CAP Accreditation for Medical Laboratories
We prepare laboratories for accreditation by the College of American Pathologists: proficiency testing planned early, procedures and records brought up to the CAP checklists for your test menu, staff training and a mock inspection, then support with deficiency responses and every inspection after.
- Granted by
- College of American Pathologists (USA)
- Standard
- CAP checklists for your test menu
Included with every engagement
- A full internal audit by our experts, at no extra cost
- A dedicated Quality Manager beside you on assessment day
- Every document handed over digitally, ready to use
- Labs & hospitals
- 150+
- States covered
- 16+
- Customer satisfaction
- 96%
Company data as of Oct. 26
Who needs CAP accreditation
CAP is a laboratory accreditation from the USA, recognised well beyond India. Laboratories usually come to us for it when their reports, or the partners who rely on them, reach outside the country.
Labs serving international clients
Laboratories whose reports are used by hospitals, doctors or patients outside India, and need an accreditation those clients recognise.
Labs testing for clinical trials
Central and reference laboratories that test samples for clinical trials, where a sponsor or partner asks for CAP accreditation.
NABL-accredited labs adding CAP
Laboratories already accredited by NABL that want CAP as well. Much of the quality system carries over, but CAP is assessed separately against its own checklists.
Reference labs with many sections
Laboratories running chemistry, haematology, microbiology, molecular and other sections, each with its own CAP checklist to meet.
CAP-accredited labs facing an inspection
Laboratories with an inspection or a self-inspection coming up, or deficiencies to answer, that want their records checked first.
What our CAP accreditation support covers
The same method we use for NABL, built around CAP's checklists and its proficiency testing rules: from the first gap analysis to the self-inspection between inspections.
ForReference laboratories · Laboratories serving international clients · Clinical trial laboratories
Gap analysis against the CAP checklists
Our experts compare your systems, documents and records with the checklists for your test menu, and give you a prioritised action plan.
Proficiency testing planned early
Enrolment planned for every test you will put forward, at least six months before you apply, and another way to check accuracy for tests with no proficiency testing available.
Procedures and records
Procedures and records rewritten with your team to meet each checklist requirement, and handed over digitally, ready to use.
Hands-on staff training
Your team trained on the checklist requirements for their section, and on the questions inspectors ask.
Application with you
We complete the CAP application with you, including the test menu your checklists will be built from.
Mock inspection and after
A mock inspection against your checklists before CAP's, help writing the responses to any deficiencies, and support for each self-inspection.
Documentation and quality management
CAP inspectors work through the checklists and ask to see the evidence for each requirement, so a procedure only counts if the records show it is followed. We put those records in place with your staff and help you keep them current between inspections.
Documents and records we prepare with you
- A quality management programme that covers every section of the laboratory
- A procedure for every test, approved by the laboratory director and reviewed on schedule
- Proficiency testing records, with every unacceptable result investigated and corrected
- Records of the alternative accuracy checks for tests with no proficiency testing available
- Quality control records, with the action taken whenever a run is rejected
- Calibration, calibration verification and analytical measurement range records
- Method validation or verification records for every test before it is used for patients
- Instrument maintenance, function checks and temperature records
- Staff qualification, training and competency assessment records
- Document control and record retention, so every record can be found when inspectors ask
Making the system work day to day
- Proficiency testing results reviewed as soon as they arrive, with failures investigated
- Quality control reviewed every run, and the action recorded when a run is rejected
- Competency assessed for every member of staff at the intervals the checklists set
- Procedures reviewed on schedule, so they keep matching what staff actually do
- Checklist requirements built into routine work, so the self-inspection between inspections is straightforward
- Quality indicators and internal audits reviewed by the laboratory's management
CAP and NABL: how they differ
CAP and NABL are granted by different bodies, after their own assessments, and one does not replace the other. A laboratory can hold both. Much of the preparation is shared, such as procedures, quality control, proficiency testing and staff competence, but each body checks it its own way.
In your free consultation we look at who relies on your reports and help you decide whether your laboratory needs CAP, NABL or both, and which to work on first.
Granted by
CAP: the College of American Pathologists (USA). NABL: a board of the Quality Council of India.
Assessed against
CAP: checklists customised to your test menu. NABL: ISO 15189:2022 and NABL's own specific criteria.
Inspected by
CAP: practising laboratory professionals, working through your checklists. NABL: NABL's assessors.
The cycle
CAP: an inspection every two years, with a self-inspection in between. NABL: surveillance visits and a reassessment.
The CAP checklists
CAP does not assess every laboratory against one fixed document. When you apply, it builds your set of checklists from your test menu: checklists that apply to every laboratory, plus one for each section you run. Each checklist is a list of requirements, and inspectors look for the evidence behind every one.
Checklists for every laboratory
- COMAll Common
- Requirements shared by every section: proficiency testing, quality control, procedures, test methods and instruments.
- GENLaboratory General
- The laboratory as a whole: quality management, personnel, the facility, safety and records.
- DRADirector Assessment
- The laboratory director's responsibilities, and how they are carried out or delegated.
