General Information and Proficiency Testing Policies

Shipping Dates

Your enrollment confirmation letter lists the products and services you ordered and your customer specific shipping schedule. Shipping dates cannot be changed. If your facility is not performing patient testing when a proficiency shipment is due to arrive, it is your responsibility to notify us prior to the due date to request excused status. Failure to do so will result in a score of "0%". Excuse Requested status will not be granted for delayed or non-delivery of samples caused by routing/receiving problems within your institution.

Most of our samples are sent via DHL courier for second day delivery. If you do not receive samples within 3 days of the ship dates listed on the schedule, please contact us. Package tracking will then be initiated.

Changing Your Order

Modifications should be directed to PT Customer Service at 800-462-5261, ext 0. Alternatively, changes can be made by fax or mail. Please be prepared to provide the following information:

• Your WSLH PT identification number (SL number).

• Facility name, address and telephone number.

• Products added or dropped.

• Identification of authorized person requesting the change.

• Purchase order number or billing information, if possible.

Please note: The price listed on the order form and in the catalog is the annual cost. This price is prorated by the number of shipments/year. Products added during the year will be charged only for the number of shipments received from enrollment date through the end of the calendar year.

Cancellation/Refunds

• Full refunds will be made for cancellations requested at least 30 calendar days before the first shipment date.

• Partial refunds will be made for cancellations requested at least 30 calendar days before each subsequent shipment.

• The annual enrollment fee is non-refundable .

Credits will be applied to your account within 2 weeks. Refund checks, if requested, will be issued within six to eight weeks.

Seasonal Participation

As mandated in CLIA '88, laboratories must "participate in an approved proficiency testing program for one year before designating a different program." We interpret this to mean that laboratories must maintain active enrollment throughout an entire year and not assume inactive or discontinued status during periods of temporary closing (e.g. student health labs). Since active annual enrollment status must be maintained, we will not rebate fees due to temporary closings. To avoid unwanted deliveries during a temporary closure period, please notify us at least 2 weeks prior to the seasonal close.

"Excuse Requested" will be printed on any reports for shipments scheduled during the times of temporary closing. A 100% score with appropriate reason code will be transmitted to the accrediting agency. It is your responsibility to document the closing/opening dates to the satisfaction of your accreditation agency.

Payment/Billing

PT is a pre-paid service. Payment can be made by check, credit card or purchase order. If paying by check or credit card, please wait for the invoice to be received. Invoices are issued on a monthly basis.

Our prices include standard shipping costs. However, a separate yearly shipping fee (based on the number of shipments expected to be sent) will be added for labs located outside the continental US.

Purchase Order numbers will be referenced on the invoice if supplied to us at the time of the order. Please send payment to:

WI State Lab of Hygiene

Accounts Receivable

PO Box 78770

Milwaukee WI 53278-0770

It is important that your customer number(s) be referenced on the check stub to ensure payment is applied to the correct account(s).

We do not charge interest; however, if payment is not received within 60 days of the receipt of your first invoice, you will be notified that we consider the enrollment incomplete and a hold will be placed on your account. No further shipments or reports will be issued until payment has been received. Since this will put your laboratory in regulatory jeopardy, it is important that payment be prompt.

Billing questions/credit card information should be directed to Fiscal Services, 800-862-1065, option #1.

Receiving & Testing Samples

Packages will contain samples (e.g., culture devices, bottles, vials, ampules, glass slides, 35 mm transparencies), instructions and result forms specific to the program(s) for which your site is enrolled. Most PT "failures" can be avoided if participants:

• Open the package immediately upon receipt. Compare contents to those listed on the packing slip.
• Check for leaking, broken, damaged or missing samples. Replacement requests must be made by the date indicated in the instructions.
• Read all instructions thoroughly before testing.
• Observe the sample storage conditions listed in the instructions.
• Follow sample preparation directions carefully. Don't assume that all samples within a set are handled in the same manner.
• Test the samples as soon as possible after you have received them and/or within any time frame specified in the instructions.
• Report results in the units requested even if different from how patient results are normally reported. This is an exception to the "treat PT samples like you would patient samples" rule and is allowable by CLIA in order to provide PT programs a means for a reasonable evaluation of data across methods.
• Review and update (if necessary) method information to ensure you are scored with the correct peer group
• Report results by the due date listed on the result form(s). In some cases programs that ship together may have differing due dates because of the types of testing procedures covered (e.g. Special Microbiology).
• Call the program coordinator prior to the due date if you have any questions or problems.

Handling Samples

PT samples should be considered potentially infectious. Follow the current local, state and federal regulations for handling biohazardous materials when processing or disposing of these samples. Most samples, with the exception of those sent for Anti-HIV and Hepatitis B testing, are tested and found to be non-reactive for Hepatitis B surface antigen, HCV and HIV-1 antibody. However, no known test method can offer complete assurance that products derived from human blood will not transmit infection. Please contact us for MSDS information in the event of an exposure.

