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Based on observation, interview, and record review, the hospital failed to ensure the GB monitored the contracted hemodialysis (a method to remove waste products such as creatinine and urea and free water from the blood when the kidneys are in a state of renal failure) services for safe and quality care provided to three dialysis patients (Patients 3, 22, and 23) as evidenced by:

1. For Patient 22, the physical assessment by the dialysis RN was incomplete and the dialysis RN was not aware of the location of the patient's pressure and the repositioning needs. In addition, medications were found in Patient 22's closet, not for the patient. The medications were prepared ahead of time by the dialysis RN for the next dialysis patients assigned to him.

2. For Patient 3, the Dialysis RN was unaware of the patient's pressure ulcer and repositioning needs.

3. For Patient 23, the dialysis RN did not clarify and obtain a complete order for hemodialysis treatment until the treatment was underway for one hour.

These failures could result in worsening of the patients' skin conditions and errors in care.

Findings:

On 4/23/14, review of the services agreement between the hospital and the dialysis company, under 3.10, Treatment showed whenever patients were to receive dialysis services, the company should provide at least one (1) RN to oversee the provision of services and such additional staff to maintain an appropriate patient/staff ratio. Dialysis staff should monitor and regulate the services in conformity with physicians' orders and the patients' condition. The duties and responsibilities of the staff providing dialysis services hereunder set forth in Exhibit 3.10. Hospital should provide nurses who would provide backup nursing support during each treatment for each patient receiving services. Hospital nurses should be responsible for non-service related care of the patient during the treatment which might include responsibility for administering medications, performing and documenting ADL and baseline assessments, and assisting dialysis staff in achieving hemodynamic stability.

Under Provision of Services 3.2, Rules and Regulations, it showed all staff should comply with the ethical and administrative rules, regulations, and policies and procedures of the hospital in effect on the date hereof that related to the provision of dialysis services.

1a. The medical record for Patient 22 was reviewed on 4/22/14. Review of Dialysis RN O's general assessment dated 4/22/14, showed a generic check-off list that was incomplete. For example, Patient 22's lungs were assessed as clear with no indicated location such as on the bases on both lungs. The patient was on a mechanical ventilator; however, the amount of oxygen being delivered was not documented. The edema (swelling) status of the patient was checked as non-applicable.

Documentation in Patient 22's care plan showed the patient had a Stage IV pressure ulcer (full thickness tissue loss with exposed bone, tendon or muscle; slough or eschar may be present on some parts of the wound bed; and often include undermining and tunneling) to the middle sacrum, with off-loading interventions to reposition the patient to the right and left sides only, never on his back.

The patient's skin assessment by the dialysis RN showed the skin was warm and pink with no description of the skin's integrity. Patient 22's sacral pressure ulcer was not noted.

The patient's abdomen was assessed as soft, but the presence of Patient 22's GT was not documented.

On 4/22/14 at 1135 hours, Dialysis RN O was interviewed and asked if he was aware of Patient 22's pressure ulcer. RN O stated the pressure ulcer was on the patient's right side. When asked when the patient last repositioned, the RN stated at the beginning of the hemodialysis treatment, the patient was turned from his right side to his back.

Further review of the Patient 22's dialysis records dated 4/14 and 4/16/14, showed no documentation Patient 22 had a Stage IV pressure ulcer and a GT.

b. On 4/23/14, review of the hospital's policy titled Administration of Medications showed on letter D, "All medications must be properly stored/secured at all times prior to administration. Prepared medications must never be left unattended."

Patient 22 was observed on 4/22/14 at 1031 hours, accompanied by the QA Director. A hemodialysis machine was at the patient's bedside but was not connected to the patient. No health care staff was in the room.

Inspection of the room's linen closet showed opened IV bags, medications, syringes with medication, and opened medication vials. The QA Director stated the linen closet was not intended for storage of prepared medications and opened vials.

Dialysis RN O then entered Patient 22's room and took all the IV medications. RN O stated he just came back from his morning breaktime. RN O stated the medications found in Patient 22's closet were not for Patient 22 but were prepared ahead of time for the next dialysis patients assigned to him. When asked, RN O acknowledged medications were not to be stored in a patient's room and then moved from one room to another while providing dialysis treatments. RN O stated the medications should be kept in the unit's medication room.

2. On 4/22/14 at 1415 hours, Patient 3 was observed with the QA Director. Patient 3 was lying on his back, a dialysis treatment was in progress.

Dialysis RN P was asked when the patient was last turned. RN P stated Patient 3 was turned at the beginning of the treatment, three hours ago.

When asked, RN P sated he was not aware the patient had pressure ulcers.

Review of Patient 3's medical record showed the patient had pressure ulcers on both sides of the buttocks with a care plan to turn the patient every two hours.

3. On 4/22/14, Patient 23's medical record review showed the physician's orders dated 4/18/14, for hemodialysis treatment did not contain a blood flow rate (rate of blood going through the dialyzer), dialysate flow rate (rate of the dialysate going through the dialyzer), and the ultrafiltration rate (rate at which fluid is removed from the patient). The ultrafiltration rate was prescribed "as tolerated."

On 4/22/14 at 1240 hours, during an interview, the above treatment orders were reviewed with RN L. When asked what the ultrafiltration rate would be, RN L stated the rate would be determined by the nephrologist and the nurse should clarify the rate with the physician.

On 4/23/14, medical record review showed Patient 23's dialysis treatment was initiated on 4/18/14 at 1930 hours. RN L obtained the specific orders for the blood flow rate, dialysate flow rate, and ultrafiltration rate on 4/18/14 at 2049 hours, one hour and 19 minutes after the patient's treatment was initiated.

The above observations were discussed with the QA Director on 4/24/14 at 1000 hours. The QA Director stated data indicators of hemodialysis were submitted, collected, and reviewed; however, she confirmed there was no monitoring of contracted dialysis bedside services.

Based on interview and record review, the hospital failed to ensure one of 33 sampled patients (Patient 30) was provided adequate information regarding provision and discontinuation of care provided. This failure created the risk of patient not receiving adequate care according to her preference.

Findings:

The 2012 Medical Staff Rules and Regulations (undated), page 1, read in part, "All licensed independent practitioners (LIP's) shall be responsible for the medical care and treatment of each patient in the Hospital, and for the...c. communication directly with the patient, family or legal representative and other Medical Staff practitioners, any changes or clarification in the patient's plan of care, condition, or therapeutic interventions ..."

The medical record for Patient 30 was reviewed on 4/21 and 4/22/14. Documentation showed the patient was transferred to the hospital from a general acute care hospital. The patient's tube feedings were stopped by the GI specialist via a telephone order after an episode of vomiting on 4/18/14. The tube feedings were not resumed in subsequent days.

Documentation in the medical record showed Patient 30's condition was discussed in detail with the patient's family; however, the details of that discussion, including the plan of care for the patient were not documented.

On 4/21/14 at 0950 hours, Patient 30 was observed in bed. The NGT was clamped shut. Patient 30 had an ongoing IV fluid at 50 ml per hour. Levophed IV (vasopressor to raise blood pressure) was also infusing at 13 ml per hour.

A concurrent interview with Patient 30's family member showed the patient had not received tube feedings since 4/18/14, after the patient had an episode of vomiting. The family member was concerned with the patient's nutritional needs, especially with an admitting diagnosis of malnutrition.

Medical record review with the Clinical Analyst on 4/23/14, showed Patient 30's tube feeding was initially ordered on 4/15/14, for Perative (formula) via NGT at a rate of 20 ml/hour. On 4/16/14, the physician ordered for the Perative rate to be increased to 55 ml/hour, starting at 25 ml/hour and increasing 10 ml every six hours or as tolerated to a goal rate of 55 ml/hour.

On 4/17/14, Patient 30's physician ordered the tube feeding be changed to Nepro (formula) at 35 ml/hour. On 4/18/14 at 0400 hours, the patient had an episode of vomiting. The physician was notified and ordered to hold the feeding until further orders.

Medical record documentation reviewed from 4/18/14 to 4/20/14, showed the amount of IV fluids or tube feeding was not documented in the intake/output segment of the patient's record.

Review of the Progress notes on 4/20/14, showed Patient 30 was evaluated by Gastroenterologist and Internal Medicine physicians. The Gastroenterologist wrote in the progress notes that the patient's prognosis was grave and the family was made aware. However, there was no written plan to hold the patient's tube feedings or any documented care plan regarding the patient's feeding status.

The Internal Medicine Progress note dated 4/20/14, showed the case was discussed in detail with the patient and family members.

During an interview with the Chief of Staff, one of Patient 30's physicians on 4/23/14 at 1030 hours, he stated he believed it was the patient's family that wished the tube feeding be stopped, and the feedings should have been resumed. The Chief of Staff stated the plan was for supportive care and end of life care, and this was discussed in detail with the family. However, the Chief of Staff concurred the content of the discussion with the family and the plan of care may not have been clearly documented.

Based on interview and record review, the hospital failed to ensure the grievance process was implemented for two of the three patient grievances reviewed (Patients 5 and 21) when allegations regarding physicians were not investigated. This failure created the risk of persistent poor practices and substandard healthcare.

Findings:

The hospital's policy titled Patient Complaint/Grievance Process, revised 2/13, read in part, The supervisor must: 1. Initiate an initial investigation, including interviews of all involved."

On 4/21/14, Patient 5 and 21's grievances containing allegations against medical staff were selected for review from a list of grievances for the month of October, 2013.

1. The Patient & Family Grievance Report Form for Patient 5 showed on 10/3/13, the patient complained, "Lack of communication with primary, 'He come 2 AM and try to wake me. Did not wake. Left me a note.' " Under the section for Department Manager Review Findings, it was written, "will fwd (forward) to peer review." There was no check in the boxes for "issue resolved" or "issue not resolved." Other allegations not involving medical staff were listed on a separate sheet, with "issue resolved" checked off.

The response letter to the patient dated October 28, 2013, read, "Please know that concerns with the medical staff are managed at the Administrative level and it has been forwarded to that department for their review."

