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Based on observation, interview, and record review, the GB failed to ensure the safe and effective operation of the hospital as evidenced by:

1. Hospital patients received imaging services at an adjacent facility; the process was not reviewed and approved by the GB and a signed business contract was not in place when patients received imaging scans. The safety and effectiveness of the process was not ensured by policies and protocols also reviewed and approved by the GB. The safety and effectiveness of the services rendered and the safety of the building were not reviewed by the hospital prior to treatment of patients. Cross reference to A0529.

2. The infection control practices of the contracted dialysis service were not ensured. Cross reference to A084, example #2.

3. The rights of the patients were not promoted and protected in a safe environment. Cross reference to A0115.

4. The QAPI program did not provide oversight of hospital processes; there was incomplete data collection and analysis, incomplete follow-up of adverse events, and the quality of a contracted imaging provider was not ensured. The GB failed to ensure adequate resources were allocated to carry out all quality improvement activities and failed to provide direction and coordination for data collection and for performance improvement projects. Cross reference to A0263.

5. Facility and equipment used for patient care were not maintained to ensure the safety of patients and staff. Cross reference to A0700.

6. Failure to ensure hospital sanitation to minimize the risk of contagious diseases and spread of the infections when the infection control program was not effectively staffed, implemented, and maintained. Cross reference to A0747.

The cumulative effect of these systematic practices resulted in the GB's inability to provide high quality healthcare in a safe environment.

Based on interview and record review, the hospital failed to ensure services performed under contract for radiological services were provided in a safe and effective manner and failed to monitor the contracted dialysis service for infection control compliance. This had the potential for patient safety issues.

Findings:

1. On 11/19/14 at 0845 hours, the Director of Radiology stated the hospital no longer had a Mobile CT unit as backup to the in house CT scanner. The Director stated the mobile unit was only used a few times a month. At the end of October 2014, the hospital began using Suite 13 in the medical office building adjacent to the hospital, owned by a radiologist on staff at the hospital. The Director stated the hospital did not lease the space but reimbursed per scan. The Director stated only CT scans were provided in Suite 13.

The business contract for the hospital's use of the CT scanner was provided for review on 11/19/14. The "Services Agreement" showed the "Agreement was entered into as of the later of October 31, 2014, or the date this Agreement had been duly executed by both parties (the "effective date")."

However, review of page 12, the signature page showed the CEO signed the contract on 11/19/14, the same day as the contract was requested for review by the surveyors. The signature of the owner of the suite was not dated.

The hospital was unable to provide a P&P developed as instructions to CT Technologists and Radiologists and the P&P for the Code Blue Team Response to emergencies in Suite 13 were signed off by the Department Director and the Medical Director of Radiology and were reviewed and approved by the GB prior to the initiating the process.

The hospital was unable to provide a P&P to show criteria was developed to guide staff in determining the appropriateness of the patients deemed safe for transport to Suite 13 for testing.

The hospital was unable to provide a P&P to address the MRI process in Suite 13.

The hospital failed to ensure Suite 13 was maintained for fire safety. Cross reference to A0710.

During an interview with the Quality Consultant on 11/20/14 at 1055 hours, he stated contractors were to supply their own QA data which was reported to QA twice a year.

During interviews with the Director of Radiology on 11/19/14 at 0845 hours, and 11/20/14 at 1100 hours, he stated he did not have quality assurance information on the MRI and CT scanners in the Suite 13 contracted imaging center.





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2. On 11/19/14 at 1100 hours, observation of the contracted dialysis service storage room was done with the Director of Trauma. Observation of the three dialysis machines stored in the room showed the reverse osmosis system mounted the to back of the machines had rusted metal parts, a white build-up on areas of the equipment, dirt at the base of the system, and a rubber glove placed over the ends of the machine hoses which contained drainage from the hoses. The outside of the gloves were wet and dripping fluid.

The Director of Trauma stated they monitored the dialysis staff when they were performing patient treatments but had not been monitoring the condition of the dialysis machines.

Based on observation, interview, and record review, the hospital failed to protect and promote the rights of the patients as evidenced by:

1. The hospital failed to ensure three of 58 sampled patients were fully informed of their rights as patients in the hospital. Cross reference to A0117.

2. The hospital failed to ensure two of the eight patient grievances reviewed were investigated following the hospital's P&P. Cross reference to A0119.

3. The hospital failed to ensure the P&P for the grievance process was developed to meet the requirement to provide a patient with a grievance a written, not verbal notice of its decisions. In addition, for three patients of the eight patient grievances reviewed, the hospital failed to provide a written response of the resolution of a grievance and failed to provide a written response describing the steps taken to investigate the grievance and the results of the grievance process. Cross reference to A0123.

4. The hospital failed to ensure the P&P for advanced directives was implemented for three of 58 sampled patients. Cross reference to A0132.

5. The hospital failed to ensure the patients received care in a safe environment. Cross reference to A0144.

6. The hospital failed to develop the P&P for Restraints to include the requirement to consult the attending physician as soon as possible if the attending physician did not order the restraint or seclusion. Cross reference to A0170.

7. The hospital failed to identify the rationale for the use of restraint for one of the three sampled patients reviewed for the use of restraints. Cross reference to A0187.

8. The hospital failed to ensure the implementation of the hospital's P&P to ensure competency for the use of restraints for two of two RNs reviewed. The RNs were not evaluated or verified for competency for the use of behavioral restraints annually. Cross reference to A0196.



The cumulative effect of these systematic practices resulted in the hospital's inability to provide quality health care in a safe environment.

Based on interview and record review, the hospital failed to ensure three of 58 sampled patients were fully informed of their rights as patients in the hospital (Patients 2, 14, and 19).

For Patient 2, the patient was not provided with information about her rights and conditions of admission in her primary language.

For Patients 14 and 19, the forms acknowledging the patients were informed and received information about their rights and conditions of admission were not completed fully.

These failures created the risk of the patients not being informed about their rights.

Findings:

1. During a review of the medical record of Patient 2 on 11/17/14, the record contained a Conditions of Services document which specified some patients' rights, consent for medical treatment and photography, and information regarding medical care, privacy, and billing. The four-page form was in English and signed by the patient. No translator was identified as used for the patient as that section of the form was left blank.

A second form, labeled Admitting Conditions of Services Addendum contained information about maternity patients and pastoral care with the information in English on the top half of the page and in another language other than English on the bottom half of the page. The non-English language half was signed by the patient.

A third document, Your Right to Receive Visitors was written in English and signed by the patient.

A fourth document, the five-page Notice of Privacy Practices was written in another language other than English and signed by the patient.

A fifth document, Patient Notification of Admission Acknowledgement was in another language other than English and signed by the patient.

During an interview with the Coordinator Perinatal on 11/17/14 at 1300 hours, she stated the patient information collected on Patient 2 indicated she was non-English speaking; and the documents were to be in the patient's language.


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2. Review of the hospital's P&P titled Admission, Patient (Conditions of Services/Addendum) approved 2/28/13, showed the Condition of Services is a contract between the patient and the hospital. It is the responsibility of the Admitting Representative to obtain valid signatures as consent is being given for hospitalization and treatment and financial responsibility is being assumed.

Signatures are to be obtained from patient, guardian, conservator or agent. A patient's signature is only valid if he/she is fully aware and understands the consent of the form. If an adult patient is unable to sign, a spouse or parent may sign for him/her.

In the case a patient is unable to sign and a spouse or parents are not available, the Admitting Representative will note "patient unable to sign due to medical condition" on the signature line and the form will be witnessed by the Admitting Representative and a Nursing Representative.

Review of the hospital's P&P titled Patient Rights, Responsibilities & Ethics approved 1/7/13, showed admitting department staff will provide a brochure to all admitted patients that informs them of their rights and responsibilities.

a. Review of Patient 14's medical record was initiated on 11/17/14. The patient was admitted to the hospital on 11/16/14.

Review of the Trauma Services History & Physical dated 11/16/14 at 1025 hours, showed Patient 14 was awake and oriented times three.

Review of the Admission Assessment Report showed Patient 14 came to the Observation unit at 11/16/14 at 1130 hours, accompanied by family/friend/significant other. The patient was alert. The patient's neurological status was "WNL" (within normal limits).

Review of the Conditions of Services dated 11/16/14 at 1200 hours, showed the box "Patient Rights and Responsibilities" was checked. The section for the patient's signature or responsible party signature showed "unable to sign."

Review of the "Your Right to Receive Visitors" form showed Patient 14's family member signed the form on 11/16/14 at 1300 hours.

There was no documented evidence to show Patient 14 or the patient's family member were informed or acknowledged the "Patient Rights and Responsibilities" notice that was given to the patient or the patient's family member.

During an interview and concurrent medical record review with DON 1 on 11/17/14 at 1525 hours, the DON confirmed the above finding.

b. Review of Patient 19's medical record was initiated on 11/18/14. The patient was admitted to the hospital on 11/17/14.

Review of the Conditions of Services form showed Patient 19 signed the form on 11/17/14 at 1700 hours. However, the box "Patient Rights and Responsibilities" was left blank.

During an interview and concurrent medical record review with DON 1 on 11/18/14 at 1330 hours, the DON confirmed the finding.

Based on interview and record review, the hospital failed to ensure two of the eight patient grievances (for Patients 13 and 51) reviewed were investigated following the hospital's P&P. This failure created the increased risk of the failed grievance process.

Findings:

The hospital's P&P titled Patient/Family Complaints/Grievances reviewed 4/14, read in part, "All patient concerns, complaint letters or phone calls are to be directed to the appropriate department and responded to within the defined time frames...The designees will respond, investigate, and take action and communication resolution back to the patient and/or appropriate family members."

The hospital's P&P titled Medical Staff Issues Reported on the Professional Activity Report (PAR) approved 4/2/12, showed for a medical staff behavior event, the Department Director was to be notified and an investigation completed within five business days and reviewed with the Department chair within seven business days. The event was then to be confirmed or unsubstantiated.

1. Patient 13's grievance was randomly selected from a list of grievances provided by the hospital. The Patient/Family Concerns Communication dated 6/22/14, showed the patient's husband had complaints regarding care provided by DR 1 during the 6/22/14 hospital visit as well as poor communication during that visit and previous visits.

