Physician Office Laboratories Research Articles

Estimation of Numbers of Testing Personnel and Test Volume in the Clinical Laboratory Improvement Amendments of 1988 Certificate of Accreditation and Certificate of Compliance Laboratories in the United States.

Two major categories of laboratories performing nonwaived testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) are the Certificate of Accreditation (CoA) and Certificate of Compliance (CoC) laboratories. Accreditation organizations collect more detailed laboratory personnel information than the Centers for Medicare & Medicaid Services (CMS) Quality Improvement and Evaluation System (QIES). To estimate total numbers of testing personnel and testing volumes in CoA and CoC laboratories, by laboratory type and state. We developed a statistical inference method by using the respective correlations between testing personnel counts and test volume by laboratory type. QIES reported 33 033 active CoA and CoC laboratories in July 2021. We estimated testing personnel to be 328 000 (95% CI, 309 000-348 000), which is supported by the count of 318 780 reported by the US Bureau of Labor Statistics. There were twice as many testing personnel in hospital laboratories as in independent laboratories (158 778 versus 74 904, P < .001). Independent laboratories had the highest test volume per person, which was twice as high as physician office laboratories (62 228 versus 30 102, P < .001). Hospital and independent laboratories comprised 34% of all CoA and CoC laboratories but performed the largest portion of testing (81%). Physician office laboratories, accounting for 44% of all CoA and CoC laboratories, performed a comparatively low proportion of total tests (9%). Numbers of testing personnel vary considerably by laboratory type and across states. These data can provide valuable insight when assessing laboratory workforce training needs and planning for public health emergencies.

Междисциплинарный подход к профилактике рецидивов мочекаменной болезни

Urolithiasis is a multifactorial metabolic disease caused by the interaction of genetic, environmental factors and is directly related to lifestyle. Multiple factors influencing the initiation of stone formation and the growth of urinary crystals are presented in the article. Based on the available data, an involvement of various specialists, including urologists, geneticists, physician office laboratory, radiation diagnostics specialists, nutritionists, endocrinologists, immunologists, physiotherapy and balneotherapy specialists, general practitioner, is necessary for effective treatment of patients with kidney stones.

Near point-of-care adoption of Cepheid Xpert® Flu/RSV XC testing within an integrated healthcare delivery network

Flu/RSV testing was implemented in out-patient clinic-based physician office laboratories throughout Pennsylvania. On-site testing reduced the collect-to-result time by 70% when compared to testing in a centralized core laboratory; over- or under-treatment for influenza A and B (measured by anti-viral prescription) was reduced by 15% (P < 0.0001). Antimicrobial prescription was not affected by on-site testing.

Setting Up and Overseeing Mass Spectrometry-Based Labs in Physician Offices and Other Non-Traditional Sites (PMSI).

In recent years, mass spectrometry-based testing has increasingly been adopted by physician office laboratories (POLs)3 and smaller laboratories. Physician groups, particularly pain management practices, are insourcing this technology owing to increased need for medication monitoring for patients treated with chronic opioid therapy and the associated testing revenue (1). Drug testing in the POL setting has historically been limited to point-of-care screening and/or immunoassay analyzer-based screening, both of which have known accuracy limitations (2). Although mass spectrometry-based drug testing, coupled with either liquid or gas chromatography, provides a more accurate and comprehensive view of …

Blocked recombinase polymerase amplification for mutation analysis of PIK3CA gene

