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Based upon medical record review, review of the facility patients rights information, review of the facility restraint policy and interview, it was determined that the facility failed to meet the Condition of Participation for Patient Rights as evidenced by:

1. Failing to have policies and procedures that addressed vitiation rights of patients. (See findings at A 117).

2. Failing to have a process for prompt resolution of grievances. (See findings at A 118).

3. Failing to establish a clearly explained procedure for complaints/grievances and written responses. (See findings at A 121).

4. Failing to provide time frames relative to the grievance process. (See findings at A 122).

5. Failing to provide written responses to grievances without patients requesting the response. (See findings at A 123).

6. Failing to ensure patients were free from restraints/seclusion and interventions were discontinued at the earliest possible time. ( See findings at A 154).

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Based upon document review, observation and interview, the facility failed to inform patients of their visitation rights. Interview with RN #5 on 4/21/11 in the afternoon indicated the information packet that was presented that informed patients of their rights did not have any information referring to visitation policies or patient rights related to their choices pertaining to visitation. The facility did not have any policies/procedures regarding the visitation rights of patients nor were they aware of the requirement that was effective 1/18/11.

Based upon review of documents presented to patients at the time of admission and interview, the facility failed to have a process for prompt resolution of patient grievances. Evidence includes the following:

Documents that are presented to patients and their families/representatives at the time of admission was requested and provided by RN #4 on 4/20/11 and RN #5 on 4/21/11. Limited information about the facility grievance process was noted in several documents.

Review of the Patient Bill Of Rights- form JE/2005 at item #17 stated- (right to) "complain without fear of reprisals about the care and services you are receiving, and to have the hospital respond to you and if you request it, a written response. You may also wish to contact the Department of Health". This same information was also found in the literature titled "Patient Rights and Responsibilities" form GFLH & MCP&P. There is no information to detail how a complaint (grievance) may be filed, to whom the complaint may be addressed to or telephone numbers and/or addressess as to whom may be contacted. Information observed posted pertained to an EMTALA sign and Notice of Privacy Practices.

Interview during the afternoon of 4/21/11 with RN #5 verified no other information was presented relative to the grievance process other than what is referenced in the documents mentioned above.

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Based on document review, and staff interview the facility failed to have a system in place that clearly explained the procedure for patients and/or their representatives to file a grievance. Limited information relative to the grievance process is presented at the time of admission to patients/families of Governor Juan Luis Hospital.

Information in the literature presented to patients related to grievances failed to contain any information about the grievance process review, the investigative process or the time frames including the facilities response to the investigation.

Interview with RN #5 confirmed on 4/21/11 that the only information about the grievance process was in the documents referenced above. (Cross refer to A 118)

Based on document review, and staff interview the facility failed to have a grievance process system in place that detailed the time frames of the grievance process of the hospital. Information provided to patients and/or families was limited and only referenced the information as stated above at A 118. (Cross refer to A 118). Interview with RN #5 confirmed on 4/21/11 that the only information about the grievance process was in the documents referenced above.

Based on document review, and staff interview regarding the grievance process, the facility failed to notify patients, families or representatives, that responses to a grievance would be in writing. Evidence includes the following:

A review of the only information that the hospital presents at the time of admission related to the grievance process indicates a written response, once a grievance has been received, would only be responded to in writing if requested. Information pertaining to the process that was presented to patients/families was limited. (Cross refer to A 118). Interview with RN #5 confirmed on 4/21/11 that the only information about the grievance process was in the documents referenced above.