Replacing Samples

Replacement sample requests must be made by the date specified in the instructions. Supplies are limited. It is your responsibility to examine the shipment as soon as it arrives and report any missing or damaged samples.

Replacement requests due to reasons within the participant's control (e.g. lab accident, improper storage, internal routing problems) must also be made by the specified date. A fee to cover the cost of the additional samples, plus shipping and handling, will be charged for samples that have been mishandled after they have been delivered to your facility.

Failure to call for replacement samples is not considered a valid excuse for unreported results.
 

Extended Storage and Disposal of PT Samples
Microbiology and most whole blood based samples (e.g. hematology, whole blood glucose) do not lend themselves to storage after analysis.  These samples should be disposed of in a timely manner.  For information regarding the storage limitations of these samples, contact the coordinator listed on the result forms.

Some serum or plasma based samples may be stable at freezer temperature (-20º) for extended periods.  Samples which have extended stability will be identified in the instructions.  Please follow instructions for long term storage (including mixing prior to reanalysis).  Identify separate storage space for already analyzed PT samples to decrease the possibility of mix-up with current PT samples. 

All proficiency testing samples should be disposed of in the same manner as other human biohazard waste.

Requesting Excused Status

If patient testing is being temporarily suspended during the time when proficiency testing samples are scheduled to be shipped and tested (e.g. extended equipment malfunction or reagent back order of more than 2 weeks), contact us before the due date to discuss the situation. If these circumstances will compromise the ability to report timely PT results, "Excuse Requested" will be noted on the evaluation report for that shipment.

It is your responsibility to file written documentation of the reasons for "Excuse Requested" status with this evaluation report. The excuse will be valid only if your documentation is accepted by your accrediting agency's surveyor.

Important 07 policy change: We have been advised by CMS that our previous policy for short term due date extensions is not acceptable. Customers must either report results by the published due date or request an excuse for that shipment.

Reporting Test Results

Instructions and forms for reporting results accompany proficiency testing samples. The due date is specified in the instructions and on the result forms and is strictly enforced. Completed result forms should be faxed to 608-265-1111 by midnight CST of the due date. Our fax server receives data 24 hours/day, every day of the week. If you experience problems with result faxing, please contact us immediately.

We use Optical Character Recognition (OCR) software to "read" result forms that are faxed to us. This software also records the date and time received as well as the phone number from which the fax was sent. To help with tracking, please be sure your fax machine is correctly programmed to print your institution's name and current fax number.

Retain your dated fax log, fax confirmation report or phone bill as verification of transmission. If you fax results, DO NOT mail them.

If you do not have fax capabilities, mail the original result forms to us. You are required to keep a copy of what was submitted to us. Results must be postmarked by the Post Office on or before the due date. If you mail results, we strongly encourage you to use registered or priority mail so that you have documentation of delivery.

Results received by fax or post marked after the due date may be evaluated, but will receive a score of zero (0%).

General Tips for Completing Result Forms

•  Use a black or blue pen. Do not use pencil.
•  Method code information must be reviewed for correctness. Follow information in instructions for notifying us of changes to methods or tests reported.
• Numbers and/or letters should be printed using block style. Do not cross zeros or sevens.
•  Report only one number in each box. Do not use leading zeros.
•  Honor the decimal point provided.
•  Report in the specified units even if those are different than what is reported for patients.
•  Use Comment section to report error codes or unusual analytical situations.
  
  

  Print numbers using block style avoiding contact with edges of boxes:

  Shade circles completely (below, top), not with an X or checkmark (below, bottom):

Please return only result forms and those comment pages and/or methodology forms which contain information we will need to evaluate your results.

If no method information is on file or provided on the result and/or methodology update form, your results will be scored against an "All Methods" group.

If circumstances prevent participation in one or more proficiency testing shipments, you must notify us before the due date.

Dropping/Discontinuing/Moving to Waived Test Procedures

It is your responsibility to notify both us AND your accreditation agency of any changes in your test menu. Please follow the instructions provided with the result forms and samples to indicate cessation of analyte/procedure testing. If you are dropping one or more products/programs, phone or fax us so that any credits or refunds (if indicated) can be applied to your account as quickly as possible.

Unless we are informed that testing has been discontinued, results that have previously been reported for an analyte or program will list a score of zero (0%) on reports. This score will also be sent to your accreditation agency.

If a method in use (usually in microbiology) changes to waived status during the enrollment year, be advised that CMS expects the laboratory to adjust their PT enrollment to maintain the "five samples per testing event" for the remaining non-waived tests in the subspecialty.

