Doucette Joseph, Lavino Joseph
Massachusetts College of Pharmacy and Health Sciences University, Candidate for Doctor of Pharmacy-Accelerated '21, 1260 Elm Street, Manchester, NH 03101, USA.
Massachusetts College of Pharmacy and Health Sciences University, 179 Longwood Ave, Boston, MA 02115, USA.
Explor Res Clin Soc Pharm. 2021 May 8;2:100024. doi: 10.1016/j.rcsop.2021.100024. eCollection 2021 Jun.
The scope of practice of community pharmacy has continued in its evolution into a clinically focused profession. A critical component to pharmacist clinical offerings in the United States is the performance of Clinical Laboratory Improvement Amendments ("CLIA") waived tests. However, state laws and regulations greatly influence a pharmacist's ability to perform a CLIA-waived test. Based on this variability and lack of clarity in state laws and regulations, a legal review was performed, which focused on the following themes: 1) states which currently allow a pharmacist to independently perform CLIA-waived testing; 2) of those states, which states impose restrictions on the scope of CLIA-waived tests that may be independently performed by a pharmacist; and 3) states that impose restrictions on the ability of a pharmacist to independently perform CLIA-waived testing. Federal laws already exist that allow individuals, pursuant to certification, to perform CLIA-waived testing. This allowance presumably includes pharmacists if they follow federal law. However, some states regulate and restrict this area for pharmacists, contrary to these federal laws. States may see an improvement in patient care and further expand the practice of pharmacy by limiting restrictions on pharmacists to perform CLIA-waived tests and following federal allowances.
社区药房的业务范围已持续发展成为一个以临床为重点的专业领域。在美国，药剂师临床服务的一个关键组成部分是进行临床实验室改进修正案（“CLIA”）豁免检测。然而，州法律法规极大地影响了药剂师进行CLIA豁免检测的能力。基于州法律法规的这种差异性和不明确性，进行了一次法律审查，审查集中在以下几个主题：1）目前允许药剂师独立进行CLIA豁免检测的州；2）在这些州中，哪些州对药剂师可独立进行的CLIA豁免检测范围施加了限制；3）对药剂师独立进行CLIA豁免检测的能力施加限制的州。联邦法律已经允许个人在获得认证后进行CLIA豁免检测。如果药剂师遵守联邦法律，这种许可大概也包括他们。然而，一些州违反这些联邦法律，对药剂师在这一领域进行监管和限制。各州可以通过限制对药剂师进行CLIA豁免检测的限制并遵循联邦许可，来改善患者护理并进一步扩大药房业务范围。
