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Due to the number and nature of deficiencies, the facility failed to be in compliance with the Condition of Patient Rights. Specifically, the facility failed to protect and promote patients' rights related to the Grievance Process.

Cross Reference: A0119- Patient Rights: Review of Grievances for findings related to the facility's failure to ensure an effective operation of the grievance process in two sample grievance investigations.

Cross Reference: A0122- Patient Rights: Grievance Review Time Frames for findings related to the facility's failure to ensure its formal grievance policy specified specific timeframes for the resolution of grievances.

Cross Reference: A0123- Patient Rights: Notice of Grievance Decision for findings related to the facility's failure to provide the patients or their representatives with written notice of its decision and the steps taken on behalf of the patient to investigate the grievance, as well as the results of the process and the date of completion.

Based on review of the facility's grievance investigations and staff interview, it was determined the facility failed to ensure an effective operation of the grievance process in two sample grievance investigations. Specifically, the facility failed to ensure grievances were fully resolved after the process was delegated to the unit directors. This failure created the potential for a negative patient outcome.

The findings were:

Eight sample grievance investigations were reviewed in detail with the facility's Patient Representative (PR) on 2/9/11 at approximately 10:20 a.m. The PR confirmed that the facility's process with grievances was to have the unit specific directors resolve the issues if and when possible.

Sample grievance #4 was in regards to several elements of nursing care provided upon discharge, 10/4/10, on a medical floor. The concerns were forwarded to the unit's director for resolution. The director documented that the patient was discharged without oxygen and "should have been" discharged with oxygen. The entries of the investigation did not state what was done about this issue but did state that a letter would not be sent per family preference. When the PR was asked if any changes or actions were taken in regards to this issues, s/he stated, "(S/he) would have taken this issue back to the staff member. That info should have been in here. A lot of times the director would not put down exactly what they did with the employee."

Sample grievance #5 was in regards to nursing care provided in the Emergency Department on 10/18/10. The concerns were forwarded to the unit's director for resolution. The last entry in the investigation, documented by the unit's director, stated that s/he had spoken with the patient and apologized for the difficult experience. It also stated, in pertinent part: "...will get with all the nurses and staff about my expectation for customer service..." When the PR was asked if s/he knew if this was done, s/he stated, "What (the director) tries to do in staff meeting: she brings it up and uses it as a learning opportunities... That is my trust in them that they are doing their piece..."

It was confirmed with the PR that neither of these cases were followed up on by the PR or grievance committee to ensure full resolution and completion of the process.

Based on review of the facility's policies/procedure and staff interview, the facility failed to ensure its formal grievance policy specified specific timeframes for the resolution of grievances. Specifically, the facility's grievance policy did not state when the patient or patient's representative would receive a written acknowledgement letter informing them that their grievance was received. This failure created the potential for a negative outcome.

The findings were:

The facility's policy titled "Problem Resolution" was reviewed on 2/8/11. The policy stated the following in the procedure section, in pertinent part:
"A. The staff or physician present and department leader will:
1. Attempt to promptly resolve whatever complaint the patient or their representative is expressing.
2. If necessary, the staff present will involve the Patient Representative, appropriate Administrator or designee.
3. Call patient or send grievance acknowledgment letter informing the patient their complaint or grievance was received and is being reviewed and investigated..."

An interview with the facility's Patient Representative was conducted on 2/9/11 at approximately 10:30 a.m. S/he confirmed that the policy did not specify a timeframe in which patients would be notified that their grievance was received.

An interview with the facility's Assistant Director of Accreditation/Medical Staff Services was conducted on 2/9/11 at approximately 12:10 p.m. S/he stated that s/he thought the grievance policy used to have the three day timeframe. S/he also stated that they had recently done revisions to the policy. After review of the previous policy, changed 1/17/11, it was confirmed that the policy did have the three day timeframe present. The Assistant Director of Accreditation/Medical Staff Services stated, "I don't know why it got changed."

Prior to exit from the facility, a newly revised and approved "Problem Resolution" policy was provided. It stated the following in the procedure section, in pertinent part: "Call patient or send grievance acknowledgement letter (within 3 days) informing the patient their complaint or grievance was received and is being reviewed and investigated..."

Based on review of the facility's grievance investigations and staff interview, it was determined the facility failed to provide the patients or their representatives with written notice of its decision and the steps taken on behalf of the patient to investigate the grievance, as well as the results of the process and the date of completion. Specifically, the facility failed to send letters in four sample grievance investigations. This failure created the potential for a negative patient outcome and did not ensure that the patients were formally notified of the grievance decision and/or resolution.

The findings were:

Eight sample grievance investigations were reviewed in detail with the facility's Patient Representative on 2/9/11 at approximately 10:20 a.m.

Sample grievance #1 was in regards to physician and nursing care within the Emergency Department on 10/7/10. The facility was notified in person of the patient's concerns on 10/8/10. The facility as well as the contracted physician group's nurse worked to resolve the grievance. On 10/12/10, the "Patient Representative Report" stated, in pertinent part: "The patient said nothing further needs to be done per (contracted physician group) at this time and that she feels comfortable knowing we will review her concerns." An entry, dated 10/13/10, stated the investigation was closed. It was confirmed with the Patient Representative (PR) that a letter was not sent. On 2/9/11 at approximately 3:25 p.m., after discussion with the contracted Emergency Department physician group's nurse, the PR stated that the nurse "felt like she had responded somewhat promptly and felt like a letter didn't need to be done." The PR also stated, "Our grievance team spent a lot of time checking out the policy and didn't finish it until December and signed off on it in January. (This patient) has been in October and our letter policy change didn't change until after that." The PR was informed that the regulation existed prior to October.

