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13681 DOCTORS WAY

FORT MYERS, FL 33912

GOVERNING BODY

Tag No.: A0043

Based on interview and facility document review, it was determined the facility failed to ensure Gulf Coast Medical Center 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).

The findings include:

1. Facility staff members were asked if the hospital had its own governing body. It 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.

3. Administrative staff were asked if the hospital had any documentation to support the hospital having its own governing body. Documentation was provided 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. During an interview with The Chief of Operations at a sister facility it was confirmed 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.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on a review of patients who were receiving wound care or pressure ulcer care, and interview with wound care and administrative staff, the hospital failed to have a methodology for complete assessments of wounds to ensure they were healing for 4 (Patients #35, #36, #37, and #47) of 7 patient records reviewed.

The findings include:

1. A review of Patient #36's clinical record revealed the patient developed skin tears on the coccyx area. There was no documentation in the record that revealed the size of either of the skin tears.

Interview with the head of the surgical unit on 1/3/11 at 11:30 a.m., indicated the nurses are not required to measure wounds. She further indicated there is a protocol to follow for treatment of the wounds, but no measurements are required.

2. Patient #35 was admitted to the hospital on 12/14/10 with a open infected chest wound following heart surgery on 9/10/10. There was one documentation in the clinical record about this wound with wound measurements dated 12/28/10. The documentation indicated the wound to be approximately 5 inches long, 1 and 1/2 inches wide, and 1 and 1/2 inch deep. There were no measurements performed upon admission to the unit to compare this with, therefore, no ability to ascertain if the wound had improved or worsened.

3. Patient #37 was admitted to the hospital on 12/30/10 with pressure ulcers on the heel and groin as identified in the nursing assessment. There were no measurements of either wound noted upon admission; however, the groin wound was identified as Stage 2. On 12/31/10, there was a physician's order for the wound care nurse to consult. This was not done until 1/4/11. The wound care nurse indicated, in interview at 3:50 p.m., that the heel pressure ulcer measures as 2.5 by 3.5 and it was unstageable due to eschar covering the ulcer. The left groin wound has a pink base, with intact skin and was 1.5 by .5 wide.

4. Interview with the wound care nurse on 1/4/11 at 9 a.m., indicated the wound care nurse gets a referral if the patient has a wound. She further stated she works Monday through Friday, but was off on 1/3/11 (Monday). Once she gets the referral, she sees the patient, evaluates, and measures the wound, establishes appropriate wound care after consulting with the physician. She stated thereafter wounds are supposed to be measured every Monday to aide in the evaluation of the treatment. The floor nurses are supposed to back up the wound care nurse for treatment and measurements.

5. Interview with administrative staff on 1/4/11 at 10:30 a.m., confirmed there is no policy in the hospital about wound measurements being a part of wound assessment. In fact, the hospital has no policy and procedure related to generalized wound care. A review of the policy and procedure for pressure ulcer assessment and treatment-adult revealed the following information: under II Part B "Pressure ulcer assessment: admission assessment must be performed on all patients entering the hospital and should include both the risk assessment (to evaluate risk of developing a pressure ulcer). These two assessments should be thought of as a single process: pressure ulcer admission assessment...." Under #2 it states "depth, size, tunneling: see "wound measuring protocol."

Under V Wound measuring protocol: "A. Wound measuring to be done on admission and weekly." The Policy goes on to describe the manner of measurements and how to obtain consistent measurements.

6. On 1/6/11 at 10:15 a.m., further interview occurred with the wound care nurse. During this interview she indicated she sees Patient #47 (the patient has multiple areas of skin breakdown and has been a patient of the hospital for several months) every 2-3 weeks. She stated she has gone in response to consult, but does not go back to assess the patient unless she receives another consult. She only follows routinely those patients she has to perform the wound care for herself. Otherwise, she signs off the case until another consult is written for her to see a patient.

PHYSICAL ENVIRONMENT

Tag No.: A0700

This Condition of Participation is not met based on observation, review of the hospital records, and interview with both clinical and supervisory personnel, the hospital failed to ensure there were systems in place to assure the water being provided for dialysis use was tested correctly and monitored as required in AAMI guidelines (Association of Advancement of Medical Instrumentation) for water testing and monitoring. This failure places all patients who receiving hemodialysis in the unit at risk for contamination with possible toxins and possible death.

The findings include:

A review the facility's water supply and distribution system was conducted to ensure the water quality is acceptable for its intended use (dialysis). A review the facility water quality monitoring and, as appropriate, treatment system was conducted and found not to meet standards of practice.


Refer to A-0722 for additional information.

FACILITIES

Tag No.: A0722

Based on observation, interview with dialysis staff, and administrative staff, the facility failed to ensure that water testing and monitoring procedures were in place to ensure safe water for hemodialysis patients.

