Provider-performed Microscopy Research Articles

Challenges of Conducting Point-Of-Care Testing Operations In The Municipal Public Health System Based Ambulatory Care Clinics In New York City

Abstract Introduction/Objective Our New York City Municipal Public Health System- based multisite ambulatory clinics that offer various waived POCT (point of care tests) and provider-performed microscopy (PPM) to our communities, ensure standardization and quality of POC testing across our health system. Our laboratory service conducts system-wide centralized implementation, monitoring and oversight of the POCT operations regarding regulatory compliance, test performance, quality control and training. With our day-to-day POCT operations, like all other clinical laboratories, our ambulatory care clinics encounter various hurdles and challenges. Here we elaborated on the issues we encounter and how we manage to overcome them. Methods/Case Report We identified and stratified the challenges that affect our managerial as well as field-level laboratory operations and devised ways to deal with those POCT operational issues. Results (if a Case Study enter NA) Among the staffing issues, rapid staff turnover causes significant delays or cessation of POCT operations in our ambulatory care clinics, due to orientation, re-education and ensuring competency to the staff, that conducts POCT in our clinics. Besides, supply shortages, staff shortages and absences due to illness and overwork are the issues, noted at the laboratory field operational level. Delays in the processing of paperwork and new staff recruitments and in the laboratory supply chains are notable management issues. Conclusion Even though the vastness and complexity of our multisite ambulatory care network sometimes affect our ambulatory care clinic POCT operation in various challenging way, our timely, planned and coordinated intervention, close monitoring and communication and rapid initiatives handle those issues very effectively to ensure the quality of POC testing for the patient safety and care across our health system, which is one of the largest municipal-based public health care, in the country.

The advantages of inhouse testing to manage vaginitis treatment.

Vaginal discharge is a common presenting complaint in ambulatory care medicine, emergency medicine, primary care, and gynecology, accounting for nearly 10 million office visits annually in the United States. This article discusses management of abnormal vaginal discharge among women of childbearing age and the clinical significance of inhouse diagnostic tools. Provider-performed microscopy is an invaluable clinical skill that allows for immediate diagnosis, treatment, and management of infections and coinfections and should be strongly considered when evaluating a patient.

A-181 Comparison of POCT Accreditation Between TJC and CAP: Which Way to Go?

Abstract Background Point-of-care testing (POCT) at UW Health University Hospital is accredited by the Joint Commission (TJC) while the main laboratory is accredited by the College of American Pathologists (CAP). Consolidating to a single accrediting agency would eliminate the burden of maintaining two separate accreditation programs, and reduce related expenses. In consideration of consolidation, we compared the accreditation requirements between the two agencies for POCT. Methods CAP standards in the All Common (n = 84), POC (n = 62), and Lab General checklists (n = 98) were evaluated for non-waived testing requirements in accordance to the POC test menu. The POC test menu includes the following non-waived tests: activated clotting time, blood gases, urine specific gravity by refractometry, and Tzanck smear; and provider performed microscopy (PPM): wet mount (skin or hair), wet prep, and fern test. A gap analysis was conducted to distinguish differences between CAP and TJC standards and further investigation was initiated when needed. Results The majority of CAP checklist standards aligned with the current processes under TJC. From the CAP All Common checklist, 5 out of 84 standards flagged as a potential gap. One notable difference was found for CAP COM.04250Comparability of Instruments and Methods—Nonwaived testing where comparison studies are required only for instruments and methods under the same CAP number. In contrast, the TJC requires instrument and method comparisons across the entire organization, regardless of separate CLIA certificates or sites. Shifting POC nonwaived tests to CAP would eliminate the need to perform comparisons across different sites, which in our hands has been labor intensive and of little clinical value. From CAP POC checklist, 10 out of 62 standards flagged as potential gaps. Specifically, CAP POC.03800Problem Resolution where the ability to provide prompt resolution for POC issues for all shifts in which POC testing is performed is demonstrated. From the CAP Lab General checklist, 4 out of 98 standards flagged as a potential gap. Specifically, CAP GEN.40470Specimen Collection Training where additional discussion with nursing education would be needed to assess collection training records. The other key difference was with CAP GEN.23584Interim Self-Inspection where self-inspection is required during the interim year. Conclusion Overall, our assessment is that moving non-waived POC testing to CAP will align the requirements for this set of largely hospital based POC tests, where the considerable effort saved from eliminating organization wide instrument/method comparisons could be more effectively applied to expanding our existing CAP mandated interim self-inspections to include nonwaived POCT. Because the vast majority of the waived testing performed at our organization occurs at ambulatory sites under CMS oversight, leaving waived POC tests under TJC oversight was felt to align better. Overall, the POCT requirements under CAP checklists were similar to TJC with minor, but potentially impactful, differences. In our situation, moving nonwaived POC testing to CAP accreditation and keeping waived POC testing under TJC accreditation provided the best balance between quality/patient safety and regulatory administrative effort.