A blocked recombinase polymerase amplification (blocked-RPA) approach has been developed for the enrichment of mutated templates in heterogeneous specimens as tumor tissues. This isothermal amplification technique opens alternative solutions for meeting the technological demand of physician office laboratories. Herein, the detection of mutations in PIK3CA gene, such as p.E545K, and p.H1047L, is presented. The main element was an oligonucleotide (dideoxycytidine functionalized at 3′-end) which matched with wild-type sequence in the target locus. The amplification was performed operating at 37 °C during 40 min. The results demonstrated that the competition between the upstream primer and the blocker reduced the percentage of amplified wild-type allele, making the detection of the present mutation easier.For mutation discrimination, a fast hybridization assay was performed in microarray format on plastic chip and colorimetric detection. This approach enabled the reliable discrimination of specific mutations against a background of up to 95% wild-type DNA. The applicability of the method, based on the combination of blocked-RPA and low-cost chip hybridization, was successfully proven for the genotyping of various cancer cell lines as well as tumor tissues. The assignations agreed with those provided by next-generation sequencing. Therefore, these investigations would support a personalized approach to patient care based on the molecular signature of human cancers.

Minimal Hematology Analyzer Plus Blood Smear Digital Imaging/ Analysis Provides Better Clinical Hematology Results Than a Complex Hematology Analyzer Alone

Introduction: Devices such as the CellaVision® DM96 (CellaVision AB, Lund, Sweden) locate and image nucleated cells on blood smears. Using image recognition software, the DM96 also pre-classifies those cells into differential categories similar to the most complex hematology analyzers. We compared the cell counts, differential counts and flagging information gained from a complex hematology analyzer, the XE5000 (Sysmex, Kobe, Japan), with information from a minimal hematology analyzer (Sysmex PocHi) plus the DM96. We found that the cell counts, differential and flagging capabilities are similar, but the PocHi plus DM96 advantages include allowing remote review of the blood smear.Methods: 210 blood samples, selected for various abnormalities, had complete blood counts with automated differentials produced by a Sysmex XE5000 hematology analyzer. These results were compared with cell counts from the Sysmex PocHi hematology analyzer, their 100-cell DM96 post reclassification differentials, and with DM96 pre-classification differentials using standard regression analyses and Rumke 95% confidence intervals (CI) as calculated using the Clopper-Pearson method. Flagging by the XE5000 for immature granulocytes (IG’s) and for blasts/abnormal cells was compared to the DM96 pre-classification using truth tables with the DM96 post reclassification as the gold standard. The following translations were used to compare flagging: IG’s > 2 for either post reclassification DM96 differential, XE5000 or the DM96 pre-classification differential; Any blast cells on the manual differential were compared to XE5000 flags WBC Abn Scg; NRBC Abn Scg; Blasts?; Atyp LY?; Abn Ly/ L_Bl? and to DM96 pre-classification % Blasts > 0%; unidentified cells >3%. .Results: Non-differential blood count parameters including white blood count, red blood count, hemoglobin, mean corpuscular volume (MCV), and platelet count showed excellent correlation between the PocHi and the XE5000 with R2>0.95. Differential-dependent blood count parameters including neutrophils, lymphocytes, monocytes, eosinophils, basophils and immature granulocytes showed excellent correlation between the XE5000 and pre-classification DM96 with R2>0.95. Nucleated red cells also showed excellent correlation between the XE5000 and the DM96 with R2>0.85.For blasts/abnormal cells, the DM96 showed 100% sensitivity and 40% specificity with 0% false negatives. The XE5000 showed 93% sensitivity and 19% specificity with 3% false negative. Two of the false negatives were shared by both instruments and were 1% blasts. Of the three false negatives with the XE5000 that were true positives with the DM96, two had 1% blasts while one had 2% blasts. For immature granulocytes (IG’s), the XE5000 showed 94% sensitivity and 79% specificity with 2% false negatives. The DM96 showed 85% sensitivity and 95% specificity with 4% false negatives. All of the false negatives were for IG’s < 5%Conclusions: Pairing the DM96 or a similar imaging instrument with a relatively inexpensive hematology analyzer, such as those commonly used in physician office laboratories, would provide all of the information available from expensive, complex hematology analyzers in high throughput laboratories AND allow remote review of the blood smear findings by experts. DisclosuresBroome:CellaVision: Consultancy, Research Funding. Bengtsson:CellaVision AB: Employment, Equity Ownership. Palm:CellaVision: Employment, Equity Ownership.

