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PS 1008

Para enmendar los Artículos 1, 3 y 4 de la Ley Núm. 2 del 7 de noviembre de 1975, según enmendada, conocida como “Ley de Certificados de Necesidad y Conveniencia del Departamento de Salud”, los fines de establecer criterios específicos y medibles en la aprobación de Certificados de Necesidad y Conveniencia para operar laboratorios clínicos dentro de la jurisdicción de Puerto Rico; y para otros fines relacionados.

2025-2028 Session

Puerto Rico bill establishes objective approval criteria for clinical laboratory operating licenses, replacing discretionary regulatory review with measurable standards to increase transparency and competition.

Comisión no recomienda aprobación de la medida
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Bill Summary · PS 1008

Legislative bill overview

Bill PS 1008 amends Puerto Rico's 1975 "Certificate of Need and Convenience" law to establish specific, measurable criteria for approving operating permits for clinical laboratories. Currently, the approval process lacks defined standards, giving regulators broad discretionary power. This reform aims to create objective benchmarks that laboratories must meet to obtain or maintain their certificates.

Why is this important

Clinical laboratory services directly affect healthcare access and quality—they conduct blood tests, diagnostics, and other essential analyses. Unclear approval criteria can create barriers to entry, reduce competition, and potentially limit patient access to testing services while protecting incumbent providers. Establishing measurable standards increases transparency and predictability for both applicants and the Department of Health.

Potential points of contention

  • Incumbent protection vs. competition: Existing laboratories may oppose stricter, objective criteria if it enables new competitors; conversely, new applicants favor clear standards over discretionary denials
  • Regulatory burden: Defining "specific and measurable" criteria requires detailed technical specifications—overly stringent standards could be costly to implement and monitor, while lenient ones may defeat quality assurance purposes
  • Definition disputes: Stakeholders will likely disagree on what metrics matter most (equipment quality, personnel qualifications, geographic coverage, service capacity) and how to weight them

Compiled from official sources — confirm details with the bill’s official record.

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