The communication document showed a phone call was placed to the Patient 13's husband on 6/23/14, but there was no answer. A response letter was sent on 6/27/14, to the patient and her husband which stated, "I have followed up with the medical staff on the issues you mentioned regarding communication with the physicians." The letter was signed by RN M, from the Patient Relations Department. However, there was no documentation in the file indicating the concerns were investigated, and no documentation that DR 1, the Department Director, or anyone from the medical staff office was contacted regarding the grievance.

During an interview with the Director of Medical Staff on 11/19/14 at 1340 hours, she stated usually complaints were sent to her by the department; however, she did not remember getting one for DR 1. During a second interview on 11/20/14 at 1250 hours, the Director stated there was no evidence of the complaint in DR 1's file.

During an interview with RN M on 11/20/14 at 1135 hours, she concurred an investigation was not documented in DR 1's file. RN M stated she thought the complaint regarding DR 1 was already sent to the medical staff by the ED when she sent the resolution letter to the patient and her husband.


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2. Patient 51's grievance was randomly selected from a list of grievances provided by the hospital for review on 11/19/14. Review of Patient 51's Patient/Family Concerns Communication showed a complaint was filed for Patient 51 on 6/27/14. The allegations were as follows:

* The patient waited for too long for the nurse to come when she asked for medication.

* The patient requested to be assisted to the bathroom, but a CNA told the patient she could not be out of bed and had to use the bed pan. The patient requested the curtain be closed, but the CNA told her no one can see her; however, the patient insisted the curtain be closed. The patient was on the bedpan for an hour but could not go. The nurses were in the hallway "chit chatting", but they would not come to help her.

Documentation showed the grievance was forwarded to DON 2.

During an interview and concurrent documentation review with DON 2 on 11/19/14 at 0855 hours, the DON was asked about her investigation of the above concerns. The DON stated she interviewed a CNA, a RN, and a charge nurse during the investigation. However, when asked, DON 2 was unable to find documented evidence to show nursing staff was interviewed.

DON 2 stated she reviewed Patient 51's medical record prior to talking to her staff. When asked, DON 2 was unable to find documented evidence to show review of patient's medical record by the DON. The DON confirmed there was no documented evidence to show an investigation was conducted or filed in the grievance filed.

Based on interview and document review, the hospital failed to ensure the P&P for the grievance process was developed to meet the requirement to provide a patient with a grievance a written, not verbal notice of its decisions.

In addition, for three patients of the eight patient grievances reviewed, the hospital failed to provide a written response of the resolution of a grievance for Patient 47 and failed to provide a written response describing the steps taken to investigate the grievance and the results of the grievance process for Patients 50 and 51.

This failure created the increased risk of the failed grievance process.

Findings:

Review of the hospital's P&P Patient/Family Complaints/Grievances approved 5/7/14, showed in the resolution of a grievance, the hospital will provide the patient with "verbal or written notice" of its decision that contains the following:

* The name of the hospital contact person.

* The steps taken on behalf of the patient to investigate the grievances.

* The results of the grievance process.

* The date of completion.

1. During an interview and concurrent document review with DON 2 on 11/19/14 at 0855 hours, the DON stated she was designated to oversee the grievances process for the hospital. The DON stated she would call, talk to the patient, and send a notice letter to the patient when the investigation was completed. DON 2 stated she verbally notified the patient of the outcome of the investigation.

DON 2 reviewed the hospital's P&P and confirmed the hospital's P&P for Patient/Family Complaints/Grievances showed to provide the patient with verbal or written notice of its decision when investigation was completed. However, the hospital's P&P did not address the requirement to provide the patient with written notice of its decision as per regulation.

2. The grievances for Patients 47, 50, and 51 were randomly selected for review from a list provided by the hospital on 11/18/14.

a. Review of Patient 47's Patient/Family Concerns Communication showed on 7/30/14, a complaint was filed for Patient 47. The complaint showed the patient did not understand why they were discharged and then asked to come back to the hospital by the physician due to abnormal chest x-ray.

Further review failed to show a written notice letter was provided to the patient to address the above concerns.

During an interview and concurrent document review with DON 2 on 11/19/14 at 0855 hours, the DON stated Patient 47's complaint was about quality of care and considered as a grievance. When asked, DON 2 was unable to show a written notice of the findings was provided to the patient. The DON stated she was not involved in this case; the final written notice was not sent to the patient as per hospital's P&P.

b. Review of Patient 51's Patient/Family Concerns Communication showed a complaint was filed for Patient 51 on 6/27/14. The allegations were as follows:

* The patient waited too long for the nurse to come when she asked for medication.

* The patient requested to be assisted to the bathroom, but a CNA told the patient they could not get up and had to use the bed pan. The patient requested to close the curtain, but the CNA said no one could see the patient. However, the patient insisted the curtain be closed. The patient was on the bedpan for an hour but could not go. The nurses were in the hallway "chit chatting" but they did not come to help her.

Further review showed a follow-up was conducted on 7/2/14, by a phone call and letter. The letter was sent on 7/2/14.

Review of the hospital's letter dated 7/2/14, signed by DON 2, showed the DON would begin an investigation of the patient's concerns and would follow up with the patient at the conclusion the investigation.

Review of another letter dated 7/3/14, signed by DON 1 showed DON 1 followed up with the nursing staff on the issues mentioned. However, there was no documentation to show how the patient's concerns were addressed and the written letter provided to the patient contained the results of the grievance process.

During an interview and concurrent document review with DON 2 on 11/19/14 at 0855 hours, the DON stated a final letter was sent to Patient 51 on 7/3/14. The DON confirmed the written response did not contain the steps taken to investigate the patient's concerns and the results of the grievance process.

c. Review of Patient 50's Patient/Family Concerns Communication showed the following:

* On 7/29/14, a complaint was filed for Patient 50. The patient complained of an inappropriate discharge; the patient was discharged when still very sick. The patient went back to ED and was readmitted.

* On 7/30/14, the patient's medical record and complaints were reviewed by the hospital. The allegations as to why the patient felt they were discharged too soon were included. The patient felt she should have had a bowel movement prior to discharge and the felt medication given prior to discharge might have made her sick.

The hospital responded to the grievance in a letter sent to Patient 50 dated 7/30/14, signed by DON 1.

Review of the letter failed to show how all the above concerns of Patient 50 were addressed. There was no documentation to show the written response from the hospital contained the results of the grievance process.

During an interview and concurrent document review with DON 1 and DON 2 on 11/19/14 at 1000 hours, DON 1 stated she investigated the allegations, reviewed Patient 50's medical record, called the patient about her findings, and sent a final letter to the patient. However, DON 2 confirmed the hospital's written letter did not contain the results of an investigation of all the above concerns.

Based on interview and record review, the hospital failed to ensure the P&P for advanced directives was implemented for three of 58 sampled patients (Patients 2, 12, and 14). For Patients 2 and 14, there was no documentation to show the patients were provided with information about advanced directives. For Patient 12, the patient's advance directive was not scanned and filed as documented by admitting staff. These failures could lead to the risk the patients not being informed about the their rights to an advance directive and the patients' health care decision not being respected.

Findings:

Review of the hospital's P&P titled Advance Healthcare Directive approved 5/1/13, showed the following:

* Admitting was to inquire as to whether the patient has a current Advance Healthcare Directive.

- If response is "YES," document on Conditions of Services form. If the patient brought the advance directive with the patient, send the Advance Healthcare Directive to the unit patient is being admitted to and document on Advance Directive Information Checklist form.

- If response is "NO," ask the patient if he/she wishes additional information regarding advance directives. If answer is "Yes," a brochure "Making an Advance Directive" will be provided to the patient.

* The nurse admitting the patient reviews/initiates the Advance Healthcare Directive Information Checklist & Initial Patient Assessment forms and indicates whether or not the patient had an Advance Health Care Directive, an Advance Directive Indication of Intent form, or requests further information.

1. The medical record of Patient 2 was reviewed on 11/17/14. The Advance Directive Checklist was filled out on 11/16/14 at 0720 hours. The section for indicating whether the patient had an advanced directive had "no" checked. The pre-printed form had sections to indicate whether an informational brochure regarding advanced directives was given to the patient or to a person with the patient, but that section was left blank.

There was another section on the form to indicate whether the person requested additional information; however, both the "yes" and "no" options were left blank. There was a section on the form for the admitting department to indicate a reason the form was not completed and that section was also left blank. The formed was signed by a hospital representative.

During an interview with the Coordinator Perinatal on 11/17/14 at 1300 hours, she stated the admitting department was to fill out the section on advanced directives.


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2. Review of Patient 12's medical record was initiated on 11/17/14. The patient was admitted to the hospital on 11/16/14.

Review of the Advance Directive Checklist showed an entry dated 11/16/14 at 1702 hours, Patient 12 had an Advance Healthcare Directive. A box for "copy in chart" was checked. The form showed the copy was attached and was "scanned in chart."

During an interview and concurrent medical record review with CNS 1 and DON 1 on 11/17/14 at 1010 hours, the CNS stated documentation showed Patient 12 had an advance directive scanned in chart. However, when asked, the CNS was unable to find the Advance Directive was scanned and filed in the patient's medical record as per admitting staff documentation.
3. Review of Patient 14's medical record was initiated on 11/17/14. The patient was admitted to the hospital on 11/16/14.

Review of Patient 14's Advance Directive Checklist dated 11/16/14 at 1200 hours, showed a box for "NO" was checked to indicate the patient had no advance healthcare directive. The section to indicate whether a brochure "Your Right to Make Decisions About Medical Treatment" was provided to the patient or to a person with the patient was left blank. Another section to indicate whether the patient requested additional information was also left blank. The form was signed by the hospital representative and a nursing staff.

During an interview and concurrent medical record review with RN A and DON 1 on 11/17/14 at 1355 hours, staff confirmed the finding.

Based on observation, record review, and interview, the hospital failed to ensure the patients received care in a safe environment as evidenced by:

1. Nursing staff failed to recognize a patient's physical incapacity (Patient 24) to use the bedside call light to communicate his needs and to call for immediate assistance.

2. One RN did not know how to check a neonatal crash cart (used for emergencies) and operate the oxygen tank and resuscitation mask.

3. The hospital failed to ensure the facility and equipment were maintained at an acceptable level of safety and quality.

4. The hospital failed to provide a sanitary environment and an active infection control program.


These failures created the risk of substandard health outcomes for the patients in the hospital.