Looking into the Laboratory Staffing Issues that Affected Ambulatory Care Clinical Laboratory Operations during the COVID-19 Pandemic.

Our New York City Municipal Public Health System-based multisite ambulatory and school-based Gotham Health clinics offer waived point-of-care tests and provider-performed microscopy to the local communities. Our Gotham Health laboratory service conducts system-wide centralized implementation, monitoring, and oversight of the POCT operations. Laboratory staffing has always been an issue for us as there is a decades-long shortage of laboratory staff, primarily licensed medical technologists and technicians, in New York, like many other states. Our clinical laboratory operations team struggled to hire qualified people even before the COVID-19 pandemic onset. It has faced more significant challenges with the emergence of SARS-CoV-2 pandemic cases in New York City and across the country since mid-March 2020. As staffing continues to be a struggle, it directly affected the POCT performances and a system-wide reduction in the test numbers during the pandemic. We investigated to identify the factors that made staffing more challenging. The impact on our POCT started after laboratory staff relocated to the acute care hospital laboratories to provide testing support during the pandemic's peak. That caused significant delays or complete cessation of POCT operations in the clinics due to a lack of oversight support. We also experienced the risk of more vacated positions where staff already feel overworked, overwhelmed, and emotionally drained, causing professional burnout. The significant challenges identified are noncompliance with vaccine mandates resulting in job dismissal and voluntary resignations in exchange for higher-paying laboratories. Finally, the other challenges identified were frequent sick calls due to mental fatigue, retirement of seasoned staff, and inability to attract qualified technologists to meet the demands of increasing test-ordering patterns. Determining the factors that culminated in the staffing issues becoming more challenging during the COVID-19 pandemic in our ambulatory care clinic laboratory operations will help us in future crisis planning and mitigation.

Challenges of Conducting Point-Of-Care Testing Operations During The COVID-19 Pandemic In The Municipal Public Health System Based Ambulatory Care And School Health Clinics In New York City

Introduction/ObjectiveOur New York City Municipal Public Health System based multisite ambulatory clinics and school-based clinics, offer various waived POCT (point of care tests) and provider performed microscopy (PPM). To ensure standardization and quality of POC testing across our health system, our laboratory service conducts system wide centralized implementation, monitoring and oversight of the POCT operations in regard to regulatory compliance, test performance, quality control and training. With the emergence of the COVID-19 infection in the New York City, like all other clinical laboratories, our ambulatory care clinics encountered numerous hurdles and challenges. Here we elaborated the issues that we encountered and how we managed to overcome during the COVID-19 Pandemic.Methods/Case ReportWe categorized the challenges that affected our managers as well as field level laboratory operations and have devised a plane to deal with COVID-19 related predicaments.Results (if a Case Study enter NA)Among the staffing issues, staff relocation to the acute care hospital laboratories during the peak of the pandemic caused massive delay or cessation of POCT operations in our ambulatory care clinics. Manual result entry, for COVID-19 testing, at the patient portals due to lack of interface with the reference testing labs, staff shortages and frequent absences due to illness and fatigue were primary issues noted at technical level. Furthermore, there were notable delays in the processing of paper works and new staff recruitments. The lack of and significant delays in the critical laboratory supplies was another major management issue.ConclusionGiven the vastness and complexity of our multisite ambulatory care network, the COVID -19 pandemic impacted our ambulatory care clinic POCT operation in a very challenging way. However, our timeliness, coordinated interventions, close communications and initiatives handled the obstacles that arose very effectively to the ensure quality of POC testing, patient safety and quality care across our health system.

