The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ADENA REGIONAL MEDICAL CENTER 272 HOSPITAL ROAD CHILLICOTHE, OH 45601 March 23, 2012
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observations, staff interviews, review of policies, and review of medical records, it was determined the hospital failed to ensure patients received care in a safe setting in regard to the security of the facility. This had the potential to affect all patients in the facility.

Findings Include:

The facility failed to put corrective actions in place after a discharged patient accessed secured areas of the facility, unsupervised, on 02/05/12, at which time the patient wandered unsupervised throughout different areas of the facility, took a nurse's staff badge and entered a secured unit with said badge, was observed stealing medications from a crash cart on another unit and was discovered with hospital medications and property when attempting to leave the facility. The facility failed to have a system and policy/procedures in place to monitor and control visitors/patients from having access to restricted areas, failed to monitor all areas of the facility for safety and security, failed to provide adequate security staff to monitor the facility, failed to ensure patient safety by developing policies/procedures for drug storage, failed to store drugs and biological's in a secure manner to prevent unauthorized use, theft and tampering and did not educate staff to the potential dangers of drug theft and wandering visitors.

Due to the cumlulative affect of these findings the System Director of Quality was notified on 03/23/12, at 12:30 PM, that a determination was made that the health and safety of the patients in the hospital was in immediate jeopardy and is ongoing.

These findings substantiate the complaint.

The hospital census was 136. The hospital has 261 beds.

Refer to 482.13(c)(2) A 0144; Patient Rights: Care in Safe Setting.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, staff interviews, review of policies/procedures, and review of medical records, it was determined the hospital failed to ensure patients received care in a safe setting by monitoring and controlling visitors/patients leaving and entering the emergency department, to prevent individuals from having access to restricted areas, and monitoring/controlling and providing accountability of visitors/individuals staying in the hospital after visiting hours have ended. The hospital failed to ensure patient safety by developing policies and procedures for drug storage and failed to store drugs and biological's in a secure manner to prevent unauthorized use, theft, and tampering. This deficient practice had the potential to affect all 136 patients in the facility. The hospital has 261 beds.

Findings include:

Review of the medical record of Patient #1 was completed on 03/20/12. According to the emergency room medical record Patient #1 was treated in the emergency room in Room 19 on 02/03/12 at 11:01 P.M. for a motor vehicle collision with head, neck and back pain. The record documented the patient had a CAT Scan of the brain and cervical spine in the radiology department. In addition, the record documented x-rays were taken of the left shoulder in the radiology department. Patient #1 was discharged ambulatory per self from the emergency room on [DATE] at 1:06 A.M. Medical record review on 03/20/12 revealed Patient #1 returned to the emergency department on 02/05/12 and was triaged at 4:27 A.M. with severe pain in the head, back, and shoulders and taken to Room 8. The patient was discharged and left the emergency department at 7:01 A.M.

An interview with Staff B (Registered Nurse on Unit 3B) was conducted on 03/20/12 at 11:25 A.M. Staff B stated on 02/05/12 she was on Unit 3B and heard another Registered Nurse (Staff C) telling a male person (Patient #1) at the crash cart to put back the Epinephrine he had removed from the crash cart. Staff B stated she saw the lock had been broken on the crash cart, the top medication drawer was open and Patient #1 had removed the Epinephrine from the cart. Staff B stated she approached the patient and replaced the Epinephrine back into the crash cart. Staff B stated the patient told different stories as to why he was on the nursing unit. Staff B stated she escorted the patient back to the emergency department where his car was parked in the emergency ambulance entrance and instructed Patient #1 to leave. Staff B stated she saw Patient #1 pulling medications and medical supplies out of his pockets and place them on the front seat of his car. Security was then notified.

The security officers report (Staff K) was reviewed on 03/20/12. The report was dated 02/05/12 at 8:45 A.M. The report documented at 8:45 A.M. security was advised of a male subject wandering in areas of the hospital that he should not be in. A second call was received from Nursing Unit 3B about the same subject taking medication from the crash cart on unit 3B. At 9:05 A.M. the security officer made contact with Patient #1 asking about the supplies on the passenger seat of the car. Patient #1 attempted to start the car and drive off; however, the security officer reached in and removed the key from the ignition and prevented the patient from leaving. The security officer escorted the patient out of the car at which time a laptop computer fell to the ground from under the patient's coat. The computer was subsequently identified as being tagged property of the hospital and was identified as being taken from the same day surgery unit located in a restricted corridor outside the emergency room . During a search of the car, several medications were found that were later identified as being removed from the crash cart in the same day surgery unit. The local sheriff's department was notified and Patient #1 was subsequently arrested.