Based upon record review and interview, the facility failed to ensure that seclusion/restraints were only used to ensure the immediate physical safety of patients and or staff and were discontinued at the earliest possible time for 1 of 1 applicable patients. Patient ID #7. Evidence includes the following:

Patient ID #7 presented to the Emergency Department on 4/14/11 with a diagnosis of Psychosis and immediately placed in seclusion. Documentation on 4/14/11 at 2000 hours (8:00 PM) described the patient as "combative, uncooperative and threatening". Further documentation revealed the patient was "kicking, threatening staff and yelling". Review of notes written in the Emergency Medicine section of the Medical Record indicated "no beds- will medicate and call in the AM". Patient received Ativan (2 mg IM (an antianxitey medication); Haldol 5 mg IM (an antipsychotic) and Cogentin 2 mg IM (a drug to reduce side effects) at 1955 (7:55 PM). Further medical record review revealed the physicians order was written on 4/14/11 to place the patient in "seclusion" with the start time written as 2000 but with no end time.

Review of assessment documentation while in seclusion noted the following for 4/14/11:
2000 - 2045 hours- preseclusion observation precipitating seclusion was combativeness, uncooperative, patient awake in seclusion yelling/screaming

2100 hours- behavior precipitating seclusion was patient "sedated, in seclusion and sleeping"

Further documentation from 2100 hours on 4/14/00 through 0630 hours on 4/15/11 noted that patient had been observed sedated and/or drowsy; remained in seclusion sleeping and/or awake and quiet; at 0636 hours on 4/15/11, nursing documentation indicated the patient was "sitting quietly in room on mattress awaiting psych eval"
0645- seclusion assessment noted patient "passive/calm in seclusion quiet"
0700- "passive/calm in seclusion quiet"
0715- seclusion assessment indicated the patient as "passive/quiet/awake/drowsy"
0730 - nursing documentation described the patient as "quiet and cooperative"
0730 - " passive/calm, in seclusion quiet"

Review of the seclusion assessment record noted documentation on related to the use of right upper and upper foam/soft limb restraints. According to the policy titled Restraint and Seclusion Usage, PC 03.05.01, effective date of May 2010 and revised March 2010, on page 8 of 19 noted. " an order for restraint or seclusion must include the date and time, duration type/placement of restraint and clinical justification for use". Documentation while the patient was restrained with soft limb restraints noted the following:
4/15 2145 hours- combative/uncooperative
4/15 2200 - combative/uncooperative
4/15 2215 - sedated
4/15 - 2230 - sedated
4/15 - 2245 - sedated
4/15 - 2300 - sedated
4/15 - 2315 - sedated
4/15 - 2330 - sedated
4/15 - 2345 -sedated
4/16 - 0000 -(right extremity left extremity) re and le "discontinued
4/16- 0015- soft limbs resumed- pt sedated
4/16- 0030- sedated
4/16- 0045- sedated
4/16- 0100 - cooperative
4/16 - 0015- cooperative
4/16 - 0130- cooperative
4/16- 0145- cooperative
There was no evidence that that patient presented clinical justification for the use of the soft limb restraints from 4/15/11 at 2215 hours through 4/16/11 at 0145 hours of that the restraints were discontinued at the earliest possible time.
Review of the policy titled Restraint and Seclusion Usage, PC 03.05.01, effective date of May 2010 and revised March 2010, on page 7 of 19 noted. " Restraints and seclusion will be discontinued at the earliest possible time...".

Based upon the documentation of patient behaviors, there is evidence from 2100 hours on 4/14/11 through 0730 on 4/15/11, or 4/15/11 at 2145 hours throuh 4/16/11 at 0145 hours that Patient ID #12 was provided discontinuance of the seclusion and/or restraints at the earliest possible time. Interview on 4/21/11 at 10:00 AM with RN #10 stated patient may have remained in seclusion d/t the "unavailability of a bed".

Based upon record review, restraint and seclusion policy and confirmed by interview, the facility failed to use restraints or seclusion in accordance with valid physician orders for Patient ID #12. Evidence includes the following:

Review of the restraint/seclusion physician order sheet dated 4/14/11 recorded seclusion to begin at 2000 hours (8 PM) on 4/14/11 but failed to have an end date. Interview with Clinical Nurse Coordinator RN #4 on 4/21/11 at 10:30 AM, confirmed that the expectation is all time specific orders need a start and end time for re-evaluation of the need for the restraint/seclusion.