Sample grievance #2 was in regards to nursing care within the Emergency Department on 10/15/10. The last entry documented in the grievance investigation stated, in pertinent part: "I will work with the staff to make sure that your IV skills are where they need to be." When the PR was asked how the patient was made aware of the plan with the grievance, s/he stated that many people knew the patient well. S/he continued that the Risk Manager called and talked to the patient directly and that the CEO also spoke with the patient. S/he also stated, "We spoke and I know it was taken care of and he was satisfied." The PR confirmed that the patient was not sent a letter about the grievance investigation/resolution.

Sample grievance #7 was in regards to physician care within the Emergency Department on 2/20/10. The patient's grievance was thoroughly investigated by the contracted Emergency Department physician group's nurse. The last entry in the investigation report stated, in pertinent part: "She seemed pleased at the end of our conversation. I do believe this is closed." It was confirmed with the Patient Representative (PR) that a letter was not sent. On 2/9/11 at approximately 3:25 p.m., after discussion with the contracted Emergency Department physician group's nurse, the PR stated that the nurse "spent a lot of time on it and didn't do a letter because (s/he) didn't feel it was a grievance and felt it was more of a clarification about (his/her) care."

Sample grievance #8 was in regards to care provided by a medical student and a physician within the Emergency Department on 12/3/10. The last entry in the investigation report stated that the contracted Emergency Department physician group's nurse had contacted the patient and informed him/her that the concerns would be forwarded to the director of the physician group and the director of the medical students for review. The entry then stated, in pertinent part: "(S/he) said nothing further needs to be done... Closed per (physician group)." On 2/9/11 at approximately 3:25 p.m., after discussion with the contracted Emergency Department physician group's nurse, the PR stated that the nurse had to find out who the person referenced in the grievance was and "by the time (s/he) did, it was a couple days later." S/he continued that the nurse wondered if it really was a grievance and that the nurse felt s/he responded promptly enough and didn't need to do a letter.

On 2/9/11, the PR was asked to define the difference between a complaint and a grievance. S/he stated, "If we can take care of the situation that day, it is a complaint, done and overwith. If a big complaint and requires investigating and interviews, then we call that a grievance."

The facility's policy titled "Problem Resolution" was reviewed on 2/8/11. It stated the following, in pertinent part: "Procedure: The following procedure will be initiated upon receipt of any complaint or grievance expressed by the patient or their representative... 1. Attempt to promptly resolve whatever complaint the patient or their representative is expressing. 2. Respond in writing the resolution of the grievance within 15 working days and determine if further investigation and/or further actions are required to resolve the complaint at which point the complaint becomes a grievance. The response will contain..."

Based on the number and nature of deficiencies, the facility failed to be in compliance with the Condition of Participation of Nursing Services. Specifically, the Nursing Services failed to ensure telemetry staff remained on duty to monitor patients, that blood products were administer safely and that patient care plans were developed and revised to address all of the identified needs of each patient.

The facility failed to meet the following Standards under the Condition of Nursing Services:

Tag A 392 Staffing and Delivery of Care
The Nursing Services failed to ensure that the telemetry technicians remained in position at the bank of monitors to provided constant observation of patients, as required.

Tag A 396 Nursing Care Plans
The Nursing Services failed to ensure that the nursing staff developed and kept current a nursing care plan for each patient based on the individual needs of the patients.

Tag A 409 Blood Transfusions and IV Medications
The Nursing Services failed to ensure that the nursing staff who administered blood transfusions adhered to facility policy and standards of care.

Based on tour/observation, staff interviews and review of facility policies/procedures and other documents, the nursing staff failed to ensure that the two telemetry technicians remained in position at the bank of monitors to provided constant observation, as required. The failure created the potential for negative patient outcome for all patients on telemetry that were being monitored at that location.

The findings were:

1. During a tour 4th floor tower cardiology step-down unit on 2/8/11 at approximately 1 p.m., the telemetry monitoring station on the unit was observed to have nine monitors with the capability of monitoring eight patients on each monitor. The chief nursing officer and the unit manager explained that the monitoring station monitored all patients on the floor and all remote telemetry patients. The surveyor observed that there were two chairs at the large console, but only one staff member, later determined to be a telemetry technician at the console observing the monitors. When questioned the chief nursing officer stated that the unit was staffed with two telemetry technicians at all times and they were expected to both remain at the console to monitor the large bank of patients on telemetry. S/he stated the technicians were to remain at the console unless relived by someone else with telemetry monitoring competencies. The telemetry technician that was at the console stated that their might be only one technician for awhile when the second technician had to go to lunch or for a bathroom break or to carry out other duties, such as placing someone on telemetry or posting telemetry strips in patient charts. S/he stated that the two technicians covered for each other and watched the whole console during those times. The second technician returned and stated, when asked, that s/he could be relieved by a nurse to take a break or leave the console, but that s/he had to make the request. S/he stated that routine relief for the technicians was not built into the daily schedule or assignments. The chief nursing officer again clarified that it was expected that the technicians would be provided relief and should never leave the console unless relieved.