Findings:

1. On 11/17/14 at 1430 hours, during the initial tour of the Neuro Observation Unit on the fourth floor, a visitor approached the nurses' station and told RN T Patient 24 needed help to go to the bathroom.

Medical record review for Patient 24 showed the patient was a victim of a motor vehicle accident. The patient suffered fractures of the wrists, arms, and legs and he was wearing a neck brace.

When the surveyor approached Patient 24's bedside, a family member uncovered the patient's extremities to show patient's arms and legs were in casts. The family member stated Patient 24 was unable to feed himself and could only wiggle his fingers. The patient was also unable to push the nurse call button to ask for help, except to yell. The patient's bed was not visible from the nurses' station.

On 11/17/14 at 1445 hours, RN T was asked if there was a dedicated staff at the nurses' station to listen for patients calling for assistance. RN T stated no, as staff were always in and out of the nurse station. When asked how else Patient 24 could communicate his needs, RN U stated the unit had a call light triggered by tapping a pad.

Patient 24's family member expressed relief when the assistive device was brought to Patient 24's room and connected.

Review of Patient 24's care plan failed to show any planned interventions were developed for the patient such as the need of assistive device to call for assistance or assistance with other ADLs since the patient was only able to wiggle his fingers.




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2. Review of the hospital's P&P titled Crash Cart revised 12/2011, showed staff should check if there was an ambu bag with mask (used to assist with breathing) and an oxygen tank with a flow regulator. The tank should be at least 1500 psi (pounds per square inch, a measuring unit of pressure).

On 11/17/14 at 1007 hours, inspection of the neonatal crash cart in the LDR unit was initiated with RN L, the Unit Manager. RN L stated the LDR nurses checked the crash cart once per day. The log showed it was last checked on 11/16/14 at 2100 hours.

On 11/17/14 at 1015 hours, an interview was initiated with RN Q regarding how to check the above neonatal crash cart. RN Q stated she did not check the ambu bag and mask; she did not know how to connect the ambu-bag with the oxygen tank attached to the crash cart. When asked how to check the oxygen tank, RN Q stated she did not check it as she only used the oxygen in the patient's room, not the oxygen tank attached to the crash cart.

3. The hospital failed to ensure the facility and equipment were maintained at an acceptable level of safety and quality. Cross reference to A0724.

4. The hospital failed to provide a sanitary environment and an active infection control program. Cross reference to A0749.

Based on interview and document review, the hospital failed to develop the P&P for Restraints to include the requirement to consult the attending physician as soon as possible if the attending physician did not order the restraint or seclusion. This could pose the potential of lack of knowledge and delivery of inappropriate care to the patients.

Findings:

Review of the hospital's P&P titled Restraints approved 9/8/14, failed to show the requirement the attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion.

During an interview and concurrent document review with DON 1 on 11/19/14 at 1315 hours, the DON confirmed the finding. DON 1 stated the hospital's P&P should be updated and revised.

Based on interview and record review, the hospital failed to identify the rationale for the use of restraint for one of the three sampled patients (Patient 49) reviewed for the use of restraints. This could lead to the potential for an unnecessary use of restraints for the patient.

Findings:

Review of the hospital's P&P titled Restraints approved 9/8/14, showed the following:

* The use of restraint occurs only after alternatives to such use have been considered and/or attempted as appropriate.

* The use of restraint is based on the assessed needs of the patient. Restraint may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm.

* The use of restraint is limited to those situations for which there is adequate and appropriate clinical justification.

* Each episode of restraint should contain at least a description of the patients' behavior and the intervention used; the patient's condition or symptoms that warranted the use of restraint; the patient's response to the interventions used, including the rationale for continued use of the intervention; individual patient assessment and reassessments.

Review of Patient 49's medical record was initiated on 11/19/14. The patient was admitted to the hospital on 11/4/14, and discharged on 11/15/14.

Review of the Daily Assessment Inquiry showed Patient 49 was initially restrained with soft restraints to the bilateral upper extremities on 11/13/14 at 0000 hours. The documented reason for restraint was the patient was trying to pull the ETT.

Review of the Daily Assessment Inquiry showed Patient 49 was restrained with soft restrains to the bilateral upper extremities on 11/4/14 at 2000 and 2200 hours, and on 11/15/14 at 0000, 0200, 0400, 0600, 0800, and at 1000 hours. However, the section for documentation of the clinical justification for restraint was left blank.

Review of the Daily Assessment Inquiry showed Patient 49 was also sedated on 11/14/14 at 2000 and 2200 hours, and on 11/15/14 at 0000, 0200, 0400, 0600, 0800, and 1000 hours.

There was no documented evidence to show the rationale for the use of soft restraints to the bilateral upper extremities for Patient 49 on the above dates and times.

An interview and concurrent medical record review was conducted with RN C and DON 1 on 11/19/14 at 1320 hours. When asked, the staff was unable to find documented evidence to show the reason for the use of soft restraints on Patient 49 for the above dates and times.

Based on interview and document review, the hospital failed to ensure the implementation of the hospital's P&P to ensure competency for the use of restraints for two of two RNs (RNs O and P) reviewed. The RNs were not evaluated or verified for competency for the use of behavioral restraints annually. This failure could lead to inappropriate use of restraints and unsafe care for the patients.

Findings:

Review of the hospital's P&P titled Restraints revised 6/14 and approved 9/8/14, showed all staff that place, intervene, or discontinue restraints must have an annual validated restraint competency.

On 11/19/14 at 1320 hours, DON 1 was asked about staff training for the use of restraints. The DON stated staff training was included in the annual reorientation and skills days.

Review of the New Employee & Annual Reorientation booklet provided by DON 1 showed the section for the Use of Restraints included the use of non-behavioral and behavioral restraints, or violent or self-destructive restraints.

During an interview and concurrent personnel file review for RNs O and P with the HR Manager on 11/19/14 at 1500 hours, the Manager was asked for RNs O and P's competency for 2014. The Manager stated she would look for information.

A follow-up interview and concurrent personnel file review of RNs O and P was conducted with the HR Manager on 11/20/14 at 1305 hours. No documented evidence was provided to show RNs O and P had a validated restraint competency for the use of behavioral restraints. The Manager verified the findings.

On 11/20/14 at 1650 hours, the HR Manager stated she was told RNs O and P did not need to have competency for the use of behavioral restraints. The Manager verified RNs O and P did not have a validated restraint competency for the use of behavioral restraints for 2014.

Based on observation, interview, and record review, the hospital failed to ensure a hospital-wide, data-driven, effective QA program was implemented and maintained as evidenced by:

1. The hospital failed to ensure the scope of the QAPI program included an ongoing program that showed measurable improvement in indicators for which there was evidence that they would improve health outcomes Cross reference to A0273.

2. The hospital failed to ensure the QAPI program recognized adverse events, grievances, and infection control data as opportunities for improvement. The program did not analyze the data to use as learning opportunities, implement actions for improvement, and evaluate whether actions were effective enough to sustain improvement. Cross reference to A0283.

3. The hospital failed to ensure follow-up of all adverse events and failed to provide documentation to show identified infection control problems were addressed in the hospital's QAPI Program. Review of adverse events did show evidence of a complete investigation and follow-up. The QAPI did not provide oversight of incidents, including unplanned readmissions, through analysis and trending. Cross reference to A0286.

4. The QAPI program failed to provide oversight of the quality of a contracted service for imaging. Cross reference to A0308.

5. The GB of hospital failed to ensure a formal process was defined for determining performance improvement projects. Cross reference to A0309.

6. The hospital's GB failed to ensure adequate resources were dedicated to the Quality Improvement Program to ensure staff was available to provide oversight of the incident reporting process. Cross reference to A0315.

The cumulative effect of these failings meant the hospital did not implement and maintain a quality improvement program to ensure the safety and quality of the services provided.

Based on observation, interview, and record review, the hospital failed to ensure the scope of the QAPI program included an ongoing program that showed measurable improvement in indicators for which there was evidence that they would improve health outcomes as evidenced by:

1. The hospital's infection control program was not incorporated into the hospital's QAPI program. Data from the infection control EOC rounds was not reported to the QA program.

2. The hand hygiene surveillance data did not reflect an accurate assessment of hospital practice.

3. Quality data collection frequency was not specified by the GB with details not also specified.

4. An audit tool used to collect reporting times of critical lab values appeared flawed.

5. There was no proactive audit access of the EMR by remote users or a proactive audit of the EMR for access by staff with no job related need to access.

6. Data was not completely collected and reviewed for the use of restraints.

These failures of the QAPI program to monitor the effectiveness and safety of services and quality of care in the hospital created an opportunity for improvement in patient care not to be identified.


Findings:

1. The hospital's Organization-Wide Infection Prevention and Control Program and Plan 2014 dated 4/23/14, read in part, "Reports of infection surveillance, prevention, and control information are provided to the appropriate staff within the hospital.

During the observations in the hospital from 11/17 through 11/20/14, poor sanitation and poor sanitary practices were observed in some areas of the hospital. Cross reference to A0749.

During the tours of the surgical suite and sterile processing area, ¿the ceiling vents in the sterile corridor, the surgical suite sterile processing area, and the central sterile processing areas were noted to have a thick build-up of dust-like material. Cross reference to A0749, example #14.

During the tour of the radiology suite on 11/17/14 at 1245 hours, the documentation to show HLD of an ultrasound probe contained two instances on 11/12/14, when the times the probe was placed in the disinfectant was recorded, but not the time it was removed. Cross reference to A0749, example #11.b.

The pre-printed Infection Control Environmental Round Discrepancy List used for EOC rounds was provided on 11/19/14. Included on the list was item H04 under the heading Environmental Services Management: "Is the department dusty? Are all high ledges and ceilings, walls and vents clear of dust and debris?" Item 145 for audit of glutaraldehyde (used for high level disinfection) use showed the question "Documentation is thorough, per policy?"

During an interview with the CNO on 11/19/14 at 1430 hours, she stated the Infection Preventionist attended EOC rounds and reported to the EOC Committee. However, the CNO stated she was not sure how the rounds were reported to the Medical Executive Committee who provided oversight of hospital quality.

The quarterly EOC/Safety Committee Minutes from 2013 and 2014 were reviewed. The minutes contained reports about functional issues involving the physical plant, equipment, and patient safety issues but did not contain information about infection control hazards seen in the hospital.