Triangulating Dynamic of Clinical Laboratory Testing.

Over the past 20 years, there has been a continuous shift in decentralizing clinical laboratory testing in the US. Historically, testing was conducted almost exclusively in centralized laboratories in hospitals. However, at present, approximately 53% of testing is performed in hospitals (including some near-patient testing in settings such as critical care and emergency rooms), 34% in commercial clinical laboratories (50% of which is done in Quest Diagnostics and LabCorp), and the remaining in physician office laboratories and other settings as well as directly by consumers using over-the-counter devices. These numbers vary depending on the state. For example, in New York State 368 million tests in chemistry were performed in 2014, 73% of which were processed in hospital laboratories and 23% in independent (commercial) laboratories (data courtesy of Dr. Robert Rej). There are many drivers for this triangulating dynamic shift, including cost reduction, convenience to patients and clinicians, quality improvement (when the frequency of performing a particular test in the hospital laboratory is low), and the use of novel technologies such as nanotechnology, microfluidics, electrical impedance, reflectance, and time-resolved fluorescence, which enabled the miniaturization of devices and the proliferation of point-of-care (POC)8 testing. Improvement in information technology has been instrumental in the process of decentralizing testing and providing clinicians with patient results; this is, however, not a trivial matter and the cost of the interface is not always justifiable. Regulatory requirements in terms of assuring competency of those performing testing, getting patient laboratory results into the medical records, billing appropriately, and providing patients with their test findings are only few of the challenges of decentralized testing. How is the testing dynamic shift in this $56 billion industry going to evolve over the next 5 and 10 years? What will be the impact of technology, reimbursement, and confidentiality in shaping this …

Trends in Point-of-Care Testing

Point-of-care testing (POCT) growth and technology have come a long way in the past 20 years. This year, we have seen health care dynamics and the role of POCT change in a way that will set the stage for future laboratory testing. As hospitals downsize, main laboratory testing becomes stagnant, technologies emerge, and the challenge to provide the best-quality care to patients relies heavily on new efficient POCTs that can provide timely results. The increase in data from POCT is going to play a large role in the future as well. There are a number of government initiatives that focus on electronic medical records and information technology focused on better patient outcomes. The outpatient areas such as physician office laboratories, clinics, and patient self-testing are growing at an even faster rate as patients try to manage their own health care through the growing resources available today.

The clinical laboratory fee schedule yesterday, today, tomorrow.

