2008 Excel Manual

8/8/2019 2008 Excel Manual

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Manual


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Thank you for choosing the College of American Pathologists (CAP) EXCEL Proficiency

Testing Program. The CAP is proud to partner with you in improving your laboratorys

performance and its positive impact on patient care.

Guided by the expertise of the CAP Point of Care Testing Committee, which combines

the unique perspectives of the committees pathologists, clinicians, and medical

technologists, EXCEL modules evolve each year to better meet your needs and to help

you stay current with new technologies and emerging analytes.

Based on years of experience and a steadfast commitment to quality, the CAP offers the

widest array of proficiency testing and educational solutions to promote laboratory

performance improvement through an educational peer-comparison program. Our

EXCEL program has been designed to meet the needs of physician office and smaller

laboratories, and we feel privileged to have you participate.

The following pages contain general information to assist you. Please read these pages

carefully before specimens arrive in your laboratory. If you have additional questions,

please contact our Customer Contact Center at 800-323-4040 option 1

or at 847-832-7000 option 1.


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1 General Information About the EXCEL Program............ ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... . 1

s Order Confirmation Report............................................................................................................................ 1

s CAP Mail.........................................................................................................................................................1

s Selection of Analytes for Regulatory Reporting............................................................................................... 2

s EXCEL Binder................................................................................................................................................. 2

s Your CAP Identification Number..................................................................................................................... 2

s Receipt of Specimens..................................................................................................................................... 2

s Shipment Dates.............................................................................................................................................. 2

s Statement on Safety........................................................................................................................................ 2

s Warning..........................................................................................................................................................3

s Reporting a Laboratory Accident....................................................................................................................3

s Policy on Replacement Specimens................................................................................................................. 3

s Completion Time and Changing Results..........................................................................................................3

s CMS Reporting Instructions............................................................................................................................4

s When to Expect Your Evaluation.....................................................................................................................4

s Corrections to the Evaluation Report..............................................................................................................4

s Program Certificates.......................................................................................................................................4

s Inquiries About EXCEL....................................................................................................................................5

s Limitations of Proficiency Testing................................................................................................................... 5

s Limitation of Proficiency Testing Letter......... ...... ...... ...... ....... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... . 6

2 General Comments.................................................................................................................................. 7

s Completing the Result Form........................................................................................................................... 7

s Teleforms....................................................................................................................................................... 7

s Preprinted Method Summary Page. ................................................................................................................7

s

Exception Codes.............................................................................................................................................7s Identification Master Lists.............................................................................................................................. 8

s Method/Instrument Master Lists..................................................................................................................... 8

s Handwriting................................................................................................................................................... 8

s Decimal Points and Box Positions..................................................................................................................8

s Less Than or Greater Than Values...........................................................................................................8

s Reviewing Your Evaluation Report..................................................................................................................9

s Use of Reason Codes for Non-Evaluated Specimens....................................................................................... 9

2 0 0 8 EX CEL M a nu a l

Ta b l e o f Co n t e n t s


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3 e-LABSolutions.....................................................................................................................................10

s Submission Instructions: Online, Fax, or Mail.......................................................................................... 11

4 General Guidelines for Evaluation............................................................................................................12

s Introduction.................................................................................................................................................12

s Peer Groups................................................................................................................................................. 12

s Method Group..............................................................................................................................................12

s Comparative Method.....................................................................................................................................13

s Calculation of Summary Statistics for Peer Group Results.............................................................................13

s Outlier Detection Technique.........................................................................................................................13s Calculation of Evaluation Range....................................................................................................................13

s Calculation of the Standard Deviation Index ( SDI) .......................................................................................14

s Evaluation When Participants Use the Other, Specify Category...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... .14

s Comparative Statistics...................................................................................................................................14

s Qualitative Procedures..................................................................................................................................14

s New Analytes................................................................................................................................................ 14

5 Continuing Education...............................................................................................................................15

s The Next Dimension in Education................................................................................................................ 15

6 Hematology, Coagulation, Immunohematology, and Urinalysis...................................................................17

s How to Complete the Result Form................................................................................................................17s Evaluation of Qualitative Procedures............................................................................................................ 18

s Evaluation of Quantitative Procedures.......................................................................................................... 19

7 Immunology, Microbiology, and Virology................................................................................................. 20

s How to Complete the Result Form................................................................................................................20

s Syphilis Serology.......................................................................................................................................... 20

s Diagnostic Allergy.........................................................................................................................................20

s Microbiology................................................................................................................................................ 20

s Virology.........................................................................................................................................................21

s Evaluation of Quantitative Procedures.......................................................................................................... 21

s Evaluation of Qualitative Procedures............................................................................................................ 21

s Regulatory Requirements for Microbiology.................................................................................................. 22

s Antimicrobial Susceptibility Testing.............................................................................................................. 22

s Selection of Antimicrobial Agents for Susceptibility Testing........ ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... 22

s Agar Diffusion...............................................................................................................................................23

s Minimum Inhibitory Concentrations (MICs) .................................................................................................23



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8 Chemistry...............................................................................................................................................24

s How to Complete the Result Form ............................................................................................................... 24

s Evaluation of Quantitative Procedures ......................................................................................................... 24

s Comparative Methods ................................................................................................................................. 24

s EXCEL Validated Chemistry Material (Module CHVM)...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... .....25

s Uses of EXCEL Validated Chemistry Material ......... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... .. 25

9 The Evaluation and Participant Summary Reports............ ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....26

s Your Evaluation Report................................................................................................................................ 26

s Reviewing Your Evaluation Report .............................................................................................................. 26

s The Participant Summary..............................................................................................................................27

s How to Perform a Self-Evaluation................................................................................................................ 28

10 Complying With CLIA.......................................................................................................................... ..29

s Introduction.................................................................................................................................................29

s Laboratory Legislation.................................................................................................................................. 29

s Provision of Results to CMS and State Agencies............................................................................................32

s Result Forms Attestation Statement........................................................................................................... 32

s CMS Performance Summary Report............................................................................................................. 32

s General Information Regarding the CMS Performance Summaries and the

Selection of Analytes for Regulatory Reporting..............................................................................................33s CMS Regional Offices.................................................................................................................................. 33



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Order Confirmation ReportAn order confirmation report will be sent to you after

your EXCEL order is received.

Review all information on your laboratorys order

confirmation report carefully. Make any necessary

additions or corrections and return it within five daysof receipt to ensure all information on your laboratory

is up-to-date.

Customer Data Maintenance Department

College of American Pathologists

325 Waukegan Road

Northfield, IL 60093-2750

Mail or fax (847-832-8168) your confirmation report

to the CAP at the above address only if you have made

changes. Retain a photocopy of your corrected

confirmation report for your records. An updated order

confirmation report will be sent to you. Keep this report

as a record of your enrollment in a proficiency testing

(PT) program and of the series/modules you have

ordered.

CAP MailThe CAP has implemented an e-mail notification service,

CAP Mail, designed to keep you informed of our receipt

of your order form(s) and result forms. For these

documents, the CAP will notify the PT shipping contact

that we have received your information. All Result Form receipt acknowledgement messages

include a Result Form Receipt link to the CAP Web

site where you can review detailed information for

each kit including the number and specific pages

received and method of receipt.

To take advantage of this service, make sure the CAP has

the appropriate e-mail addresses for your laboratory.

For EXCEL document acknowledgement, include

the appropriate e-mail address on the first page of

your order form in the section titled PT ShippingContact.

