16
Commission SBAR Communication Ww!mi^nSlakS^pnlm{nlsf WHeSth Agenda ItenVTitle: SCCA Peninsula Date SBAR Communication Prepared: 1/16/2020 Reviewer: Irina Tiginyanu Link to Action Plan: M Action IJ Information QFollow-up QReport only Situation: Pharmacy is seeking approval for their technician AUP Background: Assessment: Pharmacy technicians are performing within their scope of practice Technicians are performing specialized function: - FV admixture Recommendation: Recommendation to approve the ancillary utilization plan for technicians and specialized function listed in the AUP Follow-up Action: DOH XXX-XXX

WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

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Page 1: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

Commission SBAR CommunicationWw!mi^nSlakS^pnlm{nlsf

WHeSthAgenda ItenVTitle: SCCA Peninsula

Date SBAR Communication Prepared: 1/16/2020

Reviewer: Irina Tiginyanu

Link to Action Plan:

M Action IJ Information QFollow-up QReport only

Situation:

Pharmacy is seeking approval for their technician AUP

Background:

Assessment:

Pharmacy technicians are performing within their scope of practice

Technicians are performing specialized function:

- FV admixture

Recommendation:

Recommendation to approve the ancillary utilization plan for technicians and specialized function

listed in the AUP

Follow-up Action:

DOH XXX-XXX

IIT0303
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Page 2: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

Wai^mSistf'DfysitfnKf

B U/j/^14-1^

SCCA Peninsula19917 7th Ave ME Ste 100Poulsbo, WA 98370^555PHAR.CF.61003859

Revenue:0262010000

RECEIVED

SEP 0 5 mDOH/HSQA/OCSCREDENTIALING

Fees (Check all that apply)

icj Pharmacy Location...........................Fee

|^f Controlled Substance Acl.....—............Fee

[^Ancilfary Utilization..............................Fee

(Complote additional application)Q Differential Hours..............................Fee

(Complete additional application)

Check (he online fee uaao for current fees

All application fees are nonrehjndable.

Pharmacy License ApplicationThis is forgfNew Q Change of Ownership Q Change of Location - Current License #.

Q Name Change Only - Current Facility Name

Check OneQ AssociationD CorporationD Federal Government AgencyD Limited Liability CompanyD Limited Liability Partnership

D Limited PartnershipD Municipality (City)[3 Municipality (County)S^Non-Profit Corporation

Partnership

Q Sole ProprietorQ State Government AgencyQ Tribal Government AgencyD Trust

1- Demographic Information

UB(#60188375

Federal Tax ED (FEfN)#

91-1935159Legal Owner/Operator Name

Seattle Cancer Care AllianceMailing AddressPO Box 19023

CitySeattle

StateWA

Zip Code98109

County

KingPhone (enter 10 digit #)206-606-1400

Fax (enter 10 digit #)206-606-6643

Email [email protected]

Web Address:

https://www.seattiecca.org/

Facility/Agency Name (Business name as advertised on signs or Web site)

SCCA PeninsulaPhysical Address19917 Seventh Ave, NE. Suite 100

CityPoutsbo

State

WAZip Code

98370County

Kitsap

Facility Phone (enter 10 digit #)360-697-8000

Fax (enter 10 digit #)360-598-6227

Email Address:

[email protected]

Mailing Address (If different than physical address)825 Eastlake Ave E Maitstop G5-900

CitySeattle

StateWA

Zip Code98109

County

KjngDOH 690.152 Qecember 2013 Page 1 of 3

Page 3: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

2- Facility Informatioi^

Type of Pharmacy

DCommunity/RetailQMaH-Order

Q HospitalQ Nuclear

D JailTarenterat

Q Long-term Care (LTC)

D Internet Q Compounding

Pharmacy Hours—Indicate the hours the pharmacy wiil be openMonday-Friday

8-4; 30pmSaturday Sunday Holidays

Drug Enforcement Administration (DEA) Registration Number

DEA Number: In Process

Background Questions Yes No

1. Have any applicants, partners. or managers had a suspension, revocation, or restrictionof a professional license?.......................................................................................................................D

If yes, list and explain on a separate sheet of paper.

