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Based on observation, interview and clinical record review, it was determined the facility failed to ensure hospital had only one (1) effective governing body that met separately and was not shared with each certified hospital under the corporate system umbrella (Refer to the findings below).

Additionally, The facility failed to ensure contracted services were provided in a safe and effective manner (Refer to Standard A0084); Patient care and safety (Refer to CoP A0115 and Standard A0144); Quality Assurance Performance Improvement program was maintained as an ongoing effective data-driven hospital-wide program (Refer to CoP A0263 and Standards A0144, A0395, A0405, A0502, and A0724); Nursing followed medication orders as prescribed (Refer to Standard A0395); and Equipment was maintained to ensure an acceptable level of safety and quality that also included a regular periodical maintenance and testing program for the alarms located in the dialysis water testing and patient care areas (Refer to Standard A0724).

The cumulative effect of this lack of oversight and systemic issues resulted in the Governing Body's inability to ensure the facility maintained the provision of quality health care in a safe environment and assured that the patients' right to quality of care, treatment, and services had not been compromised. This has the potential to affect the health, safety, and well-being of all the patients the hospital serves.

The findings include:

1. Upon facility entrance on 1/3/11 at approximately 10:15 a.m., the Vice President of Patient Services was asked if the hospital had its own governing body. She reported that the hospital did not have its own governing body. The Vice President of Quality added the Board of Directors (aka Governing Body) met as a system-wide entity but rotated hospitals for their meetings.

2. The hospital was asked to provide minutes of these meetings. The submitted minutes were reviewed and confirmed the Board of Directors (aka Governing Body) meetings were held as a system-wide entity with 1/28/10 meeting held at Cape Coral Hospital, 5/27/10 meeting held at Lee Memorial Hospital and 10/28/10 meeting held at Cape Coral Hospital. No additional meeting minutes were provided.

3. During a meeting with the administrative staff on 1/6/11 at approximately 3:00 p.m., they were asked if the hospital had any documentation to support that the hospital had its own governing body. Documentation was provided at approximately 4:30 p.m. in the form of agendas for 1/28/10, 5/27/10 and 10/28/10 that did not support the presence of a single governing body and failed to correlate with the times presented in the system-wide Board of Directors (governing body) minutes.

4. A meeting was held with the Chief of Operations, Vice President of Patient Services including Risk Management and Quality Systems Director on 1/6/11 at 8:30 a.m. A sample mock agenda for 2011 was provided as an illustration of a single governing body agenda pertinent to the hospital. However, it was also reported this meeting had not been held to date and was proposed for later in January 2011. The Chief of Operations confirmed at this time that for the calendar year 2010 the hospital had no governing body that met the Condition of Participation as per regulation and only had a system-wide governing body. This confirmation substantiated the hospital failed to have only one (1) effective governing body that met separately and was not shared with each certified hospital under the corporate system umbrella.

Based on observation, interviews and contract review, the governing body failed to ensure the services performed under a contract were provided in a safe and effective manner. The governing body was not aware that two different alarm systems in the dialysis unit, which would alert the staff of a problem with the water being used in the dialysis treatments, were in working order. This lack of alarm systems decreased the level of safety for dialysis patients.

The findings include:

1. Review of a contract dated 12/03/07 revealed in part: "4. Performance of services: (name of company) will perform services in accordance with generally recognized standards of care as outlined by federal, state and local applicable laws and regulations, as such may be amended from time to time."

Observation of the water room in the dialysis unit on 1/3/11 at 10:45 a.m., revealed a deionizer (DI) system for the water used during the dialysis treatments.

During an interview on 1/5/11 at approximately 9:00 a.m., with the clinical manager who oversees four dialysis units, he was asked if there was an audible and visible alarm in the treatment area should the water system malfunction. He stated there was no alarm in the unit. He stated an alarm goes off in the PBX room and the operators are educated to call plant operations to report the alarm.

