Laboratory Compliance

Put the current certificate beside a list of the laboratory’s locations, examinations, methods, director, and referral services. This is your scope of service: a plain description of what happens in the laboratory today. A certificate in a binder does not establish that the laboratory has kept up with a new site, a changed director, or an added examination.

The distinction between preparation and testing matters in histology. CMS treats accessioning, embedding, cutting, staining, and coverslipping without diagnostic interpretation as specimen preparation. Diagnostic gross examination and microscopic interpretation are testing. Someone who prepares slides and also performs delegated gross examination therefore has two different kinds of duties to review. A preparation-only business and a laboratory performing diagnostic examinations should not be assigned identical CLIA obligations.

Keep state requirements in this review. CLIA does not replace applicable state laboratory or personnel requirements. For changes, use the notification rule for your certificate type and any additional accreditor or state instructions.

Check in your laboratory

• Ensure the examination menu matches the CMS-116 application and its updates.

  Guidance: List the current examinations and methods, including applicable histopathology and IHC services. Clearly identify work performed at this laboratory and work sent to another laboratory.

  42 CFR §493.43(c)(3) (opens in a new tab) Not applicable
• Maintain the appropriate CLIA certificate for the complexity of testing performed.

  Guidance: Diagnostic gross examination requires coverage for high-complexity testing. Obtain the appropriate authorization before providing that service; a Certificate of Waiver does not cover it.

  42 CFR §493.25(a) (opens in a new tab) Not applicable
• Ensure every testing location has the required application and certificate coverage.

  Guidance: Submit a separate application for a new testing site unless a specific location exception applies. For example, common ownership alone does not place an off-campus grossing suite under a hospital’s certificate.

  42 CFR §493.43(a)-(b) (opens in a new tab) Not applicable
• Maintain all applicable state and local laboratory approvals.

  Guidance: Keep required licenses current for the operating name, address and authorized services. Assign responsibility for renewals and required changes; requirements depend on the laboratory’s location and services.

  42 CFR §493.1101(c) (opens in a new tab) Not applicable
• Define specimen-preparation services separately from diagnostic examinations.

  Guidance: List embedding, cutting, staining and coverslipping without diagnostic interpretation as preparation. Describe diagnostic grossing and microscopic interpretation separately so CLIA scope reflects the actual work.

  CMS guidance: Appendix C, §493.1242(a)(6), PDF (opens in a new tab) Not applicable
• For a Certificate of Compliance, notify HHS or its designee of listed administrative changes within 30 days.

  Guidance: Send notice of ownership, name, location, director or high-complexity technical-supervisor changes. Retain the change’s effective date and the dated notice.

  42 CFR §493.51(a) (opens in a new tab) Not applicable
• For a Certificate of Compliance, notify HHS of a new specialty or subspecialty within six months of its first examination.

  Guidance: This applies when the specialty or subspecialty is absent from the certificate. Record the first examination date and retain the notice; adding a stain does not necessarily add a specialty.

  42 CFR §493.51(b) (opens in a new tab) Not applicable
• For a Certificate of Compliance, notify HHS of applicable test deletions or method changes within six months.

  Guidance: Document the change and send the required notice for testing within a covered specialty or subspecialty. This notification period does not replace requirements for using a changed method.

  42 CFR §493.51(c) (opens in a new tab) Not applicable
• For a Certificate of Accreditation, notify both HHS and the accreditor of listed administrative changes within 30 days.

  Guidance: Send both recipients notice of ownership, name, location or director changes. Retain dated notices and follow any earlier applicable accreditor requirement.

  42 CFR §493.63(a) (opens in a new tab) Not applicable
• For a Certificate of Accreditation, notify the accreditor of a new specialty or subspecialty within six months of its first examination.

  Guidance: When adding a specialty absent from the laboratory’s accreditation, document the first examination date and send the required notice. Follow any earlier applicable accreditor requirement.

  42 CFR §493.63(b) (opens in a new tab) Not applicable
• For a Certificate of Accreditation, notify the accreditor of applicable test deletions or method changes within six months.

  Guidance: Send the required notice for changes within covered specialties or subspecialties. Retain the change date and notice, and meet any shorter accreditor deadline.

  42 CFR §493.63(c) (opens in a new tab) Not applicable

A personnel file should answer three questions: what may this person do, which qualification route supports that work, and what evidence proves that route? A résumé or credential card may help, but it may not show the required degree, coursework, experience, training, or state license.

Use the CLIA role names in the role list: laboratory director, technical supervisor, clinical consultant, and any other applicable supervisory or testing role. These are regulatory responsibilities, which may differ from payroll titles. Histopathology has specific technical-supervisor and general-supervisor provisions. Being the laboratory’s administrative manager does not itself authorize diagnostic tissue examinations.

For delegated grossing, review high-complexity testing-personnel qualifications and the CMS grossing guidance together. For diagnostic microscopic tissue examination, use the separate histopathology qualification provisions. Document any applicable grandfather route rather than assuming years in the profession establish eligibility.

Check in your laboratory

• Ensure the director assigns each person’s authorized duties and supervision requirements in writing.

  Guidance: Specify permitted examinations, required supervision and any approval needed before results are reported. Include travelers, managers who perform testing, and qualified coverage during absences.