Program participants can choose to not participate in

this program (opt-out) by contacting the CAP

Customer Contact Center at 800-323-4040 option 1.

GENERAL INFORM ATION

ABOUT THE EXCEL PROGRAM1


7/402 General Information About the EXCEL Program


800-323-4040 Option 1 for Customer Contact Center

Selection of Analytesfor Regulatory ReportingThe CAP is approved by the Centers for Medicare &

Medicaid Services (CMS) as a proficiency testingprovider. As such, the CAP is required to send only one

set of results for analytes regulated for proficiency

testing to the CMS main office in Baltimore, Maryland.

If you have provided a CLIAidentification number and

you are enrolled in modules containing analytes

regulated for proficiency testing, the College will

forward results electronically to CMS. If you wish to

modify the reporting scheme of your results in any way,

please contact the CAP Customer Contact Center at

800-323-4040 option 1.

EXCEL BinderTwo-inch ring binders are available for purchase at $10

each. Participating laboratories can file evaluations,

Participant Summary reports, and Education activities in

the binder. EXCEL reports are printed on three-hole-

punched sheets to facilitate storage in the binder.

Your CAP

Identification NumberEach participant in the EXCEL program receives an

identification number that is printed on all kit labels

and evaluations above the name of the laboratory. Refer

to this number when making inquiries to the CAP.

Receipt of SpecimensThe vendor will ship kits as indicated on your EXCEL

shipment schedule.Refer to the EXCEL shipment schedule and advise your

laboratory staff of the approximate ship dates for the

EXCEL kits to which you have subscribed. The shipment

schedule is included in your EXCELcatalog. This

schedule should be posted prominently in your

laboratory so you will know when to expect your

EXCEL kits.

Alternative shipment dates are not possible. Make

arrangements for receipt and proper storage of kits if

your laboratory is scheduled to be closed.

Shipment DatesEXCEL is a modular PT program. Aconvenient tear-out

2008 EXCEL shipping calendar is included in your

2008 EXCEL catalog.

Each result form includes a mailing page that specifies

the modules your laboratory has ordered. The kit

information sheet contains a listing of modules that

should be included in the kit. Check the contents of

your kit against the information sheet to ensure you

have received all of the specimens for the modules you

have ordered. If your kit is incomplete or contains

broken or unlabeled specimens, notify the CAPCustomer Contact Center immediately for a replacement

(see Policy on Replacement Specimens, next page).

Statement on SafetyWhere appropriate, human source materials used in the

preparation of EXCEL samples have been tested for

antibodies to HBsAg, anti-HIV, and anti-HCV. Such

testing or other treatment of the samples does not

ensure that these samples are free of etiologic agents.

All samples of human origin, whether known or notknown to contain infectious agents, are potentially

capable of transmitting disease and should be handled

with care, and appropriate protective equipment should

be used. (See the Occupational Safety and Health

Administration [ OSHA] Final Standard, Occupational

Exposure to Bloodborne Pathogens.) Some EXCEL

samples contain viral or bacterial agents that may be

infectious. In the majority of these samples, no attempt

is made by heating, chemical treatment, or other means

to inactivate these agents or to reduce the potential

infectivity of the samples. EXCEL shipments known to

contain infectious materials are packaged accor ding to42 CFR, Part 72.25, and are identified by an Etiologic

Agent label on the outside of the shipping container.

Upon receipt, all packages should be inspected for

damage during shipment. If damage is noted and the

package appears wet, autoclave and discard the

package without opening. Damage to packages during

shipment should be reported to the CAP Customer


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EXCEL Manual


Contact Center with a request for replacement

specimens (see Policy on Replacement Specimens).

Warning

Proficiency testing specimens must be handled withcare. Each shipment includes a biohazard warning

statement explaining proper handling.

Reporting aLaboratory AccidentPersonnel exposure to infectious specimens, by

needle sticks, contamination of the mucous membrane

through splashes or aerosolization, or cuts from PT

containers, should be repor ted to a CAP coordinatorfor additional follow-up.

To report a laboratory accident, call the 24-hour

hotline at 800-443-3244.

You will be asked for the following information:

s Callers name and title

s CAP number

s Phone number

s

Name of institution/city/state

s Name of person affected, if other than caller

s Date and time of incident

s Module name and specimen number

s Description of incident and how affected

s Name and telephone number of responsible

physician

This information will be relayed to CAP technical staff

for follow-up by a CAP resource committee member orstaff for further investigation.

Policy on ReplacementSpecimensIn the event that a replacement specimen is r equired,

please retain your original result form while awaitingthe arrival of the replacement specimens. The

replacement specimens will be sent in the same manner

as your original kit. Accompanying your specimens will

be a notification that these specimens were issued as

replacements. Attach this notification to your original

result form and submit your results. If an entire kit or a

result form needs to be replaced, the result form will be

marked as replacement. You are ensured an evaluation

and do not need to provide additional documentation.

Occasionally, the manufacturer may be unable to supply

a replacement specimen. In this case, please indicateException Code 33 in the appropriate section of the

result form that indicates a replacement was requested

but not available. Unsatisfactory Specimen will appear

on your evaluation and you will not be penalized.

Completion Time andChanging ResultsPer the Federal Register, specimens must be examined

or tested with the laboratorys regular patient workloadby personnel who routinely perform the testing in the

laboratory. Sharing of PT results with another laboratory

prior to evaluation is not permitted. This program is

one way to evaluate the performance of your laboratory

staff. It is important that the personnel who routinely

perform your tests analyze the proficiency testing

specimens.

The EXCEL program is used for certification of certain

laboratories. Since promptness is considered in

determining certification, we cannot accept late entries.

Results are due by the date noted on the resultform. Result forms received beyond the date noted will

not be evaluated. Participants will receive an evaluation

indicating that the results were received past the

evaluation cut-off date along with a Participant Summary

that can be used for self-evaluation.





CMS Reporting Instructions

s Changes to submitted data cannot be made after the

due date listed on the result form. Review all entries

made on the result form for accuracy prior tosubmission.

s If you have registered your lab on the CAP Web site,

you may use Result Form Verification to verify

submitted results.

s For any testing that you do not routinely perform in

your laboratory, leave all reporting areas for that

test blank, including method information. Pleasenote, a penalty will not be applied for blank

responses in the case of educational

challenges, challenges not formally graded,or the proper use of exception codes.

s If you do not perform specific testing in an EXCEL

module, please refer to the kit instructions and

result form for the appropriate instructions.

When to ExpectYour EvaluationUnder usual circumstances, the evaluation report will

be made available online or mailed to you four weeksafter 85 percent of the result forms have been received

by the CAP. This time allows for data processing,

establishing evaluation criteria, and prepar ing repor ts.

Corrections to theEvaluation ReportOccasionally, incorrect entry of submitted data occurs.

If this is due to your transcription error or failure to

complete the result form appropriately, your entrycannot be re-evaluated. If the error is made by the CAP,

please notify the CAP of the problem within four weeks

of the evaluation date for re-evaluation.

Program CertificatesAt the completion of the program year, participating

laboratories will receive a program certificate that

recognizes each institutions participation in the CAP

EXCEL Proficiency Testing Program and its commitment

to patient care. Certificates are signed by the CAP

president and are suitable for framing.