During an interview with the hospital operator on 1/05/11 at 1:20 p.m., she stated when the alarm goes off she immediately calls plant operations (plant op) at 1860. The alarm was observed on the wall in front of the operator with the number to call.

During an interview with the secretary of plant operations on 1/05/11 at 1:25 p.m., she stated she would contact the "House Call Person" in plant operations to report the alarm going off for the dialysis unit. At 1:30 p.m., the head of plant operations stated he received an e-mail from the clinical manager stating the filter is on the wrong side and the alarm in PBX was not working.

On 1/05/11 at 2:00 p.m., a service technician stated there was an alarm in the water room which could be heard in the unit. He stated there was also an alarm above one of the beds in the unit. At 3:50 p.m., after the last patient was treated, the technician changed the value of the meter to show if the alarm was working. The alarm worked in the PBX room but not in the water room or the dialysis unit. There was no documentation as to when the last time the alarm went off. There was no documentation of the alarms being tested.

Critical alarms, such as those associated with deionizer exhaustion or low water levels in a storage tank, should be configured to sound in the patient treatment area, as well as in the water treatment room.

This Condition of Participation is not met based on observation, interviews, record reviews and review of hospital policies and procedures, which determined the hospital failed to ensure patients received care in a safe setting as it relates to the safety of the dialysis water systems and lack of functioning alarms; facility failure to maintain the security of medications. Please refer to the Standard of A-0144, A-0502 and A-0724 for additional information.
This has the potential to affect the health, safety and well-being of all the patients the hospital serves.

The findings include.

A-0144
Based on observation and interviews with staff, the facility failed to ensure the patient has the right to receive care in a safe setting. Unsecured medications were observed in the emergency room, the dialysis unit, the surgical suite and the medical-telemetry unit. A discharged patient's medications were in an unlocked drawer and not sent to pharmacy.

A-0502
Based on observation and interview with staff, the facility failed to ensure all drugs and biologicals were kept in a secure area and locked when appropriate. A refrigerator in the surgical suite had unsecured medications.

A-0724
Based on observation and interview, the facility failed to ensure facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality. The two alarms in the water room and dialysis unit were not in working order, which decreased the level of safety for dialysis patients.

