Outsourcing_Sterile_Products_Preparation_Assessment_Tool.pdf

PDF 1 MB Posted Aug 30, 2017

Attached to: INPATIENT AND NARCOTIC COMPOUNDING PHARMACEUTICALS Federal contract opportunity
Solicitation number: N6809417R6126
Issued by: Department of the Navy Bureau of Medicine and Surgery

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Outsourcing Sterile Products Preparation Assessment Form

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OUTSOURCING STERILE

PRODUCTS PREPARATION

CONTRACTOR ASSESSMENT TOOL

Developed with support from PharMEDium Services, LLC.

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Principles for Use

• When outsourcing sterile products preparation services, every hospital/health system-based department of pharmacy should take a comprehensive and organized approach to vendor selection.

•

Departments

pharmacy

are

strongly

encouraged

engage

other

key

hospital/health

system

stakeholders

the

vendor

selection

process.

•

While

this

tool

intended

useful

for

all

health-system/hospital-based

departments

pharmacy,

its

use

will

vary

based

the

institution’s

size,

geographic

location,

services

provided

and

available

resources.

•

The

ASHP

Foundation

has

attempted

include

the

assessment

questions

under

the

most

appropriate

category.

However,

some

cases

assessment

question

might

applicable

multiple

categories.

•

While

this

document

intended

helpful

hospital/health-system

departments

pharmacy

their

selection

sterile

products

outsourcing

organization,

does

not

purport

establish

standard

care.

•

Hospitals/health

systems

that

plan

use

this

tool

component

their

evaluation

sterile

products

outsourcing

organization

can

also

use

the

tool

develop

Request

for

Proposals

(RFP)

for

these

services.

•

The

ASHP

Foundation

strongly

encourages

hospitals/health

systems

use

this

tool

along

with

site

visits

ensure

comprehensive

review

potential

sterile

products

outsourcing

organizations.

Items

that

should

closely

evaluated

during

the

site

visit

are

indicated

throughout

the

tool.

•

part

the

hospital’s/health

system’s

overall

planning

for

selection

sterile

products

outsourcing

organization,

see

the

ASHP

Guidelines

Outsourcing

Sterile

Compounding

Services.

•

The

term

“disqualification”

used

this

tool

means

that

the

outsourcing

contractor

should

not

considered

for

the

provision

sterile

products

preparation

services.

• This tool is not intended for use in the evaluation of nuclear pharmacies.

The

information

contained

this

self-assessment

tool

constantly

evolving

because

ongoing

research

and

improvements

technology

and

subject

the

professional

judgment

and

interpretation

the

involved

health

care

professionals.

The

ASHP

Research

and

Education

Foundation,

the

expert

panel,

and

external

peer

reviewers

have

made

reasonable

efforts

ensure

the

accuracy

and

appropriateness

the

information

presented.

However,

any

reader

this

information

advised

that

the

ASHP

Research

and

Education

Foundation,

the

expert

panel,

and

the

external

reviewers

are

not

responsible

for

the

continued

currency

the

information,

for

any

errors

omissions

and/or

for

any

consequences

arising

from

the

use

the

information

the

self-assessment

tool

any

and

all

practice

settings.

Any

reader

this

document

cautioned

that

the

ASHP

Research

and

Education

Foundation

makes

representation,

guarantee

warranty,

express

implied,

the

accuracy

and

appropriateness

the

information

contained

this

self-assessment

tool

and

will

bear

responsibility

liability

for

the

results

consequences

its

use.

Downloaded from www.ashpfoundation.org Page 3

How to Use this Tool Step 1. Minimum Requirements for a Vendor When outsourcing the production of sterile products the first step in vendor evaluation is to see if they meet the minimum requirements. We have developed a group of questions that can be used to qualify a vendor. There is not a score for this section. A vendor simply meets the minimum requirements or

they

are

disqualified.

Once

vendor

has

been

qualified

suggest

further

assessment

the

vendor

determine

which

vendor

the

best

fit

for

your

hospital

health-system.

Step 2. Vendor Assessment The questions in this section are designed to help you objectively compare the services offered by potential outsourcing vendors. After answering each question, the Assesment Tool provides a score for the vendor and a table to interpret the score.

Step 3. Vendor Comparison The vendor scores and score legend provided in the Assessment Summary can be used to compare potential outsourcing vendors.