Checklists for the sections you run
- CHMChemistry and Toxicology
- Clinical chemistry, immunoassays and drug testing.
- HEMHematology and Coagulation
- Blood counts, smears and coagulation testing.
- MICMicrobiology
- Bacteriology, mycology, parasitology and virology.
- MOLMolecular Pathology
- Molecular and genetic testing.
- ANPAnatomic Pathology
- Histopathology, from specimen receipt to report.
These are some of the most common section checklists; CAP has others, such as immunology, urinalysis, transfusion medicine and cytopathology. CAP updates its checklists regularly, so we always work from the edition it sends your laboratory. Compare CAP with NABL and NABH.
The CAP accreditation process, step by step
- Granted by
- College of American Pathologists (USA)
- Standard
- CAP checklists for your test menu
What CAP asks for
Step 1: Enrol in proficiency testing
At least six months before you apply.
How we help
We plan enrolment for every test you will put forward.
Step 2: Apply
CAP sends checklists customised to your test menu.
How we help
We complete the application with you.
Step 3: Meet the checklists
Every requirement met, with evidence ready to show.
How we help
We rewrite procedures and records, and train your team.
Step 4: Inspection
Practising lab professionals inspect your lab against the checklists.
How we help
We run a mock inspection first.
Step 5: Respond and stay accredited
Answer deficiencies by CAP's deadline. Inspections every two years, self-inspection in between.
How we help
We write the responses and support each self-inspection.
Free CAP consultation
Get a timeline for your organisation, or our step-by-step roadmap.
Common challenges in CAP preparation
Laboratories preparing for CAP tend to struggle in the same places. We plan for them from the gap analysis onwards.
Proficiency testing left too late
Enrolment has to be in place at least six months before you apply, so starting it late pushes back the whole timeline.
We plan proficiency testing for every test you will put forward in the first weeks of the engagement.
Tests with no proficiency testing
Some tests have no proficiency testing scheme to enrol in, and the laboratory has no other check of their accuracy on record.
We set up another way to check accuracy for those tests, such as split samples with another laboratory, with the records to show it.
The size of the checklists
A laboratory running several sections faces a long list of requirements, and working through them one by one stalls.
We go through your checklists section by section with the staff who run each one, so the work is shared and nothing is left to the last month.
Procedures that miss checklist detail
Procedures written for another standard cover the same ground but leave out details the checklists ask for, or lack the director's approval.
We check every procedure against its checklist requirements and bring it up to date with your team.
Gaps in competency records
Staff are trained, but competency assessments are not done at the intervals the checklists set, or not recorded.
We set up a competency schedule for each member of staff, with the records inspectors ask to see.
Letting it slip between inspections
Records fall behind after the first inspection, and the self-inspection or the next inspection finds the gaps.
We build the checklists into routine work and support each self-inspection.
CAP accreditation: common questions
How much does CAP accreditation support cost?
It depends on the size of your laboratory: the number of sections, tests and sites, and so the number of checklists. After your free consultation, we share the full price up front, with internal audits included at no extra cost.
How long does CAP accreditation take?
CAP expects you to be enrolled in proficiency testing at least six months before you apply, so plan for at least that. The rest depends on your test menu and how much is already in place; after the gap analysis, your free roadmap sets out your timeline.
Does Qualityveda grant CAP accreditation?
No. CAP accreditation is granted only by the College of American Pathologists, after its own inspection of your laboratory. We prepare your laboratory and your team for that inspection and support you through it.
We already have NABL. Do we need CAP as well?
Only if someone who relies on your reports asks for it, such as international clients or clinical trial sponsors. CAP and NABL are separate: one does not replace the other, though much of the preparation is shared. In your free consultation we help you decide.
What are the CAP checklists?
The requirements CAP inspects against. CAP builds your set from your test menu: checklists that apply to every laboratory, such as All Common and Laboratory General, plus one for each section you run, such as chemistry or microbiology.
What if there is no proficiency testing for one of our tests?
The laboratory still has to check that test's accuracy another way, for example by exchanging split samples with another laboratory, and keep the records. We help you choose the method and set up the records.
Who carries out a CAP inspection?
Practising laboratory professionals, who work through your checklists, look at your records and talk to your staff. We run a mock inspection the same way first, so your team knows what to expect.
Do you work on-site or remotely?
Both. Our experts visit your lab or hospital for key stages such as the gap analysis and the internal audit, and support you remotely in between. Training runs as live online sessions.
What happens if the inspectors find deficiencies?
Each deficiency has to be answered with a corrective action and evidence by CAP's deadline. We help you write the responses and gather the evidence.
Can you help us stay accredited?
Yes. CAP inspects every two years, with a self-inspection in between. We help you keep your records current and support each self-inspection and inspection.
Which states do you work in?
We work with labs and hospitals in 16+ states across India, including Delhi, Uttar Pradesh, Haryana, Rajasthan, Madhya Pradesh, Gujarat, Bihar, Andhra Pradesh and Goa.
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