analysis
Performed By: Tony Tech, MT(ASCP) Date: 04/28/10Regulatory Analysis
Performed By: Susie Supervisor Date: 04/28/10
EQUIPMENT QUALIFICATION WORKSHEET (cont.)
Equipment Calibration(s) Requirements: Calibrate internal thermometer and graph using an NIST traceable digital thermometer.
Equipment Maintenance Requirements: Alarm checks, battery replacement and cleaning
Maintenance Frequencies: Quarterly: Alarm check, battery check.Annually and As Needed: Cleaning probe bottle, interior and exterior.
To be performed By: Laboratory staffMaintenance Procedure(s): Refer to Equipment manual, section 7.1Spare/Repair Parts List: Refer to Equipment ManualEquipment Cleaning Procedure: Refer to Equip. manual, section 7.3
Operating Procedures Written: Refer to Equipment ManualTroubleshooting Guide Written: Refer to Equipment ManualBasic Procedures for Monitoring and Control of the Operation:Refer to procedure Q0321.
Personnel Training Documentation Completed: N/A(Attach All Qualification/Validation/Training Documentation)
EQUIPMENT QUALIFICATION WORKSHEET (cont.)
Interpretation of Equipment Qualification/Validation:
Supervisor Review: ____________________________Date:___________
Medical Director Review:________________________Date:___________
Date Equipment Placed In Service:___________
Suitable for its Intended Purpose? Y N
Installed Properly? Y N
Functioning as Intended? Y N
Qualification/Validation Successful? Y N
Added to Critical Equipment List? Y NAdded to Equip. Operating Limits List? Y N
Validation Protocol: EquipmentEquipment being validated:
ACME Plasma Freezer
Asset Number: 1033852
Date of Purchase: 04/16/10 Received: 04/27/10
Purpose / Scope:What is the equipment
supposed to do?
Verify reliable storage of frozen plasma products.
Materials/Supplies /Equipment:
NIST traceable digital thermometer for calibration.
ResponsibilitiesWho is involved in this
validation and what is each of their roles?
Supervisor: write the procedure & this validation plan.Medical Director: approve the procedure and plan.Blood bank CLS: complete the validation testing.Supervisor: review the validation and write summary. Medical Director: review/approve the validation results.Supervisor: develop training documents/program for staff & document competency of all staff using the validation results.
Validation Protocol: Equipment (cont.)
Risk AnalysisIs patient or product
safety affected should this equipment fail?
High Moderate Low N/A
Failure of the plasma freezer will result in loss of one storage unit for frozen products. The alarm would alert us before products are destroyed and products would be moved to backup storage.
Safety AnalysisAre there any related
hazards with this equipment?
There are no identified chemical or safety hazards with the plasma freezer.
Regulatory AnalysisAre there changes in
licensure, registration, proficiency testing or accreditation needed?
There are no identified changes in regulatory needs with the acquisition of the plasma freezer.
Validation Protocol: Equipment (cont.)Procedure / Steps:
Include an adequate number of variables to test the process
Verify that the plasma freezer is able to maintain proper temperatures.Calibrate the internal thermometer and graph using an NIST traceable digital thermometer.Verify that internal thermometer readings and graph readings are consistent with NIST traceable thermometer readings.Perform alarm checks.
Expected Results / Acceptance Criteria
Clearly define an acceptable end result.
Plasma freezer should maintain proper temperatures consistent with NIST traceable digital thermometer within 2 C for at least 24 consecutive hours.Graph chart should be consistent with upper NIST traceable thermometer readings within 2 C for at least 24 consecutive hours.Manual alarm checks should verify audible alarm functionality at temperatures at or above -19 C.
Statistically valid number of samples
How is the sample size determined?Normal & Abnormal samples
Proper temperature maintained for 24 consecutive hours monitored using the min-max read-outs of the digital thermometer and graph chart.Manual alarm check (upper sensor and lower sensor) performed successfully at least once.
Validation Protocol: Equipment (cont.)Plan approval:Signatures and Dates
Supervisor:____________________Date______Medical Director:________________Date_____
Documentation/DataFailures must be tracked, evaluated and resolved. Documentation / Data sheets Investigation / Resolution Re-execution validation
Performance Qualification performed by Tony Tech on 04/27/10 – 05/02/10. Included: 04/27/10:Adjusting internal thermometer readings to match NIST traceable digital [email protected]/27/10:Adjusted graph to match readings.04/28/10:Fine adjustment of graph.04/28/10:Performed upper sensor automatic & manual alarm check successfully (-19 C)04/28/10:Engineering/ Plant Services adjusted defrost cycles to twice per day @12:00 and 16:30.04/28/10:Engineering/ Plant Services installed digital thermometer probes through interior path.04/29/10:Performed lower sensor manual alarm check unsuccessfully. Corrective action: contacted ACME Tech Support and received guidance on activating the lower sensor alarm settings (using service code: 5354).04/29/10:ACME Tech Support recommended to have defrost cycles remain at factory setting (3 times/ day).05/01/10:Performed lower sensor manual alarm check successfully (-19 C).