  42 CFR §493.1445(e)(15) (opens in a new tab) Not applicable
• Document the applicable high-complexity qualification route for each person performing delegated grossing.

  Guidance: Identify the relevant §493.1489 paragraph and retain its supporting education and training records. A PA(ASCP) card alone does not document the degree route. A grandfather route requires the applicable qualifying-service and continuity records.

  42 CFR §493.1489(b) (opens in a new tab) Not applicable
• Ensure personnel hold current state licenses for assigned work wherever licensing is required.

  Guidance: Keep the applicable license category and scope aligned with the assignment. For example, provide cytology screening through a properly licensed cytotechnologist where the state requires that license; national certification is a separate credential.

  42 CFR §493.1489(a) (opens in a new tab) Not applicable
• Provide qualified technical supervision for each pathology specialty performed.

  Guidance: Document the applicable medical license, board certification and specialty route. General histopathology, dermatopathology, ophthalmic pathology and oral pathology have distinct provisions; any resident delegation must meet the relevant rule.

  42 CFR §493.1449(b), (f), (g) (opens in a new tab) Not applicable
• Ensure the laboratory director meets and documents an applicable director qualification route.

  Guidance: For the physician-pathologist route in §493.1443(b)(1), retain the state medical license and anatomic or clinical pathology board certification. Other routes have different experience, continuing-education or continuity requirements. Document any additional technical-supervisor role separately.

  42 CFR §493.1443(a)-(b) (opens in a new tab) Not applicable
• Ensure the high-complexity laboratory director completes the required onsite visits.

  Guidance: Complete visits at least once every six months, with at least four months between the minimum two visits. Record actual attendance dates; for example, January 15 and July 15 fit those intervals.

  42 CFR §493.1445(c)(1) (opens in a new tab) Not applicable
• Document the director’s activities during each onsite visit.

  Guidance: Record the visit date and work within the director’s responsibilities, such as resolving an IHC control problem, updating staff authorization or discussing quality-assessment findings. A sign-in entry alone does not describe that work.

  42 CFR §493.1445(c)(2) (opens in a new tab) Not applicable

Delegation should describe the work a particular person may perform. CMS allows the technical supervisor to delegate specified gross examination tasks to qualified personnel using a specific written protocol. The technical supervisor remains responsible for the diagnosis and examination report. This delegation is distinct from authorization to perform diagnostic microscopic interpretation.

A useful self-review is to follow one recent specimen from the grossing record back to the person’s authorization and forward to the report. The choice of case is yours; it is not a claim that every inspector selects a complex resection or follows one fixed sampling method.

CMS guidance says gross examinations performed in the technical supervisor’s absence should be reviewed within 24 hours. Preserve that wording: it is guidance for this situation, not a universal 24-hour reporting deadline. Build a review and escalation process appropriate to the laboratory’s staffing and applicable personnel rules.

Check in your laboratory

• Ensure each person performing delegated grossing has written authorization for that work.

  Guidance: The technical supervisor’s delegation should identify the qualified person and permitted work. Authorize the relevant specimen types and tasks before assigning them.

  CMS guidance: Appendix C, §493.1461(e), PDF (opens in a new tab) Not applicable
• Ensure case block keys match the cassette contents, gross descriptions and authorized specimen protocols.

  Guidance: A block key identifies the tissue placed in each cassette. For example, entries such as ‘A1: superior tip’ and ‘A2: central section’ should describe the actual submitted sections and remain consistent with recorded orientation and ink colors.

  CMS guidance: Appendix C, §493.1461(e), PDF page (opens in a new tab) Not applicable
• Ensure the test record identifies the person who performed the gross examination.

  Guidance: Record the performer’s name or a traceable individual identifier, including traveling staff. A shared ‘gross room’ login is insufficient by itself. The identifier may be elsewhere in the test record rather than on the final report.

  42 CFR §493.1283(a)(4) (opens in a new tab) Not applicable
• Ensure the gross examination and its date are documented in the test record.

  Guidance: Create a dated entry for the gross examination itself. Preserve that testing date when correcting or transferring the record; collection and final-report dates do not replace it.

  42 CFR §493.1283(a)(4) (opens in a new tab) Not applicable
• Arrange technical-supervisor review of gross examinations performed during the supervisor’s absence.

  Guidance: CMS guidance recommends this review within 24 hours. Document the examination and review times. Apply any additional supervision requirement tied to the employee’s qualification route; the guidance is not a universal final-report deadline.

  CMS guidance: Appendix C, §493.1461(e), PDF page (opens in a new tab) Not applicable
• Ensure staff obtain appropriate help for specimens or problems outside their authorized work.

  Guidance: Provide a consultation procedure naming the responsible supervisor or director. Staff should follow the required hold, notification and documentation steps. Grossing authorization alone does not authorize diagnostic microscopic interpretation.

  42 CFR §493.1495(b)(5) (opens in a new tab) Not applicable
• Ensure the responsible qualified technical supervisor signs the examination report.

  Guidance: The technical supervisor retains responsibility for the diagnosis and report. The grossing employee’s entry identifies their portion of the work and does not replace the examination-report signature.

  CMS guidance: Appendix C, §493.1461(e), PDF page (opens in a new tab) Not applicable

Training teaches a task; competency assessment checks whether someone can perform it correctly. A signed orientation sheet, annual employment review, or successful proficiency-testing event does not by itself demonstrate all six required assessment elements.