Ensuring Standardization, Quality Management And Improvement Of Point-Of-Care Testing In The Municipal Public Health System Based Ambulatory Care And School Health Clinics In New York City

Introduction/ObjectiveOperated under different acute care hospital clinical laboratory limited-service laboratory (LSL) licenses, our New York City five borough spanning multisite ambulatory clinics and school-based clinics have been offering various waived point-of-care tests (POCTs) and provider-performed microscopy (PPM) to the local communities. A wide range of variability existed among the clinics concerning regulatory compliance, test performance, quality control and training. To ensure standardization and quality of POCT across the health system, our laboratory service adopted and implemented a plan for systemwide LSL transfer from the acute care hospitals to ambulatory care laboratory service for centralized implementation, monitoring, and oversight of the POCT operations.Methods/Case ReportHaving over 60 clinics, while transferring the LSLs, we chose multi-site license with ten or more sites on each license and by phase transfer from NYSDOH. Since the commencement of the transfer, system wide our qualified laboratory personnel have been updating and providing standard operating procedures (SOP), performing quality assurance and validation of new tests/devices, providing competency assessments and helping clinical staffs maintain compliance with state and other regulatory agencies.Results (if a Case Study enter NA)After the final phase of the transfer and POCT standardization implementation in 63 clinics, currently the clinical staffs performing POCT, get expeditious training and troubleshooting in more timely manner and the providers get the results of the ordered POCTs much faster and more efficiently and overall the quality metrics get improved markedly, indicated by internal audit team.ConclusionEven though Implementation of the planned POCT standardization was initially challenging due to the vastness and complexity of our multisite ambulatory care network and later confounded by the COVID -19 pandemic effect but eventually, it helped improve patient care delivery significantly and very effectively. Expectedly, our planned transfer implementation provided standardization and ensured improved quality of POC testing across our health system.

MediaLab Compass for Point-of-Care Testing and Provider-Performed Microscopy

From the MediaLab, Inc, Lawrenceville, GA. Reprints: Leah Coppolino, MPH, MLS(ASCP), MediaLab, Inc, Lawrenceville, GA. E-mail: [email protected]. The author declares no conflict of interest.

Provider-performed microscopy empowers PAs at the point of care

Provider-performed microscopy (PPM) is a diagnostic tool recommended when patients present with several types of gynecologic infections or fungal infections of skin or nails. PPM allows for immediate and accurate treatment, and can strengthen the relationship between clinician and patient. This article reviews two microscopy techniques, the saline wet mount and the potassium hydroxide (KOH) preparation, and discusses their indications for use.

Promoting Good Laboratory Practices for Waived Infectious Disease and Provider-Performed Microscopy Testing

Laboratory testing at the point of patient care was documented hundreds of years ago and has greatly expanded in the last 25 years due to improvements in technology, miniaturization, and the availability of rapid tests for a wide variety of analytes and microorganisms. Since the implementation of the Clinical Laboratory Improvement Amendments of 1988, the number of non-traditional testing sites that provide testing with minimal oversight through a Certificate of Waiver (CW) or Certificate of Provider-Performed Microscopy (PPM) has increased. Concerns have been expressed about some practices, and data have identified quality gaps in these sites where testing may be performed by personnel who do not have laboratory training or experience. The Centers for Disease Control and Prevention has developed free educational tools to promote regulatory compliance and good laboratory practices in CW and PPM sites. Uptake and positive reviews of these materials indicate their value as a resource to improve testing quality.