1. Joan Longberry, CLDir (NCA)[⇑][1] 1. is a retired clinical laboratory manager and consultant and an advisor for the ASCLS Government Affairs Committee 1. Address for Correspondence: Joan Longberry, 45 West Dunedin Road, Columbus, Ohio 43214, JoanLongberry{at}aol.com 1. Describe at least three changes in Medicare payment methodology for laboratory services following the implementation of the clinical laboratory fee schedule (CLFS) in 1984. 2. List the key provisions of the Balanced Budget Act of 1997 affecting payment for Medicare laboratory services. 3. Compare the initial mechanism for annual inflation adjustments to the CLFS with the actual updates between 1991 and 2007. 4. Discuss two reasons for the actual decreases in reimbursement for laboratories since the CLFS was implemented. 5. Explain the difference between the “cross-walking” and “gap-filling” processes used to set CLFS payment amounts for new tests. 6. List five recommendations in the IOM Report “Medicare Laboratory Payment Policy: Now and in the Future”. 7. Describe the key elements of the design for the Competitive Bidding for Medicare Clinical Laboratory Services demonstration project. 8. List the specific purposes for an alternative payment system outlined in the Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008. Introduction For well over two decades, the laboratory community has been confronted with a myriad of legislative and regulatory changes in payment policies and reimbursement levels for services provided to Medicare beneficiaries for outpatient clinical laboratory services. When Medicare was first implemented, clinical laboratories were reimbursed according to usual, customary and reasonable charges and beneficiaries were responsible for a copayment. Following the enactment of the Deficit Reduction Act in 19841, payment to laboratories providing Part B services to Medicare changed to a national clinical laboratory fee schedule (CLFS) system. Although the fee schedule established in 1984 bears little resemblance to the actual cost of laboratory testing in 2009, it remains the mechanism by which laboratories are reimbursed. An Institute of Medicine study in 2000 made several recommendations for reimbursement that have yet to be implemented. This article will review the many problems and challenges to the CLFS that have occurred since its inception in 1984. The Beginning Initially under Medicare, clinical laboratories were paid for outpatient Part B services based on customary and reasonable charges. Each state had fiscal intermediaries (which reimbursed hospital laboratories) and carriers (which reimbursed independent and physician office laboratories) and each had different ranges of customary and reasonable charges. Clinical laboratories found collecting the then-required beneficiary co-payments of 20% to be exceedingly difficult, as most did not have a billing relationship with patients. In addition, the costs of billing and collecting such small amounts were financially and administratively burdensome. Thus, the laboratory industry supported the fee… ABBREVIATIONS: ASCLS = American Society for Clinical Laboratory Science; BBA = Balanced Budget Act; CLFS = clinical laboratory fee schedule; CMS = Centers for Medicare & Medicaid Services; CPI = consumer price index; CPT = current procedural terminology; FY = fiscal year; HCFA = Health Care Financing Administration; HHS = Department of Health & Human Services; HR = House of Representatives; IOM = Institute of Medicine; MSA = metropolitan statistical area; MMA = Medicare Prescription Drug, Improvement, and Modernization Act; NLA = national limitation amount; PL = public law 1. Describe at least three changes in Medicare payment methodology for laboratory services following the implementation of the clinical laboratory fee schedule (CLFS) in 1984. 2. List the key provisions of the Balanced Budget Act of 1997 affecting payment for Medicare laboratory services. 3. Compare the initial mechanism for annual inflation adjustments to the CLFS with the actual updates between 1991 and 2007. 4. Discuss two reasons for the actual decreases in reimbursement for laboratories since the CLFS was implemented. 5. Explain the difference between the “cross-walking” and “gap-filling” processes used to set CLFS payment amounts for new tests. 6. List five recommendations in the IOM Report “Medicare Laboratory Payment Policy: Now and in the Future”. 7. Describe the key elements of the design for the Competitive Bidding for Medicare Clinical Laboratory Services demonstration project. 8. List the specific purposes for an alternative payment system outlined in the Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008. [1]: #corresp-1

Medicare and the laboratory.

