Initial Comments:
This report is the result of an unannounced onsite complaint investigation (PA00069546) completed on March 11, 2024, at Allegheny General Hospital. It was determined the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 482-Conditions of Participation for Hospitals.
Plan of Correction:
482.22(c) STANDARD
MEDICAL STAFF BYLAWS
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The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must:
Observations:
Based on review of facility policies, medical records (MR), and interview with staff (EMP), it was determined the medical staff failed to follow its bylaws by failing to abide by facility policies for obtaining informed consent and performing timeout prior to bedside procedures for two of twenty medical records reviewed (MR1, MR2).
Findings include:
Review of facility policy entitled "Universal Protocol: Pre-procedure Verification, Site Marking, and Time-Out ... POL-6953392", last revised 10/31/2023, revealed: " ... Allegheny Health Network will protect patient safety by correctly identifying the patient, the procedure, and the site prior to operative and invasive procedures, including procedures done for both diagnostic and treatment-related purposes. This policy applies not only to procedures being performed in the operating room but to other procedural rooms or at the beside. ... ".
Review of facility policy "General and Informed Consent ... POL-6241648 ...", last approved 5/19/2023, revealed: " ... Except in emergency situations, Informed Consent must be obtained from the patient or appropriate Legally Authorized Representative prior to the performance/administration of surgery; anesthesia; radiation; ... insertion of a surgical device or appliance ... It is the responsibility of the Physician who will perform, order or supervise the treatment or procedure to obtain the patient's Informed Consent. ...".
Review of MR1 revealed that on February 13, 2024 at 8:44 AM, the patient signed an informed consent for a right side thoracentesis. On February 13, 2024, at 9:34 AM, a left side thoracentesis was performed. Further review of MR1 revealed no time out was performed prior to the procedure.
Review of MR2 revealed the patient signed a informed consent on February 25, 2024 at 10:15 AM, for a "TALC Pleurodesis". On February 25, 2024 at 12:35 PM, a "Pleurodesis" was performed on the patient of MR2, but the site was not marked during the pre-procedure time out per facility policy.
Further review of MR2 revealed the patient consented to and underwent a left sided thoracentesis on March 1, 2024, at 4:44 PM. Further review of MR2 revealed the site was not marked during pre-procedure time out per facility policy.
The above was confirmed with EMP1 during medical records review on March 11, 2024, between approximately 11:00 AM and 1:00 PM.
Plan of Correction:The Director of Regulatory Affairs/Manager of Regulatory will share this deficiency with the Chief Medical Officer. The Chief Medical Officer will provide education to our AHN physicians and qualified practitioners on these findings and the need to have:
- Understanding and acknowledgement of the Universal Protocol and General and Informed Consent policy will occur electronically as well as a distribution in our Medical Executive Committee (MEC), provided to our Institute Chairs and Division Chiefs, Directors of Procedural areas, and our Graduate Medical Education (GME) and
- Patient safety will be protected by correctly identifying the patient, the procedure, and the site prior to operative and invasive procedures, including procedures done for both diagnostic and treatment-related purposes as evidence by timeout documentation within the nursing flowsheet of the EMR
- Beginning May 2024, a review of 10 inpatient charts and 20 Emergency Department charts to assure compliance per policy elements.
Audits of patient charts will begin May 1, 2024. The audit will be as follows:
- The results of the record audit will be analyzed monthly by the Director of Regulatory Affairs/Manager of Regulatory and Nursing leadership beginning in May 2024 and will continue for three months until 100% compliance is achieved.
- Results of the review will be reported monthly beginning in June 2024 to the Regulatory Readiness Committee and Performance Improvement Oversight Committee
Initial Comments:
This report is the result of an unannounced onsite complaint investigation completed on March 11, 2024, at Allegheny General Hospital. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 PA Code, Part IV, Subparts A and B, November 1987, as amended June 1998.
