Proficiency

Testing
Manual

cap.org
 Table of Contents
Content s
Surveys & Educational Anatomic Pathology Programs Manual
1 Order Confirmation, Specimen Handling, and Customer Service 3–7
n Confirmation 3
n Regulatory Reporting 3
n Binders/Glossaries 3
n Alerting the Mailroom 3
n CAP Identification Number 4
n Replacement Specimens 4
n Testing Instructions and Completion Time 4
n Changing Results and CMS Reporting Instructions 4
n Fax-Back Response Programs 5
n Evaluation Reports 5
n Corrections 5
n Customer Support 5
n Program Certificates 6
n Letters 6
n Limitations of Proficiency Testing 6
n Handle With Caution 6
n Laboratory Accidents 6
n Limitations of Proficiency Testing Letter 7
2 General Comments 8–9
n Completing the Result Form 8
n Teleforms 8
n Preprinted Method Summary Page 8
n Exception Codes 8
n Identification Master Lists 9
n Method/Instrument Master Lists 9
n Handwriting 9
n Decimal Points and Box Positions 9
n “Less Than” or “Greater Than” Values 9
3 e-LAB Solutions TM
10–11
n Using Online Features 10
n Security 10
n Online Data Submission 11
n Interactive Evaluations 11
n Online Reports 11
4 How to Interpret the Evaluation Report 12–14
n General Guidelines for Evaluation 12
n Selection of a Target Value 12
n Calculation of Summary Statistics 12
n Comparative Statistics 14
Surveys & Educational Anatomic Pathology Programs Manual
5 Continuing Education 15–17
n CME Category 1 15
n CE for Cytotechnologists 15
n Continuing Education (CE) for Nonphysician Laboratory Personnel 16
n EXCEL® CE Program 16
6 Discipline-Specific Reporting Information 18–19
n How to Complete the Result Form 18
7 The Evaluation and Participant Summary Reports 20–22
n Your Evaluation Report 20
n Reviewing Your Evaluation Report 20
n The Participant Summary 21
n How to Perform a Self-Evaluation 21
8 Laboratory Legislation and Centers for Medicare and
Medicaid Services (CMS) Reporting 23–28
n Provision of Results to CMS and State Agencies 25
n Use of Reason Codes for Nonevaluated Specimens 26
n CMS Performance Summary Data 27

Interlaboratory Comparison Program Cycle

1 CAP
Catalog Delivery
September: The
catalog is sent to your
laboratory.
2 Your Laboratory
Subscriptions
September–December:
3
Your laboratory places its order.
CAP
Order Processing
September–December:
Order quantities are reserved.

4 CAP
Order Confirmation
September–December:
Confirmation reports are sent
to your laboratory after your
order is processed.
5 Surveys Mailing
Kits Mailed
Kits are prepared
and sent from the
manufacturer to your
laboratory.
6 Your Laboratory
Result Form
Completed result forms
are returned via mail, fax, or
online submission to the CAP
where data are summarized.

7 Scientific Resource
Committee
Evaluation Criteria
The scientific resource
committee reviews results
8 CAP
Reports Mailed/
Available Online
Reports are sent to or made
available online for your
laboratory, regulatory
9 Certificate
Certificate of Participation
As a CAP Surveys and
Anatomic Pathology
Educational Programs and
EXCEL subscriber, your
and the impact of evaluation
criteria. agency, and/or consultants. laboratory is entitled to receive
a Certificate of Participation. The
certificate will be issued at the
beginning of the program year.
1
Order Confirmation,
Specimen Handling,
and Customer Service

Confirmation Center at 800-323-4040 option 1 or access your

report online at cap.org.
After your order is received, an order Documentation will be requested and may be
confirmation report is sent that contains the faxed to 847-832-8168. An explanation of
following information: regulatory reporting and current laboratory
legislation is included in Chapter 8 of this manual.
n Shipping address
n Billing address
Binders/Glossaries
n Telephone and fax number
Please see your catalog for instructions on how
n List of products ordered to obtain three-ring binders for filing results and
n List of agencies and/or consultants to reports. Surveys results are printed on three-
whom you have requested copies of hole-punched sheets for storage in the binders.
your evaluation report be sent If you are enrolled in hematology and/or clinical
Please review your laboratory order confirmation microscopy Surveys containing photographs for
report carefully. If you have changes, return the morphologic identification, you will be able to
form within two weeks of receipt to: access an online glossary of terms for your
general use. If you need a hardbound copy,
Customer Data Management please call the CAP Customer Contact Center.
College of American Pathologists
325 Waukegan Road
Northfield, Illinois 60093-2750 Alerting the Mailroom
847-832-8168 (fax)
Refer to the shipping schedule and advise your
receiving department accordingly. A shipping
Regulatory Reporting schedule is provided to your laboratory with
the ordering catalog, or you can obtain a
The CAP will automatically forward results for customized shipping calendar through e-LAB
analytes regulated for proficiency testing to the Solutions™ at cap.org.
Centers for Medicare and Medicaid Services
(CMS) for laboratories that have provided a CLIA The receiving department of your hospital or
identification number. laboratory should be advised how to handle
the CAP kits. Insist on prompt transfer to the
To request that no results be forwarded or to laboratory. (Kits received by the hospital but
make changes to your laboratory’s analyte not delivered to the laboratory are not
selection report for the information provided eligible for free replacement.) Unless otherwise
to CMS, please contact the Customer Contact specified, store the specimens in the refrigerator.
 Order Confirmation, Specimen Handling, and Customer Service

CAP Identification Number Testing Instructions and

Each participant receives a CAP identification
number that is printed on all result forms. This
Completion Time
number will also appear on each evaluation Per the Federal Register, proficiency testing (PT)
report received by your laboratory. It is helpful specimens must be tested with the laboratory’s
to have this number available when contacting regular workload, using routine methods and
the College. testing the PT specimens the same number of
times it routinely tests patient specimens.
Replacement Specimens When handling PT specimens, laboratories must
The kits contain a result form and specimens for not communicate results nor share or refer
analysis. Check the contents of the kit against specimens for tests not on the laboratory’s
the instructions. EXCEL® participants should verify menu. If referral for testing is routinely performed
that all modules listed on the mailing page are for patient specimens, the practice cannot be
included in the kit. If the kit is incomplete or followed for PT specimens. Referral is considered
contains broken or unlabeled specimens, to be movement of the specimen from a
contact the College within the number of days laboratory with a CLIA identification number
indicated in the kit instructions following the to another laboratory that has a different CLIA
actual shipping date for a free replacement. identification number. Laboratories must ensure
Additional replacement specimens may be that personnel do not share results or refer PT
purchased within the same time frame. Because specimens for any reflex or testing outside their
proficiency testing materials must be procured CLIA identification number.
in advance of shipment, on occasion, The Surveys and EXCEL programs are used
additional inventory is available for a nominal for certification of certain laboratories. Since
fee. To purchase these materials contact the promptness is considered in determining
Customer Contact Center at 800-323-4040 certification, we cannot accept late entries.
option 1. All literature associated with this Results are due by the date noted on the result
product including the summary data would be form. Result forms received beyond the date
provided. This option does not replace routine noted will not be evaluated. Participants will
proficiency testing. receive an evaluation indicating that the results
These materials may be used for but not limited were received past the evaluation cut-off date
to: along with a Participant Summary that can be
used for self-evaluation.
n Competency assessment
n Instrument troubleshooting
n Training
Changing Results and CMS
n Education Reporting Instructions
n Research
n Changes to submitted data cannot be
In the event that a replacement specimen is made after the due date listed on the
required, retain your original result form while result form. Review all entries made on
awaiting the arrival of the replacement the result form for accuracy prior to
specimens. The replacement specimens will submission. For results approved online,
be sent in the same manner as your original corrections must also be done online.
specimens. When you receive the Faxed or mailed corrections will not be
replacement specimens, you will be allowed accepted.
the same amount of time for analysis as was
allowed with the original shipment. You are n If you have registered your lab on the
ensured an evaluation. CAP website, you may use “Result Form
Verification” to verify submitted results.
Occasionally, it may not be possible for the n For any testing that you do not routinely
manufacturer to replace your specimen(s) kit. perform in your laboratory, leave all
In this case, fill the exception code 33 bubble reporting areas for that test blank,
on the result form. Specimen Problem will including method information. Please
appear on your evaluation report, and you note, a penalty will not be applied for
will not be penalized. blank responses in the case of