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EXCEL Manual


Inquiries About EXCELFor general or specific information regarding EXCEL

evaluation criteria or submission of additional results,

contact:

CAP Customer Contact Center


325 Waukegan Road


800-323-4040 option 1 for US and Canadian

participants

All other participants, call 847-832-7000

(collect)

For EXCEL order processing, address changes,

regulatory type changes, and consultant copy changes,

write (only) to:

Customer Data Maintenance DepartmentCollege of American Pathologists

325 Waukegan Road


(Be sure to include your CAP number in all

correspondence)

For EXCEL billing, contact:

Accounting Department


325 Waukegan Road


800-323-4040 for USAand Canadianparticipants

All other participants, call 847-832-7000

(collect)

Limitations ofProfi ciency TestingDue to the manufactured nature of the specimens and

logistics of result processing, proficiency testing doesnot always correlate with the manner in which fresh,

clinical specimens are handled. Aletter addressing

these differences is included (page 6) for your use.





6 General Information About the EXCEL Program

Dear Proficiency Testing Participant:

The College of American Pathologists (CAP) proficiency testing programs are the largest external quality assessment

programs in the world. As such, they provide an unparalleled selection of challenges and offer the largest database in

existence for interlaboratory comparison. The CAP has accumulated significant experience in managing these types ofprograms and is knowledgeable in their uses and limitations.

It is important to note that performance in the CAP EXCEL program is not to be taken as the sole indicator of a

laboratorys abilities. Proficiency testing is but one of a number of quality assurance programs that laboratories may

employ to assess, manage, and improve quality. In addition to proficiency testing, internal and regional quality control,

laboratory inspection and accreditation, and quality assurance monitoring provide important tools for measuring

laboratory performance using multiple parameters.

Furthermore, the EXCEL program, although outstanding, does not provide perfect measuring devices. Indeed, a

number of limitations of external quality assessment limit this tools ability to measure proficiency. Specific limitations

include: requisite use of control materials of which the analytic behavior differs from that of patient specimens;

the appropriateness of method grouping according to analytic measurement system and instrument; varying size

of comparison groups with attendant variability of statistical parameters; regulated limitations in sampling of

laboratories testing systems; difficulties in quantitating quality at the extremes of analyte concentration; and

inappropriateness of certain federally regulated external evaluation limits.

Thus, even with control of all of the above factors, a certain number of challenges that are graded as unacceptable

in the EXCEL program will in fact be acceptable, and a certain number of challenges graded as acceptable will in fact

be unacceptable. Therefore, although unsuccessful or unsatisfactory proficiency testing performance may indeed reflect

problems within a laboratory, it does not constitute proof of insufficient performance to meet patient needs.

Sincerely,

Cynthia Foss Bowman, MD, FCAP

Chair, Point of Care Testing Committee

Limitations of Profi ciency Testing Letter


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Completing the Result FormThe result form is a prepared form on which you

record your methods of analysis and results of labora-

tory testing. The completed result form must be

returned online or by fax or mail to the CAP for

evaluation. Prepare your result form carefully according

to the instructions. Double-check your answers foraccuracy and completeness and retain a photocopy of

the completed result form for your records.

The result form includes result boxes in which you

should enter your results using the box that

corresponds to the respective specimens. Instructions

accompanying the result form indicate which specimens

may be expected for a given set of modules. This key

may be used as a reference when completing the result

form.

It is important to photocopy or print a copy of the

completed forms for your r ecords before mailing orsubmitting them online to the CAP.

Per directive from the Centers of Medicare and

Medicaid Services (CMS), changes to submitted data

cannot be made after the due date printed on the result

form. Review all information on the method summary

page and all entries made on the r esult form for

accuracy prior to submission. Once you have opted in,

you can use the Result Form Data Entry and Receipt

Verification option on the CAP Web site ( under e-LAB

Solutions) to verify the submitted data.

TeleformsTeleforms are scannable forms. Because these forms

are scanned, please refer to the kit instructions for

more detailed instructions on completing the result

form.

Preprinted Method SummaryPageThe computer system is designed to enhance result

reporting from your laboratory. Once you have initially

provided a master list code for a method, instrument,

and/or reagent, the computer will maintain these codes,

ending your need to report them throughout the year.

Please check each master list to ensure the correct

codes are listed. Should you need to change a code,

enter it in the appropriate boxes on the result form.

Exception CodesIf it is necessary for you to report an analytical problem

for an entire test or individual specimens within a test,

leave the result area blank and fill the bubble for the

appropriate Exception Code. Select the appropriate

two-digit code from those listed on the next page and

fill the appropr iate bubble.

GENERAL COM M ENTS2See Chapter 3 for details on the new online data entry option!


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Exception Code* Reason

11 Unable to analyze (documentation to

be provided by laboratory) .

22 Result is outside method/instrument

reportable range.33 Specimen determined to be

unsatisfactory after contacting the CAP.

*It is the laboratorys responsibility to document the

appropriate use of these exception codes should this be

requested during a laboratory inspection. Please refer

to the kit instructions for more information.

Identification Master ListsMaster lists of possible identifications are provided for

microbiology, blood cell identification, urine sediment,clinical microscopy, and provider-performed

microscopy. Select your answers from the appropriate

master lists provided. Record the appropriate master

list code for your choice on the result form.

For blood cell identification, urine sediment, clinical

microscopy, and provider-performed microscopy, all

possible identifications are included on the master lists.

Do not use the code 010, Other, Specify. The use of

this code will be evaluated as an unacceptable response.

Method/ Instrument MasterListsMethod/instrument master lists are provided for

hematology, coagulation, immunology, urinalysis, and

chemistry. For these tests, choose the appropriate

instrument and/or method.

It is important that you notify the CAP and the

manufacturer if your instrument or method is not listed

on a master list. This may be done by listing this

information in the Use of Other section of the resultform. You may also contact the CAP directly while

completing the result form to see if a code has already

been established for your method and/or instrument but

was not available in time for printing of the result form.

HandwritingThe result forms are designed for quick, easy

scanning by our computers. If you fax or mail your

results, the information on your r esult form must be

clearly readable. Please follow the guidelines in the kitinstructions for optimum efficiency and accuracy in

processing your results.

Decimal Points and BoxPositionsThe computer is programmed to accept only those

answers conforming to the boxes and decimal points on

the result form.

If a number is not large enough to fill the boxes, insert zero

in the remaining spaces. Results should be right-justified.

When submitting results online, this will be done

automatically

Example: Correct Incorrect

Glucose

73 mg/dL

Urea Nitrogen

12.8 mg N/dL

Less Than or GreaterThan ValuesDo not attempt to add less than or greater than to

the value you submit unless this option is provided on

the result form. Where provision is made to report less

than or greater than results, you must fill in the

bubble of the appropriate box to indicate your response

is a less than or greater than value. All other results

will be considered equal to values.Where no option to report greater than or less thanis given, refer to exception codes on this page or inyour kit instructions.



0 7 3

0 1 3 1 2 8. .

..

8 General Comments


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General Comments 9

EXCEL Manual

Reviewing YourEvaluation ReportUpon receipt of your EXCEL evaluation report, review

your laboratorys performance by comparing yourcopy of the result form with the computer-generated

evaluation report. If the information you provided is not

the same as on the evaluation report, immediately notify

the CAP. Your entry will be re-evaluated if the CAP is

notified within four weeks after your evaluation was

mailed.

Check for any results marked unacceptable. At thesame time, check the evaluation codes to see how yourresults were evaluated.

Although results may not be formally evaluated, you can

compare your result with the data provided in theParticipant Summary where appropriate. For peer

groups consisting of five to nine laboratories, median,

low, and high values are listed in the Participant

Summary where appropr iate. You can use the median

result to compare your submitted results

for a self-evaluation of your performance. Refer to

Chapter 9 for more information on how to perform a

self-evaluation.