Review of the policy titled Restraint and Seclusion Usage, PC 03.05.01, effective date of May 2010 and revised March 2010, on page 9 of 19 noted. "Behavioral Health Needs- face to face assessment will be made within 1 hour after the initiation of restraint or seclusion and written orders not to exceed 4 hours for Adults 18 years and older... if restraint or seclusion requires to be continued, the LIP ( License Independent Practioner) or physician shall write a new order. The facility failed to ensure that a new order was written.

Review of the seclusion assessment record noted documentation on 4/15/11 at 2130 hours ((9:30 PM) that "foam/soft limb restraint on the right ue (upper extremity) and left ue (upper extremity) had been applied while patient was in total body ( seclusion). Review of the medical record failed to contain any physicians order for the soft limb restraints. According to the policy titled Restraint and Seclusion Usage, PC 03.05.01, effective date of May 2010 and revised March 2010, on page 8 of 19 noted. " an order for restraint or seclusion must include the date and time, duration type/placement of restraint and clinical justification for use". Documentation while the patient was restrained with soft limb restraints noted the following:
4/15 2145 hours- combative/uncooperative
4/15 2200 - combative/uncooperative
4/15 2215 - sedated
4/15 - 2230 - sedated
4/15 - 2245 - sedated
4/15 - 2300 - sedated
4/15 - 2315 - sedated
4/15 - 2330 - sedated
4/15 - 2345 -sedated
4/16 - 0000 -(right extremity left extremity) re and le "discontinued
4/16- 0015- soft limbs resumed- pt sedated
4/16- 0030- sedated
4/16- 0045- sedated
4/16- 0100 - cooperative
4/16 - 0015- cooperative
4/16 - 0130- cooperative
4/16- 0145- cooperative
There was no evidence that that patient presented clinical justification for the use of the soft limb restraints from 4/15/11 at 2215 hours through 4/16/11 at 0145 hours. (Cross refer with A415).

Review of the seclusion assessment record noted on 4/16/11 at 0000 hours that the upper and lower extremity restraints were "discontinued" but on 4/16/11 at 0015 ( 12:15 AM) notes the use of the upper and lower extremity restraints were again in place. The use of these restraint continued through 4/16/11 0400 hours. The facility was not able to provide any evidence of a valid physician order to use limb restraint in the medical record. On 4/16/11 at 0345 hours, a right le ( lower extremity) was applied and on 4/16/11 at 0620 a left le (lower extremity) restraint was also applied. . The only order noted for restraints was noted on 4/16/11 at 8:00 ( no indication of AM or PM) until 12:00 noon, limb restraint (3 points) due to aggressive behavior twoard staff .Documentation for 4/16/11 at 0620 now indicated Patient ID #12 was in seclusion, with both upper and lower extremities in restraints without any valid orders.

RN #10 and Clinical Nurse Coordinator RN #4 confirmed the findings above between 10:00 AM and 10:15 AM on 4/21/11.

Based upon medical record review, review of policies of the facility and interview, it was determined that the facility failed to meet the Condition of Participation for Nursing Services as evidenced by:

Failure to supervise and evaluate the provision of nursing services. (See findings at A 395).

Failure to develop/revise/update care plans.(See findings at A 396).

Based upon record review, policy review and interview, the facility failed to ensure that patient care was supervised and evaluated for 5 of 12 patients. ( Patient ID #1, #2, #3, #7 and #12). The facility failed to ensure that nursing staff supervised medication administration and that medications were administered according to physician order for 2 of 12 patients( Patient ID #1 and #12), failed to ensure that facility nursing policies related to intake and output were adhered to for 4 of 12 patients( Patient ID #1, #2, #3 and #7), failed to ensure that facility nursing policies related to Braden Scale Assessment was followed for 4 of 12 patients ( Patient ID #1, #4, #6 and #11) and failed to evaluate that nursing care was provided according to physician orders as a standard of practice for 3 of 12 patients.(Patient ID #2, #3 and #12), Evidence includes the following:

1. Failure to ensure that medications were administered according to physicians' orders

Medical record review for Patient ID #1 noted a physicians order written on 2/27/11 to renew Celebrex 200 mg daily and included "if hospital out- may taker her own." Review of the Medication Administration Record (MAR) noted the medication was not given on 2/28/11 without any explanation as to why it was not received, not given on 3/1 due to the medication not being "available", not given on 3/2/11 due to medication nor being available, not being administered on 3/3/11 without any explanation, not given on 3/4/11 due to the medication being unavailable,and not given 3/5/ through 3/9/11 without any explanation, never recorded on the MAR for 3/10 and 3/11 and not administered on 3/12 and 3/13 without explanation. There was no evidence that the physician had been notified that the patient had not received the medication as ordered or that the facility had tried to procedure the patient's medication from home as stated in the physician's original order. Findings were confirmed by interview with the Clinical Nurse Coordinator RN #4 at 3:15 PM on 4/20/11.

Medical record review for Patient ID #12 revealed a physicians order was written on 4/18/11 at 1600 hours ( 4 PM) for Haldol (an antipsychotic medication) , 10 MG IM ( intramuscular); Ativan (an antianxiety medication) 1 MG IM and Benadryl (sedative effects) 50 MG IM now for aggressive behavior". Review of the Medication Administration Record ( MAR) noted these medications were administered as ordered on 4/18/11 at 1600 hours. Additional review of the MAR noted the medications were also administered again twice on 4/19/11 and 4/20/11 without any valid physicians orders. Interview with RN #4 and RN #9 on 4/21/11 at 8:50 AM confirmed that the 4/18/11 order for medications ordered as "now" was a one time medication administration and there was no evidence in the medical record that the medications had been ordered to be repeated on 4/19/11 and 4/20/11.

2. Failure to ensure that facility policies were followed

According to the "Intake and Output" policy Reference #3261 without an effective or revision date, indicates that intake and output is to be recorded as indicated in a plan of care and for those patients with chronic renal failure. In addition, interview with Clinical Nurse Coordinator RN #4 at 3:15 PM on 4/20/11 confirmed that monitoring of intake and output is also a standard of practice that should be documented consistently.

Medical record review for Patient #1 revealed an admission diagnosis that included ESRD (End Stage Renal Disease). Documentation revealed that intake and output was not consistently recorded based upon the following examples:
1/20/11 - nothing entered for intake and output
1/21/ through the 26 th- no recording for intake and output
2/2 through 2/6 no output recorded
2/8 - 2/12- nothing recorded
2/24 - 3/3- nothing recorded
3/28 - nothing recorded
3/29- nothing recorded
4/2- nothing recorded
4/15 - 4/19 nothing recorded

Patient ID # 2 was being treated for Acute Renal Failure and receiving hemo-dialysis three times a week during the admission of 3/22/11. Review of the documentation of the intake and output noted the following inconsistencies.
3/23/11- nothing recorded
3/27/11- no intake was recorded
3/28/11 - no output was recorded
3/29/11- no output was recorded
4/2/11- nothing was recorded
4/4/11- nothing was recorded
On 4/5/11, the physician wrote a note for "intake and output please"
Review of the documentation continued to reveal:
4/6/11 through 4/8/11 nothing was recorded
4/9/11 no intake was recorded
4/10/11 nothing was recorded
4/11/11- no intake was recorded
4/13 through 4/18/11- no intake was recorded

Patient ID #3 was being treated for Acute Renal Failure. Care plan generated on 2/5/11 indicated a problem with "fluid volume excess" and need to "maintain balanced intake and output" . A nephrology consult of 2/6/11 also noted "strict I & O ( intake and output). Documentation review revealed on 2/6/11 nothing was recorded for oral intake, 2/8/11- nothing was recorded through 2/18/11. Interview with Clinical Nurse Coordinator RN # 4 at 9:10 AM on 4/20/11 confirmed documentation was inconsistent and did not meet standards of clinical practice.