4 College of American Pathologists Proficiency Testing Manual

 Order Confirmation, Specimen Handling, and Customer Service

educational challenges, challenges
not formally graded, or the proper use of Customer Support
exception codes.
n If you do not perform specific testing in a Customer Contact Center Hours
Surveys program, please refer to the kit
instructions and result form for the 7:00 am–5:30 pm CT
appropriate instructions. Extended Customer Contact Center hours ensure
For any regulated analytes that your laboratory coverage for all time zones. Call 800-323-4040
does not report or may have discontinued, you option 1 to speak with a Contact Center
must notify the CAP in writing. Please fax any representative. For international customers,
changes in writing on your CMS report to please call 847-832-7000 option 1.
847-832-8168 to avoid receiving a zero score
on your next PT evaluation. (Your reporting 24-hour Messaging Service
preferences are outlined on the CMS Analytes The CAP’s 24-hour voice mail system allows you to
Reporting Selections document, which is leave a message after hours. A response will be
available online at cap.org on the Accreditation provided the following business day.
and Laboratory Improvement tab.) If you have
any questions, please call the Customer Contact
Center at 800-323-4040 option 1.
24-hour Service Fax Hotline
(800-289-1815)
As with the 24-hour voice mail system, the Service
Fax-Back Response Fax Hotline makes it easy for you to fax requests
Programs any time, day or night. Response is guaranteed
by the next business day.
The College offers immediate (fax-back)
responses for the submission of the laboratory Contact the CAP via the Website
forms for the following educational anatomic You can submit your request or question
pathology programs: conveniently online via the CAP Web page. Log
n Interlaboratory Programs in Cervicovaginal on to cap.org and click on the “Contact Us” icon
and Nongynecologic Cytopathology located at the top of the main page.
(PAP/NGC)
CAP Mail
n Fine-Needle Aspiration Glass Slide Program
Individual result forms can be submitted online The CAP has implemented an email notification
(preferred method) or faxed to the CAP. CME/CE service, CAP Mail, designed to keep you informed
forms will be self claimed online through the of our receipt of your order form(s) and result
Education tab. forms. For each document type, the CAP will
notify the appropriate individuals that we have
received your information.
Evaluation Reports n All result form receipt acknowledgment
messages include a result form receipt.
The evaluation report will be posted online and
mailed approximately two to five weeks after the n Link to the CAP website page where you
ship date of the kit. This time is needed for can review detailed information for each
processing data, establishing evaluation criteria, kit on the number and specific pages
and preparing the summary report. received and method of receipt.
To take advantage of this service, ensure the
CAP has the appropriate email addresses for your
Corrections laboratory.
n For document acknowledgment, include
Occasionally, incorrect entry of submitted data the appropriate email address on the first
occurs. If this is due to your transcription error or page of your order form in the section
failure to complete the result form appropriately, titled, “PT Shipping Contact.”
your entry cannot be re-evaluated. If the error is
made by the CAP, please contact the Customer To choose not to participate in this program,
Contact Center at 800-323-4040 option 1 for participants can contact the CAP Customer
further assistance. Contact Center at 800-323-4040 option 1.

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 Order Confirmation, Specimen Handling, and Customer Service

Contact the CAP via Email Handle With Caution

General inquiries may be routed to the College
at the following email address: Proficiency testing specimens must be handled
contactcenter@cap.org. with caution. Each shipment includes a
biohazard warning statement explaining proper
handling.
Program Certificates
After the completion of the program year, Laboratory Accidents
participating laboratories will receive a program
certificate that recognizes each institution’s Incidents of personnel exposure to infectious
participation in the CAP proficiency testing specimens, through needlesticks, contamination
program and its commitment to patient care. of the mucous membranes through splashes or
Certificates are signed by the CAP president aerosolization, or cuts from containers, should
and are suitable for framing. be reported immediately to the CAP.
24-hour hotline: 800-443-3244
Letters Please try to have the following information
available:
All letters received by the College are reviewed
and, if appropriate, forwarded to a medical n CAP number
technologist or a scientific resource committee n Phone number
member for response. Your input is encouraged
and has always served as a valuable vehicle n Name of institution/city/state
for changes and improvements to the
interlaboratory comparison programs. n Name of person affected, if other
than caller
The College does not require that you submit
documentation for all proficiency testing n Date and time of incident
deficiencies. However, it is recommended
n Where and how affected
that such documentation be retained in your
laboratory. The CAP Laboratory Accreditation n Survey and specimen number
Program issues a separate report, the
“Proficiency Testing Exception Summary,” that n Name and telephone number of
addresses proficiencies for CAP-accredited laboratory director
laboratories. Instructions for response will be
included with the report. This information will be relayed to a pathologist
member of the appropriate resource
committee who will contact the participant’s
Limitations of Proficiency laboratory director or hospital employee health
services physician with instructions concerning
Testing prophylaxis.

Due to the manufactured nature of the

specimens and the logistics of shipping,
proficiency testing does not always correlate
with the manner in which fresh, clinical
specimens are handled. A letter addressing
these differences is included on page 7 for
general use by your laboratory.

6 College of American Pathologists Proficiency Testing Manual

Limitations of Proficiency Testing Letter

The College of American Pathologists (CAP) Surveys program is the largest external quality
assessment program in the world. As such, it provides an unparalleled selection of challenges
and offers the largest database in existence for interlaboratory comparison. The CAP has
accumulated significant experience in managing this type of program and is knowledgeable
in its uses and limitations.

Performance on CAP Surveys is not to be taken as the sole indicator of a laboratory’s abilities.
A proficiency testing Survey is but one of a number of programs that laboratories should employ
to assess, manage, and improve quality. In addition to Surveys, proper method validation,
quality control testing, periodic calibration and instrument maintenance, employee
competency testing, and laboratory inspection and accreditation provide important tools
for measuring laboratory performance and ensuring quality.

The Surveys program, although outstanding, is not a perfect measuring device. A number
of factors limit this tool’s ability to measure laboratory accuracy. Specific limitations include
requisite use of matrix materials that may impact test systems differently than patient
specimens; the appropriateness of grouping responses according to methodology,
instrumentation, and test platforms; varying size of comparison groups with attendant
variability of statistical parameters; regulated limitations in sampling of laboratories’ testing
systems; difficulties in quantitation at the extremes of analyte concentration; and unsuitability
of certain federally-mandated evaluation limits.

Thus, a certain number of responses that are graded as unacceptable in Surveys will in fact
be acceptable, and a certain number of responses graded as acceptable will in fact be
unacceptable. Although unsuccessful or unsatisfactory Surveys performance may reflect
problems within a laboratory, it does not constitute proof of inadequate performance or an
inability to meet patient needs.

