A manikin-based assessment of loose-fitting powered air-purifying respirator performance at variable flow rates and work rates.

Loose-fitting powered air-purifying respirators (PAPRs) are used in healthcare settings, although barriers to routine, everyday usage remain, including usability concerns and potential interference with work activities. Loose-fitting PAPRs are approved by the National Institute for Occupational Safety and Health (NIOSH) and must meet minimum performance requirements, including a minimum airflow requirement of 170 L/min. One course of action to address usability concerns is to allow for the use of PAPRs designed with reduced airflow rates. The primary objective of this study was to assess the effect of PAPR flow rate and user work rate on PAPR performance, using a manikin-based assessment method. PAPR performance was quantified using the "Manikin Fit Factor" (mFF), a ratio of the challenge aerosol concentration to the in-facepiece concentration. Flow rates from 50-215 L/min and low, moderate, and high work rates were tested. Two models of NIOSH Approved loose-fitting facepiece PAPRs were tested, both having an Occupational Safety and Health Administration Assigned Protection Factor (APF) or expected level of protection, of 25. A two-way analysis of variance with an effect size model was run for each PAPR model to analyze the effects of work rate and flow rate on PAPR performance. Flow rate and work rate were found to be significant variables impacting PAPR performance. At low and moderate work rates and flow rates below the NIOSH minimum of 170 L/min, mFF was greater than or equal to 250, which is 10 times the OSHA APF of 25 for loose-fitting facepiece PAPRs. At high work rates and flow rates below 170 L/min, mFF was not greater than or equal to 250. These results suggest that some loose-fitting facepiece PAPRs designed with a flow rate lower than the current NIOSH requirement of 170 L/min may provide respirator users with expected protection at low and moderate work rates. However, when used at high work rates, some loose-fitting facepiece PAPRs designed with lower flow rates may not provide the expected level of protection.

Laboratory assessment of bacterial contamination of a sterile environment when using respirators not traditionally used in a sterile field environment.

OBJECTIVE: During infectious disease outbreaks or pandemics, an increased demand for surgical N95s that create shortages and necessitate the use of alternative National Institute for Occupational Safety and Health (NIOSH)-approved respirators that do not meet the Food and Drug Administration (FDA) additional requirements. The objective of this research was to quantify the level of bacterial contamination resulting from wearing NIOSH-approved respirators lacking the additional protections afforded by surgical N95s. METHODS: Participants performed simulated healthcare tasks while wearing 5 different respirators approved by the NIOSH. Sterile field contamination resulting from use of a surgical mask cleared by the FDA served as a baseline for comparison with the NIOSH-approved respirators. RESULTS: The bacterial contamination produced by participants wearing the N95 filtering facepiece respirators (FFRs) without an exhalation valve, the powered air-purifying respirators (PAPRs) with an assigned protection factor of 25 or 1,000 was not significantly different compared to the contamination resulting from wearing the surgical mask. The bacterial contamination resulting from wearing the N95 FFR with an exhalation valve and elastomeric half-mask respirator (EHMR) with an exhalation valve was found to be statistically significantly higher than the bacterial contamination resulting from wearing the surgical mask. CONCLUSIONS: Overall, NIOSH-approved respirators without exhalation valves maintain a sterile field as well as a surgical mask. These findings inform respiratory guidance on the selection of respirators where sterile fields are needed during shortages of surgical N95 FFRs.

Association of Beneficiary-Level Risk Factors and Hospital-Level Characteristics With Medicare Part B Drug Spending Differences Between 340B and Non-340B Hospitals.

