Initial Comments:
This report is the result of a State Relicensure survey conducted onsite on January 23, 2024 and completed offsite on January 29, 2024, at Lehigh Valley Vascular Institute. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.
Plan of Correction:
553.3(8)(v) LICENSURE
Governing Body Responsibilities
Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(v) Written job descriptions shall exist for each type of job in the ASF.
Observations:
Based on review of facility documents and personnel files (PF) and staff interview (EMP), it was determined the Governing Body failed to maintain personnel policies and practices which adequately support sound patient care including written job descriptions for each type of job in the ASF
Findings include:
Review on February 1, 2024 of facility policy "Associates' Records and Files", revised January 8, 2024 revealed "2. A personnel file is maintained on each associate and contains information regarding the individual's employment, required state licensing, salary history, performance, and training records. Copies of all personnel forms, recommendations, and documentation of any disciplinary actions are also included..."
Review on January 23, 2024, of PF6 revealed, employee was hired on November 26, 2023 and worked as a Client Coordinator for the facility. Further review revealed PF6 did not have a written job description outlining duties and responsibilities.
Interview with EMP1 on January 23, 2024 at approximatley 1:58 PM confirmed the above findings.
Plan of Correction:The Facility Administrator is responsible for this plan of correction. The Client Coordinator has signed a job description. This was completed on January 24, 2024. The Facility Administrator will provide education to all staff on the requirement to have a signed job description on file in each staff member's personnel file. This in-service will occur by February 16,2024 and will be documented on an in-service sign-in sheet. The Facility Administrator will audit all employee files upon hire and annually, to ensure completeness. The audit will be reported to the QA committee, which reports to the Governing Body. Any deficiencies will be addressed by the Governing Body.
561.1 LICENSURE
Drugs & Biologicals
Name - Component - 00
561.1 Drugs and Biologicals
The ASF shall provide drugs and biologicals in a safe and effective
manner to meet the needs of patients, and to adequately support the organization's clinical capabilities commensurate with their licenses classification, in accordance with accepted ethical and professional practice and applicable State and Federal law, including the Pharmacy Act (63 P.S. 390-1 -390.13), 49 Pa. Code Chapter 27 (relating tot he State Board of Pharmacy), The Controlled Substance, Drug, Device and Cosmetic ACT (35 P.S. 780-101-780-144) and Chapter 25 (relating to controlled substances, drugs, devices and cosmetics).
Observations:
Based on observation, review of policy and procedure and interview with staff (EMP) it was determined the facility failed to ensure disposal of used medication vials, used syringes and used needles were rendered unrecoverable.
Findings include:
Observation on January 23, 2024, at approximately 10:30 AM of Pre operation and Post Operational Bay area revealed wall mounted type, red biohazard-container that contained discarded syringes and used needles. Further observation revealed the lid to the container was opened and the contents accessible.
Request made on January 23, 2024 to EMP1 for a facility policy that addresses the proper disposal and of used medication vials, used syringes in an unrecoverable red bin. None available.
Interview on January 23, 2024 at 10:47 AM, with EMP1 confirmed used syringes and empty propofol vials are discarded in a manner that did not render them unrecoverable.
Plan of Correction:The Director of Nursing is responsible for this plan of correction. The Director of nursing will revise or create policies on drug and sharps disposal to ensure materials are unrecoverable, by February 16, 2024. The policy will be approved by the governing body by February 19, 2024. All staff will receive education on updated policies and the proper usage of biohazard containers, by February 20, 2024. This will be documented on an in-service sign-in sheet. The Director of Nursing will audit all biohazard containers weekly for one month. If no deficiencies, then the audit will be conducted monthly and documented on the monthly environment of care checklist. The audits will be reported to the QA Committee, which reports to the Governing Body. Any deficiencies will be addressed by the Governing Body.
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