2, Have any applicants, partners. or managers been found guiity of a drug or controlledsubstance violation?..........................................................................................................................

if yes, list and explain on a separate sheet of paper.

Ptwmacist in Charge

Pharmacist En ChargeAbby MisRe

License Number

PH60388921Date of Appointment

12/2/20193. Contact Information

Contact PersonName

Abby MiskeTitle

Lead Pharmacist

Phone (enter 10 digit #)

503-407-8931

Email Address

[email protected]

Contact PersonName ^_ ,. .

Amy NgaiTitle Pharmacy Q

Manager

Phone (enter 10 digits)perations

208-327-2219

Email Address

[email protected]

4. Additional InformationDate of Incorporation

6/16/1998Corporate Number

601883375State of Corporation

Washington

Legal Owner Information-attach additional completed pages if you need more space.

List names, addresses, phone numbers, and titles of corporate officers, partners, members and managers.Name I Address j Phone (enter 10 digit #) | Tltte

See Attached:

1} SCCA Board of Directors RECEIVED

2) SCCA Execultives SEP 0 5 ?niqDpH/HSQA/009

}REDENTIAUNG

DOH 69&.152 December 2013 Page 2 of 3

Page 4: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

cha_n8?-oy Ownership Inform?" i

Previous Name of Legal Owner

Previous Name of Facility Previous Pharmacy License # Effective Date of Ownership Change

List ail Pharmacist-attach additional completed pages if you need more space.

Name

Abby Miske

License #

PH60388921

Amy Ngaj PH60859488

Signature

I certify I have received. read. understood, and agree to comply with stale law and rule regulating this licensingcategory. I also certify the information herein submitted is true to the best of my knowledge and belief.

QJ^IIDateSignature of Owner/Authorized Representative of Pharmacy

. -s ^\A^L/ ^ . .V-^Tt^Ai^ < ^ ^fc=j^!t cT ^ k\JJiiA^y

Print Name Print Title

RECEIVED

SEP o 5 ?niaDOH/HSQA/OCSCREDENTIALING

DOH 690-152 December 2013 Page 3 of 3

Page 5: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

SCCA Board of Directors

ROSTERFY 2018 (July 1, 2017-June 30, 2018)

Robb BakwndcrPresident Bshemeier Law Firm7683 S.E. 27th StreetSuite 464Mercer Island, WA 98040Ph: 206-23{M»600

Carl BehnkePresident, RE8 EnterprisesGOl Union Street, Suite 3016Seattle. WA 98101Ph: 206-623-W89

Jacquelina (Jacque) CabaChief Financial Officer, UW MedicineVice President for Medical Affairs, Unh/er^fty of WashingtonUW Health Sciences Building1959 NE Pacific StreetRoom C-314D, Box 356350Seattle WA 98195Ph: 206-616-9886

Bruce Cturman/ M,D., Ph-D.Executive Vice President and Deputy Director, Fred HutchProfessor, Department of Medicine, UW School of Medicine1100 Fairview Avenue N.P.O. Box 19024, MS 02-100Seattle, WA 98109Ph: 20^667-4524

Mike DetmanTreasurer, SCCA BoardCorporate Vice President, Microsoft (retired)7708 S.E 78th St.Mereer Island, WAS8040Ph7206-230.0704' "~ ' SEP 0 5 POffl

DOH/HSQA/OCSK?wn<Kari)s!ow . CREDENTIAUNGVice Chair, SCCA BoardGlobal integration Partner, K&L Gates (retired)16202 Beach Dr. NESeattle, WA 98155Ph: 206-367-65S3