2. Review on 2/9/11 of the staffing matrix for 4th floor tower cardiology step-down unit revealed that the unit had two telemetry technicians scheduled for each shift, seven days a week, regardless of patient census.

3. Review on 2/10/11 of the "Position Summary" for the telemetry technician position revealed the following, in pertinent parts:

"Job Title: Telemetry Tech - 613 - Cardiac Telemetry"
"Purpose of Job:
-Understand who our customers are and what our customers expect of us.
-Be the first to respond to any customer request or need.
-Support other members of the work team in meeting customer needs.
-Be accountable for the technical and behavioral competencies of the job.
-To monitor telemetry tracings under the direct supervision of a Registered Nurse."

Further review of the "Position Description" revealed that it contained no addition explanation of the duties or tasks related to telemetry monitoring, including the requirement to continue to monitor assigned telemetry patients from the monitoring station unless relieved of duty by another telemetry technician or other professional (such as a nurse or EMT) with telemetry monitoring competency.

4. Review of the "Telemetry Step-Down Telemetry Technician Orientation Manual" on 2/10/11 revealed the following, in pertinent parts:

"We recognize that ongoing performance improvement efforts are necessary to help create a safe patient environment. We also recognize that ongoing staff education and training is essential in reducing and eliminating potential risk to patient safety."

"Parts of this training packet contains information and instructions regarding aspects of care that, by their nature, may put patients at risk. Understanding the importance of adhering to safe practices relating to these aspects of care is essential."

"Telemetry Patients" policy/procedure (Official Revision 1, dated effective 10/3/05) stated the following, in pertinent parts:
"Policy: (The facility) will utilize telemetry for continuous evaluation of patients based on diagnosis/need, bed availability, admission/discharges and triage potential."

Further review of the orientation manual and attachments, revealed that they contained no requirement to continue to monitor assigned telemetry patients from the monitoring station unless relieved of duty by another telemetry technician or other professional (such as a nurse or EMT) with telemetry monitoring competency.

5. Review on 2/9/11 of the current policy/procedure for "Telemetry Monitoring," (Official Revision 9, which contained no effective date, but was provided at the request of the surveyor 2/9/11) revealed that it contained numerous task and duties, such as posting telemetry strips in patient records on other units and hooking patients up to telemetry equipment on various units, which would take the technicians away from their primary duties to monitor the telemetry patients from the monitoring consoles. The policy/procedure contained no requirement to continue to monitor assigned telemetry patients from the monitoring station unless relieved of duty by another telemetry technician or other professional (such as a nurse or EMT) with telemetry monitoring competency.

6. Review on 2/10/11 of a new revision of the "Telemetry Monitoring" policy/procedure (Official Revision 10), which the chief nursing officer stated s/he had just revised to clarify that technicians should not leave the monitoring station unless relieved, revealed the following additional statement added to the Official Revision 9:

"1. Telemetry monitoring stations will be covered by two staff members at all times."

When given feedback by the surveyor that the change did not describe the process for obtaining competent relief, s/he stated that s/he thought that was implied in the change, but would consider adding more specific directions about seeking and providing competent relief to the telemetry technicians in the policy/procedure. S/he stated that staff had been counseled about the expectation that a technician would not leave the console for any reason without having competent relief.

Based on medical record review, policy review and interview, it was determined the facility failed to ensure the nursing staff developed and kept current a nursing care plan for each patient based on the individual needs of the patient for seven of 30 sample records reviewed (#1, #10, #12, #13, #14, #19 and #27).

The findings were:

POLICY

According to, "Standards of Care IV, VI, VII : Planning - Interventions - Evaluation/Re-evaluation" in pertinent part;
"The patient/family can expect the registered nurse to plan for interventions to promote, maintain or restore health by:
-Planning for age appropriate care directed by patient needs which include biophysical, psychosocial, environmental, educational aspects
-Planning for self care
-Planning for personal hygiene and comfort
-Planning for safe environment
The patient/family can expect to receive appropriate safe care as determined in the planning process and re-evaluated as needed. Implementation/intervention is based on:
-An individualized written Plan of Care reflective of the age and developmental needs of the patient.
The patient/family can expect the nurse to provide an on-going assessment of the patient's progress toward goal achievement. The evaluation/re-evaluation is based on:
-A re-evaluation of the plan of care will be done on an on-going basis."

From 02/08 to 02/10/11, the medical records were reviewed and revealed the facility utilized an electronic system, which generates a care plan based on the assessment data entered by the nurse. The program produced a list of problems activated by the nurse based on her knowledge of the patient. Each problem contained a drop down box of interventions from which the nurse determines which are pertinent. The problems identified and the interventions initiated are then dated and initialed by the nurse. Additionally, the program allows the nurse to use free text to add any additional information, problems and/or interventions as needed. However, review of the plans of care revealed that although the electronic care plans were generally initiated the nursing staff failed to follow the facility's policy, which required evidence of on-going assessments or re-evaluation of the interventions chosen to meet the goals and resolve the problems identified. As examples,

1. On 02/08/11, the clinical record for sample patient #1 was reviewed. Date of admission was 02/02/11 and diagnoses included chest pain. On 02/07/11, s/he underwent a coronary artery bypass and graft (CABG) procedure and was administered two units of blood.

a) Review of the Plan of Care revealed eight problems and the related interventions had been activated and initialed by the same nurse. However, there was no evidence the problem list and interventions were individualized and/or re-evaluated as the patient's condition and needs changed. Specifically,

(i) Problem activated on 02/02/11: Biophysical status - Patient will achieve optimal biophysical status. Interventions activated on 02/02/11 included:
-Vital signs, monitor and record. There was no evidence the frequency to record was established, parameters to maintain and report and what monitoring tools were utilized. There was no evidence of additional information added to the interventions after the patient underwent CABG on 02/07/11 (five days later) or when the patient was administered two units of blood on the same day.
-Devices and document, Use of assistive equipment/devices. There was no evidence of what those devices were, when implemented and how the devices were monitored (and by whom) for accuracy and proper function. It could not be determined if any additional equipment was utilized after the CABG procedure and blood transfusions.

