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CMS ID/CMS QCDR ID: CAP 28 Title: Helicobacter pylori Status and Turnaround Time Specifications Description CAP QCDR Percentage of stomach biopsy cases with gastritis that addresses presence or absence of Helicobacter pylori included AND meet the maximum 2 business day turnaround time (TAT) requirement (Report Date Accession Date 2 business days). 1 Denominator Statement Denominator Exclusions Denominator Exceptions Numerator Statement INSTRUCTIONS: This measure has two performance rates that contribute to the overall performance score: 1. Percent of cases in which presence or absence of Helicobacter pylori is addressed. 2. Percent of cases that meet the maximum 2 business day turnaround time. The overall performance score submitted is a weighted average of: (Numerator 1 + Numerator 2)/(Denominator 1 + Denominator 2). All final pathology reports for stomach biopsy cases with a diagnosis of chronic gastritis, chronic inactive gastritis, lymphocytic gastritis, chronic active gastritis or gastric lymphoma. CPT 2 : 88305 AND ICD10: K29.20: Alcoholic gastritis without bleeding K29.30: Chronic superficial gastritis without bleeding K29.31: Chronic superficial gastritis with bleeding K29.4: Chronic atrophic gastritis K29.40: Chronic atrophic gastritis without bleeding K29.41: Chronic atrophic gastritis with bleeding K29.5: Unspecified chronic gastritis K29.50: Unspecified chronic gastritis without bleeding K29.51: Unspecified chronic gastritis with bleeding K29.70 : Gastritis, unspecified, without bleeding K29.71: Gastritis, unspecified, with bleeding Gastric resections Cases requiring intra-departmental or extra-departmental consultation Final pathology report for stomach biopsy cases with a diagnosis of chronic gastritis, chronic inactive gastritis, lymphocytic gastritis, chronic active gastritis or gastric lymphoma that address the of the presence or absence of Helicobacter pylori organisms AND 1 Highlights indicate changes from 2018 reporting to 2019 reporting 2 CPT copyright: 2018 American Medical Association. All rights reserved. Last updated: 1/21/2019 Page 1 of 6

Numerator Exclusions CAP QCDR The final pathology report is in the laboratory/hospital information system with result verified and reported by the laboratory, available to the requesting physician(s) within 2 business days. Numerator definitions: 1. The presence or absence of Helicobacter pylori can be determined by any method deemed appropriate by the case pathologist, including but not limited to routine H&E sections, immunohistochemical stains, or special stains. 2. Documentation of the presence of absence of Helicobacter pylori can occur anywhere in the final pathology report deemed appropriate by the case pathologist (e.g. final diagnosis line, microscopic description, comment, etc.). 3. Turnaround Time (TAT): The day the specimen is accessioned in the lab to the day the final report is signed out. Business days counted only. 4. Accession Date: The date recorded in the laboratory/hospital information system that documents when a specimen was received by the laboratory. 5. Report Date: The date recorded in the laboratory/hospital information system that documents when a result is verified and reported by the laboratory and is available to the requesting physician(s) (signed out). 6. Signed Out: The pathology report with a final diagnosis is released. None Information NQS Domain Meaningful s Area(s) Meaningful Rationale Communication and Care Coordination Transfer of Health Information and Interoperability Helicobacter pylori infection increases the risk for gastric cancer; treatment of the infection reduces that risk and can only be effectively applied following appropriate testing (1). The average TAT for surgical pathology reports is an indicator of a laboratory s efficiency and can also affect coordination of patient care. Prior studies have shown that the average time to verification is 2 days (2-5). 1. Batts KP, et al Appropriate use of special stains for identifying Helicobacter pylori: Recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society. Am J Surg Pathol. 2013 Nov;37(11):e12-22 2. Novis DA1, Zarbo RJ, Saladino AJ. Arch Pathol Lab Med. Interinstitutional comparison of surgical biopsy diagnosis turnaround time: A College of American Pathologists Q-Probes study of 5384 surgical biopsies in 157 small hospitals. 1998 Nov;122(11):951-6. 3. Alshieban S. and Al-Surimi K. Reducing turnaround time of surgical pathology reports in pathology and laboratory medicine departments. Last updated: 1/21/2019 Page 2 of 6

CAP QCDR Type Data Source Summary of Performance Gap Evidence Owner NQF ID Number of Performance Rates Overall Performance Rate High-priority Improvement Notation BMJ Qual Improv Rep. 2015 Nov 24;4(1). pii: u209223.w3773. doi: 10.1136/bmjquality.u209223.w3773. ecollection 2015. 4. Volmar, KE et al. Turnaround Time for Large or Complex Specimens in Surgical Pathology: A College of American Pathologists Q-Probes Study of 56 Institutions. Archives of pathology & laboratory medicine. 139. 171-7. 10.5858/arpa.2013-0671-CP. 2015. 5. Patel, S. et al. Factors that impact turnaround time of surgical pathology specimens in an academic institution. Hum Pathol. 2012 Sep;43(9):1501-5. doi: 10.1016/j.humpath.2011.11.010. Epub 2012 Mar 8. Process Laboratory Information Systems; pathology reports "Helicobacter pylori is a major cause of gastroduodenal injury, gastric cancer, and lymphoma, and, thus, there is great interest in its detection and eradication. Several detection methods are available, including histochemical and immunohistochemical stains. Application of these stains in clinical practice is heterogenous, to say the least" (1). And "despite national and international guidelines for managing Helicobacter pylori infection, the American Gastroenterological Association guidelines are infrequently adhered to (2). 1. Batts KP, et al Appropriate use of special stains for identifying Helicobacter pylori: Recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society. Am J Surg Pathol. 2013 Nov;37(11):e12-22. 2. El-Zimaity H, Serra S, Szentgyorgyi E, Vajpeyi R, Samani A. Gastric biopsies: the gap between evidence-based medicine and daily practice in the management of gastric Helicobacter pylori infection. Can J Gastroenterol. 2013 Oct;27(10):e25-30. College of American Pathologists N/A 1 1 st Performance Rate Yes Inverse : No Proportional : Yes (Higher score indicates better quality) Continuous Variable : No Ratio : No Risk-adjusted: No Last updated: 1/21/2019 Page 3 of 6

CAP QCDR Specialty Current Clinical Guideline the is Derived From Pathology None Last updated: 1/21/2019 Page 4 of 6

CAP QCDR Flow Last updated: 1/21/2019 Page 5 of 6

CAP QCDR Last updated: 1/21/2019 Page 6 of 6