Other Accrediting Bodies
In addition to CMS, CAP, COLA, and The Joint Commission, API programs are accepted by the other organizations providing laboratory accreditation under CLIA. We communicate with each of them according to their preferences.
As a long-time member of the PT community, API is approved to provide PT to many different types of clinical laboratories.
CMS / CLIA / State health departments
For US laboratories or any laboratory subject to CLIA regulations, API is approved by CMS and renews that approval every year. Many laboratories receive their routine inspections from their state health department or CLIA office. As a CMS-approved provider, API programs are accepted by all states, including New York, New Jersey, California, Florida, and Texas.
CAP (College of American Pathologists)
For laboratories choosing CAP accreditation, API works with CAP to ensure that our accepted programs continue to be accepted and are reported to CAP on a regular basis. Most API programs can be used to fulfill CAP accreditation requirements. Where a program or analyte is not accepted by CAP, it will be marked with a black triangle (►) in our catalog, and is also noted on price quotations and other materials. CAP-accredited laboratories are welcome to enroll in those programs, but they cannot be reported to CAP to fulfill accreditation requirements.
COLA
Over 75% of COLA laboratories choose API for their proficiency testing. COLA accepts all API programs, and requires scores for regulated analytes to be reported electronically on a regular basis. Providing your current CLIA and COLA numbers to API ensures this data flows smoothly. We also have points of contact with COLA to ensure we can help with any questions you may have about using API to meet your COLA accreditation requirements.
The Joint Commission
API has a long history of working with The Joint Commission to help laboratories meet their accreditation needs, and the majority of Joint Commission laboratories use API for their proficiency testing. The Joint Commission has access to laboratory evaluations through our website as long as we have your Joint Commission accreditation number. We carry over your accreditation history from year to year to ensure The Joint Commission has access to your performance information whenever they need it.
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A2LA (American Association for Laboratory Accreditation) – A2LA also offers accreditation for PT providers, and API has our ISO/IEC 17043 accreditation through A2LA (see below). As a result, we understand A2LA processes and requirements and have a good relationship with them.
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ACHC (Accreditation Commission for Health Care) - API works with ACHC on a regular basis and sends proficiency testing data for laboratories accredited by ACHC and labs that previously were accredited by HFAP (Healthcare Facilities Accreditation Program), which now is ACHC.
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AABB and ASHI (American Society for Histocompatibility and Immunogenetics) - As accrediting organizations with deemed status from CMS, these organizations accept PT from all CMS approved providers. They do not require data from API programs to be sent to them, but we are happy to help with any requests they might have.
ISO Accreditation
API has been active in the ISO accreditation community since before the first ISO standard for PT providers, ISO/IEC 17043, was published in 2010. We are accredited to this standard by A2LA under certificate number 3094.01 (www.A2LA.org). A2LA is a signatory to the ILAC Mutual Recognition Arrangement (MRA) which provides global recognition of PT accreditations. This means our ISO/IEC 17043 accreditation is recognized around the world for any accredited laboratory using our services.
We are assessed regularly by A2LA to ensure our programs continue to meet international requirements, and our reports are marked with our accreditation to ensure they are recognized by your laboratory accreditation provider.
Please see our scope of accreditation for details on accredited programs, which are clearly marked in our catalog.
Frequently asked questions
When will the CLIA changes go into effect? What do I need to do?
In March 2023 CMS announced a January 1, 2025 implementation date for the addition and deletion of analytes or microbiology tests, and the updates to the criteria for acceptable performance. This date aligns with PT provider approval and laboratory PT enrollment processes.
This means not much will change for most laboratories in 2024 unless you want to start increasing the number of samples you are testing ahead of the 2025 change. API already has 5-sample programs for most of the analytes that will be regulated in 2025.
More guidance will be available from API and other channels later in 2024 as the industry prepares for 2025.
If my CLIA number changes, can API correct my evaluation?
API will report future scores under the new CLIA number and regulatory agencies will be updated accordingly. However, if the change was not reported when it occurred, this is considered a clerical error and correcting past evaluations is not allowed. Instead, you should document the situation, including the date you reported the change to API so that future evaluations would be correct.
If I add or change my COLA number, will updated information be sent to COLA?
API will report future scores under a new COLA number. If you received a notice from COLA requesting previous scores, you will need to fax or email past evaluations to COLA using the contact information on the notice. COLA will manually enter scores from your past Performance Summary pages, which you can download from our website. Include the latest Performance Summary for each year, for each discipline COLA needs. For example, in the middle of the year, send the latest chemistry and hematology evaluations you have, plus the third event chemistry and hematology evaluations from the previous year.
How do I handle a notice from CAP about missing PT enrollment?
If the list of missing analytes appears to be your entire order, you probably need to provide your 7-digit CAP accreditation number to API. Email Customer Service at CustomerService@api-pt.com <or download a . Updates are provided to CAP on a weekly basis.
If the list of missing analytes is shorter, look carefully at the analyte description including terms like waived, non-waived, serum, urine, etc. Ensure your API enrollment and your CAP test menu agree, and that both correspond to the testing you are performing in your laboratory. An update to either your API enrollment or your CAP test menu should resolve the notice within a week. If you need assistance, contact Technical Support at TechSupport@api-pt.com.
How do I handle a notice from CAP about a missing or incorrect score?
A missing score is usually due to an incorrect or updated method. For example, if CAP is expecting a non-waived score and the method was indicated to API as waived due to an error or because your laboratory switched to waived testing, the waived score will not fulfill a requirement for non-waived testing. An incorrect method should be explained to CAP and updated when reporting your next PT event. A change in your method should be updated on your test menu with CAP.
For incorrect scores in CAP’s records, the most common cause is a 0% score from CAP Surveys if you are receiving samples from CAP but reporting results for those analytes with API. You may need to notify CAP Surveys that you no longer intend to report that analyte in their program.
If I provide my CAP number to API or enroll in additional programs, how soon will CAP be notified?
API sends data to CAP on a weekly basis and will follow up on any records that are not added to CAP’s database successfully.