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Step 1: Minimum Requirement Questions Part 1: Regulatory Compliance

1. Does the outsourcer have a state pharmacy license available where the compounding center resides?

2. Is the outsourcer licensed to ship to my state?

the

outsourcer

prepares

significant

number

non

patient-specific

preparations

(e.g.,

>5%

the

outsourcer’s

volume),

the

outsourcer

registered

drug

manufacturer

with

the

FDA,

required?

the

outsourcer

prepares

non

patient-specific

controlled

substance

preparations,

the

outsourcer

registered

drug

manufacturer

with

the

DEA?

5. Are all pharmacists working for the outsourcer licensed in the state in which they are practicing?

required,

are

all

the

outsourcer’s

pharmacy

technicians

licensed

registered

the

state

where

they

are

practicing?

7. Does the outsourcer meet or exceed state required pharmacist-to-pharmacy technician ratios for the state in which the compounding center is located?

FDA-approved

product

commercially

available

(not

backorder),

does

the

outsourcer

compound

the

same

drug

formulation

using

non-sterile

powders?

Yes

No N/A

N/A

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When

commercial

source

exists

prepare

admixtures,

does

the

outsourcer

use

USP

grade

bulk

ingredients

obtained

from

cGMP

compliant

supplier?

yes,

can

the

outsourcer

provide

certificate

analysis

and

potency

testing

all

bulk

ingredients

used?

10. Does the outsourcer have the required minimum amount of product liability insurance as outlined by my institution?

11.

Will

institution

covered

this

insurance

the

event

that

there

written

contract

with

the

outsourcer?

Part 2: Quality and Patient Safety Measures

12. Can the outsourcer provide documentation that confirms staff competency (garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to compounding of actual drug preparations?

13.

Can

the

outsourcer

provide

documentation

that

confirms

that

the

outsourcer

tests

aseptic

techniques

preparing

media

fill

units

per

USP

chapter

<797>

standards?

14.

Can

the

outsourcer

provide

documentation

that

confirms

that

pharmacists

and

pharmacy

technicians

are

pre-qualified

using

media

fills

before

compounding

actual

drug

preparations?

15. How often are outsourcing staff required to undergo re-qualification using media fills?

16.

positive

media

fill

occurs,

does

the

outsourcer

perform

comprehensive

investigation

identify

root

cause?

Yes

More than once per year Annually Less than annually or never

Yes No

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17. If a positive media fill occurs, does the outsourcer institute corrective and preventive action?

18.

Does

the

outsourcer

provide

customers

with

substantial

evidence

that

supports

extended

expiration

dating

for

compounded

sterile

preparations

when

this

evidence

exists?

19. Does the outsourcer perform studies to determine extended expiration dates, using evidence-based

and

validated

stability

testing

procedures,

for

compounded

sterile

preparations

for

which

extended

expiration

evidence

exists?

20.

Does

the

outsourcer

verify

that

staff

members

are

complying

with

gowning,

gloving,

and

glove-tip

processes

that

are

consistent

with

USP

chapter

<797>

standards?

21. Does the outsourcer perform routine surface microbiological environmental monitoring to minimize microbiologic contamination?

22.

Does

the

outsourcer

perform

comprehensive

investigations

out-of-limit

findings,

recommended

USP

chapter

<797>,

determine

root

cause,

followed

corrective

and

preventative

actions?

23.

How

frequently

does

the

outsourcer

perform

nonviable

and

viable

particle

testing

primary

engineering

controls

(e.g.,

laminar

flow

workbench,

biological

safety

cabinet)

and

room

air

according

USP

chapter

<797>

standards?

Yes

Performs More than Weekly

Exceeds	USP	<797>	Guidelines
(Performs	more	than	weekly)

Meets	USP	<797>	Guidelines
(Performs	weekly)

Does not meet USP 797 Guidelines

Performs Weekly

Does Not Perform Weekly

Exceeds	USP	<797>	Guidelines
(Performs	more	than	semiannually)

Meets	USP	<797>	Guidelines
(Performs	semiannually)

Does not meet USP 797 Guidelines

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24.

Does

the

outsourcer

have

policy

that

requires

validation

new

changed

facilities,

equipment,

processes,

container

types,

for

sterility,

and

repeatability?

Part 3: Medication Administration Safety Features

25.

Does

the

outsourcer

provide

readily

accessible

information

regarding

status

latex,

DEHP

and

preservatives

the

preparations

they

prepare?

Part 4: Service Excellence

26.

Does

the

outsourcer

compound

products

variety

containers

(e.g.,

syringes,

minibags,

pump-specific

cassettes)

meet

the

needs

institution?

27. Does the outsourcer have business continuity plans in place in the event of a natural or man-made disaster or public health emergency?