For personnel performing high-complexity testing, assess and document performance at least semiannually during the first year of patient testing and at least annually afterward. Reevaluate performance with a changed method or instrument before reporting patient results using it. Match the assessment to the tests the person actually performs.

CMS distinguishes testing personnel from people who only label, accession, or prepare specimens. Do not automatically impose the federal six-element testing assessment on every preparation-only position. The director still needs a way to ensure staff can carry out their assigned work, and state or accreditation requirements may add obligations.

For high-complexity testing, the technical supervisor performs the assessments or delegates them in writing to an appropriately qualified general supervisor. Apply histopathology’s specific supervisory provisions when selecting the assessor; a manager’s title alone is insufficient.

Check in your laboratory

• Ensure each person’s competency plan covers their actual testing duties.

  Guidance: Apply the six testing-assessment elements to applicable testing work, including delegated diagnostic grossing. Do not automatically impose that same federal testing assessment on preparation-only duties; provide appropriate training and monitoring for all assigned work.

  CMS guidance: Appendix C, §493.1242(a)(6), PDF (opens in a new tab) Not applicable
• Assign competency assessments to personnel who meet the applicable assessor qualifications.

  Guidance: For high-complexity testing, the technical supervisor may delegate assessment in writing to an appropriately qualified general supervisor. Apply histopathology’s specialty provisions and any additional accreditor requirements; a manager’s title alone does not establish eligibility.

  CMS guidance: CMS - Assessing Personnel (opens in a new tab) Not applicable
• Complete and document high-complexity testing competency assessments at the required intervals.

  Guidance: Assess personnel at least semiannually during their first year of patient testing and at least annually afterward. Schedule from the actual testing start date. Training attendance and annual employment evaluations do not substitute for the six assessment elements.

  42 CFR §493.1451(b)(9) (opens in a new tab) Not applicable
• Complete and document direct observation of routine test performance during competency assessment.

  Guidance: Record the procedure observed, date, assessor and outcome. For someone who performs grossing, include relevant specimen identification, handling, examination and documentation tasks.

  42 CFR §493.1451(b)(8)(i) (opens in a new tab) Not applicable
• Document assessment of the person’s recording and reporting of test results.

  Guidance: Assess the employee’s actual reporting task, including correct measurements, units and specimen parts. Record the assessed work, outcome and response to errors; a dictated measurement of ‘2.3 cm’ should remain accurate in the saved description.

  42 CFR §493.1451(b)(8)(ii) (opens in a new tab) Not applicable
• Include the applicable testing-record assessment in each person’s competency documentation.

  Guidance: Document assessment of the person’s worksheets or intermediate results, quality-control records, proficiency-testing results and preventive-maintenance records, as applicable to their work. Identify the records assessed, outcome and any needed follow-up.

  42 CFR §493.1451(b)(8)(iii) (opens in a new tab) Not applicable
• Complete and document direct observation of applicable maintenance and function checks.

  Guidance: For example, when balance checks are part of testing duties, document the employee’s use of a check weight, result and response to an unacceptable reading. Assess actual performance rather than documenting only that a log was read.

  42 CFR §493.1451(b)(8)(iv) (opens in a new tab) Not applicable
• Assess and document test performance using an appropriate test challenge.

  Guidance: Use a suitable previously analyzed specimen, internal blind sample or external proficiency sample. Record expected and observed results for the method assessed. A single challenge does not automatically cover unrelated methods or all six competency elements.

  42 CFR §493.1451(b)(8)(v) (opens in a new tab) Not applicable
• Assess and document the person’s ability to resolve testing problems.

  Guidance: Use a suitable scenario or documented event, such as a jar and requisition with conflicting laterality. Record whether the person applies the required hold, documentation and consultation steps; a real discrepancy must not be resolved by guessing.

  42 CFR §493.1451(b)(8)(vi) (opens in a new tab) Not applicable
• Reevaluate performance with a changed method or instrument before patient results are reported using it.

  Guidance: Document competency with the new method or instrument, including relevant operation, result entry and checks. Complete this assessment before the employee reports patient results using the change.

  42 CFR §493.1451(b)(9) (opens in a new tab) Not applicable
• Address identified skill gaps with appropriate retraining and documented follow-up.

  Guidance: Document the original problem, instruction provided and subsequent demonstration of the corrected skill. For a specimen-part entry error, retain the retraining and corrected-performance record rather than merely relabeling the original assessment as complete.

  42 CFR §493.1445(e)(13) (opens in a new tab) Not applicable

Start with the original test request, often called the requisition, and the container label. Then follow the accession number—the laboratory’s case identifier—through the gross description, cassette, tissue block, slide, and report. The identifiers need to establish the same patient and specimen part throughout; they do not have to be printed in an identical format on every object.

Here is a hypothetical self-audit: case S26-01452 contains part A, a skin excision, and part B, a separate margin. Compare the request and jars with the accession record, follow A1 and B1 through their cassettes and slides, and check the corresponding report headings. A matching patient name alone would not catch a swap between those two parts.

Use the laboratory’s own procedures for acceptance, exceptions, preservation, and referral. Fixation requirements depend on the specimen and intended test. The cited CLIA handling rule does not prescribe one universal fixation interval for all tissue.