Based on observation and interviews with staff, the facility failed to ensure a patient has the right to receive care in a safe setting. Unsecured medications were observed in the emergency room, the dialysis unit, the surgical suite and the medical-telemetry unit. A discharged patient's medications were in an unlocked drawer and not sent to pharmacy. The alarm for the water treatment used in the dialysis unit was not working.
The findings include:
1. Observation on 1/03/11 at 12:15 p.m., during the tour of the Emergency Room (ER) in the presence of the ER Director revealed a syringe filled with normal saline on top of the counter next to the bed a patient was lying on in room 5. The tour continued to room 17 where an IV (intravenous therapy) cart was observed to have been left open next to the bed where the patient was laying in. The cart contained various syringes, IV fluids and 18 Bact/Alert vials in the drawers of the cart.
Interview with the ER Director at the time of the tour confirmed the items identified should have been out of patient reach and in a locked cart.
2. On 1/03/11 at 10:30 a.m., while touring the medical-telemetry unit on the 3rd floor with the charge nurse and the Intensive Care Unit Director (ICUD), the medication drawers for Room #372 and Room #373 were observed to be unlocked. The medication drawer for Room #373 had no medication but did have medication cups, syringes and needles. The medication drawer for Room #372 contained medications for Patient #21 which include Sinemet 25/100 mg tablets, a Vitamin B-12 1000 mcg bottle and a bottle of Nitrostat 0.4 mg. Neither the primary nurse nor any other facility staff (with the exception of the staff accompanying the surveyor) was in the area during the observation of the unsecured medications.
Interview with the charge nurse and the ICUD on 1/03/11 at 10:35 a.m., confirmed that both medication drawers were unlocked with no facility staff in the area. The charge nurse stated the medication drawers are required to be locked at all times when they are not being monitored. The charge nurse confirmed Room #372 medication drawer contained Sinemet 25/100 mg tablets, a bottle of Vitamin B-12 unit dose and Nitrostat 0.4 mg bottle. The charge nurse stated the Sinemet 25/100 mg and the Vitamin B-12 were put in the drawer by pharmacy but the Nitrostat 0.4 mg bottle should not be in the medication drawer because it is coded to be in the pharmacy dispensing cabinet.
On 1/03/11 at 10:45 a.m., interview with the nurse for Rooms #372 and #373 confirmed she left the medication drawers unlocked while she was down the hall.
On 1/05/11 at 1:30 p.m., a follow-up to Room #372 and Room #373 revealed the medication drawer for Room #373 was locked. The medication drawer for Room #372 was not locked. The medication drawer revealed Patient #21's Sinement 25/100 mg tablets and a bottle of Nitrostat 0.4 mg tablets with no staff present.
Interview with the unit charge nurse at 11:40 a.m., confirmed Room #372 the medication drawer was not locked and contained Patient #21's Sinemet 25/100 mg tablets and Nitrostat 0.4 mg bottle. The charge nurse confirmed there was no staff present and the medication drawer should be locked when there is no staff present. The charge nurse further stated the Nitrostat 0.4 mg did not belong in the locked drawer; he then took the Nitrostat 0.4 mg bottle and threw them in the sharps container on the wall.
On 1/05/11 at 11:45 a.m., interview with the nurse for Room #372 (Patient #35) and the unit director, the nurse confirmed she had left the medication drawer for Room #372 unlocked. She further stated she had worked on 1/04/11 and had discharged Patient #21 at around 6:00 p.m. and the medications in the medication drawer should have been returned to the pharmacy at that time. She stated Patent #21's medication should not be in Patient #35's unlocked medication drawer.
Interview with the Unit Director on 1/05/10 at 11:55 a.m., confirmed the medication drawers are required to be locked at all times. She also stated when a patient is discharged from the room the nurse is required to take the medications from the medication drawer and send them to the pharmacy. At no time should another patient's medication be allowed in another patient's medication drawer.
3. Observation of the water room in the dialysis unit on 1/03/11 at 10:45 a.m., revealed a deionizer (DI) system for the water used during the dialysis treatments.

Observation in the dialysis unit on 1/03/11 at 11:00 a.m., revealed 2-30 cc bottles of heparin on a cart near a patient being dialyzed. The bottles were given to the staff nurse who stated she would lock them in the cabinet. On 1/04/11 at approximately 9:00 a.m., another bottle of heparin was observed in the same cart.

Observation of the "Block" cart on 10/4/11 at 11:00 a.m., in the surgical suite revealed unsecured Lidocaine, Bupivacaine Hcl with epinephrine. This was noted with 2 nurses present.
Observation on 1/04/11 at 11:10 a.m., in an operating room which was not in use revealed a "Multi-lumen Central Venous catheter" kit containing a 5 ml ampule of HCL/1% lidocaine solution on the top of an anesthesia cart. In one of the obstetric operating rooms an unsecured spinal tray containing an ampule of Bupivacaine Hcl was observed.
Observation of the "Traveling Difficult Intubation Cart" in the surgical suite revealed unsecured exactacaine in a drawer. In the soiled room an observation of the "Flammable box" revealed unsecured acetic acid, lidocaine Hcl (7 ampules) and silver nitrate applicators.
In the Genito-urinary (GU) room unsecured Isovue-300 was observed in a bin.
In a refrigerator in the surgical suite at 2:30 p.m. on 1/04/11, an observation was made of thrombin topical, bacitracin and methylergonome maleate. There was no lock on the door.
4. During an interview on 1/05/11 at approximately 9:00 a.m., with the clinical manager who oversees four dialysis units, he was asked if there was an audible and visible alarm in the treatment area, he stated there was no alarm in the unit. He stated an alarm goes off in the PBX room and the operators are educated to call the plant operations to report if/when the alarm in the dialysis unit went off.