Minimum Requirement Assessment Results

Yes

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PART I: REGULATORY COMPLIANCE

(20% of Total Score)

Section One: Current Registration and Licensure

What

percentage

the

outsourcer’s

pharmacy

technician

staff

are

certified

authoritative

board

(e.g.,

Pharmacy

Technician

Certification

Board)?

2. Does the outsourcer provide pedigree information that documents that they do not purchase products outside of traditional drug distribution networks or through secondary wholesalers?

commercial

product

component

preparation

backorder,

can

the

outsourcer

provide

certificate

analysis,

potency

testing,

and

proof

that

all

other

requirements

are

met

(e.g.,

higher

level

clean

room)

for

High

Risk

Level

Compounding?

4. Does the outsourcer meet ASHP guidelines for handling of hazardous agents?

5. Does the outsourcer meet NIOSH guidelines for handling of hazardous agents?

6. Does the outsourcer meet USP chapter <797> guidelines for handling of hazardous agents?

Step 2. Vendor Assessment The following questions are designed to help you objectively compare the services offered by potential outsourcing vendors. After answering each question, the Assessment tool provides a score for the vendor and a table to interpret the score.

< 50 %

Yes, all available Some or no Pedigree Information available

50-94% ≥95%

Yes

No N/A

Yes No N/A

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Section Two: Availability of Reports and Technical Summaries

Has

the

outsourcer

disclosed

any

disciplinary

punitive

action

any

regulatory

agency.(e.g.,

FDA

warning

letter,

state

board

pharmacy)

within

the

past

months?

8. Does the outsourcer provide quality control history and quality assurance trend reports on a regular basis and upon request?

PART 2: QUALITY AND PATIENT SAFETY MEASURES

(50% of Total Score)

Section One: Personnel Competency Through Media Fills

Can

the

outsourcer

provide

documentation

that

confirms

that

sterile

media

used

are

certified

the

manufacturer

sterile

and

guaranteed

promote

growth?

10. Can the outsourcer provide detailed reports on the incidence of positive media test results and the

follow-up

retests

after

corrective

action

completed?

During

ongoing

media

monitoring,

how

many

times

the

last

year

were

positive

media

fills

reported

requalifications?

Part 1 Score

Yes, still unresolved

All available Some or none available

Yes, resolved No

Yes

Never Once More than once

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Section Two: Availability of Reports and Technical Summaries

11.

assigning

expiration

and

beyond-use

dating,

does

the

outsourcer

evidence-based

and

validated

stability

testing

procedures

evaluate

each

preparation’s

(drug,

diluent

and

device/container)

potency

room

temperature

refrigerated

temperature

applicable?

12.

assigning

expiration

and

beyond-use

dating,

does

the

outsourcer

evidence-based

and

validated

stability

testing

procedures

evaluate

each

preparation

(drug,

diluent

and

device/

container), based on a range of extreme temperatures, to ensure stability and determine the impact on the preparation (e.g. evaporation, precipitation, degradation, concentration)?

13.

assigning

expiration

and

beyond

use

dating,

does

the

outsourcer

evidence-based

and

validated

stability

testing

procedures

evaluate

each

preparation

(drug,

diluent

and

device/container)

for

chemical

characteristics

such

pH,

particulate

matter,

color,

sterility

(container

closure

integrity

testing)?

14. Does the outsourcer provide minimum guaranteed shelf life upon delivery?

Section Three: Maintenance of Sterility and Environmental Monitoring

Site Visit Question

15. Does the outsourcer document that cleaning methods and agents are effective in preventing contamination of the sterile preparations area?

Site Visit Question

16. Are sporicidal agents used to sanitize vials and ports to prevent spore growth?

17. Does the outsourcer have action and alert limits for environmental monitoring?

Follows procedures

Does not follow procedures

Yes

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18. For systems that require validation, does the outsourcer initiate corrective and preventive actions based on a formal review process?

19.

Does

the

outsourcer

have

change

control

process

for

times

when

preventive

maintenance

completed

equipment

software

upgrades

are

installed?

20.

Does

the

outsourcer

have

documented

processes

and

procedures

(including

shipping

validation

studies)

ensure

that

preparations

leaving

the

site

retain

their

integrity

and

stability

through

the

shipping

cycle?

PART 3: MEDICATION ADMINISTRATION SAFETY FEATURES

(20% of Total Score)

Section One: Quality Label

21.

Does

the

outsourcer

use

drug

name

differentiation

the

form

TALL

MAN

lettering

defined

authoritative

body

for

sound-alike

and

look-alike

drugs?

22. Does the outsourcer use visual cues on the label to differentiate drug names and drug concentrations within a therapeutic class?

23.