Page 6: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

Gerald (Jerry) GrlnstelnStrategic Director, Madrona Venture Group999 mrdAve./Ste. 3400Seattle, WA 98104Ph: 206^25-6001

Ruth MahanChief Business Officer, UW MedicineVice President for Medical Affairs, University of WashingtonWarren <3. Magnuson Buildlngi Health Sciences1959 NEPacffic StreetRoom C-315, Box 356340Seattle, WA &8195Ph: .206-221-4747

UndaMattox6321 Seavlew Ave NW, fl24Seattle, WA 98107Ph: 20&-283-9216

Rich McCuneChair, SCCA BoardPartner, KPMG UP (retired)4415173rd Ave SEBelfevue. WA 98006Ph: 425^44-8083

Kimberiy McMalFy. MH, WSecretary, SCCA BoardPresident, McNatly & Associates3300 Meridian Avenue North, #310Seattle, WA 98103Ph: 206-547-3133

Sanford (Sandy) Metwr, MD, MBAExecutrve Vice President for Networks and Population Health &Chief Strategy OfficerSeattle Children's4BOO Sand Point Way NEMS RB.2,419Seattle WA 98105Ph: 206-987-4972

SEP 0 5 ?n)9DOH/HSQA/OCSCREDENTIALING

Page 7: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

BruccPymManaging Director, Meridian Capital U.C1809 Seventh Avenue, Suite 1330Seattle, WA 98101-1393Ph: 206-224-6158

Steve StadumExecutive Vice President and Chief Operating Officer, Fred Hutch1100 Fafrvlew Avenue N.P.O. Box 19024, MS DX-060Seattle, WA 98109Ph: 206-667-5987

Bruder Stapteton, M.D.Chief Academic Officer & Senior VP» SCFord/Morgan Professor & Chair, Dept. of Pediatrics, UWSOMAssociate Dean, UWSOM4800 Sand Point Way NEM/S RB.2.401Seattte, WA 98105Ph: 206-987-2150

AJWintcrrothAudit Partner, Ernst & Young (retired)416 NW 162nd StShoreline/WA 98177Pb: 206^72-9748

Rkharrf YarmuthPartner, Yarmuth Wltsdon PLLC818 Stewart St, Suite UOOSeattle, WA 98101Ph; 206-5X6-3870

RECEIVE

SEP 05WDOH/HSCWO^CSCTE'DENTIAUNO

Page 8: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

SCCA Executives

Dave AckcreonVice President, Chief Informatton Officer, SCCAChief Information Security OfficerSeattle Cancer Care Alliance825 Easttake Avenue £.P.O. Box 19023MS LG-500Seattle, WA 98109-1023Ph; 206-606-6942

Nancy Davldson, MDExecutive Director and President, SCCASenior Vtee President & Director, Clinical Research Dh/lslon, Fred HatchDivision Head, Department of Medicine, Otvision of Medical

Oncology, UW1100 Fatrview Avenue N.P.O. BOX 19024MS D5-310Seattle, WA 98109-1024Ph: 206-667-6363

Debby GentecnVice President, Chief Strategy Officer, SCCA825 Eastlake Avenue E.P.O. BOX 19023MSLG-500Seattle, WA 98XOMQ23Ph: 20&-606-8292

Norman HubbardExecuth/e Vice President, SCCAActing Chief Financial Officer, SCCASeattle Cancer Care Allfance825 Eastlake Avenue E.P.'O. BO;'19023""~ " SEP 0 5 ?nil<

MSLG-500Seattle, WA9810M023Ph: 206-606-1051

Barb Jagels, RNVice Pfesfdent/ Quality, Safety and ValueChief Quality Officer, Seattle Cancer Care Ailjance825 Eastlake Avenue E.P.O. Box 19023MSU3-500Seattle, WA 98109-1023Ph: 206^06-2127