Validation Protocol: Equipment (cont.)Validation Summary:
The ACME plasma freezer was able to maintain proper storage temp. for 24 consecutive hours based on the data derived from the temperature logs, digital thermometer readings and temperature chart.The manual alarm checks for both upper and lower sensors at -19 C were successful.The validation was successful and it is recommended that the frozen plasma products be transferred from the backup freezer to the new ACME plasma freezer.Notes:The defrost cycles observed so far had a high temp. of -24.6 C, which was considered an outlier. ACME tech support was contacted. We will monitor the defrost log for 1 week and follow up.
Review & Approval ofValidation Results:
Signature and Date
"This validation study has been reviewed and the performance of the equipment is considered acceptable for regular operational use“
Medical Director:________________Date_____
Training / Competency
Whenever Applicable - Develop training document(s) & document Competency of all staff performing the process or using the equipment.
Life
Quality ControlCalibrationsService ContractsMaintenanceCorrective ActionsRepair Records
Equipment Management Documents
Maintaining a list of all critical equipment helps in the control function of scheduling and performing functional and safety checks, calibrations, preventive maintenance, and repair.
Sample: Critical Equipment ListControl Number
Equipment / Model
Serial Number
Manufacturer Purchase Date
Retire Date
1010003 Blood Processor 1627 COBE 07/07/89
1015374 Heat Block Marsters 425380 Clay Adams 06/14/01
1012899 Tube Sealer ACS152 0010021 Terumo 02/01/01
1020416 Blood Refrigerator BBR55
66288-200 Jewett 07/20/00
1024648 Plasma Thawer DH8 248219L Helmer 10/23/01
1018231 Sterile Connecting Device SCD 312
50278 Terumo 04/03/96
1051547 Echo Analyzer M00615 Immucor 04/27/09
1010021 Immufuge II 70860 Baxter Dade 06/06/89
1010017 Cellwasher 2 8600540 Sorvall 03/01/86 04/03/09
Sample: Equipment Operating Limits List
Control Asset Number
Equipment / Model Temperature Operating Limits
Humidity Operating Limits
AlarmY/N
Automatic Shut Down
Y/N1010003 Blood Processor 55 F to 85 F Not defined N N1015374 Heat Block Marsters Not defined Not defined N N
1012899 Tube Sealer ACS152 Op. Instructions: Do not install in a very hot and humid place.
N N
1032066 Blood Refrigerator IB120 5 C to 32 C 80% at 31 C
50% at 40 CY N
1024648 Plasma Thawer DH8 5 C to 35 C Not defined Y N
1018231 Sterile Connecting Device SCD 312
10 C to 38 C 10% to 80% N N
1010021 Immufuge II Not defined Not defined N N1010042 Cellwasher UltraCW 5 C to 40 C Not defined N N
Quality Control
QC testing is performed to ensure the proper functioning of materials, equipment and methods.QC records provide evidence that the process was performed as intended and provide information needed to assess the quality of products and services.
Calibrations / Maintenance
CAP TRM.32000: There must be a routine plan or maintenance schedule available for checking the critical operating characteristics of all the instruments in use on a regular, periodic basis. The procedure and schedule must be, at a minimum, as thorough and as frequent as specified by the manufacturer.
Sample: Maintenance ChecklistAny HospitalAnywhere, State
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
Alarm Checks: Refrigerators,Platelet Incubator, Freezer,
Water Bath MLA Pipettes - Accuracy
RPM - Centrifuges
Timers - Centrifuges & Irradiator
Scales - Accuracy
Stopwatch - Accuracy
Calibrate Serologic Centrifuges
The Joint CommissionWhen Preventive Maintenance is performed on a piece of equipment, the documentation needs to state specifically that “Manufacturer’s guidelines were followed in performing the required preventive maintenance.”Good idea… add this statement and a check box on your PM documents!
