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751 LIBERTY STREET

MEADVILLE, PA 16335

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on review of facility documents, observation and staff interview (EMP), it was determined that the facility failed to prepare and administer medications in accordance with hospital policies for one of one observations of anticoagulant medication administration. (MR5)

Findings include:

Review of a facility document on February 9, 2016, at 1:00 PM revealed, "...High Risk (High Alert) Medications. Purpose: High Risk Medications are medications identified by the institution as having a higher risk of causing significant patient harm if used in error. this policy identified those medications by category or individual agent that are deemed high risk and provides guidance on the safe handling, preparation, labeling, procuring, storing, transcribing, dispensing, administering, and/or monitoring of these agents...Procedure: .."High Risk" is designated by "pop-up" warning on Electronic MAR [Medication Administration Record]. In some cases a dose must be verified by another using in Meditech.

Review of facility document "High Risk Drug List" last reviewed at the Pharmacy and Therapeutics Committee (P&T) on October 9, 2015, revealed, "High Risk Drug List...Enoxaparin (Lovenox)...Reason for Inclusion in High Risk Category...Bleeding complications or underdosed risk of clotting..."

1. Observation of a medication injection on February 8, 2016, at approximately 12:22 PM revealed that EMP20 administered the subcutaneous injection of Lovenox to the patient of MR5. EMP20 then requested another nurse to verify the injection. EMP21 entered the patient's cubical, cosigned the verification in the computer and exited.

During an interview on February 8, 2016, at approximately 12:30 PM, EMP20 confirmed that the second nurse verification should have been completed prior to the medication injection.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on review of facility documents, observation and staff interviews (EMP), it was determined that the facility failed to ensure that medical records, filed and retained in the Medical Records Department, were protected from water damage.

Findings include:

Review of Administrative Policy A-103 G, "Confidentiality of Protected Health Information (PHI)," original date April 1, 2004, revealed, "PROCEDURE: ... Files and information will be kept secure within each Department using locked files, secured files, restricted access entry using computer password and coded door locks. The principle is to maintain PHI in such a way as to meet accreditation and government regulation as well as to limit the unauthorized viewing ..."

Review of Administrative Policy A-019, "Control of Records," original date January 1996 revealed, "PURPOSE: To provide a directory to guide all departments in regards to control of records. POLICY: Refer to attached guide for identification, storage, protection, retrieval, retention and disposition of records. If any department has specific regulations from the Federal Government or the State Licensing Agency, please adhere to those regulations."

1. Review of Administrative Policy A-103 G and Administrative Policy A-019 (including attachment) revealed no requirement that medical records be stored in areas where they are protected from water or other threats.

2. Tour of the Medical Record Department on February 9, 2016, at 1:40 PM revealed paper medical records stored on mobile and fixed shelving. Further observation during the tour revealed no drop ceiling. Multiple sprinkler heads were visible above the medical record storage shelving.

3. On February 9, 2016, at 1:41 PM, EMP3 confirmed the multiple sprinkler heads above the medical record storage shelving.

4. On February 10, 2016, at 12:07 EMP3 confirmed that the medical records observed in the Medical Records Department were not protected from water damage stating, "Right. I talked to EMP50 this morning and he/she agreed."

5. On February 10, 2016, at 12:10 PM when asked if the medical records stored in the Medical Record Department would be compromised, should the sprinkler system be activated, EMP51 stated, "Yes. They would be ruined."

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on review of medical records (MR) and facility documentation, and employee interview (EMP), it was determined that the facility failed to ensure that times were included with physician signature entries for two of two Wound Center medical records (MR28, MR29).

Findings include:

Review, at approximately 12:00 PM on February 10, 2016, of Policy A-111.04, "Medical Record Documentation," published December 17, 2015, revealed, "... Policy: ... All Entries should be identified with a date and a time of entry clearly marked. ..."

Review, at approximately 12:30 PM on February 10, 2016, of the "Meadville Medical Center Medical/Dental Staff Rules and Regulations," approved by the Board on May 2015, revealed, "... 6. All orders for treatment or medications shall be in writing and shall include the physician's signature, date and time. ..."