During an interview with the Patient Safety Officer on 11/19/14 at 1445 hours, he stated he coordinated the EOC rounds. The Patient Safety Officer stated the Infection Preventionist usually attended EOC rounds but was an ad hoc member reporting to her own committee (the Clinical Monitoring Committee).

During an interview with RN K from the Quality Department and the Infection Preventionist on 11/19/114 at 1420 hours, the staff stated the Infection Preventionist reported to the Clinical Monitoring Committee.

The minutes of the Clinical Monitoring Committee for 2013 and 2014, were reviewed; however, the minutes did not contain information from the infection control EOC rounds.

During a second interview with the Infection Preventionist on 11/20/14 at 0900 hours, she stated the infection control EOC data should be in the EOC and Clinical Monitoring Committee minutes.

During an interview with the CNO on 11/20/14 at 1110 hours, the CNO stated the activities of the Clinical Monitoring Committee were reported to Quality Council; she was not sure why the QA program had not noted the infection control EOC rounds were not reported.

On 11/20/14 at 0900 hours, a meeting was held with hospital personnel regarding the hospital's infection control program. The CNO stated the QA oversight for infection control was separate. Infection control issues were not reported to QA.

EOC rounds were done each month to identify any environmental infection issues; however, there was no documentation in the EOC or Clinical Monitoring Committee meeting minutes to show any identified issues discussed that might affect patient safety.

Review of the hospital's QAPI meeting minutes did not show review of any identified infection issues.

2. On 11/17 at 0935 hours, and 11/18/14 at 0850 hours, during the observation of the Critical Care Units with the Director of Critical Care and RN C, and on 11/18/14 at 1350 hours, with RN M on the 6th floor, multiple episodes of deficient hand hygiene were observed. Cross reference to A0749, example #13.

The hospital's 2014 National Patient Safety Goals Compliance Summary was reviewed. Documentation showed hand hygiene rates of 99% for the first quarter, 94% for the second quarter, and 100% for the third quarter of 2014.

On 11/20/14 at 1020 hours, the CNO stated the QA program was to provide oversight of data collection and presentation to the MEC.

On 11/20/14 at 0930 hours, the Infection Control Preventionist stated she thought the hand hygiene data showing 100 percent hand hygiene was probably not accurate.

On 11/20/14 at 0930 hours, the Quality Consultant concurred the hand hygiene surveillance may not have been accurately carried out.

On 11/20/13 at 0928 hours, the CNO stated hand hygiene competency was being developed.

On 11/20/14 at 0930 hours, the hand hygiene worksheets data and any planned change in data gathering were requested; however, no further information or documentation was presented prior to the survey team's exit on 11/20/14 at 1700 hours.

3. The Continuous Quality Improvement and Performance Improvement Plan 2014 dated 2/6/14, read on page 17, "Each department/service will determine frequency of data collection for indicators."

During interviews with the CNO, Patient Safety Officer 2, and Wound Care RN on 11/18/14 at 1400 hours, the staff stated the frequency and detail of data collection for evaluating the timeliness of urinary catheter removal, timely reporting of critical lab values, and occurrence of hospital acquired pressure ulcers was not specified in writing.

The CNO, in an interview on 11/19/14 at 1450 hours, stated the Continuous Quality Improvement and Performance Improvement Plan 2014, specified the reporting frequency for QA measures, but not the frequency with which data was to be collected.

4. The 2014 National Patient Safety Goals Compliance Summary showed the total number of critical lab values called to the physician within 60 minutes of notification was 78% in the first quarter and 54% in the second quarter.

Patient Safety Officer 2 described a sampling process for determining the timeliness of critical lab value reporting. The Safety Officer stated she evaluated 30 closed medical records and the nursing units sent a sample of 10 record reviews each month. However, the Safety Officer stated she was unable to state who devised the sampling process or whether it was in a policy.

The Safety Officer provided copies of some completed worksheets used to determine timeliness of critical lab value reporting. The worksheets, completed by nurses in different areas of the hospital, contained a pre-printed goal, "Report critical results of tests and diagnostic procedures on a timely basis" followed by the item, "All critical values must have documentation of time received, person notified, and outcome (new orders, expected value, covered by current orders) either on sticker or in the critical values tab in the daily assessment."

There was no parameter specified to indicate what was considered timely and no request the timeliness of the report to the physician be assessed. This was followed by columns in which the staff member was to check "met," "not met," or "NA."

For each of the worksheets provided for review, either "met" or "N/A" was checked. Patient Safety Officer 2 indicated a checkmark in the "met" column indicated the critical value was reported timely. However, Patient Safety Officer 2 was unable to explain how she could be sure the results were reported within the hospital's time parameters based on the questions and responses on the worksheet.

A second worksheet completed by the Safety Officer showed out of four medical records reviewed for October 2014, two contained critical values. One medical record contained one critical value which was reported timely. For the second medical record, only two of six critical lab values were reported timely.


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5. On 11/18/14 at 1315 hours, the HIM Director was interviewed. The Director stated remote access to the medical record was granted to physicians and to their selected office staff. The Director stated the office staff granted privileges signed a Security Access Authorization form. When asked, the Director stated the office staff could potentially access the records of any patient in the system, not just the patients belonging to their physician.

The Director stated the HIM Department did not conduct proactive random auditing of the remote access granted to office staff or physicians. The Director stated audits were conducted to address specific complaints of improper access only.

The Director stated no proactive auditing of improper access of the EMR was conducted by the hospital.


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6. Review of the hospital's P&P titled Restraints revised 6/14 and approved 9/8/14, showed the hospital measures and assesses its restraint use to identify opportunities to introduce preventive strategies, alternatives to use, and process improvements that reduce the risks associated with restraint use. Restraint data is reported quarterly and an annual summary report is submitted to the MEC and GB.

a. The hospital failed to develop a hospital's P&P for Restraints to address the attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion. Cross reference to A0170.

b. The hospital failed to identify the rationale for the use of restraint for Patient 49. Cross reference to A0187

c. The hospital failed to ensure the hospital's P&P was implemented when the competencies of two RN staff on the Observation Unit for the use of behavioral restraints were not evaluated or verified annually. Cross reference to A0196.

d. Review of the Observation Unit Daily Restraint Log showed three patients were restrained inn 2013, and one patient was restrained on 9/30/14. The section for the Director Review/Signature was left blank.

The use of a restraint for Patient 52 was randomly selected for review from the Observation Unit Daily Restraint Log. The following was identified:

* On 5/16/13, Patient 52 was admitted to the observation unit. On 5/18/13 at 0430 hours, a physician's telephone order was obtained to place soft restraints on the patient for safety.

* The Physician Order Restraints showed a physician's telephone order dated 5/18/14 at 0420 hours, showing "soft wrist tie(s)," and "soft ankle tie(s)" were ordered for violent/self-destructive or behavioral restraints. The reason for the use of these restraints was the patient "is physically assaultive to others or is highly agitated and assaultive behavior preeminent."

* The 24-hours Restraint Flowsheet & Plan of Care failed to show nursing staff conducted visual observation and intervention for Comfort/Safety at a minimum of 30 minutes. The box the criteria for release explained to patient/family member/significant and the box of criteria met for discontinuation of restraint were left blank.

* There was no documented evidence to show when the restraints were discontinued.

* There was no documented evidence to show physician conducted face to face assessment when the patient was restrained.

* The Plan of Care for the use of restraint dated 5/18/14 at 0420 hours, was left blank.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 1325 hours, the DON confirmed the above findings.

e. During an interview with DON 1 on 11/20/14 at 0945 hours, the DON was asked about collecting data for the use of restraints in the hospital. The DON stated the restraint logs were sent to the previous CNO on Mondays; the collected data was to be presented to the Quality Council. The DON was not certain about the specific system used for collecting data for the use of restraints.

During the meeting with QA staff on 11/20/14 at 1020 hours, QA staff stated the use of restraints would be reported from each unit throughout the hospital. The collected data would be captured and graphed. The graphs would be used to present the collected data.

However, review of the graph from the Restraints 2013, and the restraint log for September 2014, failed to show the data collected and captured for the use of restraints for patients in the Observation Unit. Staff confirmed the graph did not capture the use of restraints in the Observation Unit.

QA staff was asked whether the use of restraints was reviewed and evaluated for appropriate use. The CNO stated the quality program was to ensure complete reporting of restraints. The CNO stated the use of restraints was reviewed by using a paper tool. The CNO was asked to provide the tool. The CNO stated she would provide the tool as requested.

QA staff was asked who oversaw and reviewed the use of restraints. The staff did not answer.

On 11/20/14 at 1700 hours, at the time of the survey team's exit no further documentation was provided by CNO regarding to the tool used to review/evaluate the use of restraints.

Based on record review and interview, the hospital failed to ensure the QAPI program recognized adverse events, grievances, and infection control data as opportunities for improvement. The program did not analyze the data to use as learning opportunities, implement actions for improvement, and evaluate whether actions were effective enough to sustain improvement. This failure could potentially affect health outcomes and poor quality care.

Findings:

1. On 11/19/14, review of the Quality Council meeting minutes on 3/11/14, showed patient complaints were reported to the committee. The majority of the complaints were patient care related and focused on nursing and the medical staff. The graph showed there were less complaints in 2013, than the past year. This was attributed the identification of key staff to help resolve patient dissatisfaction.

Further review of the meeting minutes showed the hospital met the national benchmark of having less than 10 complaints per month, considering there were only a total of 14 complaints in a quarter. Review of the committee's discussion/action showed members reviewed the complaints by hospital location and no more questions were asked.

2. On 11/20/14 at 1020 hours, during a meeting with the QAPI committee and review of their meeting minutes, no complaints or grievances were found discussed from April to June 2014. The CNO, a leading member of the QAPI and the Grievance Committee responded stating the chairman of the Grievance Committee should be able to explain why.

In an interview on 11/20/14 at 1130 hours, RN M, chairman of the Grievance committee presented a document from the GB dated 4/28/14, delegating the oversight of the grievance review and resolution process to the Grievance Committee.

RN M stated the Grievance Committee would now report to the GB on a biannual basis but would no longer report to the QAPI committee. The members of the Grievance Committee aside from RN M were the CNO and Director of Performance Improvement, both of whom were experienced in QAPI organization.

3. On 11/19/14, review of the hospital's infection control program and plan dated January to December 2013, showed, "The hospital evaluates the effectiveness of its infection control plan annually and whenever risks were significantly changed." The highest priority risk assessed was "admission of patients with MDRO posing the risk of horizontal transmission."