Use of Reason Codes forNon-Evaluated SpecimensSome individual results are not evaluated for certain

laboratories for a variety of reasons. The reason codeexplaining that circumstance will appear on theindividual evaluation report with a brief explanation ofwhat that code means. Akey is provided below.

Code Description

11 Unable to analyze (documentation to be provided by

laboratory).

20 No appropriate target/response cannot be graded.

21 Specimen problem.

22 Result is outside method/instrument repor table range.

24 Incorrect response due to failure to provide a valid.

response code.

25 Inappropriate use of antimicrobial.

26 Educational challenge.

27 Lack of participant or referee consensus.

28 Response qualified with a greater than or less than si

or, unable to quantitate.

30 Scientific committee decision.

33 Specimen determined to be unsatisfactory after contacting

CAP.35 Testing not performed on this specimen type.

40 Results for this kit were not received.

41 Results for this kit were received past the due date.

42 No credit assigned due to absence of response.

43 The order for this kit was canceled; results not evaluated.


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e-LABSolutionse-LABSolutions provides Internet access to the EXCEL

program via the CAP Web site. Great care has been

taken to ensure the online capabilities are secure. A

multi-tiered system will allow laboratory directors or

designees, to specify functionality and access privilegesfor laboratory staff. Advantages of online services

include:

s Online entry and submission of data: Kit instructions

and pre-populated result forms will be available for

online use. Online submission of data eliminates the

chance of reporting errors due to faxing/scanning.

An e-mail reminder will be sent if you have not

submitted your results prior to the evaluation of the

mailing. While paper copies of result forms will be

provided, laboratories are encouraged to submit

their data online.

s Receipt verification: laboratories that submit data by

fax can verify receipt of result forms and review the

scanned data to ensure there are no scanning

errors. If errors are found, corrections can be made

online (prior to generation of evaluations).

s Interactive evaluations/ scorecard: An e-mail will be

sent when your online evaluation is available for

viewing. With online access there is no more

waiting for reports to be received by mail.

The online evaluation will be available in a format that

can be printed or downloaded and stored electronically

at your laboratory. The online evaluation will allow theuser to view the entire evaluation or browse the data

analyte by analyte. For those products that include

photopages, you will be able to access the Participant

Summary discussion and a copy of the image simply by

clicking on the result on the evaluation. The new online

evaluation will also include an All Analyte Scorecard

so you can quickly and easily assess your performance

for all analytes (not just those reported to CMS).

We are confident you will find these enhanced services

a benefit to the EXCEL program. For more information

about online services, contact the Customer ContactCenter at 800-323-4040 option 1.

In order to take advantage of e-LAB Solutions, the

laboratory must be opted-in and laboratory

personnel need to establish personal Web accounts as

well. Detailed information on how to opt-in and request

accounts was sent to your laboratory administrator or

e-LABSOLUTIONS3


16/40e-LABSolutions

11


personnel need to establish personal Web accounts as

well. Detailed information on how to opt-in and request

accounts was sent to your laboratory administrator or

director in 2004. If your laboratory has not activated its

account yet, please contact the CAP at 800-323-4040

option 1 for more information. While faxing or mailing

results is still acceptable, we strongly encourage

laboratories to take advantage of the online submission

option to improve the timeliness of data submission and

the integrity of the data. For more information on how to

submit results via the Internet, see the following

instructions.

Submission Instructions

ONLINE Submission of Results

(e-LAB Solutions)In order to submit results online, your lab must first

establish a laboratory Web account, often referred to as

Opting In. Information about Opting In, and a unique

PIN, has been mailed to all laboratory administrators or

directors. If your lab director does not have this

information, please contact the CAP at 800-323-4040

option 1 for a replacement letter.

Lab staff that will be entering results, accessing data, or

approving data online need to establish a personal Web

account (click on Create an Account on the CAP home

page and follow instructions). Once a personal account

is established, lab staff can log in and request access totheir labs information:

s After log in, click on Administrative Options under

e-LAB Solutions on the left side navigation bar.

s Click on Request Access (in center of page) and

enter your laboratorys 7-digit CAP Number.

s Your request will be sent to your laboratorys Site

Administrator to grant access.

s Once access has been granted, you will receive a

confirmation, via e-mail, notifying you of your accessprivileges.

s Click on Proficiency Testing under e-LAB Solutions

on the left navigation bar.

s Click on Result Forms under Surveys/EXCEL

Proficiency Testing.

s Alisting of the mailings will be displayed or you can

search by using the Filter Options. Click on View

Details to access the Result Form.

s Instructions for result form submission will be

available online. When entering data online, the

electronic form will be identical to the paper version.

Enter and Save the results following the online

instructions. Either the staff entering the results oranother designated laboratory staff must approve the

entered data by clicking the Approve Pending Pages

button in order to be received by the CAP.

s Changes to data submitted online can be made only

online, and cannot be made after the due date printed

on the results form.

FAX or MAIL Submission of Results

1. Print r esults clearly in blue or black ink, as yourresults are scanned by a computer.

2. Information written outside of designated areas will

not be recorded.

3. Changes to submitted data cannot be made after the

due date. Use the Result Form Data Entry and Receipt

Verification option to ensur e the accur acy of the

submitted data.

4. Do not attempt to move or add a decimal point

when recording results on result forms.

5. If you fax your forms,

Fax your input forms toll-free to866-329-2227.

Program your fax machine to print yourinstitution name and fax number at the top ofeach page.

You should not receive a busy signal. Check tobe sure the 866 area code is programmed as atoll-free number.

Do not fax a cover sheet. Do not also mail your result form. Maintain a copy of the fax transmission

confirmation and input forms. You can verify

receipt and edits responses to input forms viathe Internet.

6. If you mail your result forms, Do not staple the forms. Keep a copy of the forms for your records.

EXCEL Manual


17/40

IntroductionOn February 28, 1992, the Secretary of Health and

Human Services (HHS) published rules implementing

the Clinical Labor atory Improvement Amendments of

1988 (CLIA). These regulations established evaluation

criteria limits for many of the analytes included in theEXCEL program. As a CMS-approved PT program, the

limits are specified by these uniform PT regulations.

However, the specific target value for which the

evaluation limits will be applied is determined by

scientific resource committees. For analytes in the

EXCEL program, the peer group mean is designated as

the target value for evaluation. For those analytes not

regulated by CLIA, the evaluation criteria (target value

and limits) are determined solely by scientific resource

committees.

Peer GroupsTo minimize the effect of method differences and to

allow comparison of all methods in the EXCEL program,

participants results are combined into comparable

method/instrument groups called peer groups.

Depending on the analyte, the CAPs resource

committees classify peer groups by method principle,

instrument, and/or reagent. It is, therefore, important

for participants to provide complete information

regarding the method or instrument used. Apeer group

must consist of more than nine results after outlier

exclusion (see Outlier Detection Technique).

Method GroupAmethod mean group consists of results obtained by

the same method and similar instrument. For example,

there may be fewer than 10 labs using the glucose

oxidase, colorimetric method on the Vitros DT 60 and

fewer than 10 labs using this same method on the

Roche Reflotron. The data from these two instruments

can be combined because they use the same

methodology on similar manual instruments. The

method mean group must also consist of more thannine results after outlier exclusion. If method group

statistics do not meet these criteria, the comparative

method mean group will be designated as the target

value. If no comparative method exists for an analyte,

results will not be formally evaluated.