1. Kathy Hansen, CLS(NCA)[⇑][1] 1. is Director of Laboratory Operations at the University of Minnesota Medical Center, Minneapolis, MN and an Advisor for the ASCLS Government Affairs Committee 1. Address for Correspondence: Kathy Hansen, Director, Laboratory Operations, University of Minnesota Medical Center, Fairview, MMC 198, 420 Delaware St SE, Minneapolis, MN 55455. Khansen3{at}fairview.org. 1. Describe the purpose of the Medicare program. 2. Compare the payment methodologies for inpatient and outpatient laboratory services under Medicare. 3. Describe the differences between a fiscal intermediary, a carrier, and a MAC. 4. List three mechanisms used by CMS to limit payments to laboratories for services provided to Medicare beneficiaries. 5. Contrast Correct Coding Initiative limitations with those imposed by Medically Unlikely Edits. This article discusses the impact on the laboratory of Medicare payment policies and limitations imposed on payment for laboratory services. As the size of the population receiving Medicare benefits increases, and other payers adopt similar polices, the challenge to the laboratory becomes greater. The Medicare program was created by legislation amending the Social Security Act that was signed into law on July 30, 1965 by President Lyndon Johnson. The bill-signing ceremony was held at the Truman Library in Independence, MO, as a tribute to former President Harry S. Truman, who had first proposed health insurance legislation 20 years before.1 Medicare legislation passed despite opposition from the American Medical Association, which characterized it as socialized medicine. Medicare has grown as the population has aged and currently covers 44.8 million beneficiaries2, about 14% of the U.S. population, with this number expected to grow significantly as the 76 million members of the baby boomer generation, born in 1946–1964 3, become eligible for the program's benefits. By 2031, the number of beneficiaries will be an estimated 77 million4. Medicare beneficiaries typically constitute a significant percentage of patients served by hospital laboratories, physician office laboratories, and independent laboratories. A report by the Institute of Medicine reported that in 1999, clinical laboratories derived 29% of their revenues from Medicare and 12% from Medicaid5. The Medicare program is designed to cover the cost of diagnosis and treatment for illness, and does not cover wellness services or screening for disease in the absence of symptoms. A few notable… Abbreviations: ABN = Advance Beneficiary Notice; ASCLS = American Society for Clinical Laboratory Science; BBA = Balanced Budget Act; CBC = Complete blood count; CCI = Correct Coding Initiative; CLFS = Clinical Laboratory Fee Schedule; CMS = Center for Medicare and Medicaid Services; CPT = Current Procedural Terminology; DRG = Diagnosis Related Group; EOB = Explanation of Benefits; FI = Fiscal intermediary; HCFA = Healthcare Financing Agency; HCPCS = Healthcare Common Procedure Coding System; HMO = Health Maintenance Organization; ICD = International Classification of Diseases; LCD = Local Coverage Decision; LMRP = Local Medical Review Policy; MAC = Medicare Administrative Contractor; MUE = Medically Unlikely Edit; NCD = National Coverage Decision; PC = Professional Component; TC = Technical Component; TEFRA = Tax Equity and Fiscal Responsibility Act; UB = Uniform Billing 1. Describe the purpose of the Medicare program. 2. Compare the payment methodologies for inpatient and outpatient laboratory services under Medicare. 3. Describe the differences between a fiscal intermediary, a carrier, and a MAC. 4. List three mechanisms used by CMS to limit payments to laboratories for services provided to Medicare beneficiaries. 5. Contrast Correct Coding Initiative limitations with those imposed by Medically Unlikely Edits. [1]: #corresp-1

Prevalence of Estimated GFR Reporting Among US Clinical Laboratories

Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting in clinical laboratories is unknown; thus, the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine results is not quantified. Observational analysis. National Kidney Disease Education Program survey of clinical laboratories conducted in 2006 to 2007 by mail, web, and telephone follow-up. A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by 6 major laboratory types/groupings. Laboratory reports serum creatinine results. Reporting eGFR values with serum creatinine results. Percentage of laboratories reporting eGFR along with reporting serum creatinine values, reporting protocol, eGFR formula used, and style of reporting cutoff values. Of laboratories reporting serum creatinine values, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; and others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (P < 0.001). Of laboratories reporting eGFR, 66.7% do so routinely with all adult serum creatinine determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the ">60 mL/min/1.73 m(2)" reporting convention. Independent laboratories are least likely to routinely report eGFR (50.6%; P < 0.05) and most likely to report only when specifically requested (45.4%; P < 0.05). High-volume laboratories across all strata are more likely to report eGFR (P < 0.001). Self-reporting by laboratories, federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of federal database for sample purposes. Routine eGFR reporting with serum creatinine values is not yet universal, and laboratories vary in their reporting practices.

United States Government Accountability Office (GAO) targets laboratory quality.

