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800 SPRUCE STREET

PHILADELPHIA, PA 19107

PATIENT RIGHTS: NOTICE OF RIGHTS

Tag No.: A0117

Based on review of facility documents and medical records (MR), and staff interviews (EMP), it was determined that the facility failed to follow their adopted policy of informing patients of their rights, in advance of furnishing or discontinuing patient care whenever possible for five of eight medical records reviewed (MR6, MR8, MR9, MR10 and MR13).

Findings include:

Review of "Pennsylvania Hospital Administrative Policy Manual Subject: Notification of Acute Care Hospital Discharge Appeal Rights for Medicare Patients Policy Number: RE17 ... Effective:0616" revealed "Policy Statement ... Pennsylvania Hospital will adhere to the Centers for Medicare and Medicaid Services (CMS) discharge notice policy. The hospital will implement a formal process for notifying Medicare patients of the discharge notice requirements and their rights to appeal the decision to discharge. The discharge notice will be provided to the patient or representative within 2 calendar days of admission and the patient's or representative's signature will be obtained indicating that he/she received the notice and understood the contents. Within 2 calendar days of discharge, the patient or representative will receive a copy of the previously signed notice. ... Procedure 1. At or near admission to the hospital, but in no event later than 2 calendar days of admission, the registrar will provide the patient or representative with the "Important Message from Medicare" form. This form will be made in triplicate. ... 2. The patient or representative will be provided a copy of the signed form on admission. The additional copies will be placed in the Discharge section of the medical record. Prior to discharge, the patient or representative will be given the copy of his/her "Important Message from Medicare" form ... , by the nurse, or designee, providing care to the patient. ... ."

Review on January 24, 2018, of MR6, MR8, MR9, MR10 and MR13 revealed no documented evidence that patients or their representative were provided a copy of the signed "Important Message from Medicare" form on admission.

An interview conducted on January 24, 2018, with EMP2, confirmed the above findings and revealed "Our process is to provide a consent package on admission and at PAT (Pre-Admission Testing) anywhere in the system. The consent package contains the Important Message from Medicare form, they sign it then and then the patient or patient's representative gets the Important Message from Medicare form signed again on hospital admission, if they signed it at pre-admission testing. ... . I will have to re-educate staff about getting the Important Message from Medicare form to patient during admission." In addition, EMP2 confirmed that the facility failed to follow their policy.

CONTENT OF RECORD: FINAL DIAGNOSIS

Tag No.: A0469

Based on review of facility policy, Bylaws, documents and interview with staff (EMP), it was determined that the facility failed to follow their policy for completing medical records within 30 days.

Findings Include:

Review of facility policy "Completion Of Medical Records" last reviewed on February 29, 2016, revealed "DEFINITIONS: A medical record not completed within thirty (30)days of discharge is considered a "delinquent record."

Review of facility policy "Completion of Medical Records" last reviewed on February 29, 2016, revealed ... . "NOTIFICATION OF INCOMPLETE RECORD STATUS TO PHYSICIANS. All Attending Physicians and House Staff will receive weekly notifications regarding the status of their incomplete records. NOTIFICATION SCHEDULE. 1. Weekly notifications of the number of records requiring completion will be sent each Monday. 2. Delinquency Notification-Notification indicating that all delinquent records must be completed within seven (7) days of notice. 3. Final Delinquency Notification-Notification indicating failure to comply with previous requests and all delinquent records must be completed within 48 hours of notice. 4. Suspension/Restriction Notification.

Review of the "Pennsylvania Hospital Bylaws" last revised on December 22, 2017, revealed "... . "11.1 BASIS FOR CORRECTION ACTION (c) Medical and Other Records (i) Timely Completion: The failure to prepare and/or complete medical records in a timely fashion (as set forth in Article III of the Medical Staff Rules and Regulations) will result in the restriction of the admitting privileges of Appointees to the Medical Staff until the delinquency is corrected, in accordance with Section 3.9 of the Medical Staff Rules and Regulations."

Review of facility document "Delinquent Physician Report" dated January 26, 2018, revealed EMP9, a physician had 57 incomplete medical records which were delinquent for 30 days and greater from June 2017 to January 26, 2018. Further review revealed EMP9 had recently admitted patients on January 17, January 19, January 22, and January 23, 2018.

An interview conducted on January 26, 2018, at 9:20AM with EMP8 confirmed that EMP9, a physician had 57 incomplete medical records that were delinquent for 30 days and greater from June 2017 to January 26, 2018. EMP3 and EMP8 also confirmed that EMP9 continued to have full privileges for admitting patients to the facility, and the facility had failed to follow its policy for addressing physicians who had delinquent medical records for 30 days or longer.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on a Life Safety Code Validation Survey, the Condition for Physical Environment was not met based on the results of the Department of Safety Inspection survey completed on January 12, 2018. Those deficient practices and associated regulations can be found on the respective Life Safety Code survey.