Page 9: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

Theresa (Terry) McOonnelf, ONP, ACNP-BCChief Nurse Executive and Wee Preddent ofOlnical OperationsSeattle Cancer Care Alliance825 Eastlake Avenue E.P.O. Box 19023MS LG-500$eattte,WA 98109-1023Ph: 20fr606"2Z66

F.MarcStewart.WD

Medical Director and Vice President, Clinic & lab Operations, SCCASeattle Cancer Care Alliance82S Easttake Avenue E.P.O. Box 19023MS LG-500Seattle, WA 98109-1023Ph; 206-606-1192

RECEIVED

SEP 0 5 7mDOH/HSQA/OCSCREDENTfAUNG

Page 10: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

Phormacy Quality AssuranceCommissionPO Box 47877OlympiaWA 98507-7877360.236-4700

Revenue:0262010000

RECEIVB)

SEP 0 5 701RDOH/HSQA/OCSCREDENTIAL1NG

Fee

Ancillary Utilization........................... Fee

ChecK the fee oaae for current fees.

Alt application fees are nonrefundabfe

Pharmacy Ancillary Utilization ApplicationAll utilization plans must be submitted 60 days prior to next Pharmacy Commission business meeting. You canfind the Commission meeting schedule on the Department of Health website.

Note: Utilization pians for technicians and assistants must accompany this application.

Select One: SfNew Q Update

1. Demographic InformationUBI#

60188375Federal Tax ID (FEIN) #

91-1935159Legal Owner/Operator Name

Seattle Cancer Care AlliancePharmacy License #

PendingPharmacy Name

SCCA PeninsulaPhysiceU Address

19917 Seventh Ave, NE Suite 100City

PoulsboState

-^-

Zip Code

98370County

KitsapFacility Phone (enter 10 digit #)

3606978000

Fax (enter 10 digit #)

3605986227

2. Facility Specific InformationNumber of Employees:

Pharmacists Technicians Assistants

3. Key Individuals

Responsible Pharmacist Abbv Miske License # PH60388921

SignatureI certify I have received. read, understood, and agree to comply with state law and rule regulating this licensing

Jhe information herein submitted is true to the best of my knowledge and belief.

Signature of Owner/Authoriged Representative of Pharmacy

L^fs^ ^ U

sj^i11Date

AUf^ .KT^iLPrint Name Print TitleDOH 690-056 April 2016 PagB2 of 2

Page 11: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

RECE/VED[ANCILLARY PERSONNEL UTILIZATION PLAN

SEP 0 5 7mSeattle Cancer Care Alliance Department of Pharmacy Services ^9H/HSQA/OCS

CREDENTtAUN'GPOUCYThe Pharmacy Department shall utilize ancillary pharmacy personnel {Phannacy Techniciansand Pharmacy Assistants) in accordance to the regulations promulgated by the Washington StateBoard of Pharmacy (WAC 246-901).

PHARMACY TECHNICIAN UTILIZATIONUnder the immediate supervision of a licensed pharmacist, a pharmacy technician may assist inperforming manipulative, non-discretionary functions associated with the practice of pharmacyOVAC 246-901 -020).

Pharmacy Technician (IV area)• Accurately fills medications labels.• Delivers medications to nursing units and other areas of the Clinic.• Removes all expired/discontinued medications from nursing units and returns them to

pharmacy.

• Accurately prepares pharmaceutical solulions.

• Packages medications inio single-unil doses.

• Maintains repackaging records,

» Maintains appropriate levels of inventory stock on patient care areas.

• Monitors stock for expiration dates and removes outdaies.

• Performs charging and/or billing functions.• Performs unit inspections, documenting deficiencies and communicating results

• Accurate operation of controlled substance inventory and storage system.o Performs daily refill process of controlled substance medications into ADM

systemo Maintains perpetual inventory and communicates discrepancies to pharmacist

manager.

o Performs routine audits< Accurate operation of automatic drug dispensing machines (ADM).

o Accurately loads and removes unit dose medications from ADMo Assists pharmacy staff in monitoring and resolving ADM discrepancies.

