Unit 6 - Ch 5 CoC Standards 2020: Patient Care Expectations and Protocols (Standards 5.1 - 5.9)
Rationale and Scope of Patient Care Expectations and Protocols
Foundational Importance: Patient care expectations serve as the backbone of the accreditation program for the American College of Surgeons (ACS) Commission on Cancer (CoC). These expectations cover areas from the patient's psychosocial well-being to the quality of cancer surgery and the completeness of operative and pathologic reports.
Development of Standards through : These specific standards were developed based on the guidelines found in the Operative Standards for Cancer Surgery (OSCS). The OSCS is a surgical manual providing recommendations on the technical conduct of surgical operations and reviews the quality of evidence supporting those recommendations.
Goal of Implementation: CoC accreditation reaches approximately of patients with newly diagnosed cancer annually. Incorporating OSCS recommendations as accreditation standards aims to improve oncologic outcomes by reducing procedural variation across the United States.
Application to Curative Intent: Standards through apply to all operations conducted with curative intent.
Assignment of Intent: The operating surgeon must assign intent postoperatively based on preoperative evaluation and intraoperative management.
Documentation: Intent must be clearly documented in the operative report for any operation covered by these standards.
General Definition of Curative Operations: Generally involves the complete resection of the primary tumor and nodal evaluation for therapeutic or staging purposes.
Exceptions to Nodal Evaluation: Lymphadenectomy is not performed for certain curative operations, such as the resection of a thin melanoma.
Intent and Deviations: Any operation where a surgeon deliberately deviates from these standards (e.g., due to patient frailty or comorbidity) is not considered curative.
Regulatory Context: These standards are qualification criteria for CoC accreditation. They do NOT constitute a standard of care and are not intended to replace the medical judgment of healthcare professionals in individual cases.
Standard 5.1: College of American Pathologists Synoptic Reporting
Definition and Core Requirements: The cancer program must conduct an internal audit annually to confirm that at least of eligible cancer pathology reports are structured using the synoptic reporting format defined by the College of American Pathologists (CAP) cancer protocols.
Internal Audit Protocol:
Frequency: Each calendar year.
Sample Size: A minimum of total surgical resection cases.
Diversity of Cases: Selected cases must include at least different disease sites.
Personnel: The audit must be performed by a clinician. While not required, it is recommended that a pathologist perform the audit.
Documentation: Results and any required action plans must be documented in the cancer committee meeting minutes.
Synoptic Format Definition: A structured format that includes:
Core Elements: All core elements must be reported whether applicable or not, unless defined as "conditional." Conditional elements are only reported if applicable.
Diagnostic Parameter Pair Format: Data elements must be followed by their response (answer).
Visual Separation: Each diagnostic parameter pair must be on a separate line or in a tabular format (unless CAP protocols specify an exception).
Location: All core elements must be listed together in one location within the pathology report.
Eligibility for Synoptic Reporting:
Definitive surgical resection of primary invasive malignancies.
Ductal carcinoma in situ (DCIS).
Definitive surgical resection in patients receiving neoadjuvant therapy AND who have residual tumor.
Exclusions from CAP Cancer Protocol Reporting:
Definitive surgical resection with no residual tumor present.
Additional surgical procedures performed after definitive resection (e.g., resection of positive margins or node biopsy).
Diagnostic biopsies, cytology specimens, or procedures done before definitive surgical therapy.
Surgical resection for recurrent tumor.
In situ carcinomas (excluding DCIS).
Special studies (e.g., biomarker or prognostic testing).
Documentation:
Submitted with Pre-Review Questionnaire
Cancer committee meeting minutes documenting the required audit of pathology reports each calendar year, including any required action plans.
Compliance Measure: If compliance is below , an action plan must be developed to investigate and resolve barriers. The results and action plans must be presented to the cancer committee in the same calendar year.
Standard 5.2: Psychosocial Distress Screening
Protocol Requirement: The cancer committee must implement a protocol for providing and monitoring psychosocial distress screening and referral. This process must be evaluated and documented annually.
Psychosocial Services Protocol: Services must address physical, psychological, social, spiritual, cultural, and financial needs. These must be available on-site or by referral.
Screening Frequency and Timing: Patients must be screened for distress at least time during their first course of treatment.
Exemptions from Screening:
Biopsy only or class of case "" patients.
Patients admitted for non-cancer related issues with a history of cancer.
Inpatients with cancer who do not receive cancer treatment during that stay.
