News
HHS strengthens patients’ right to access lab test reports. The U.S. Department of Health and Human Services (HHS) has acted to give a patient or a person designated by the patient a means of direct access to the patient’s completed laboratory test reports.
The final rule announced last month amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient, or a person designated by the patient as his or her “personal representative,” access to the patient’s completed test reports on the patient’s or personal representative’s request. At the same time, the final rule eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory. While patients can continue to get access to their laboratory test reports from their doctors, these changes give patients a new option to obtain their test reports directly from the laboratory while maintaining privacy protections.
The final rule was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA; the Centers for Disease Control and Prevention (CDC), which provides scientific and technical advice to CMS related to CLIA; and the Office for Civil Rights (OCR), which is responsible for enforcing the HIPAA Privacy Rule.
Under the HIPAA Privacy Rule, patients, patients’ designees, and patients’ personal representatives can see or be given a copy of the patient’s protected health information, including an electronic copy, with limited exceptions. The patient or the personal representative may have to put the request in writing and pay the cost of copying, mailing, or electronic media on which the information is provided. In most cases, copies must be given to the patient within 30 days of the request.
New Study
New prognostic tool accurately predicts mortality risk in pediatric septic shock. Researchers have developed a diagnostic tool that allows clinicians to quickly and accurately predict the risk of death in children with septic shock. Results were reported recently in PLOS ONE. The tool, which has been named PERSEVERE, measures five biomarkers and combines this data with information about the patient to estimate the probability the child won't survive the illness. Based on earlier research, which included genetic screening and analysis, the researchers say detection of the biomarkers would help doctors decide much faster which children need to receive aggressive life-saving therapy.
Cancer
Biomarkers in blood show potential as early detection method of pancreatic cancer. Researchers have identified diagnostic microRNA panels in whole blood that have the ability to distinguish, to some degree, patients with and without pancreatic cancer, according to a study recently published in JAMA. The authors caution that the findings are preliminary, and that further research is necessary to understand whether these microRNAs have clinical implications as a screening test for early detection of pancreatic cancer.
The researchers examined differences in microRNA in whole blood between patients with pancreatic cancer (n = 409) and healthy participants (n = 312) and patients with chronic pancreatitis (n = 25) to identify diagnostic panels of microRNAs. Serum cancer antigen 19-9 (CA19-9; an antigen that is elevated in approximately 80% of patients with pancreatic cancer) was also measured for comparison. The team identified two novel panels with the potential for diagnosing pancreatic cancer.
Guidelines
New edition of M100-S24 is now available from CLSI. The Clinical and Laboratory Standards Institute (CLSI) has released a new edition of its document M100-S24-Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement. This document provides the revised breakpoints, new recommendations, and reporting changes to incorporate into routine practice to improve detection and reporting of antimicrobial resistance. M100-S24 provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8.
M100-S24 includes revised cefepime disk diffusion and minimal inhibitory concentration (MIC) interpretive criteria along with dosage regimens for using susceptible-dose dependent (SDD) interpretive criteria. The document provides revised doripenem, imipenem, and meropenem disk diffusion and MIC interpretive criteria with dosage regimens on which the breakpoints are based. This edition also includes new cefazolin interpretive criteria and recommendations for use as a surrogate test for uncomplicated UTIs to predict results for oral cephalosporins.
Additionally, M100-S24 includes a definition of susceptible-dose dependent (SDD) with educational information explaining the introduction of SDD interpretive criteria; an example and explanation for antimicrobial agents having only susceptible interpretive criteria; information for reporting first- and second-generation cephalosporins and cephamycins for Salmonella spp. and Shigella spp.; and updated recommendations for the placement of disks on a 100-mm plate. Quality control ranges added and/or revised for M100-S24 include aztreonam-avibactam, biapenem, ceftolozane-tazobactam, eravacycline, surotomycin, and telavancin.
Worth Re-quoting
This month’s conversation starter:
“Humans are flexible and can make decisions and discern. Instruments are clever, but only because they have rules.” The sentence comes from this issue’s Education article, “Zeroing in on digital imaging in microbiology,” by Gabriela Franco, BS, MIMS. Do you agree, or disagree, or have a comment or example or other response to this interesting assertion? We invite reactions from readers. Write us at mlo-online.com.