Patient ID #7 was receiving hemo-dialysis three times a week. Review of the care plan noted a problem identified of "fluid volume excess" and noted the plan to "maintain balanced intake and output" as well as to "maintain fluid restrictions". There was no evidence that any monitoring was being done for intake and output.

3. Failure to ensure that the facility policies related to the completion of the Braden Scale Assessments were followed

Review of the facility policy titled Wound Care Policy with an effective date of 9/2/06 and revised on 9/2/09 indicated under the section titled General Policy states: "All patients will be assessed by the nurse for the risk of breakdown using the Braden Scale on admission, re-admission and with any major change in condition. Daily nursing assessment to be performed for ongoing risk assessment". In the section titled Criteria it states "Braden Scale assessment will be completed daily....the interdisciplinary plan of care will address problems, goals and interventions directed toward the prevention and/or treatment of impaired skin integrity/pressure ulcer. (Cross refer A 396)

Review of the medical record for Patient ID #1 noted the admission date of 1/9/11. A note from the emergency room noted "skin breakdown on buttocks". The physical assessment done on 1/10/11 notes a sacral medial decubitus, and an assessment of the wound done 1/15/11 noted the medial sacral pressure ulcer without any measurements. Review of the last wound assessment dated 4/19/11 notes the sacral wound to be a stage IV, a stage II on the left hip and a stage III on the right hip. Interview with the Clinical Nurse Coordinator RN #4 on 4/20/11 at 9:00 AM confirmed there was no evidence that the Braden Scale was completed according to policy.

Medical review for Patient ID #4 noted an admission date of 4/11/11. Clinical Nurse Coordinators RN #4 and RN #6 confirmed that the Braden Scale assessment was not completed according to policy during the record review on 4/20/11 at 10:30 AM.

Patient ID #6 was admitted on 2/25/11. The admission Braden was completed on 2/25/11 with a score of 11 indicating the patient was at "high risk". Interview with Clinical Nurse Coordinator RN #4 at 3:45 PM confirmed there was no evidence that additional Braden Scale assessments had been completed according to policy.

Patient ID #11 was admitted on 4/4/11. Interview on 4/20/11 at 3:50 PM confirmed the Braden Scale assessment was not completed according to facility policy.

4. Failure to ensure that standards of practice were followed- failure to follow physician orders

The record review for Patient #2 indicated patient received hemo-dialysis three times a week ( Tuesday, Thursday and Saturday). On 4/18/11, the physician wrote an order "transfuse 10 units of Platelets during dialysis". Interview with RN #7 and RN #4 at 3:30 PM confirmed that the platelets were not transfused as ordered by the physician. According to RN #8 when called at the dialysis unit, the transfusion was not given as was ordered and (dialysis) nurse assumed it had been given prior to dialysis. An incident report written on 4/19/11 which confirmed "platelets not transfused".

Review of the medical record for Patient ID #3 noted a physicians order for a STAT
(immediately) SMA 7 (lab test of 7 different values) on 4/15/11. Record review failed to provide any evidence that the facility notified the physician of the results of the lab test. Interview with RN#4, Clinical Care Coordinator on 4/20/11 at 9:45 AM indicated there is no policy outlining the process for STAT lab tests but the expectation as a standard of practice would be to notify the physician of the results.

Medical record review for Patient ID #12 revealed a physicians order was written on " 4/18/11 at 1600 hours ( 4 PM) for Haldol (an antipsychotic medication) , 10 MG IM ( intramuscular); Ativan (an antianxiety medication) 1 MG IM and Benadryl (sedative effects) 50 MG IM now for aggressive behavior". Review of the Medication Administration Record ( MAR) noted these medications were administered as ordered on 4/18/11 at 1600 hours. Additional review of the MAR noted the medications were also administered again twice on 4/19/11 and 4/20/11 without any valid physicians orders. Interview with RN #4 and RN #9 on 4/21/11 at 8:50 AM confirmed that the 4/18/11 order for medications ordered as "now" was a one time medication administration and there was no evidence in the medical record that the medications had been ordered to be repeated on 4/19/11 and 4/20/11.