Sincerely,

R. Bruce Williams, MD, FCAP

Chair, Council on Scientific Affairs

2 General Comments

Completing the Result Preprinted Method

Form Summary Page
The result form is a prepared form on which you The computer system is designed to enhance
record your methods of analysis and results of result reporting from your laboratory. Once
laboratory testing. The completed result form you have initially provided a master list code
must be returned online or by fax to the CAP for for a method, instrument, and/or reagent, the
evaluation. Prepare your result form carefully computer will maintain these codes,
according to the instructions. Double-check ending your need to report them throughout
your answers for accuracy and completeness. the year. Please check each master list to
ensure the correct codes are listed. Should you
It is important to photocopy or print a copy of need to change a code, enter it in the
the completed forms for your records before appropriate boxes on the result form.
mailing or submitting them online to the CAP.
Per directive from the Centers of Medicare
and Medicaid Services (CMS), changes to Exception Codes
submitted data cannot be made after the
due date printed on the result form. Review all If it is necessary for you to report an analytical
information on the method summary page and problem for an entire test or individual
all entries made on the result form for accuracy specimens within a test, leave the result area
prior to submission. Once you have opted in, blank and fill the bubble for the appropriate
you can use the “Result Form Data Entry and exception code. Select the appropriate
Receipt Verification” option on the CAP website two-digit code from those listed and fill the
(under e-LAB Solutions) to verify the submitted appropriate bubble.
data.
Exception
Code* Reason
Teleforms 11 Unable to analyze
(documentation to be provided
Teleforms are scannable forms. Because these by laboratory).
forms are scanned, please refer to the kit
22 Result is outside method/
instructions for more detailed instructions on instrument reportable range.
completing the result form.
33 Specimen determined to be
unsatisfactory after contacting
the CAP.
* It is the laboratory’s 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.
 General Comments

Identification Master Lists Decimal Points and

Master lists of possible identifications are Box Positions
provided for microbiology, blood cell
identification, urine sediment, clinical The computer is programmed to accept only
microscopy, and provider-performed those answers conforming to the boxes and
microscopy. Select your answers from the decimal points on the result form.
appropriate master lists provided. Record the
appropriate master list code for your choice on If a number is not large enough to fill the boxes,
the result form. insert zero in the remaining spaces. Results
should be right-justified. When submitting results
For blood cell identification, urine sediment, online, this will be done automatically
clinical microscopy, and provider-performed
microscopy, all possible identifications are Example: Correct Incorrect
included on the master lists. Do not use the
code 010, “Other, Specify.” The use of this Glucose
code will be evaluated as an unacceptable 73 mg/dL 0 7 3 . 7 3 .
response.
Urea Nitrogen
12.8 mg N/dL 0 1 3 . 1 2 8 .
Method/Instrument
Master Lists
Method/instrument master lists are provided “Less Than” or “Greater
in the kit instructions. Choose the appropriate
instrument and/or method and provide this Than” Values
information on the result form.
Do not attempt to add “less than” or “greater
It is important that you notify the CAP and the than” to the value you submit unless this option
manufacturer if your instrument or method is not is provided on the result form. Where provision
listed on a master list. This may be done by listing is made to report “less than” or “greater than”
this information in the “Use of Other” section of results, you must fill in the bubble of the
the result form. You may also contact the CAP appropriate box to indicate your response is
directly while completing the result form to see a “less than” or “greater than” value. All other
if a code has already been established for results will be considered “equal to” values.
your method and/or instrument but was not
available in time for printing of the result form. Where no option to report “greater than” or
“less than” is given, refer to “exception codes”
on page 8 or in your kit instructions.
Handwriting
The result forms are designed for quick, easy
scanning by our computers. If you fax your
results, the information on your result form must
be clearly readable.

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3
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Using Online Features Opting In

A user (the laboratory administrator, by
Powerful Internet-based tools are available to default) enters a CAP # and College-
give participating laboratories many exciting provided PIN #, thereby enabling the
choices. Simple instructions for use of these laboratory to access advanced features
tools are provided. And as always, CAP online. This process only needs to be done
Customer Contact Center representatives once per lab; and once accomplished, the
stand ready to offer assistance. lab will have access to all of the features
currently accessible online as well as those
In order to take full advantage of the that will be offered in the near future.
functionalities available online, users can
selectively enable laboratories and
personnel by undertaking enrollment
procedures as outlined below:
Security
Self Registration The nature of the individualized accounts
for laboratory users allows for flexibility in
This is the process of creating an account with determining what levels of access each user
the College for online activities. All users of the should have. Because users are independent
advanced features of the CAP website are entities from the laboratory, the users can be
required to have a personal Web account associated with multiple laboratories and their
and be logged in to be able to use the site. security can be administered in a different
This process only needs to be done once per manner at each site. This is carried out by
user; it allows the user to select an ID that can the delegated security administrator at the
be easily recalled and that belongs to the laboratory who is responsible for overseeing
user, regardless of laboratory affiliation. Both the access and site privileges for each user
members and nonmembers are required to associated with that lab. Because of the
be registered, thereby allowing the entire changing nature of the employee-employer
laboratory community to participate online. relationship in the laboratory, this feature
This registration is also valid for CME/CE online allows the most flexibility for the administrator
learning activities. to add, modify, and/or remove users’ access
privileges as the administrator sees fit. This has
Logging In the overall effect of eliminating the need to
have to call the Customer Contact Center
Once users have established an account with to carry out some of the more routine
the College, they will be prompted by the maintenance of an account. The delegated
system to enter their user ID and password. This security administrator(s) can confer as many
must be done every time users visit the site, or or as few permissions as they see fit, and the
users can choose to have the system administrator(s) can configure personnel
remember their login. Both members and security so that it closely matches individuals’
nonmembers utilize the same login roles within the laboratory. This will enable the
functionality. lab to replicate the same workflow model that
it employs for paper-based submission of
results, thereby helping to increase the integrity
and confidence in the data entered online.
 e-LAB Solutions

Online Data Submission Interactive Evaluations

Once the lab has opted in and security for As soon as the College receives a statistically
employees has been administered, one of the significant population of the results from kits
first features a lab can take advantage of is the mailed for each Survey mailing, the data are
ability to submit its data results online. A lab will processed and graded according to stringent
receive its PT material and paper result forms governmental and committee criteria. The lab
as usual and will test them in its customary results and grading interpretations are displayed
manner. Most laboratorians may prefer to in an individualized report that will be available
record their results on the paper result form for to all users via paper or online. The paper report
ease of transcription to the online system. The that labs are used to seeing has an updated
users will log in to the site, navigate to their lab graphical format. The new format also allows for
and kit, and they will be presented with an more data to be displayed per page, thereby
Adobe PDF version of the same paper result cutting down on the amount of paper that must
form they have in hand. The form is designed be stored for future retrieval. The online version is
to prevent errant data from being saved to the available in a static format that can be
form. Users will be able to select method and printed or downloaded and stored locally,
qualitative codes from drop down lists rather thereby negating the need to create a
than having to refer to a separate document separate library of evaluations for future
for the code. Invalid codes and data will reference. In addition, the online evaluation
prevent the user from saving the form. Users will will allow the user to navigate through the
enter the data into the virtual form and save the evaluation and browse the data analyte by
data as they finish. For Surveys in which multiple analyte. Also, users will benefit by the inclusion
laboratorians perform the testing and resulting, of detailed images that will be hyperlinked from
the flexible nature of the data entry system will the online evaluation report only. Laboratory
allow multiple users to log in to the system at managers will find a useful tool in the All Analyte
different times and enter their data, so as to Scorecard, which will allow them to filter and
minimize any interruption to their normal customize the scorecard data for their
laboratory work. Depending on the normal laboratory as a means of identifying
workflow within the lab, the administrator has deficiencies or trends in performance.
a choice to designate an additional approver
role for another user whose job it is to verify that
all data was entered as intended and to submit Online Reports
the data. Once this step is finished, the data is
committed to the College’s system and is ready Other ancillary reports that accompany the
for normal processing. The advantages to this evaluation report will be available online, as
system lie in speed, efficiency, and clarity of the well, for review and to download for future
resultant data. reference. This includes participant summary
reports, final critiques, and annual summaries,
In addition to these benefits, labs who continue which contain useful data and education that
to fax their result forms in can also take can be reviewed and accessed by all users with
advantage of the online entry since the system appropriate security. These documents may be
will be able to present the data as it has been downloaded and stored locally for future use.
interpreted by computerized scanning This will help to increase the dissemination of
equipment. Users can access their interpreted the information contained in these documents
data and will have the opportunity to correct to multiple personnel, especially now that the
any scanning errors that may have occurred information contained therein is being used
due to the nature of errors inherent in these increasingly for educational enhancements
media. Giving the participants the opportunity for which individuals can obtain continuing
to correct for these scanning errors also medical education/continuing education
increases the accuracy of their data which, (CME/CE) credits.
if allowed to propagate through the system,
could have negative consequences in their
performance interpretation.