Plan of Correction:
107.51 (a)(1-3) LICENSURE
MEDICAL CARE REVIEW - RESPONSIBILITIES
Name - Component - 00
107.51 Medical staff responsibilities
(a) In order for the medical staff
to take reasonable steps to ensure
clinical practice of the highest
quality, each staff member should
endeavor to:
(1) provide his patients with
the best quality of care consistent
with the circumstances of each case;
(2) conduct his professional
activities in accordance with the
bylaws, rules and regulations of the
medical staff; and
(3) assist in the promotion and
maintenance of high quality care
through the analysis, review, and
evaluation of the clinical practice
which exists within the hospital.
Observations:
Based on review of facility policies, medical records (MR), and interview with staff (EMP), it was determined the medical staff failed to provide patients with the highest quality of care by failing to abide by facility policies for obtaining informed consent and performing timeout prior to bedside procedures for two of twenty medical records reviewed (MR1, MR2).
Findings include:
Review of facility policy entitled "Universal Protocol: Pre-procedure Verification, Site Marking, and Time-Out ... POL-6953392", last revised 10/31/2023, revealed: " ... Allegheny Health Network will protect patient safety by correctly identifying the patient, the procedure, and the site prior to operative and invasive procedures, including procedures done for both diagnostic and treatment-related purposes. This policy applies not only to procedures being performed in the operating room but to other procedural rooms or at the beside. ... ".
Review of facility policy "General and Informed Consent ... POL-6241648 ...", last approved 5/19/2023, revealed: " ... Except in emergency situations, Informed Consent must be obtained from the patient or appropriate Legally Authorized Representative prior to the performance/administration of surgery; anesthesia; radiation; ... insertion of a surgical device or appliance ... It is the responsibility of the Physician who will perform, order or supervise the treatment or procedure to obtain the patient's Informed Consent. ...".
Review of MR1 revealed that on February 13, 2024 at 8:44 AM, the patient signed an informed consent for a right side thoracentesis. On February 13, 2024, at 9:34 AM, a left side thoracentesis was performed. Further review of MR1 revealed no time out was performed prior to the procedure.
Review of MR2 revealed the patient signed a informed consent on February 25, 2024 at 10:15 AM, for a "TALC Pleurodesis". On February 25, 2024 at 12:35 PM, a "Pleurodesis" was performed on the patient of MR2, but the site was not marked during the pre-procedure time out per facility policy.
Further review of MR2 revealed the patient consented to and underwent a left sided thoracentesis on March 1, 2024, at 4:44 PM. Further review of MR2 revealed the site was not marked during pre-procedure time out per facility policy.
The above was confirmed with EMP1 during medical records review on March 11, 2024, between approximately 11:00 AM and 1:00 PM.
Plan of Correction:The Director of Regulatory Affairs/Manager of Regulatory will share this deficiency with the Chief Medical Officer. The Chief Medical Officer will provide education to our AHN physicians and qualified practitioners on these findings and the need to have:
- Understanding and acknowledgement of the Universal Protocol and General and Informed Consent policy will occur electronically as well as a distribution in our Medical Executive Committee (MEC), provided to our Institute Chairs and Division Chiefs, Directors of Procedural areas, and our Graduate Medical Education (GME) and
- Patient safety will be protected by correctly identifying the patient, the procedure, and the site prior to operative and invasive procedures, including procedures done for both diagnostic and treatment-related purposes as evidence by timeout documentation within the nursing flowsheet of the EMR
- Beginning May 2024, a review of 10 inpatient charts and 20 Emergency Department charts to assure compliance per policy elements.
Audits of patient charts will begin May 1, 2024. The audit will be as follows:
- The results of the record audit will be analyzed monthly by the Director of Regulatory Affairs/Manager of Regulatory and Nursing leadership beginning in May 2024 and will continue for three months until 100% compliance is achieved.
- Results of the review will be reported monthly beginning in June 2024 to the Regulatory Readiness Committee and Performance Improvement Oversight Committee
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