The Role of the Recovery Room in Improving Adherence During an Enhanced Recovery After Surgery (ERAS) Implementation Program for Colorectal Surgery: A Single-Center Retrospective Analysis.

Purpose: The purpose of thisstudy was to evaluate the clinical impact of the Recovery Room (RR) in an Enhanced Recovery After Surgery (ERAS) pathway in colorectal surgery.

Design: Single-center retrospective study.

Methods: From November 2019 until September 2021, a total of 149 consecutive patients that underwent to colon-rectal surgery were enrolled.

Implementing routine testing for severe combined immunodeficiency within Wisconsin's newborn screening program.

Severe combined immunodeficiency (SCID) is the result of genetic defects that impair normal T-cell development. SCID babies typically appear normal at birth, but acquire multiple life-threatening infections within a few months. Early diagnosis and treatment with a bone-marrow transplant markedly improves long-term outcomes.

Statewide newborn screening for severe T-cell lymphopenia.

Context: A newborn blood screening (NBS) test that could identify infants with a profound deficiency of T cells may result in a reduction in mortality.

Objective: To determine if quantitating T-cell receptor excision circles (TRECs) using real-time quantitative polymerase chain reaction on DNA extracted from dried blood spots on NBS cards can detect infants with T-cell lymphopenia in a statewide program.

Design, Setting, And Participants: Between January 1 and December 31, 2008, the Wisconsin State Laboratory of Hygiene screened all infants born in Wisconsin for T-cell lymphopenia by quantitating the number of TRECs contained in a 3.

Regulatory compliance for point-of-care testing: 2009 United States perspective.

All clinical laboratory testing in the United States is regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88 or CLIA) and overseen by the Centers for Medicare and Medicaid Services. CLIA profoundly changed the prevailing United States regulatory philosophy by imposing uniform requirements for all clinical laboratory testing regardless of where tests are performed. In the hospital, regulatory compliance is usually ensured by regular inspections of the laboratory by either the Joint Commission or by the College of American Pathologists.

Development of a routine newborn screening protocol for severe combined immunodeficiency.

Background: Severe combined immunodeficiency (SCID) is characterized by the absence of functional T cells and B cells. Without early diagnosis and treatment, infants with SCID die from severe infections within the first year of life.

Objective: To determined the feasibility of detecting SCID in newborns by quantitating T-cell receptor excision circles (TRECs) from dried blood spots (DBSs) on newborn screening (NBS) cards.

Point-of-care testing, medical error, and patient safety: a 2007 assessment.

Point-of-care testing (POCT) is the fastest growing segment of a US$30 billion worldwide market. "Errors" in the testing process, as well as medical data interpretation and treatment associated with POCT, are recognized as leading to major compromises of patient safety. In today's environment, most testing errors (pre-analytical, analytical and post-analytical) can be virtually eliminated by proper design of testing systems.

Newborn screening for cystic fibrosis in Wisconsin: nine-year experience with routine trypsinogen/DNA testing.

Objective: To describe the development and follow-up confirmatory results of the routine cystic fibrosis (CF) newborn screening (NBS) program in Wisconsin.

Methods: CF NBS has been performed on a routine clinical basis in Wisconsin since July 1994. The 2-tiered immunoreactive trypsinogen (IRT)/DNA technique was used on dried blood on filter paper spots.

Evidence on improved outcomes with early diagnosis of cystic fibrosis through neonatal screening: enough is enough!

Objective: To generate and examine evidence in support of diagnosing cystic fibrosis (CF) early through newborn screening (NBS).

Study Design: Using a randomized controlled trial with unique unblinding/surveillance, we evaluated patients with CF receiving similar treatment after assignment to an early diagnosis (screened) group or to a control group. Outcomes studied at diagnosis and longitudinally included measures of nutritional status and lung disease.

Polybrominated diphenyl ethers (PBDEs): new pollutants-old diseases.

Polybrominated diphenyl ethers (PBDEs) are a class of recalcitrant and bioaccumulative halogenated compounds that have emerged as a major environmental pollutant. PBDEs are used as a flame-retardant and are found in consumer goods such as electrical equipment, construction materials, coatings, textiles and polyurethane foam (furniture padding). Similar in structure to polychlorinated biphenyls (PCBs), PBDEs resist degradation in the environment.