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4 How to Interpret the
Evaluation Report

This chapter includes general information outlier exclusion, and the variability of the peer
regarding evaluations. A section explaining how group data must not be too great.
to interpret your individual evaluation will be
included with each mailing. If peer group data are not available or are too
variable, method group statistics may be used.
The method group must also consist of greater
General Guidelines for than nine results and demonstrate acceptable
variability before it is used as the target group.
Evaluation If peer and method group statistics are not
available, a comparative method group may
On February 28, 1992, the Secretary of Health be designated as the target mean. The
and Human Services published the final rules comparative method is not the method
implementing the Clinical Laboratory recommended by the College. However it is
Improvement Amendments (CLIA) of 1988. established as a historically reliable method and
These regulations established evaluation criteria is used for evaluating results from methods that
limits for many of the analytes included in the have an insufficient number of participants to
CAP Surveys programs. The target values are generate a separate peer group and/or
determined by the scientific resource method group statistics. If no comparative
committees of the CAP. For those analytes method exists for the analyte, results will not
not included in the proficiency testing portion of be evaluated.
CLIA, the target values and evaluation criteria
are determined solely by the scientific resource For some analytes, a single target value is used
committees. in which consistent results are demonstrated
across all peer groups.

Selection of a Target Value Calculation of Summary

To minimize the effect of method differences
and to allow comparison of all methods,
Statistics
participants’ results are combined into
comparable method/instrument groups called Peer Group Results
peer groups. It is important for participants to
provide complete information regarding the Results are grouped according to the method
method or instrument used in order to be used for analysis and screened for outliers.
combined in the appropriate peer group. Various statistics are calculated from the
remaining data that summarize the peer
For most analytes, the peer group mean is group’s responses. These summary statistics
designated as the target value for evaluation. include the following:
The peer group mean is the preferred target if
no single target value exists that can provide n the mean (the average of the reported
an accuracy-based target that is traceable to results);
the “true value” as determined by a definitive n the standard deviation (a measure of
or reference method analysis. The peer group the variability of the participant results,
must consist of greater than nine results after often abbreviated as SD);
 How to Interpret the Evaluation Report

n the coefficient of variation (CV); using benefit-of-the-doubt rounding. Therefore,

your reported result of 3.1 mg/dL is within the
n the median (the middle value in an calculated acceptable range of 3.0 to
ordered list of the non-outlier results); 3.8 mg/dL.
n the low value;
Standard Deviation Example
n the high value;
Your laboratory reports a TSH result of
n the final count of reported results that 16.4 µU/mL. The peer group statistics are as
were not excluded as outliers. follows: mean = 15.7 µU/mL, SD = 1.5, and
CV = 9.6. The evaluation limit for TSH is ± 3 SD.
Outlier Detection Technique 3 x 1.5 = 4.5. The acceptable range is
determined using the formula 15.7 µU/mL ± 4.5
Outlier exclusion is necessary because a large µU/mL, which is 11.2 to 20.2 µU/mL when using
series of results frequently will include some benefit-of-the-doubt rounding. Therefore, your
aberrant values. These may arise from result of 16.4 µU/mL is within the acceptable
instrument malfunction, technical errors, range of 11.2 to 20.2 µU/mL.
specimen mix-ups, misplaced decimals,
incorrect units of measure, or data entry errors. Variable Range Example
If any results are excluded, the outlier process
is repeated using the remaining values. The Your laboratory reports a total bilirubin result of
summary statistics that appear on your reports 4.5 mg/dL. The peer group mean is 4.68 mg/dL.
do not reflect results that were considered to be The evaluation limit for total bilirubin is
outliers during either outlier pass. ± 0.4 mg/dL or 20%, whichever is greater. Twenty
percent of 4.68 is 0.936. Since the percentage
Quantitative Procedures/Rounding limit of 0.94 is greater than the interval limit of
0.4, the percentage limit is applied to the target
All quantitative responses are evaluated based value. The acceptable range is determined
upon a range of acceptability. This range is using the formula: 4.68 ± 0.936, which is 3.7 to
determined using a target value and a limit. The 5.7 mg/dL when using benefit-of-the-doubt
limit will be either a fixed interval (eg, ± 5 mg/dl), rounding. Therefore, your result of 4.5 mg/dL
a percentage of the mean (eg, ± 25%), an SD is within the acceptable range of 3.7 to
(eg, ± 3 SD), or a variable range (eg, ± 6 mg/dL 5.7 mg/dL.
or 10%, whichever is greater). The Participant
Summary included with your evaluation will list The Participant Summary Report included with
the criteria used to evaluate your performance. your evaluation report will list the criteria used
The following sections provides specific to evaluate your performance. To determine
examples of how to calculate the range of the acceptable range, a benefit-of-the doubt
acceptability depending upon the criteria used. rounding procedure is utilized when grading.
The upper limit of acceptability is obtained by
Fixed Range Example rounding up to the next reportable result, while
the lower limit is determined by truncating.
Your laboratory reports a sodium result of 138
mmol/L. The peer group mean is 139.5 mmol/L. Calculation of the Standard Deviation
The evaluation limit for sodium is ± 4 mmol/L. Index (SDI)
The acceptable range is determined by the
formula 139.5 mmol/L ± 4 mmol/L, which is 135 The computer-printed evaluation report lists
to 144 mmol/L. Therefore, your reported result of your results and the evaluation statistics for your
138 mmol/L is within the calculated acceptable peer group. It also lists your normalized results as
range of 135 to 144 mmol/L when using benefit- an SDI. This value is obtained by subtracting the
of-the-doubt rounding. group mean from your result and then dividing
by the SD.
Percentage of the Mean Example
The SDI is expressed in terms of the number
Your laboratory reports an albumin result of 3.1 of SDs from the mean, with an arithmetic sign
mg/dL. The peer group mean is 3.39 mg/dL. The indicating the direction of the difference. The
evaluation limit for albumin is ± 10%. Ten percent calculation of the SDI normalizes your result and,
of 3.39 mg/dL is 0.34 mg/dL. The acceptable therefore, allows for a comparison of results from
range is determined by the formula 3.39 mg/ specimens of different concentrations of an
dL ± 0.34 mg/dL, which is 3.0 to 3.8 mg/dL when analyte.