On 1/05/11 at 2:00 p.m., a service technician stated there was an alarm in the water room which could be heard in the unit. He stated there was also an alarm above one of the beds in the unit. At 3:50 p.m., after the last patient was treated, the technician changed the value of the meter to show if the alarm was working. The alarm worked in the PBX room but not in the water room or the dialysis unit. There was no documentation as to when the last time the alarm went off.

Based on record review, observation, interview and review of policies and procedures, it was determined the facility failed to ensure the Quality Assurance Performance Improvement (QAPI) program was maintained as an ongoing effective data-driven hospital-wide program (Refer to CoP's A0043, A0115 and Standards A0084, A0144, A0395, A0405, A0469, A0502 and A0724).
The findings include:
1. Based on observation, interview and clinical record review, it was determined the facility failed to ensure: 1. That the Hospital had only one (1) effective governing body that met separately and was not shared with each certified hospital under the corporate system umbrella; 2. Contracted services were provided in a safe and effective manner (Refer to Standard A0084); 3. Patient care and safety (Refer to CoP A0115 and Standard A0144); 4. Nursing followed medication orders as prescribed (Refer to Standard A0395 and A0405); 5. Medication was stored in a safe and secure manner (Refer to Standard A0502) 6. Medical Records were completed within thirty days of patient discharge and 7. Equipment was maintained to ensure an acceptable level of safety and quality that also included a regular periodic maintenance and testing program for the alarms located in the dialysis water testing and patient care areas (Refer to Standard A 0724). The cumulative effect of this lack of an ongoing effective data-driven hospital-wide program and systemic issues resulted in the failure to ensure the facility maintained the provision of quality health care in a safe environment and assured that the patients' right to quality of care, treatment and services had not been compromised. This has the potential to affect the health, safety and well-being of all the patients the hospital serves.

Based on observation, interviews and record review, the facility failed to ensure all drugs and biologicals were administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements and in accordance with the approved medical staff policies and procedures for 1 (Patient #15) of 25 actively sampled patients. Patient #15 was administering his own medication without an order from the physician to do so. The facility failed to ensure 1 (Patient #17) of 25 actively sampled patients' primary nurse assessed and evaluated the use of Morphine, a narcotic pain medication.

The findings include:

1. On 1/04/11, review of Patient #17's medical record revealed she was administered Morphine 2 mg, a narcotic pain medication, on 1/01/11 at 0700, 1300 and 2300, on 1/02/10 at 0545, 1815 and 2302 and on 1/3/11 at 0120.
A review of the order for the Morphine written by the physician on 12/28/10 revealed the order as Morphine Sulfate 2-4 mg IV (intravenous) every 30 minutes as needed for chest pain not relieved by Nitroglycerine.
A review of the MAR (the medication administration records) revealed the order was written as Morphine 2-4 mg IV every 30 minutes as needed for chest pain not relieved by Nitroglycerin.
Further review of the medical record revealed the patient did not receive Nitroglycerin before the administration of the Morphine 2 mg at the times and dates listed. Review of the nursing progress notes did not reveal Patient #17 had symptoms or showed signs of chest pain during the times and dates the Morphine was administered.
On 1/04/11 at 4:00 p.m., an interview with the nurse that worked day shift on 1/01/11 and 1/02/10 and the Unit Director was completed. The nurse stated she had administered the Morphine on those dates noted. She had administered the Morphine because the patient appeared to have chest discomfort. When asked why she did not administer the Nitroglycerin she stated the patient did not have chest pain, only chest discomfort, because the patient had fluid drawn from her lung the day before and the spouse said she always had pain the next day. The Unit Director and the nurse reviewed the medical record and confirmed the Morphine was written by the physician to be administered for chest pain only (not chest discomfort) after the Nitroglycerin was administered.
Further review disclosed the patient had Ultram 50 mg ordered for pain.
The Unit director and the Nurse both stated the Morphine should not have been administered without clarification with the physician for use other than chest pain if the Nitroglycerin did not work.
2. Observation of Patient #15 on 1/ 04/11 at 2:45 p.m., in his room revealed an Advair Diskus on the table top. He stated he takes the inhaler at 10:00 a.m. and 10:00 p.m. The nurse who was present during this observation stated the patient brought the medication from home.

