HospitalInspections.org

Based on interview with and written statement from Employee
Identifier (EI) # 7, the Director of Nursing, it was determined the hospital failed to ensure all clinical personnel had current Cardiopulmonary Resuscitation (CPR) which included 6 of 6 Licensed Practical Nurses (LPN) and 8 of 8 Certified Nurse Aides (CNA) employed by the facility. This had the potential to affect all patients served by the facility.

Findings include:

An interview conducted on 2/17/11 at 1:20 PM, with EI # 7 confirmed that not all required clinical personal had a current CPR certification and none could be provided.

Receipt of a written document 2/18/11 from EI # 7 included the following:"...In trying to get copies of the LPN's and CNA's CPR card I found that they all expired 04/2010..."

Based on review of Emergency Department (ED) medical records, review of inpatient medical records and staff interviews it was determined the facility failed to provide the patient or a patient representative of a notice of their rights on admission and failed to document provision of the rights for 30 of 30 ED medical records reviewed and for 7 of 7 inpatient records reviewed. This had the potential to affect all patients who presented to the ED for treatment and all patients admitted to the facility.

Findings include:

A review of 30 ED medical records and 7 inpatient records revealed no documentation of Patient Rights being discussed or documented as being provided to the patients or their representatives.


During interview on 2/17/11 at 1:00 PM, EI #7, the Director of Nursing (DON), confirmed there was no documentation the Patient Rights were given to or explained to any patients.

Based on observations and an interview with administrative staff, it was determined the hospital failed to post instructions informing patients of their right to file a grievance with the State agency. Also, this information was not included in the paperwork provided to the patients upon admission. This had the potential to affect all patients receiving services from the hospital.

Findings include:

1. During a tour of the Emergency Department (ED) on 2/16/11 at 8:30 A.M. with the Director of Nursing, Employee Identifier (EI) 7, it was noted the hospital did not have the toll free State Hot Line number posted for patients to voice grievances.

An interview with EI #7 on 2/17/11 at 1:00 P.M. confirmed the above.

Based on observation, review of facility policy, review of United States Pharmacopoeia (USP) procedures and requirements for compounding sterile preparations, review of Alabama State Board of Pharmacy Sterile Compounding Pharmacy-USP <797> Risk Level Assessment Form and staff interview, it was determined the hospital failed to assure the USP procedures were followed for mixing of intravenous (IV) medications. This had the potential to affect all patients served.


Findings include:

Pharmacy Times August 2006

Particle Monitoring Must Meet USP <797> Requirements

The USP recently released procedures and requirements for compounding sterile preparations. General chapter <797> titled "Pharmaceutical Compounding--Sterile Preparations," states that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. The nature of defining how these preparations shall be compounded is related to the potential risk to patients, should errors occur,

Environmental Requirements

Preparations are compounded according to 1 of 3 risk factors: low, medium, and high. Those preparations that are compounded as aseptic parenterals have the greatest risk of contamination, and therefore they must be compounded in an area tolerating only the lowest level of risk. According to the USP <797>, "aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are errors of nonsterility and large errors in ingredients," and therefore the greatest level of control over compounding must be proven. They must be compounded under a "laminar flow hood, barrier isolator, or other contamination control device appropriate for the risk level, that provides an adequate critical site environment."

While on tour of the hospital pharmacy on 2/16/11 at 10:00 AM with Employee Identifier (EI) # 1, Pharmacist in Charge, it was noted the hospital did not have a laminar flow hood, a barrier isolator, or any other contamination control device for use when mixing medications into sterile intravenous fluids for patient infusions.

Hospital Policy

Pharmacists

Page 26

(Paragraph 3) All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist and performed consistent with state and Federal laws.

Hospital Policy

Immediate-Use Medication Policy

Page 88-90

Page 89 (Paragraph 2) The pharmacy shall prepare, label, distribute and store sterile and parenteral products in accordance with recognized authoritative references and pharmacy policies and procedures.