DELIVERY OF ANESTHESIA SERVICES

Tag No.: A1002

Based on review of facility documentation, tour of the operating room and interview with facility staff (EMP), it was determined that the facility failed to follow their adopted policies for the discarding of expired medications.

Findings Include:

Pennsylvania Hospital Penn Medicine Pharmacy Policies ... Subject: Expiration Dates of Vials, Ampoules and Syringes Policy Number: PAH PP PH.605MEDMGT (PAH Intranet # PH-24) ... Reviewed: November 2017 policy and procedure. " Policy Statement This policy applies to Pennsylvania Hospital (PAH) and those parts of the Clinical Practices of the University of Pennsylvania (CPUP) which practice at or in conjunction with PAH, operating under the PAH license. ... Policy Pennsylvania Hospital shall utilize a standardized process for managing expiration dates of vials, ampoules or syringes, according to the recommendations provided by the United States Pharmacopoeia, the Association for Professionals in Infection Control and Epidemiology (APIC) and The Joint Commission. Purpose To delineate the proper procedures for the expiration dating of medications stored in vials, ampoules or syringes. To assure that medications are utilized in a safe manner according to established regulatory guidelines. Scope and Responsibilities It shall be the responsibility of all hospital staff who store, dispense, and/or administer medications to patients to assure that medications are not utilized past their recommended expiration dates. ... Hospital staff shall check expiration dates and integrity of medications prior to administration to a patient. Procedure 1. All medications contained in a vial, ampoule or syringe shall be stored with an expiration date or beyond use date, as determined by the manufacturer or other regulatory entity. 2. Proper aseptic technique shall be mandatory in the handling of all medication vials, ampoules, and syringes to assure that the integrity, stability and sterility of the preparation is not compromised. 3. Prior to use, vials, ampoules and syringes shall be checked and discarded if: 3.1. The medication is obviously contaminated or suspected to be contaminated. 3.2 The container is cracked. 3.3 The contents are not clear or if contents are discolored upon visible inspection. 3.4 The medication has not been stored according to the directions on the label or per manufacturer recommendations. 3.5 The container was previously opened, and it is unclear when or what its storage conditions were to determine a viable expiration date. ... 5. Single Use Vials Ampoules and Manufacturer Syringes ... 5.2 All ampoules and syringes shall be for single use only and shall be discarded after use. ... 5.3 Vials that do not contain a bacteriostatic agent shall be considered and used as single use vials. They shall be used immediately after opening and discarded after one use. ... 6. Multidose Vials ... 6.5 Stock medication stored outside of the Department of Pharmacy shall bear the manufacturer ' s expiration date until opened or outside of the manufacturer ' s recommendations. The person opening the vial shall assume responsibility of appropriate expiration date labeling in this circumstance. However, if a multi-dose vial is used in an immediate treatment area the vial must be discarded after a single use. Examples of immediate patient treatment areas include the operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays. ... 11. Any staff that identifies a medication past its expiration date shall remove it immediately from its storage location and segregate/discard it to prevent possible use by other staff. ... . "

1) During a tour of the third floor, Perivascular Operating Room 3 on January 24, 2018, at 10:15 AM, EMP4 opened the first drawer of the Omnicell medication cart upon request of the surveyor. Upon inspection there were multiple IV push medications, vials and IV mini bags that were opened and/or mislabeled. The medications included: 15 IV push syringe medications; Esmolol dated January 18, 2018, Succinylcholine dated January 18, 2018, Atropine dated January 18, 2018, Glycopyrrolate dated January 18, 2018, Rocuronium undated, Lidocaine undated, Ephedrine undated, Nitroglycerine (two syringes) dated January 23, 2018, Glycopyrrolate dated January 23, 2018, Succinylcholine dated January 23, 2018, Norepinephrine dated January 21, 2018, Epinephrine dated January 21, 2018, Esmolol dated January 23, 2018, and Atropine dated January 23, 2018. Additional medications included: Three open vials; Succinylcholine 200 mg (20mg/ml) multiple dose vial, Rocuronium Bromide (100 mg/10 ml) multiple dose vials and Nitroglycerine (50 mg/10 ml) single dose vial. Lastly, the medications included: Two IV mini bags; Phenylephrine 0.1 mg/ml dated January 23, 2018, and Vasopressin dated January 24, 2018, (use by) 5:30 AM. There were no expiration dates on the IV push syringe medications, open vials or IV minibags.

2) Interview with EMP4 on January 24, 2018, at 10:15 AM confirmed the above and revealed, " We usually draw up the medications in the morning and discard them at the end of the day. The date on them is the date they were drawn up. I can take credit for the ones dated the 23rd because I was here, but not the other ones. They should all have been thrown out."