On 11/20/14, during the surveyors' meeting with the infection control committee at 0900 hours, the committee was asked which HAI organism was the most prevalent according to the current year's surveillance. None of the infection control committee members were able to identify the most prevalent HAI organism.

When asked which of the reportable diseases to the Public Health had the highest incidence, there was also no reply by the committee. The hospital's 2014 HAI surveillance and the reportable diseases data as collected by members of the infection control committee were presented. The committee was then asked if there were interventions planned for the collected data. The only response was from the Director of Clinical Performance Improvement who stated, "You caught us in a bad time."

Based on interview and record review, the hospital failed to ensure follow-up of all adverse events and failed to provide documentation to show identified infection control problems were addressed in the hospital's QAPI Program. Review of adverse events did show evidence of a complete investigation and follow-up. The QAPI did not provide oversight of incidents, including unplanned readmissions, through analysis and trending. These failures created the risk of persistent poor practices and substandard healthcare.

Findings:

1. The Continuous Quality Improvement and Performance Improvement Plan 2014 dated 2/6/14, read on page 8, "The Director of Quality Management functions as the Risk Manager and is responsible for implementing a systematic, ongoing monitoring/evaluation process for actual/potential Risk Management issues (i.e., occurrence reporting of visitor, employee, patient issues)."

On page 12, it read, "The hospital will make every effort to minimize potential risk to patients, visitors, and the employees. Clinical risk issues included events identified as sentinel events. Unanticipated adverse events/near misses would be evaluated through intensive review, which may include root cause analysis, and communicated as appropriate through Administrative and Medical Staff channels."

During an interview with RN H on 11/19/14 at 1010 hours, an incident from 9/10/14, was reviewed. The incident involved an elderly patient who acquired an abrasion on the head during an ophthalmology procedure. RN H stated she reviewed the incident and no opportunities for improvement were identified. RN H stated the patient was sedated using monitored anesthesia care (a form of deep sedation) but was moving and injured herself on a piece of surgical equipment.

Review of the incident documentation did not show documentation staff present during the patient's procedure was interviewed, including the anesthesia professional providing sedation. RN H concurred she was unable to state from the information documented whether the sedation provided was reviewed and found to be appropriate. RN H stated the electronic incident reporting system did not ask for documentation of interviews.

During an interview with the DON on 11/19/14 at 1025 hours, she stated she could not recall trending and analysis of incident reports from the surgery department by the quality assurance department.

During an interview with the CNO on 11/19/14 at 1030 hours, she stated the main components of the investigation of an incident should be in the electronic incident reporting system.

2. During a review of hospital quality data on 11/19/14, no data regarding unplanned readmissions was seen.

During an interview with the CNO on 11/20/14 at 1110 hours, she stated she was not aware of an initiative for tracking unplanned readmissions; however, the CNO stated one needed to be started.

3. During an interview with the CNO on 11/19/14 at 1030 hours, she stated the Code Blue Committee followed up on all code blues (emergency resuscitation) with an intensive review of the patient's record.

During an interview with the Code Blue Committee Leader on 11/20/14 at 1015 hours, she stated the Code Blue Committee reviewed survival and rhythms; however, the review did not specifically comment on whether there was a missed opportunity to rescue the patient prior to the code.

During a second interview with the Code Blue Committee Leader on 11/20/14 at 1130 hours, she stated there was no specific policy on rapid response and code blue reviews, but the responses to the emergencies were expected to be consistent with the national registry of cardiopulmonary resuscitation data collection parameters.

The national registry criteria were provided and reviewed; however, the criteria did not include reviewing the record for a possible missed opportunity to rescue the patient prior to the code.

Based on observation, interview, and record review, the QAPI program failed to provide oversight of the quality of a contracted service for imaging, creating the increased risk of substandard contracted services.

Findings:

The hospital's Organization-wide Infection Prevention and Control Program and Plan 2014 dated 4/23/14, read in part, "The organization collects data about, but not limited to: ...Contract Services review".

During an interview with the Director of Radiology and the Director of Trauma on 11/19/14 at 0930 hours, the staff stated the CT scanner in the adjacent medical building was used if necessary as a backup to the in house CT scanner for ICU and ED patients.

The adjacent medical building imaging center Suited 13 was toured on 11/19/14 at 0915 hours. Several safety issues were identified, such as the possible lack of an emergency generator and emergency lights, and a fire extinguisher overdue for inspection. Cross reference to A0529.

Hospital patient information was stored on the imaging center's computer.

During an interview with the Director of Facilities on 11/19/14 at 1045 hours, he stated he had not visited the Suite 13's imaging center and was not sure if the building had a generator.

During an interview with the Director of Radiology on 11/20/14 at 1100 hours, he stated he did not have any quality information about the CT or MRI scanners in Suite 13.

During an interview with the CNO on 11/20/14 at 1105, she stated she was not aware of a quality improvement person assigned to provide oversight of the contracted service for imaging. The CNO stated administration provided oversight of a new contract.

Based on interview and record review, the GB of hospital failed to ensure a formal process was defined for determining performance improvement projects. This created the risk of performance issues not addressed by performance improvement activity.

Findings:

The Continuous Quality Improvement and Performance Improvement Plan 2014 dated 2/6/14, read on page 18, "Performance improvement may be performed by a single department/service, committee review or through interdepartment and/or interdisciplinary teams." and "The effectiveness of the action is assessed and directed at improving processes through a mechanism identified by the department/service." There was no separate description of performance improvement projects in the Plan.

During an interview with the CNO on 11/18/14 at 1430 hours, she stated there was no formal process for determining performance improvement projects. The CNO stated the projects were decided by various departments with no central decision making process coordinating the projects. The CNO stated the process was being standardized.

Based on interview and record review, the hospital's GB failed to ensure adequate resources were dedicated to the Quality Improvement Program to ensure staff was available to provide oversight of the incident reporting process, creating the increased risk of unrecognized poor health care practices.

Findings:

The Continuous Quality Improvement and Performance Improvement Plan 2014 dated 2/6/14, read on page 12, "The hospital will make every effort to minimize potential risk to patients, visitors, and the employees. Clinical Risk issues including events identified as sentinel events and unanticipated adverse events/near misses will be evaluated through intensive review, which may include root cause analysis and communicated as appropriate through Administrative and Medical Staff channels." On page 6 it read, "The leaders perform the following functions:..Allocate adequate resources including personnel, time, and data collection systems for assessment and improvement of the organization's governance, managerial, clinical and support processes."

During an interview with QM Staff 1 on 11/19/14 at 1020, she stated there was no oversight by the Quality Department to ensure appropriate follow-up of incidents. QM Staff 1 stated the Quality Department assumed this was done.

QM Staff 1 stated the Quality Department did not have staff to conduct follow-up. QM Staff 1 stated she occasionally saw the follow-up was not done correctly, in which case she recontacted the Department for additional investigation. QM Staff 1 stated there was no documentation of trending or analysis of the incident reports by the Quality Department.

During an interview with the DON on 11/19/14 at 1025 hours, she stated she could not recall trending and analysis of incident reports from the Surgery Department by the Quality Improvement Department.

On 11/20/14 at 1020 hours, the CNO stated the Quality Improvement Program was to provide oversight of the incident reporting system follow-up. The CNO stated there was a gap in the follow-up of the incident reporting system; this would be closed in the future.

Based on interview and record review, the hospital failed to ensure the Medical Staff bylaws were enforced as evidenced by:

1. Two ED physicians with multiple medical records delinquencies over 14 days were not suspended per bylaws.

2. The handwriting by the physicians on two obstetrics records (Patients 1 and 2) was illegible and inaccurate.

These failures created the risk of substandard medical care for patients cared for by those physicians.

Findings:

1. The Medical Staff Bylaws dated 6/23/14, page 7, read in part, "Except for the emeritus staff, the ongoing responsibilities of each member of the medical staff shall include the following: ...(f) prepare and complete in timely fashion medical records for all patients to whom the member provides care under the auspices of the hospital..."

The General Medical Staff Rules and Regulations dated 6/23/14, read in part on page 10, "The attending physician shall complete the medical record within 14 days of the patient's discharge" and "Failure to comply with deadlines for record completion will result in suspension of admitting and surgical privileges. Privileges to treat patients' already in-house and true emergencies in the Emergency Room with or without subsequent admission, including imminent deliveries, are excluded from this suspension policy."

The Physician's Suspension List dated 11/17/14 at 1306 hours, was reviewed on 11/18/14. The suspension list showed the physicians on the list were suspended from "ALL clinical privileges." There were five physician's names on the list.

Also reviewed was a listing of physicians, listed by specialty, with outstanding medical record delinquencies. Thirteen ED physicians were listed. DR 2 was listed with 409 delinquent encounters out of possible 456 patient encounters. DR 9 was listed with 46 delinquent encounters out of possible 52 patient encounters. However, the names of DRs 2 and 9 were not found on the suspension list dated 11/17/14.

On 11/18/14 at 1315 hours, the Director of HIM was interviewed. The Director stated the HIM Department was responsible to ensure the patients' medical records were complete following discharge from the hospital. The Director stated the medical record was to be complete within 30 days of discharge.

When asked why the two ED physicians, DRs 2 and 9 were not listed on the suspension list, the Director stated ED physicians could not admit patients and so they were not subject to suspension. Their medical record delinquencies were referred to their Department Director for follow-up.

The Director of HIM was asked how long DR 2 had been delinquent. The Director reviewed the delinquencies in the computer and stated the oldest delinquencies dated back to March 2014.

The medical staff files for DR 2 were reviewed on 11/19/14. No evidence was found to show the medical record delinquencies were documented or of physician suspension.

During an interview with the Director Medical Staff on 11/19/14 at 1350 hours, she stated she was not informed by the HIM Department about the ED physicians' medical records delinquencies, so the physicians were not suspended as per the medical staff by-laws.

2. The medical records of Patients 1 and 2 were reviewed on 11/17/14 at 0935 hours, with RN J.

a. Patient 1's record contained a History and Physical for Gravid Patients form. However, the pre-printed form had information omitted, such as the patient's age and information on previous pregnancies.

The section for vital signs did not contain information about the patient's blood pressure, pulse, respiratory rate, or temperature, but instead contained an illegible note.

