Kristy Lucabaugh

- Served as regulatory contact with Pennsylvania Department of Health coordinating occupancy, attestation, complaint, etc. surveys and investigations.

- Utilized CMS, The Joint Commission and PA DOH resources to provide regulatory guidance to hospital organizational leadership.

- Developed strong, impactful relationships with leadership to promote compliance with hospital standards through change.

- Facilitated meetings with leaders to discuss newly issued Federal and State hospital law and regulations and identify actions needed to ensure compliance.

- Developed regulatory training materials including screen savers and an interactive game to promote staff awareness and knowledge of hospital standards.

- Completed audits to ensure compliance with PA DOH regulations and laws specific to hospital regulations.

- Presented monthly accreditation updates to the hospital wide Quality Steering Committee for organizational and Board awareness

- Coordinated multi-disciplinary regulatory readiness tracers in all areas of the hospital and outpatient testing centers

- Worked closely with Infection Prevention team to ensure compliance with infection control standards especially in high-risk areas such as Sterile Processing, Surgical Services, procedural areas, etc.

- Served as subject matter expert for CMS, The Joint Commission and PA DOH hospital and laboratory standards

- Actively participated and contributed regulatory input at Safety Performance, Environment of Care, Workplace Safety and Infection Prevention and Control Committees meetings

- Participated in root cause analyses that included identifying and developing corrective action plans and monitoring ongoing compliance.

- Lead Sentinel Event Alert review and gap analysis to ensure compliance with Joint Commission standards

- Coordinated Joint Commission hospital, home care and laboratory surveys

- Provided ongoing regulatory guidance and input to leaders and staff

- Presented annual accreditation update to the hospital wide Patient Safety Committee.

- Coordinated regulatory consultant visits and issued findings and recommendations to improve compliance with hospital regulations.

- Utilized various resources to identify areas of focus from regulatory surveys (e.g., CMS, DOH) to determine if any actions needed organizationally for compliance.

- Coordinated Joint Commission chapter leader meetings to review current issues and trends in compliance.

- Received awards from hospital Board and employee nominated for commitment and efforts for accreditation

- Assisted in development and revision of policies, protocols, etc. associated with patient care, treatment and services to be compliant with applicable laws, regulations and accreditation standards.

- Successfully completed Evidence of Standards Compliance for hospital and laboratory survey findings.

- Conducted procedural audits and inspections for nonclinical studies under Good Laboratory Practice (GLP) regulations 21 CFR Part 58 regulations to ensure the accuracy and integrity with study protocols and Standard Operating Procedures. This included studies for Toxicology, Developmental and Reproductive Toxicology, Genetic Toxicology and TAQMAN DNA studies including PCR data.

- Prepared audit and inspection reports, reviewed findings with scientific and technical personnel and documented corrective actions.

- Assisted with development of audit and inspection plans and training manual to support monitoring of nonclinical studies.

- Collaborated effectively with staff and teams across the organization.

- Cross trained to perform computer validation audits under 21 CFR Part 11, electronic signatures.

- Conducted audits and inspections at Contract Research Organizations (CROs) to ensure compliance with GLP regulations.

- Served as liaison to Clinical Pathology and Genetic Toxicology, fielding questions from nonclinical quality auditors and laboratory staff.

- Executed independent projects as assigned towards departmental goals under broad administrative guidance.

- Served as Acting Manager providing administrative and technical direction to staff through coaching and training.

- Performed chemistry, hematology, coagulation and urinalysis testing of preclinical specimens to support GLP studies submitted to FDA.

- Conducted instrument calibrations, maintenance and quality control to ensure effective operation of laboratory analyzers.

- Assisted in the development and revision of laboratory procedures to support GLP studies.

- Performed testing in the Special Chemistry Laboratory.

- Co-developed an enzyme immunoassay that included solid-phase extraction for assay optimization. Results published with Clinical Ligand Assay Society and American Association of Clinical Chemistry.

- Participated in assay development initiatives that required strong time management, organizational and technical skills.