The quality file for Patient 5's physician, DR 5 was reviewed. The file contained a copy of the complaint regarding DR 5's behavior; however, there was no evidence DR 5 was contacted about the complaint and no evidence the allegation was reviewed.

2. Patient 21's family member submitted a complaint with multiple allegations dated 10/11/13. The complaint included the allegation "Doctor never call family."

Review of the Patient & Family Grievance Report Form showed evidence of an investigation of some of the allegations; however, there was no information about the complaint of the physician not calling the family.

The response letter to Patient 5 dated October 28, 2013, read, "We will forward the complaint about the doctor not calling you to the appropriate administrative area since those issues are managed at that level."

However, a review of the quality folder for DR 1 contained a copy of the complaint, but no information indicating the physician was contacted regarding the complaint.

During interviews with the DQM on 4/22/14 at 1315 hours and 4/23/14 at 0900 hours, he reviewed the documentation in the file of DR 5 and DR 21. The DQM stated he was not sure the grievances were discussed with the physicians. The DQM stated the CEO generally spoke with the physicians; however, he was not sure as to when this had occurred as it was not documented in the files.

During an interview with the QM Director on 4/24/14 at 1115 hours, the Director concurred the physicians should be contacted about grievances to allow the opportunity to for them to clarify events and receive feedback. The QM Director stated the physician contact was to be tracked in the OPPE process. The QM Director concurred the contact was not documented.

Based on observation, interview, and record review, the hospital failed to follow their P&P to include the patient and/or family representative in care planning for one of 33 sampled patients (Patient 30). This failure had the potential to result in a violation of the patient's rights.

Findings:

On 4/22/14, review of the hospital's P&P titled Assessment /Re-assessment -Interdisciplinary Patient showed patients with the same health problems and care needs could expect to receive the same level of care throughout the hospital. The medical staff was responsible for the medical plan of care and had the responsibility to assess and improve the patients' care at the hospital. All patients at the hospital would have appropriate follow-up assessments based upon the patient's specific identified needs, including physical status. The goal of the assessment /reassessment process was to provide an interdisciplinary approach for assessment(s) and ongoing reassessment(s) of individual patient care needs and for planning and implementing patient specific care. The patient information might include the patient's condition and any recent or anticipated changes.

On 4/21/14 at 0950 hours, Patient 30 was observed in bed. The patient's NGT was clamped shut and the patient had ongoing IV fluids at 50 ml per hour. A Levophed IV was infusing at 13 ml per hour.

A concurrent interview with Patient 30's family member showed the patient had not received tube feedings since 4/18/14, after an episode of vomiting. The family member was concerned with the patient's nutritional needs especially with an admitting diagnosis of malnutrition.

Medical record review with the Clinical Analyst on 4/23/14, showed Patient 30's tube feeding was initially ordered on 4/15/14, for Perative via NGT at a rate of 20 ml/hour. On 4/16/14, the physician ordered to increase Perative to a rate of 55 ml/hour, start at 25 ml/hour and increase 10 ml every six (6) hours or as tolerated to a goal rate of 55 ml/hour.

On 4/17/14, the physician ordered the tube feeding be changed to Nepro (formula) at 35 ml/hour. On 4/18/14 at 0400 hours, the patient had an episode of vomiting. The physician was notified and ordered to hold the patient's tube feeding until further order.

Medical record documentation reviewed sated 4/18/14 to 4/20/14, showed no documentation of the amount of IV fluids or tube feeding in the intake/output segment of the patient's record.

Review of the Progress notes dated 4/20/14, showed the patient was evaluated by Gastroenterologist and Internal Medicine physicians. The Gastroenterologist physician wrote in the progress note that the patient's prognosis was grave and the family was made aware. The Internal Medicine progress note on 4/20/14, also showed the case was discussed in detail with the patient and family members. However, neither physicians documented the plan to hold the patient's tube feedings and the plan regarding the patient's feeding status.

Based on record review and interview, the hospital failed to ensure the patient and/or their representative had the right to consent to basic procedures and care during their hospital stay for one of 33 sampled patients (Patient 6). This failure had the potential to result in the hospital treating patients without patient/responsible party's consent.

Findings:

Review of the hospital's P&P titled Health Care Decision for Unrepresented Patients showed health care professionals were guided to make medical treatment decisions on behalf of an incapacitated patient who lacked a surrogate decision maker. The unrepresented patients were entitled to have ethically and medically appropriate medical decisions to their best interests. The policy should be used when the patient had been determined by the primary physician to lack capacity to make health care decisions and there was no surrogate decision maker or family member that could be located.

When the policy was appropriate, the medical decisions would be made by a multidisciplinary team. The team should review the diagnosis and prognosis to determine appropriate goals of care and establish a care plan.

Patient 6's medical record was reviewed on 4/21/14, and showed the patient was admitted to the hospital on 3/28/14.

Review of Patient 6's H&P examination dated 3/28/14, showed the patient had a chronic respiratory failure and was dependent on a mechanical ventilator.

Review of the Case Management/Social Services progress note dated 3/31/14, showed Patient 6 was resting in bed and was nonresponsive. The patient's family was unable to be contacted.

Review of the hospital's Admission Agreement, Notice of Privacy Practices, Valuables Statement, and Designation of Individuals showed the forms were not signed. The forms were stamped as "unable to obtain the patient's signature."

Review of the Case Management/Social Services progress notes dated 4/1/14, showed the patient had no contact number for his family, no public guardian, and no advanced directives (legal documents that allow you to spell out your decisions about end of life care ahead of time).

During an interview with the Social Worker on 4/21/14 at 1045 hours, she stated the physician made the medical decisions on behalf of Patient 6.

Review of the Interdisciplinary Team Meetings for Patient 6 showed no evidence the IDT reviewed the patient's diagnosis and prognosis to determine appropriate goals of care.

The above finding was confirmed with the hospital's CEO and CCO on 4/23/14 at 0900 hours.

Based on observation, interview, and record review, the hospital failed to ensure the patients were cared for in an safe and sanitary environment. Observations of the lack of infection control oversight and unsafe food handling practices had a potential of foodborne illness and cross contamination compromising medically compromised patients.

Findings:

1. In the Food Services Department, the kitchen ice machine was not maintained clean, the cook did not follow safe food handling practices for cool-down of cooked ahead food, thawing of raw meat in the refrigerator was stored over ready to eat products, and dishwashing staff did not follow sanitary practices to prevent cross contamination. Cross reference to A-0620.

2. A physician failed to follow guidelines for wearing and changing of gloves and hand hygiene for a patient on isolation. In addition, the physician failed to follow safe injection practices when using needles and syringes during a procedure. Cross reference to A-0749, example #3.

3. Medications found stored in a patient's room were labeled intended for use by two other patients. Cross reference to A-502.

4. Unlabeled urinals and bedpans were found stored in two shared patient bathrooms. Cross reference to A-0749, example #8.

5. The surface integrity of a desk and wall behind the bed in a patient room did not allow for thorough cleaning and the bathroom showed dirty grout, a running toilet, and a hole in the wall. Cross reference to A-0724, example #2.

Based on interview and record review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope services provided as evidenced by:

1. Failure to identify issues in safe food handling practices and food storage in food and dietetic services, all of which could result in foodborne illness and failure to identify opportunities for improvement of nutritional processes might compromise safety and quality care of patients.

2. The QA program failed to provide oversight of the physicians' ongoing provider performance evaluations, creating the risk of persistent poor practices by hospital providers.

Findings:

1. During the survey process, specific issues related to food services were identified. Cross references to A-0620; A-0724, example #1; and A-0749, example #1.

During an interview on 4/24/14, starting at 1015 hours, the Food Service Manager and the Director of Nutrition Services reviewed the department's QAPI program. The Food Service Manager stated he had quality assessment monitoring for temperatures and other food service activities. The Nutrition Services Director stated there were ongoing monitoring and measuring of basic food service functions. The Food Service Manager stated he had never looked for indicators that would be developed for performance improvement monitoring in food services.



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2. The hospital's policy titled Physician Performance Improvement Process, Including Focused and Ongoing Professional Practice Evaluation, revised 8/12, read in part, "The Director of Quality Management is responsible for: coordinating and facilitating review activities...trending data related to individual practitioner performance."

For 12 of 12 physician quality files reviewed for DRs 1 through 12, the files were missing performance data that reflected the performance of the physicians because the criteria did not match the privileges granted or there were multiple parameters for which "0" data was recorded. In addition, the printed activity profile showing what services the providers performed in the hospital were non-specific as they listed patient care activity as "consult" and did not indicate what specific service, such as a procedure was performed. Cross reference to A-0340.

Based on observation, interview, and record review, the hospital failed to ensure maintenance turnaround time data accurately reflected performance time, the data collected regarding verbal order authentication times was used to improve timeliness of order authentication, and the data collected regarding physician grievances was used to ensure the grievance process was functioning correctly. This failure created the risk of persistent poor practices in the hospital.

Findings:

The hospital's Strategic Plan for Quality 2014, included (page 8) "The leadership team must align all improvement activities with the strategic AIMS for the organization and identify gaps in activities and infrastructure that would be barriers to reaching goals."

1. On 4/21/14 and 4/22/14, ice build-up was observed on food in the kitchen walk-in freezer. The Engineering Director was interviewed on 4/22/14 at 1400 hours. The Director stated there was a problem with the heat strip on the condenser drain pipe of the freezer, which was allowing liquid to flow onto the food below and freeze. The Engineering Director stated he did not know when this problem was scheduled to be repaired but know there had been some work orders.

Review of work order dated 4/8/14, showed the order was opened at 1423 hours, and closed on the same day at 1929 hours, with the work order completed. An additional work order dated 4/9/14, was opened at 0606 hours showing, "Freezer's temperature at 50 degrees. Please come and check." The work order was closed 1700 hours. There was no pending work order for ice buildup in the walk-in freezer for the clogged condensation drain until 4/21/14. The Engineering Director indicated the Department knew of the long standing problem, but did not state why the problem was not fixed in a timely manner. The Engineering Director stated the department's process was to close a work order. There was no system to communicate with the Dietary Department of continuing repairs.