Clinical Laboratory Medicine — Understanding Point-of-Care Testing and Provider-Performed Microscopy in Clinical Practice: Case-Based Curriculum for OBGYN and Pathology Residents

Abstract Introduction This session was designed to teach OB-GYN and pathology residents the concepts behind regulatory requirements for laboratory testing in clinical settings. Point-of-care (POC) ...

Managing Provider-Performed Microscopy Procedure Proficiency Test Results and Responses

Managing Provider-Performed Microscopy Procedure Proficiency Test Results and Responses

Waived tests and testing

Eighty-one percent of U.S. laboratories operate under a certificate of waiver or a provider-performed microscopy certificate, which allow them to perform a strictly defined subset of tests essentially without oversight. Waived tests, under the Clinical Laboratory Improvement Amendments statute, are required to be “simple” and to have an “insignificant risk of an erroneous result.” The number of analytes and individual test systems available as waived methods is large and increasing. Infectious disease tests available in waived format include Helicobacter pylori antibody, HIV-1 and 2 antibody, Influenza A/B antigen, Lyme antibody screen, Monospot, respiratory syncytial virus (RSV) antigen, RSV antibody, and Streptococcus group A antigen. Waived tests represent a compromise between access and quality of care. Quality problems in waived testing settings, demonstrated by state and Centers for Medicare and Medical Services (CMS) surveys, suggest that laboratory professionals could improve care by supporting waived testing laboratories, if systems to facilitate such interactions can be developed.

Provider-Performed Microscopy

The examinations of labile specimens under the bright-field or phase contrast microscope are classified as provider-performed microscopy (PPM). With a PPM certificate issued by the Centers for Medicare and Medicaid Services Administration, a physician, nurse practitioner, nurse midwife, physician assistant, or dentist may perform PPM and waived procedures. Provider-performed microscopy procedures use specimens, such as body fluids or skin scrapings. Because quality control material is not available for PPM procedures, quality assurance assessment is complicated. Policies and procedures must be written for each test procedure. Provider-performed microscopy procedures include wet mounts, KOH preparations, pinworm detection, fern test, postcoital test, microscopic urinalysis, fecal leukocytes, semen analysis for presence of sperm and motility, and eosinophils in nasal smears. The quality of PPM is dependent on adequate training and retraining to achieve optimal skills.

Practice patterns of testing waived under the clinical laboratory improvement amendments.

To determine operational practices in laboratories operating under a Certificate of Wavier (waived laboratories), or equivalent, under the Clinical Laboratory Improvements Amendments (CLIA) of 1988 when performing tests designated as having an insignificant risk of an erroneous result (ie, waived tests). Waived laboratories that were part of the Centers for Disease Control and Prevention Laboratory Sentinel Monitoring Network project in the states of Arkansas, New York, and Washington were surveyed about their quality control (QC) and quality assurances (QA) practices when performing waived testing. Arkansas and Washington sent out similar questionnaires, whereas on-site surveys were conducted in New York. The survey in Arkansas and Washington also included nonwaived laboratories. The New York visits were designed to pilot test a regulatory inspection program for limited testing sites, which, in New York, are roughly equivalent to laboratories operating under a CLIA Certificate of Wavier and/or Provider-Performed Microscopy but are generally not located in physicians' offices. Laboratories visited in New York were selected from a list of limited testing sites and were representative of that population. Arkansas received responses from 211 facilities (37% response rate), of which 38% had Certificates of Waiver. Washington received responses from 190 waived laboratories (71% response rate) and from 116 nonwaived laboratories (32% response rate). In New York, 607 of the 2751 limited testing laboratories were visited. Reporting laboratories in all 3 states most frequently performed testing for glucose, urinalysis, urine human chorionic gonadotropin, occult blood, and group A Streptococcus antigen, although other waived tests were performed less frequently. Washington found that 57% of waived laboratories followed manufacturers' QC requirements. Arkansas found that 58% of laboratories doing waived tests that required liquid controls performed these controls, and 59% performing waived testing requiring electronic controls used these controls. In New York, 68% of the laboratories complied with the manufacturer's QC requirements for a variety of tests. Being accredited by an external organization or affiliated with a more complex laboratory improved compliance. Nonwaived laboratories in Washington and Arkansas complied with manufacturer's instructions at a higher rate than did waived laboratories. Similar deficiencies in following CLIA requirements were found in other areas of laboratory operation. Just more than half of waived laboratories in 3 diverse states follow manufacturer's instructions for recommended QC and QA. These instructions help ensure that the test will produce results that have an insignificant chance of an error. Although we did not study the impact of this and other findings on patient care, the results show that imposing good laboratory practices by regulation alone was insufficient to ensure quality laboratory results in any location evaluated. A system that can continually provide accessible education on laboratory practices, coupled with new thoughts on the regulatory environment, is in order.