Also in Patient 1' medical record a sheet of Post Cesarean Section physician's orders showed a pre-printed order sheet completed by the physician, signed, dated, and timed "11 AM," which was more than an hour after the time it was reviewed.

During a concurrent interview, RN J concurred the History and Physical contained omissions and illegible writing. In addition, she concurred that the Post Cesarean Section orders were labeled as having been written at 11 AM, a time that was in the future.

b. The medical record for Patient 2 contained a pre-printed form for obstetrics patients. On a line for the follow up plan, there was an illegible note.

During an interview with the Coordinator Perinatal on 11/17/14 at 1300 hours, she stated she also could not read the note.

Based on observation, interview, and record review, the hospital failed to ensure nursing care was provided to meet the needs of four of 58 sampled patients (Patients 6, 12, 14, and 47) as evidenced by:

1. For Patient 14, nursing staff failed to obtain the laboratory tests, failed to assess the initial vital signs within the required times frames after admission as per hospital's P&P, and failed to assess the vital sign every four hours for six and a half hours as ordered. In addition, nursing staff failed to identify changes in Patient 14's EKG rhythm, and failed to notify the physician timely when Patient 14 had a change in condition.

2. For Patient 12, nursing staff failed to obtain a physician's order for the use of oxygen as per hospital's P&P.

3. For Patient 47, nursing staff failed to initiate an assessment for discharge planning needs as per hospital's P&P and failed to assess the patient's functional mobility and stability when discharged.

4. For Patient 6, nursing staff failed to document accurate information on an MRI screening form.

These failures created the risk of substandard health outcomes for the patients in the hospital.

Findings:

Review of the hospital's P&P titled Assessment and Reassessment, Patient approved 3/4/11, showed the following:

* Information gathered throughout assessment and reassessment is used by the team to identify and prioritize the patient's plan of care in collaboration with the patient/family as appropriate, with the physician acting as the coordinator of care.

* The registered nurse is responsible for assessment and prioritization of the patient's need at the time of the initial assessment and throughout the patient's stay.

* Initial assessment shall include physical, functional status, discharge planning/social service needs.

* The healthcare team will perform a reassessment when there is a significant change in the patient's diagnosis or condition that necessitates a change in the plan of care reflecting the change in the diagnosis or condition.

* Assessment of discharge planning needs is initiated within 24 hours of admission and is ongoing throughout the patient's stay.

* Additional assessments/reassessments are made throughout the patient's treatment to meet health care needs and included changes in level of care, and at the time of discharge form a unit.

1. The hospital's P&P titled Assessment and Reassessment, Patient, approved 3/4/11, showed for the Observation Unit, assessment and reassessment areas include an initial physical assessment within two hours of admission and an initial patient assessment completed within three hours of admission; the reassessment was based on priorities of the patients' needs every shift and as warranted by the patient's conditions, response to previous treatment and desire for treatment.

Review of Patient 14's medical record was initiated on 11/17/14. The patient was admitted to the Observation Unit on 11/16/14. The patient had a history of heart disease and a syncope (fainting) fall and loss of consciousness.

a. Review of the Physician Orders-Trauma Unit Orders dated 11/16/14 at 1030 hours, showed a physician's order to obtain adult standard trauma laboratory panel which included a urine toxicity screen.

Further review of the medical record failed to show urine for toxicity screen was obtained for Patient 14 as ordered.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 1315 hours, the DON verified urine for toxicity screen was not obtained for Patient 14 as ordered

b. Review of the Trauma Report dictated 11/16/14 at 1345 hours, showed Patient 14's heart was "regular rate, sinus rhythm." The patient's heart rate was 67 (normal heart rate is between 60 to 100). The physician documented the patient's syncope may have been due to hypotension (low blood pressure) or symptomatic bradycardia (low heart rate). The plan was for the patient to receive ongoing serial neurological checks.

Review of the Physician Orders Trauma Services Admission Order dated 11/16 (no year documented) at 1100 hours, showed to place Patient 14 in the Observation Unit with telemetry (the patient is continuously monitored for heart rate and heart rhythm).

Review of the Admission Assessment Report showed Patient 14 arrived on the Observation unit on 11/16/14 at 1130 hours.

Review of the physician's order dated 11/16/14 at 1147 hours, showed vital signs were to be taken every four hours.

Review of the Observation unit Transport Log showed Patient 14 left the unit on 11/16/14 at 1610 hours, and returned to the unit at 1724 hours.

Review of the Vitals Inquiry showed Patient 14's initial vital signs were completed on 11/16/14 at 1800 hours, six and a half hours after admission.

There was no documented evidence to show nursing staff assessed Patient 14's initial vital signs within the two hours as per hospital's P&P.

There was no documented evidence to show nursing staff assessed Patient 14's vital signs every four hours for six and a half hours (from 1130 hours to 1800 hours) when the patient was admitted to the unit on 11/16/14 at 1130 hours.

An interview and concurrent medical record review was conducted with DON 1 and RN A on 11/17/14 at 1400 hours. When asked, RN 1 was unable to find documented evidence to show nursing staff assessed Patient A's vital signs for six and a half hours when the patient was admitted to the unit on 11/16/14 at 1130 hours.

c. Review of the hospital's P&P titled Hospital Plan for the Provision of Nursing Care approved 1/28/13, showed the practice of nursing by a RN includes, but is not limited to, assuming responsibility and accountability for nursing actions/interventions to diagnose and treat human responses to actual or potential health problems based on interpretation of assessment data. Further review showed the telemetry technician is to monitor and interpret EKG rhythms consistently and correctly and notifies the RN of EKG changes or concerns.

Review of the Mount Sheet showed Patient 14's cardiac (heart) rhythm strips were obtained on 11/16/14 at 1408 and 2000 hours, and on 11/17/14 at 0102 hours. The patient's cardiac rhythm strips were interpreted as sinus rhythm with BBB (Bundle Branch Block) on 11/16/14 at 1408 hours, and as sinus bradycardia with BBB on 11/16 at 2000 hours, and at 11/17/14 at 0102 hours.

An interview and concurrent document review was conducted with DON 1 on 11/18/14 at 1045 hours. Patient 14's cardiac rhythm strips were reviewed from the monitor system. The patient's cardiac rhythm changed to an irregular rhythm on 11/16/14 at 2059 and 2233 hours. The patient's heart rate decreased to 48 on 11/17/14 at 0046 hours.

The DON confirmed the above findings and verified the patient's irregular heart rhythm was not printed, interpreted, and filed in the patient's medical record. The DON stated the monitor technician was expected to notify nursing staff and document when the patient's cardiac rhythm changed as the above.

On 11/18/14 at 1120 hours, the Observation Unit Telemetry sheet from the Telemetry unit was reviewed. The Observation Unit Telemetry sheet failed to show documented evidence nursing staff was notified or aware Patient A's heart rhythm changed to an irregular rhythm on 11/16/14 at 2049 and 2233 hours. DON 1 confirmed the findings.

On 11/18/14 at 1330 hours, the Observation Unit Communication Log was reviewed. There was no documented evidence to show nursing staff was made aware or was notified of Patient 14's heart rhythm when it changed to an irregular rhythm as the above. DON 1 confirmed the findings.

d. Review of the physician's order dated 11/16/14 at 1150 hours, showed neurochecks would be done every two hours for Patient 14.

Review of the "neuromuscular" section of the Daily Assessment Inquiry showed the following:

* On 11/16/14 at 1330 hours, Patient 14's speech was clear. The patient's right and left arms and right and left legs were weak.

* On 11/16/14 at 2000 and 2200 hours, Patient 14's speech was garbled. The patient's left arm was weak. The patient's right arm and the patient's left and right leg were within functional limits. The patient had a droop to the left side of face, possibly related to old CVA.

* On 11/17/14 at 0000 hours, Patient 14 had general weakness. The patient's speech was garbled. The patient's left arm was weak. The patient's right arm and right and left legs were within functional limits.

Review of the Progress Notes Reports showed an entry dated 11/17/14 at 0253 hours, showing "at about 0100 hours noted the left side of facial droop was more prominent." Patient 14 would have to smile to see the left sided facial droop during initial assessment. At about 0100 hours, the patient did not have to smile and could see the facial droop.

Documentation showed RN O spoke with RN P and the patient's family member. The patient's family member reported they did not notice the patient's left side drooping. The physician was called and was informed of the left side droop. The physician ordered to activate code stroke. The Rapid Response Team was called and Code Stroke was activated.

A CT of the head was done and the result reported to the physician. The physician said to keep the patient on the nursing unit and continue with neurochecks every two hours.

There was no documented evidence to show nursing staff notified the physician when Patient 14 was noticed with left side facial droop on 11/16/14 at 2000 and 2200 hours.

During an interview and concurrent medical record review with DON 1 and RN A on 11/17/14 at 1400 hours. RN A stated nursing staff did not need to assess vital signs for Patient 14 when neurochecks were done for the patient. The RN stated nursing staff did vital signs when there was change in the patient's neurological assessment. When asked, the RN was unable to find documented evidence to show nursing staff assessed Patient 14's vital signs on 11/16/14 at 2200 hours, when the patient was noted with left facial drooping.

RN A stated nursing staff was expected to notify the charge nurse when left facial drooping was noted on 11/16/14 at 2000 hours; the charge nurse and the bedside nurse would perform further nursing assessment and would notify the physician. However, RN A was unable to find documented evidence to show RN O notified the charge nurse conducted a further assessment and notified the physician when Patient 14's left facial drooping was noticed on 11/16/14 at 2000 hours.

RN A confirmed nursing staff delayed in notification of the physician for five hours after noticing the patient's left facial drooping on 11/16/14 at 2000 hours.

e. Review of the hospital's P&P titled In-House Code Stroke - Rapid Response Team (RRT) reviewed 11/13, showed the procedure included to notify attending physician of the events; RRT RN used the standardized procedure for in-house stroke; the RRT RN evaluates the patient NIHSS (National Institute of Health Stroke Scale) and history; the RRT RN ensures the second IV placement and blood drawn is sent to laboratory STAT (immediately) and ensures a CT scan non-contrast head is done

Further review showed the Stroke In-patient Stroke for Rapid Response Team Only showing in-patient stroke standardized procedure includes to perform a STAT lab draw for CKMB (a high level indicates the heart muscle or skeletal muscle was damaged) and Troponin (a high level indicates the heart muscle or skeletal muscle was damaged) if not done in the past 24 hours.