2. On 4/21/14 at 1025 hours, the family member of Patient 9 asked to speak to a surveyor. The family member complained about the exposed rough surfaces on the computer desk and the headboard wall behind the bed, rendering it not cleanable.

In addition, the family member pointed out the grout around the bathroom sink that was growing a black molding substance. Under the sink in the bathroom was a wall penetration approximately the size of a melon. The family member also stated the toilet had water continuously running during the past 3 weeks. The family member also pointed up to the air vent which was covered with dust.

The QM Director was made aware of the environmental complaints from the family member and stated the Maintenance Supervisor would be notified.

On 4/23/14 at 1000 hours, two days after the issues were reported, inspection of the room showed the listed environmental complaints were unchanged except the hole under the sink which was covered with a blue plastic cover. The toilet tank, when flushed, ran continuously. The grout around the bathroom sink was untouched. The non-intact porous surfaces of the headboard wall and computer desk were not repaired.

During an interview with the CEO on 4/24/14 at 1045 hours, she stated the department had been closing work orders if a temporary fix was in place; however, the hospital identified a process improvement was needed. The CEO stated a plan was made not to close work orders until a permanent fix was in place.

3. The Health Information Management Committee Dashboard Report dated April 11, 2014, was reviewed. The report showed the hospital did not meet its goal of 90% for authentication and legibility. There was a note indicating the hospital's quality improvement organization identified a problem with authentication of verbal orders within 48 hours, but no data shown.

The Chart Orders & Progress Notes Date, Time and Signature analysis prepared by the Medical Records Director for February and March, 2014, showed detailed information about the dates, times and signatures on orders, displayed by physician and location.

During an interview with the QM Director on 4/23/14 at 1500 hours, she concurred the data on verbal order signage was not reviewed by the quality council.

4. The Leadership Dashboard Master from 2014 displayed third and fourth quarters data from 2013. In the category for Complaints/Grievance, the notes indicated eight complaints and six grievances were received, with the top three issues being identified as "patient care, MD, staff." The notes indicated the complaints and grievances were shared with Nurse Leadership to raise awareness of issues, but there was no indication of how physicians or medical staff leadership was informed of issues.

Review of two grievances for Patients 5 and 21 showed allegations regarding physician behavior was reported, but no investigation of the specific allegations was documented. Copies of the allegations were placed in medical staff files, but there was no documented follow-up by the medical staff. Cross reference to A-0119.

Based on interview and record review, the hospital failed to ensure response to the identified risk of decannulation (accidental removal of a tracheal airway device) of at risk patients was complete. This failure created the increased risk of poor health outcomes to the patients obtaining services in the hospital.

Findings:

During a review of the Event Log Report from the month of October, 2013, showed four episodes of decannulation were documented, two of which related to the same patient, on 10/18 and 10/20/13.

During a meeting with Quality Council representatives on 4/24/14 at 1035 hours, the QM Director stated the RT was to assess the patients for risk of decannulation, complete a worksheet, and put the patients on decannulation precautions if needed.

On 4/24/14 at 1045 hours, the CCO stated decannulation precautions included an extra tracheostomy tube (breathing through a small plastic tube placed in the neck) at the bedside, moving the patient closer to the nursing station, more frequent rounding, and placing a sign above the bed announcing the risk of decannulation.

On 4/24/14 at 1050 hours, the CEO stated the risk of decannulation was identified on the risk management plan and a team was planned to analyze the data; however, this task had not yet been completed.

Based on interview and record review, the hospital failed to develop performance criteria specific for the services provided by the medical staff members and collect data on physician performance criteria. These failures created the increased risk of substandard care provided by the medical staff.

Findings:

The hospital's P&P titled Physician Performance Improvement Process, Including Focused and Ongoing Professional Practice Evaluation ,revised 8/12, read in part, "The monitoring of a Practitioner's ongoing performance begins with initial appointment and continues for the duration of his appointment." and "The MEC will determine the indicators/triggers that will be monitored for OPPE. The indicators/triggers will be selected based on their ability to identify negative trends that relate to quality of care and patient safety."

1. The medical staff's quality file for DR 4 was reviewed on 4/22/14. The file did not contain a provider quality spreadsheet. The file did contain a profile on in-hospital activities; however, the medical records function results on the file showed, "no activity."

During an interview with the Medical Staff Coordinator and the DQM on 4/22/14 at 1115 hours, the Medical Staff Coordinator stated DR 4 was a house physician who was in the hospital from 2000 until 0700 hours. Dr 4 did not admit patients so he did not perform H&P examinations. The Medical Staff Coordinator and the DQM stated there were no specific criteria used for evaluating a house physician.

2. The medical staff's quality file for DR 6, a podiatrist was reviewed on 4/22/14. The file did not contain performance criteria that matched the provider's duties. For example, the spreadsheet used for performance evaluation contained criteria such as "weaning rate" (the rate at which a patient regains the ability to breathe without a machine). Since a podiatrist does not perform that duty, there was no data collected. All of the criteria on the spreadsheet showed "0" activity. There were no criteria specific to the duties performed by a podiatrist.

3. Review of the medical staff's quality files for DRs 10, 11, and 12 (three anesthesiologists) showed there were no practice parameters on the OPPE spreadsheet specific to the practice of anesthesia. All parameters on the spreadsheet had a "0" indicating no data was gathered, except one parameter for medical records.

4. For 12 of 12 physician quality files reviewed for DRs 1 through 12, the files were missing performance data that reflected the performance of the physicians because the criteria did not match the privileges granted or there were multiple parameters for which "0" data was recorded. In addition, the printed activity profile showing what services the providers performed in the hospital were non-specific as they listed patient care activity as "consult" and did not indicate what specific service, such as a procedure was performed.

During an interview with the DQM on 4/22/14 at 1315 hours, he stated the provider performance evaluation criteria was currently being developed by the departments.

During an interview with the CEO on 4/24/14 15 1045 hours, she stated the physician quality review criteria were in development and had not yet been approved.

Based on observation, interview, and record review, the hospital failed to ensure RNs supervised the care provided to four of 33 sampled patients (Patients 19, 22, 28, and 30). For Patients 28 and 30 who were at risk for skin breakdown, the heels of the feet were not positioned so as not be in contact with the surface of the bed. For Patient 22, the RN failed to notify the physician when the patient's heart rhythm became irregular. For Patient 19 who was at nutritional risk, the patient's weight was not monitored for three weeks. These failures could potentially contribute to poor quality care and worsening of the patients' conditions.

Findings:

1. On 4/21/14 at 0820 hours, Patient 30 was observed in bed. The patient's heels were in direct contact with the pillows. A pair of Moon Boots (boots used to cushion pressure off the heels) was on the floor. Concurrent interview with RN I revealed Patient 30 required total care staff assistance for every two-hour repositioning. The RN stated the patient's care plan for skin breakdown included to "float" the patient's heels (lift up the heels from the mattress). RN I stated Patient 30 was turned "not too long ago."

Patient 30's medical record was reviewed on 4/23/14, with the Clinical Analyst. No documentation was found to show the patient was assessed by the RN on the night shift on 4/19/14.

When asked, the Clinical Analyst confirmed the finding. The Analyst stated the hospital's P&P required the primary care RN to perform a head to toe assessment of each assigned patient per shift.

2. On 4/24/14 at 0830 hours, Patient 28 was observed in bed. A pillow was underneath the patient's lower extremities; however, both the patient's heels were in direct contact with the mattress.

In a concurrent interview, RN H stated Patient 28 required maximum assistance from staff for all activities and was on a two-hour turning schedule. The preventive care plan for skin breakdown in place for the patient included to "float heels".


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3. Patient 22's medical record was reviewed on 4/22/14. Documentation showed the patient had an irregular heart rhythm from 4/5/14 at 1934 hours to 4/6/14 at 0005 hours, with a heart rate of 90-100 beats per minute.

On 4/22/14 at 1400 hours, Patient 22's record was reviewed with the Charge Nurse RN N. When asked, RN was unable to locate documentation to show the patient's physician was notified regarding patient's change of condition.


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4. On 4/22/14, medical record review for Patient 19 showed the patient was admitted on 4/1/14. One of the patient's admitting diagnoses included malnutrition. The admission weight was recorded as 80 pounds and height was 57 inches. The BMI (measurement of a person's thickness or thinness) was 17.3. A BMI lower than 18.5 suggests the person is underweight and at nutritional risk.

Review of Patient 19's record did not show the patient's weight was measured after admission. In a concurrent interview with the 2W Charge Nurse (RN G), she stated it was the hospital's policy to weigh patients on a weekly basis.

Based on observation, interview, and record review, the hospital failed to ensure a nursing plan of care was developed and implemented specific to the needs of five of 33 sampled patients (Patients 3, 22, 28, 30, and 33). A lack of comprehensive nursing care plan development may result in interventions not developed which could further compromise the patients' medical status.

Findings:

Review of the hospital's P&P titled Physical Restraints (Violent and Non-Violent Behavior) and Seclusion dated 4/14, showed the RN will create and modify the patient's plan of care. Other licensed staff modifies the patient's plan of care after it is initiated by the RN. The elements of the plan of care are: the safety issue resulting in restraint use, desired measurable outcome oriented goals, alternative interventions to minimize restraint use, ongoing evaluation to assess potential use of less restrictive alternatives, patient and family education, monitoring to fulfill care plan goals.

1. Medical record review for Patient 33 was initiated on 4/21/14. Patient 33 was admitted to the hospital on 4/9/14.

On 4/21/14 at 1030 hours, observation of Patient 33 showed the patient lying in bed, a hand mitten (a restraint designed to restrict hand movement) was in place to the bilateral hands. The patient had an IV access in his right arm.

Review of the 24 hours Restraint Order and Flow Sheet dated 4/21/14, showed a physician's assessment was completed for the use of restraints for Patient 33. Documentation showed Patient 33 pulled at lines, tubes, and drains; was at risk for falls; attempted to ambulate without assistance, and was at risk for self-harm. Reorientation, diversion stimulation, bed in lowest position, side rails up (3), and pain management were considered as the least restrictive measures attempted prior to the use of restraints.