Administration Method: Determined by the cancer committee (e.g., patient questionnaire or clinician-administered). Medical staff (medical assistants, nurses, social workers, physicians) must be properly trained.
The protocol must address the sites of service where screenings occur, including at the CoC-accredited facility and/or with designated providers (for example, offices of medical oncologists and/or radiation oncologists affiliated with the CoC program).
Screening Tools: Preference is given to standardized, validated instruments with established clinical cutoffs. The cancer committee determines the specific cutoff score to identify distress.
Assessment and Referral:
Clinical evidence of moderate or severe distress requires an assessment by a member of the oncology team.
Direct Contact: Assessment must occur via face-to-face, telephone, or telemedicine discussions.
Documentation:
The screening process, timing of screening, identified tool, and distress level triggering a referral to services are documented in the protocol.
The distress screening(s) results, referral for provision of care, and any follow-up are documented in the patient medical record to facilitate integrated, high-quality care.
Annual Reporting Requirements: The Psychosocial Services Coordinator must present an annual report to the cancer committee during the first quarter. Elements include:
Number of patients screened.
Number of patients referred for distress resources.
Location of referral (on-site or external).
Measure of Compliance: Each calendar year, the cancer program fulfills all of the compliance criteria
Protocols are in place to provide patient access to psychosocial services either on-site or by referral.
The cancer committee implements a protocol that includes all requirements for providing and monitoring psychosocial distress screening and referral for psychosocial care.
Cancer patients are screened for psychosocial distress at least once during the first course of treatment.
The psychosocial distress screening process is evaluated, documented, and the findings are reported to the cancer committee by the Psychosocial Services Coordinator.
Standard 5.3: Sentinel Node Biopsy (SNB) for Breast Cancer
All sentinel nodes for breast cancer must be identified, removed, and subjected to pathologic analysis to ensure that lymphatic mapping and sentinel lymphadenectomy provide accurate information for breast cancer staging.
Definition of Sentinel Nodes:
Nodes showing uptake of a localization substrate (radioactive tracer or colored dye).
Nodes to which an afferent colored lymphatic travels.
Dominant lymph nodes that are palpably suspicious to the surgeon.
Nodes with radioactive counts at least of the most radioactive node.
Technical Requirements: Standard is satisfied if a diligent search results in the removal of all sentinel nodes and documentation is complete in synoptic format.
Neoadjuvant Considerations: To reduce false-negative rates in neoadjuvant chemotherapy patients, surgeons should remove a clipped node, at least to sentinel nodes, and/or use multiple substrates.
Synoptic Operative Report Elements:
Operation performed with curative intent: Yes/No.
Tracers used in upfront setting (Non-neoadjuvant): Dye; Radioactive tracer; Superparamagnetic iron oxide; Other; N/A.
Tracers used in neoadjuvant setting: Dye; Radioactive tracer; Superparamagnetic iron oxide; Other; N/A.
All dye-filled lymphatic channel nodes removed: Yes; No (explanation); N/A.
All significantly radioactive nodes removed: Yes; No (explanation); N/A.
All palpably suspicious nodes removed: Yes; No (explanation); N/A.
Biopsy-proven clipped nodes identified and removed: Yes; No (explanation); N/A.
Audit Requirement: Internal audit identifying at least compliance in a minimum of cases annually. If fewer than cases occur, all must be reviewed.
If the internal audit demonstrates less than 80% compliance with Standard 5.3, an action plan must be developed and implemented. The internal audit must be performed 6 months after the action plan is approved to determine the impact of the intervention.
Documentation:
Reviewed On-Site
The site reviewer will review synoptic operative reports from applicable sentinel node biopsies for breast cancer.
Submitted with Pre-Review Questionnaire
CoC Operative Standards Audit Template for Sentinel Node Biopsy for Breast Cancer.
Cancer committee meeting minutes documenting the required audit of operative reports each calendar year, including any required action plans.
Standard 5.4: Axillary Lymph Node Dissection (ALND) for Breast Cancer
Definition: Removal of Level I and II lymph nodes within the anatomic triangle defined by the axillary vein, chest wall, and latissimus dorsi.
Purpose:
To provide important staging and prognostic information that can inform treatment decisions.
To improve local-regional control in certain settings in which sentinel node biopsy, systemic therapies, and radiotherapy—alone or combined—have not yet been demonstrated to adequately control disease.
Technical Boundaries for Completion:
Axillary vein.
Latissimus dorsi muscle.
Chest wall (serratus anterior muscle).