Review of the Rapid Response Team Event Record dated 11/17/14, showed the following:

* At 0100 hours, Patient 14 was noticed with new onset of questionable left sided facial droop by bedside nurse. The physician was notified by the bedside nurse of assessment and findings. The physician verbalized telephone order to call rapid response and/or stroke team if needed.

* At 0135 hours, Rapid Response was initiated. At 0143, Stroke team was initiated. Laboratory tests were drawn and an EKG was completed. The patient's NIHSS score was "2" (a score between one and four indicated the patient had a minor stroke) due to minor left facial droop and mild dysarythmia.

However, there was no documented evidence to show nursing staff obtained a physician's order for CKMP and Troponin level for Patient 14 as per the hospital's P&P.

During an interview and concurrent medical record review with DON 1 and RN C on 11/20/14 at 0830 hours, RN C stated the blood tests would be drawn for the patient when a Code Stroke was initiated. Staff confirmed the CKMP and Troponin levels would be obtained when the Code Stroke was called for the patient in accordance to the hospital's P&P. The DON was asked to confirm if the CKMP and Troponin levels were obtained for Patient 14.

On 11/20/14 at 1315 hours, DON 1 stated the CKMP and Troponin levels were not obtained for Patient 14 when a code stroke was called on 11/17/14.

2. Review of the hospital's P&P titled Oxygen Therapy approved 5/2/14, showed to obtain a physician's order for oxygen therapy to include delivery method and rate. In an emergency situation, oxygen may be initiated and titrated to keep the oxygen saturation above 90% and a physician order must be obtained. Oxygen therapy may not be removed, interrupted, or liter flow changed without obtaining a physician's order.

On 11/17/14 at 0920 hours, Patient 12 was observed in bed, receiving oxygen at two liters per minute of oxygen via nasal cannula.

Patient 12's medical record review was initiated on 11/17/14. The patient was admitted to the hospital on 11/16/14.

Review of the Emergency Department-DMD Triage Report showed Patient 12 was triaged on 11/16/14 at 1452 hours. The patient's oxygen saturation (the concentration of oxygen in blood) was 95% on room air.

a. Review of the Admission Assessment Inquiry dated 11/16/14 at 2032 hours, showed Patient 12 was admitted to the nursing unit on 11/16/14 at 2000 hours. The patient's heart rhythm was irregular. The patient's capillary refill (a quick test done by applying pressure to cause blanching on the nail beds, used to monitor dehydration and the amount of blood flow to tissue) was brisk. The capillary refill time (the time taken for the nail bed's color returned after pressure is applied to cause blanching the nail bed. Normal capillary refill time is usually less than 2 second. A prolonged capillary refill time may indicate dehydration and decreased peripheral perfusion) was less than three seconds. The patient received two liters oxygen per minute via nasal cannula. The patient's breath sounds were diminished.

However, there was no documented evidence to show a physician's order was obtained for the use of oxygen for Patient 12 as per hospital's P&P and there was no documented evidence to show the reason for the use of oxygen for Patient 12.

An interview and concurrent medical record review was conducted with CNS 1 and DON 1 on 11/17/14 at 1010 hours. When asked, the CNS was unable to find a physician's order for the use of oxygen for Patient 12.

b. Review of the Daily Assessment Inquiry dated 11/17/14 at 0830 hours, showed Patient 12's heart rhythm was irregular. The patient's capillary refill was sluggish. The capillary refill time was more than three seconds. The patient received three liters oxygen per minute via nasal cannula.

There was no documented evidence to show an physician's order was obtained for changing oxygen to three liters per minutes on 11/17/14 at 0830 hours.

An interview and concurrent medical record review was conducted with RN B and DON 1 on 11/18/14 at 1015 hours. When asked, the RN was unable to find documented evidence to show the reason why oxygen was increased to three liters per minute on 11/17/14 at 0830 hours. When asked, the RN was unable to find documented evidence to show the physician's order was obtained to increase oxygen to three liters per minute via nasal cannula on 11/17/14 at 0830 hours.

3. Review of the hospital's P&P titled Discharge Planning approved 1/6/14, showed nursing staff are to assess discharge planning needs as part of the initial nursing assessment; refer high-risk patients to Case Management Services; include discharge needs in the plan of care and update as needed; assist patient in maintaining functional status. Nursing staff are to assess quality parameters for patient stability at discharge and provide consultation to patient and family regarding continuing care need.

Review of Patient 47's medical record was initiated on 11/19/14. The patient was admitted to the hospital on 5/10/14.

Review of the Admission Assessment Inquiry dated 5/10/14 at 0937 hours, showed the following:

* Patient 47 arrived to the floor on 5/10/14 at 0805 hours.

* The patient had changed in functional mobility (gait, balance, or transferring difficulties), and had newly identified difficulty in performing ADLs.

* The patient had a history of falls. The patient's upper and/or lower body strength was inadequate for safe mobility. The patient had weight bearing restriction on one or more extremities. The patient was identified as high risk for fall.

* The patient was unable to ambulate.

Review of the Daily Assessment Inquiry showed an entry dated 5/11/14 at 0845 hours, Patient 47 had an initial PT evaluation. The patient required "Contact Guard Assist" (the PT needs to have one or two hands to on the patient's body to help steady the patient's body or help with balance) for positioning from supine to sitting and from sitting to supine and for transferring from bed to chair and gait. The recommendations included PT treatment twice daily six times a week and once daily on Sunday.

Review of the physician's order signed by a PT on 5/11/14 at 0915 hours, and signed by the physician on 5/11/14, indicated the physician approved the recommended PT treatment plan.

Review of a physician's order dated 5/11/14, showed to discharge the patient home.

Review of Discharge Assessment/Summary Report showed Patient 47 was discharged on 5/11/14 at 1400 hours.

a. Further review of Patient 47's medical record failed to show documented evidence Patient 47 was assessed for discharge planning needs within 24 hours of admission when the patient was identified having changed in functional mobility and required PT treatment. There was no documented evidence to show nursing staff assessed the patient for continuing care needs when discharged.

An interview and concurrent medical record review was conducted with DON 1 and RN C on 11/19/14 at 1350 hours. Staff was asked about discharge planning assessments when a patient was admitted. The DON stated nursing staff would initiate a discharge planning assessment when the patient needed to be referred a Case Manager would be involved. When asked, staff was unable to find documented evidence to show an assessment of discharge planning needs was initiated within 24 hours of admission for Patient 47 as per hospital's P&P.

b. Review of the Discharge Assessment/Summary Report dated 5/11/14, failed to show Patient 47 was reassessed for functional mobility or ambulatory for stability when discharged.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 0830 hours, the DON confirmed the finding.


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4. On 11/18/14, Patient 6's closed medical record review showed the patient was admitted on 10/30/14, for a decreased of level of consciousness. The patient had two MRI scans of the brain done on 10/31 and 11/3/14.

On 11/20/14 at 0856 hours, an interview and concurrent medical record review was conducted with RNs Y and M. RN Y stated nursing staff reused the same form from the first MRI done on 10/31/14, for the second MRI done on 11/3/14.

Review of the MRI Screening Questionnaire form for the 11/3/14 MRI showed nursing staff documented "No change." The questionnaire form showed the nurses documented the patient never had an MRI scan before; however, an MRI was done on 10/31/14, three days ago.

The inaccurate assessment of Patient 6 as never having an MRI scan previous to the 11/3/14, scan was shown to RNs Y and M. RN M acknowledged the finding.

Based on observation, interview, and record review, the hospital failed to ensure nursing staff developed individualized nursing care plans for six of 58 sampled patients (Patients 10, 11, 12, 14, 24, and 46). This failure could lead to lack of knowledge in providing care and delivery improper care to the patients.

Findings:

Review of the hospital's P&P titled Documentation of the Nursing Process approved 7/7/14, showed planning is the process of prescribing interventions to attain expected outcome. Standards of practice for the nursing process showed the registered nurse is responsible for initiating the plan of care for patients within 12 hours of admission or per unit protocol.

1. On 11/17/14 at 0920 hours, Patient 12 was observed in bed, receiving two liters of oxygen per minute via nasal cannula. The patient had an indwelling urinary drainage catheter inserted.

Review of Patient 12's medical record was initiated on 11/17/14. The patient was admitted to the hospital on 11/16/14.

a. Review of the Admission Assessment Inquiry dated 11/16/14 at 2032 hours, showed Patient 12 was admitted to the unit on 11/16/14 at 2000 hours. The patient's heart rhythm was irregular. The patient received two liters oxygen per minute via nasal cannula. The patient's breath sounds were diminished.

There was no documented evidence to show nursing staff developed a care plan to address care for Patient 12 for oxygen administration.

b. Review of the Admission Assessment Inquiry dated 11/16/14 at 2032 hours, showed Patient 12 had an indwelling urinary catheter inserted on 11/16/14 at 1945 hours.

There was no documented evidence to show nursing staff developed a care plan to address the use and the care of an indwelling urinary catheter for Patient 12.

An interview and concurrent medical record review was conducted with CNS 1 on 11/17/14 at 1010 hours. When asked, the CNS was unable to find care plans were developed to address care for oxygen administration and the use of an indwelling urinary catheter.

2. Review of Patient 14's medical record was initiated on 11/17/14. The patient was admitted to the Observation unit on 11/16/14. The patient had a history of heart disease. The patient had a syncopal fall and loss of consciousness.

Review of the Admission Assessment Report showed Patient 14 arrived on the Observation Unit on 11/16/14 at 1130 hours.

Review of a physician's order dated 11/16/14 at 1150 hours, showed neurochecks were to be done every two hours for Patient 14.

There was no documented evidence to show a care plan was developed to address care for Patient 14 to address the use of cardiac monitoring and neurochecks every two hours.

An interview and concurrent medical record review was conducted with RN A on 11/17/14 at 1400 hours. When asked, the RN was unable to find a care plan was developed for Patient 14 to address the use of cardiac monitoring and neurochecks every two hours. The RN stated a care plan should be developed for the patient.

3. On 11/20/14 at 0910 hours, Patient 46 was observed receiving propofol (anesthetic medication) infusing via an IV at 15 mcg per kg per minute.

Review of Patient 46's medical record was initiated on 11/20/14. The patient was admitted to the hospital on 11/10/14.

