American Pathologists Laboratory Accreditation Program Research Articles

Participation in the College of American Pathologists Laboratory Accreditation Program Decreases Variability in B-Lymphoblastic Leukemia and Plasma Cell Myeloma Flow Cytometric Minimal Residual Disease Testing: A Follow-up Survey.

Minimal residual disease (MRD) testing by flow cytometry is ubiquitous in hematolymphoid neoplasm monitoring, especially B-lymphoblastic leukemia (B-ALL), for which it provides predictive information and guides management. Major heterogeneity was identified in 2014. Subsequently, new Flow Cytometry Checklist items required documentation of the sensitivity determination method and required lower level of detection (LLOD) inclusion in final reports. This study assesses Laboratory Accreditation Program (LAP) participation and new checklist items' impact on flow cytometry MRD testing. To survey flow cytometry laboratories about MRD testing for B-ALL and plasma cell myeloma. In particular, enumerate the laboratories performing MRD testing, the proportion performing assays with very low LLODs, and implementation of new checklist items. Supplemental questions were distributed in the 2017-A mailing to 548 flow cytometry laboratories subscribed to the College of American Pathologists FL3 Proficiency Testing Survey (Flow Cytometry-Immunophenotypic Characterization of Leukemia/Lymphoma). The percentage of laboratories performing MRD studies has significantly decreased since 2014. Wide ranges of LLOD and collection event numbers were reported for B-ALL and plasma cell myeloma. Most laboratories determine LLOD by using dilutional studies and include it in final reports; a higher proportion of LAP participants used these practices than nonparticipants. Several MRD testing aspects vary among laboratories receiving FL3 Proficiency Testing materials. After the survey in 2014, new checklist items were implemented. As compared to 2014, fewer laboratories are performing MRD studies. While LLOD remains heterogeneous, a high proportion of LAP subscribers follow the new checklist requirements and, overall, target LLOD recommendations from disease-specific working groups are met.

Conventional Pap smear cervical cancer screening in 11 rural counties in Hainan Province, China: analysis of Bethesda system reporting rates for 218,195 women (predominantly ages 35-64 years) screened in China's National Cervical Cancer Screening Program in Rural Areas (NCCSPRA)

Recently the Chinese government has introduced support for cervical screening in rural areas. The College of American Pathologists (CAP)-certified Guangzhou Kingmed Diagnostics laboratory supported rural screening program in Hainan Providence utilizing low-cost conventional Papanicolaou smears (CPS). This was a retrospective study of CPS screening results from 2011 to 2014 in 11 rural counties in Hainan Province. Women, most previously unscreened, volunteered to attend free CPS screening. The targeted population was women aged 35-65 years. Among total 218,195 conventional Papanicolaou smears, the reported abnormal rate was 4.4% of all smears, with 0.5% for high-grade squamous intraepithelial lesion (HSIL), 0.9% for low-grade squamous intraepithelial lesion (LSIL), 2.6% for atypical squamous cells of undetermined significance, and 0.3% for atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion. Reporting rates for different TBS categories were generally within CAP benchmark ranges, except for low reporting rates for unsatisfactory smears and for atypical glandular cells. Abnormal cytology rates varied among counties. Comparing different age groups, the LSIL rate was significantly higher in women <50 years than in women ≥50 years (1.04% versus 0.64%). The HSIL rate was significantly higher in women ≥40 years than in women <40 years (5.3% versus 0.38%). A total of 2286 women with abnormal Papanicolaou smears had documented colposcopic and histopathologic follow-up. Cervical cancer was diagnosed in 23 of 2286 (1.01%) of screened and biopsied patients. Histopathologic HSIL results were confirmed in 80% of biopsied women with HSIL Papanicolaou tests. CPS offered a low cost method to introduce cervical screening in rural China. The international College of American Pathologists Laboratory Accreditation Program provided laboratory quality control standards not otherwise readily available. Educational training programs have been instituted to address areas identified for quality improvement.

Reduction in Citations and Higher-Quality Clinical Laboratory Operations Achieved through Dual Accreditation and Compliance to the College of American Pathologists Laboratory Accreditation Program and CAP15189

Reduction in Citations and Higher-Quality Clinical Laboratory Operations Achieved through Dual Accreditation and Compliance to the College of American Pathologists Laboratory Accreditation Program and CAP15189

Bethesda System reporting rates for conventional Papanicolaou tests and liquid-based cytology in a large Chinese, College of American Pathologists-certified independent medical laboratory: analysis of 1394389 Papanicolaou test reports.