Importance: Critics of the federal 340B Drug Pricing Program raised concerns that the program might provide financial incentives for participating hospitals to prescribe more and/or more expensive drugs because the revenue generated from Medicare reimbursement exceeds the purchase price by a substantial margin. Studies showing higher Medicare Part B drug spending at hospitals that are 340B hospitals, which can purchase outpatient drugs from manufacturers at discounted prices, compared with non-340B hospitals were used by the Centers for Medicare & Medicaid Services to justify their 340B payment policy that reduced Medicare payments for drugs in the 340B program in 2018 and thereafter. The Centers for Medicare & Medicaid Services attributed higher spending to the 340B benefit and believed that payment cuts would reduce the financial incentives associated with higher spending. However, the lack of sufficient risk adjustments is a significant concern of study validity. Objective: To examine whether per-beneficiary Medicare Part B drug spending is significantly different between 340B and non-340B hospitals while adequately controlling for patient-level and hospital-level risk factors. Design, Setting, and Participants: A cross-sectional study was conducted from October 1, 2020, to May 30, 2021, using 2017 administrative claims data from a random 5% sample of Medicare fee-for-service beneficiaries. Included beneficiaries had at least 1 separately payable non-pass-through drug claim in 2017, were fully enrolled in Part A and Part B through 2017, and did not die in 2017. Main Outcomes and Measures: The outcome was separately payable Part B drug spending. Results: The sample included 35 364 beneficiaries (21 825 women [61.7%]; 29 996 White patients [84.8%]; mean [SD] age, 70.6 [12.0] years) and 2446 hospitals. A total of 918 hospitals (37.5%) were in the 340B program and 938 hospitals (38.3%) were teaching hospitals. There was a higher percentage of teaching hospitals among 340B hospitals (517 of 918 [56.3%]) than non-340B hospitals (421 of 1528 [27.6%]), and beneficiaries who went to 340B hospitals were more likely to be non-White than those who went to non-340B hospitals (3360 of 19 139 [17.6%] vs 1583 of 13 710 [11.5%]). The Part B drug spending difference between 340B and non-340B hospitals was not statistically significant after controlling for beneficiary-level risk factors and hospital-level characteristics ($568; 95% CI, -$283 to $1419; P = .19). Conclusions and Relevance: The results show that the differences in patient population and hospital-level characteristics may explain drug spending differences between 340B and non-340B hospitals, which raises doubt about the financial incentive theory of the 340B program drug discount and the justification for the Centers for Medicare & Medicaid Services's 340B payment policy.

Assessment of respirator fit capability test criteria for full-facepiece air-purifying respirators.

An ASTM International subcommittee on Respiratory Protection, F23.65 is currently developing a consensus standard for assessing respirator fit capability (RFC) criteria of half-facepiece air-purifying particulate respirators. The objective of this study was to evaluate if the test methods being developed for half-facepiece respirators can reasonably be applied to nonpowered full-facepiece-air-purifying respirators (FF-APR). Benchmark RFC test data were collected for three families of FF-APRs (a one-size-only family, a two-size family, and a three-size family). All respirators were equipped with P100 class particulate filters. Respirators were outfitted with a sampling probe to collect an in-mask particle concentration sample in the breathing zone of the wearer. Each of the six respirator facepieces was tested on the National Institute for Occupational Safety and Health 25-subject Bivariate Panel. The RFC test assessed face seal leakage using a PortaCount fit test. Subjects followed the corresponding Occupational Safety and Health Administration-accepted fit test protocol. Two donnings per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of subjects in the panel achieving acceptable fit on at least one of two donnings) was determined for each respirator family at specified fit factor passing levels of 500, 1,000, and 2,000. As a reasonable expectation based on a previous analysis of alpha and beta fit test errors for various panel sizes, the selected PPR benchmark for our study was >75%. At the fit factor passing level of 500 obtained on at least one of two donnings, the PPRs for three-, two-, and one-size families were 100, 79, and 88%, respectively. As the fit factor passing criterion increased from 500 to 1,000 or 2,000, PPRs followed a decreasing trend. Each of the three tested families of FF-APRs are capable of fitting ≥75% of the intended user population at the 500 fit factor passing level obtained on at least one of two donnings. The methods presented here can be used as a reference for standards development organizations considering developing RFC test requirements.

Advancing return on investment analysis for electronic health record investment. Impacts of payment mechanisms and public returns.

This paper reviews a sample of studies reporting evidence on the implementation of electronic health record systems and identifies connections between reported benefits and hospitals' internal returns as well as public returns to external stakeholders, such as patients, the government and insurers. The study indicates that payment mechanisms play an important role in whether and to what extent reported benefits can be translated into a healthcare provider's financial profits. Under fee-for-service, reported benefits, such as reducing duplicate tests or improving preventive practice, will have a negative effect on a provider's financial performance. However, providers can realize those benefits financially under capitation. EHRs can improve clinician's compliance with pay-for-performance guidelines and promote the collection and report of quality data. But P4P's financial impact on EHR adoption is not clear. The study also suggests that returns from adopting EHRs can flow from the internal improvements in a healthcare entity resulting in returns to external stakeholders.