Check in your laboratory

• Obtain written or electronic test requests from authorized persons.

  Guidance: Record the ordering person's identity with the request. For an oral request, solicit written or electronic authorization within 30 days and retain the authorization or documentation of efforts to obtain it.

  42 CFR 493.1241(a) (opens in a new tab) Not applicable
• Record patient identifiers accurately on specimen labels and in the accession record.

  Guidance: The request, container, and accession record must identify the same patient. Carry the supplied patient identifier and sex and age or date of birth accurately into the laboratory information system (LIS). Resolve discrepancies through the laboratory's procedure.

  42 CFR 493.1241(e) (opens in a new tab) Not applicable
• Record each requested examination and applicable specimen source accurately in the accession record.

  Guidance: For a skin excision with a separately submitted margin, record both parts, their source descriptions, and their requested examinations without exchanging the part assignments.

  42 CFR 493.1241(c)(4) (opens in a new tab) Not applicable
• Record collection details and relevant clinical information accurately in the case record.

  Guidance: The request process must solicit the collection date, time when appropriate, and information needed for the specific test. Transcribe supplied information accurately and handle missing or conflicting information through the laboratory's procedure.

  42 CFR 493.1241(c)(6) (opens in a new tab) Not applicable
• Maintain patient and specimen-part identity through testing and the final report.

  Guidance: Use identifiers that consistently connect the container, gross description, block key, cassettes, blocks, slides, and report. For case S26-01452, A1 remains the skin excision and B1 remains the separate margin throughout the case.

  42 CFR 493.1232 (opens in a new tab) Not applicable
• Preserve source-block identity on every recut, level, and replacement label.

  Guidance: A deeper level cut from B1 must identify B1 on the new slide and in the case record. Handle and document label corrections through the laboratory's procedure so the original specimen identity remains clear.

  42 CFR 493.1232 (opens in a new tab) Not applicable
• Record the date and time each specimen reaches the laboratory.

  Guidance: The accession record should contain the laboratory arrival timestamp. Keep it distinct from the specimen collection time and the time of any later test order.

  42 CFR 493.1242(b) (opens in a new tab) Not applicable
• Document the condition and disposition of specimens that fail acceptance criteria.

  Guidance: For a leaking or mislabeled jar, record the condition and what happened to the specimen. Include the notification, resolution, and rejection or authorized exception required by the laboratory's written acceptance procedure.

  42 CFR 493.1283(a)(3) (opens in a new tab) Not applicable
• Follow written collection, preservation, transport, and processing instructions for each intended examination.

  Guidance: Use the fixative, transport conditions, and any fixation timing required for that specimen and test. Make the necessary preservation information available to staff; one assumed fixation interval does not cover every examination.

  42 CFR 493.1242(a)(4) (opens in a new tab) Not applicable
• Refer specimens only to CLIA-certified laboratories or laboratories meeting CMS-recognized equivalent requirements.

  Guidance: Use the receiving testing laboratory's actual identity and certification status to select an eligible referral destination. The courier's name or a trading name alone does not establish the testing laboratory's certification.

  42 CFR 493.1242(c) (opens in a new tab) Not applicable
• Prepare send-out specimens and paperwork according to the written referral procedure.

  Guidance: Use the receiving laboratory's submission instructions for patient and specimen identifiers, requested examination, container, preservation, and packaging. Keep the tracking or receipt information required by your referral procedure.

  42 CFR 493.1242(a)(8) (opens in a new tab) Not applicable
• Provide referring clients with current written specimen submission instructions.

  Guidance: For clinics sending biopsies, make the applicable labeling, preservation, transport, and rejection instructions available. Include the other patient-preparation and specimen-handling information that applies to the examinations offered.

  42 CFR 493.1242(d) (opens in a new tab) Not applicable

An effective procedure tells staff what to do with the equipment, specimens, and reagents actually in use. Ask a staff member to open the current version and walk through a real task with it. This reveals more than checking whether a manual exists.

A standard operating procedure, or SOP, is the laboratory’s written instruction for a task. Manufacturer instructions can supply applicable technical details, but the laboratory must add required information the manufacturer does not provide. Textbooks may supplement the manual; they do not replace the laboratory’s procedures.

Keep instructions for failed controls, unacceptable specimens, reporting, and equipment downtime where staff can use them. Treat a change to an instrument program or reporting step as a reason to compare practice with the approved procedure.

Check in your laboratory

• Make current written procedures available to the staff performing the work.

  Guidance: Provide access that staff can use at the work location. Keep printed and electronic working copies current so personnel can follow the approved instructions.

  42 CFR 493.1251(a) (opens in a new tab) Not applicable
• Perform bench procedures according to the laboratory's current written instructions.

  Guidance: Write usable steps for the stain sequence, reagent preparation, instrument program, acceptance decisions, and result entry. Keep the instructions aligned with the procedure staff are authorized to perform.

  42 CFR 493.1251(b)(3) (opens in a new tab) Not applicable
• Supply laboratory instructions for applicable procedure requirements missing from the manufacturer's material.

  Guidance: Add local instructions such as specimen rejection criteria when the manufacturer's material omits them. Provide the laboratory's reporting and downtime procedures. Textbooks may supplement the written procedure but do not replace it.

