Legionella Test Reporting at a Regional Veteran Affairs Medical Center

2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S139-S139
Author(s):  
J M Petersen ◽  
D Jhala

Abstract Introduction/Objective The appropriate reporting and monitoring of legionella antigen and culture test volumes and results is a veteran affairs quality assurance regulatory requirement. Legionnaires disease incidence has been noted to be increasing in the United States, and it has also been documented that health care facilities are especially high- risk settings for the transmission of Legionella bacteria from the building water systems to the occupants. However, studies of Legionella test epidemiology for non-veteran hospitals is sparse in the literature. To provide perspective, here we report the total legionella antigen and culture tests from quarter 1 2016 to quarter 4 2019 to provide a regional perspective. Methods Quality assurance data on both the total number of Legionella antigen and culture tests and the recorded number of positive cases were reviewed from quarter 1 2016 to quarter 4 2019 and tabulated. This data is collected routinely as per veteran affairs regulatory directives. Results There were a total of 1613 legionella antigen tests and 1287 legionella cultures. None of the Legionella cultures were positive during the study period. Nonetheless, there were 3 positive urinary antigen tests for a total calculated percentage of 0.00002%. Conclusion The presence of positive Legionella antigen tests at a regional veteran affairs medical center indicates that a robust quality assurance program is tremendous benefit to monitoring Legionella at a major medical institution in order to prompt action to prevent hospital-based spread.

Author(s):  
J. J. Balkey ◽  
L. J. Sanchez ◽  
R. E. Wieneke

Los Alamos National Laboratory (LANL) is one of two design laboratories in the United States Department of Energy’s (DOE) weapons complex. It has over 60 years of experience in handling radioactive materials and, consequently, in radioactive waste management. The current focus at LANL for actinide research and development is the Plutonium Facility, which has been in operation since 1978 and is the major source of transuranic (TRU) waste. The Nuclear Materials Technology (NMT) Division is responsible for operating the Plutonium Facility. It has a dedicated group of personnel who manage radioactive and hazardous waste, and address environmental regulations. The TRU Waste Certification Program has prescriptive requirements that must be met for waste to be certified by the DOE’s Carlsbad Field Office, which provides oversight to the final waste repository, the Waste Isolation Pilot Plant (WIPP) in Carlsbad, New Mexico. Quality assurance expectations are also well defined, from top-tier documents such as 10 Code of Federal Regulations 830.120. Quality Assurance Requirements, which carry the force of law, through CAO-94-1012, Quality Assurance Program Document, from WIPP, to LANL internal working documents. Internal and external audits are conducted regularly to verify the adequacy of the program for meeting these requirements. To ensure compliance with quality requirements in waste operations, the NMT-7 Waste Management and Environmental Compliance Group has two full-time quality assurance (QA) specialists. They are responsible for maintaining the Quality Assurance Program (QAP). They work directly with waste management personnel, and they are frequently in the field, working beside waste management technicians. They are responsible for ensuring that applicable QAP elements are implemented as required, and that waste operations are effective. They review waste management program documents and waste operations for compliance with requirements, and they observe selected waste operations regularly to ensure that these operations are being conducted in accordance with established procedures. A yearly surveillance schedule is established to guide assessment activities, but it has the flexibility to allow the QA specialists to address any problem areas they may encounter. The QA specialists track performance indicators and evaluate them for systemic issues that may affect quality, including tracking program corrective actions to completion. Monthly reports on QA activities are submitted to group managers. The QA specialists are also asked, on occasion, to lead quality-related investigations and to work with operations personnel to propose solutions. As a direct result of their efforts, the waste management group won Pin˜on quality assurance recognition from Quality New Mexico for the group’s commitment to quality.


Author(s):  
Matthew Faciane ◽  
Susan K. Fan ◽  
Rocky J. Dwyer

The purpose of this qualitative case study was to explore quality improvement strategies senior manufacturing production managers use to reduce Cost of Poor Quality (COPQ) to increase profit. The participants for this study were production managers within a manufacturing company located in the southeastern region of the United States who successfully developed and implemented strategies to lower COPQ to increase profitability. Six major themes emerged from the study: continuous improvement, quality assurance, employees as agents of quality improvement, communication between stakeholders, holding all firm members accountable for quality, and training. Manufacturing managers can use these strategies to lower COPQ and increase profits, which could result in enhancing other organizations’ financial performance. Findings from this study may enable manufacturing managers to improve organizational performance when continuous quality improvement processes are implemented throughout the manufacturing process and senior leaders champion lessons learned, support the training program approach, and implement a quality assurance program that empowers frontline employees as agents of quality throughout the manufacturing process.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S334-S335
Author(s):  
Natasha E Hongsermeier-Graves ◽  
Rohan Khazanchi ◽  
Nada Fadul