Reports that use the Bethesda System categories for Chinese Papanicolaou test results are rare. To document and analyze rates reported in the Bethesda System for conventional Papanicolaou tests and liquid-based cytology between 2007 and 2012 in China's largest College of American Pathologists-accredited laboratory. Results from 1,394,389 Papanicolaou tests, rendered between 2007 and 2012 by the Guangzhou Kingmed Diagnostics Cytology Laboratory, were documented by the Bethesda System report categories and Papanicolaou test methodology, which included both conventional Papanicolaou tests and 4 different liquid-based cytology preparations. Results were documented for 326,297 conventional Papanicolaou tests and 1,068,092 liquid-based cytology specimens, which included 928,884 ThinPrep (Hologic, Bedford, Massachusetts), 63,465 SurePath (BD Diagnostics, Franklin Lakes, New Jersey), 50,422 Liqui-Prep (LGM International, Melbourne, Florida), and 25,321 Lituo liquid-cytology (Lituo Biotechnology Co, Hunan, China) specimens. Abnormality rates reported were significantly higher with liquid-based cytology than they were with conventional Papanicolaou tests in all the Bethesda System categories (P < .001). Reporting rates were within the 2006 benchmark ranges from the College of American Pathologists, except for atypical glandular cells (low) and unsatisfactory rates for conventional Papanicolaou tests (low). Participation in the international College of American Pathologists Laboratory Accreditation Program provides laboratory quality standards not otherwise available in many international settings.

PPV of an HSIL cervical cytology result in China's largest CAP-certified laboratory

Cervical cancer remains a major health problem in China, where no uniform national standards for cervical cytology quality control exist. This study extends previously reported findings on cervical cytology performance in China's largest independent laboratory to have achieved accreditation under the international Laboratory Accreditation Program of the College of American Pathologists. A retrospective study identified high-grade squamous intraepithelial lesion (HSIL) cervical cytology reports between 2007 and 2013 from the Cytology Laboratory, Guangzhou Kingmed Diagnostics. Four liquid-based cytology (LBC) preparations were used in 73% of cases and conventional Papanicolaou tests (CPT) in 27%. Follow-up histopathologic diagnoses after HSIL reports were identified in the laboratory database. The positive predictive value for laboratory HSIL cytology results was determined for follow-up histopathologic diagnoses of cervical intraepithelial neoplasia 2 or worse (CIN2+), a recognized international quality control monitor. Of 1,804,108 cervical cytology reports, 11,929 HSIL reports (0.66%) were identified. The LBC HSIL rate was 0.79%, which was higher than the CPT HSIL rate of 0.33% (P < 0.001). Follow-up CIN2+ histopathologic diagnoses within 6 months after HSIL were identified in 1994 of 2414 patients (82.6%), including 1860 of 2246 LBC HSIL (82.8%) and 134 of 168 CPT HSIL (79.8%). Cervical cancers were diagnosed on follow-up in 244 of 2414 HSIL cases (10.1%). The positive predictive value of HSIL cervical cytology results for follow-up histopathologic CIN2+ was within currently recognized benchmark ranges for cytology laboratories. The high rate of cervical cancer diagnoses likely reflects the largely unscreened population. The College of American Pathologists Laboratory Accreditation Program provided quality standards not otherwise available in many international settings.

Fifteen years' experience of a College of American Pathologists program for continuous monitoring and improvement.

The Q-Tracks program, created in 1999, is a quality monitoring subscription service offered by the College of American Pathologists. To establish benchmarks in quality metrics, monitor changes in performance over time, and identify practice characteristics associated with better performance. The Q-Tracks program provides ongoing study of multiple metrics offered in most laboratory disciplines. The design enables measuring the effects of process changes and comparisons with other participating laboratories. Each laboratory Q-Tracks monitor has a primary quality indicator and additional secondary indicators. To date, 19 Q-Tracks monitors have been offered, with 12 currently active monitors. Q-Tracks are primarily conducted in hospital-based laboratories in the United States, Canada, and 21 other countries. Common to most Q-Tracks monitors is a demonstration of performance improvement by subscribers with long-term participation. This finding was seen in preanalytic, turnaround time, and postanalytic measures. Q-Tracks monitors contribute to the overall demonstration and improvement of laboratory and hospital quality because they address core quality measures for the College of American Pathologists Laboratory Accreditation Program and multiple Joint Commission National Patient Safety Goals. The Q-Tracks program has established multiple benchmarks in most disciplines of the laboratory and has demonstrated significant performance improvement in benchmarks and individual laboratories over time.

Pathologists and the third wave of medical genomics.

