HospitalInspections.org

Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to conform to all applicable Federal regulations.

Penn Presbyterian Medical Center was not in compliance with the following Federal regulations related to the use of restraints:

482.13(e)(5) The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under 481.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law.

This was not met as evidenced by:

Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to follow their established policy to require a written order for restraints for one of 14 restraint records reviewed (MR35).

Findings include:

A review on July 14, 2011, of facility policy "Restraints and Seclusion Used to manage Violent or Self Destructive Behavior," last revised 1/6/09 revealed, "In an emergency, an appropriately trained registered nurse ("RN") certified registered nurse practitioner (CRNP), physician assistant ("PA"), or qualified personnel may initiate the use of restraints/seclusion based on an appropriate assessment of the patient or staff safety needs. 1. In such an emergency the order for use must be obtained either during the emergency application or immediately after the initiation of the restraint or seclusion ... "

A review on July 14, 2011, of MR35 revealed nursing documentation that four point locked restraints were applied. The medical record not contain an order for the restraint use.

An interview conducted on July 14, 2011, at 2:00 PM with EMP2 confirmed that MR35 did not contain an order for the restraint use.
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?482.13(g)(1)(ii) The hospital must report the following information to CMS: Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion.

This is not met as evidenced by;

Based on a review of medical records (MR) and interview with staff (EMP), it was determined the facility failed to notify CMS by the next business day of the deaths of patients within 24 hours of restraint usage for 12 of 13 restraint death medical records reviewed (MR2, MR3, MR4, MR5, MR6, MR68, MR69, MR70, MR71, MR72, MR73 and MR74)

Findings include:

A review on July 13, 2011, of facility administrative policy "Restraints for Non-violent, Non-self Destructive Behavior," effective July 6, 2011, revealed: " ... Reporting: Risk management shall report to CMS and the Department of Health Division of Acute and Ambulatory Care any death that occurs while a patient is restrained, within 24 hours after the patient has been removed from restraints..." Further review of the policy failed to reveal the requirement that the reporting of these deaths be completed by the next business day.

A review on July 13, 2011, of MR2, MR3, MR4, MR5, MR6, MR68, MR69, MR70, MR71, MR72, MR73 and MR74 revealed that the patients met the criteria for death within 24 hours of restraint usage. Further review of the medical records revealed that the notification to CMS was not made by the next business day.

An interview conducted on July 13, 2011, at 11:30 AM with EMP3 confirmed that MR2, MR3, MR4, MR5, MR6, MR68, MR69, MR70, MR71, MR72, MR73 and MR74 died within 24 hours of restraint usage.

An interview conducted on July 13, 2011, 1:30 PM with EMP1 confirmed that the restraint deaths had not been reported to CMS by the next business day.

Based on a review of Medical Staff Rules and Regulations, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure that intra-procedure orders were signed by the physician for five of five endoscopy suite medical records reviewed (MR51, MR52, MR53, MR54, and MR55).

Findings include:

A review on July 14, 2011, of facility "Medical Staff Rules and Regulations," last reviewed January 2011 revealed "...24. Medication, diagnostic or treatment shall be administered only upon written, signed, flagged, and properly documented order by practitioners within the scope of their licenses."

A review on July 14, 2011, of MR51, MR52, MR53, MR54, and MR55 revealed the medical records contained intra-procedure orders. The orders were not signed by the physician.

An interview on July 14, 2011, at 10:45 AM with EMP4 confirmed that MR51, MR52, MR53, MR54, and MR55 contained unsigned intra-procedure orders.

Based on a review of facility policy, facility documentation, observation and interview with staff (EMP), it was determined that the facility failed to provide a safe and sanitary environment.