Review of a physician's order dated 4/21/14, showed a restraint order to place mittens to the left and right hands (restraints bilaterally) to Patient 33.

Review of Patient 33's Patient Care Plan initiate on 4/16/14, showed a care plan was developed to address the potential for injuries related to age, impaired thought process, unfamiliar surroundings, and history of previous falls. The desired outcome was for the patient not to sustain an injury during the hospital stay. Interventions included implementing safety measures specific to patient.

No documentation was found in Patient 33's care plan to show specific interventions were developed for the use of restraints. The care plan did not specify the type of restraint applied, individualized nursing interventions, and goals developed for restraint discontinuation.

During an interview with RN G on 4/21/14 at 1400 hours, she stated restraint interventions should be documented on the electronic forms in a patient record. RN G confirmed Patient 33's care plan did not reflect specific interventions to meet the patient's care needs.

The above findings were confirmed at the time of medical record review during interviews with the QM Director and RN G.



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2. The medical record for Patient 22 was reviewed on 4/22/14. Review of the care plan showed the patient had a Stage IV pressure ulcer to the middle lower back. The plan was to off-load pressure on the back by repositioning the patient to right and left sides only, never on the back.

On 4/22/14 at 1130 hours, Patient 22 was observed lying on his back during a hemodialysis treatment.

On 4/22/14 at 1135 hours, during an interview, Dialysis RN O was asked about Patient 22's pressure ulcer. RN O stated the pressure ulcer was on the patient's right side. When asked when the patient was last turned, the RN stated the patient was turned at the beginning of the hemodialysis treatment from the right side to his back.

3. Review of Patient 3's medical record on 4/22/14, showed the patient had pressure ulcers present on both sides of the buttocks. The care plan showed to turn the patient every two hours.

Patient 3 was observed with the QM Director on 4/22/14 at 1415 hours, lying on his back during a dialysis treatment.

Dialysis RN P was asked about Patient 3's pressure ulcers. RN P stated he was not aware the patient had pressure ulcers. When asked when the patient was last turned, the RN stated at the beginning of the treatment.

4. On 4/21/14 at 0820 hours, Patient 30 was observed in bed. The patient's heels were in direct contact with the pillows. A pair of Moon Boots (boots used to cushion pressure off the heels) was on the floor. Concurrent interview with RN I showed Patient 30 required total care staff assistance for every two-hour repositioning. The RN stated the patient's care plan for skin breakdown included to "float" the patient's heels (lift up the heels from the mattress). RN I stated Patient 30 was turned "not too long ago."

5. On 4/24/14 at 0830 hours, Patient 28 was observed in bed. A pillow was underneath the patient's lower extremities; however, both of the patient's heels were in direct contact with the mattress.

In a concurrent interview, RN H stated Patient 28 required maximum assistance from staff for all activities and was on a two-hour turning schedule. The preventive care plan for skin breakdown in place for the patient included to "float heels".

Based on observation, interview, and record review the hospital failed to implement P&P on medication administration for three of 33 sampled patients (Patients 12, 22, and 25) as evidenced by:

1. The RN failed to assess the proper placement and patency of Patient 25's GT prior to administering the medications (the introduction medications through a tube that has been surgically inserted into the stomach through the abdominal wall). The failure could potentially result in clogging of the tube with the medications if the GT was not working properly.

2. The RN failed to document Patient 12's medication administration immediately after medication administration and failed to notify the physician timely when medications were held and not administered to the patient. In addition, the patient's allergies were not written on the red allergy armband.

3. Medications prepared ahead of time for patients were stored unattended and unsecured in another patient's room.

When P&Ps on preparation, handling and administration of medications were not implemented and followed, the failures could potentially result in unsafe practice and substandard care.

Findings:

1. Review of the hospital's P&P for Medication Management/Administration, revised 2/13, showed the placement and patency of a feeding tube should be checked prior to administration of medications through the tube.

During a medication pass observation on 4/22/14 at 0915 hours, RN F administered three medications via a GT to Patient 25. Prior to administration, RN F did not assess the GT for patency or placement.

When interviewed on 4/22/14 at 0940 hours, RN F was asked about the facility's policy for assessment of a GT prior to medication administration. RN F stated the nurse should withdraw stomach contents with a syringe before giving the medication; however, he forgot to do this with Patient 25.



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2a. On 4/23/14, review of the hospital's P&P titled Administration of Medications showed the general guidelines for administration of medication included the seven rights of administering medications: "right patient, right medication, right dose, right time, right route, right reason, right documentation."

Under documentation, it showed the individual administering the medications(s) must document all medications immediately after administration in the patient's medical record. If the medication was not administered ("held" due to blood pressure parameters, patient refused, etc), the appropriate documentation on the MAR, including reason must be recorded.

Review of the hospital's P&P titled Timely Administration of Scheduled Medications showed clinical circumstances might necessitate omitting medications, deviating from standard administration schedules and might necessitate administering early or late. If these occurred, the prescriber should be notified, then document the reasons administration was late or early.

During a medication pass observation on the ICU on 4/22/14 at 0930 hours, RN M stated two kinds of beta blocker medications were ordered for Patient 12, sotalol (medication to slow down heart rate and regulate heart rhythm) and metoprolol (medication to slow down heart rate and lower blood pressure). Patient 12's blood pressure was 128/56 mmHg with normal heart rate and rhythm. RN M stated she decided to hold the sotalol and administered metoprolol only. RN M stated the physician who ordered the medications would be notified by her as soon as medication administration was over.

At 1100 hours, on the same day, the QM Director was asked to check Patient 12's electronic health record for the time RN M documented the medication administration. The electronic MAR was blank. That was 1 and 1/2 hours post medication administration. The QM Director stated she would remind RN M to sign off on the medication administration. The QM Director stated nurses were expected to document immediately after medication administration.

At 1430 hours, the surveyor together with the QM Director went back to the ICU to ask RN M the time Patient 12's physician was notified with regards to holding the sotalol administration. RN M responded "I have not had the time."

On 4/23/14 at 1400 hours, the interim Director of Pharmacy was asked if he was aware of the above observation. The Director stated he reviewed Patient 12's medication list and spoke to RN M regarding the two beta blockers. RN M volunteered to notify the MD, but she forgot.

b. On 4/23/14, review of the hospital's P&P titled Administration of Medications, under Documentation, letter D showed the healthcare professional administering the medication in collaboration with the pharmacist, second nurse and review of the medical record, would verify that there were no contraindications for administering the medication. Patient allergies must be checked on the patient allergy band, the patient MAR or in the Kardex prior to administering any medications.

During a medication pass observation on the ICU on 4/22/14 at 0930 hours, RN M verified Patient 12's identity by calling out the patient's name and looking at her wrist ID tag. RN M also verified Patient 12's documented list of allergies which included ciproflaxacin, vancomycin and penicillin (antibiotics). However, observation of the allergy red tag on the patient's wrist was blank.

On 4/22/14 at 1430 hours, the QM Director acknowledged checking for allergies was part of the "rights" per hospital's P&P for medication administration.

3. On 4/23/14, review of the hospital's P&P titled Administration of Medications, under Administration, letter C showed following the dispensing of drugs from pharmacy, medications were to be administered by the practitioner who prepared them. Under Administration, letter D showed all medications must be properly stored/secured at all times prior to administration. Prepared medications must never be left unattended.

Patient 22 was observed on 4/22/14 at 1031 hours, accompanied by the QA Director. A hemodialysis machine was at the patient's bedside but was not connected to the patient. No health care staff was in the room.

Inspection of the room linen closet showed opened IV bags, medications, syringes with medication, and opened medication vials. The QA Director stated the linen closet was not intended for storage of prepared medications and opened vials.

Dialysis RN O then entered Patient 22's room and took all the IV medications. RN O stated he just came back from his morning breaktime. RN O stated the medications found in Patient 22's closet were not for the patient but were prepared ahead of time for the next dialysis patients assigned to him. When asked, RN O acknowledged medications were not to be stored in a patient's room and then moved from one room to another while providing dialysis treatments. RN O stated the medications should be kept in the unit's medication room.

Based on observation, interview, and record review, the hospital failed to ensure the P&P on self-administration of two inhaler medications was implemented for one of 33 sampled patients (Patient 20). The physician's order was not specific to show the inhalers could be safely stored unsecured at Patient 20's bedside, the capacity of Patient 20 to self-administer the inhalers was not assessed, and there was no documentation to show Patient 20 was instructed in safe administration of the inhalers. In addition, documentation of the patient's use of the inhalers was not consistent to show the dosage used by the patient. This resulted in the potential for overuse of the inhalers and adverse medication reactions.

Findings:

During a tour of the 2W unit with the unit's Nurse Manager on 4/21/14 at 0955 hours, Patient 20 was observed sitting on the edge of her bed. The drawer of the overbed table in front of the patient was open. Two inhaler medication bottles were noted in the drawer. When asked, Patient 20 stated she used the inhalers as needed and had for years.

Review of the hospital's P&P titled Self-Administered Medications, revised 2/14, showed patients are permitted to self-administer medications with an order for "self-medication" that specifies the medications that may be self- administered while a patient in the facility.

* The physician must write an order for each of the patient's medications that may be self-administered including name, dose, route, and frequency.

* If the medication is stored in the patient's room where the patient has access to the medication, there must be a physician's order stating the medication can be stored at bedside.

* Patients must successfully demonstrate competency to a licensed nurse or certified respiratory therapist before self-administration may occur.

* The nurse or therapist assigned to the patient will document each dose of medication that is self-administered in the medical record.

The medical record for Patient 20 was reviewed on 4/21/14, with the Nurse Manager. The patient was admitted to the hospital on 4/8/14. Review of physician's orders showed orders dated 4/9/14 at 2000 hours, for the following:

* Atrovent inhaler 2 puffs twice a day, patient's own medication. Medications need to be checked by pharmacy. Nurse to give medication back to the patient at discharge.

*Qvar 80 mcg 2 puffs twice a day. Patient's own medication. Medications need to be checked by pharmacy. Nurse to give medication back to the patient at discharge.