Interview with Staff L (Registered Nurse, Supervisor) on 03/20/12 at 10:15 A.M. stated that on 02/05/12 she was paged to the emergency department triage area. Upon arrival to the triage area Staff L stated she saw a gentleman wearing a coat and patient identification band surrounded by a security officer and two emergency room nurses. Staff L stated she was advised of the removal of medications and computer. Staff L stated she went to the same day surgery area and called staff in to check for missing items. Staff P (Registered Nurse from cath lab) came in and found the tag was broken on the crash cart in the same day surgery area and medications were missing (Vera, Heparin and saline flushes, Epinephrine, and Narcan). It was also verified a laptop computer was missing in same day surgery from a workstation on wheels. Staff L verified Patient #1 also had an employee badge in his possession (badge of Staff R, Registered Nurse in cath lab). Staff L stated when she checked the cath lab area she noticed the doors to the cath lab looked like they had been pried open. Staff L stated the cath lab doors were supposed to be locked, but when she checked them they were unlocked.

On 03/22/12, at 3:50 P.M. to 4:00 P.M., a telephone interview was conducted with Staff HH (emergency room registered nurse) who discharged Patient #1 on 02/05/12 at 7:01 A.M. This employee stated he gave Patient #1 verbal direction at discharge on how to exit the hospital. Staff HH stated he did not escort or monitor the patient leaving the hospital and had no way of knowing if the patient left the hospital building. Staff HH confirmed there is only one security officer on duty on the night shift and was not always in the security office where the security monitors are located.

Observations were made on 03/21/12, accompanied by Staff F, L, N, V, and E between 1:55 P.M. and 3:45 P.M. Observations in the emergency department revealed two areas with unsecured drugs/biological's, and syringes. The "code" room was unlocked with the door open. The room contained multiple shelves and carts filled with medical supplies (i.e., dressing supplies, tape, mobilizers, skin cleansing products, etc...). In addition, there was an open walk through area by Room 3. There was an overhead cabinet with two doors that had a sign posted stating IV amniocenteses, syringes, and medication needles. The cabinet was unlocked and was not able to be visually monitored from the nurses station. There was a locking mechanism on the outside cabinet door but the cabinet was not locked. Staff on the unit did not have a key to the locking device on the cabinet door. Staff N (Director of Emergency Department) verified this cabinet should be locked. Staff N further verified none of the Emergency Department staff had a key to this cabinet.

Observations further revealed the patients/visitors leaving the emergency department exited into a corridor that housed restricted patient care areas. The restricted corridor was unmonitored and unsecured and contained access to radiology, same day surgery, cath lab, and service elevators that could access inpatient care units. During tour of this corridor and adjoining ancillary departments there were 30 vials of Isoview (contrast dye used in X-ray procedures) in an unlocked, unsecured warmer in the radiology department. In addition, there were two vials of Lidocaine sitting on the shelf ledge by the observation window in the CAT scan room. There was no staff present in the room at this time. Plastic tag locked crash carts containing emergency medications and syringes and needle were seen placed in the same day surgery unit and radiology unit. The locker room (where the staff name badge was removed by Patient (#1) was observed to be accessible/unsecured from the corridor. Observations revealed service elevators in those areas providing access to inpatient care areas.

A tour was conducted with Staff L, Staff DD (Registered Nurse Manager of Labor/Delivery and Mother/Infant Unit) and Staff II (Registered Nurse Manager of Nursery and Pediatrics) on 03/22/12 between 4:20 PM and 4:35 P.M. of the clean supply room. This room was located on the locked and secure Women/Children/Infants Unit at the far end of the main corridor in which labor and delivery rooms were located and is located on a different floor of the hospital at the opposite end of the emergency room . Staff DD stated that Staff R's employee badge does permit access to this unit and to the clean supply room. Staff DD stated the only way to enter the secured unit was to either use an authorized employee badge or have staff release the electronic door release. Staff DD also stated the only way to enter the clean supply room was to use an authorized employee badge. Observations of the clean supply room revealed supplies for starting intravenous lines, syringes, and needles. Both Staff DD and II stated there was no process in place to tell if items were missing as they do not keep inventory logs of the supplies.

The Employee Badge Events Access Granted Report was provided for review on 03/20/12. The report documented Staff R's employee badge was used on 02/05/12 at 7:34 A.M. to enter the clean supply room (NEE 1N-166). This was the same employee's badge that was recovered from Patient #1's possession on 02/05/12 at 9:05 A.M. This patient was discharged from the Emergency Department on the same date at 7:01 A.M. An interview with Staff L (Nurse Manager/House Supervisor) on 03/22/12, at 4:20 P.M. revealed Staff R did not work in the facility on 02/05/12.