• Performs medication reconciliation functions:0 Obtains patient's medicaiions list.o Transcribes patient's medication list into medication reconciliation database.

• Performs ambulatory pharmacy lechnician and pharmacy assistant functions when

necessary.

• Adheres to SCCA Pharmacy Services and SCCA policies and procedures,

Ancillary Personnel Ulilization Plan | Seattle Cancer Care Alliance (SCCA) 08/2019

Page 12: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

I^ECEfVED

• Performs all duties within the scope of Hcensure, ^^.DOH/HSQA/OCS

SPECIALIZED FUNCTIONS1 CREDENTfAUNGA pharmacy technician who meets established criteria for employment, experience, and trainingand demonstrated proficiency may perform specialized functions (WAC 246-901-035).

• Accurately prepares IV admixturcs using proper aseptic technique per ASHP and USPChapter <797>, USP Chapter<800> guidelines.

• Able to perform pharmaceutical calculations necessary for IV preparation.

• Inspects all prepared IV admixtures for clarity and particulate matter.

• Uses appropriate precautions / procedures when preparing and handling chemotherapy orbiohazardous medications.

• Perfonns IV room computer functions including order entry, list generation, standardreport generation, label printing, time changes, and IV charging) crediting, anddiscontinuation.

Uses appropriate procedures when handling and wasting control substances.Perform appropriate Quality Assurance and sterility testing.Performs proper cleaning of IV area per USP <797> and USP<800> ASHP guidelines.Orders and receives pharmaceuticals from the wholesaler and/or manufacturer.

Check unil-dose medications for ADM refills by another pharmacy technician.

Performs record keeping and monitors stock expiration dating for Investigational Drugs.Adheres to SCCA Pharmacy Services and SCCA policies and procedures.Duties within the scope oflicensure.

Performs all duties in accordance to the regulations promulgated by the Washington StateBoard of Pharmacy and under ihe immediate supervision of a licensed pharmacist.

' This document describes duties that trained technicians may perform when assigned by ihe appropriatemanager. It should also be noted that WAC 246-901-100 requires alE duties (including specializedfunctions) performed by Ancillary Personnel be listed in the utilization plan, even if not all AncillaryPersonnel perform every duty.

SPECIALIZED FUNCTIONS! Ancillary Personnel Utilization Plan | Seattle Csncer Care Alliance(SCCA) 08/2019

Page 13: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

WK'tb^S'^Difnliwtcf

Pharmacy Quality Assurance Commission

P.O. Box 47877

Olympia WA/ 98504-7877360-236-4700Fax: 360-236-2901

Technician Specialized Function Review FormChapter 246-901-100 WAC

Date: 1/16/2020

Responsible Pharmacist: Abbv Miske

Pharmacy Name: SCCA Peninsula License #:

Pharmacy Address: 825 Eastlake Ave E Maiistoo G5-900Phone #: 360-697-8000

Yes No Comments

Does the Program identify pharmacy technicians who meet the criteria for participation? DDid the responsible pharmacist sign the program proposal? DThe program must include a description of the methods of training and of initialdemonstration of proficiency. Please attach explanatory documents

D

The program must include a quality assurance plan for technicians performing thefunction. Please attach the expianafory documents.

D

Forms used in training, policies and procedures pertaining to the function aresubmitted with program?