Nerve Preservation: The long thoracic nerve and thoracodorsal nerve must be preserved unless involved with cancer. Intercostobrachial nerves should be spared when possible.
Axillary dissection of Levels I and II should be complete, with resection of all soft tissue within the boundaries specified above.
Level III Nodes: May be removed if clinically involved/suspicious, but removal is mainly for local-regional control with limited data support.
Synoptic Operative Report Elements:
Operation performed with curative intent: Yes/No.
Resection performed within defined boundaries (Axillary vein, chest wall, latissimus dorsi): Yes; No (explanation).
Nerves identified and preserved: Long thoracic; Thoracodorsal; Branches of intercostobrachial; Other.
Level III nodes removed: Yes (explanation); No.
Audit Requirement: Internal audit of minimum cases (or all cases if less) with at least compliance.
If the internal audit demonstrates less than 80% compliance with Standard 5.4, an action plan must be developed and implemented. The internal audit must be performed 6 months after the action plan is approved to determine the impact of the intervention.
Documentation:
Reviewed On-Site
The site reviewer will review synoptic operative reports from applicable axillary lymph node dissections for breast cancer.
Submitted with Pre-Review Questionnaire
CoC Operative Standards Audit Template for Axillary Lymph Node Dissection for Breast Cancer.
Cancer committee meeting minutes documenting the required audit of operative reports each calendar year, including any required action plans.
Standard 5.5: Wide Local Excision (WLE) for Primary Cutaneous Melanoma
Clinical Margin Width Definition: Based on the original Breslow thickness of the primary tumor from the initial biopsy pathology report.
Required Margin Thresholds:
Melanoma in situ (MIS): clinical margin width of at least .
Invasive melanoma < 1\,mm thick: margin.
Invasive melanoma to thick: to margin.
Invasive melanoma > 2\,mm thick: margin.
Measurement: Wide local excision margins are measured from the periphery of gross residual tumor or the edges of the previous biopsy scar (shave or excisional).
Depth of Resection:
Invasive Melanoma: Includes skin and all underlying subcutaneous tissue to the level of the underlying fascial plane.
Melanoma in situ: Includes skin and superficial subcutaneous fat.
Synoptic Operative Report Elements:
Operation performed with curative intent: Yes/No.
Original Breslow thickness: MIS or value in (to the tenth of a millimeter).
Clinical margin width: ; ; ; Other (with explanation for cosmetic/anatomic concerns).
Depth of excision: Full-thickness skin/subcutaneous tissue down to fascia; Only skin and superficial subcutaneous fat; Other.
Scope of Standard: Applies to all curative-intent wide local excisions of primary cutaneous melanoma lesions. Mucosal, ocular, and subungual melanomas are excluded.
Audit Requirement: Annual internal audit of a minimum of cases with at least compliance.
Documentation:
Reviewed On-Site
The site reviewer will review synoptic operative reports from applicable wide local excisions for melanoma.
Submitted with Pre-Review Questionnaire
CoC Operative Standards Audit Template for Wide Local Excision for Primary Cutaneous Melanoma.
Cancer committee meeting minutes documenting the required audit of operative reports each calendar year, including any required action plans.
Standard 5.6: Colon Resection
Tumor Location: If there is a discrepancy between preoperative and intraoperative findings, the intraoperative location is considered definitive.
In some cases, the rectal location may not have been anticipated preoperatively.
Colon and Rectum, NOS can be used sparingly for rare tumors where more than one segment of colon is involved, and origin cannot be determined.
Extent of Resection and Vascular Ligation: Resection must be en bloc with proximal vascular ligation at the origin of primary feeding vessels.
Specific Resection Standards:
Right Hemicolectomy: ileocolic and right colic (if present).
Extended Right Hemicolectomy: ileocolic, right colic, and middle colic.
Transverse Colectomy: middle colic.
Splenic Flexure: middle colic and ascending left colic.
Left Hemicolectomy: inferior mesenteric.
Sigmoid Resection: inferior mesenteric.
Total Abdominal Colectomy: ileocolic, right colic, middle colic, and inferior mesenteric.
Total Abdominal Colectomy with Proctectomy: additionally involves superior and middle rectal vessels.
Other — Describe segments and vasculature resected anamalous to standard practice and explain the reasons.
Operative Report Elements: Curative intent: Yes/No; Tumor location (Cecum, Ascending, etc.); Extent of vascular resection (refer to above detailed list).