Findings Include:

A review on July 11, 2011, of facility policy "Infection Control", effective June 2010 revealed: "... Laryngoscope blades and fiber optic laryngoscope blades and handles will be thoroughly cleaned after use according to Administrative Policy and Procedure Cleaning and Disinfecting of Fiber Optic Laryngoscopic Blades and Handles (attached)"

A review on July 11, 2011, of administrative policy "Cleaning and Disinfecting of Fiber Optic Laryngoscopic Blades and Handles", effective date June 2010 revealed: "... Procedure: 1. Transport of contaminated equipment: all dirty blades and handles must be transported in a clearly marked container with a lid labeled Biohazard. ... Residues and other deposits must be removed immediately after use, for example by wiping or brushing with a soft brush... "

Observation on July 11, 2011, of the clean anesthesia work room revealed a plastic container labeled "Biohazard" located in the sink. Further observation of the container revealed the presence of contaminated laryngoscope blades.

An interview conducted at on July 11, 2011, at 11:00 AM with EMP5 confirmed that there was a container of contaminated laryngoscope blades in the sink of the clean anesthesia work room. Further interview with EMP5 revealed that the contaminated laryngoscope blades were transported from the operating rooms to the clean work room where deposits were removed with a brush.

Based on a review of facility policy, facility documentation, medical records (MR), and interview with staff (EMP), it was determined that the facility failed to conform to the following Federal regulation related to reporting deaths to the OPO.

482.45(a)(1) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital; the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose.

This is not met as evidenced by:

Based on a review of facility policy, Organ Procurement Reconciliation List, medical records, (MR) and interview with staff (EMP), it was determined the facility failed to ensure that eight of 288 deaths were reported to the OPO (Organ Procurement Organization), (MR56 through MR58) and (MR80 through 84).

Findings include:

A review on July 11, 2011, of facility policy, "Organ Donation/Anatomical Donation" last revised 06/06/07, revealed, "In accordance with Pennsylvania's Anatomical Gift Act..., it is the policy of the Penn Presbyterian Medical Center of the University of Pennsylvania Health System to identify the routine referral of all deaths or pending deaths to the regional organ procurement organization for the determination of medical suitability for organ and tissue donation in collaboration with the attending physician and his/her designee."

A review on July 11, 2011, of the Gift of Life referral list and the facility list of deaths for the period from January 2010 through March 2011 revealed there were eight unreported deaths.

A review on July 11, 2011, of MR56 through MR58 and MR80 through 84 revealed there was no documentation that the Gift of Life Donor Program was notified.

An interview conducted on July 11, 2011, at 1:30 PM with EMP1 confirmed there was no documentation that eight deaths were referred to the Gift of Life Donor Program.

Based on a review of facility documents, facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to comply with the required criteria as stated in the exception letter granting the use of alcohol based skin preparation solutions for eight of eight surgical records reviewed where alcohol based skin preparation solutions were used (MR10, MR11, MR12, MR13, MR14, MR15, MR25, and MR26).

Findings include:

A review on July 11, 2011, of facility's Operating Room policy, "Skin Preparation of Patients," effective July 2011 revealed: " ... 2. Operative site Antisepsis ... j. Confirmation of dry antimicrobial prepping agents is imperative prior to surgical draping in the case of alcohol containing compounds must be documented."

A review on July 11, 2011, of the exception letter dated April 7, 2007, revealed: "The facility shall ensure the skin preparation solution is completely dry prior to draping and shall inspect the prepped area to confirm it is dry prior to draping. The facility shall document in the patient's medical record that the above has occurred prior to the surgical procedure."

A review on July 11-13, 2011, of MR10, MR11, MR12, MR13, MR14, MR15, MR25 and MR26 revealed that alcohol based skin preparations were used for these patients. There was no documentation in the medical records to indicate that the skin preparation solution was dry prior to draping the patients for the surgical procedures.

An interview conducted on July 11, at 1:00 PM with EMP6 confirmed that alcohol based skin preparations had been used for MR10, MR11, MR12, MR13, MR14, MR15, MR25 and MR26. Further interview with EMP6 confirmed that the facility did not document in the medical record that the solutions were dry prior to draping the patients for the surgical procedures.