Utilization plan for specialized pharmacy technician functions is included withthe progiram?^

Comments: approve IV admixfure specialized function

For staff use only

Review completed on January 16, 2020 bv Irina Tiginyanu Agreement type: Kl New Q Renewal

Staff decision:Board decision:

Approved D Revisions needed D Commission agendaD Approved D Denied D Notice sent to investigator

Page 14: WHeSth Commission SBAR Communication …...Jan 31, 2020  · o Assists pharmacy staff in monitoring and resolving ADM discrepancies. • Performs medication reconciliation functions:

Viewing IV Admixture Servicf Orientation, Training and Competency n 'iluation :: Poli.,. Page I of 4

RECEIVEDWehMms Staff Momber | Soanie Cancer Csra AlUanca OulpaUflnl Poticwa

Iffiblfepf Contents^ Attachments

SEP 0 5 7M9DOH/}cRge tUN'Q"

^. 0 ' Q[ Policy StatSeattle Cancer Care Alliance l" '"

Momo Q Titto Q Policy Aren ' Q, Owner

Q, \ Search Policies

Viewing; IV Admixture Service: Orientation, Training andCompetency Evaluation S

Q, Referencea

6 Printer Friendly (3 Email Copy

Current Status: ActivQ

^^^°^Seattle '^•ufs'-'

Cancer CareAlliancef.riH.-ih ^ftCkid'tni UW'J-iiu"*

Original Approval:

Approval:

Next Review:

Owner:

Policy Area:

Referenc&g:

Applicability;

PoltcyStat ID: 5537469

6^4/2016KV22/201810^1/2021

RichBFd LeFrsnce: DirPhBrmacy

Pharmacy - Outpetient

SBQttla CQncer Csre

AHience OutpGlient Policies

IV Admixture Service: Orientation, Trainingand Competency Evaluation

POLICY PURPOSE:DEFINITION:The purpose of this policy i8 to provide a consistent process and mechanisms to measure and

document tha acquired skiil sets necessary to operate the equipment end perform processes

required for pharmacy staff compounding sterile preparations.

POLICY:1, The orientation, training and competency evaluation of compounding personnel is designed

to ensure that staff are adequately skilled, educated, instructed and trained to correctlyperform and document the critical activities in Iheir sterile compounding duties.

2. Initial and ongoing training wili be facilitated by the Lead Pharmacy Technidan, Managers

and Lead Pharmacists.

3. To facilitate a true quality culture, ail compounding staff are encouraged to be observant ofeveryone's behavior and correct if necessary.

4. All compounding personnel ere required to pass the following; didactic ooursework; practical

skill assessments through competency evaiuation; initial gloved fingertip sampling as well as

https://seaitlecca.poIicystaLcom/policy/5537469/latest/?z:=eyJpljogOXO 9/3/2019

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Viewing IV Admixture Servicp- Orientation, Training and Competency r'-^luaiion :: Poli... Page 2 of 4

^i Attachments

resting with gloved fingertip sampling performed at the conclusion of the media fillunit preparation before compounding sterile preparations for human use.

5. Ongoing competency evaluation of Aseptic Technique and media-fiil testing (wNdi includes

gtoved fingertip sampling performed immediately following media (111 unit preparation) must ats minimum be completed annual)/ for employees performing low/medium risk level

compounding.

6, Any employee handling, disposing or compounding Hazardous Drugs must successfully

complete the Competency Assessment: Hazardous Drugs prior to working with hazardous

drugs and annually thereafter. Employees are not eligible to complete Hazardous OFUQ

Competency Assessments until they successfully complete the Hand Hygiene and Carting

and Asepllc Technique competendes.

7. Personnel who fail wrinen or media-fill tests, will be immediately reinstaicled and reevaluatedby the lead IV technician or manager to ensure correction to all aseplic processes as wetf asdemonstrate the ability to pass repeated written and/or media-fill tests. Personnel who fail

written or media testing a second time will bo evaluoied by UIB suporvising managflf todetermine whether or not the individual is eligible to continue sterile product preparation

training.

PROCEDURE:1, Each employee will receive comprehensive orientation to their specific job role. Orientation

consists of didactic training experiences os well 88 hands on prectical training and

mentorship by the lead IV lec^nician or technician supervisor.

2. As new processes and equipment are introduced, employees require ongoing training in

order to property use such new equipment or processes.