Audit Requirement: Annual audit of minimum cases with an compliance threshold.
Documentation:
Reviewed On-Site
The site reviewer will review synoptic operative reports from applicable resections for colon cancer.
Submitted with Pre-Review Questionnaire
CoC Operative Standards Audit Template for Colon Resection.
Cancer committee meeting minutes documenting the required audit of operative reports each calendar year, including any required action plans.
Standard 5.7: Total Mesorectal Excision (TME)
Requirement: Radical surgical resection of mid and low rectal cancers must utilize TME to ensure negative margins and lower recurrence rates.
Technical Guideline: Leveraging tissue planes between the mesorectum and endopelvic fascia while maintaining an intact fascia propria.
The surgeon can achieve a resection with a negative margin, while simultaneously preserving neurovascular structures.
Quality Grading (CAP Protocol): Synoptic pathology reports must document the quality of TME resection as:
Complete (Meets standard).
Near Complete (Meets standard; survival outcomes similar to complete).
Incomplete (Associated with significantly higher risk of local recurrence and cancer-related death).
Scope of Standard: This applies to all radical, anatomic operations for rectal adenocarcinoma performed with curative intent and excludes in-situ lesions and primary resection specimens with no residual cancer (e.g. following neoadjuvant therapy).
Tumor Location Guidance:
High Rectal: Entirely above anterior peritoneal reflection.
Mid Rectal: Straddles anterior peritoneal reflection.
Low Rectal: Entirely below anterior peritoneal reflection.
Documentation:
Reviewed On-Site
The site reviewer will review synoptic pathology reports from applicable radical resections for middle and low rectal cancers.
Exemption: CoC programs accredited by the National Accreditation Program for Rectal Cancer (NAPRC) are exempt from demonstrating compliance with CoC Standard .
Standard 5.8: Pulmonary Resection
Reporting Status of Lymph Nodes: Surgical pathology reports for primary lung malignancy must report oncologic status from:
At least hilar station (named and/or numbered station or higher).
At least distinct mediastinal stations (named and/or numbered stations ).
Scope: Applies to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and carcinoid tumors of the lung. Excludes primary resection specimens with no residual cancer (neoadjuvant post-treatment).
Procedure Specifics: Surgeons must designate the station for each node/group on the histology requisition form.
Documentation:
Reviewed On-Site
The site reviewer will review synoptic pathology reports from applicable pulmonary resections for NSCLC, SCLC, or carcinoid tumors of the lung.
Standard 5.9: Smoking Cessation (Effective Jan 1, 2026)
Definition of Current Smoking: Any cigarette smoking within the past days.
Protocol Requirements: Cancer committee must implement screening for newly diagnosed patients at the initial encounter/consultation.
Screening Method: Must distinguish between: Currently smoking; Formerly smoking; Never smoking (mutually exclusive).
Assessment and Referral: All current smokers must be referred or provided access to evidence-based treatment within of screening.
Cancer programs must provide access to smoking cessation treatment, either on-site or by referral, consisting of core elements of behavioral counseling and pharmacotherapy, which must include one or more of the following:
Individual counseling by certified Tobacco Treatment Specialists.
Physicians or healthcare providers providing counseling concordant with evidence-based smoking cessation guidelines.
Referral to on-site smoking cessation group or classes.
Referral to state quitlines or other community resources such as Health Departments or the American Cancer Society smoking cessation program.
Prescription of FDA-approved smoking cessation medication.
Enrollment in established mobile health program (Ex: SmokefreeTXT).
Combination of the above treatment approaches.
Note: Providing brochures without referral or verbal suggestions without evidence-based counseling does NOT meet the standard.
Smoking cessation treatment should include core elements of behavioral counseling and pharmacotherapy.
Internal Audit Requirements:
Minimum of newly diagnosed patients annually.
Audit must include at least current smokers to evaluate referral status.
Thresholds for Compliance: Screening rate must be ; Treatment/Referral rate must be .
A patient's refusal of referral counts as a referral for audit purposes.
An action plan must be documented in the cancer committee meeting minutes if:
Less than 90% of patients with newly diagnosed cancer received current smoking status screening, and/or
Less than 80% of patients with newly diagnosed cancer who reported current smoking were treated or referred to smoking cessation treatment.
Documentation:
Submitted with Pre-Review Questionnaire
Protocol for smoking screening and providing access to smoking cessation treatment.
Cancer committee meeting minutes documenting the required internal audit of the smoking cessation process each calendar year, including any required action plans.