1. Judy Davis 2. Don Lavanty Once again, the quality of services provided by clinical laboratories across the nation is under the scrutiny of the federal government. CLIA '88 was implemented in 1992 to ensure that all laboratories meet the same minimal standards, based on the complexity of testing performed rather than by location. However, laboratory quality problems recently surfaced in several locations, prompting proposed federal legislation and a study of clinical laboratory quality by the US Government Accountability Office (GAO) to assess: The study, presented to Congress in June 2006, focused on oversight by CMS, state CLIA-exempt programs, and laboratory accrediting agencies including the College of American Pathologists (CAP), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and COLA. Principal findings cited by GAO in the study include: 1. Insufficient data exists to identify the extent of the problem. CMS state survey data prior to 2004 is not available. When inspection guidelines changed in 2004, the prior data was purged. GAO is concerned that potential quality problems are masked. 2. Announced inspections are problematic. Laboratories prepare specifically for inspection so announced inspections fail to provide a true picture of the laboratory's quality. CAP and JCAHO inspections have since begun announced inspections. All agree that physician office laboratory inspections should be announced due to disruption of patient care,…

Sensitivity of a rapid antigen detection test for group A streptococci in a private pediatric office setting: answering the Red Book's request for validation.

In the office laboratory of our private practice, the sensitivity of a single rapid antigen detection (RAD) test for group A streptococci (compared with backup throat culture) was examined over 3 winter periods. When cultures were held only 24 hours, the sensitivity was 92%; in the second period, when cultures were held to 48 hours, the sensitivity declined significantly to 86%; when the cultures were read without knowledge of the RAD test result, the sensitivity was 85%. As the Red Book Committee has suggested, physician office laboratories should validate the sensitivity of their RAD test against culture onto blood agar before abandoning the backup throat culture.

HIPAA Privacy Rule: the debate continues.

1. Karrie B Hovis, CLS(NCA)[⇑][1] 1. is an Instructor, Louisiana State University Health Sciences Center, Shreveport LA 2. Dianna M Veillon, MD 1. is an Associate Professor, Louisiana State University Health Sciences Center, Shreveport LA 1. Address for correspondence: Karrie B Hovis CLS(NCA), Louisiana State University Health Sciences Center, 1107 Mountainbrook Dr, Shreveport LA 71118. (318) 675-6807, (318) 675-6937 (fax). Khovis{at}lsuhsc.edu The Fourth Amendment of the United States Constitution guarantees that “the right of the people to be secure in their persons, houses, papers, and effects against unreasonable searches and seizures, shall not be violated.” In other words, the Fourth Amendment guarantees the privacy of Americans. Yet, many Americans feel that this freedom has been violated when discussing the privacy of their medical information. They are concerned that the privacy of their medical information is not protected. In January 1999, a national survey conducted by the California HealthCare Foundation found that one in five Americans feel that their health information is being disclosed inappropriately. Without this trust, patients are compromising their own healthcare either by providing inaccurate information to their physician, changing physicians, or avoiding care altogether.1 With the rising concern about patient privacy, the United States federal government realized that something needed to be done. On August 21, 1996, the Health Insurance Portability and Accountability Act (HIPAA) was enacted. Although this legislation was well intended, its supporters failed to recognize several potential problems. One of the biggest short-falls was the fact that patient health information may be exposed without patient consent. Even though all states had laws in effect to cover this deficit, the laws varied from state to state. The Department of Health and Human Services (DHHS) has subsequently issued another law entitled the HIPAA Privacy Rule. This law is expected to prevent exposure of a patient's confidential medical information. New questions have arisen. Should the HIPAA Privacy Rule… ABBREVIATIONS: DHHS = Department of Health and Human Services; HIPAA = Health Insurance Portability and Accountability Act; LIS = laboratory information system; PHI = protected health information; POL = physician office laboratory. [1]: #corresp-1

Career alternative: clinical trials.