GENERAL GUIDELINES

FOR EVALUATION4


18/40General Guidelines for Evaluation 13

EXCEL Manual


Comparative MethodAnumber of factors enter into the decision to designate

a given method as a comparative method. Included are

considerations of historical reliability and widespread

use of these methods over previous years. Thecomparative method should not be construed as the

method recommended by the CAP. It is established as a

historically reliable method and is used for evaluating

results from methods that have an insufficient number

of participants to generate a separate peer group and/or

method group.

Calculation of Summary

Statistics for Peer GroupResultsSubmitted test results are computer-processed to

calculate statistics that summarize the participants

responses. First, the responses are grouped according

to the method used for analysis (the peer group). Next,

the peer group results are screened for outliers

(below). Finally, various statistics are calculated from

the remaining data that summarize the peer group

responses. These summary statistics include the mean,

the standard deviation (SD), the coefficient of variation(CV), and the final count of reported results that were

not excluded as outliers. An extensive discussion of

statistical terms used in quality control is provided in

Appendix 2.

Outlier Detection TechniqueOutlier exclusion is necessary because experience has

shown that a large series of results frequently includes

some bizarre values. These may arise from various

sources, including instrument malfunction, technicalerrors, clerical error s ( reversal of vial values,

misplaced decimals, and incorrect units of measure),

or data-entry errors. If any results are excluded, the

outlier process is repeated using the remaining values.

Because it is repeated, this technique is often called a

two-pass outlier screen. The summary statistics that

appear on your reports do not reflect results that were

considered to be outliers during either outlier pass.

Calculation of EvaluationRangeAll quantitative responses are evaluated based upon a

range of acceptability. This range is determined using atarget value and a limit. The limit will be either a fixed

interval (eg, 5 mg/dL) , a percentage of the mean (eg,

25 percent), an SD (eg, 3 SD) , or a variable range

( eg, 6 mg/dL or 10 percent, whichever is greater) .

The Participant Summary included with your evaluation

will list the criteria used to evaluate your performance.

The evaluation criteria ar e also included throughout this

manual. The following section provides specific

examples of how to calculate the range of acceptability

depending upon the criteria used.

To determine the acceptable range, a benefit-of-the-doubt rounding procedure is utilized by the computer

system. The upper limit of acceptability is obtained by

rounding up to the next reportable result, while the

lower limit is determined by truncating.

Fixed Range ExampleYour laboratory reports a sodium result of 138 mmol/L.

The peer group mean is 139.5 mmol/L. The evaluation

limit for sodium is 4 mmol/L. The acceptable range is

determined by the formula 139.5 mmol/L 4 mmol/L,

which is 135 to 144 mmol/L. Therefore, your reported

result of 138 mmol/L is within the calculated acceptablerange of 135 to 144 mmol/L when using benefit-of-the-

doubt rounding.

Percentage of the Mean ExampleYour laboratory reports an albumin result of 3.1 mg/dL.

The peer group mean is 3.39 mg/dL. The evaluation

limit for albumin is 10 percent. Ten percent of 3.39

mg/dL is 0.34 mg/dL. The acceptable range is

determined by the formula 3.39 mg/dL 0.34 mg/dL,

which is 3.0 to 3.8 mg/dL when using benefit-of-the-

doubt rounding. Therefore, your reported result of 3.1

mg/dL is within the calculated acceptable range of 3.0

to 3.8 mg/dL.

Standard Deviation ExampleYour laboratory repor ts a TSH result of 16.4 U/mL.

The peer group statistics are as follows: mean = 15.7

U/mL, SD = 1.5, and CV= 9.6. The evaluation limit for

TSH is 3 SD. 3 x 1.5 = 4.5. The acceptable range is


19/4014 General Guidelines for Evaluation



determined using the formula 15.7 U/mL 4.5 U/mL,

which is 11.2 to 20.2 U/mL when using benefit-of-the-

doubt rounding. Therefore, your result of 16.4 U/mL is

within the acceptable range of 11.2 to 20.2 U/mL.

Variable Range Example

Your laboratory repor ts a total bilirubin result of 4.5mg/dL. The peer group mean is 4.68 mg/dL. The

evaluation limit for total bilirubin is 0.4 mg/dL or 20

percent, whichever is greater. Twenty percent of 4.68 is

0.936. Since the percentage limit of 0.94 is greater than

the interval limit of 0.4, the percentage limit is applied

to the target value. The acceptable range is determined

using the formula: 4.68 0.936, which is 3.7 to 5.7

mg/dL when using benefit-of-the-doubt rounding.

Therefore, your result of 4.5 mg/dL is within the

acceptable range of 3.7 to 5.7 mg/dL.

Calculation of the StandardDeviation Index (SDI)The computer-printed evaluation report lists your

results and the evaluation statistics for your peer group.

It also lists your normalized results as an SDI (standard

deviation index).

The SDI is expressed in terms of the number of SDs

from the mean with an arithmetic sign indicating the

direction of the difference. The calculation of the SDInormalizes your result and, therefore, allows for a

comparison of results from specimens of different

concentrations of an analyte.

Evaluation When ParticipantsUse the Other, SpecifyCategoryThe kit instruction sheets include a list of well-

established methods. If your method is not listed, mark

the Other, Specify category. In this case, evaluations

are based on the comparative method, if available. If no

comparative method is available, results will not be

formally evaluated.

Comparative StatisticsYour evaluation report will display plots of the relative

distance of your reported results as a percentage of

allowable deviation from the target value. The numeric

digit indicates the number of results at a plot location.The allowed deviation may be calculated as follows:

If your result is greater than the target mean:

Percentage of = 10 0 x your result - target mean

Acceptable Deviation upper limit - target mean

If your result is less than the target mean:

Percentage of = 10 0 x your result - target mean

Acceptable Deviation target mean - lower limit

Qualitative ProceduresThe consensus method is used for evaluating qualitative

procedures. In accordance with CLIAregulations,

analytes (tests) regulated for proficiency testing must

attain a minimum of 80-percent consensus of referee or

participant response to be evaluated. In other cases, the

appropriate CAP resource committee will determine

what constitutes consensus for each procedure. Results

for a specimen will not be evaluated if the required

percentage of referee and participant laboratories is not

reached.

New AnalytesNew analytes are regularly introduced into the EXCEL

Program. It is the general policy to use the data from

the first year that an analyte is introduced for

information purposes only; therefore, results may not

be formally evaluated for the first year.


20/40

The Next Dimension inEducationEducation is an integral component of all the CAP

Laboratory Improvements Programs. For the 2008

EXCEL program, each individual may receive up to 9Continuing Education (CE) credits/hours for

participating in the education activities. Each mailing of

EXCEL will include an education activity designed to

provide technical and nontechnical information to keep

your staff on the leading edge to ensure quality patient

care. The education activity consists of a related reading

found in the Participant Summary and learning

assessment questions online at www.cap.org.

All laboratory professionals in your lab may now

earn individual CE credits/hours by completing

the related education reading and onlinelearning asses sment questio ns on the CAP Web

site. Upon completion of the education activity, you will

receive a CAP Continuing Education certificate.

Designed by the CAP Point of Care Testing Committee,

each activity combines the unique perspective of the

committees pathologist, clinician, and medical

technologist members. The education activities are

designed to challenge and educate while providing the

convenience of earning free CE credits and fulfilling

licensure and education requirements without leaving

your laboratory. The education activities are alsovaluable tools for in-house continuing education

programs.