  42 CFR 493.1251(c) (opens in a new tab) Not applicable
• Obtain the current laboratory director's signed, dated approval before using any new or changed procedure.

  Guidance: A revised stain procedure scheduled for first use on September 10 needs approval before that use. Keep the approval with the procedure's controlled record.

  42 CFR 493.1251(d) (opens in a new tab) Not applicable
• Write corrective-action instructions for unacceptable calibration or control results.

  Guidance: State what work or reporting is held, how the problem is addressed, and how acceptable performance is established before affected patient results are reported.

  42 CFR 493.1251(b)(8) (opens in a new tab) Not applicable
• Provide written instructions for an inoperable test system.

  Guidance: For a stainer outage, define how staff hold work, use an approved alternative or referral when appropriate, and handle delayed reporting. Make the instructions accessible during the outage.

  42 CFR 493.1251(b)(14) (opens in a new tab) Not applicable
• Retain each discontinued procedure for at least two years after discontinuance.

  Guidance: Include its initial-use and discontinuance dates. A procedure discontinued September 10, 2026 remains available through at least September 10, 2028 under this rule; apply longer

  42 CFR 493.1105(a)(2) (opens in a new tab) Not applicable

Verification means demonstrating that your laboratory can achieve the applicable performance claimed for an unmodified FDA-cleared or approved test system. Establishing performance specifications, often called validation, is the route for modified systems and methods without applicable manufacturer specifications or FDA clearance or approval. The work must fit the actual test and intended use.

Accuracy concerns agreement with the correct or accepted result. Precision concerns how reproducible results are. Other applicable characteristics can include analytical sensitivity, specificity and interfering substances, reportable range, and reference intervals. Not every characteristic is expressed in the same way for a qualitative tissue stain and a numerical assay.

Read the study as a decision record: what was evaluated, what counted as acceptable, what happened, and why the method was accepted. A vendor demonstration alone does not establish the laboratory’s performance. There is no single case count in this CLIA section that validates every IHC assay. The rule also contains an applicability provision for systems the laboratory used before April 24, 2003.

Check in your laboratory

• Determine and document whether each test system requires verification or establishment of performance specifications.

  Guidance: Use verification for an applicable unmodified FDA-cleared or approved system; establish specifications for modified and other systems covered by paragraph (b)(2). When the pre-April 24, 2003 exception applies, document the actual system's qualifying use.

  42 CFR 493.1253(b)(1) (opens in a new tab) Not applicable
• Verify local performance of each applicable unmodified FDA-cleared or approved test system.

  Guidance: Document the laboratory's accuracy, precision, and reportable-range results against the manufacturer's specifications. Verify that the manufacturer's reference intervals suit the laboratory's patient population. The record must show the laboratory's performance.

  42 CFR 493.1253(b)(1)(i) (opens in a new tab) Not applicable
• Establish applicable performance specifications for modified and other test systems covered by §493.1253(b)(2).

  Guidance: Document accuracy, precision, analytical sensitivity, specificity and interferences, reportable range, reference intervals, and other needed characteristics as applicable. Use a study appropriate to the qualitative or quantitative method, with results and a documented decision on whether the defined criteria were met.

  42 CFR 493.1253(b)(2) (opens in a new tab) Not applicable
• Complete and document required performance work before reporting patient results.

  Guidance: The study record should show the work performed, results, acceptance decision, and completion before the first patient report. Select study material appropriate to the method; this section does not prescribe one universal IHC case count.

  42 CFR 493.1253(b)(1) (opens in a new tab) Not applicable
• Have the technical supervisor evaluate method changes and establish the performance evidence needed for the configuration in use.

  Guidance: Address changes to retrieval, reagents, detection, instruments, or specimen preparation. Complete the supporting performance work needed for the changed method and keep the current procedure and controls aligned with it.

  42 CFR 493.1451(b)(2) (opens in a new tab) Not applicable
• Set calibration and control procedures from the method's verified or established performance specifications.

  Guidance: For a new IHC method, use the study's supported control acceptance criteria in the written procedure. Define calibration procedures where they apply to the test system.

  42 CFR 493.1253(b)(3) (opens in a new tab) Not applicable
• Reevaluate each testing person's performance after method or instrument changes, before that person reports patient results using the change.

  Guidance: Provide needed training and document the person's performance with the new methodology or instrument. The reevaluation must cover the changed work rather than relying only on the previous method's assessment.

  42 CFR 493.1451(b)(9) (opens in a new tab) Not applicable
• Evaluate and document the relationship between results twice a year when the same test uses different methods, instruments, or sites.

  Guidance: Define how results from the different systems relate and document the comparison activities. For a stain performed on two instruments, record both comparison rounds and the evaluation of differences. This requirement applies when the described multiple-system situation exists.

  42 CFR 493.1281(a) (opens in a new tab) Not applicable

Quality control, or QC, checks whether a method is working acceptably when it is used. A control is material with a known or expected response. The record should let someone determine which control supported a particular patient slide or group of slides and whether that response met the laboratory’s criteria.

CLIA’s histopathology rule requires positive and negative reactivity checks each time fluorescent or immunohistochemical stains are used. Other differential or special stains require a known-reactivity control slide with each patient slide or group, and the reaction must be documented. Select the actual control approach to suit the method; this wording does not prescribe an identical control configuration for every IHC assay.