Abstract Background It is well known that the HIV epidemic and COVID-19 pandemic have both disproportionately harmed marginalized minority and immigrant communities in the United States. The risk factors associated with disease incidence and outcomes reaffirm that structural vulnerabilities—sociopolitically imposed risk factors like discrimination, legal status, poverty, and beyond which impact a patient’s opportunity to achieve optimal health—play a key role in facilitating the inequitable harms of COVID-19 and HIV alike. This study explores the role of structural forces in increasing the risk of SARS-CoV-2 coinfection among people with HIV (PWH). Methods We performed a retrospective chart review of PWH receiving care at the University of Nebraska Medical Center HIV clinic in Omaha, Nebraska, to collect patient demographics, comorbidities, HIV outcomes, and COVID-19 outcomes for 37 patients with HIV and SARS-CoV-2 coinfection as of August 27, 2020. As a comparison group, we obtained demographic data from a registry of all patients seen at the HIV clinic. We used R Statistical Software to perform descriptive statistical analysis. Results Relative to our overall HIV clinic population, over twice as many Hispanic patients (35.1% vs. 16.0%), three times as many undocumented patients (13.5% vs. 4.2%), and four times as many refugee patients (16.2% vs. 4.0%) had COVID-19. The majority (67.6%) of coinfected patients reported working in “essential” jobs during the pandemic. Thirty-four of the 37 people with HIV and COVID-19 (PWHC) had at least one comorbidity, including increased BMI (83.7%), hypertension (64.9%), or hyperlipidemia (48.6%). All 37 PWHC remained alive as of October 4, 2020. Demographics and HIV Disease Progression of People with HIV and SARS-CoV-2 Coinfection vs. Overall HIV Clinic Registry Demographics and HIV Disease Progression of People with HIV and SARS-CoV-2 Coinfection vs. Overall HIV Clinic Registry (continued) Conclusion The disproportionate burden of SARS-CoV-2 coinfection on Hispanic, undocumented, and refugee PWH may be a product of structural vulnerabilities contributing to greater risk of exposure. Although all 37 PWHC had well-controlled HIV and relatively mild COVID-19 courses, the broader theme of disproportionate COVID-19 incidence among vulnerable sub-populations of people with HIV reaffirms the importance of structural interventions to mitigate current and downstream harms. Disclosures All Authors: No reported disclosures


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
David Winchester ◽  
Omkar Betageri ◽  
Patrick Perche ◽  
Brandon Allen ◽  
Ryan Theis

Background: High sensitivity troponin assays (hsTn) have received regulatory approval for use in the United States and health care facilities are beginning to adopt these new assays. Questions remain about how to implement these assays and what affect they may have on demand for cardiovascular services. Methods and Results: We conducted a mixed-methods implementation science-based investigation of hsTn adoption at a single academic medical center. We designed the investigation based on the Consolidated Framework for Implementation Research, exploring clinicians’ perspectives on intervention characteristics, inner setting, individual characteristics, and process of implementation domains. Focus groups were conducted with clinicians from multiple service lines. Participants reported that the new hsTn assay did not fundamentally change processes of care such as cardiology consultations or inpatient admissions. Implementation was facilitated by leveraging the electronic medical record to provide useful suggestions for hsTn management at the point-of-care. Participants expressed satisfaction with the multidisciplinary and collaborative approach taken to educating clinicians prior to implementation. The use of case-based teaching was considered most effective. Emergency department clinicians expressed greater confidence about decisions to discharge to home with the hsTn assay, compared to the older assay. Areas of ongoing concern included management of high risk patients, outpatient follow-up, and feasibility of accelerated diagnostic protocols for early discharge from the emergency department. Deidentified quantitative data on cardiovascular service use were gathered from administrative sources and analyzed on runcharts. A decrease in the number of hsTn assays ordered was observed; no change was noted for admissions, cardiology consultations, or noninvasive cardiac imaging. Conclusions: A comprehensive educational campaign, based on multidisciplinary collaboration can effectively prepare clinicians for implementation of hsTn. New hsTn assays may not have any substantial effect of acute management of patients with cardiac complaints. Many questions remain about best clinical practices for hsTn assays.