Page 90 (Paragraph 1) Prior release from the pharmacy, a pharmacist shall examine all final products....

Page 90 (Paragraph 3) Nursing Service is responsible for the administration of the finished product.....



On 2/16/11 at 10:30 AM, EI # 1, Pharmacist in Charge, confirmed the hospital did not have the proper equipment to compound IV medications and had been using premixed IV solutions. EI # 1 stated that the registered nurses (RN) started mixing the IV solutions in January 2011 since the solutions are for Immediate Use only. At 11:30 AM on 2/16/11 a copy was provided of the USP <797> Risk Level Assessment Form that was sent to the Board of Pharmacy on 12/7/10.

During interview on 2/17/11 at 9:55 AM, EI # 1 confirmed The USP <797> Risk Level Assessment Form was resubmitted on 12/7/10 for renewal as Immediate-Use CSPs (Compounded Sterile Preparations) as immediate-use level only. EI # 1 confirmed they have not received anything back from the Pharmacy Board that they have been approved as an Immediate-Use Level CSPs. No documentation was provided the RN's could mix the IV medications even if the Immediate-use Level CSPs was approved by the Pharmacy Board.

Based on observation, an interview with facility staff and review of the hospital's policies and procedures, the facility failed to ensure all medications and biologicals available for patients were not expired. This had the potential to affect all patients.

Findings include:

1. Hospital Policy

Outdated (Expired) and Other Unusable Drugs and Devices.

Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use.
Unusable drugs and devices include those that are:
Expired
Recalled
Contaminated
Mislabeled
The pharmacy shall identify outdated and other unusable drugs and devices and prevent their distribution and administration. Pharmacy, nursing, and other personnel who discover outdated and other unusable drugs and devices, and containers with worn illegible, or missing labels shall return them to the pharmacy for proper disposition.

If an expiration date is expressed only as a month and year, the date of expiration shall be the last day of the stated month.

An observation was conducted in the Emergency Department(ED)on 2/16/11 at 8:30 AM. The surveyor and the Directory of Nursing, Employee Identifier #7 observed the following expired drugs and sterile supplies:

Crash Cart
4 syringes Lidocaine 2% injection 20 milligrams(mg)/milliliter(ml) expired 12/10.
2 vials Solu Medrol 500 mg expired 12/10.
3 vials Magnesium Sulfate(MgSO4) expired 1/11.
3 250 ml bag 5% Dextrose with Lidocaine 1 gram expired 10/10.

Drug Room
10 vials Amiodarone 150 mg/3 ml expired 1/11.
6 vials Vitamin B12 expired 10/10.
4 vials Haldol 5 mg expired 12/10.
1 vial Heparin 10,000 units expired 8/10.
1 vial Nitroglycerin 50 mg/10 ml expired 9/10.
1 container Nitrolingual Pump Spray expired 12/10
6 vials 0.9% Normal Saline 10 ml expired 7/10.

Exam Room #1
1 pack Steri Strips expired 3/10.
1 Obstetrical Pack expired 9/05.

Exam Room #2
56 Insytes Intravenous Catheter 18 gauge expired 8/10.
11 Insytes Intravenous Catheter 18 gauge expired 1/11.

Trauma Room #1
6 Enteral Nutrition Bags expired 11/07.
5 Female Catheter Kits expired 7/07.
1 bottle Iodoform Packing expired 1/11.
4 vials 0.9% Normal Saline 10 ml expired 7/10.(In Ear Tray)
1 pack Steri Strips expired 3/10.
9 packs Vicryl Sutures expired 1/00.
1 Insytes Intravenous Catheter 24 gauge expired 12/10.

Based on observations during a facility tour with hospital staff by the Fire Safety Compliance Officer and staff interviews, it was determined that the facility was not constructed, arranged and maintained to ensure patient safety.

Findings include:

Refer to Life Safety Code violations.