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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.

Based on review of departmental policies and procedures and interview with staff, the facility failed to follow their policy for review of departmental manuals. This had the potential to affect all patients.

Findings include:

The policy titled "Hospital Policies and Procedures" included, "The hospital wide policies are updated annually by the person responsible for this area".

During the survey departmental manuals to include Rehabilitation, Nursing, Emergency Room, Radiology, Infection Control, Respiratory, Surgery and Pharmacy were reviewed.

There was no documentation of an annual review and no "reviewed" sheet was available for review when requested by surveyors.

An interview with Employee Identifier # 1, the Chief Nursing Officer, on 4/28/11 at 11:00 AM confirmed no policy review signature sheets were available for review.

Based on record review, observation of medication pass and interview with facility staff, it was determined the facility failed to assure medication was available for a patient in a timely manner. This affected Medical Record (MR) #5.

Findings include:

1. MR # 5 was admitted on 4/25/11 with diagnoses to include Pneumonia, Respiratory Distress and Chronic Obstruction Pulmonary Disease (COPD).

During an observation on 4/27/11 at 9:50 AM of a medication pass, MR #5 was given his medications except Brovana "1 puff patient's own". Employee Identifier (EI) #3, the staff Licensed Practical Nurse (LPN), asked the patient if he had this medication and he stated, "No". The LPN went to the pharmacy department to ask about this medication and EI #4, the Pharmacy Technician, stated, "His family was suppose to bring that, because we don't have it on our formulary".

Review of the patient's medication record revealed the Brovana was ordered to start on 4/25/11 at 11:00 PM and documentation of medication administration by the nurse was as follows:
4/25/11 at 11:00 PM: circled as given with no reason documented
4/26/11 at 10:00 AM: circled with "family to bring" documented
4/26/11 at 11:00 PM: circled with "family to bring" documented

There was no documentation the physician was informed this medication was not available for patient use.

An interview on 4/27/11 at 12:10 PM with EI #1, the Chief Nursing Officer, confirmed the above.

Based on observation, interview and review of the hospital's policies and procedures, it was determined the facility failed to ensure that all medications and supplies available for patient use in the Emergency Room (ER) and in the Surgical Department were not expired. This had the potential to affect all patients.

Findings include:

Facility Policy No. 11-13

DEPARTMENT: Pharmacy
SUBJECT: Unusable Drugs and Devices
ISSUED BY: Pharmacy and Therapeutic Committee
EFFECTIVE/REVIEW DATE 6/93

IDENTIFICATION OF UNUSABLE DRUGS AND DEVICES
The pharmacy shall identify unusable drugs and devices and prevent their distribution and use. The Director of Pharmacy or qualified designee shall check for unusable drugs and devices during the monthly inspection of drug storage areas.


1. Observations were conducted in the Emergency Room (ER) on 4/27/11 at 7:35 AM. The surveyor and Employee Identifier (EI) # 5, the ER Nurse Manager, observed the following expired supplies:

ER#3 bed area:
Vicryl 2-0 suture times(x) 1 box expired (exp) 7/09
Prolene 3-0 x 1 box exp 1/09
Ethilon 7-0 x 1 box exp 1/09
Ethilon 6-0 x 1 box exp 1/09
Vicryl 1 x 1 box exp 1/09
Prolene 3-0 x 1 box exp 7/10
Vicryl 0 x 1 box exp 7/06
Prolene 2-0 x 1 box exp 7/06

ER Crash Cart:
Blue Top collection tube x 2 expired 11/10
Bone Marrow Aspiration/Intraosseous Infusion Needled x 1 exp 3/10
Bone Marrow Aspiration/Intraosseous Infusion Needled x 1 exp 7/10
Adult Defibrillator Electrodes x 1 pack exp 4/09
Tracheal Tube Introducer x 1 exp 7/09

ER#4 bed area:
Plain Packing Strip x 2 exp 1/11
Plain Packing Strip x 1 exp 1/08
Thoracentesis/Paracentesis Tray x 1 exp 9/07
Thoracentesis/Paracentesis Tray x 1 exp 11/09
Peritoneal Lavage Tray x 2 exp 5/09
Pediatric Two-Lumen Central Venous Catheterization Kit x 2 exp 11/09

An interview on 4/27/11 at 7:35AM with EI # 5 confirmed the above supplies were expired.


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2. Observations were conducted in the Surgical Department on 4/27/11 at 12:05 PM. The surveyor and Employee Identifier (EI) # 6, the Surgery Nurse Manager, and EI # 7, the Certified Registered Nurse Anesthetist (CRNA), observed the following expired medications in the Malignant Hypothermia Cart:

5 vials Furosemide 40mg (milligrams) (10 mg per milliliter) Expired 11/1/10
4 vials 25 % Mannitol 50 ml (milliliter) Expired 4/1/11
2 vials Calcium Chloride 10 ML single dose vials expired 12/10
3 bags 50 ml 50% Dextrose expired 12/1/10
5 injectable 8.4 % Sodium Bicard Expired 3/1/11

An interview on 4/27/11 at 12:05 PM with EI # 6 and EI #7 confirmed the above medications were expired.