3, Employees are required to demonstrate knowledge end sKit) in select procedures or tasks

before they can Independently perform those procedures in real fife production.

4. A qualified staff member must observe all newly learned skfils or procedures and staff areevatuated for their ability to return demonstrate the skill/knowledge Independently.

5. The competencies are required to be completed as part of sterile product preparation training

and annually for employees performing low/medium rlsK level compounding.

1. Competency Assessment: Hen(S Hygfene and Gerbsng:

2. CompQtency AssBSSffiQnt: AsQptlc Techniquff;

3, Competency assessment Cfeaning end DisinfBctfng

6. Depending upon Ihe operation, the following compotendes may be required:

1. Competency Assessment: Primary Engineering Controls CAis/CACls

2. Competency AssBssment: Pnmsfy Engineefing Confrofs LAFW

3. Competency Assessment: HBiardous Drugs

4. CwnpQtwcy As$ossmQnt: Hsxerdous Drug GBfbing

7. The orientation and training program will include, but is not limited to:

1. An orientation to IV admixture pharmacy.

S. View demonstrations of sseptic technique and proper use of first air.

3. View demonstration of the preparation of all types/ctasses of madicaUons compounded.

fl. DemonatraiQ adequate knowledge in end ability to perform steriel compounding akifls.

5. Completion of required coursework.

RECEi?D

SEP05|DOH/MSQtCREDENTl

w/OCS^UNG

hnps://sealtlecca.policystat.com/policy/5537469/latest/?%aaeyJpijogOXO 9/3/2019

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Viewing iy Admixture Servicf Orientation, Training and Competency r-^Iuation :: Poli... Page 3 of 4

^j Attachmonls

latlon about viable and non-viatile particulate and microblal contamination.

7. Review all IV Admlxlure pharmacy policies and procedures.

8. Phsmiaceutica! calculations.

9. Review operating principles of the facility, equipment and maintenance procedures.

10. Demonstrate a thorough understanding of documentation requirements and the requiredforms for documentation.

11. Review of ths performance improvement progrsm and quality management initiatives.

12. Refer to policy for information on training relative to Hazardous Drug compounding.

8. Expert Compounding Personnel and Qualified Competency Evaluator/Menior

1. Expert Compounding Personnel

1. Expert compounding personnel are personnel who have demonslroted proficiencyin all skills and hnowledge.

1. The Pharmacy will designate Individuals who are considered Expert

Compounding Personnel

2. Qualified Competency Evaluator/Mentor

1. Other personnel may be eligible to facilitate initial and ongoing staff competency by

mentoring/coBching and evaiualfng competency of employees as requested by the

Sterile Compounding Experts.

2. To be eligible to become a Qualified Competency Evaluator/Mentor. the employeemust have demonstrated proficiency related lo the competencies for which they wi!f

be a mentor within 3 months of becoming a mentor.

3. Demonstrate abiiities to successfully perform as a Qualified Competency

Evaiuator/M enter on the policy; Orientation, Training and Competency Evaluation.

Documentation1. All occurrences of training whether during initial orientalion or ongoing tfeining must be

documsnted.

2. Written competency assessment forms must be developed for any competendea required

end used to document competency testing. Results of competency assessment wii! bedocumented in SimplifL

3. Media-fill testing and Gloved Fingertip sampting must be documented on the EmployeeGloved Fingertfp Sempling snd MedSa-FHI Resutfs Logs end results will be documenled m

Simpiiri.

4. Should ?e employee fail Media-Fiil Testing or Fingertip Sampling, this must be docufnentedin the results section of the log with description of actions taken..

CROSS REFERENCE:ATTACHMENT:

'Attachments:

RECEIVED!

-SEP-0-5-9fl^

Approval Signatures

DOH/HSQA/OpSCREDENTIAL^G

https://seattlecca.policystat>com/poIicy/5537469/latest/?z=eyJpIjogOXO 9/3/2019