Does

the

outsourcer’s

labeling

provide

total

drug

amount

and

concentration

(e.g.,

mg/mL)

ensure

administration

the

correct

dose?

Part 2 Score

Yes

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24. Does the outsourcer provide auxiliary cautionary labeling to indicate contraindicated routes of administration?

25.

Does

the

outsourcer

use

ASTM

(American

Society

for

Testing

and

Materials)

color

coding

for

anesthesia

syringe

preparations?

26.

Does

the

outsourcer

have

the

capability

provide

additional

risk

cues

anesthesia

syringes

differentiate

drugs

within

therapeutic

class

and/or

concentration?

27. Does the outsourcer provide access to information on latex, DEHP and preservative free products 24 hours per day, 7 days per week?

28. Does the outsourcer provide bar codes on all of its labels?

29.

Does

the

outsourcer

provide

comprehensive

bar

coding

that

includes

the

national

drug

code

(when

available)

number,

lot

number,

and

expiration

date?

30.

Does

the

outsourcer

provide

label

formats

and

bar

code

placement

that

allow

visualization

drug

name

and

concentration

when

used

the

institution’s

automated

infusion

pumps

syringe

pumps?

Section Two: Tamper Evidence

31.

Does

the

outsourcer

offer

tamper-evident

options

which

may

include

overwrap,

shrink

wrap,

tamper-evident

foil,

and/or

tamper-evident

caps?

Part 3 Score

Yes

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PART 4: SERVICE EXCELLENCE

(10% of Total Score)

Section One: Product Availability and Breadth of Line

32.

Can

the

outsourcer

provide

concrete

examples

their

ability

provide

new

services

meet

the

evolving

patient

care

needs

institution?

33. Does the outsourcer compound medications for epidural administration?

34. Does the outsourcer compound medications for intrathecal administration?

35. Does the outsourcer compound controlled substances?

36. Does the outsourcer compound patient controlled analgesia solutions?

37. Does the outsourcer compound anesthesia syringes?

38. Does the outsourcer compound solutions for continuous nerve blocks?

39. Does the outsourcer compound antibiotics?

40. Does the outsourcer compound electrolyte solutions?

Yes

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41. Does the outsourcer compound total parenteral nutrition?

42. Does the outsourcer compound cardioplegia solutions?

43. Does the outsourcer compound solutions for use in the critical care setting?

44. Does the outsourcer compound CRRT (Continuous Renal Replacement Therapy) preparations?

45. Does the outsourcer compound oxytocin solutions?

46. Does the outsourcer compound chemotherapy?

47. Does the outsourcer fill elastomeric containers/pumps?

48. Does the outsourcer compound medications for use in pediatric patients?

Section Two: Ease of Ordering

49. Does the outsourcer provide easy, convenient and reliable web-based ordering?

Yes

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50. Does the outsourcer offer E-222 “CSOS” ordering for controlled substance purchases?

51. Does the outsourcer offer a real-time, online reporting tool (e.g., shipment tracking, order history, invoices)?

Section Three: Order Turnaround Time

52. Does the outsourcer provide guaranteed delivery timeframes for compounded sterile preparations?

53. Does the outsourcer provide same-day delivery?

54. Does the outsourcer provide next-day delivery?

Section Four: Storage and Space

Site Visit Question

55. Does the outsourcer’s current production capacity meet the requirements of the organization?

56.

the

outsourcer

willing

work

with

the

organization

suggestions

for

improvement

storage

solutions

(e.g.,

customized

packaging)?

57. Has the outsourcer incorporated green programs (e.g., waste reduction initiatives) into their services?

Site Visit Question

58. If the outsourcer prepares compounded sterile products using controlled substances, is the storage area for these secure and is staff identification required prior to entry into the area?

Yes No

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Section Six: Service Considerations

59. Does the outsourcer negotiate prices with group purchasing organizations?

60. Does the outsourcer have a mechanism to respond to customer service issues or questions 24 hours a day, 7 days a week?

61. Does the outsourcer have the clinical expertise in the area of products provided (e.g., TPN)?

62.

Does

the

outsourcer

have

staff

members

who

are

knowledgeable

the

necessary

clinical

pharmacy

areas

the

support

the

efforts

its

customers

driving

change

within

the

hospital?

63.

Does

the

outsourcer

have

staff

members

who

are

knowledgeable

the

necessary

clinical

pharmacy

areas

who

can

ensure

that

order

received

from

hospital

clinically

and

therapeutically

appropriate?

64.	Can	the	outsourcer	provide	consultation	services	regarding	potential	compounding	efficiencies	and
practice	changes	that	can	result	from	analysis	of	compounding	patterns?

65.

