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Biomedical subjects

R Decker

Publications and source records attributed to R Decker.

At least 37 records · Page 2Linked to original sources

Anti-GOR and hepatitis C virus in autoimmune liver diseases.

Anti-GOR is an autoantibody found in hepatitis C virus (HCV) infection. We have studied the specificity of this antibody for HCV infection in various groups of autoimmune liver diseases. Anti-HCV was detected by a second generation HCV enzyme-linked immunosorbent assay in 14 of 29 patients with liver-kidney-microsomal (LKM-1) -antibody-positive autoimmune hepatitis type 2 and in all 6 control patients with HCV-RNA-positive chronic hepatitis C. Anti-HCV was not found in those with antinuclear-antibody-positive autoimmune hepatitis type 1 (10 patients), with soluble-liver-protein-antibody-positive autoimmune hepatitis type 3 (8), with primary biliary cirrhosis (9), with systemic lupus erythematosus (SLE) (10), or in healthy controls (13). Anti-GOR was detected in 11 of 14 patients with autoimmune hepatitis type 2 who were all positive for anti-HCV but only in 1 of 15 LKM-1 patients who were negative for anti-HCV. We did not find anti-GOR in any other group of autoimmune liver disease, SLE, or control sera, but this antibody was detected in 3 of 6 patients with chronic hepatitis C. Autoimmune hepatitis type 2 patients who were anti-GOR positive and anti-HCV positive were less likely to be female, were older (p less than 0.001), and had lower LKM-1 antibody titres (p less than 0.001), lower disease activity, and responded less effectively to immuno- suppression than did those who were anti-HCV negative/anti-GOR negative. The findings show that anti-GOR reflects HCV-specific autoimmunity. HCV seems to induce autoimmunity to both GOR (an HCV-specific autoepitope) and LKM-1 (an epitope that is also recognised by autoimmune hepatitis sera of a different cause). Anti-GOR and LKM-1 antibodies contribute to a better differentiation of chronic hepatitis, a finding that has therapeutic implications.

Adolescent↗

Abnormal urate transport in patients with intracranial disease.

Based on our demonstration of a high incidence of hypouricemia, tubular urate transport abnormality, and cerebral atrophy in patients with acquired immunodeficiency syndrome (AIDS), we performed prospective renal clearance studies in 29 consecutive neurosurgical patients with intracranial diseases of multiple etiologies to test our hypothesis that patients with intracranial disorders had defective tubular urate transport. Similar studies were performed in 21 age-matched controls. None of the subjects had serum creatinine greater than 123.8 mumol/L (1.4 mg/dL), sickle cell or liver diseases, or received intravenous fluid or uricosuric drugs at the time of study. Seven patients had no surgical procedures, 12 were studied after a neurosurgical procedure, and 10 had preoperative and postoperative studies. Ten had more than one postoperative study. Twelve had 24-hour urine collections. We found that 18 of 29 patients had elevated fractional excretion (FE) of urate greater than 10%. There was no difference in preoperative and postoperative FE urate by nonpaired t test for all patients and by paired t test in the 10 patients who had preoperative and postoperative studies performed. Seven patients had hypouricemia, defined as serum urate less than or equal to 0.18 mmol/L (3 mg/dL). Only one had hyponatremia (serum sodium less than 130 mmol/L). Urate excretion averaged 3.6 +/- 0.32 mmol (603 +/- 52.7 mg)/24 h, suggesting that the hypouricemia was not due to decreased urate production. None of the medications or surgical procedures could be considered to have caused the urate transport abnormality, nor was it associated with any specific intracranial location or type of disease.(ABSTRACT TRUNCATED AT 250 WORDS)

Biological Transport↗

How the laws govern advertising and promotional allowances given by suppliers.

A hospital materials manager reports that a supplier has offered his hospital some advertising and promotional allowances. He wonders what laws govern these allowances and how the courts have interpreted them. In this dialogue, Dr. Decker develops the law relating to advertising and promotional allowances given by manufacturers and suppliers.

Advertising↗

Hospitals may be bound by terms added in supplier's acceptance of an offer.

A hospital materials manager reports that a supplier is attempting to hold the hospital to new terms that the supplier added in the acceptance of an offer to buy. The offer to buy was made in the hospital's purchase order. In this dialogue, Dr. Decker develops the law relating to such a transaction.

Contract Services↗

Hospital materials managers must understand HHS's safe harbor regulations. Part 1.

Much has been written and said in the past year about what is being called the Safe Harbor Regulations of the Department of Health and Human Services. It is vital that hospital materials managers be attentive to these regulations and to the statutes from which they arose. In this dialogue, Dr. Decker reviews the background of the regulations and lists principal parts which relate to the hospital materials manager. Also covered are some of the provisions of the regulations which are of lesser concern to the hospital materials manager. In subsequent articles, provisions of the regulations which are of greatest concern to hospital materials managers will be dealt with in some detail, and several cases which preceded the regulations will be briefed. This is Part 1 of a three-part series.

Fraud↗

How warranties, discounts, GPO activities are governed by Safe Harbor regulations. Part 2.