Based upon record review, and interview, the facility failed to keep current nursing care plans for 8 of 12 patients.(Patient ID #3, #3, #4, #5, #6, #8, #9 and #11). Examples include the following:

Patient ID # 2 was admitted to the facility on 3/22/11 with diagnoses that include Acute Renal Failure, Paraplegia and Urosepsis. Review of the care plan revealed the facility staff did not revise/update the care plan to reflect pertinent clinical needs of the patient. A care plan was generated on 3/23/11 but failed to be updated to reflect wound consult which identified a stage II thigh ulcer 5 cm x 2 cm, a right buttock pressure ulcer measuring 8 cm x 2 cm, a bilateral thoracentesis performed on 4/13/11, and a sacral would pressure ulcer 25 cm x 20 cm x 3- staged as full thickness loss.

Patient ID #3 was admitted to the facility with diagnoses that included Renal Failure. On 4/15/11 the patient also required Open Reduction Internal Fixation surgery of the left hip after a fall in the facility. The facility staff failed to revise/update the care plan to reflect the individualized current needs of the patient as it related to the surgical procedure, the risk for infection, safety factors for the risk of falls, pain management or the fact the patient has a right eye implant.

Medical record review for Patient ID #4 noted the patient was admitted to the facility on 4/11/11 with issues that included GI (Gastrointestinal Bleed), Diabetes, Blind and SOB (Shortness of breath). The facility failed to ensure the care plan was an accurate reflection of the needs of the patient. Under the problem area of altered glucose metabolism the signs and symptoms to be monitored indicated "blurred vision" yet the patient is blind. The facility also failed to identify the problem related to the GI Bleed and Anemia and include the colonoscopy of 4/15/11 and necessary monitoring.

Medical record review for Patient ID #5 noted the patient was admitted to the facility on 12/26/10 with significant diagnoses that included ESRD (End Stage Renal Disease) and Diabetes. Review of the care plan dated 12/27 identified a problem of impaired mobility and noted the patient to be "at risk for developing pressure ulcers". The facility failed to revise/update the care plan to be reflective of a 8 x 8 cm pressure ulcer per the wound consult of 1/11/11. Another problem identified in the care plan was related to impaired skin integrity which also was not revised to reflect the present skin care issues for the patient. In addition the patient was receiving hemo-dialysis three times a week and was blind, neither of which was reflected in the care plan.

Patient ID #6 was admitted to the facility on 2/25/11 with a diagnosis that included Ischial Ulceration. Although the care plan developed on 2/25/11 noted problem identification of impaired skin integrity, the facility staff failed to update the plan to reflect any of the wound assessments. This included wound identification of stage II pressure ulcers to the sacrum, left buttocks and a stage IV pressure ulcer to the right hip

Patein ID #8 was admitted to the facility with a diagnosis of Severe Dehydration. The facility failed to update the care plan to reflect the multiple stage II decubitus ulcers found on bilateral hips and the ulcer found on the patient's right ankle. In addition, the nursing notes indicate the patients was not eating and/or drinking yet interventions to address the nutritional needs and feeding system was not addressed in the plan of care.

Medical Record for Patient ID #9 revealed a diagnosis of Failure to Thrive". Review of the care plan noted the patient to be at "high risk" but was not revised/update to reflect the skin tear on the left knee or the left hip skin tear.

Patient #11 was admitted to the facility on 4/4/11 with diagnoses that included left foot gangrene and decubitus on the sacrum, left hip and left anterior leg. Review of the care plan found the only problem identified was "amputation". The facility failed to edit the care plan to be reflective of the multiple stage II skin areas.