1. Peter M Colaninno, MS CLS(NCA)[⇑][1] 1. is Laboratory Manager, Infectious Diseases, Icon Laboratories Inc, Farmingdale NY, and Adjunct Professor, Allied Health Professions, at St John's University, Jamaica NY, City University of NY, Queensborough Campus, State University of NY, Farmingdale Campus, and Hofstra University, Hempstead NY 1. Address for correspondence: Peter M Colaninno MS CLS(NCA), Laboratory Manager, Infectious Diseases, Icon Laboratories Inc, 260 Smith Street, Farmingdale NY 11735. As an adjunct professor instructing clinical laboratory science (CLS) students, I'm frequently asked about employment opportunities in the field. Historically, the proclivity of graduating students is to find employment in a hospital setting, but with hospitals under severe fiscal constraint, especially in the New York City area, they are no longer the hiring centers for clinical laboratory scientists (CLSs) that they were in the past.1,2 Because of this, graduates are forced to find career alternatives in order to utilize their degree. There are a number of employment opportunities available to CLSs.3,4 These include: Technical: Private laboratories; physician's office laboratories; college research laboratories; health maintenance organization and union health offices; government laboratories; state and city health departments; blood banks; veterinary offices. Non-technical: Inspector; infection control officer; quality assurance officer; safety officer; laboratory management; planning and development; information technology; risk management officer; consultant. Education: Teaching; administration; mentoring. Commercial: Marketing; sales; public relations; technical writing and illustrations.5 However, a career alternative that has come to the forefront in recent years is employment in a clinical trials laboratory. What are clinical trials? Clinical trials laboratories work closely with pharmaceutical companies to assist them in the FDA approval process of new compounds and are dedicated to testing samples procured from patients who are enrolled in phase 2, phase 3, and phase 4 trials, testing the efficacy of compounds being introduced by the pharmaceutical companies. After working in a hospital setting for more than 17 years as a microbiologist, I made the transition five years ago… ABBREVIATIONS: CAP = College of American Pathologists; FDA = Food and Drug Administration. [1]: #corresp-1

Testing for group A streptococci: Practices reported by 790 laboratories enrolled in the College of American Pathologists Excel Proficiency Testing Program

c Context.—Laboratory diagnosis of group A streptococcal pharyngitis in physician office and small-hospital laboratories. Objective.—To characterize laboratory practices for the diagnosis of group A streptococcal pharyngitis and to identify opportunities for improvement. Design.—Voluntary self-assessment questionnaire, used to assess the laboratory practices of 790 laboratories subscribing to the College of American Pathologists Excel Microbiology Proficiency Testing Program. Results.—We observed discrepancies between self-reported and recommended specimen collection and laboratory testing practices for some laboratories. The most notable discrepancies were failing to provide a written specimen-collection procedure (17.8%), sampling the tongue and oral mucosa (2%), failing to always perform back-up cultures when rapid antigen test results were negative (57.5%), and finalizing culture reports within 24 hours or less (34.0%). Additionally, among those respondents who used the bacitracin disk, 57.9% (277 respondents) applied the disk directly onto a primary plate. Conclusions.—Opportunities exist to improve testing practices for the diagnosis of group A streptococcal pharyngitis for some physician office and small-hospital laboratories. (Arch Pathol Lab Med. 2002;126:1467‐1470)

Office laboratory procedures, office economics, parenting and parent education, and urinary tract infection

We once again review four areas of interest to office-based pediatricians: office laboratory procedures, office economics, parenting and patient education, and urinary tract infections. Sean Elliott reviews the current status of the Clinical Laboratories Improvement Amendments (CLIA) and their continuing impact on physician office laboratories. Eve Shapiro reviews office economics, this year focusing on managed care, the physician workforce, practice management, and health care financing for the uninsured. Anna Binkiewicz provides an update on parenting and parent education, with recent reports on nutrition and childhood immunizations. Richard Wahl again reviews recent research on urinary tract infection, discussing voiding physiology, dysfunctional voiding patterns, acute urinary retention, urine collection techniques, diagnosis in young infants, and antibiotic prophylaxis.