Over the past two decades, our notions about how genome science and technology would improve health and healthcare have changed. The first wave of medical genomics occurred in the mid-to-late 1990s during the pioneer period of the Human Genome Project and led to overly optimistic expectations about the development of abundant new drugs [1,2]. This optimism rested on rapid and massive gene discovery that would, in turn, quickly yield hundreds if not thousands of new and novel drug ‘targets’, whose roles in disease would be rapidly ‘validated’ through new technologies, especially comparative [3], functional [4] and structural [5] genomics. A plethora of new drugs designed to antagonize these targets and thereby effectively treat or cure disease would then ensue. In reality, only a handful of genome-derived drugs have reached the market to date.

Guidelines for the reporting of nongynecologic cytopathology specimens.

Abstract Context.—Gynecologic cytology terminology and report formatting have been nationally standardized since the implementation of The Bethesda System of 1988, but standard reporting for nongynecologic cytology has never been formally addressed on the same scale. Objectives.—To promote patient safety through uniform reporting in nongynecologic cytology (including fine-needle aspiration cytology) and to improve communication between laboratories and health care providers. Data Sources.—Sources include the College of American Pathologists Cytopathology Resource Committee; the College of American Pathologists Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization; the College of American Pathologists Laboratory Accreditation Program inspection checklists; the Joint Commission for Accreditation of Healthcare Organizations; and the Clinical Laboratory Improvement Amendments of 1988. Conclusions.—We describe the major elements of quality nongynecologic cytology reporting and disc...

Guidelines for the Reporting of Nongynecologic Cytopathology Specimens

Gynecologic cytology terminology and report formatting have been nationally standardized since the implementation of The Bethesda System of 1988, but standard reporting for nongynecologic cytology has never been formally addressed on the same scale. To promote patient safety through uniform reporting in nongynecologic cytology (including fine-needle aspiration cytology) and to improve communication between laboratories and health care providers. Sources include the College of American Pathologists Cytopathology Resource Committee; the College of American Pathologists Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization; the College of American Pathologists Laboratory Accreditation Program inspection checklists; the Joint Commission for Accreditation of Healthcare Organizations; and the Clinical Laboratory Improvement Amendments of 1988. We describe the major elements of quality nongynecologic cytology reporting and discuss areas of controversy in cytology reporting. Standardized nongynecologic specimen reporting will expand the concept of common report elements already widely implemented in gynecologic cytology reporting. The intent is to improve communication with the health care team while remaining in compliance with federal mandates and accreditation guidelines.

Reporting guidelines for clinical laboratory reports in surgical pathology.

Abstract Context.—The surgical pathology report (SPR) is an essential part of patient care because it documents the pathologic findings in tissues removed from patients for diagnostic or therapeutic reasons. Despite the importance of the SPR, exhaustive guidelines outlining the various elements of the SPR have not, to our knowledge, been published. Objectives.—To outline recommendations delineating the required, preferred, and optional elements that should be included in the SPR. These guidelines, if implemented, will bring uniformity to the reporting of surgical pathology specimens. Data Sources.—The Surgical Pathology Resource Committee of the College of American Pathologists compiled and prioritized the elements that have been included in various institutional SPRs. Additional data sources include the College of American Pathologists Laboratory Accreditation Program checklists and the recommendations of the Association of Directors of Anatomic and Surgical Pathology. Each element was assigned a priorit...

Reporting Guidelines for Clinical Laboratory Reports in Surgical Pathology

The surgical pathology report (SPR) is an essential part of patient care because it documents the pathologic findings in tissues removed from patients for diagnostic or therapeutic reasons. Despite the importance of the SPR, exhaustive guidelines outlining the various elements of the SPR have not, to our knowledge, been published. To outline recommendations delineating the required, preferred, and optional elements that should be included in the SPR. These guidelines, if implemented, will bring uniformity to the reporting of surgical pathology specimens. The Surgical Pathology Resource Committee of the College of American Pathologists compiled and prioritized the elements that have been included in various institutional SPRs. Additional data sources include the College of American Pathologists Laboratory Accreditation Program checklists and the recommendations of the Association of Directors of Anatomic and Surgical Pathology. Each element was assigned a priority of required, preferred, or optional. These priorities were discussed and consensus was reached. This report does not address issues of formatting or style substantively. These recommendations afford a framework for the creation of an SPR containing all of the components that are required or optimal for patient care.

The College of American Pathologists laboratory accreditation program

The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves.

Requirements for accreditation by the College of American Pathologists Laboratory Accreditation Program.

The College of American Pathologists Laboratory Accreditation Program expects a participant laboratory or laboratory section to be able to demonstrate that it is in compliance with the Standards for Laboratory Accreditation. The program expects laboratories to demonstrate that they are continually taking steps to identify and correct deficient areas and improve performance, in compliance with the Clinical Laboratory Improvement Amendments of 1988 regulatory requirements, particularly those pertaining to proficiency testing performance, and participating as inspectors in the accreditation process.