Keep routine hematoxylin and eosin, or H&E, slide quality in the quality program. CMS distinguishes H&E quality management from the differential-stain control requirement. The laboratory should be able to explain how unacceptable routine preparations are identified and addressed.

Check in your laboratory

• Check IHC and fluorescent stains for positive and negative reactivity each time of use.

  Guidance: Document the controls and observed reactions for that use under an identifiable run or equivalent record. Apply the laboratory's acceptance criteria to the reactions.

  42 CFR 493.1273(a) (opens in a new tab) Not applicable
• Stain a known-reactivity control with each patient slide or group for other differential or special stains.

  Guidance: For a fungal-stain group, include the appropriate control in that staining group and identify the control in the group record.

  42 CFR 493.1273(a) (opens in a new tab) Not applicable
• Document the reaction of each special-stain control.

  Guidance: Record the observed reaction and whether it meets the laboratory's acceptance criteria. The record needs the reaction, not merely confirmation that a control slide was present.

  42 CFR 493.1273(a) (opens in a new tab) Not applicable
• Ensure control results meet laboratory and applicable manufacturer acceptance criteria before reporting patient results.

  Guidance: When controls are unacceptable, hold the affected patient results while the problem is addressed. Establish acceptable control

  42 CFR 493.1256(f) (opens in a new tab) Not applicable
• Document every control procedure, including failed runs and repeats.

  Guidance: If run 041 fails and run 042 repeats the work, keep both control results intact and identifiable. The successful repeat does not erase the failed result.

  42 CFR 493.1256(g) (opens in a new tab) Not applicable
• Check and document H&E stain response each day it is used.

  Guidance: Record the daily check of intended response and expected staining characteristics. Apply the laboratory's criteria for features such as nuclear detail and stain balance; this daily H&E statement is CMS interpretive guidance.

  CMS guidance: CMS Appendix C, interpretive (opens in a new tab) Not applicable
• Identify and address inadequately prepared slides under the laboratory's written procedure.

  Guidance: Provide instructions for problems such as poor nuclear staining, folds, and suspected contamination. Record the recut, restain, communication, or other response required by the laboratory's procedure.

  42 CFR 493.1251(b)(2) (opens in a new tab) Not applicable

A completed log is useful only if its entries were acceptable or someone acted on a problem. Choose equipment that affected a case—such as a processor or stainer—and read the relevant records across the time the specimen was handled. Compare the required maintenance, operating limits, actual values, and any corrective action.

Use manufacturer maintenance and function-check requirements for applicable unmodified equipment. When equipment is modified, developed in-house, or lacks manufacturer protocols, the laboratory must establish suitable protocols. Do not turn a convenient local practice, such as one particular daily log, into a claimed federal requirement for every device.

A function check establishes that equipment is operating within its required limits. An excursion is a result outside an established limit, such as an unacceptable storage temperature. Both the limit and the response need to be clear to the person recording the result.

Check in your laboratory

• Perform and document required equipment maintenance.

  Guidance: Set tasks and intervals from the manufacturer's instructions, or establish laboratory protocols where required for modified equipment or missing instructions. For processor TP-1, record the task, instrument ID, completion date, and service details.

  42 CFR 493.1254(a)(1) (opens in a new tab) Not applicable
• Complete required function checks within acceptable limits before patient testing.

  Guidance: Record actual results against the manufacturer's or laboratory's established limits. If a check is outside those limits, resolve it before testing patients. Complete any required return-to-use checks after service.

  42 CFR 493.1254(a)(2) (opens in a new tab) Not applicable
• Define, monitor, and document required storage and operating conditions.

  Guidance: Set conditions consistent with applicable manufacturer instructions. For a reagent refrigerator, document its acceptable temperature range and monitoring results. Address water quality, humidity, and protection from electrical interruptions where applicable.

  42 CFR 493.1252(b) (opens in a new tab) Not applicable
• Resolve and document storage conditions outside approved limits.

  Guidance: After a refrigerator excursion, assess the affected reagents or specimens, decide their disposition, restore acceptable storage, and record the corrective action. Include when acceptable conditions resumed.

  42 CFR 493.1282(b) (opens in a new tab) Not applicable
• Label reagents and prepared solutions with the required use information.

  Guidance: For a prepared stain, include identity, significant strength or concentration, storage requirements, preparation date, expiration date, and other information needed for proper use. Use clear labels that staff can interpret.

  42 CFR 493.1252(c) (opens in a new tab) Not applicable
• Keep expired, deteriorated, and substandard reagents out of use.

  Guidance: Remove an expired stain or a visibly deteriorated solution from the working supply. Replace it with material that meets its expiration and quality requirements before proceeding.

  42 CFR 493.1252(d) (opens in a new tab) Not applicable
• Use components from different reagent-kit lots only when the manufacturer permits it.

  Guidance: Keep kit components associated with their lot numbers. If the manufacturer permits a particular combination, use that combination according to its instructions.

  42 CFR 493.1252(e) (opens in a new tab) Not applicable
• Perform required batch, lot, and shipment reactivity checks when prepared or opened.

  Guidance: For a new stain lot, document the expected reaction, observed result, and acceptance decision when it is opened. Include positive, negative, and graded reactivity where applicable.