(ii) Problem activated on 02/02/11: Pain - Patient will achieve and maintain established comfort goal. Interventions activated on 02/02/11 included:
-Assess/reassess pain per policy and document. There was no evidence the patient's pain was assessed when admitted for CP and no evidence it had been reassessed after the CABG procedure five days later. There was no evidence of documentation to indicate the acceptable level of pain had been established on the day of admission and re-evaluated after the CABG procedure.
-Provide comfort measures. There was no evidence of the specific comfort measures identified for the patient when s/he was initially admitted with chest pain (02/02/11) and then re-evaluated after the patient had surgical intervention (02/07/11).

2. On 02/10/11, the clinical record for sample patient #27 was reviewed. Date of admission was 02/01/11 and diagnoses included gastrointestinal bleed, syncopal episode and esophageal cancer. S/he received two units of blood on 02/01/11. The patient had an advance directive, do not resuscitate and on 02/03/11 an order for comfort measures only.

a) Review of the Plan of Care revealed seven problems and the related interventions had been activated and initialed by the same nurse. However, there was no evidence the problem list and interventions were individualized and/or re-evaluated as the patient's condition and needs changed. Specifically,

(i) Problem activated on 02/01/11: Pain - Patient will achieve and maintain patient's established comfort goals. Interventions activated on 02/02/11 included:
-Comfort goal, determine and document. There was no evidence of documentation to indicate the acceptable level of pain had been established with the patient.
-Provide comfort measures, however, there was no evidence the specific comfort measures were identified and implemented and no evidence of a re-evaluation of those measures based on the patient's response.
-Devices and document, use of assistive equipment/devices. There was no evidence of what those devices were, when implemented and how the devices were monitored (and by whom) for accuracy and proper function. It could not be determined if any additional equipment was utilized and/or discontinued after the patient was placed on comfort measures only.

INTERVIEW

On 02/09/11, the Director of Accreditation/Medical Staff Services was interviewed. S/he stated, we know the care plans are not great. The computer program is somewhat limiting but the nurses have the ability to write free text to add additional problems and interventions as needed but I can see they aren't doing that. The nurses don't generally use the care plans as their working document, they use the kardex for that purpose. However, the kardex is not a part of the clinical record so there is no evidence of the on-going assessments/evaluations and changes made to the plan of care that the nurses really are doing on an on-going basis. We plan to tie the nurses progress notes to the care plan problem list but we have not yet implemented the process.

In summary, the facility failed to ensure the nursing staff followed the policy/procedure, which governed the standard of care for the nursing process of care plan development, implementation and evaluation.

Based on medical record review, staff interviews, review of facility documents and policies and procedures, the facility failed to ensure that personnel who administered blood transfusions adhered to facility policy and standards of care. The failure created the potential for a negative patient outcome.

The facility failed to ensure that staff administering fresh frozen plasma to a patient (sample patient #26) on the medical/surgical floor followed the facility's policy of having another hospital staff member independently document the required check prior to blood product transfusion on the transfusion record. The facility failed to ensure that staff administering blood to a patient (sample patient #26) on the medical/surgical floor followed the facility's policy to completely document all aspects of the blood product transfusion and the patients reaction to the transfusion, specifically the presence or absence of signs and symptoms of a transfusion reaction.

The findings were:

1. Medical Record Review:

On 2/10/11, the medical record for sample patient #26, who received blood product transfusions, was reviewed.

Sample patient #26 was an adult patient on a medical/surgical floor for hematuria and overanticoagulation. On 12/19/10, an order for the transfusion of four units of fresh frozen plasma (FFP) was written. A consent for blood transfusion was present in the patients chart that was signed. On 12/19/10 at 4:35 a.m., the transfusion record indicated that pre-transfusion vital signs were obtained and the first unit of FFP was started. The transfusion record reflected only one signature in a section labeled "Unit Identified By." The record indicated the first unit was completed at 4:55 a.m. On 12/19/10 at 4:58 a.m., the transfusion record indicated that pre-transfusion vital signs were obtained and the second unit of FFP was started. The transfusion record reflected only one signature in a section labeled "Unit Identified By." The record indicated the second unit was completed at 5:16 a.m. On 12/19/10 at 5:45 a.m., the transfusion record indicated that pre-transfusion vital signs were obtained and the third unit of FFP was started. The transfusion record reflected only one signature in a section labeled "Unit Identified By." The record indicated the third unit was completed at 6:04 a.m. On 12/19/10 at 6:04 a.m., the transfusion record indicated that pre-transfusion vital signs were obtained and the fourth unit of FFP was started. The transfusion record reflected no signatures in a section labeled "Unit Identified By." The record indicated the fourth unit was completed at 6:23 a.m. The record did not have any information filled in for sections that were provided for which person started the blood, the date started, what blood product was given, the blood type and Rh factor, the blood bank armband number, the donor number, the expiration date of the blood product, and the verification of the blood consent being signed. There was no documentation if a transfusion reaction was present after transfusion of the first, second, third, or fourth units of blood products transfused on the record where space was provided to indicate so. On 12/19/10 at 5:55 p.m., the transfusion record indicated that pre-transfusion vital signs were obtained and the fifth unit of FFP was started. The transfusion record had all areas provided filled out with the appropriate information. The record indicated the fifth unit was completed at 6:15 p.m. On 12/19/10 at 6:15 p.m., the transfusion record indicated that pre-transfusion vital signs were obtained and the sixth unit of FFP was started. The transfusion record reflected only one signature in a section labeled "Unit Identified By." The record did not indicate, where provided space, whom started the blood product. The record indicated the sixth unit was completed at 6:20 p.m.