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 How to Interpret the Evaluation Report

When a comparative method has been

designated for Surveys analysis, a second set of
statistics is listed on the printout comparing your
results with those obtained using the comparative
method. The figures shown are the mean and SD
for the comparative method and your result as an
SDI using these statistics. It is possible for your result
to be defined as “good” performance in your
method group and yet produce a comparative
SDI greater than two. This will occur if your method
has a large analytic bias or a large SD. It is
possible to receive a comparative SDI lower
than the method group SDI, although this rarely
occurs. In practice, most participants receive
similar method group and comparative SDIs.

Comparative Statistics
Quantitative Procedures
Your 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 your result-target
______________________
Acceptable Deviation =100 x
upper limit-target mean

If your result is less than the target mean:

Percentage of your result-target

______________________
Acceptable Deviation =100 x
target mean-lower limit

Qualitative Procedures
For qualitative responses, consensus agreement
of referee or participating laboratories is used for
evaluation. Generally, 80% agreement is required.

14 College of American Pathologists Proficiency Testing Manual

5 Continuing Education

CME Category 1
The College of American Pathologists (CAP) is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide continuing medical education for
physicians.
The CAP designates these educational activities for a maximum of the stated number of AMA
PRA Category 1 Credits™. Physicians should only claim credits commensurate with the extent of
their participation in the activity.

The American Medical Association has determined that physicians not licensed in the US who
participate in these CME activities are eligible for AMA PRA Category 1 Credit™.
See the current Surveys catalog for available CME programs.

CE for Cytotechnologists
Cytotechnologists may apply the credits from the FNAG, FNA, PAPCE1/PAPJE1/PAPKE1/PAPME1,
PAP PT and NGC programs toward the required educational activities for the American Society
for Cytopathology (ASC) Continuing Education Credit Program.

Online Virtual Microscopy Education Programs

The CAP offers online education programs that use advanced imaging technology to present
images from actual glass slides for a variety of sites and specimen types. This technology
simulates a microscope, allowing you to scan the image and use multiple magnifications to
view the material. From the images and clinical information provided, you select a diagnosis,
answer learning assessment questions, and receive immediate feedback online.
See the current Surveys catalog for available online virtual microscopy education programs.

15
 Continuing Education

Continuing Education (CE) for Nonphysician

Laboratory Personnel

Surveys CE Programs
Discipline Maximum CE Credits
Chemistry
The number of credits are
Coagulation
specific to the program mailing.
Hematology
Histology (HistoQIP)
Immunology Please go to cap.org and click
Microbiology on the Education tab for
Therapeutic Drug Monitoring/Endocrinology up-to-date activity listings.
Toxicology
Transfusion Medicine

EXCEL CE Program clinician, and medical technologist members.

The education activities are designed to
challenge and educate while providing the
For the EXCEL program, each individual may convenience of earning free CE credits and
receive continuing education (CE) credits for fulfilling licensure and education requirements
participating in the education activities. without leaving your laboratory. The education
Selected mailings of EXCEL will include an activities are also valuable tools for in-house
education activity designed to provide continuing education programs.
technical and nontechnical information to
keep your staff on the leading edge to ensure Learning Cycle Information
quality patient care. The education activity
consists of a related reading found in the Each education activity provides information
Participant Summary and learning assessment on common technical and nontechnical
questions online at cap.org. issues encountered in all laboratory settings. To
receive continuing education credit, you must
All laboratory professionals in your lab may now complete the education reading provided in
earn individual CE credits by completing the your Participant Summary and answer the
related education reading and online online learning assessment questions. Each
learning assessment questions on the CAP education activity will be available for six
website. Upon completion of the education months and must be completed within that
activity, you will receive a CAP continuing time frame. Continuing education credit will be
education certificate. applied toward the year in which the activity is
completed. Detailed information on how to
Designed by the CAP Point-of-Care Testing
access the online components will be included
Committee, each activity combines the unique
in each Participant Summary.
perspective of the committee’s pathologist,

16 College of American Pathologists Proficiency Testing Manual

 Continuing Education

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)
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.

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6 Discipline-Specific Reporting
Information

How to Complete the Coagulation

For plasma-based coagulation testing (PT, APTT,
Result Form Fibrinogen), an instrument and reagent code
are required for proper evaluation. Participants
To ensure statistically valid data, it is essential enrolled in whole blood proficiency testing
that participants provide all necessary method, for PT need only indicate an instrument
reagent, and/or instrument information as (if requested) and their results. For all
required. Please remember, once you have prothrombin time modules, reporting of
provided accurate information, our computer International Normalized Ratio (INR) results is
system will retain this information. optional. Plasma-based and whole blood INR
are evaluated.
Verify that the correct method, reagent, and/or
instrument code is noted on the preprinted Urinalysis
method summary page included with your
result form or listed on the online result form. There is a separate urinalysis and specific
If a code is not noted or you’ve changed gravity method master list and instrument
instruments, you must enter the correct code master list. To ensure an accurate peer group
on the result form. evaluation of your results, it is critical to provide
accurate method and instrument information.
Hematology
A specific list of reporting options is provided
To report your blood cell identification, select for each urinalysis procedure. It is not feasible
the best identification code from the to provide a list of reporting choices specific
Hematology Blood Cell Identification Master for every possible dipstick being marketed to
List provided in the kit instructions. To assist you laboratories. Subsequently, the result ranges
with blood cell identification, the Hematology, listed may not exactly correlate with the ranges
Clinical Microscopy, and Body Fluids Glossary used with your instrument/dipstick. In these
is availiable online at cap.org. few cases, choose the range that most closely
matches your intended result. To ensure an
If results are reported for both blood cell accurate peer group evaluation of your results,
identification and auto differentials, the blood it is critical to select an appropriate result that
cell identification will be reported to CMS. the method allows.
The Hematology Blood Cell Identification Master To report urine sediment, clinical microscopy, or
List choice, “Immature cell or abnormal cell, provider-performed microscopy, select the best
would refer for identification,” must be reserved identification code from the Urine Sediment/
for cells you rarely encounter and are unable Clinical Microscopy Master List provided. To
to specifically identify. Grading of this response assist with identification, the Hematology,
will follow the guidelines set forth in the July 26, Clinical Microscopy, and Body Fluids Glossary
1993, Federal Register Notice. is available online at cap.org.
 Discipline-Specific Reporting Information

Urinalysis Dipstick Tests Specimen results will be evaluated if 80% or

more of the participant laboratories agree on
For qualitative procedures in urinalysis, the identification of the test organism(s) to
evaluation is based on participant consensus genus or to genus and species. In the absence
by method and instrument. For each analyte, of participant consensus, referee laboratories
a minimum of two, but not more than four, will be used.
responses will be given a passing score. Analyte
results graded “good” performance must have The CLIA regulations state that a laboratory
80% participant consensus. Eighty percent must perform a minimum of five specimens
participant consensus can be determined by in each testing event for the subspecialty of
grouping the mode with the next one or two bacteriology. The five challenges can include a
most frequent responses. This group will be combination of the following specimens:
given “good” performance. “Acceptable”
performance will be given to additional n bacterial antigen detection
responses until a minimum of 90% of participant
n bacterial identification (culture)
results are given a passing score. In the case
of a negative specimen, negative responses n Gram stain
must constitute 90% participant consensus.
Specimens with results for one or more methods n antimicrobial susceptibility
distributed over both negative and positive
response (nonconsensus) will not be evaluated. Please note that procedures assayed with
Specimens for which there is greater than 90% waived methodologies will not count toward
of participant responses distributed over more the five-challenge minimum. The laboratory is
than four responses will be graded as responsible for maintaining the five specimens
nonconsensus. per testing event for its remaining nonwaived
tests in the subspecialty when a test is waived
Microbiology by the FDA midyear.