  42 CFR 493.1256(e)(1) (opens in a new tab) Not applicable

Proficiency testing, or PT, uses external samples to evaluate laboratory performance. Determine which examinations or analytes on the actual menu fall under regulated PT requirements. Do not treat routine histopathology as if it were the separate gynecologic cytology proficiency-testing program.

For tests or procedures outside the regulated PT list, or where compatible samples are not offered by a CMS-approved program, CLIA requires accuracy verification at least twice annually. This is often called alternative assessment. The director and technical supervisor should choose a defensible method and acceptance criteria for the service; a convenient exercise is not automatically sufficient.

Accuracy assessment addresses the laboratory’s test performance. Personnel competency addresses an individual’s ability to do the work. Evidence may contribute to both reviews, but a PT score or an accuracy comparison alone does not replace the full competency assessment.

Check in your laboratory

• Establish an accuracy-assessment method for every test or procedure.

  Guidance: Assign each menu item its required regulated PT program or applicable accuracy-verification method. Keep routine histopathology separate from gynecologic cytology PT. Maintain staff competency assessments separately from laboratory accuracy assessment.

  42 CFR 493.801(a)(2)(ii) (opens in a new tab) Not applicable
• Verify applicable test accuracy at least twice annually.

  Guidance: Complete accuracy verification for tests outside Subpart I and listed tests without compatible samples from a CMS-approved PT program. Document the material tested, comparison result, actual result, acceptance criteria, date, and evaluation.

  42 CFR 493.1236(c) (opens in a new tab) Not applicable
• Handle regulated PT samples in the same manner as patient specimens.

  Guidance: Use routine testing personnel, methods, workload, and repeat frequency. Document the testing and reporting steps, with the analyst's and laboratory director's signed attestation to routine handling.

  42 CFR 493.801(b)(2) (opens in a new tab) Not applicable
• Prevent interlaboratory and cross-site PT result discussions until after the reporting due date.

  Guidance: Tell staff when the event's reporting due date has passed before allowing discussion with other laboratories or separate sites. Keep PT results out of cross-site chats and shared result discussions until then.

  42 CFR 493.801(b)(4) (opens in a new tab) Not applicable
• Prevent referral of regulated PT samples to another laboratory for analysis.

  Guidance: Stop the PT workflow before the point at which a patient specimen would normally be referred for further testing. A laboratory receiving another laboratory's PT sample for testing must notify CMS.

  42 CFR 493.801(b)(5) (opens in a new tab) Not applicable
• Evaluate each PT event's results and document required follow-up.

  Guidance: Record the laboratory's assessment of the provider report. Investigate unacceptable performance and document the corrective action needed to maintain accurate and reliable patient results.

  42 CFR 493.1236(a) (opens in a new tab) Not applicable
• Verify accuracy when PT results are unscored or do not reflect test performance.

  Guidance: Perform and document verification when required by § 493.1236(b), such as when the program cannot score a challenge or a score reflects late submission rather than laboratory performance.

  42 CFR 493.1236(b)(1) (opens in a new tab) Not applicable
• Maintain complete records of accuracy evaluations and verification.

  Guidance: Keep the underlying results, comparison or expected values, acceptance criteria, evaluation, and follow-up together. For example, an assessment packet can identify the tested cases or materials, date, reviewer, and outcome.

  42 CFR 493.1236(d) (opens in a new tab) Not applicable

Do not stop at the report displayed inside the laboratory information system, or LIS. Compare it with the version that reaches the final destination, such as the ordering clinician’s record. Interfaces, manual entry, and amendments can introduce errors after the laboratory has completed the examination.

For tissue pathology, verify the qualified signatory and authorization of any electronic signature. Keep a workable process for urgent findings, reporting delays, and corrected reports. An addendum or correction should not erase the original record.

Build the retention schedule by material and record type. Under federal CLIA, pathology reports and histopathology slides have ten-year minima, but their starting events differ: reporting for reports, examination for slides. Blocks have a two-year minimum after examination; tissue remnants must remain properly preserved until diagnosis. Apply a longer period when another applicable requirement calls for it.

Retention also means being able to retrieve and preserve what was retained. Review access after an LIS migration, off-site storage change, laboratory sale, or closure.

Check in your laboratory

• Send complete and accurate reports to the final report destination.

  Guidance: Include required patient identification, performing laboratory name and address, date, examination, appropriate specimen source, result or interpretation, and relevant specimen-acceptability information. Send every specimen part and its corresponding diagnosis accurately through manual and electronic reporting.

  42 CFR 493.1291(a) (opens in a new tab) Not applicable
• Have tissue pathology reports signed by an appropriately qualified individual.

  Guidance: Authorize tissue-report signers who meet the qualification provisions referenced in § 493.1273(b), or the specific neuromuscular-pathology provision in paragraph (c), as applicable.

  42 CFR 493.1273(d) (opens in a new tab) Not applicable
• Obtain electronic-signature authorization from the examiner who made the diagnosis.

  Guidance: Use a reporting workflow in which the diagnosing examiner authorizes the electronic signature. For example, individual sign-out authorization can identify that examiner and the report they approved.

  42 CFR 493.1273(d) (opens in a new tab) Not applicable
• Immediately alert the requester and applicable result user to life-threatening or alert results.