Patient 20 was interviewed again on 4/22/14 at 1240 hours. The patient stated she could not recall if the nurse or therapist had conducted an assessment of her ability to properly use the inhalers. Patient 20 stated she used the inhalers twice a day and additionally when needed. The patient stated she often used them with respiratory treatments. When asked, the patient stated she told the nurses she used the medications only if they asked.

RN E was interviewed on 4/22/14 at 1245 hours. RN E stated she was assigned to care for Patient 20. The RN stated she instructed Patient 20 in the use of the inhalers initially; however, she stated she might not have documented the instructions. When asked how self-administration of Patient 20's inhalers should be documented, RN E stated the nurse should ask the patient if the medication was taken and then document the amount and time done.

Documentation of Patient 20's inhaler administration was reviewed with the Regional Resource Chief Clinical Officer on 4/22/14 at 1300 hours.

Review of documentation of self-administration of the Atrovent inhaler from 4/10 to 4/21/14, showed documentation by the RT that the RT did not administer the inhaler. Documentation showed "not done;" however, the RT added in parenthesis, the medication was self-administered, performed by other discipline, or patient already performed independently. The ordered dose of the inhaler (2 puffs) was documented for only six of the 26 entries.

Review of documentation of self-administration of the Qvar inhaler from 4/10 to 4/21/14, showed documentation by the RT that the RT did not administer the inhaler. Documentation showed "not done;" however, the RT added in parenthesis, the medication was self-administered, performed by other discipline, or patient already performed independently. The ordered dose of the inhaler (2 puffs) was documented for only five of the 26 entries.

Based on observation, interview and record review, the hospital failed to ensure the physicians for one of 33 sampled patients (Patient 30) documented the medical plan for supportive care and end of life care, including the reason for the withholding tube feedings for three days. This failure had the potential of not having complete medical information to identify patient care needs.

Findings:

On 4/22/14, review of the hospital's P&P titled Assessment /Re-assessment -Interdisciplinary Patient showed patients with the same health problems and care needs could expect to receive the same level of care throughout the hospital. The medical staff was responsible for the medical plan of care and had the responsibility to assess and improve the patients' care at the hospital. All patients at the hospital would have appropriate follow-up assessments based upon the patient's specific identified needs, including physical status. The goal of the assessment /reassessment process was to provide an interdisciplinary approach for assessment(s) and ongoing reassessment(s) of individual patient care needs and for planning and implementing patient specific care. The patient information might include the patient's condition and any recent or anticipated changes.

On 4/21/14 at 0950 hours, Patient 30 was observed in bed. The patient's NGT was clamped shut and the patient had ongoing IV fluids at 50 ml per hour. A Levophed IV was infusing at 13 ml per hour.

A concurrent interview with Patient 30's family member showed the patient had not received tube feedings since 4/18/14, after an episode of vomiting. The family member was concerned with the patient's nutritional needs especially with an admitting diagnosis of malnutrition.

Review of the Progress notes dated 4/20/14, showed the patient was evaluated by Gastroenterologist and Internal Medicine physicians. The Gastroenterologist physician wrote in the progress note that the patient's prognosis was grave and the family was made aware. The Internal Medicine progress note on 4/20/14, also showed the case was discussed in detail with the patient and family members. However, neither physicians documented the plan to hold the patient's tube feedings and the plan regarding the patient's feeding status.

During an interview with the Chief of Staff, one of Patient 30's physicians on 4/23/14 at 1030 hours, he stated he believed it was the patient's family that wished the tube feeding be stopped, and the feedings should have been resumed. The Chief of Staff stated the plan was for supportive care and end of life care, and this was discussed in detail with the family. However, the Chief of Staff concurred the content of the discussion with the family and the plan of care may not have been clearly documented.

Based on observation, interview, and record review, the hospital failed to ensure complete and accurate medical records for two of 33 sampled patients (Patients 12 and 15). For Patient 12, an RN did not document medication administration at the time of the administration and did not record the patient's response to holding off a medication. For Patient 15, information on a procedure checklist and physician orders for treatment were incomplete, and orders were not dated and timed. An incomplete patient record could potentially result in unsafe practice and substandard quality of care.

Findings:

1. On 4/23/14, review of the hospital's P&P on Administration of Medications showed the general guidelines for administration of medication included the seven rights of administering medications: "right patient, right medication, right dose, right time, right route, right reason, right documentation."

Under documentation, it showed the individual administering the medications(s) must document all medications immediately after administration in the patient's medical record. If the medication was not administered ("held" due to blood pressure parameters, patient refused, etc), the appropriate documentation on the MAR, including reason must be recorded.

Review of the hospital's P&P titled Timely Administration of Scheduled Medications showed clinical circumstances might necessitate omitting medications, deviating from standard administration schedules and might necessitate administering early or late. If these occurred, the prescriber should be notified, and then the reasons administration was late or early should be documented.

During a medication pass observation on the ICU on 4/22/14 at 0930 hours, RN M stated two kinds of beta blocker medications were ordered for Patient 12, sotalol and metoprolol. Patient 12's blood pressure was 128/56 mmHg with normal heart rate and rhythm. RN M stated she decided to hold the sotalol and administered metoprolol only. RN M stated the physician who ordered the medications would be notified by her as soon as medication administration was over.

At 1100 hours, on the same day, the QM Director was asked to check Patient 12's electronic health record for the time RN M documented the medication administration. The electronic MAR was blank. That was 1 and 1/2 hours post medication administration. The QM Director stated she would remind RN M to sign off on the medication administration. The QM Director stated nurses were expected to document immediately after medication administration.

At 1430 hours, the surveyor together with the QM Director went back to the ICU to ask RN M the time Patient 12's physician was notified with regards to holding the sotalol administration. RN M responded "I have not had the time."

On 4/23/14 at 1400 hours, the interim Director of Pharmacy was asked if he was aware of the above observation. The Director stated he reviewed Patient 12's medication list and spoke to RN M regarding the two beta blockers. RN M volunteered to notify the MD, but she forgot.


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2. On 4/22/14, Patient 15's medical record review was conducted.

a. Patient 15 had a procedure on 4/21/14. The documentation on Procedure Checklist form showed "each category must be checked." Item #33 showed the patient was diabetic, and the holding and procedure forms were checked yes for this; however, documentation to show the patient's blood sugar level and date/time of the blood sugar level were left blank.

On 4/24/14, the Clinical Analyst stated the RNs should document the patient's blood sugar levels and acknowledged the information was missing.

b. Review of Patient 15's Nutrition Order Sheet showed the RD recommended for the patient to start with Nepro for enteral feeding. The RD signed the order sheet; however, there was no documentation of the date and time of the recommendation.

On 4/23/14 at 0805 hours, the Medical Records Director stated the hospital had a system for auditing medical records. The clinical staff was responsible for auditing open records (in hospital patients) for completion. The medical records staff would do the auditing weekly.

c. Patient 15's record contained MRSA Screen Admission progress notes. The document showed the statement "I have informed patient and/or patient representative of positive MRSA Screening, Treatment. Options have been discussed." The physician signed and dated the document; however, the time of the signature was omitted.

On 4/22/14 at 0925 hours, the CCO concurred with the findings.

d. Patient 15's record contained a pre-printed form "Venous Thromboembolism Event (VTE)/ Risk Assessment and Therapeutic Guidelines. The upper part of the form was for "Assessment." The Assessment had three sections, I, II, and III

On Section II, documentation showed the patient was identified with the risks of age greater than 40, bed confinement/immobile, central venous IV access, and medical risk factors (respiratory disease). Below the assessment section was a physician's order. The instruction was for the physician to choose the prophylaxis indicated based on risk section identified.

The Prophylaxis Regimen Options were for three risk levels. The moderate level was for the patient who had risks identified on assessment Section II. The Prophylaxis Regimen Options for the physician to check off included heparin (blood thinner medication) SQ, sequential compression device, and anti-embolictic hose. The physician signed, dated, and timed the order; however, none of the options were checked off.

On 4/22/14 at 0900 hours, Patient 15 was observed with a sequential compression device in use. During a concurrent interview with RN J, the RN stated the form was confusing to use. RN J was unable to explain which section was used for the physician to order the treatment.

Based on interview and record review, the hospital failed to ensure the physician's orders were authenticated, dated, and timed within 48 hours for three of 33 sampled patients (Patients 1, 13, and 14). This failure created the increased risk of physician order errors.

Findings:

The Health Information Management Committee Dashboard Report dated April 11, 2014, was reviewed. The report showed the hospital did not meet its goal of 90% for authentication and legibility. There was a note indicating that the hospital's quality improvement organization identified a problem with authentication of verbal orders within 48 hours, but no data was shown.

1. During a review of the medical record for Patient 13 on 4/23/14, the medical record contained telephone physician's orders that were signed on a printed paper copy of the electronic medical record. A telephone order for discontinuing therapy and obtaining a pharmacy consultation was dated 5/21/13 at 1019 hours. The record was printed on 6/4/13 at 1427 hours (the date and time printed on the top of the page), 13 days later. The printed page was signed by the ordering physician, DR 3, but there was no date and time accompanying the signature.

A telephone order for Patient 13, for Lidocaine 1% (a local anesthetic) was obtained on 5/21/13 at 0958 hours. The page was printed on 6/4/13 at 1426 hours. The page was signed by DR 3, but there was no date or time with the signature.

An order for albumin 25% (a protein found in the blood) was dated 5/26/13 at 1542 hours. The signature of the ordering physician was seen on a page with the date of 6/5/13 0949 hours, as printed at the top. There was no date or time accompanying the signature.

In an interview with the Regional Resource CCO DQM on 4/24/14 at 1345 hours, he concurred there were no dates or times accompanying the physician's signatures for the medications for Patient 13.

In an interview with the Medical Records Director on 4/24/14, she stated verbal/telephone orders were expected to be signed within 48 hours. The Medical Records Director stated it was not possible for a nurse to know whether a physician had signed a verbal/telephone order if it was signed electronically.


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2. On 4/21/14 at 1330 hours, Patient 1's medical record review was conducted with the QM Director. A verbal order was taken by a nurse to administer on 4/10/14 at 1157 hours, and was authenticated by the physician on 4/15/14, five days later.