An earlier article dealt with the general background of the Safe Harbor regulations issued by the Department of Health and Human Services in July 1991. That article also briefly outlined several parts of the regulations which are of lesser interest to hospital materials managers. In this dialogue, Dr. Decker develops those parts of the regulations that are of primary concern of hospital materials managers. A subsequent article will brief several court cases that were decided before the regulations were finally promulgated and will offer some conclusions and recommendations. This is Part 2 of a three-part series.

Commerce↗

Issuance of HHS's Safe Harbor regulations resulted from several court cases.

Earlier articles covered the background of the Safe Harbor regulations issued by HHS in July 1991. These articles also contained some details of the provisions of the regulations that are of concern to hospital materials managers. In this dialogue, Dr. Decker briefs several major cases that preceded the regulations and reflect the reasons for their being issued. This is Part 3 of a three-part series.

Crime↗

The purchase order does not stand alone as formal contract obligation, HCFA says.

A controversy has developed over whether a purchase order for a large item of movable equipment amounts to an obligation under the new Medicare Capital Prospective Payment System (PPS) of the Health Care Financing Agency (HCFA). HCFA's draft revision to the Provider Reimbursement Manual indicates that a p.o. doesn't stand alone as a binding contract and that such purchases should be by formal contract. Some hospital trade groups argue that, in the normal practice of most hospitals, the p.o. is a contract to buy and should be treated as an obligation under the Medicare rules. In this dialogue, Dr. Decker addresses the issues of this controversy.

Capital Expenditures↗

O6-methylguanine-DNA methyltransferase in human normal and tumor tissue from brain, lung, and ovary.

The resistance of human tumor strains in culture to cell killing by alkylating nitrosoureas is correlated with their levels of the DNA repair activity O6-methylguanine-DNA methyltransferase. Strains with the Mer- phenotype have no activity and are extremely sensitive. However, the relationship between the sensitivity of human tumors in vivo and transferase levels is not known, and even the existence of Mer- human tumors in vivo has been questioned. In this study 73 human tumor and normal tissue samples from brain, lung, and ovary were assayed for transferase levels and methylpurine glycosylase activity. For each organ, transferase levels varied over 100-fold, and Mer- tumors were detected in each group. There was no correlation between transferase and glycosylase levels, indicating that the absence of transferase in some tumor samples was not an artifact due to necrosis or inactivation of enzymes in the extract.

Bacterial Proteins↗

Home visiting outcomes and quality of life measures.

Public Health agencies are faced with the task of self-evaluation. For years, they have evaluated themselves solely through utilization as demonstrated by the numbers of patients that they have served. A new thrust is to change the methods of evaluation by devising and implementing a quality assurance (QA) system. Traditional QA systems focus on acutely ill patients and are based on the medical model. In contrast, public health focuses on well or chronically ill patients with services that involve mostly palliative treatment, disease prevention, and/or health promotion. The criteria used by hospitals do not apply. Thus, public health agencies are forced to review their standards and develop criteria applicable to public health. This re-examination of public health can stimulate new ways of viewing old programs and therefore, elicit information that has never been gathered before.

Baltimore↗

Hospital materials managers should recognize and promote their roles in their institutions.

The hospital board has instructed the hospital administrator to make a study that will lead to a better organization of the lines of responsibility and authority within the hospital. The administrator has asked the materials manager to make recommendations as to where materials management should fit into the organizational structure of the hospital. In this dialogue, Dr. Decker speaks to the place of materials management in the internal organization of the hospital.

Interdepartmental Relations↗

Hospitals should include clauses in contracts when renting medical equipment to patients.

A piece of equipment was loaned by the hospital to a patient for home use. The equipment required an electrical connection for proper functioning. The use of the equipment placed an overload on the electrical circuit in the patient's home. A fire resulted. The home was extensively damaged, the patient suffered third-degree burns, and the patient's cat was killed. In this dialogue, Dr. Decker discusses the legal issues involved.

Consumer Product Safety↗

GPOs and their product evaluation committees should be aware of their legal liabilities.

A materials manager for a large group purchasing organization is a member of a committee involved in the decision as to which products and equipment are purchased for and used by the hospitals belonging to the GPO. These decisions are based upon requests from the member hospitals and proposals submitted to the GPO by suppliers. After review by the committee, a decision to buy is made. In this dialogue, Dr. Decker discusses the issues of legal liability assumed by the GPO, the committee and its individual members in making these decisions on which to buy.

Consumer Product Safety↗

Purchase contract is performed and title passes at least when goods are delivered.

The hospital received a quotation from a supplier offering to provide an item of biomedical equipment at a stated price. The hospital issued a purchase order providing delivery instructions. The equipment was delivered to the hospital, properly received, and put into service. A month later the supplier's representative came to the hospital and asked that the materials manager sign a sales order report covering the equipment. The supplier's representative explained that the equipment was from demonstrator stock and the only way it could be replaced was for the hospital to sign this form. When the materials manager refused to sign, the supplier's representative threatened to remove the equipment contending that title hadn't passed to the hospital. Later the materials manager did sign the sales order report, all the while contending that the representative had no legal right to remove the equipment. In this dialogue, Dr. Decker considers the legal issues involved in this transaction.

Commerce↗