  Guidance: When a result indicates an imminently life-threatening condition or a panic or alert value, immediately contact the requesting individual or entity and, when applicable, the person responsible for using the result.

  42 CFR 493.1291(g) (opens in a new tab) Not applicable
• Determine whether clinical urgency requires notification when a report is delayed.

  Guidance: When an established reporting time frame cannot be met, decide whether the appropriate person needs notification based on the urgency of the requested testing. Apply the laboratory's notification process to that decision.

  42 CFR 493.1291(h) (opens in a new tab) Not applicable
• Promptly notify the appropriate people when a reporting error is discovered.

  Guidance: Notify the authorized person who ordered the test and, when applicable, the person using the result. For an incorrect specimen designation, communicate the error promptly through the laboratory's established process.

  42 CFR 493.1291(k)(1) (opens in a new tab) Not applicable
• Issue corrected reports promptly to the appropriate people.

  Guidance: Send the corrected report to the authorized ordering person and, when applicable, the person using the result. Ensure that electronic interfaces and manual delivery convey the corrected information accurately.

  42 CFR 493.1291(k)(2) (opens in a new tab) Not applicable
• Retain both the original and corrected reports.

  Guidance: Preserve a duplicate of each version in the retained record. Correcting a report must not erase the original version.

  42 CFR 493.1291(k)(3) (opens in a new tab) Not applicable
• Retain pathology reports and materials for the applicable minimum periods.

  Guidance: Keep reports for 10 years after reporting; histopathology slides for 10 years after examination; blocks for 2 years after examination; and preserved tissue remnants until diagnosis. Apply longer periods when otherwise required.

  42 CFR 493.1105(a)(7)(i)(B) (opens in a new tab) Not applicable
• Retain supporting laboratory records for at least two years.

  Guidance: Keep requisitions and authorizations, quality-control and patient-test records, analytic-system records, PT records, and quality-assessment records for their applicable minimum periods. Include instrument printouts where applicable.

  42 CFR 493.1105(a)(3) (opens in a new tab) Not applicable
• Retain discontinued procedures for at least two years after discontinuance.

  Guidance: Archive each discontinued procedure with its dates of initial use and discontinuance. Keep that copy available throughout the required retention period.

  42 CFR 493.1105(a)(2) (opens in a new tab) Not applicable
• Retain performance studies throughout test-system use, with a minimum retention of two years.

  Guidance: Keep establishment and verification records while the laboratory uses the system. A system used for five years needs its studies retained throughout those five years.

  42 CFR 493.1105(a)(3)(i) (opens in a new tab) Not applicable
• Arrange continued retention and access if the laboratory ceases operation.

  Guidance: Provide for records, slides, blocks, and tissue to remain retained and available for their required periods. Identify the custodian, storage location, and access process in the closure arrangements.

  42 CFR 493.1105(b) (opens in a new tab) Not applicable

Quality assessment is the ongoing review of how the whole service performs, from specimen receipt through testing and reporting. A quality-control failure concerns a particular process or run; quality assessment asks whether the laboratory recognizes patterns, fixes causes, and checks that the fix worked.

Choose measures that help the laboratory find its own problems. Labeling discrepancies, processing failures, repeat preparations, amended reports, and reporting delays are useful examples, not a federally prescribed list of indicators. Define each measure so that staff collect comparable information over time.

Finish this walkthrough by following several recent cases and a problem case through the relevant records. That is a suggested self-audit, not an inspection sampling rule. Give each unresolved finding an owner, a target date, and an evidence location. Address anything that could compromise patient results through the laboratory’s immediate corrective-action process.

Check in your laboratory

• Maintain an ongoing process to assess and correct specimen-handling problems.

  Guidance: Follow written quality-assessment procedures and document the work. For example, define a local mislabeled-specimen measure, record incidents consistently, assess their causes, and act on identified problems.

  42 CFR 493.1249(a) (opens in a new tab) Not applicable
• Correct equipment or testing failures and document the actions taken.

  Guidance: When a processor operates outside established limits, follow the corrective-action procedure. Record the problem, investigation, correction, and decision about returning the equipment to use.

  42 CFR 493.1282(b)(1)(i) (opens in a new tab) Not applicable
• Assess patient results and specimens affected by a testing failure.

  Guidance: For failed controls or calibration, evaluate all results in the unacceptable run and since the last acceptable run. For processor or storage failures, assess affected specimens and results under the laboratory's procedure and document their disposition.

  42 CFR 493.1282(b)(2) (opens in a new tab) Not applicable
• Document whether corrective actions resolved the problem.

  Guidance: After changing a cassette-labeling step, assess later results or incidents using a follow-up method suited to the problem. Record the outcome and take further action if the problem continues.

  42 CFR 493.1289(b) (opens in a new tab) Not applicable
• Revise procedures when needed to prevent a problem from recurring.

  Guidance: If an interface problem requires a new report-checking step, put that step into the procedure staff use. Document the quality assessment and any necessary changes.

  42 CFR 493.1299(b) (opens in a new tab) Not applicable
• Discuss reporting-quality findings and follow-up with the appropriate staff.

  Guidance: Include relevant amendments, delays, or interface problems in the reporting-quality review. Document the review and staff discussion so those involved understand the problem, response, and follow-up.

  42 CFR 493.1299(b) (opens in a new tab) Not applicable