Education activities are acceptable to meet the

continuing education requirements for the ASCP Board

of Registry (BOR) Certification Maintenance Program

(CMP). Individuals newly certified beginning January

2004 in the entry-level categories will be required to

par ticipate in the BOR Certification Maintenance

Program in order to maintain their cer tification status.

Individuals who were certified prior to 2004 may

participate on a voluntary basis.

CONTINUING EDUCATION5


21/4016 Continuing Education



Learning Cycle InformationEach education activity provides information on

common technical and nontechnical issues encountered

in all laboratory settings. To receive continuing

education credit, you must complete the education

reading provided in your Participant Summary andanswer the online learning assessment questions. Each

education activity will be available for six months and

must be completed within that time frame. Continuing

education credit will be applied toward the year in

which the activity is completed. Detailed information on

how to access the online components will be included

in each Participant Summary.

Overall Learning Objective

Upon completion of these education activities, the

learner will be able to:

1. List preanalytic, analytic, and postanalytic

variables that affect patient testing.

2. Identify quality improvement opportunities

within his/her own laboratory setting.

3. Apply appropriate quality assurance measures

to ensure accurate patient results.

CE (Continuing Education)The College of American Pathologists designates these

education activities for a maximum of 9 credits/hours of

continuing education. Each participant should claim

only those credits/hours he/she actually spent in the

activity.This activity is acceptable to meet the continuing

education requirements for the ASCP Board of Registry

Certification Maintenance Program.

This activity is approved for continuing education credit

in the states of California and Florida.


22/40

How to Complete the ResultForm

Regular, Automated Differential

and QBC HematologyVerify that the correct Hematology instrument code is

noted on the preprinted method summary page

included with your result form or listed on the online

result form. If a code is not noted or youve changed

instruments, you must enter the correct code on the

result form.

Aseparate Instrument Master List is provided for

participants using a QBC analyzer (Modules XH6 andXH7) .

To report your blood cell identification, select the best

identification code from the Hematology Blood Cell

Identification Master List provided in the kit

instructions. To assist you with blood cell identification,

the EXCEL Hematology and Clinical Microscopy Glossary

is availiable online at www.cap.org.

If results are repor ted for both blood cell identification

and auto differentials, the blood cell identification will

be reported to CMS.

Coagulation

For plasma-based coagulation testing (PT, APTT,Fibrinogen), an instrument and reagent code are

required for proper evaluation. Participants enrolled

in whole blood coagulation modules for PT, need only

indicate an instrument (if requested) and their results.

For all prothrombin time modules, reporting of

International Normalized Ratio (INR) results is

optional. Plasma-based and whole blood INR are

evaluated.

UrinalysisThere is a separate urinalysis and specific gravity

method master list and instrument master list. Toensure an accurate peer group evaluation of your

results, it is critical to pr ovide accurate method and

instrument information.

Aspecific list of reporting options is provided for each

urinalysis procedure. It is not feasible to provide a list

of reporting choices specific for every possible dipstick

being marketed to laboratories. Subsequently, the result

HEM ATOLOGY, COAGULATION,

IMMUNOHEMATOLOGY, AND

URINALYSIS

6


23/4018 Hematology, Coagulation, Immunohematology, and Urinalysis



ranges listed may not exactly correlate with the ranges

used with your instrument/dipstick. In these few cases,

choose the range that most closely matches your

intended result. For example, if your total protein

dipstick result reads 600 mg/dL, you should report

code 114, 300 to 600 mg/dL, instead of code 115,

> 1,000 mg/dL. To ensure an accurate peer groupevaluation of your results, it is critical to select an

appropriate result that the method allows.

To report urine sediment, clinical microscopy, or

provider-performed microscopy, select the best

identification code from the Urine Sediment/Clinical

Microscopy Master List provided. To assist with

identification, the EXCEL Hematology and Clinical

Microscopy Glossary is available online at www.cap.org.

Evaluation of QualitativeProcedures

Morphologic IdentificationsBlood cells, ur ine sediment, and clinical microscopy

challenges are reviewed by referee laboratories and

selected committee members who determine good

and acceptable performance. In general, an 80 percent

consensus for an identification by either participants or

referee laboratories (in the absence of participant

consensus) is required for formal evaluation andconstitutes good per formance. ( Remember, the popular

choice is not necessarily the cor rect choice.)

The Hematology Blood Cell Identification Master List

choice, Immature cell or abnormal cell, referred to

high-complexity laboratory for identification, must

be reserved for cells you rarely encounter and are

unable to specifically identify. Grading of this response

will follow the guidelines set forth in the July 26, 1993,

Federal RegisterNotice.

ImmunohematologySamples are provided for ABO grouping, Rh typing, and

antibody detection.

1. ABO/Rh. Evaluation is based on 95-percent

participant or 100 percent referee consensus.

2. Antibody detection. Evaluation is based on

95-percent participant or referee consensus.

Urinalysis Dipstick TestsFor qualitative procedures in urinalysis, evaluation is

based on participant consensus by method and

instrument. For each analyte, a minimum of two, but

not more than four, responses will be given a passing

score. Analyte results graded good performance musthave 80 percent participant consensus. Eighty-percent

participant consensus can be determined by grouping

the mode with the next one or two most frequent

responses. This group will be given good performance.

Acceptable performance will be given to additional

responses until a minimum of 90 percent of participant

results are given a passing score. In the case of a

negative specimen, negative responses must constitute

90 percent participant consensus. Specimens with

results for one or more methods distributed over both

negative and positive response ( nonconsensus) will not

be evaluated. Specimens for which there is greater than90 percent of participant responses distributed over

more than four responses will be graded as

nonconsensus.

Urine hCGUrine hCG results are evaluated based on 80 percent

participant consensus by method. Manufacturers

stated sensitivity levels are listed for informational

purposes only.


24/40Hematology, Coagulation, Immunohematology, and Urinalysis 19

EXCEL Manual


Evaluation ofQuantitative ProceduresEach Participant Summary will list current

evaluation criteria for quantitative hematology,coagulation, and urinalysis.

Comparative MethodsIf no comparative method is established, instruments

or methods used by fewer than the required number

of participants will not be formally evaluated.

Descriptions

Peer Group Target: Participant performance is evaluated

using the peer group mean as the target value. Good

performance is defined as the peer group mean plus orminus a limit.

Method Mean Target: If fewer than 10 participants are

in your method peer group, your performance is

evaluated using the mean value of 10 or more

laboratories using a similar method. Good performance

is defined as the similar method mean plus or minus a

limit.

Comparative Method Target: If there are fewer than 10

participants in your peer group and fewer than 10

laboratories using a similar method, evaluation is based

on the comparative method mean as the target value

where applicable. Good performance is defined as the

comparative method mean plus or minus a limit.

Not Evaluated: Participants may review their

performance by comparing their results with data

published in the Participant Summary.

Peer Group Target

Method Mean Target

Comparative Method Target

Not Evaluated

Peer Group Target

10 in Peer Group


25/40

How to Complete theResult FormMethod master lists are provided for each analyte

included in the immunology portion of the EXCEL

program. If you have used more than one methodto test the EXCEL specimens, select the method you

consider most reliable. Refer to the kit instructions

for specific reporting requirements.

Syphilis SerologyIf you perform more than one method (eg, VDRL, RPR,

MHA-TP) in your laboratory to test patients for syphilis,

you may also test the EXCEL specimens by each method.

Refer to the master list of reagent manufacturers in the

kit instructions or online for the appropriate suppliercode for each procedure performed. Indicate either

reactive, nonreactive, weakly reactive (VDRL only), or

equivocal (EIAonly) by filling in the bubble for the

appropriate code for each specimen.