The findings include:

1. Observation in the water room on 10 a.m., revealed the facility's water system includes 2 carbon tanks placed one in front of the other. Both of these tanks have outlet valves to enable samples to be drawn for chlorine/chloramine. Following and connected to the carbon tanks are 2 sets of deionizer tanks which then run the water through a sensitivity monitor (ensure the water is clean enough to use for dialysis patients) and then piped out to the floor where patients receive dialysis. Observation of one of the staff nurses performing the chlorine/chloramine testing revealed she took the sample from the 2nd carbon tank. She stated she always took the sample from this port. She swished the test strip in the sampled water. When questioned she indicated she does this for 5 or 6 seconds, but there was no attempt by the staff member to ensure the accuracy of the time by using a watch or clock. There was no clock in the room.

Review of the policy and procedure titled "water treatment system total chlorine monitoring for multi-station (non portable) water treatment systems. Under #7. "Samples for total chlorine testing are drawn from the sample port located downstream from the first (primary) carbon tank."

2. Interview with the System Director for Renal Transplant (also in charge of dialysis) was performed on 1/5/11 at 11 a.m. When questioned about the water sampling procedures, he indicated he goes up to the water room each day and tests the water himself. There was a log he used to document this and the sensitivity reading. He further indicated he always takes his chlorine sample from the 2nd carbon tank. He stated it was "not a big deal." He indicated the 2nd carbon tank is the most important. (taking the reading from the first tank ensures that the water getting to the patient is good for use. If the first tank goes bad, and the 2nd is tested as good it allows for the dialysis to continue. However, if both tanks are bad, the patient must be removed from the dialysis treatment immediately as there is the potential to cause death to a patient. Testing after the first tank is required under AAMI (Association of Advancement of Medical Instrumentation) guideline established for dialysis units.)

3. Interview with nursing staff present in the dialysis unit on 1/5/11 at 1:15 p.m., indicated they do nothing at all in the water room except check for chloramines.

4. Further interview with the Head of Renal Transplant Unit indicated he does the sensitivity readings on the deionizer equipment himself once a day. He agreed it was not being performed a 2nd time as required.

5.2.8 Deionization: continuous monitor resistivity/logged 2 X day
Refer to RD62:2001, 4.3.6 Deionization: Deionization systems, when used to prepare water for hemodialysis applications, shall be monitored continuously to produce water of one megohm/cm or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25?C.

6.2.8 Deionization
Deionizers shall be monitored continuously using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms. Resistivity monitors shall have a minimum sensitivity of 1.0 megohm-cm. Patients shall not be dialyzed on deionized water with resistivity less than 1.0 megohm-cm measured at the output of the deionizer.

Resistivity monitor readings should be recorded on a log sheet twice each treatment day.

GOVERNING BODY

Tag No.: A0043

Based on interview and facility document review, it was determined the facility failed to ensure Gulf Coast Medical Center 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).

The findings include:

1. Facility staff members were asked if the hospital had its own governing body. It 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.

3. Administrative staff were asked if the hospital had any documentation to support the hospital having its own governing body. Documentation was provided 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. During an interview with The Chief of Operations at a sister facility it was confirmed 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.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on a review of patients who were receiving wound care or pressure ulcer care, and interview with wound care and administrative staff, the hospital failed to have a methodology for complete assessments of wounds to ensure they were healing for 4 (Patients #35, #36, #37, and #47) of 7 patient records reviewed.

The findings include:

1. A review of Patient #36's clinical record revealed the patient developed skin tears on the coccyx area. There was no documentation in the record that revealed the size of either of the skin tears.

Interview with the head of the surgical unit on 1/3/11 at 11:30 a.m., indicated the nurses are not required to measure wounds. She further indicated there is a protocol to follow for treatment of the wounds, but no measurements are required.

2. Patient #35 was admitted to the hospital on 12/14/10 with a open infected chest wound following heart surgery on 9/10/10. There was one documentation in the clinical record about this wound with wound measurements dated 12/28/10. The documentation indicated the wound to be approximately 5 inches long, 1 and 1/2 inches wide, and 1 and 1/2 inch deep. There were no measurements performed upon admission to the unit to compare this with, therefore, no ability to ascertain if the wound had improved or worsened.

3. Patient #37 was admitted to the hospital on 12/30/10 with pressure ulcers on the heel and groin as identified in the nursing assessment. There were no measurements of either wound noted upon admission; however, the groin wound was identified as Stage 2. On 12/31/10, there was a physician's order for the wound care nurse to consult. This was not done until 1/4/11. The wound care nurse indicated, in interview at 3:50 p.m., that the heel pressure ulcer measures as 2.5 by 3.5 and it was unstageable due to eschar covering the ulcer. The left groin wound has a pink base, with intact skin and was 1.5 by .5 wide.

4. Interview with the wound care nurse on 1/4/11 at 9 a.m., indicated the wound care nurse gets a referral if the patient has a wound. She further stated she works Monday through Friday, but was off on 1/3/11 (Monday). Once she gets the referral, she sees the patient, evaluates, and measures the wound, establishes appropriate wound care after consulting with the physician. She stated thereafter wounds are supposed to be measured every Monday to aide in the evaluation of the treatment. The floor nurses are supposed to back up the wound care nurse for treatment and measurements.