For example: your laboratory is enrolled in a microbiology program which contains a combination of samples for antigen and culture testing each event. If the antigen method becomes waived, your lab must change its enrollment to a program which provides 5 cultures for the remaining shipments of the year. You may also need to enroll in a separate PT program for the waived antigen. Please check with your accreditation agency prior to adjusting your enrollment in these situations.

 

A list of current waived methods can be obtained from the FDA or JCAHO websites

http://www.fda.gov/cdrh/clia/ or http://www.jcaho.org/.

Assessing PT Performance

Your proficiency testing results are analyzed with results submitted by all customers participating in that program and are scored according to CLIA ’88 regulations. We make every attempt to provide a specific peer group when applicable and allowed by CLIA regulations. A current event performance report, a cumulative report summarizing performance over the past 3 events and in some cases a statistical report covering all scored methods and analytes are mailed approximately 15-40 days after the due date.  Please review these reports as soon as possible after receipt.

As of April, 2007 reports will be posted to our web portal the day they are released for printing.  At the same time they will be sent via e-mail if the customer has indicated they wish to receive this service and their e-mail server does not block pdf attachments.  Instructions will be provided to enable customers to set up their mailbox to auto-forward our reports to other staff within their institution.  This electronic report will not replace the paper report but will allow customers to receive reports several days earlier because there is no mail delay. 

An event summary is also included when reports are released.  This summary contains general information and grading observations for a specific program or group of programs and may contain information to help you in evaluating your results.   Questions or comments should be directed to the coordinator at the extension listed on the bottom of the Evaluation Report.

Scoring Information

CLIA '88 defined scoring criteria for regulated analytes analyzed by non-waived methods. These criteria are used by all CMS approved proficiency testing providers. An overview of the scoring types used by WSLH PT, along with specific criteria applied to individual analytes, can be found on our website under "General Information". Hard copy is also available upon request.

Correcting Reports

Reports are mailed within a day or two of the Report Run Date listed on the bottom of the cumulative summary report; usually 30-45 days after the due date.

Scores are sent to accreditation agencies at 60 days after the due date.

Therefore, it is important that you review reports as soon as possible after receipt. If you note an error on our part (e.g. wrong number entered; analyte data missing), immediately contact the coordinator at the number and extension listed on the bottom of the Evaluation Report. Errors on the part of WSLH PT (e.g. incorrect result entered/scanned in or comment overlooked), when brought to our attention, will usually result in a corrected report.

If "No Results Received" is listed on the report and you feel it is in error, you must provide proof of timely response/submission of data (fax log, telephone bill) in order to request a correction.

Errors on the part of the customer (e.g. results reported in the wrong order, wrong number copied from instrument read-out, wrong units reported) are considered by CLIA to be post-analytical mistakes and cannot be corrected.

Obtaining Copies of Past Reports

It is your responsibility to keep records of participation in proficiency testing for a minimum of two years [42CFR 493.801, Federal Register, pp. 7146]. This includes enrollment confirmation, results sent to us, reports sent to you and any documentation of review and/or corrective actions taken in the event of unsatisfactory performance.

Reports will be available to current customers on our website starting in 2007. If you do not have web access or need copies of the raw data that was submitted, we will provide them at no cost within 2 days of a request. However, requests for immediate service or retrieval of raw data submitted to us may be subject to a minimum $25 charge.

Other Services

WSLH PT Web Site

You can find us at: http//www.wslhpt.org. Our "virtual catalog" contains the most current program offerings. Please check the website frequently since we often add PT programs in mid-year as new technologies emerge. Our shipping schedule, order forms and report interpretation keys are also available in pdf file format. Customer feedback is always welcome and encouraged.

WSLH PT Plus Products

WSLH PT is a department of Wisconsin 's public health laboratory which is part of the University of Wisconsin-Madison . We have a long history of sponsoring and co-sponsoring a variety of seminars and continuing educational opportunities for clinical labs, public health nurses and physicians in Wisconsin . Staff members are actively involved with professional associations at the state and national levels. We also sponsor seminars, teleconferences and training materials in association with the National Laboratory Training Network (NLTN).

Given our unique position as part of a working laboratory in a major university setting, we have expanded educational offerings to all our customers by means of our PT Plus products which include an online Training Library and bi-annual lab and PPMP competency assessment modules.

VeriSamp sample sets are a product line intended to help laboratories and POCT sites meet method evaluation, compliance and training requirements. Each set contains samples with known characteristics and target values to independently verify method performance. These sample sets are currently available only for a small number of specialties. These products do not replace required proficiency testing but can be used to assess and document employee competency, train employees on new procedures, perform correlation studies when changing methods and validate methods in use.

We also offer a variety of no-cost, time saving services for managers or POCT coordinators who have responsibility for multiple sites. Services in this area include copies of reports for technical consultants or lab directors and options to have re-enrollment and/or confirmation forms sent to one person. A modestly priced, quarterly management report, summarizing a year's worth of data is also available.

