Adams Alex J, Klepser Donald G, Klepser Michael E
Idaho Division of Financial Management, Boise, ID, USA.
College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
J Pharm Technol. 2024 Dec 23:87551225241306678. doi: 10.1177/87551225241306678.
Community pharmacies have grown to be an increasingly important provider of CLIA-waived tests, just second to physician offices as the venue with the most waivers. Yet, individual variation is still observed across states with respect to the percentage of pharmacies holding a CLIA-waiver, with a reported range of 10.7% in Massachusetts to 87.9% in Delaware. To identify how state laws can either impede or enhance access to POCT services by pharmacies by comparing the percentage of pharmacies in each state holding a CLIA-waiver to the legal model for POCT services in each state. Data from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website reported on December 4, 2023, were used to determine the number of pharmacies holding CLIA-waivers in each state. This was then divided by the number of community pharmacies in each state, as reported in the 2023 National Community Pharmacy Association Digest, and then compared with 2 public reports on pharmacy CLIA laws. States categorized as allowing pharmacists to independently perform CLIA-waived tests in public reports actually had a lower percentage of pharmacies with a CLIA-waiver (49.60%) than those categorized as allowing CLIA-waived tests (60.19%). As many as 10 241 pharmacies hold a CLIA-waiver in states that did not affirmatively report that pharmacists ordering lab tests was allowed. The paradoxical finding is likely a result of the underreporting of pharmacist CLIA-waived testing authority given the complexity of pharmacy law relative to other professions. Simplifying pharmacy law through adoption of a "standard of care" regulatory approach may enhance patient access to POCT services moving forward.
社区药房已逐渐成为临床实验室改进修正案（CLIA）豁免检测的重要提供者，仅次于医师办公室，是豁免检测最多的场所。然而，各州持有CLIA豁免权的药房比例仍存在个体差异，据报道，马萨诸塞州为10.7%，特拉华州为87.9%。通过比较每个州持有CLIA豁免权的药房百分比与每个州即时检验（POCT）服务的法律模式，来确定州法律如何阻碍或促进药房获得POCT服务。利用美国疾病控制与预防中心CLIA实验室搜索网站2023年12月4日报告的数据，确定每个州持有CLIA豁免权的药房数量。然后将其除以2023年全国社区药房协会摘要中报告的每个州的社区药房数量，并与两份关于药房CLIA法律的公开报告进行比较。在公开报告中被归类为允许药剂师独立进行CLIA豁免检测的州，实际持有CLIA豁免权的药房比例（49.60%）低于被归类为允许CLIA豁免检测的州（60.19%）。在未明确报告允许药剂师订购实验室检测的州，多达10241家药房持有CLIA豁免权。这一矛盾的发现可能是由于相对于其他职业，药房法律复杂，药剂师CLIA豁免检测权限报告不足所致。通过采用“护理标准”监管方法简化药房法律，可能会增加患者今后获得POCT服务的机会。