Where appropriate, a clinical diagnosis, age, Antimicrobial Susceptibility Testing

and source are listed to simulate a true
clinical situation and to allow laboratory Participants will be asked to perform
personnel to select appropriate media or susceptibility tests using the antimicrobial agents
methods for processing these specimens. and techniques in routine use in their individual
However, as the pathogenic bacteria present laboratories. The laboratories should report only
in any of these samples may be isolated from antibiotics appropriate for therapy of infections
multiple sources of the body, all participants at the site indicated in the patient history. See
should attempt identification of the organisms current Clinical and Laboratory Standards
present in all these specimens. Institute (CLSI) documents M2, M7, M100, or
other appropriate documents for guidance.
Per the Federal Register, a Survey must grade
a laboratory’s ability to distinguish between a Interpretation results (susceptible, intermediate,
pathogen and a contaminant. Culture and resistant) will be penalized for:
challenges will be designated in the instructions n Agents that are not clinically appropriate
to be handled as “identify principal pathogen” for the site of infection (meningitis,
or “ identify all organisms” challenges. pneumonia, urinary tract, etc)
Participants must report in this manner even
when this differs from their laboratory’s routine n Use of methods CLSI advises against
practice. For example, a urine specimen
contains Klebsiella pneumoniae and n Use of methods that the manufacturer
Staphylococcus epidermidis. If the instructions recommends against using, due to poor
indicate to “Identify all organisms,” both performance
organisms should be reported. If the instructions
indicate to “identify principal pathogen,” only Selective reporting for the presumed site of
the Klebsiella pneumoniae should be reported. infection helps improve clinical relevance,
If the Staphylococcus epidermidis is reported, it encourages appropriate therapy, and helps to
would be penalized. minimize selection of resistance.

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7 The Evaluation and
Participant Summary Reports

Your Evaluation Report 1. Review the demographic information on

the evaluation report. If any information
is incorrect or has changed, contact the
Shortly after you submit your proficiency testing CAP at 800-323-4040 option 1.
results to the CAP, an evaluation report
evaluating your submitted results will be 2. Compare information on your
available online or mailed back to you. Your evaluation report with results on your
evaluation report can be used as a quality photocopy or printed copy of the result
assurance tool to assess how you performed form. If any of your data was entered by
compared to other participants. To benefit from the CAP incorrectly, contact us
this report, it is important that you review and immediately. Corrections due to
understand the information presented. Here is data entry errors made by the CAP must
a review of the information contained on your be requested within four weeks after the
evaluation report: first evaluation was mailed.
n Demographic Information: Provides 3. Look for any unacceptable results.
information about your laboratory, Common, easily corrected reasons for
including the name of your institution, unacceptable results include:
your CAP Identification Number, and any
agencies or consultants you have n Incorrect or incomplete method/
designated to receive copies of your instrument data
evaluation. n Clerical error
n Result Area: Contains all results reported n Decimal point placement
for a particular mailing and statistical
data used for evaluation purposes. A n Specimen handling error
detailed description of evaluation data
specific for each discipline is presented in Remember, whatever the cause, CLIA
each Participant Summary. states that all PT deficiencies must be
documented and corrective action
n CMS Performance Summary Report: taken to resolve the deficiency.
Includes information on current and
cumulative performance for regulated 4. Although the results may not be formally
analytes to be sent to CMS. evaluated, you can compare your
results with the data provided in the
Participant Summary. You can use the
Reviewing Your Evaluation “all method mean” or median, low, and
high values to compare your results for a
Report self-assessment of your performance.

To 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 your laboratory’s overall processes
by following these easy steps in reviewing this
report.
 The Evaluation and Participant Summary Reports

5. For quantitative data, just knowing that you Quantitative Data

are “within limits” does not tell you if you
are experiencing a slowly developing bias The Participant Summary provides the statistical
that may result in future failures. The key to data needed to review your proficiency testing
optimal use of your evaluation data is to (PT) results. The report lists the mean, standard
look at the column where standard deviation (SD), and coefficient of variation (CV)
deviation indexes (SDI) are reported. If you for peer groups consisting of 10 or more
note any of the following tendencies, it may laboratories.
be advantageous to examine your
laboratory processes further: Qualitative Data

n The average SDI is more than +/- 1.5: Qualitative data evaluation is based on
this may indicate a significant systematic consensus of participant and/or referee
error. Review calibration data and responses. The Participant Summary lists the
technique. Review expiration dates of participant responses along with the
calibrators and reagents. percentage reporting that response. Where
available, referee data is also included. This
n One of your SDIs is greater than +/- 3 practice provides higher-quality, evaluated
or total SDI is greater than 4 (one SDI is challenges to our participants.
-2 and one is +2.5 for a total of 4.5): this
may indicate a significant random error.
Review your procedure to determine How to Perform a
where any unwanted imprecision may
be occurring. Self-Evaluation
6. When the evaluation report has a
nonevaluation code listed, refer to your As mentioned previously, occasionally a PT
Participant Summary for valuable challenge cannot be evaluated for a variety of
information. reasons:
n Lack of participant consensus
7. Verify that all regulated analytes for which
you reported results are included on the n Insufficient data (<10 responses for a
CMS Performance Summary Report. given method)
8. Make sure the laboratory director reviews n Perceived compatibility issues
and signs all proficiency testing evaluations.
In order to comply with the quality assurance
aspect of proficiency testing as outlined in CLIA,
The Participant Summary you must have some mechanism to evaluate
your proficiency testing results. Here are a few
In addition to your evaluation report, each examples of how the data presented in the
laboratory receives a Participant Summary for Participant Summary can assist with this task.
that mailing that lists results from all participants Quantitative Results
for each analyte grouped by the methodology.
This report provides valuable information to the If you perform a test and there are fewer than
participant in the form of comparative data nine other laboratories reporting results for that
and education activities. test, your result will not be evaluated. You can
determine how well you performed compared
Program Update to all participants who reported results by using
the “all instrument method” data presented in
This section of the Participant Summary contains the Participant Summary (if provided). For
information about evaluation criteria in use for example, you perform hemoglobin analysis
that mailing. It also highlights important method, using the Coulter S-plus IV. There are an
manufacturer, and specimen information that insufficient number of results to form a peer
pertains to that mailing. group (<10); therefore, your results are not grad-
ed. Note that in the Participant Summary there

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 The Evaluation and Participant Summary Reports

is an all-instrument mean, standard deviation,

and coefficient of variation, which can be used
as a reference value. By applying the published
CMS evaluation limits (±7%) to this mean, you can
determine how well you performed compared to
this reference value. For example:
Your result: 13.8 g/dL
All Instrument Mean: 13.77 g/dL
Range of Acceptability: 12.8–14.8 g/dL
In this example, your result would be considered
within range when compared to the all-instrument
mean. Document this self-assessment on your
evaluation report. When you perform this self-
assessment, any unacceptable result should be
documented and investigated and corrective
action should be taken as would be done for
formally evaluated results. This same technique
can be used when only a median, low, and high
value are reported for an analyte.

Qualitative Results
If a qualitative result is not evaluated due to lack
of referee or participant consensus, you can still
evaluate how well your laboratory’s result agreed
with the correct response by using the data in the
Participant Summary. For example, one of the
Gram stain challenges could not be graded due
to lack of participant consensus (77% reported
gram-negative, 23% reported gram-positive). The
Participant Summary indicates that the organism
was Pseudomonas aeruginosa, a gram-negative
rod/bacilli. Compare your result with the correct
result. Investigate and document any corrective
action taken. Review the educational critique
accompanying the result for helpful suggestions
on laboratory technique.