2. Policy/Procedure Review:

On 2/10/11, the policy/procedure "Blood Administration, Packed Cells-Whole, Fresh Frozen Plasma, Platelet, Cryoprecipitate" dated and approved 4/6/2009 was reviewed and revealed the following, in pertinent parts:
"Policy:
Safe appropriate practice and standard precautions will be maintained by hospital personnel during the administration of blood and blood products...
...Person Responsible:
All RNs...
...Procedure:...
...5. The RN is to complete the following items under the nursing section of the Transfusion Record Form before starting the blood product.
-Blood Started by
-Date/time
-Blood Product
-Group and Rh
-Blood Bank armband number
-Donor number
-Expiration Date
-Filter used
-Blood Warmer
-Consent for treatment
-Ordering physician...
...7. After receiving blood from blood bank, it is necessary for the RN and another hospital employee to check and cosign Blood Administration Record. The blood will be checked at the patient's bedside for the following identification information:
a. Identify patient by hospital ID band and blood bank band checking name and identification number.
b. A second identification of patient by asking patient his/her name or encourage family to identify the patient.
c. All four of the following means of identification and their corresponding information need to correlate before a transfusion of blood can be initiated:
-the hospital ID band
-the blood bank ID band
-the Transfusion Record Form
-the blood bank label...
...18. Complete all sections of Transfusion Record Form..."

3. Staff Interview:

On 2/10/11 at approximately 9:00 a.m., the findings of incomplete documentation on the transfusion record forms for sample patient #26 were confirmed with the Lead Clinical Nurse that was present during medical record review.

On 2/10/11 at approximately 11:10 a.m., the findings of incomplete documentation on the transfusion record forms for sample patient #26 were confirmed with the Director of the patient care floor where sample patient #26 was treated and provided blood product transfusion. Electronic nursing notes were reviewed at that time with the Director of the patient care floor, which revealed that the LPN caring for sample patient #26 had written in his/her nursing notes that the first, second, third, and fourth units of FFP were verified at the bedside with the author and an RN (who had not written any electronic nursing notes in the patients record). The Director confirmed that the policy for blood transfusion did not currently allow for electronic documentation of the two staff member verification or required documentation that was specified in the policy.

Further review of the electronic nursing notes revealed that documentation of the two staff member verification of the first unit of FFP was documented at 5:17 a.m. (after the second unit of FFP had infused). The documentation of the two staff member verification of the second unit of FFP was documented at 5:25 a.m. (10 minutes after the second unit of FFP had infused). The documentation of the two staff member verification of the third unit of FFP was documented at 6:30 a.m. (after the fourth unit of FFP had infused). The documentation of the two staff member verification of the fourth unit of FFP was documented at 6:38 a.m. (15 minutes after the fourth unit of FFP had infused). In summary, the electronic documentation by the LPN caring for sample patient #26 was not at the time of the transfusion and was not electronically authenticated by the other staff member mentioned in the notes.

Electronic nursing notes for the fifth and sixth units of FFP revealed no mention of the second staff member that verified the sixth unit of FFP.

In summary, the facility failed to ensure that nurses in the facility followed the facility's policies/procedures for the transfusion of blood products. Documentation during the transfusion of blood products to sample patient #26 were inconsistent or absent and lead to the potential for negative patient outcome.

Based on staff interview and review of the facility's policies/procedure, the facility failed to develop and maintain policies regarding maintenance of personal radiation monitoring devices and proper storage of radiation monitoring badges when not in use. This failure created the potential for a negative outcome as staff did not have reference and/or provisions for proper monitoring device storage and maintenance.

The findings were:

Review of the facility's Diagnostic Imaging polices was done on 2/8/11. There was not an exclusive policy related to maintenance and storage of monitoring devices. The policy titled "Radiation Safety" stated the following, in pertinent part:
"Protective Equipment... 4. Radiation film badges are worn to monitor the amount of exposure you receive. They should be worn at all times except when you are having medical or dental examination. Film badges should be worn waist high and under the apron. Technologist/Radiologist with increased exposure to fluoroscopy shall have a collar badge in addition. This badge will be worn on the collar, outside the lead apron. 5. Dosimetry (Radiation Badge) results are available for review monthly. Please contact your supervisor if you need to review..."