Quantitative results should be submitted for reactive

specimens by the VDRL slide test and RPR 18 mm circle

card. You should also perform the VDRL quantitative

test when the qualitative test is weakly reactive.

Diagnostic AllergyThe allergens listed on the result form may be more

specific than the allergens included in your panel. For

example, the result form may state White Oak;

Quercus alba as the specific allergen; however, your

panel includes Oak. Refer to the manufacturerspackage insert for a list of the specific oak allergens

that show reactivity with your reagent kit. If the specific

allergen listed on the result form is included on the

package insert, a class result should be reported. If it is

not indicated in the package insert, do not report a

class result for the specific allergen. Diagnostic Allergy

results are not formally evaluated.

Aqualitative multiallergen screen is available as an IgE

antibody screening assay and is formally evaluated.

Quantitative IgE results should be reported in the units

of IU/mL and are formally evaluated.

MicrobiologyWhere appropriate, a clinical diagnosis, age, and source

are listed to simulate a true clinical situation and to

allow laboratory personnel to select appropr iate media

or methods for processing these specimens. However,

as the pathogenic bacteria present in any of these

IM M UNOLOGY, M ICROBIOLOGY,

AND VIROLOGY7


26/40Immunology, Microbiology, and Virology 21

EXCEL Manual


samples may be isolated from multiple sources of the

body, all participants should attempt identification of the

organisms present in all these specimens.

Urine Culture: Laborator ies performing urine cultures

should refer to the clinical diagnosis, age, and source

to select the appropriate media for processing thespecimens. After you have reached a decision about the

presence or absence of bacteria, refer to the Bacteria

Master List on the kit instructions to select the identifi-

cation you would normally report. Enter the code

number in the appropriate boxes.

For urine cultures, it is important to note that although

space is provided for the reporting of two bacterial

identifications, this does not imply that two different

bacteria are present. Participants should only report

identification of organisms to the level of actual patient

testing. Do not guess genus and/or species of an

organism if this is not your normal labor atory practice.

If it is your normal pr actice to repor t all organisms

present regardless of pathogenicity, you may report

these findings in the second set of identification boxes

provided. Please note, if you r eport a second or ganism,

it must be present and correctly identified to receive

full credit for that challenge regardless of the primary

organism being reported correctly. For example,

specimen XM-06 is a pure culture ofEscherichia. Your

laboratory reports that the specimen containsE. coli;

additionally, it reports Staphylococcus epidermidis as a

second organism. You will only receive half credit for

this challenge because no second organism was

present.

Note: Participants are given the opportunity to perform

Gram stains on the ur ine specimens to check the

proficiency of their Gram stain technique. The CAP

does not recommend that Gram stains routinely be

performed on throat or urine cultures.

Instructions for entering susceptibility results are

included in the kit instructions. However, please refer to

Antimicrobial Susceptibility Testing (page 25) forfurther information on reporting susceptibility results.

Urine Colony Count: Laboratories enrolled in Urine

Colony Count will indicate the range of colonies found

with each specimen. Additionally, those enrolled in

Module M15, M16, or M17 should report a

presumptive bacterial identification using the

Presumptive Identification Master List.

Only presumptive identification results are regulated

and reported to CMS.

Virology

Module M21 is for rapid antigen detection of InfluenzaA, B, RSV, and Rotavirus by enzyme immunoassay

and/or latex agglutination.

Note: Participants must test a minimum of five

challenges per mailing to meet proficiency testing

requirements for the subspecialty of virology. Waived

methods do not contribute to the minimum of five

specimens per mailing. If you switch to a waived

method dur ing the program year you must ensure you

are meeting the five specimen per mailing requirement

for testing using a nonwaived method.

Evaluation ofQuantitative Procedures

ImmunologyFor your convenience, curr ent evaluation criteria are

listed in each Participant Summary.

If your laboratory reports only quantitative results for

RF, your scor es for this challenge will be sent to CMS.No further interpretation is necessary.

Evaluation ofQualitative Procedures

Diagnostic ImmunologyAll regulated analyte challenges demonstrating

80-percent or greater participant or referee consensus

will be evaluated.

Syphilis SerologyAll tests for syphilis should be performed in accordance

with theManual of Tests for Syphilis, published by the

American Public Health Association, or in accordance

with the manufacturers directions.


27/4022 Immunology, Microbiology, and Virology




MicrobiologyThe microbiology specimens are designed to provide an

appropriate challenge to those laboratories performing

basic bacteriology procedures. The pathogenic bacteria

present in the dry loop in any of these specimens are

organisms typically seen in the physician office or smalllaboratory environment.

Specimen results will be evaluated if 80 percent or

more of the participant laboratories agree on the

identification of the test organism(s) to genus or to

genus and species. In the absence of participant

consensus, referee laboratories will be used.

In all instances, clinical significance will serve as the

major determining factor in evaluating a participants

identification.

Remember, participants should identify bacteria

according to the description of their laboratory type

classification.

Regulatory Requirementsfor MicrobiologyImportant Note: In order to meet the

regulatory requirements for Microbiology

subspecialt ies, carefully follow the kit

instructions included with each EXCELmailing.

The CLIAregulations state that a laboratory must

perform a minimum of five specimens in each testing

event for the subspecialty of Bacteriology. The five

challenges can include a combination of the following

specimens:

s bacterial antigen detection

s bacterial identification ( culture)

s Gram stain

s antimicrobial susceptibility

Several EXCEL microbiology modules have beenconfigured to provide cost and time savings by

combining multiple sources and procedures while

meeting this CLIArequirement. Participants must

perform all the microbiology procedures in a module to

ensure compliance. Please note that procedures assayed

with waived methodologies will not count toward the

five-challenge minimum. The laboratory is responsible

for maintaining the five specimens per testing event for

its remaining non-waived tests in the subspecialty when

a test is waived by the FDAmidyear.

AntimicrobialSusceptibility TestingParticipants will be asked to perform susceptibility tests

using the antimicrobial agents and techniques in routine

use in their individual laborator ies. The laboratories

should report only those antimicrobial r esults

considered appropriate for the organism and the

infection site noted in the accompanying clinical history,

according to CLSI guidelines. Inappropriate

antimicrobials that are reported will be

considered an incorrect response.

Selection of AntimicrobialAgents for SusceptibilityTesting1. The grading significance of antimicrobial sensitivity

testing and r eporting:

A. Repor t results for antimicrobials specific for

urinary tract site organisms only.B.Do not report, or report as resistant, any

cephalosporin susceptibility result on oxacillin-resistant staphylococci (eg, somecephalosporins, such as cephalothin,cefamandole, and cefoperazone, may haveminimum inhibitory concentrations [MICs]or zone diameters that erroneously havesusceptible interpretations compared todocumented poor clinical experience).

2. Other recommendations for antimicrobialsusceptibility testing and reporting:

A. Repor t only one penicillinase-stable penicillin(penicillin G) for Gram-positive organisms otherthan enterococci ( eg, penicillin G should beused to represent ampicillin, amoxicillin,azlocillin, carbenicillin, mezlocillin, piperacillin,and ticarcillin).

B.Report only one penicillinase-stable penicillin(oxacillin) for Gram-positive cocci other thanenterococci ( eg, oxacillin must be used to


28/40Immunology, Microbiology, and Virology 23

EXCEL Manual


represent methicillin, nafcillin, cloxacillin, anddicloxacillin).