22 College of American Pathologists Proficiency Testing Manual

8 Laboratory Legislation and
CMS Reporting

On February 28, 1992, the Secretary of Health Under CLIA, all clinical laboratories, regardless of
and Human Services (HHS) published the final location, size, or type, must meet standards
rules implementing CLIA. The CLIA regulations based on the complexity of the tests they
replaced the Medicare, Medicaid, and CLIA ’67 perform. Three levels of testing complexity are
standards with a single set of requirements that defined in the regulations: waived, provider-
apply to almost all laboratories testing human performed microscopy, and nonwaived.
specimens. Standards for laboratory personnel, Laboratories performing provider-performed
quality control, and quality assurance are microscopy or nonwaived testing must
based on test complexity and risk factors. The meet requirements for proficiency testing (PT),
regulations also establish application procedures patient test management, quality control,
and fees for CLIA certification, as well as quality assurance, and personnel. These specific
enforcement procedures and sanctions requirements do not apply to tests in the waived
applicable when laboratories fail to meet category.
standards.
The uniform proficiency testing program
CLIA applies to all laboratories, physician offices, regulations mandate that your laboratory must
or other entities performing testing on human enroll in a PT program approved by the
specimens for the purpose of providing Department of Health and Human Services,
information for the diagnosis, prevention, or CMS’s parent regulatory agency, for each of the
treatment of disease or impairment of human specialties and subspecialties for which it seeks
beings. Laboratories that conduct testing for the certification. All analytes that are regulated for
purpose of assessing the health of individuals (eg, proficiency testing appear in bold type in the
testing for insurance purposes) are also subject Surveys and Educational Anatomic Pathology
to CLIA. The following lists certain laboratories Programs or EXCEL catalogs.
that are not subject to CLIA:
Your laboratory must notify CMS of the approved
n Laboratories conducting only forensic program(s) in which you participate and
testing authorize the PT program to release all data to
CMS. Your laboratory must participate in an
n Research laboratories that do not report approved PT program for one year before
patient results designating a different program. CMS must be
n Components or functions of laboratories notified before your laboratory changes PT
certified by the Substance Abuse and programs. For tests that are not subject to PT in
Mental Health Services Administration these regulations, your laboratory must still
establish the accuracy and reliability of its test
n Laboratories located in a state in which procedures at least twice a year.
the licensure program is approved by
the Centers for Medicare and Medicare
Services (CMS) as meeting CLIA
standards
n International laboratories not performing
tests on United States citizens.
 Laboratory Legislation and CMS Reporting

PT specimens must be tested with the regular As part of these regulations, criteria have been
patient workload by personnel who routinely established by which a PT provider’s program
perform testing. Your laboratory’s routine testing may be evaluated for approval by HHS. The
methods must be used. The individual testing CAP has made every effort to ensure that the
the specimens and the laboratory director must Surveys program has met the requirements set
attest to the routine integration of specimens forth by the February 28, 1992, Final Rule.
using a form provided by the PT program.
Laboratories that perform tests on proficiency Special Considerations for the Regulatory
testing samples must not engage in Requirements for the Specialty of
interlaboratory communications pertaining to Immunohematology
the results of proficiency testing sample(s) until
after the date by which the laboratory must The Specialty of Immunohematology comprises
report proficiency testing results to the program four subspecialities as follows:
for the testing event in which the samples were n ABO/Rh
sent. Laboratories with multiple testing sites or
separate locations must not participate in n Unexpected antibody detection
communications or discussions concerning
proficiency testing sample results until after the n Compatibility testing
date by which the laboratory must report
proficiency testing results to the program. Your n Antibody identification
laboratory must also maintain a copy of all A 100% score is required to achieve satisfactory
records, including the form used to record the performance for ABO/Rh and Compatibility
PT results (including the attestation signatures), Testing.
for a minimum of two years.
For unexpected antibody detection and
Your laboratory must successfully participate antibody identification, an 80% score is required.
in a PT program approved by CMS. “Unsuc- The consensus percentage required to establish
cessful proficiency testing performance” is a a graded challenge is set at 95% participant
“condition level” deficiency and may result in or 100% referee consensus for ABO/Rh and
laboratory sanctions such as suspension of the compatibility testing and 95% referee or
CLIA certificate and Medicare payments for the participant consensus for unexpected antibody
specialty, subspecialty, and analyte involved. or antibody identification challenges.
Failure to achieve a satisfactory overall testing
event performance for two consecutive testing Special Consideration for the Regulatory
events or two out of three consecutive testing Requirements for the Specialty of
events is considered unsuccessful performance. Microbiology
Please note that procedures assayed with The CLIA regulations state that a laboratory
waived methodologies will not count toward must test a minimum of five specimens in
the five-challenge minimum. each testing event for the subspecialties of
Failure to attain an overall testing event score bacteriology, mycobacteriology, mycology,
of at least 80% is unsatisfactory performance parasitology, and virology. Within each of these
for analytes in all specialties and subspecialties subspecialties, various types of testing are
except ABO group, D(Rh) typing, and required.
compatibility testing for which 100% is required. For bacteriology, the five challenges may
Failure to return PT results for a testing event is include a combination of the following
unsatisfactory performance and will result in a specimens:
score of “0.” For any unsatisfactory testing event n Bacterial antigen detection
for reasons other than failure to participate, your
laboratory must undertake appropriate training n Bacterial identification
and employ the technical assistance necessary
to correct the problem. All remedial action must n Gram stain
be documented and such documentation kept
n Antimicrobial susceptibility
for two years at your laboratory for possible
reference by inspection and accreditation teams. Chlamydia trachomatis results are aggregated
under the subspecialty of bacteriology.

24 College of American Pathologists Proficiency Testing Manual

 Laboratory Legislation and CMS Reporting

For mycobacteriology, the five challenges

may include a combination of the following Provision of Results to CMS
specimens:
and State Agencies
n Acid-fast stain
To assist in complying with the requirement
n Mycobacterial identification that your laboratory results be released to HHS,
n Antimycobacterial susceptibility the CAP will transfer data to CMS if you have
provided a CLIA identification number. We will
For mycology, five identifications are required. forward paper or electronic copies of your
For parasitology, five identifications are required results to your state department of health,
and may consist of testing by fecal suspension, acting on behalf of CMS, if you authorize us to
Giemsa-stained blood smear, antigen do so. To authorize release of results to state
detection, and/or PVA slide. agencies, indicate your request on the order
confirmation report sent after your Surveys order
For virology, the five challenges may include a is processed, or send a letter to the CAP. Your
combination of the following specimens: Surveys evaluation will then reflect the name
n Viral antigen detection of the agency to which the information was
provided. Any questions regarding requirements
n Viral identification (culture) for forwarding your proficiency testing results
Important Note: In order to meet the regulatory may be answered via your state department of
requirements for microbiology subspecialties, health or one of the CMS regional offices.
carefully follow the kit instructions included with
Consult with your state department of health
each Surveys mailing.
for additional laws or regulations concerning
Regulatory Requirements for the Specialty inspection, accreditation, and proficiency
of Cytology: Gynecologic Examinations testing requirements that may affect the
licensing of your laboratory and its personnel.
For cytology, the examination consists of ten
slides from four diagnostic categories, including Copies of the February 28, 1992, CLIA
Unsatisfactory, Negative or Benign, LSIL and regulations can be obtained by contacting
HSIL or carcinoma. To be successful in the Government Printing Office by telephone
cytology, a score of 90% must be achieved. at 202-512-1800 or by fax at 202-512-2250 and
Detailed instructions will be provided with the requesting CFR Title 42 Parts 400-429 and
test materials.
430-End. You may also access documents
online at access.gpo.gov/su–docs/.