2007 ◽  
Vol 13 ◽  
pp. 283-288
Author(s):  
Morrie Craig ◽  
G. Rottinghaus ◽  
K. Walker ◽  
E. Ishikuro

Quality assurance and quality control is the foundation of any diagnostic test. The two laboratories in the United States that use HPLC to quantitate endophyte toxins in tall fescue (Festuca arundinacea) and perennial ryegrass (Lolium perenne) are Oregon State University (OSU) and University of Missouri (MU). Japan, the major importer of grass straw has six new laboratories that will test agricultural imports for endophyte toxins. A quality assurance program was set up between the Japanese Ministry of Agriculture and the State of Oregon. The latter includes both OSU and the MU. All units are using an accurate crystalline standard and have exchanged "check" samples among themselves. To date OSU and MU have values that differ by 10%. OSU has identified a contaminating and coeluting peak as the cause of the differences. Both laboratories are changing to a Gemini column to rectify the differences. Japanese laboratories are in the process of evaluating their split check samples. Keywords: quality assurance, quality control, endophyte, tall fescue, perennial ryegrass


2020 ◽  
Author(s):  
Jeffrey M Petersen ◽  
Sahil Patel ◽  
Sharvari Dalal ◽  
Darshana Jhala

Abstract Objective Sexually transmitted infections because of Neisseria gonorrhoeae (NG) and/or Chlamydia trachomatis (CT) remain a major public health problem. Although the literature describes the population-based epidemiology of CT/NG, it does not appear to contain reference points for the statistical analyses of specimen positivity rates by nucleic acid testing (NAT) with polymerase chain reaction (PCR) that would be collected by a laboratory following best laboratory and regulatory practice. For facilities that diagnose NG and CT by a real-time PCR assay, an understanding of the expected specimen positivity rate of gonorrhea and chlamydia would be helpful for monitoring the assay for quality assurance. Therefore, on behalf of the Michael J. Crescenz Veteran Affairs Medical Center (VAMC), we present this novel quality assurance study on its CT/NG specimen positivity rates conducted by NAT with PCR. Methods Quality assurance/improvement quarterly data from April 1, 2012 to September 30, 2019 were reviewed to obtain both the test volume of PCR for CT/NG and the number of positive test results at the VAMC to collate and perform statistical analyses. Testing had been performed using the Abbott m2000 RealTime System (Abbott Park, IL). Results A total of 22,709 PCR tests for CT/NG had been performed on the veteran population; of these, 502 tests were positive for NG and 744 were positive for CT. Quarterly percentage rates ranged from 1.67% to 5.30% for CT and from 1.00% to 3.25% for NG, with average rates of 3.35% and 2.22% for CT and NG, respectively. Conclusion The establishment of an expected rate of specimen positivity of CT/NG by NAT with PCR at the VAMC is a significant novel reference point in the quality assurance (QA) literature and provides a benchmark that aids tremendously in QA for the microbiology/molecular laboratory.


2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S144-S145
Author(s):  
J M Petersen ◽  
S Dalal ◽  
D Jhala

Abstract Introduction/Objective Due to the spread of SARS-CoV-2 – the causative pathogen behind COVID-19, a significant impact on society including significant death, morbidity, strain on the nation’s medical systems, and an economic shutdown of many sectors has come to pass. While society has been affected by this virus, it has also been documented in the mainstream news that this pandemic has disproportionately affected non-white minority groups, and that access to testing for vulnerable populations have been limited. Similarly, previously published epidemiological data by Zuvekas et al. show that populations with health insurance, higher socioeconomic class, and white in race have received significantly better access to private health care resources. As veterans represent a vulnerable population, as part of quality assurance, testing data was reviewed to verify that this trend was not also affecting the VAMC. Methods As part of a quality assurance/quality improvement project, a retrospective manual review of all SARS-CoV- 2 RT-PCR tests performed at the VAMC from March 11th, 2020 to April 13th, 2020. These tests were reviewed within the computerized medical record system to determine the age, gender, and ethnicity of the patients. The demographic data from this search was compared with the population statistics of the major metropolitan city that the VAMC is located in. Results Out of 571 patients who were tested for SARS-CoV-2, 264 (46%) had an ethnic African-Americans background, 135 (24%) had an ethnic Caucasian or white background, 8 had an ethnic Hispanic background, 3 had an ethnic native Hawaiian or other Pacific Islander background, 2 had an ethnic Asian background (0.4%), and 1 had an ethnic American Indian or Alaskan Native background. The rest had left ethnicity unanswered or was unknown/declined to state. The majority of those tested were males (392 or 69%). Ages of patients tested ranged from 24 to 98 years of age. The ethnic distribution of those tested was like the ethnic distribution within the city where the VAMC was located. Conclusion Quality healthcare to the entire population also means that healthcare should be accessible to all members who require it. The VAMC offers broad access for testing to all its patients of all ethnicities. This demonstrates, in the changing healthcare landscape, one of the many advantages of the Veteran Affairs system.