On 03/20/12 at 11:40 A.M. an interview was conducted with Staff F (Charge of Security). During the interview, Staff F stated on 03/20/12 at 8:50 A.M. they had a "Visitor Control" meeting with Staff J (former Charge of Security) and Staff M (System Director/Support Services) a few months ago to look at possible color coded badges for certain areas, limited entry to the hospital, and access control to certain areas such as same day surgery, and radiology. Staff F stated they were working on security assessments in the hospital, however, these were not completed and no systems had been put in place for visitor identification, monitoring of visitor whereabouts, or notification of security officers of individuals in the hospital after the end of visiting hours.

Interview with Staff J (former Chief of Security) on 03/20/12 at 9:55 A.M. staff stated on Saturdays and Sundays there is one security officer on duty between 6:00 A.M. and 10:00 A.M. to 11:00 A.M. Staff J further stated there was no formal written job duties or set rounding schedule for the security officers. Staff J stated there was no continuous monitoring of the security cameras in the security office. Staff stated the only criteria in place at present was for security officers to make rounds in the emergency department every half hour. Staff J stated there are currently changes ready to be made in the standards of operation procedures; however, these have not been implemented yet. Staff J further stated there was no paging system in place to alert staff of unauthorized individuals in patent care areas or restricted access areas.

The policy and procedure titled "Visitor Policy", policy number 1100-002 was reviewed on 03/21/12. The policy directed security's responsibility as "Security shall also maintain the proper function of the Access control System, limiting after-hours and unauthorized access to secured areas."

Refer to 482.25(b) A500; Delivery of Drugs.

Refer to 482.25(b)(2)(i) A502; Secure Storage.

These findings substantiate the complaint.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on staff interviews, observations, and review of facility policies/procedures, the facility failed to have approved pharmacy policies/procedures, failed to ensure drugs and biologicals were locked and secured, and failed to review and update the formulary. This affected all patients in the facility. The facility has a total of 261 beds and a census of 136 patients.

Findings include:

The facility failed to develop policies and guidelines to ensure patient safety through the appropriate control and distribution of medications, medication-related devices and biologicals.

Refer to 482.25(b) A500; Delivery of Drugs.

The facility failed to ensure only authorized personnel had access to locked in which medications were stored.

Refer to 482.25(b)(2)(i) A502; Secure Storage.

The facility failed to ensure only authorzied personnel have access to locked areas where drugs and biologicals are stored.

Refer to 482.25(b)(2)(iii) A504; Access to Locked Areas.

These findings substantiate the complaint.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interviews and review of facility policies/procedures, the facility failed to develop policies/procedures to ensure patient safety through the appropriate control and distribution of medications, medication-related devices and biologicals. This affected all patients in the facility. The facility has a total of 261 beds and a current census on 03/20/12 of 136 patients.

Findings include:

On 03/20/12 between 3:38 P.M. and 4:18 P.M., an interview with Staff V (Interim Pharmacy Director) verified the facility did not have any pharmacy policies/procedures in place. Staff V stated the former contracted pharmacy consultant company terminated their contract in December, 2011, and a new contracted company, of which Staff V is an employee, began providing consultant pharmacy services to the facility on [DATE]. Staff V stated he/she began working in this facility on 01/03/12 as the Interim Pharmacy Director. When asked if the facility had pharmacy policies/procedures, Staff V stated the former contracted pharmacy consultant company "shredded" the policies when they left and the facility does not currently have any pharmacy policies in place.

On 03/21/12 at 10:40 A.M., Staff V and Staff W both stated the facility does not have any policies in place in regard to medication storage and security of medications. Staff W stated the facility does not have any backup policies. Staff W stated Staff CC (System Director of Pharmacy) contacted the contracted company to get the policies; however, was informed by the company the policies were shredded. Staff W also stated the facility found a total of 13 pharmacy policies; however, they have not been through the policy/procedure review committee, with the exception of the stop date policy.

According to the termination agreement, dated 11/17/11, with the previous contracted pharmacy company, the agreement terminated at 11:59 P.M. on 12/31/11. The agreement stated the contracted company shall leave one copy of the Policy and Procedure Manual with the facility; however, the agreement was not signed by the contracted pharmacy company. A termination letter, dated 12/20/11, by the same company was written to Staff CC (System Director of Pharmacy) stating the termination of the agreement will occur at midnight on 12/31/11. The letter also stated the following materials to be retained by the facility is one copy of the Policy and Procedure Manual provided by the management company for hospital's internal use only.