Performance Standards for Allergen Skin Testing: An Approach to Proficiency Testing

The importance ascribed to clinical laboratory tests with respect to having well-defined and validated methodology, test that fall within acceptable limits for accuracy, precision, and sensitivity, and ongoing documentation that operators performing test are proficient are subject of federal regulations derived from Clinical Laboratory Improvement Amendments (CLIA) of 1988. 3 The Health Care Financing Administration (HCFA) operates CLIA laboratory certification program in conjunction with Center for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). 3 CLIA defines laboratory testing as the examination of materials derived from human body for purpose of providing information for diagnosis, prevention, or treatment of any disease or impairment of, or assessment of health of human beings. 2 Under CLIA all entities providing laboratory testing are regulated and required by law to perform proficiency testing for specific tests. 2 Proficiency testing involves sending blind sample specimens with defined properties to each laboratory during year to evaluate whether laboratory's matches samples' defined properties. 2 Samples are required to be tested in same manner and by same individuals performing patient testing. 2 Results of proficiency test programs have been analyzed, 2 resulting in recognition that physician-operated testing laboratories experience a lower rate of successful test performance than traditional, previously regulated laboratories or physician-operated laboratories in which a laboratory professional provides supervision. The introduction of required proficiency testing has increased accuracy of test and quality of laboratory practice in physician-office laboratories, reflecting positive impact of CLIA over time. 2,15 FDA-licensed allergen vaccines approved for diagnostic use commonly are employed clinically to detect cutaneous immediate hypersensitivity to allergens of interest. Results of allergen skin tests impact clinical decisions. Positive test may indicate likelihood of life-threatening hypersensitivity to food, insect, or drug allergens or presence of environmental aeroallergens responsible for allergic disease. In each circumstance, there is an important impact on quality of life in terms of interventions designed to avoid exposure, pharmaco- and immunotherapeutic interventions indicated to reduce expected allergic response (if re-exposed), and psychosomatic sequelae and economic cost to patient associated with diagnosis. The adverse impact if test are falsely positive or negative should be considered, and attendent health and economic costs should be calculated. Similar considerations concerning adverse impact of inaccurate tests on quality of health care lead to passage of CLIA to increase patient and physician confidence in ability of tests to perform accurately according to objective standards, thus improving medical decisions and quality of care and decreasing economic burden of inaccurate test results. 2 Practice parameters for allergen skin testing 1 specify that the proficiency of skin tester should be validated by intrapatient and interpatient test results 1,11 and refer to proficiency tests and performance standards required by FDA for allergen standardization. 1 In latter context, investigators who submit allergen skin test data to FDA to define biologic potency of allergen vaccines for estimating US Standard of Potency 23 and to estimate cutaneous sensitivity of subjects 23 enrolled in clinical trials submitted to FDA in support of diagnostic or therapeutic efficacy of allergen vaccines are provided a skin test proficiency 22 The method is suitable for assessing proficiency of operator who is carrying out this technique and can be used to qualify personnel for submission of skin test data to CBER. 22 Before submitting allergen skin test data to FDA, Investigators should be familiar with Proficiency Method … and have submitted proficiency data qualifying their use of this method. 23 The allergen skin test Proficiency Method based on parallel line bioassay methodology described in 1982 24 has been subjected to international collaborative evaluation. 12,17,21 It has been used in support of skin test data submitted to FDA in support of licensure of standardized cat, housedust mite, and grass pollen extracts (see FDA-approved package inserts that reference use of FDA skin test methods). Test performance can be divided into two categories: analytical test performance and clinical test performance. 19 Analytical test performance refers to accuracy, precision, and sensitivity of a test to measure analyte of interest. 5 Clinical test performance is defined by clinical accuracy of test with respect to whether test accurately discriminates between disease and nondisease states. 25

Quality control of test systems waived by the Clinical Laboratory Improvement Amendments of 1988. Perceptions and practices.

Context Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. Objective To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. Design and setting Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. Results Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. Conclusions Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.

Quality Control of Test Systems Waived by the Clinical Laboratory Improvement Amendments of 1988

Abstract Context.—Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. Objective.—To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. Design and Setting.—Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. Results.—Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. Conclusions.—Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.