Does

the

outsourcer

have

track

record

for

innovation

and

process

evolution

evidenced

customer

testimonials?

Part 4 Score

Yes No N/A

Yes No

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Step 3: Assessment Summary

20%

50%

20%

10%

100%

371 - 412 Excellent

309 - 370 Good

285 - 308 Consider Other Sterile Products Outsourcing Options

This outsourcing contractor should not be considered for the provision of sterile products preparation services as this outsourcer was unable to meet one or more of the minimum requirments.

Interpret Your Score:Contractor Assessment Tool Score:

Interpret Your Score:

412-371 Excellent

370-330 Good

329-301 Consider other options

Vendor is disqualified due to an unacceptable response to one or more minimum requirement questions.

Contractor Assessment Tool Score:

zero

the

Total

Points

section

under

Vendor

Qualification

indicates

that

the

vendor

disqualified

due

unacceptable

response

one

minimum

requirement questions.

Part 1: Regulatory

Part 2: Quality and Patient Safety

Part 3: Medication Administration Safety Features

Part 4: Service Excellence

Vendor Assessment Number of Questions

Total Raw Score

Section Weight

Weighting Multiplier

Total Points

Number of Questions

Total Raw Score

Total PointsVendor Qualification*

Part 1-4

Total

Sterile Products Outsourcing Tool (SPOT)

NA: Off

NA_2: Off

NA_3: Off

NA_4: Off

Annually: Off

Less than annually or never: Off

Performs Weekly: Off

Performs More than Weekly: Off

Does Not Perform Weekly: Off

Exceeds USP 797 Guidelines: Off

Exceeds USP 797 Guidelines_2: Off

Meets USP 797 Guidelines: Off

Does not meet USP: Off

Does not meet USP_2: Off

Meets USP 797 Guidelines_2: Off

eg, Pharmacy Technician Certification Board: Off

50-94: Off

toggle_6: Off

Yes, all available: Off

Some or no Pedigree: Off

NA_5: Off

NA_6: Off

Yes, still: Off

Yes, resolved: Off

No_24: Off

All available: Off

Some or none: Off

Part 1 Score: 0

Never: Off

Once: Off

More than once: Off

Follows: Off

Follows_2: Off

Follows_3: Off

Does not follow: Off

Does not follow_2: Off

Does not follow_3: Off

Part 2 Score: 0

NA_7: Off

MR:P1:Q1: Off

MR:P1:Q2: Off

MR:P1:Q3: Off

MR:P1:Q4: Off

MR:P1:Q5: Off

MR:P1:Q6: Off

MR:P1:Q7: Off

MR:P1:Q8: Off

MR:P1:Q9: Off

MR:P1:Q10: Off

MR:P1:Q11: Off

MR:P2:Q12: Off

MR:P2:Q13: Off

MR:P2:Q14: Off

MR:P2:Q15: Off

MR:P2:Q16: Off

MR:P2:Q17: Off

MR:P2:Q18: Off

MR:P2:Q19: Off

MR:P2:Q20: Off

MR:P2:Q21: Off

MR:P2:Q22: Off

MR:P2:Q23: Off

MR:P2:Q24: Off

MR:P3:Q25: Off

MR:P3:Q26: Off

MR:P3:Q27: Off

S1:P1:Q2: Off

S1:P1:Q3: Off

S1:P1:Q4: Off

S1:P1:Q5: Off

S1:P1:Q6: Off

S1:P1:Q7: Off

S1:P1:Q8: Off

S1:P1:Q1: Off

VA:S2:Q9: Off

VA:S2:Q10: Off

VA:S2:Q11: Off

VA:S2:Q12: Off

VA:S2:Q13: Off

VA:S2:Q14: Off

VA:S2:Q15: Off

VA:S2:Q16: Off

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Part 3 Score: 0

VA:S3:Q21: Off

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Part 4 Score: 0

VA:Part 1:Raw Score: 0

Part 1: Weighted score: 0

Part2: Raw Score: 0

50% weight: 5

Part 2 Weighted Score: 0

Part 3: Raw Score: 0

20% Weight: 2

Part 3 Weighted Score: 0

Part 4: Raw Score: 0

10% Weight: 1

Part 4: Weighted Score: 0

MR-Raw-Score:

Contractor Assessment Tool Score: 0

MR-QUALIFIED-TEXT:

MR-Qualified-Explanation: You must answer all 27 minimum requirement questions before the results of the Minimum Requirement Assessment are displayed.

Total Score: 0

MR-Number: 0

MR-Total-Raw-Score:

MR-Total-Points:

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File details come from the government source that posted it. Updated Nov 14, 2017.