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3. Patient 14's medical record was reviewed on 4/22/14, with the QM Director. Review of a written order by the physician for three physician consultations, PT, laboratory tests, and a chest x-ray were dated 4/21/14; however, there was no time documented to show when the order was written.

Based on observation and interview, the hospital failed to ensure medications intended for use for multiple dialysis patients were stored securely, resulting in the potential for cross contamination and medication tampering when left unattended.

Findings:

On 4/23/14, review of the hospital's policy on Administration of Medications showed on letter D, "All medications must be properly stored/secured at all times prior to administration. Prepared medications must never be left unattended."

Patient 22 was observed on 4/22/14 at 1031 hours, accompanied by the QA Director. A hemodialysis machine was at the patient's bedside but was not connected to the patient. No health care staff was in the room.

Inspection of the room linen closet showed opened IV bags, medications, syringes with medication, and opened medication vials. The QA Director stated the linen closet was not intended for storage of prepared medications and opened vials.

Dialysis RN O then entered Patient 22's room and took all the IV medications. RN O stated he just came back from his morning breaktime. RN O stated the medications found in Patient 22's closet were not for the patient but were prepared ahead of time for the next dialysis patients assigned to him. When asked, RN O acknowledged medications were not to be stored in a patient's room and then moved from one room to another while providing dialysis treatments. RN O stated the medications should be kept in the unit's medication room.

Based on observation, interview, and record review, the hospital failed to have a full time Director of Food and Nutrition services to manage dietary services and supervise food service staff. The lack of management could contribute to ineffective implementation of safety practices in food handling, cost-effective menu planning, and supervision of personnel.

Findings:

1a. Per Food Code 2013, foodborne bacteria in large numbers could cause food poisoning. Foodborne illness became more dangerous in patients with immune compromise, young children, elderly and pregnant women. Time temperature control is critical in food safety systems. To prevent time temperature abuse and the growth of pathogenic microorganisms that caused food borne illness and the amount of time food spent in the danger zone must be minimized and documented to ensure food was properly cooled after preparation. Cooked foods required cooling from 135 degrees F to 70 degrees F in 2 hours and from 70 degrees F to 41 degrees F in 4 hours of less.

On 4/23/14, review of the hospital's policy H-NS04-017 on Cooling methods showed under no. 2, "Staff should monitor the cooling process and assure all potential hazardous foods (able to grow pathogenic microorganisms) are cooled to below 70 degrees F within two hours and from 70 degrees F to below 41 degrees F in an additional 4 hours. Under no.5, Cooling Logs are to be utilized to document time and temperature control during cooling process."

On 4/22/14 at 1330 hours, in an interview with Cook 1, he was asked about the meat prepared for service in the cafeteria on 4/21/14. Cook 1 stated the meat was boiled for the Pho soup (Vietnamese soup) in the afternoon of 4/21/14. The meat then was wrapped and placed in the refrigerator. Cook 1 stated the meat was in the refrigerator from 1800 hours when she went home. Cook 1 stated she did not document any cool down temperatures because this meat was for the cafeteria and not patient food.

In a concurrent interview with the Food Service Manager, he stated the cooks were to document the cool down temperatures on the log for all foods prepared for service including both patient and cafeteria food. The Food Service Manager stated he was responsible for monitoring the work of the cooks and ensuring the documentation of food temperatures. The Food Service Manager acknowledged he had not been monitoring the logs to ensure their completion.

During an interview with the Nutrition Services Director on 4/23/14 at 1000 hours, the Director stated the cook should be aware of the cool down policy as all of the food service personnel had the Serve Safe course. The Nutrition Services Director stated she expected the Food Service Manager to check the documentation and staff competencies.

b. Foods should be protected from cross contamination by raw animal foods. Raw animal foods like raw meats require separation to prevent cross contamination from raw meat product dripping onto ready to eat products per FDA Food Code 2013.

On 4/21/14 at 0935 hours, during a kitchen tour with the Director of Nutrition Services, there was a case of raw thawing meat stored on the second rack of a walk-in refrigerator. The raw thawing meat was directly above canned soda and bottled water. Cook 2 concurrently stated the product was placed there yesterday. The Nutrition Services Director stated storing thawing raw meat above ready to eat products or ready to serve canned soda and water was not appropriate.

c. Dishes stored away wet can become contaminated with bacteria. Holding wet dishes can be contaminated because warm moist environment provides good conditions for bacterial growth according to the Journal American Dietetic Association. The FDA Food Code 2013 specifies that all dishes should be air-dried before being stacked and stored. Use of a drying cloth will re-contaminate the surface of the dishware.

On 4/23/14 at 1020 hours, Food Service Aide 1 (FSA 1) was observed stacking glasses coming out of the dish machine. On inspection the interior of approximately 12 glasses showed wet interior surfaces. FSA 1 concurrently acknowledged the interior were wet. FSA 1 stated the dishware should be dry before stacking. The glasses were still wet, but there were a lot of dishes being washed.

d. On 4/23/14 at 1020 hours, FSA 1 was observed wearing the same apron when handling the clean sanitized dishes as she wore while spraying and stacking dirty patient dishes.

In a concurrent interview regarding the observations of FSA 1 stacking wet dishware and not changing her apron when moving from dirty to clean items, the Food Service Manager acknowledged FSA 1 was to change aprons when moving from the dirty dishes to handling clean and sanitized dishes. In addition, the Food Services Manager acknowledged there was a problem where there were not adequate drying racks to ensure dishwashing staff allowed the dishware to air dry before stacking. The Food Service Manager confirmed he was responsible for supervision of the staff practices.

e. Food should be protected from cross contamination. Dripping liquid from the condenser unit constitutes a source of contamination to the food stored below per Food Code 2014.

On 4/21/14 starting at 0935 hours, ice build-up was observed on the walk-in freezer condenser and ice on the stored foods below extended for two racks measuring 4 feet across by 2 feet deep. In a concurrent interview the Nutrition Services Director stated there was liquid leaking from the condenser and freezing on the food stored below. The Nutrition Services Director stated there were work orders in for the repair as it was a continuing problem.

On 4/22/14 at 1400 hours, during an interview, the Food Service Manager stated this problem was ongoing for approximately one month. The Food Service Manager stated there was a significant build-up of ice on the food under the condenser and acknowledged he was waiting for the freezer to be fixed.

Food was not protected from potential of cross contamination from the liquid from the condenser. Food continued to be stored covered in ice and this food was used in food production. After discussing the potential cross contamination hazard the Food Service Manager cleared the area under the source of contamination.

2a. Review of the 12/18/13 Food Safety in-service titled "avoid time-temperature abuse" showed Cook 1 was present. The content reviewed the cooling practice for food with documentation: "cooking, cooling, and holding TCS (time and temperature control for safety) food the right way can help keep food safe."

Review of the Food Service Manager's job description showed the Manager position is responsible for overall operation of the food service department.

Review of the Cook 1's job description showed the cook was responsible for proper handling and food safety techniques for patients, employees, and special events. The last job evaluation 12/6/13, showed average to above average evaluation on areas under Cook 1's competencies for "documenting food temperatures in the correct log."

b. Review of the Food Service Manager's 90 day evaluation dated 12/31/13, showed he exceeded expectations for job specific duties and responsibilities. The Manager's personnel file showed a Serve Safe certificate. The Serve Safe course discusses foodborne illness, including information on specific foodborne pathogens and biological toxins, contamination, prevention, sanitation guidelines, and food safety regulations.

c. Review of the inservice titled "principles of ware washing" dated 12/18/13, attended by FSW 1 showed "allow dishware to air dry or store in a way that allows the dishes to air dry." Review of the FSW's last job competency dated 5/13/13, showed the staff was evaluated at meet or exceeds standard, including "assists in washing of patient trays and adheres to proper policies and procedures."

The Food service Manager and staff had evaluations and training in safe food handling practices and specific training for infection control but failed to supervise staff and practice safe food handling.

3. During an interview on 4/24/14 starting at 1015 hours, the Food Service Manager and the Director of Nutrition Services reviewed the department's QAPI program. The Food Service Manager stated he had quality assessment monitoring for temperatures and other food service activities. The Nutrition Services Director stated there were ongoing monitoring and measuring of basic food service functions. The Food Service Manager stated he had never looked for indicators that would be developed for performance improvement monitoring in food services.

Based on observation, interview, and record review, the hospital was not maintained to an acceptable level of safety and quality as evidenced by:

1. Ice build-up on the kitchen walk-in freezer condenser was not repaired in a timely manner allowing liquid to flow onto the food below and freeze. Previous work orders showed the work on the freezer was completed. There was no system to communicate with the Dietary Department for continuing repairs.

2. A patient's room showed exposed pourous surfaces, grout in the bathroom was dirty, the toliet was running, and a large hole in the wall was noted behind the sink.

3. A patient care device was found with preventive maintenance not done timely.

Failures to ensure its facilities, supplies, and equipment were functional could affect quality of care and patient safety.

Findings:

1. During observations of the kitchen on 4/21 and 4/22/14, ice build-up was observed on the food in the walk-in freezer.

During an interview on 4/22/14 at 1400 hours, with the Engineering Director he stated there was a problem with the heat strip on the condenser drain pipe in the freezer allowing liquid to flow onto the food below and freeze. The Engineering Director stated he did not know when this problem was scheduled to be repaired; however, he stated he knew there were work orders.

Review of a work order dated 4/8/14, showed the order was opened at 1423 hours and was closed on 4/8/14 at 1929 hours, with the work order completed.

Review of a work order dated 4/9/14, was opened at 0606 hours, showing documentation the "Freezer's temperature at 50 degrees. Please come and check." The work order was closed 1700 hours.

There were no pending work orders again for ice build-up in the walk-in freezer for the clogged condensation drain until 4/21/14. The Engineering Director stated the Department knew of the long standing problem but did not state why the problem had not been fixed in a timely manner. The Engineering Director stated their process was to close the work order. There was no system to communicate with the Dietary Department for continuing repairs.