1. Review, at approximately 11:25 AM on February 10, 2016, of MR28 did not reveal times to be included with the physician signature on the "Wound Recovery Hyperbaric Department Wound Debridement Record," for December 3 and 17, 2015, nor for January 7, 14, and 28, 2016.

Further review of MR28 did not reveal times to be included with the physician signature on the "Wound Recovery / Hyperbaric Department Physician Orders, Discharge / Home Instruction Sheet," for December 3 and 17, 2015, nor for January 7, 14, 21, or 28, 2016.

At approximately 11:50 AM on February 10, 2016, EMP1 confirmed the above findings.

2. Review, at approximately 11:40 AM on February 10, 2016, of MR29 did not reveal times to be included with the physician signature on the "Wound Recovery / Hyperbaric Department Physician Orders, Discharge / Home Instruction Sheet," for January 12 and 19, 2016.

At approximately 11:55 AM on February 10, 2016, EMP1 confirmed the above findings.

PHYSICAL ENVIRONMENT

Tag No.: A0700

The Condition for Physical Environment was found to be out of compliance during a Life Safety Survey completed on February 3, 2016. Further details are outlined in that Division of Life Safety Survey Report.

ALCOHOL-BASED HAND RUB DISPENSERS

Tag No.: A0716

Based on review of facility documents, observation, and staff interviews (EMP), it was determined the hospital failed to install alcohol-based hand rub dispensers in a manner that minimizes leaks and spills that could lead to falls, and failed to install in accordance to manufactures guidelines.


Findings include:

Review of a facility policy dated October 28, 2015, revealed, "...Fire Prevention in the Operating Room Suite. Purpose: To provide a safe environment for the patients and the staff...At the Start of Any Surgery: 1. Enriched oxygen and Nitrous Oxide atmospheres can vastly increase flammability of drapes, plastics, and hair. Be aware of possible oxygen enrichment under the drapes near the surgical site and in the fenestration, especially during head/neck surgery...2. Do not drape the patient until all flammable preps have fully dried...Control of Anesthetic Explosion Hazards:...A. will only use A. Are pre-packaged to ensure controlled delivery to the patient in unit dose applicators, swabs or other similar applicators..."

1. During a procedure observation and tour of the OR [Operating Room] suite on February 9, 2016, it was observed that the anesthesia carts in OR1 and OR2 had individual bottles of alcohol-based hand sanitizer on top of the carts but not secured to the cart.

2. Observation of the alcohol-based hand sanitizer dispenser in OR2 on February 9, 2016, revealed, "...Ethyl Alcohol 65%...Warning for external use only Flammable, keep away from fire or flame, heat, sparks and sources of static...Ingredients...cetyl alcohol, ECOLAB - Advance Gel...18 ounces..."

3. During an interview on February 9, 2016, at 12:00 PM EMP6 indicated, "Yes, we are allowed to have them on the anesthesia carts, they can't be on the wall, because our anesthesia carts are moved to other walls for different surgeries..."

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on review of facility documents, observation and staff interview (EMP), it was determined that the facility failed to follow developed systems for controlling infections and communicable diseases of patients and personnel.

Findings include:

Review of a facility document on February 9, 2016, at 1:00 PM revealed, "...Critical Notes!...The Association of Professionals in Infection and Control and Epidemiology guidelines and the World Health Organization recommend using single-use or single-dose vials whenever possible...Clinical alert:...Perform hand hygiene...Remove the vial lid and disinfect the rubber stopper on the first drug vial with an alcohol pad using friction and allow it to dry..."

1. Observation of the Gastrointestinal Laboratory of Meadville Hospital's Grove Street campus on February 9, 2016, at approximately 8:50 AM revealed that EMP31 removed the lid on the vial of Propofol and did not disinfect prior to drawing up the medication. The medication was then administered to the patient of MR13.

2. During an interview on February 9, 2016, at approximately 9:00 AM, EMP34 confirmed that EMP31 did not disinfect the Propofol vial prior to drawing the medication.

3. During an interview on February 9, 2016, at approximately 9:15 AM, EMP31 indicated that if a vial is being entered for the first time after removing the lid, it is not necessary to disinfect.