An interview with the Clinical Lead was conducted on 2/9/11 at approximately 9:00 a.m. S/he stated that the staff were in charge of their own badges and storage. S/he stated that staff keep their own because they frequently work at other diagnostic imaging locations and need the ensure their exposure time is calculated for each facility.

An interview with the Director of Diagnostic Imaging was conducted on 2/9/11 at approximately 2:30 p.m. S/he confirmed that the facility did not have policies related to monitoring device storage/maintenance. S/he stated that the staff was educated in their respective training about proper maintenance and storage of badges and that it benefited them to do so. S/he also confirmed that dosimetry monitoring was done monthly and results of such were reviewed and investigated, thereafter, if issues.

Based on the food and dietary tours, staff interviews and review of the facility's policies and procedures, the facility failed to ensure that food and dietetic services organization requirements were met. Specifically, the facility failed to ensure that proper sanitation and monitoring requirements were met.

The findings were:

1. A tour of the food and dietary area at the main hospital kitchen and the Perk-view Cafe was conducted on 2/9/11 at approximately 9:10 a.m. with the dietary manager. In the Perk-view Cafe, preparation and storage there were various reach-in refrigerators and freezers that did not have back-up thermometers. There were various left-overs such as salads and sandwiches that were not dated. In the dry storage area, there were three cardboard boxes of supplies, five cases of soda pop and three cases of bottled soda pop stored directly on the floor.

The facility's policy and procedure entitled "Food Storage" under the heading of Perishable Storage (cooled and frozen) stated, in pertinent part: "Manual thermometers are supplied on all smaller reach-in refrigerators & freezers, and are situated so that they are easily and readily observed for reading." The policy and procedure did not address the dry storage parameters or the storage of left-overs.

The dietary manager was interviewed during the tour on 2/9/11. The manager stated that left-overs should be dated and food items should not be stored on the floor. S/he further stated that normally the reach-in refrigerators and freezers have thermometers for back-up.

2. A tour of the food and dietary area at the Health Plaza North Campus and the 17th Street Cafe was conducted on 2/10/11 at approximately 11:15 a.m. In the food preparation area at the Health Plaza North Campus, there was observed to be a scoop stored in the flour bin with the handle of the scoop down in the flour. At the 17th Street Cafe, there were several trays of dessert with individual servings on them that were not dated.

An onsite complaint investigation was completed (see event ID #8UEV21), January 11 through 19, 2011, was conducted by two (2) Life Safety Code Inspectors and included an inspection for compliance with the fire safety requirements of Chapters 19 and 39 of NFPA-101, Life Safety Code, (2000 edition) and the 1999 Edition of NFPA 99 Health Care Facilities, published by the National Fire Protection Association. The facility failed to comply with the regulations set forth and, therefore, the complaint is substantiated.

Deficiencies were cited.

Based on staff interview, facility tour, and review of the facility's policies/procedures, the facility failed to ensure that the overall hospital environment was developed and maintained in such a manner that the safety and well-being of patients were assured, specifically in the event of an emergency/natural disaster situation.

The findings were:

A facility tour of the surgical areas of the hospital was conducted on 2/7/2011 at approximately 11:30 a.m., by two surveyors with the Vice-President of Patient Care Services. It was revealed that the emergency crash cart for the post-anesthesia care unit did not have a portable suction machine or any other such provisions that would allow for the suctioning of a patient's airway in the event of loss of wall suction or hospital power failure.

A facility tour of the emergency department of the hospital was conducted on 2/8/2011 at approximately 8:15 a.m., by two surveyors with the Director of Emergency Services and the Vice-President of Patient Care Services. It was revealed that the emergency crash carts for the Emergency Department did not have a portable suction machine or any other such provisions that would allow for the suctioning of a patient's airway in the event of loss of wall suction or hospital power failure.

A facility tour of the off-site emergency department of the hospital was conducted on 2/8/2011 at approximately 9:30 a.m. by two surveyors with the Director of Emergency Services and the Vice-President of Patient Care Services. It was revealed that the emergency crash carts for the Emergency Department and the building (which also included an outpatient sleep lab) did not have a portable suction machine or any other such provisions that would allow for the suctioning of a patient's airway in the event of loss of wall suction or building power failure.

A facility tour of the Medical/Surgical/Cardiac Intensive Care Unit of the hospital was conducted on 2/8/2011 at approximately 9:15 a.m. by one surveyor with the Vice-President of Nursing Services. It was revealed that the emergency crash carts for the entire hospital known as the "house cart" was the only cart with a portable suction machine. The machine only would work if plugged into an electrical outlet and had no battery backup. There were no additional provisions that would allow for the suctioning of a patient's airway in the event of loss of wall suction or hospital power failure.

A review of the facility's policies/procedures conducted on 2/8/2011, revealed the following, in pertinent parts:
"Equipment Failure...
...Policy
Essential equipment will be continually available in the Emergency Department, to provide safe and comprehensive care for all patients.
Procedure...
...D. Suction failure: Maintenance Department will be notified immediately in the event of wall-suction failures. Sterile Process Department will also be called to bring portable suction units, if needed. Suction head failures will be reported to Biomed Department promptly for repairs and replacement..."

An interview with the Director of Facilities Management in the presence of the Vice-President of Patient Care Services on 2/10/2011 at approximately 10:45 a.m., revealed that the facility's back-up portable suction units must be plugged into an electricity source and that the "house cart" housed in the Medical/Surgical/Cardiac ICU was the only emergency cart that had a portable suction machine (which required an electrical outlet to function).