Multiplexed genetic analysis using an expanded genetic alphabet.

Background: All states require some kind of testing for newborns, but the policies are far from standardized. In some states, newborn screening may include genetic tests for a wide range of targets, but the costs and complexities of the newer genetic tests inhibit expansion of newborn screening. We describe the development and technical evaluation of a multiplex platform that may foster increased newborn genetic screening.

Has compliance with CLIA requirements really improved quality in US clinical laboratories?

Background: The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites.

Screening newborns for congenital disorders.

The Newborn Screening Laboratory at the Wisconsin State Laboratory of Hygiene (WSLH) tests all newborn babies in the state of Wisconsin for 26 congenital disorders. The screening is mandated by state statute (253.13) and attempts to identify those babies at highest risk for any of the screened-for congenital disorders.

Analysis of the costs of diagnosing cystic fibrosis with a newborn screening program.

Objectives: To compare the cost of diagnosing cystic fibrosis (CF) through a newborn screening program with the traditional method and to estimate the cost of CF diagnosis if a national newborn screening program is implemented.

Study Design: Surveys were conducted to determine the annual number of sweat tests in 1991 and in 2000 after implementation of statewide screening. A national survey of sweat test costs was used to estimate the annual expense for diagnosing CF in the United States through newborn screening.

Newborn screening with tandem mass spectrometry: examining its cost-effectiveness in the Wisconsin Newborn Screening Panel.

Objective: To examine the cost-effectiveness of tandem mass spectrometry (MS/MS) in a neonatal screening panel for 14 fatty acid oxidation and organic acidemia disorders in the Wisconsin Newborn Screening Program.

Study Design: An incremental cost-effectiveness analysis with a hypothetical cohort of 100,000 infants was performed. A threshold of $50,000/QALY (quality-adjusted life-year) was used to determine whether screening for medium-chain acyl-CoA dehydrogenase deficiency (MCAD) alone is cost-effective or whether additional disorders would need to be incorporated into the analysis to arrive at a conclusion regarding the overall cost-effectiveness of MS/MS.

Electronic "Quality Control" (EQC): is it just for unit use devices?

The US Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandated daily quality control (QC) for all laboratory tests. CLIA'88 clearly envisioned traditional, matrix-based controls. However, recent interpretations allow routine use of "electronic" controls (EQC).

Early diagnosis of cystic fibrosis through neonatal screening prevents severe malnutrition and improves long-term growth. Wisconsin Cystic Fibrosis Neonatal Screening Study Group.

Objective: Despite its relative frequency among autosomal recessive diseases and the availability of the sweat test, cystic fibrosis (CF) has been difficult to diagnose in early childhood, and delays can lead to severe malnutrition, lung disease, or even death. The Wisconsin CF Neonatal Screening Project was designed as a randomized clinical trial to assess the benefits and risks of early diagnosis through screening. In addition, the incidence of CF was determined, and the validity of our randomization method assessed by comparing 16 demographic variables.

Newborn screening in Wisconsin: program overview and test addition.

The prevention of congenital anomalies and their sequelae is an important public health objective. One strategy for preventing morbidity and mortality due to congenital disorders is Wisconsin's Newborn Screening Program. Wisconsin has been a national leader in newborn screening since its inception with phenylketonuria screening in 1966.

Effect of legislation (CLIA'88) on setting quality specifications for US laboratories.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandated, in response to concern over the perceived quality of clinical laboratory testing, universal regulation for all testing sites in the USA, including previously unregulated sites in physician offices. The intent of CLIA'88 is to ensure quality of testing through a combination of total quality management and mandated minimum quality practices. CLIA also defines, intentionally or unintentionally, through its proficiency testing requirements, intralaboratory performance standards.

Application of the Department of Health and Human Services proposed waived status requirements for in vitro diagnostic testing devices: case study.

The CLIA'88 classified all clinical laboratory testing as waived, moderate, or high complexity. The eight original waived tests were characterized as simple, accurate, error-free, risk-free, and suitable for home use by non-laboratory professionals. The subjective nature of the classification process was challenged immediately.