If you have any questions regarding the

automatic transfer of results to CMS or your
performance summaries, please contact the
College at 800-323-4040 option 1.

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 Laboratory Legislation and CMS Reporting

Use of Reason Codes for Nonevaluated Specimens

Some individual results are not evaluated for certain laboratories for a variety of reasons. A
reason code explaining the specific circumstance will appear on individual evaluation reports,
along with a brief explanation of what that code means. Below is a ledger of possible reason
codes that can be assigned.

Reason Code Description or Explanation

11 Unable to analyze (documentation to be provided by laboratory).
20 No appropriate target/response could not be graded.
21 Specimen problem.
22 Result is outside the method/instrument reportable range.
24 Incorrect response due to failure to provide a valid response code.
25 Inappropriate use of antimicrobial.
26 Educational challenge.
27, 31 Lack of participant or referee consensus.
28 Response qualified with a “greater than” or “less than” sign; or unable
to quantitate.
29 Inappropriate response.
30 Scientific committee decision.
33 Specimen determined to be unsatisfactory after contacting the CAP.
35 Testing not performed on this specimen type.
40 Results for this kit were not recieved.
41 Results for this kit were recieved past the due date.
42 No credit assigned due to absence of response.
43 The order for this kit was canceled; results not evaluated.
44 This drug is not included in our test menu. Use of this code counts as a
correct response.
46 Quantitation not appropriate.
55 Exemption granted due to a natural disaster.
77 Improper use of exception code for this mailing.
88 Lab does not perform tests from this source or does not perform this test
on patients.
91 There were an insufficient number of contributing challenges to
establish a composite grade.
92 Composite grade could not be established due to the use of multiple
nongraded reason codes for the individual challenges.
It is the laboratory’s responsibility to document the appropriate use of these exception codes
should this be requested during a laboratory inspection.

26 College of American Pathologists Proficiency Testing Manual

 Laboratory Legislation
Laboratory Legislation and CMS Reporting

CMS Performance Summary

CAP
CAP Number: 1234567-01 4
Number:1204101-01 Kit# 1 Kit# 1 87654321 1a
ID: 21876162
KitID:
Kit
Institution: Community
Institution: Quest Hospital
Diagnostics Inc Kit Mailed:
Kit Mailed: 6/1/0000 1b
6/1/2009
Attention: Lab Director
Attention: William Tarr JR MD Evaluation: 7/10/0000 1c
Original7/10/2009
Original Evaluation:
City// State:
City State: Teterboro
Anytown,NJ USA 12345
07608-1070
EVALUATION
ORIGINAL
Z-B 2009 Therapeutic Drug Monitoring

CMS Peformance Summary for Analytes Regulated Under the Clinical Laboratory Improvement Amendments of 1988

CLIA ID #: 31D0696246 Subspecialty : Toxicology

Proficiency Event Proficiency Event Proficiency Event 7 8
5 2008 3 2009 1 2009 2 Current Event Cumulative CLIA
2 3 6 Performance '88 Performance
Regulated Analyte Test Event Score % Test Event Score % Test Event Score % Interpretation Interpretation
Ethanol AL1-C 5 /5 100 AL1-A 5 /5 100 AL1-B 5 /5 100 Satisfactory Successful
Blood Lead BL-C 5 /5 100 BL-A 5 /5 100 Successful
Carbamazepine Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Digoxin Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Gentamicin Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Lithium Z-C 5 /5 100 Z-A 3 /5 60 Z-B 5 /5 100 Satisfactory Successful <1>
Phenobarbital Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Phenytoin Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Primidone Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Quinidine Z-C 5 /5 100 Z-A 0 /5* 0 Unsuccessful <3>
Theophylline Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Tobramycin Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful
Valproic Acid Z-C 5 /5 100 Z-A 5 /5 100 Z-B 5 /5 100 Satisfactory Successful

Toxicology 65/65 100 58/65 89 55/55 100 Satisfactory Successful

<1> Currently successful - At risk for the next mailing.

<3> Currently unsuccessful.
<*> Per your reporting preferences, this analyte is currently identified as being tested by your laboratory. A score of zero has been given due to the lack of response.

CMS Performance Summary Data

1a. Kit ID: defines
definesthe
the customer’s
customer’s unique
unique kit
kit number 3. Summary
Summary ofofYour YourPrevious
Previous Responses:
Responses: lists lists
the
number for each
for each mailing. mailing. the total number of
total number of specimens you have tested specimens you have
and
The College of American Pathologists recommends that the result of this interlaboratory comparison not be usedtested
the number
as a sole and
criterion forofthe number
acceptable
judging the ofof
any acceptable
performanceresponses for previous
individual clinical laboratory.
responses
testing events. for previous testing events.
1b. Kit Mailed:
Mailed:lists liststhethedate date thethe
SurveysSurveys mailing mailingwas Page 6 of 6
0002
was shipped.
shipped. 4. CAP CAP Number Numberand and Kit:Kit: defines
defines the theCAPCAP number
number
and kit sequence. and kit sequence.

1c. Original
1c. Evaluation:lists
Original Evaluation: liststhethe date
date the
the evaluation 5. Test Event:identifies
Test Event: identifiesthethe product
product fulfillment
fulfillment group
evaluation report was originally
report was originally generated. generated. group and
and shipment. shipment.

2. Regulated Analyte:
Regulated Analyte: listslists
all all regulated
regulated tests tests 6. Summary
Summary ofofYourYourCurrent
Current Responses:
Responses: lists lists
the the
included in the specialty/subspecialty
included in the specialty/subspecialty as defined as total number of specimens you have
total number of specimens you have tested and tested
defined by the CLIA regulations for
by the CLIA regulations for the modules in whichthe and the number
the number of acceptable
of acceptable responses
responses for that
modules in which you are enrolled.
you are enrolled. for that testing
testing event. event.

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 Laboratory Legislation and CMS Reporting

7. Current Event Performance Interpretation:

indicates either satisfactory (≥80%) or
unsatisfactory (<80%) performance for each
analyte and the overall performance for the
specialty/subspecialty. For ABO group,
D (Rho) type, and compatibility testing, a
score of 100% is required. When results have
not been received from your laboratory for
a shipment, this area will be blank.

A score may not appear (field is blank) due to the

following reasons:

n Lab has indicated to the College that

the regulated analyte should not be
reported to agencies

n Challenges were not graded, using

reason codes that are not reported on
the scorecard

n The method reported for the analyte is

waived by CMS

n No results were reported

8. Cumulative Performance Interpretation:

indicates successful (≥80%) or unsuccessful
(<80%) performance for each analyte and
for the specialty/subspecialty. For ABO
group, D (Rho) type, and compatibility
testing, a score of 100 percent is required.
A <1> symbol denotes that your performance
is successful; however, because you had less
than 80% on the previous mailing, you are still
at risk to be unsuccessful for the next mailing.
A <2> denotes you are currently successful but
at risk for the next two mailings as you were
unsatisfactory for this mailing. These codes are
applicable to both the analyte and the
overall specialty/subspecialty scores. A <3>
denotes currently unsuccessful performance.
A <4> denotes that scorecard performance is
pending a future evaluation or may not be
applicable due to discontinued testing or the
use of a waived method.

28 College of American Pathologists Proficiency Testing Manual