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9125-QE Managing Equipment in the Blood Bank Laboratory 10/9/2010 2:00 PM - 3:30 PM

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Page 1: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

9125-QE Managing Equipment in the Blood Bank Laboratory

10/9/2010

2:00 PM - 3:30 PM

Page 2: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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

Page 3: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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

Page 4: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

2010-10-28

1

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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2010-10-28

2

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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2010-10-28

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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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2010-10-28

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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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2010-10-28

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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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2010-10-28

6

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

Page 10: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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

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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.

Page 12: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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)

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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.

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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.

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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

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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.

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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!

Page 18: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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.

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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

Page 20: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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.

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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;

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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]

Page 23: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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

Page 24: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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

Page 25: 9125-QE Managing Equipment in the Blood Bank … · Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010

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

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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!

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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

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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)

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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

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DeathDecontaminationDecommissionDisposal Records

DEATH

Decontamination

More than cleaning with H2O?

Who will do this?

Document

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Decommission

BiomedAccountingLISPurchasing (ex. service contracts)Others?

Do they KNOW what needs to be done?

Document: disposal records!

You will always be on the lookout..

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…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????

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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.

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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!

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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]

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Questions?