Author(s):  
John G. Adkins

In 2009 the United States Nuclear Regulatory Commission (NRC) will issue Regulatory Guide 1.28 [1] endorsing the Nuclear Quality Assurance (NQA) Standard, NQA-1-2008 Edition with NQA-1a-2009 Addenda [2] as the appropriate quality assurance (QA) requirements for the design, construction and operation of new and existing U.S. nuclear generating facilities. This endorsement will change the U.S. regulatory QA position from NQA-1-1994 and incorporate 15 years of quality experience, lessons learned, technology enhancements and regulatory changes. This regulatory position change will subsequently be included in a revision to the NRC’s NUREG-0800, Standard Review Plan (SRP) 17.5, Quality Assurance Program Description – Design Certification, Early Site Permit and New License Applicants [3]. The Nuclear Energy Institute’s NEI 06-14A, Quality Assurance Program Description (QAPD) [4], which provides a generic QA template for use by new generation early site permit and combined license applicants for implementing QA regulatory requirements of SRP 17.5 will subsequently be revised to document the new regulatory position for the use of NQA-1a-2009. These new quality requirements will be passed on by the utilities constructing new generating facilities to the both U.S. and international suppliers, thus changing the basis of QA requirements for the nuclear industry. The NQA-1 Standard is a four-part criteria standard that provides quality requirements and acceptance criteria for the implementation of a nuclear facility quality assurance program. Part I describes the basic QA program elements and Part II provides requirements for specialized support and application activities for design, construction and operations. Part III contains guidance that support Parts I and II, and Part IV provides guidance for comparison of NQA-1 with other quality standards. This paper will focus on the background of the quality changes included in the endorsement on NQA-1-2008 with the NQA-1a-2009 Addenda and provide a detailed discussion of the following major changes: • Facility configuration control – measures to ensure changes that may affect the approved facility configuration are recognized and processed. • Engineering interface controls – controls to ensure interfaces for design changes are established among design organizations. • Software design controls – alternate design measures specifically for software design to ensure design input, design processes, verification and change control are appropriately performed. • Software application requirements – controls for the software engineering requirements for the acquisition, development, operation, maintenance, and retirement of software. • Electronic records – controls that address use of electronic media for QA record activities. • Commercial grade items – a composite document of criteria for the identification and dedication of commercial grade items and services. • Clarifications for consistency of basic QA requirements – areas in the Standard where the QA text needed to be return to basic principles and to add clarification to ensure national and international consistent application.


Author(s):  
Taunia Van Valkenburg ◽  
Ernie F. Petru ◽  
Paula R. Diepolder ◽  
Gary M. Sandquist

The Los Alamos National Laboratory (LANL) is a one of the largest and diverse science and technological institutions in the world. The size and sophistication of LANL’s facilities and workforce present a unique challenge to develop and implement a Quality Assurance (QA) program that meets LANL’s needs. LANL has updated its QA Program to a targeted, requirements-based approach, and broadened its Quality Assurance technical expertise into essential technical areas. The expanded areas of expertise include engineering, project management, nuclear facility operations, and weapons design and fabrication. This approach is achieving success as evidenced on an institutional level by LANL’s receipt of various national, international and local awards for its products and services. Success is also realized on the QA Program level with sufficient recognition of the importance of the QA Program by the LANL workforce. However, QA program challenges remain in areas of expanding the importance of QA; streamlining the grading process and ensuring the program is commensurate with risk and customer expectations; maintaining sufficient authority and freedom from line management for deployed QA personnel while continuing to increase the technical breadth of QA personnel. These are the focus areas to continuously improve the LANL QA Program.


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