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2. On 4/21/14 at 1025 hours, the family member of Patient 9 asked to speak to a surveyor. The family member complained about the exposed rough surfaces on the computer desk and the headboard wall behind the bed, rendering it uncleanable.

In addition, the family member pointed out the grout around the bathroom sink that was growing a black molding substance. Under the sink in the bathroom was a wall penetration approximately the size of a melon. The family member also stated the toilet had water continuously running during the past 3 weeks. The family member also pointed up to the air vent which was covered with dust.

At this time, the QA Director was made aware of the environmental complaints of the family member and stated the Maintenance Supervisor would be notified.



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3. On 4/21/14 at 1430 hours, the surgical suites were toured with the CCO. A pulse
oximeter machine (a non-invasive method for monitoring a patient's oxygen saturation
was found and showed a sticker for preventive maintenance "due 3/14." RN A stated the
pulse oximeter was used to monitor a patient's oxygen saturation (a measure of how much
oxygen the blood is carrying) when the procedure was not performed in the OR.

On 4/21/14 at 1450 hours, during an interview, Biomedical Engineering stated the pulse
oximeter machine was locked in the cart and not listed on the hospital's inventory list, so
the preventive maintenance was not done as per the hospital's schedule.

Based on observation, interview, and record review, the hospital failed to ensure the Infection Control Officer developed a system to maintain a sanitary environment as evidenced by:

1. In the Food Services Department, the kitchen ice machine was not maintained clean, the cook did not follow safe food handling practices for cool down of cooked ahead food, thawing raw meat in refrigerator was stored over ready to eat products, and dishwashing staff did not follow sanitary practices to prevent cross contamination. Although the Infection Prevention and Control Assessment Tool included identifiers for dietary areas, the tool was not effective in surveillance of the food service operation.

The lack of infection control oversight and unsafe food handling practices had a potential of foodborne illness and cross contamination compromising medically compromised patients.

2. The hospital's EVS Department failed to ensure patients' beds and side rails were clean and free of stains.

3. A physician failed to follow guidelines for wearing and changing of gloves and hand hygiene for a patient on isolation. In addition, the physician failed to follow safe injection practices when using needles and syringes during a procedure.

4. Irrigation solution bottles in a two-patient room were not labeled with the patients' names and the dates as to when the bottles were opened.

5. Infection control measures were not followed when two suction canisters were not changed timely for two patients.

6. Medications found stored in a patient's room were labeled intended for use by two other patients.

7. The surface integrity of a desk and wall behind the bed in a patient room did not allow for thorough cleaning and the bathroom showed dirty grout, a running toilet and a hole in the wall.

8. Unlabeled urinals, bedpans, and an item used for OT training exercises were found stored in two shared patient bathrooms.

Failures to systematically monitor and evaluate the infection control program could lead to cross contamination and the spread of bacteria throughout the hospital.

Findings:

1a. Immune-compromised patients are those patients whose immune mechanisms are deficient because of immunological disorders (e.g., human immunodeficiency virus [HIV] infection or congenital immune deficiency syndrome), chronic diseases (e.g., diabetes, cancer, emphysema, or cardiac failure), or immunosuppressive therapy (e.g., radiation, cytotoxic chemotherapy, anti-rejection medication, or steroids). Immunocompromised patients have the greatest risk of infection caused by airborne or waterborne microorganisms

Review of the CDC's guidelines showed mold and slime build-up inside ice machines allows bacteria growth and slime buildup inside commercial ice-making machines which can contain pathogenic microorganism.

On 4/22/14 at 1400 hours, the Engineering Director opened the top of the bin ice machine in the kitchen. There were brown/yellow deposits visible on the front (6 x 6 inch area) and the interior ledge (15 to 20 inches long and 1 inch deep) connected to the ice making component. The Engineering Director stated the ice machine was due for cleaning in April, 2014. The Director stated he did not know why there were areas of brown yellow deposits inside where the ice was made.

b. In addition, survey findings regarding the cook not following safe food handling practices for meat cool down, thawing of raw meat in refrigerator over ready to eat products, and dishwashing staff not following sanitary practices to prevent cross contamination were were discussed in a meeting with the Infection Control RN on 4/24/14 at 0900 hours. The Infection Control RN stated there was an infection control audit monthly that included the kitchen.

The Infection Prevention and Control Assessment tool-Dietary dated 3/18/14, was conducted concurrently with the Infection control meeting on 4/14/14 at 0900 hours. The Infection Control RN stated the form was used to identify problems and then inform the Department Managers for follow-up. The Assessment tool identified areas to assess such as "inspect employee for proper food handling techniques."

The Infection Control RN did not state how this monitor was evaluated including the proper food cool down practice. The "Staff is observed using proper infection control practice and no cross contamination between clean and dirty." The Infection Control RN marked this as being met. Under freezers, the tool identified pipes are free of ice build-up and the form recorded "no." There were no comments or discussion in the follow-up column as to what needed to be done.


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2. On 4/24/14 at 0820 hours, during the tour of the 2W unit with the CCO, an occupied patient room was visited. The bed frame had dark red stains. The side rails were soiled with dry residues.

The base of the IV pole stand had several drops of the patient's tube feeding formula. A stuffed animal was on the floor.

A patient care machine (a pump) was on the bedside table and a clear liquid was observed on the surface of the table.

When interviewed, the CCO stated EVS was responsible to provide cleaning of the room.

In a further interview with Charge Nurse RN B at 1135 hours, RN B stated he made rounds in the morning, and all patient rooms were clean. The RN stated he inspected the environment including the beds, IV poles, and restrooms.

3a. Medical record review for Patient 15 on 4/22/14, showed the patient was on contact isolation for MRSA in the sputum.

During a procedure observation with the CCO in the OR on 4/22/14 at 0935 hours, Patient 15 was escorted by the RT using an ambu bag assisting breathing. DR 13 (the anesthesiologist) received the patient not wearing gloves and took over the use of the ambu bag. DR 13 then donned gloves and connected the patient to a mechanical ventilator. Wearing the same gloves, DR 13 administered the IV medications to Patient 15 and then changed the gloves after the procedure started.

DR 13 changed gloves after the procedure when he disconnected the patient from the anesthesia machine and used the ambu bag to ventilate patient into Post Anesthesia Care Unit.

DR 13 gave the report to the RN and removed the gloves. There was no hand hygiene observed before initial patient care, between changing of gloves, during the procedure, and after patient care.

b. During Patient 15's procedure DR 13 was observed using four syringes to administer the IV medications to Patient 15. Before administering the IV medications, DR 13 used a syringe to withdraw the IV fluid from the patients's line port. The IV line was connected to the patient's IV bag. DR 13 flushed the IV line with some of the fluids via a port of the IV line.

DR 13 wasted the remaining fluid from the syringe to a waste container and used that same syringe to withdraw the medication from a new medication vial.

In addition, DR 13 opened a syringe from a package, attached a needle, injected the syringe needle into a medication vial, withdrew medication, disconnected the syringe from the needle, left the needle attached to the vial, and using the syringe, administered the medication via the IV. The DR then reconnected the used empty syringe to the needle.

DR 13 repeated the same technique with four different syringes, leaving the needles attached the vials while administering the medications then reconnecting the syringes to the needles for four IV medications (four medication, 4 vials, 4 syringes, and 4 needles).

After the patient left the OR, DR 13 put away all the medications, cleaned and discarded all the used the syringes, and left the room. Left in the room was a 5 ml syringe containing liquid attached to a vial by surgical tape. There was no label on the syringe or the vial. The end of the syringe was not covered or capped. The surgical tech started to clean the room. There was no communication to the staff about the left-over medication. The CCO noted the syringe and discarded it.

On 4/24/14 at 1000 hours, during an interview, the hospital's Infection Control RN stated the hospital followed the APIC's guidelines for safe injection practices.

Review of the APIC Recommendations for Safe Injection Practices showed the following:

* To use a new syringe and a new needle for each entry into a vial or IV bag.

* Discard syringes, needles, and cannulas after use directly on an individual patient or in an IV administration system.

* Prepare syringes as close to administration as feasible. Always use a new sterile syringe and new needle/cannula when entering a vial.

* Never enter a vial with a syringe or needle/cannula that has been previously used (e.g., to inject a patient or access a medication vial).

* Discard any vial that has been placed on a contaminated surface or a used procedure tray or that has been used during an emergency procedure.

* Use multi-dose medication vials- access all vials using a new sterile syringe and new needle/cannula adhering to aseptic technique. Never pool or combine leftover contents of vials for later use.

* Never leave a needle, cannula, or spike device (even if it has a 1-way valve) inserted into a medication vial rubber stopper because it leaves the vial vulnerable to contamination.


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4. Review of the hospital's P&P titled Medication Labeling (undated) showed medications will be labeled in a standardized manner in accordance with the state and federal laws and regulations.

An initial tour of the 2E unit was conducted on 4/21/14 at approximately 0930 hours, accompanied by the Infection Control RN.

a. During an observation of the patients in Room A, a bottle of 0.9% Sodium Chloride irrigation solution was observed on top of the medication storage cabinet in front of Beds 1 and 2. The bottle of solution were not labeled with the patient's name and there was no date to show when the half empty bottle was opened.

b. During an observation of the patients in Room B, a bottle of 0.9% Sodium Chloride irrigation solution was observed on top of the medication cabinet door in front of Bed 1. The bottle was not labeled with the patient's name and the date to show when the bottle was opened.

During an interview with RN C on 4/21/14 at 0940 hours, she stated she did not know when the irrigation solution bottles were opened.

During an interview with the Infection Control RN on 4/21/14 at 0945 hours, she stated the nursing staff were instructed to label and date the irrigation solutions when opened and dispose of them after 24 hours.

5. Review of the hospital's P&P titled Respiratory Care Suctioning via Closed Suction System, revised on 1/8/11, showed to replace disposable canisters every 48 hours and as needed.

a. Medical record review for Patient 6 was initiated on 4/21/14. Patient 6's diagnosis included chronic respiratory failure.