In summary, the lack of a portable suction machine that did not require an electrical outlet or any other such provisions that would allow for the suctioning of a patient's airway in the event of loss of wall suction or hospital power failure failed to assure the safety and well being of patients which includes, according to the Center for Medicare and Medicaid Services' (CMS) interpretive guidelines: "developing and implementing appropriate emergency preparedness plans and capabilities. The hospital must develop and implement a comprehensive plan to ensure that the safety and well being of patients are assured during emergency situations...must coordinate with Federal, State, and local emergency preparedness and health authorities to identify likely risks for their area (e.g., natural disasters, bio-terrorism threats, disruption of utilities such as water, sewer, electrical, communications, fuel; nuclear accidents, industrial accidents, and other likely mass casualties, etc.) and to develop appropriate responses that will assure the safety and well being of patients. The following issues should be considered when developing the comprehensive emergency plans(s):...The special needs of patient populations treated at the hospital...Pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster situations;...Provisions if gas, water, electricity supply is shut off to the community;..."

Based on staff interview, facility tour, review of facility documents, and review of the facility's policies/procedures, the facility failed to ensure that policies governing surgical care were designed to assure the achievement and maintenance of high standards of medical practice and patient care.

The findings were:

1. Separation of unrestricted and restricted areas in the operating room:

A facility tour of the surgical areas of the hospital was conducted on 2/7/2011 at approximately 11:30 a.m. by two surveyors with the Director of Surgical Services and the Vice-President of Patient Care Services. The tour revealed that in the main operating area the restricted corridor that lead to the operating rooms and scrub sinks had no physical barrier from the unrestricted area where personnel and visitors were passing in street clothing. Above the door frame from the unrestricted area to the restricted corridor was a sign reading "Surgical Attire Required Beyond This Point," however, no physical barrier or door was present to prevent unauthorized personnel from entering the restricted corridor. In the adjacent pre-operative areas, visitors in street clothes and law enforcement officers in uniforms were noted to be present. No physical barrier was present between the pre-operative and unrestricted corridor that was adjacent to the restricted operating room corridor.

An interview with the Director of Facilities Management on 2/7/2011 at approximately 12:50 p.m. revealed that the OR rooms are kept at a constant positive air pressure and that the positive pressure results in there being a positive air pressure from the sterile corridor into the unrestricted area. When asked, s/he confirmed that the air pressure difference is not measured regularly as was done constantly by maintenance for the operating rooms.

On 2/7/2011 at approximately 1:00 p.m. one of the hospital's HVAC Technicians with the assistance of the Director of Facilities Management demonstrated that positive air pressure was present from the operating room corridor into the unrestricted area with a reading of 0.0001 inches of column water.

An interview with the Director of Surgical Services on 2/7/2011 at approximately 1:00 p.m., revealed that "generally staff come in the back way to the locker rooms, but there is still a fair amount of traffic that comes through here" when discussing the area where the unrestricted corridor was adjacent to the restricted surgical corridor.

A subsequent interview with the Director of Facilities Management on 2/8/2011 at approximately 4:00 p.m. with the Vice President of Patient Care Services present revealed that placing doors between the unrestricted corridor and the restricted sterile corridor was possible. S/he stated that the addition of doors would allow more control of air pressure.

A review of the facility's policies/procedures on 2/8/2011, revealed the following, in pertinent parts:
"Infection Control - Surgery...
...Procedure
1. Traffic Control...
...B. Semi-Restricted/Restricted Areas:
1. Semi-restricted areas require scrub attire except for masks and include main OR hallways, storage areas and sterile supply rooms.
2. Restricted areas require scrub attire and masks and include the operating rooms and sub-sterile rooms..."
"Traffic Patterns in the O.R.
Policy
The O.R. department will provide a safe and organized plan for the flow of traffic in the operating room area. Planning and controlling these movements is essential for infection control and providing a safe environment for patients and personnel...
...Procedure
1. Any person entering the operating room area shall adhere to the defined traffic areas.
a. Unrestricted area: allows street clothes to be worn to provide access for communication between O.R. personnel, hospital personnel, physicians and PAR.
b. Semi-restricted area: approved O.R. clothing is required by all entering that area. This area includes all areas beyond the front hall, and is designated as such by a sign above the entrance to the O.R. suite access corridor.
c. Restricted areas: requires masks in addition to approved O.R. attire. Sterile procedures are carried out in this area.

Staff meeting minutes from the 12/9/2010 Surgical Services staff meeting were reviewed and revealed the following, in pertinent parts:
"...Staff...
...Closure for doors were adjusted on 12/10/10. All doors should be able to stay open while the patient is brought in, always close the OR door once the stretcher is out of the room..."

2. Storage of sterile instruments in unrestricted corridor:
A facility tour of the surgical areas of the hospital was conducted on 2/7/2011 at approximately 11:30 a.m. by two surveyors with the Director of Surgical Services and the Vice-President of Patient Care Services. The tour revealed that in the unrestricted hallway, an uncovered cart contained sterile instrument trays.

An interview with the Director of Surgical Services was conducted at the time of the observation, which revealed that the cart was "brought up here in the morning and used during the day or (here for when instrument trays are) ready to go back." When asked, s/he confirmed that the trays could be taken to the operating room and used at that time. S/he stated that the cart should be covered to prevent contamination, but confirmed that the cart was not covered currently. S/he stated that the place where the cart was currently was "probably not the best place."