Provider-Performed Microscopy (PPM) Testing

What regulation governs PPM testing and what specifically does it state? The monitoring of PPM tests falls under the Clinical Laboratory Improvement Amendments (CLIA) 88 Federal Register documentation of April 25, 1995 and revised in October of 1998. The regulation specifically states the criteria for PPM procedures as follows: The examination must be personally performed by a practitioner. The procedure must be categorized as moderately complex. The primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy. The specimen is labile, or delay in performing the test could compromise the accuracy of the test result. Control materials are not available to monitor the entire testing process. Limited specimen handling or processing is required. A CLIA certificate is required to perform PPM testing. It can be a certificate of moderate, PPM, or high complexity testing. A PPM certificate must be obtained by the testing area for physicians, dentists, or midlevel practitioners to perform the testing. The two accrediting bodies, the Joint Commission on Accreditation and Healthcare Organizations (JCAHO) and the College of American Pathologists (CAP) have two different views on physician competency for PPM tests. Is it necessary to monitor physician competency for PPM tests? The JCAHO states that there is no requirement for documentation of physician competency when the test is a logical part of his or her specialty, unless the organization requires it through policy. The expectation is that a physician has received this training during his or her residency or fellowship. Competency for mid-level providers is required, however. The JCAHO requires that the accuracy and reliability of PPM testing be assessed at least twice per year. This requirement is usually due to the lack of quality control procedures for the test. This can be accomplished through proficiency testing, duplicate reading of a defined number of slides, or identification of previously analyzed samples. Examples of this include: the CAP Excel and Wisconsin State Proficiency programs, Kodachrome images, intranet enabled exams, and tutorial software (the University of Washington School of Medicine has an excellent software program). The CAP does not distinguish between complexity levels of testing, or the personnel performing the test. The CAP states that laboratories that have PPM are held to the same checklist questions for training and competency as any other point-of-care area. The laboratory director is responsible for deciding who is appropriately trained, and what training is required for all laboratory tests. Because many of the physicians are performing tests in their area of expertise, the laboratory director may decide that there is a reasonable expectation that these individuals are competent and do not require additional training or competency testing. This would not apply to residents or physicians performing testing outside their scope of training. Whether or not it is necessary, how would one go about it? Most agree that it is difficult to enforce the monitoring of this testing, whether for competency or accuracy and reliability. A champion for PPM testing at the peer level for these physicians is often times successful at implementing a sound PPM testing program.

Provider-Performed Microscopy

The category of provider-performed microscopy was defined in the Federal Register to provide a unique regulatory approach for bright-field and phase-contrast microscopy performed by a physician, dentist, or midlevel practitioner examining labile specimens. A CLIA certificate for this category of testing is available, which also permits the performance of waived tests. Because these provider-performed microscopy procedures do not have quality-control materials available, special challenges are encountered in establishing and monitoring such testing within a hospital. Vigilance is required to maintain a provider-performed microscopy program within a hospital.

National Inventory of Clinical Laboratory Testing Services (NICLTS). Development and test distribution for 1996

Context A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main outcome measure Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 +/- 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.