These cost-effective services are outlined in detail on our website and in the catalog, under the PTPlus section. Order forms for these products are available in the catalog, online or by calling 800-462-5261, ext 0.

Additional Samples

Samples from past events, summaries and statistics for uses other than proficiency testing (e.g., evaluating new tests or methods, trouble-shooting PT failures, staff training or assessing staff competency) may be purchased if supplies are available. The price will include the cost of samples, printed materials, shipping and handling. Contact the appropriate program coordinator for further information.

Unsatisfactory Performance/Troubleshooting Assistance

Request the "TEN STEPS TO SUCCESSFUL PROFICIENCY TESTING" checklist from our customer service staff or contact the coordinator of the program for help in resolving questions about PT failures. We may also be able to offer suggestions regarding troubleshooting instrument/kit problems.

Off-schedule PT

Samples for remedial/reinstatement situations are available on a limited basis. The price will include the cost of samples, printed materials, shipping and handling and reporting to your accreditation agency. Contact the appropriate program coordinator for further information.

Reporting PT Scores to Accreditation Agencies

A proficiency testing provider is not an accreditation agency and does not inspect your laboratory or testing site. However, participation in an approved PT program may be part of accreditation requirements or your facility's QA plan.

In order to be a CMS approved proficiency testing provider under CLIA '88 law and be listed as an accepted provider for other accrediting agencies (e.g. CAP, COLA, JCAHO), we are obliged to report PT scores in a manner that meets federal and state laws and accreditation agency requirements. In general, requirements of non-CMS accreditation agencies and state statutes are more stringent than what is defined as "reportable" to CMS under CLIA (federal) law.

If your site is not defined under, or is considered exempt from, CLIA law [e.g. military, veterinary, manufacturer, foreign country, etc.] nothing is reported to CMS. However, if a military lab has indicated that their results need to be reported to the Department of Defense, DOD will be listed as an "agency" and receives PDF files via e-mail of all reports.

For facilities covered by CLIA law, determining which scores are reported - and the agency they are reported to - is defined by a combination of 5 parameters: the customer's accrediting agency requirements, the state statutes under which the business operates, CLIA rules, the complexity of the testing performed (e.g. waived/moderate/high), and whether enrollment with more than one PT provider is required by the customer's own Quality Assurance plan.

The following may help define what is reported:

• All regulated analyte scores [e.g. those listed in black in our catalog] tested by non-waived methods are reported to the CMS national office using electronic OSCAR format. These scores are accessed by the state surveyors and other deemed agencies (e.g. JCAHO) that conduct on-site inspections.
• If your accrediting agency is CMS and your lab only reports unregulated analytes and/or waived methods, no scores are sent to the CMS national office. However…
• If we have documentation from your state agency in charge of CLIA inspections that either state statutes or their inspection process require it, paper copies or pdf files of all reports (regardless of waived/unregulated designation) are sent to the state inspection office
• If your lab resides in, or is licensed to do business in, the states of CA, PA or WA, all scores are transmitted electronically to the state CMS office using CA format.
• If your lab is accredited by the CAP's Laboratory Accreditation Program, scores for all analytes for which we are an approved provider are transmitted electronically using LAP format.
• If your lab is accredited by COLA, .pdf files of all reports are sent via e-mail.
• If your lab is accredited by AOA, .pdf files of all reports are sent via e-mail.
• If your QA plan requires enrollment with more than one PT program and you have notified us that we are not your primary PT provider, voluntary status is indicated on your enrollment confirmation and no scores are sent.

Lab Director/Technical Consultant Reports

Copies of reports can be sent to a lab director, technical consultant, POCT coordinator or QA officer if the information is supplied to us. Consultant copies are mailed at the same time as the lab reports. Other management services are also available. These are listed under Management Services in the PTPlus section of our catalog.

Waived Method Lists

Information on waived methods can be obtained from the FDA or JCAHO web sites http://www.fda.gov/cdrh/clia/ or http://www.jcaho.org/

WSLH PT Business Hours & Contact Information

Telephone numbers and other contact information are listed below. We are available to assist you Monday through Friday, 7:30 am to 4:30 pm , CST/CDT at 800-462-5261. Our fax server operates 24/7 so you may fax us anytime at 608- 265-1111. Alternatively, you may leave voice mail or e-mail messages.

Customer Service: 800-462-5261 or 608-265-1100, x0 or PTService@mail.slh.wisc.edu

Business Hours: 7:30-4:30, CST/CDT

Fax: 608-265-1111 (available 24/7)

Website: http//www.wslhpt.org

Telephone List/Electronic Mail Addresses

Please Note: Extension numbers changed March 5, 2007