The hospital provided a copy of an email, authored by Staff CC, dated 01/24/12, to the terminated management company that the policy and procedures that was left behind did not include the most recent policies for the IV room and the records demonstrating staff review of policies. A response email, dated later that same date (01/24/12) by the terminated management company documented: "I am sorry. The books have been destroyed." The facility provided a copy of a letter, dated 03/21/12, written by the facility's general counsel, to the Executive Vice President & COO of the terminated consulting company. This letter stated the former management company did not leave a copy of the Policy and Procedure Manual in the hospital's possession, and the hospital is formally demanding the facility be given a manual by the end of business day on 03/26/12.

Refer to 482.13(c)(2) A-0144; for an incident in which a discharged patient wandering unsupervised into restricted areas was observed removing medications and medical supplies without permission. This incident occurred on 02/05/12.

This finding substantiates the complaint.
VIOLATION: SECURE STORAGE Tag No: A0502
Based on staff interviews, review of facility policies and observations, the facility failed to ensure drugs and biologicals were kept in a secure area and locked when appropriate. The hospital census was 136. The hospital has 261 beds.

Findings include:

Observations were made on 03/21/12, accompanied by Staff F, L, N, V, and E between 1:55 P.M. and 3:45 P.M. Observations in the emergency department revealed two areas with unsecured drugs/biological's, and syringes. The "code" room was unlocked with the door open. The room contained multiple shelves and carts filled with medical supplies (i.e., dressing supplies, tape, mobilizers, skin cleansing products, etc...). In addition, there was an open walk through area by Room 3. There was an overhead cabinet with two doors that had a sign posted stating IV amniocenteses, syringes, and medication needles. The cabinet was unlocked and was not able to be visually monitored from the nurses station. There was a locking mechanism on the outside cabinet door, but the cabinet was not locked. Staff on the unit did not have a key to the locking device on the cabinet door. Staff N (Director of Emergency Department) verified this cabinet should be locked. Staff N further verified none of the Emergency Department staff had a key to this cabinet.

Observations further revealed the patients/visitors leaving the emergency department exited into a corridor that allowed for individuals to enter into restricted patient care areas. Staff N confirmed ambulatory patients are discharged without staff escort into this corridor which had open, accessible access to the restricted areas. The restricted corridor contained access to radiology, same day surgery, cath lab, and service elevators that could access inpatient care units. During tour of this corridor and adjoining ancillary departments there were 30 vials of Isoview (contrast dye used in X-ray procedures) in an unlocked, unsecured warmer in the radiology department. In addition, there were two vials of Lidocaine sitting on the shelf ledge by the observation window in the CAT scan room. There was no staff present in the room at this time. Plastic tag locked crash carts containing emergency medications and syringes and needle were seen placed in the same day surgery unit and radiology unit.

These unlocked medications and biologicals were verified per interview with the aforementioned staff on tour.

Refer to 482.13(c)(2) A-0144; for an incident in which a discharged patient wandering unsupervised into restricted areas was observed removing medications and medical supplies without permission. This incident occurred on 02/05/12.

This finding substantiates the complaint.
VIOLATION: ACCESS TO LOCKED AREAS Tag No: A0504
Based on observations, facility policy review, and staff interviews, the facility failed to ensure only authorized personnel had access to locked areas in which medications were stored. The facility has a total of 261 beds and a census of 136 patients.

Findings include:

On 03/20/12 between 3:38 P.M. and 4:18 P.M., an interview with Staff V (Interim Pharmacy Director) verified the facility did not have pharmacy policies/procedures in place to address how it prevents unauthorized personnel from gaining access to areas where biologicals and drugs were stored.

Refer to 482.25(b) A500; Delivery of Drugs.

During observation of the facility, on 03/20/12, unlocked and unsupervised medications and biologicals were observed in the Emergency Department and Radiology.

Refer to 482.25(b)(2)(i) A502; Secure Storage.

On 02/05/12, a discharged patient had access to restricted areas in which unlocked medications were stored.

Refer to 482.13(c)(2) A 0144; Patient Rights: Care in Safe Setting.

This substantiates the complaint.
VIOLATION: FORMULARY SYSTEM Tag No: A0511
Based on staff interviews and review of the hospital formulary, the facility failed to ensure the formulary was periodically reviewed and updated. This affected all patients in the facility. The facility has a total of 261 beds and census of 136 patients.

Findings include:

On 03/21/12, at 3:38 P.M., an interview was conducted with Staff V (Interim Pharmacy Director) regarding the hospital formulary regarding the last time the formulary was reviewed. The facility lacked documented evidence of the last date the hospital reviewed the formulary. Staff V stated the formulary has not been reviewed since at least 01/01/10. When asked what the facility practice is for reviewing the formulary, Staff V stated it should be reviewed on an annual basis.

This finding substantiates the complaint.