Review of the physician order dated 1/03/11 reads: clarification: Advair 500/50 1 puff twice a day (BID).

Review of the hospital policy for self-administration of medication revealed: "It is the policy of (hospital system) to permit patient/ family's self administration of medications only upon the written order by the physician which includes "Patient/family to self-administer meds" or similarly noted statement."

Review of the procedure part of this same policy revealed: The physician must write the medication order to include a statement that the patient/family is to self-administer his/her medication.

The nurse failed to have a written a medication order for the patient to self administer his medication.

Based on record review, the facility failed to have 3 (Patients #22, #25 and #26) of 5 medical records completed within 30 days following discharge.

The findings include:

1. Review of record on 1/4/11 for Patient #22 revealed a telephone order dated 9/20/10 at 1410 (2:10 p.m.) for "Two wheeled walker" that was unsigned by the physician 30 days following discharge thereby having an incomplete medical record at the time of review.

2. Review of record on 1/4/11 for Patient #25 revealed a telephone order dated 11/21/10 at 1320 (1:20 p.m.) for "Two wheeled walker for home use" that was unsigned by the physician 30 days following discharge thereby having an incomplete medical record at the time of review.

3. Review of record on 1/4/11 for Patient #26 revealed a telephone order dated 9/23/10 at 1410 (2:10 p.m.) for the following: "Continue home meds as per med rec Inderal, Xanax, Soma. New meds: Levaquin, Flagyl, Vicodin" that was unsigned by the physician 30 days following discharge thereby having an incomplete medical record at the time of review.

Based on observation and interview with staff, the facility failed to ensure all drugs and biologicals were kept in a secure area and locked when appropriate.

The findings include:

1. Observation on 1/03/11 at 12:15 p.m., during the tour of the Emergency Room (ER) in the presence of the ER Director revealed a syringe filled with normal saline on top of the counter next to the bed a patient was lying on in room 5. The tour continued to room 17 where an IV (intravenous therapy) cart was observed to have been left open next to the bed the patient was lying in. The cart contained various syringes, IV fluids and 18 Bact/Alert vials in the drawers of the cart.
Interview with the ER Director at the time of the tour confirmed the items identified should have been out of patient reach and in a locked cart.
2. On 1/03/11 at 10:30 a.m., while touring the medical-telemetry unit on the 3rd floor with the charge nurse and the Intensive Care Unit Director (ICUD), the medication drawers for Room #372 and Room #373 were observed to be unlocked. The medication drawer for Room #373 had no medication but did have medication cups, syringes and needles. The medication drawer for Room #372 contained medications for Patient #21 which include Sinemet 25/100 mg tablets, a Vitamin B-12 1000 mcg bottle and a bottle of Nitrostat 0.4 mg. Neither the primary nurse nor any other facility staff (with the exception of the staff accompanying the surveyor) was in the area during the observation of the unsecured medications.
Interview with the charge nurse and the ICUD on 1/03/11 at 10:35 a.m., confirmed that both medication drawers were unlocked with no facility staff in the area. The charge nurse stated the medication drawers are required to be locked at all times when they are not being monitored. The charge nurse confirmed Room #372 medication drawer contained Sinemet 25/100 mg tablets, a bottle of Vitamin B-12 unit dose and Nitrostat 0.4 mg bottle. The charge nurse stated the Sinemet 25/100 mg and the Vitamin B-12 were put in the drawer by pharmacy but the Nitrostat 0.4 mg bottle should not be in the medication drawer because it is coded to be in the pharmacy dispensing cabinet.
On 1/03/11 at 10:45 a.m., interview with the nurse for Rooms #372 and #373 confirmed she left the medication drawers unlocked while she was down the hall.
On 1/05/11 at 1:30 p.m., a follow-up to Room #372 and Room #373 revealed the medication drawer for Room #373 was locked. The medication drawer for Room #372 was not locked. The medication drawer revealed Patient #21's Sinement 25/100 mg tablets and a bottle of Nitrostat 0.4 mg tablets with no staff present.
Interview with the unit charge nurse at 11:40 a.m., confirmed Room #372 the medication drawer was not locked and contained Patient #21's Sinemet 25/100 mg tablets and Nitrostat 0.4 mg bottle. The charge nurse confirmed there was no staff present and the medication drawer should be locked when there is no staff present. The charge nurse further stated the Nitrostat 0.4 mg did not belong in the locked drawer; he then took the Nitrostat 0.4 mg bottle and threw them in the sharps container on the wall.
On 1/05/11 at 11:45 a.m., interview with the nurse for Room #372 (Patient #35) and the unit director, the nurse confirmed she had left the medication drawer for Room #372 unlocked. She further stated she had worked on 1/04/11 and had discharged Patient #21 at around 6:00 p.m. and the medications in the medication drawer should have been returned to the pharmacy at that time. She stated Patent #21's medication should not be in Patient #35's unlocked medication drawer.
Interview with the Unit Director on 1/05/10 at 11:55 a.m., confirmed the medication drawers are required to be locked at all times. She also stated when a patient is discharged from the room the nurse is required to take the medications from the medication drawer and send them to the pharmacy. At no time should another patient's medication be allowed in another patient's medication drawer.

3. Observation in the surgical unit on 1/04/11 at approximately 2:30 p.m., revealed an unlocked refrigerator. It contained thrombin topical, bacitration and methylergonome maleate. There was no lock on the door. The nurse accompanying this surveyor stated pharmacy was aware of the situation but had not addressed it at this time.

Based on observation and interview, the facility failed to ensure facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality. The two alarms in the water room and dialysis unit were not in working order, which decreased the level of safety for dialysis patients.

The findings include:

1. Observation of the water room in the dialysis unit on 1/3/11 at 10:45 a.m., revealed a deionizer (DI) system for the water used during the dialysis treatments.

During an interview on 1/5/11 at approximately 9:00 a.m., with the clinical manager who oversees four dialysis units, he was asked if there was an audible and visible alarm in the treatment area, he stated there was no alarm in the unit. He stated an alarm goes off in the PBX room and the operators are educated to call the plant operations to report the alarm in the dialysis unit went off.

During an interview with the hospital operator on 1/05/11 at 1:20 p.m., she stated when the alarm goes off she immediately calls plant operations (plant op) at 1860. The alarm was observed on the wall in front of the operator with the number to call.

During an interview with the secretary of plant operations on 1/05/11 at 1:25 p.m., she stated she would contact the "House Call person" in plant operations to report the alarm going off for the dialysis unit. At 1:30 p.m., the head of plant operations stated he received an e-mail from the clinical manager stating the filter is on the wrong side and the alarm in PBX was not working.

On 1/05/11 at 2:00 p.m., a service technician stated there was an alarm in the water room which could be heard in the unit. He stated there was also an alarm above one of the beds in the unit. At 3:50 p.m., after the last patient was treated, the technician changed the value of the meter to show if the alarm was working. The alarm worked in the PBX room but not in the water room or the dialysis unit. There was no documentation as to when the last time the alarm went off. There was no documentation of the alarms being tested.

Critical alarms, such as those associated with deionizer exhaustion or low water levels in a storage tank, should be configured to sound in the patient treatment area, as well as in the water treatment room.