A subsequent interview with the Director of Surgical Services on 2/10/2011 at approximately 9:30 a.m., revealed that after the observations on 2/7/2011, the cart with instrument trays would no longer be brought to the unrestricted hallway to avoid the possible contamination of sterile instrument trays.

A review of the facility's policies/procedures on 2/8/2011, revealed the following, in pertinent parts:
"Transporting Sterile Instruments...
...Procedure
1. All sterile instruments or other items coming from Sterile Processing to O.R. will be transported in a covered, clean cart or covered with clean towel when hand carried..."
"Traffic Patterns in the O.R....
...8.b. Sterile supplies should be delivered and transferred in restricted areas on containers selected to protect the integrity of the sterile packaging..."

3. Obstetrical/gynecological operating room semi-restricted area:
A facility tour of the obstetrical/gynecological surgery area was conducted on 2/7/2011 at approximately 1:30 p.m., by two surveyors with the Director of Women's Services and the Vice-President of Patient Care Services. The tour revealed that from the Labor and Delivery floor, double doors opened into a recovery area that was immediately adjacent to the door to the operating room that was used for Caesarian sections. When asked, the Director of Women's Services stated that the staff and visitors did not need a hat cover in the recovery area outside of the operating room. Staff was seen in street clothing in the recovery room area.

A subsequent tour of the obstetrical/gynecological surgery area conducted on 2/10/2011 at approximately 10:15 a.m. with the Vice-President of Patient Care Services and the Director of Women's Services revealed that hair and shoe covers were available outside the operating room door. In the unrestricted recovery area, three tables with sterile drapes covering sterile instruments prepared for possible Caesarian sections were noted to be present and unattended.

An interview with the Vice-President of Patient Care Services on 2/10/2011 at approximately 10:50 a.m. confirmed that there were three tables with sterile instruments in the unrestricted area that were prepared for possible Caesarian sections. S/he stated that the facility could make the recovery area into a semi-restricted area by moving the hair covers and shoe covers outside the semi-restricted area that contained the recovery area.

4. Pre-cleaning of endoscopes:
A facility tour of the surgical areas of the hospital was conducted on 2/7/2011 at approximately 11:30 a.m. by two surveyors with the Director of Surgical Services and the Vice-President of Patient Care Services. The tour revealed that in the room where endoscopes were cleaned there was a sink used for pre-cleaning the endoscopes in enzymatic detergent. The sink did not have any markings indicating the amount of water in the sink. The Lead Clinical Nurse of the endoscopy area stated, during the tour of the area, that staff "just fill it (the sink) up halfway and add two squirts" to the water. Manufacturers instructions on the detergent stated that one ounce of detergent was to be added to one gallon of water.

A review of the facility's policies/procedures on 2/8/2011, revealed the following, in pertinent parts:
"High Level Disinfection...
...Procedure...
...3. Disinfectants must be prepared according to manufacturer instructions.
4. All instruments will be clean prior to soaking.
5. Instruments will be soaked according to manufacturers' recommendations..."
"Endoscopy Cleaning Procedure...
...Procedure...
...2. Remove valves and place in enzymatic cleaner..."

5. Intravenous and irrigation fluid warming. lack of policy and inconsistent practice:
A facility tour of the surgical areas of the hospital was conducted on 2/7/2011 at approximately 11:30 a.m., by two surveyors with the Director of Surgical Services and the Vice-President of Patient Care Services. The tour revealed that in the operating rooms and outside the operating rooms there were warming cabinets that contained intravenous fluid and irrigation fluid. A sign on the outside of the cabinet stated, "ALL irrigations must have an expiration date & initials when put in the warmers. Any found not dated will be discarded. Irrigation solution in plastic bottles may be stored in warmer for 30 days. Bags of irrigation solution may be stored in warmers for 14 days. All irrigations must remain in their outer wrap. Solutions taken out of warmer for a period of time may not be re-warmed. Solution expiration date will then become expiration date on manufacturers label."

A facility tour of the emergency department of the hospital was conducted on 2/8/2011 at approximately 8:15 a.m. by two surveyors with the Director of Emergency Services and the Vice-President of Patient Care Services. The tour revealed that warming cabinets were present that contained intravenous and irrigation solutions. The items contained the dates when items were placed in the cabinet.

An interview with the Vice-President of Patient Care Services on 2/10/2011 at approximately 3:30 p.m., revealed that the hospital did not have a policy on fluids placed in warming cabinets.

A subsequent tour of the Surgical Services and Emergency Services area was conducted by one surveyor with the Vice-President of Patient Care Services on 2/10/2011 at approximately 9:00 a.m. It was revealed through observations and interviews with the Department Directors at that time that the ER staff's practice was to write the date that fluids were placed in the warmer and to remove after 14 days. The OR staff's practice was to write the date that the fluids needed to be removed from the warmer. It was revealed that the OB Surgery area only had bottled irrigation fluid in the warming cabinet and wrote the day the fluids needed to be removed, which the Director of Women's Services stated was after three days.

A lack of a policy lead to inconsistent practices in different areas of the hospital and could lead to confusion of facility staff on when fluids were placed in the warming cabinets and how long was allowed by manufacturer's specifications and standards of practice.