During an observation of the patient's room on 4/21/14 at 1000 hours and 4/22/14 at 1500 hours, a suctioning unit was noted attached to the wall. The canister was approximately half full with a greenish liquid and the date on the canister was 4/19/14.

b. Medical record review for Patient 32 was initiated on 4/21/14. Patient 32's diagnosis included right lung abscess.

During an observation on 4/22/14 at 1500 hours, a suctioning unit was noted attached to the wall. The canister was approximately half full with a greenish liquid and the date on the canister was 4/19/14.

During an interview with Infection Control RN on 4/21/14 at 1005 hours, she confirmed the canisters should be changed and dated every 48 hours.


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6. Patient 22 was observed on 4/22/14 at 1031 hours, accompanied by the QA Director. A hemodialysis machine was at the patient's bedside but was not connected to the patient. No health care staff was in the room.

Inspection of the room linen closet showed opened IV bags, medications, syringes with medication, and opened medication vials. The QA Director stated the linen closet was not intended for storage of prepared medications and opened vials.

Dialysis RN O then entered Patient 22's room and took all the IV medications. RN O stated he just came back from his morning breaktime. RN O stated the medications found in Patient 22's closet were not for the patient but were prepared ahead of time for the next dialysis patients assigned to him. When asked, RN O acknowledged medications were not to be stored in a patient's room and then moved from one room to another while providing dialysis treatments. RN O stated the medications should be kept in the unit's medication room.

7. On 4/21/14 at 1025 hours, the family member of Patient 9 asked to speak to a surveyor. The family member complained about the exposed rough surfaces on the computer desk and the headboard wall behind the bed, rendering it uncleanable.

In addition, the family member pointed out the grout around the bathroom sink that was growing a black molding substance. Under the sink in the bathroom was a wall penetration approximately the size of a melon. The family member also stated the toilet had water continuously running during the past 3 weeks. The family member also pointed up to the air vent which was covered with dust.

At this time, the QA Director was made aware of the environmental complaints of the family member and stated the Maintenance Supervisor would be notified.

8. On 4/21/14 at 1030 hours, a tour was conducted in the Telemetry unit on the third floor with the QA Director. The following was observed:

a. In two different rooms containing two patients in each room, bedpans and urinals with no labels to determine ownership were found in the shared bathrooms.

The QA Director acknowledged patients' personal equipment should be labeled to prevent cross contamination.

b. A bag of rice was found in the cupboard above the sink in patient room. The QA Director inquired of Charge Nurse RN N but was unable to determine whether it belonged to staff or the former patient, or how long the bag was in the room.

During an interview on 4/21/14 at 1400 hours, PT Tech 1 stated he had seen OT staff use the bag of rice for patients to insert their hand and exercise their fingers.

Based on record review and interview, the hospital failed to ensure a post anesthesia evaluation was preformed for one of 33 sampled patients (Patient 15), creating the risk of a substandard health outcome to this patient.

Findings:

On 4/22/14 at 0935 hours, Patient 15 was observed undergoing MAC for a surgical procedure. Review of the documented post-operative note #2 showed there was no assessment documented by DR 13 (anesthesiologist) for post anesthesia recovery. In addition, DR 13 signed the document; however, there was no date or time.

Based on observation, interview, and record review, the hospital failed ensure the P&Ps on respiratory services were implemented as evidenced by:

1. There was no spare, same size tracheostomy tube immediately available at the bedside for one of 33 sampled patients (Patient 31), two nonsampled patients in the ICU, and one nonsampled patient on the 2E unit to be able to intervene in case of accidental decannulation (unintended removal or dislodgement of a plastic tube inserted in the neck to assist in breathing).

2. There was no care plan developed to address the patient's risk of decannulation for one of 33 sampled patients (Patient 19) who had episodes of self-extubation.

3. There was no oxygen tank available on the 2W unit for emergencies on the morning of 4/21/14.

These failures could potentially lead to patients' respiratory arrest and death.

Findings:

1. Review of the hospital's P&P titled Decannulation Risk Assessment dated 1/8/11, showed the hospital should have specific measures in place to prepare the IDT for unintentional decannulations. The RT would determine and communicate the decannulation risk classification level as appropriate. Based on established criteria, patients identified as high risk for airway decannulation would be placed on airway precautions per protocol. The primary care giver would be notified. DECANNULATION PRECAUTIONS sign would be posted at the head of the patient's bed.

a. During the initial tour rounds on 4/21/14 at 1045 hours, accompanied by RN G and the Infection Control RN, Patient 31 was observed lying in bed on his back. He was breathing through a tracheostomy tube. RN G stated the patient was nonverbal, but responsive at times.

Observation of a sign posted at the head of Patient 31's bed showed "Decannulation Risk Precautions: same size trach tube at bedside, two caregivers to assist with turning or moving the patient, one of the two caregivers will manage the airway while the patient is being moved".

On 4/21/14 at 1100 hours, an interview with RT 1 was conducted. The RT stated 14 out of 26 patients located on 2W unit had tracheostomy and were ventilator dependent. The RT stated if a decannulation occured, the nurses' station would alarm the RT. RT 1 stated many nurses knew how to reconnect the tracheostomy tube to the patients' neck.

On 4/21/14 at 1120 hours, an interview with RT 2 was conducted. The RT 2 was asked to show the emergency replacement tracheostomy tube to ensure a replacement was readily available. RT 2 stated the replacement tracheostomy tube was locked in the RT's cabinet in Patient 31's room. RT 2 stated the RTs were the only caregivers who had a key to open the cabinet. RT 2 stated Patient 31's tracheostomy size was 7 and the replacement tracheostomy tube inside the RT's cabinet was 8.

During an interview with the Director of the RT Department on 4/21/14 at 1500 hours, he stated if the replacement tracheostomy tube was not readily available, it could cause a delay of care during an emergency. The Director stated ideally, the patient's tracheostomy and the replacement tube should be the same size.



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b. On 4/22/14 at 1305 hours, during the tour in ICU, a patient was observed with a sign of "Decannulation" posted in the room. The patient had a tracheostomy tube and was connected to a mechanical ventilator.

A concurrent interview with RN D showed there was no spare tracheotomy tube in the room in case of decannulation.

c. On 4/22/14 at 1310 hours, another ICU patient was observed with a posted sign of "Decannulation" in the room. The patient had a tracheostomy tube and was connected to a mechanical ventilator. There was no spare tracheostomy tube observed in the patient's room in case of decannulation.

A concurrent interview with RN I showed a spare tracheostomy tube was locked up in the room. The RN stated the RTs had the key. In case of an emergency, the nursing staff had to find the RT to get the tracheostomy tube.

d. On 4/22/14 at 1435 hours, during a tour on 2E unit, a patient with a tracheostomy tube connected to a mechanical ventilator was observed.

A concurrent interview with RT 4 showed the patient had a spare tracheostomy set next to the patient; however, the size of the spare tracheostomy tube was one size smaller than the patient's current tracheostomy tube size. RT 4 further explained the smaller size of tracheotomy tube was placed by other RT, not him. The RT stated since there was one tracheotomy set, it was fine, and there was no need to replace it. When asked about the P&P for preparing the spare tracheotomy tube for patients, RT 4 stated it was up to the RT's discretion.

e. On 4/24/14 at 0830 hours, Patient 19 was observed. The patient was not responsive to conversation; however, the patient moved both hands slowly and touched the tracheostomy stoma without difficulty. A brown stuffed bear was noted on the floor. There was no decannulation sign posted in the room.

According to RN H, Patient 19 was alert but confused. Patient 19 could not use the call light for assistant due to his confusion. The intervention to prevent self-extubation included to place the patient near the nursing station and frequent visits by the care staff.

RT 3 was interviewed on 4/24/14 at 0900 hours, and stated Patient 19 had a tracheostomy tube connected to a mechanical ventilator. The patient was ventilator dependent. RT 3 stated he witnessed Patient 19's self-extubation on 4/23/14, in the morning. RT 3 stated he inserted the tracheostomy tube back immediately and the rapid response team was called.

The follow-up blood gas specimen to evaluate the patient showed the patient had hypoxia (low level of oxygen) after the above incident. RT 3 stated Patient 19 had another episode of disconnecting the breathing tube while RT 3 was suctioning the patient. The RT stated the patient became agitated and disconnected the tracheostomy tube.

RT 3 stated the patient could be upset when he searched for his family, but the family was not nearby or when the patient was bored. RT 3 stated the patient could be distracted by playing with his stuffed animal "brown bear", watching TV, or having the family come in to talk to him. RT 3 stated the patients identified with a high risk of self-extubation should have the sign "Decannulation" posted and care planned for decannulation.

The patient's medical record was reviewed by RT 3 and RT Director on 4/25/14. Both staff stated there was no documented evidence a care plan was developed to address the patient's risk of decannulation.


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3. Review of the hospital's P&P Procurement of Medical Gases, review 1/11, showed Engineering was responsible for procurement and dispensing of all medical gas cylinders (i.e. oxygen). If the Respiratory Therapy Department requires any medical gas cylinders, that department is to call Engineering.

During a tour of the 2W unit with the 2W unit's Nurse Manager on 4/21/14 at 1030 hours, the unit crash cart (emergency) was inspected. There was no oxygen tank noted in the holder. Review of the checklist on the cart showed the last time the cart was checked was on the night shift of 4/20/14. The Nurse Manager stated the cart was to be checked every shift and part of that check was to ensure portable oxygen was available.

The 2W unit's Charge Nurse, RN B was interviewed on 4/21/14 at 1040 hours. The RN stated the oxygen tank from the crash cart was used by the RT to transfer a patient to the ICU at 0800 hours, that morning. When asked if oxygen tanks were stored elsewhere on the unit, he stated no.

The RT Supervisor on the 2W unit was interviewed on 4/22/14 at 1300 hours. When asked the availability of portable oxygen on the 2nd floor for the 2W and 2E units, the Supervisor stated portable oxygen tanks were stored in the clean utility room on the 2E unit. Observation of the utility room showed a rack for storage of the tanks; however, the rack was empty. When asked, the RT Supervisor stated other than the crash carts, the only other immediately available portable oxygen was on the 3rd floor.