5. Interview with administrative staff on 1/4/11 at 10:30 a.m., confirmed there is no policy in the hospital about wound measurements being a part of wound assessment. In fact, the hospital has no policy and procedure related to generalized wound care. A review of the policy and procedure for pressure ulcer assessment and treatment-adult revealed the following information: under II Part B "Pressure ulcer assessment: admission assessment must be performed on all patients entering the hospital and should include both the risk assessment (to evaluate risk of developing a pressure ulcer). These two assessments should be thought of as a single process: pressure ulcer admission assessment...." Under #2 it states "depth, size, tunneling: see "wound measuring protocol."

Under V Wound measuring protocol: "A. Wound measuring to be done on admission and weekly." The Policy goes on to describe the manner of measurements and how to obtain consistent measurements.

6. On 1/6/11 at 10:15 a.m., further interview occurred with the wound care nurse. During this interview she indicated she sees Patient #47 (the patient has multiple areas of skin breakdown and has been a patient of the hospital for several months) every 2-3 weeks. She stated she has gone in response to consult, but does not go back to assess the patient unless she receives another consult. She only follows routinely those patients she has to perform the wound care for herself. Otherwise, she signs off the case until another consult is written for her to see a patient.

PHYSICAL ENVIRONMENT

Tag No.: A0700

This Condition of Participation is not met based on observation, review of the hospital records, and interview with both clinical and supervisory personnel, the hospital failed to ensure there were systems in place to assure the water being provided for dialysis use was tested correctly and monitored as required in AAMI guidelines (Association of Advancement of Medical Instrumentation) for water testing and monitoring. This failure places all patients who receiving hemodialysis in the unit at risk for contamination with possible toxins and possible death.

The findings include:

A review the facility's water supply and distribution system was conducted to ensure the water quality is acceptable for its intended use (dialysis). A review the facility water quality monitoring and, as appropriate, treatment system was conducted and found not to meet standards of practice.


Refer to A-0722 for additional information.

FACILITIES

Tag No.: A0722

Based on observation, interview with dialysis staff, and administrative staff, the facility failed to ensure that water testing and monitoring procedures were in place to ensure safe water for hemodialysis patients.

The findings include:

1. Observation in the water room on 10 a.m., revealed the facility's water system includes 2 carbon tanks placed one in front of the other. Both of these tanks have outlet valves to enable samples to be drawn for chlorine/chloramine. Following and connected to the carbon tanks are 2 sets of deionizer tanks which then run the water through a sensitivity monitor (ensure the water is clean enough to use for dialysis patients) and then piped out to the floor where patients receive dialysis. Observation of one of the staff nurses performing the chlorine/chloramine testing revealed she took the sample from the 2nd carbon tank. She stated she always took the sample from this port. She swished the test strip in the sampled water. When questioned she indicated she does this for 5 or 6 seconds, but there was no attempt by the staff member to ensure the accuracy of the time by using a watch or clock. There was no clock in the room.

Review of the policy and procedure titled "water treatment system total chlorine monitoring for multi-station (non portable) water treatment systems. Under #7. "Samples for total chlorine testing are drawn from the sample port located downstream from the first (primary) carbon tank."

2. Interview with the System Director for Renal Transplant (also in charge of dialysis) was performed on 1/5/11 at 11 a.m. When questioned about the water sampling procedures, he indicated he goes up to the water room each day and tests the water himself. There was a log he used to document this and the sensitivity reading. He further indicated he always takes his chlorine sample from the 2nd carbon tank. He stated it was "not a big deal." He indicated the 2nd carbon tank is the most important. (taking the reading from the first tank ensures that the water getting to the patient is good for use. If the first tank goes bad, and the 2nd is tested as good it allows for the dialysis to continue. However, if both tanks are bad, the patient must be removed from the dialysis treatment immediately as there is the potential to cause death to a patient. Testing after the first tank is required under AAMI (Association of Advancement of Medical Instrumentation) guideline established for dialysis units.)

3. Interview with nursing staff present in the dialysis unit on 1/5/11 at 1:15 p.m., indicated they do nothing at all in the water room except check for chloramines.

4. Further interview with the Head of Renal Transplant Unit indicated he does the sensitivity readings on the deionizer equipment himself once a day. He agreed it was not being performed a 2nd time as required.

5.2.8 Deionization: continuous monitor resistivity/logged 2 X day
Refer to RD62:2001, 4.3.6 Deionization: Deionization systems, when used to prepare water for hemodialysis applications, shall be monitored continuously to produce water of one megohm/cm or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25?C.

6.2.8 Deionization
Deionizers shall be monitored continuously using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms. Resistivity monitors shall have a minimum sensitivity of 1.0 megohm-cm. Patients shall not be dialyzed on deionized water with resistivity less than 1.0 megohm-cm measured at the output of the deionizer.

Resistivity monitor readings should be recorded on a log sheet twice each treatment day.