C. Report only one first-generation cephalosporinfor Gram-positive cocci other than enterococci(eg, cefazolin or cephalothin to represent allthese cephalosporins).

D.Report a limited number of clinically indicatedand/or locally used aminoglycosides for allenteric bacilli (eg, gentamicin or tobramycinonly. Amikacin and/or netilmicin might be testedand not reported unless the organism is resistantto a first-line drug in this therapeutic class.)

E. Report only one clinically indicated andprevalently used representative of the first- andsecond-generation cephalosporins against theEnterobacteriaceae ( eg, cefazolin or cephalothinfor the first generation; cefoxitin or cefuroximefor the second-generation drugs. If the organism

was found to be resistant to the oldercephalosporin, a third-generation cephalosporinresult should be reported.).

F. Report a limited number of antimicrobial agentsfor enterococci, depending on the site of infection( see CLSI [ formally NCCLS] M2-A8, M7-A6, andM100-S17) eg, ampicillin and/or penicillin G,vancomycin, nitrofurantoin, and tetracycline forurinary tract isolates.

Agar DiffusionParticipants using disk diffusion methods are to r eport

their interpretation (ie, susceptible, intermediate, or

resistant). Emphasis is placed upon interpretation of

disk methods; information regarding diametermeasurement is provided with the summary data.

Minimum InhibitoryConcentrations (MICs)Participants using dilution techniques, such as MICs,

should report the qualitative interpretation (ie,

susceptible, intermediate, or resistant) of MICs for each

antimicrobial agent tested.


29/40

How to Complete theResult FormTo ensure statistically valid data, it is essential that

participants provide all necessary method, reagent,

and instrument information as required. Pleaseremember, once you have provided accurate

information, our computer system will retain this

information, thus ending the need to provide it with

each mailing. You ar e encouraged to review master lists

included in the kit instructions for changes or revisions.

Evaluation ofQuantitative Procedures

All analytes included in the chemistry shipment are

evaluated based upon a range of acceptability

determined by a target value plus or minus an

evaluation limit. Please refer to Chapter 4 for a

discussion on how the target value (peer group, method

group, or comparative method mean) is determined.

The evaluation limits currently in use for analytes in the

chemistry shipment are listed in each Participant

Summary report.

Comparative MethodsThe comparative method is used as the target valuefor evaluation if there are fewer than 10 laboratories

comprising the peer group or method group, if the

participant did not provide complete

instrument/reagent/method information, or if the

participant indicates Other, Specify. The results

derived by the comparative method will be used for

computation of the comparative method statistics.

Please refer to your Participant Summary for a listing of

constituents and their compar ative method.

CHEM ISTRY8


30/40Chemistr y 25

EXCEL Manual


EXCEL Validated ChemistryMaterial (Module CHVM)

Validated chemistry materials are a valuable optionavailable to EXCEL participants. These vials of validated

material contain the same pooled material sent in

EXCEL shipments and are numbered in the same

manner as the EXCEL specimens. Analytic values for

validated chemistry materials will be sent to you in the

Participant Summary you receive with your computer-

printed evaluation report. This summary report lists the

mean values calculated from the results submitted by

the participants.

Validated chemistry materials must be ordered in

advance and are available only to those laboratories

enrolled in Chemistry Modules CH or CH1-CH7 and

CH9.

Uses of EXCEL ValidatedChemistry Material

s If the EXCEL evaluation suggests an analysis is out

of control and you wish to determine if a real

problem is still present, additional EXCEL material

can define the existence of the problem and its

magnitude.

s If a new method is initiated, it can be checked

against the database provided to the EXCEL program

by other users of this same method.

s It can be used to check backup systems and

alternative methods.

s It can be used occasionally as a blind quality

control challenge.

s It can be used to check internal quality control

pool material.

s It can be used for personnel competency

verification.

Validated chemistry materials are shipped in three

mailings, each sent approximately three weeks after

shipment of each chemistry module in the EXCEL

program.


31/40

Your Evaluation ReportShortly after you submit your proficiency testing results

to the CAP, an evaluation report evaluating your

submitted results will be available online or mailed

back to you. Your evaluation repor t can be used as a

quality assurance tool to assess how you performedcompared to other EXCEL participants. To benefit from

this report, it is important that you review and

understand the information presented. Dont just look

for incorrect results; take the time to review all the data.

More how to steps will be provided later in this

chapter, but first here is a review of the information

contained on your evaluation r eport:

s Demographic Information: Provides informationabout your laboratory, including the name of yourinstitution, your CAP Identification Number, and anyagencies or consultants you have designated to

receive copies of your evaluation.s Result Area: Contains all results reported for a

particular mailing and statistical data used forevaluation purposes. Adetailed descr iption ofevaluation data specific for each discipline ispresented in each Participant Summary.

s CMS Performance Summary Repor t: Includesinformation on current and cumulativeperformance for regulated analytes to be sent toCMS. Detailed information is included in Chapter 10.

Reviewing Your EvaluationReportTo truly realize the benefit of proficiency testing, it is

important that you take the time to carefully review your

evaluation. You can gain valuable insight into yourlaboratorys overall processes by following these easy

steps in reviewing this report.

1. Review the demographic information on theevaluation report. If any information is incorrect orhas changed, contact the CAP at 800-323-4040option 1.

2. Compare information on your evaluation repor t withresults on your photocopy or pr inted copy of theresult form. If any of your data was entered by theCAP incorrectly, contact us immediately. Correctionsdue to data entry errors made by the CAP must be

requested within four weeks after the first evaluationwas mailed.

3. Look for any unacceptable results. Common, easilycorrected reasons for unacceptable results include:

s Incorrect or incomplete method/instrument data

s Clerical error

s Decimal point placement

s Specimen handling error

THE EVALUATION AND

PARTICIPANT SUMMARY REPORTS9


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Remember, whatever the cause, CLIAstates that all PT

deficiencies must be documented and corrective action

taken to resolve the deficiency.

4. Although the results may not be formally evaluated,you can compare your results with the data providedin the Participant Summary. You can use theall method mean or median, low, and high valuesto compare your results for a self-assessment ofyour performance.

5. For quantitative data, just knowing that you arewithin limits does not tell you if you areexperiencing a slowly developing bias that mayresult in future failures. The key to optimal use ofyour evaluation data is to look at the column wherestandard deviation indexes (SDI) are reported. Ifyou note any of the following tendencies, it may beadvantageous to examine your laboratory processesfurther:

s The average SDI is more than + /- 1.5: thismay indicate a significant systematic error.Review calibration data and technique.Review expiration dates of calibrators andreagents.

s One of your SDIs is greater than + /- 3 or totalSDI is greater than 4 (one SDI is -2 and one is+2.5 for a total of 4.5): this may indicate asignificant random error. Review your procedureto determine where any unwanted imprecisionmay be occur ring.

6. When the evaluation repor t has a nonevaluation

code listed, refer to your Participant Summaryfor valuable information.

7. Verify that all regulated analytes for which youreported results are included on the CMS Perfor-mance Summary Report. Detailed information aboutthis report is included in Chapter 10.

8. Make sure the Laboratory Director reviews and signsall proficiency testing evaluations.

The Participant SummaryIn addition to your evaluation report, each laboratoryreceives a Participant Summary for that mailing that lists

results from all participants for each analyte grouped by

the methodology. This report provides valuable

information to the participant in the form of

comparative data and education activities.

Program UpdateThis section of the Participant Summary contains

information about evaluation criteria in use for that

mailing. It also highlights important method,

manufacturer, and specimen information that pertains

to that mailing.Quantitativ

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