Sample: Corrective Action- Equipment
Date/Time: Department: Equipment Name: Asset #:
DESCRIPTION OF PROBLEM:
Does this problem create a possible patient safety issue? No Yes
If yes, describe investigation and action taken for resolution:
Taken out of service by: Date/Time:
Corrective Action- Equipment (cont.)Type of service required:
IN-LAB Vendor Service Hospital Engineer
Service call initiated to: Date/Time:Expected arrival Date/Time: Response by: Date/Time:
Delayed TAT Process Required? No YesIf yes, initiated by: Date/Time:
CORRECTIVE ACTION TAKEN:
(include date/time of each action)
Complete upon resolution of problem:Document Performance Criteria according to specific test protocol before reporting patient results:CALIBRATION Acceptable Not RequiredPATIENT SAFETY F/U Acceptable Not RequiredQUALITY CONTROL Acceptable
Placed back in service by: Date/Time:
Repair RecordsRepair records should be kept with each equipment’s history file. Should include:
In-House repairService tech repairHelp-Line / Remote repair
Repair reports and Corrective Action sheets are important to maintain a chronological & comprehensive Equipment History Record.
Sample: Equipment History Record
EQUIPMENT:_______________________ Asset No.:_____________
Model No.:_________________________ Serial No.:_____________Date Purchased:_____________________ Cost:________________Manufacturer:____________________________________________City:___________________State:_________________Zip:________Telephone:______________Contact Person:____________________
Dealer:__________________________________________________City:___________________State:_________________Zip:________Telephone:______________Contact Person:____________________
Warranty:_________________________Expiration Date:__________Technical Representative:________________ Telephone:__________
SERVICE RECORDDate Comments Who contacted, action taken____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
When there’s just no more fixing that can be done…
DeathDecontaminationDecommissionDisposal Records
Sorry… there is a bit more involved in disposing of an old worn-out friend…
Sample:Asset Decommission Form
Name of Supervisor:_______________________ Department:_____________Cost Center:______Asset Name:_____________Asset #:__________ Serial Number:___________
Date Completed
Begin by reviewing the manufacturer’s recommendations for shut down, removal from service and/or disposal. Comments:
Removal of all liquid reagents.
Decontamination of external/accessible surfaces.
Brief description of asset:
Deletion of patient information to comply with HIPAA regulations. Deletion needs to be "destructive" enough to remove any patient information, but still allow for the equipment to be functional in the event of a sale to another buyer.
Sample: (cont.)Asset Decommission Form
Plan for final disposition of asset:Date Completed
Notification to BioMed to remove the asset from the Safety Checks list & any Maintenance Agreements.
Notification to Laboratory LIS System Administrator to deactivate any interfaces.
Notification to stop any other service contracts on the asset.
Referral to BioMed for disposition when determined appropriate.
Notification to Accounting when the instruments are actually removed from the premises and require removal from the Laboratory Assets Lists.
Technical Supervisor Final Check List:All related procedures/forms updated or changed. Removed from department asset list.CAP contacted to update equipment list.
How long must we save these records?AABB Reference Std. 6.2CCAP TRM.32250
Years
Equipment Qualification 5
Equipment Validation 5
Unique Identification of Equipment 5
Instrument Quality Control 5
Monitoring and Maintenance 5
Temperature Monitoring 5
Temperature Monitoring of Tissue (CAP) 10
Irradiation Dose Delivery 5
It’s a good idea to save yourequipment files for the life ofthe equipment plus a fewmore years.
If records are maintained electronically, adequate backups should exist in case of system failure.
Sample: QSE: Equipment Self-Assessment Checklist
Records are maintained for each item of equipment contributing to the performance of examinations. These records include at least the following:
YES NO
Identity of the equipment;
Manufacturer’s name, type identification, and serial number or other unique identification;
Manufacturer’s contact person and telephone number, as appropriate;
Date of receipt and date put into service;
Current location, where appropriate;
YES NO
Condition when received (e.g., new, used, or reconditioned);
Manufacturer’s instructions, if available, or reference to their retention;
Equipment performance records that confirm the equipment’s suitability for use; to include:
copies of reports/certificates of all calibrations and/or verifications including dates, time and results, adjustments,
the acceptance criteria and due date of the next calibration and/or verification,
the frequency of checks carried out between maintenance / calibration, as appropriate
YES NO
Maintenance carried out and maintenance planned for the future;
Damage to, or malfunction, modification, or repair of, the equipment;
Predicted replacement date, if possible.
Records are maintained, and readily available for the life span of the equipment or for any time period required by law or regulation.
Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals and directions for use provided by the manufacturer of the equipment) are readily available to laboratory personnel.
Contact information
Sheri Goertzen, MT(ASCP)BB, CLSTransfusion ServiceChildren’s Hospital Central [email protected]
References:
AABB Standards, 26th Edition AABB Technical Manual, 16th EditionAABB Assessment Tool, 11/01/09CAP Checklist, 6/15/09CLSI “The KEY to Quality”, 2007CAP Audioconference “Checklist Updates”, 9/15/10
AABB Meeting: 2010
Managing Equipment in the Blood Bank Laboratory: Part 3
Challenges in Documentation of Equipment Maintenance
Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ)
Objective
Discuss challenges in documentationof equipment maintenance when other departments service Blood Bank equipment.