Based on review of the hospital formulary, review of hospital policies and staff interview, it was determined the hospital failed to ensure the medical staff documented its review and acceptance of the formulary on an annual basis. This had the potential to affect all patients.

Findings include:

Hospital Policy No. 12-02
Department: Pharmacy
Subject: Formulary: Maintenance
Effective/Review Date: 6/93

Review and Revision

The Director shall review the formulary at least annually, and update it as necessary. The medical staff should document its review and acceptance of the updated formulary at least annually.


1. During a tour of the hospital pharmacy on 4/27/11 at 10:25 AM with Employee Identifier (EI) # 8, the pharmacist, a copy of the hospital formulary was provided to the surveyor. During the tour the surveyor requested documentation that the formulary had been reviewed and accepted by the medical staff. EI # 8 provided a copy of the 9/3/09 Pharmacy and Therapeutics Committee Meeting minutes which documented the Formulary was reviewed and approved but was unable to provide documentation that the formulary had been reviewed and accepted by the medical staff since 2009.

During an interview on 4/27/11 at 10:30 AM, EI # 8 confirmed there was no documentation the formulary had been reviewed and accepted on an annual basis since 2009.

Based on observations, policy review and staff interview, it was determined the hospital failed to ensure their policy was followed to protect the safety of the unborn child during radiological exams. This had the potential to affect all pregnant patients receiving radiology services.

Findings include:

Hospital Policy Reference #1039a
Subject: Radiological Examinations on Pregnant Patients
Effective: 08/18/2007

Procedure:
All female patients will be asked if they may be pregnant prior to the examination. Signs are also posted in English requesting that potentially pregnant patients inform the technologist.

1. On 4/27/11 a tour of the radiology department was conducted with Employee Identifier (EI) # 9, the Radiology Director.

Observations during the tour of the Mammography Room at 2:25 PM revealed there was no posting of the required pregnancy sign in the Mammography Room or at the entrance to the Mammography Room. EI # 9 confirmed there was no pregnancy sign posted.

Observations during a tour of the mobile computed tomography (CT) unit at 2:30 PM revealed there was no posting of the required Pregnancy sign in the mobile unit or at the entrance of the mobile CT unit. Room. EI # 9 confirmed there was no pregnancy sign posted.

During an interview after the tour was completed at 3:20 PM on 4/27/11, EI # 9 confirmed these findings.

Based on review of Radiology Department policies, review of Radiation Dosimetry Reports, and staff interview, it was determined the hospital failed to ensure the radiation workers were checked according to their policy for radiation exposure.

Findings include:

Hospital Policy Reference #4029
Subject: Radiation Monitoring Badge
Effective 8/18/2007

Policy

A film badge shall be worn at all times while performing any radiographic procedures, including mammograms. The badge shall be worn on the collar or waist, checked monthly and reviewed by the Radiation Safety Officer monthly. Records shall be kept as required. Any over-exposures shall be reported to the State of Alabama Department of Health Services.

Hospital Policy Reference #3001
Subject: Imaging Services
Effective: 8/18/2007

Policy:

Paragraph 3
All Imaging Services employees shall report defective equipment, unsafe conditions, acts or safety hazards to Imaging Services Manager.

(Bulleted item # 17)
Radiation exposure badges shall be worn by all employees. Badges will be processed and recorded monthly.

1. During the tour of the Radiology Department on 4/27/11 at 1:55 PM, Employee Identifier # 9, the Radiology Director stated badges were used to monitor employee radiation exposure. The surveyor requested to see documentation of the Radiation Dosimetry Reports.

The following Radiation Dosimetry Reports were provided and reviewed at 2:00 PM on 4/27/11:
Report Date 3/19/10 for Dosimeters received 3/12/10 for the monitoring period 11/20/09-1/19/10
Report Date 4/01/10 for Dosimeters received 3/26/10 for the monitoring periods 9/20/09-11/19/09 and 1/20/10-3/19/10.
Report Date 5/24/10 for Dosimeters received 5/17/10 for the monitoring period 3/20/10-5/19/10
Report Date 9/13/10 for Dosimeters received 9/7/10 for the monitoring periods 11/20/09-1/19/10 and 5/20/10-7/19/10, 5/20/10 and 7/20/10-9/19/10.

There was no documentation the exposure badges had been monitored for the time period of 9/20/10 through 4/27/11.

During interview on 4/27/11 at 2:00 PM, EI # 9 had stated that the exposure testing was suppose to have been done at least every other month. EI # 9 confirmed the radiation checks had not been done monthly and the badges had not been checked for radiation exposure since September 2010.

Based on observation and interview with facility staff, it was determined the facility failed to ensure equipment was monitored to maintain safety of patients and staff. This had the potential to affect all patients.

Findings include:

A tour of the physical therapy department was conducted on 4/27/11 at 1:50PM. an operable Hydro collator was observed with packs present. The surveyor requested the temperature monitoring logs and the current temperature of the contents. There were no temperature monitoring logs available for review and Employee Identifier # 2, the Physical Therapy Manager, stated, "I don't think the thermometer is working right".