Will include: when “others” are involved in the life cycle of BB equipment
Equipment Lifecycle
BirthPlan, Justification, Quotes, Purchase or Lease Agreement, Installation, Validation, Training
LifeQuality Control, Calibrations, Service Contracts, Maintenance, Corrective Actions, Repair Records
DeathDecontamination, Decommission, Disposal Records
Birth
PlanBudget JustificationQuotesAcquisition Records / Purchase OrderService Agreements / ContractsQualification:
Installation, Operational, Performance
Validation (if used in a process)Training
BIRTH
Birth Complications: Plan ex. Freezer
You’re not a refrigeration expertYou know regulatory requirements!
Possible action steps:
- Incorporate help from “inside” expert
- Chart options for review by biomed / “inside” expert (include specs…the stuff you don’t understand, they do!)- Get a signature to document decision!
Birth Complications: Justification
Hospital has no $$$ Administration says it’s not a priority
Possible action steps:
- Letter from Maintenance - Medical Director involvement - Justify with increased TAT; patient care
issues; extra $$$ if not replaced, including supply loss
Birth Complications: Purchase
o BEWARE !! - Your boss will “handle” it- Purchasing director will “handle” it
o Have you outlined / have they asked about regulatory needs?
o Are these needs being met?o Don’t forget city/county/state requirements!
Birth Complications: Installation
Who does what? Maintenance/ Biomed?
Where will they document? Time line?
Possible action steps:
- What does your Quality Plan say to do?- YOU have to ensure all is done- YOU may have to create forms as needed
Life
Quality ControlCalibrationsService ContractsMaintenanceCorrective ActionsRepair Records
LIFE
Life: Who does what?
Done by BB staffDone by in-house MaintenanceDone by in-house BiomedDone by company service tech
Documentation must be there!
Life: BB staff
Proper tools (ex. Calibrated thermometer, tachometer; correct range?)
Proper operation of toolsSchedule (that is followed)
Initiative, knowledge, trainingAccountability You may need to be vigilante! Computerization of schedule may help (generates reminders)
Documentation
Hospital personnel
Maintenance? Biomed? OTHER?Old /new staff…do they understand what needs to be done?Lack of cross-trained maintenance staffDocumentation - Copy of their form
- Directly on your form
IDEAL: BB has on line access to ALL documentation (maintenance; biomed)
Contracted service
What is defined in contract?If you want/need more done, communicate BEFORE contract renewal Contracted services (ex. Biomed) come and go….you need to maintain continuityReminder: Verification of service tech certification (pre-contract/include in contract)
Documentation
Life: Service Contracts
What is covered? NOT covered?Service hours?Timeliness of service techSkill level of service tech Ensure documentationIs QC OK before service tech leaves? Contract renewal: who’s responsible?DON’T LET CONTRACT LAPSE!!
Hardships in Life
“Missing” equipment a.k.a. death of unknown causes
“Additional” equipment miraculously walks into your department
Lab “cleaners”pre-inspection dumpster…..leads to “missing” equipment
DeathDecontaminationDecommissionDisposal Records
DEATH
Decontamination
More than cleaning with H2O?
Who will do this?
Document
Decommission
BiomedAccountingLISPurchasing (ex. service contracts)Others?
Do they KNOW what needs to be done?
Document: disposal records!
You will always be on the lookout..
…for complete documentation of equipment life cycle
Wait…..
…you started a new job,and in the cycle of life,we call that …..
….INHERITANCE!
Inheritance
Missing Documentation o Acquisition Recordso Qualificationo Installationo Etc.
Now What????
Back to the Basics: Possible action steps
Refer to quality program (QP), policies & SOPs Meets AABB standards? Other regulations? Yes…begin to look for missing documentation.If not, you have another place to begin (Updating QP, SOPS)
Ask first! (Possible action steps)
Documentation in Record Storage?Purchasing Records?Maintenance Records?Biomed Records?Ask techs?
Take action
Document what you know Document what you don’t know & whyRequalify / revalidate?Use available historical data GOAL: Thorough and complete documentation, as per your QP, SOPs.
Why Do We Do This?
Ensure Justification of decisions The validity of dataThe safety, potency and purityof blood products
• Regulatory Compliance!!
FDA AABB CAP JCAHOOTHERS
Your Quality Plan, defined processes,SOPs and forms are the backbone you need for good equipment maintenance and documentation!
Must work together….follow what you have defined!
With Good Equipment Maintenance andDocumentation………
Remember
…..what a wonderful world it will be!!!
Contact information
Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ)Blood Bank (Transfusion Service)Holy Cross Hospital Chicago, [email protected]
Questions?