Review of the physician's order dated 11/18/14 at 1608 hours, showed to initiate the propofol infusion at 5 mcg per kg per ml and titrate with a parameter of 5 mcg per kg per minute every five minute to a goal of a Riker Score of "3."

Review of the Patient Care Plan Report failed to show a care plan was developed to address the use of propofol for Patient 46.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 1145 hours, the DON confirmed the finding.


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4. On 11/20/14, medical record review for Patient 10 was initiated. Patient 10 was admitted to the hospital on 11/17/14, with a diagnosis of compartment syndrome (injury that causes painful swelling and increased pressure within a body compartment to the point blood is not able to supply muscles and nerves with oxygen).

Review of a physician's order dated 11/19/14 at 1331 hours, showed to administer intravenous morphine 1 mg/ml via PCA and PCA dose morphine 1 mg was ordered for moderate pain, 4 to 6 on a pain scale of 0 to 10 (0 being no pain and 10 being worst pain) and 3 mg for severe pain, 7 to 10 with a delay interval 10 minutes.

Review of the care plan dated 11/20/14 at 0340 hours, for Patient 10 showed a care plan was developed to address the patient's knowledge deficit. The desired outcome included the patient would verbalize discomfort after interventions and the patient and family would verbalize understanding and demonstrate proper use of PCA pump.

There was no documentation in Patient 10's care plan to show specific interventions were developed to address assessment of the patient for narcotic medication side effects, in particular, level of sedation and respiratory depression parameters during morphine therapy.

During a concurrent interview with RNs E and F on 11/20/14 at 0940 hours, they confirmed the lack of care plan interventions to address Patient 10's pain management.

5. On 11/20/14, at approximately 0930 hours, during a tour of the Medical Surgical Unit, accompanied by the Director of the Critical Care Unit and RN E, Patient 11 was observed lying in bed. The patient was receiving hydromorphone (a narcotic pain reliever) via a PCA.

On 11/20/14, medical record review for Patient 11 was initiated. Patient 11 was admitted to the hospital on 11/09/14, with diagnoses including pancreatitis (inflammation of the pancreas, a long, flat gland that sits tucked behind the stomach in the upper abdomen. The pancreas produces enzymes that assist digestion and hormones that help regulate the way your body processes sugar).

Review of a physician's order dated 11/15/14 at 1615 hours, showed to administer IV hydromorphone 1 mg/ml via PCA in 30 ml of normal saline and PCA dose hydromorphone was ordered for 0.2 mg for moderate pain, 4 to 6 and 0.6 mg for severe pain, 7 to 10 with a delay interval of 10 minutes.

Review of the plan of care dated 11/18/14 for Patient 11 showed a care plan was developed to address the patient's alteration in comfort. The desired outcomes included for the patient to demonstrate adequate pain management. The interventions included to assess discomfort using pain assessment tools, reposition for maximum comfort, provide comfort measures, and medicate when indicated.

However, there was no documentation in Patient 1's care plan to show specific interventions were developed to address specific interventions to address assessment of the patient for narcotic medication side effects, in particular, level of sedation and respiratory depression parameters during hydromorphone therapy.

During a concurrent interview with RNs E and F on 11/20/14 at 0940 hours, they confirmed the lack of care plan interventions to address Patient 10's pain management.



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6. On 11/17/14 at 1430 hours, during the initial tour of the Neuro Observation Unit on the fourth floor, a visitor approached the nurses' station and told RN T Patient 24 needed help to go to the bathroom.

Medical record review for Patient 24 showed the patient was a victim of a motor vehicle accident. The patient suffered fractures of the wrists, arms, and legs and he was wearing a neck brace.

When the surveyor approached Patient 24's bedside, a family member uncovered the patient's extremities to show patient's arms and legs were in casts. The family member stated Patient 24 was unable to feed himself and could only wiggle his fingers. The patient was also unable to push the nurse call button to ask for help, except to yell. The patient's bed was not visible from the nurses' station.

On 11/17/14 at 1445 hours, RN T was asked if there was a dedicated staff at the nurses' station to listen for patients calling for assistance. RN T stated no, as staff were always in and out of the nurse station. When asked how else Patient 24 could communicate his needs, RN U stated the unit had a call light triggered by tapping a pad.

Patient 24's family member expressed relief when the assistive device was brought to Patient 24's room and connected.

Review of Patient 24's care plan failed to show any planned interventions were developed for the patient such as the need of assistive device to call for assistance or assistance with other ADLs since the patient was only able to wiggle his fingers.

Based on observation, interview, and record review, the hospital failed to implement the hospital's P&P regarding the RNs, who administered moderate sedation for the patients in the Endoscopy Lab, monitored these patients continuously with no other duties assigned. This created an unsafe patient care environment for the patients.

Findings:

The hospital's P&P titled Staffing in the Endoscopy Lab reviewed 4/11, showed if an ACLS certified RN is administering moderate sedation for the patients in the Endoscopy Lab, the RN should monitor the patient continuously. The monitoring nurse will have no other duties that would restrict him/her from continuous monitoring.

On 11/18/14 at 1330 hours, a GI procedure was observed with the Director Perioperative Services. The GI room light was dimmed as the procedure required. During the procedure, RN V administered operative sedative drugs, Versed and fentanyl, throughout the procedure via the patient's IV line.

However, at the same time RN V was observed assisting preparation of lab requisitions for the lab after the GI physician obtained a specimen. RN V turned his back to the vital signs monitor and walked away from the patient's gurney toward the end of the room to pull out the requisition forms from the bottom drawer.

In a concurrent interview, the Director Perioperative Services stated there was only one RN assigned for moderate sedation and circulating in the GI Lab.

Based on observation, interview, and record review, the hospital failed to ensure two of 58 sampled patients (Patients 10 and 46) were administered medications per the hospital's P&Ps.

For Patients 10, the patient was not consistently assessed for pain, vital signs, and sedation levels during administration of narcotic pain medications via PCA in accordance with the hospital's P&P.

For Patient 46, nursing staff failed to identify the rationale when the rate of propofol was increased.

This had the potential for oversedation caused by operation errors, inadequate patient assessment, and monitoring of patients using PCA.

Findings:
1. Review of the hospital's P&P titled Patient Controlled Analgesia revised 10/13, showed the purpose of the PCA is to allow the patients to self-administer small amounts of opioids at frequent intervals within programmed limits and keep blood levels of the narcotic within a safe and effective range.
Policy:
A. A physician's order is needed for PCA therapy.
B. Every new program or change in the program must be witnessed, in person, by another RN or MD, and co-signed on the PCA tab.
C. Patients on PCA will have their vital signs, sedation rate, and pain level assessed every 4 hours for the duration of the therapy.
D. These assessments will be increased to every 15 minutes times four, every hour times four, then every four hours:
1. When the therapy is started.
2. With any increase in therapy.
E. Only the patient is to push the medication button, not nursing, not family. A sticker with that reminder in attached to each pump.
F. The patient is to be on continuous pulse oximeter (non-invasive method for monitoring a patient's oxygen saturation) during therapy.
G. The date, time, and initials of the nurse initiating, on the PCA syringe.
H. The pump totals should be documented on the PCA tab/flowsheet then cleared to zero at the end of each shift.
I. Monitor PCA patients for urinary retention and respiratory depression, a potential narcotic side effect. If respiratory rate drops below 8, and sedation scale is 3: turn the PCA pump off, and stop infusion.

On 11/20/14 at approximately 0830 hours, during a tour of the Medical Surgical Unit, accompanied by the Director of Critical Care Unit and RN E, Patient 10 was observed lying in bed, receiving morphine via PCA.

Observation of Patient 10's PCA pump at the patient's bedside did not show a sticker attached to the pump to remind the family and nurses not to activate the medication button for the patient. There was no pulse oximeter device attached to the patient in order to monitor his oxygen levels continuously. The PCA syringe of morphine was observed locked inside the pump; however, the syringe was not dated, timed, and initialed by the nurse who started the therapy.

On 11/20/14, medical record review for Patient 10 was initiated. Patient 10 was admitted to the hospital on 11/17/14, with a diagnosis of compartment syndrome.

Review of a physician's order dated 11/19/14 at 1331 hours, showed to administer IV morphine 1 mg/ml via PCA and the PCA dose morphine 1 mg was ordered for moderate pain, 4 to 6 and 3 mg for severe pain, 7 to 10 with a delay interval 10 minutes.

Review of the Order Inquiry form dated 11/19/14, showed the first dose of morphine via PCA was given to Patient 10 at 1331 hours. However, there was no documentation to show Patient 10's vital signs, pain scores, and sedation rate were assessed as per hospital P&P every 15 minute increments times four hours, every hour times four, then every four hours.

The first assessment of the patient was documented at 1800 hours (approximately five hours after the beginning of the therapy). In addition, there was no documentation to show second RN or the physician cosigned when a new program/syringe was initiated on the PCA to prevent incorrect programming errors which can result in oversedation.

Review of the Daily Focus Assessment Report from 11/19/14 to 11/20/14, showed the assessments were done on 11/19/14 at 1800 and 2000 hours, and on 11/20/14 at 0610 hours. There was no documentation to show the ongoing assessments were conducted every four hours for the duration of the therapy.

During a concurrent interview with RNs E and F on 11/20/14 at 0940 hours, they confirmed the vital signs, sedation rate, and pain should have been assessed based on the hospital's P&P for the PCA.

During a follow-up interview with RN E on 11/20/14 at 0945 hours, she stated documentation was performed at the beginning and at the end of each shift. RN E stated she documented the pump totals of volume of medication infused on the PCA's flowsheet, then cleared the pump controls to 0.


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2. Review of the hospital's P&P titled Titration of Hemodynamic/Sedation/Pain Management Drips Protocol (Adult) for Critical Care Area approved 7/30/14, showed the following:

* For titration of sedative infusion titrate to Riker Sedation Agitation Scale (measures patient behaviors to identify level of sedation and agitation. Levels range from unarousable to dangerous agitation).

* The response to the medication is assessed and documented in the medical record based on desired outcome with vital signs and/or pain scale and/or the Riker Scale as applicable.

* Any change in the infusion rate is documented in the medical record.

The Riker Sedation Agitation Scale score of 3 indicated a patient is sedated or difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again.

Review of Patient 46's medical record was initiated on 11/20/14. The patient admitted to the hospital on 11/10/14.

Review of the physician's order dated 11/18/14 at 1608 hours, showed to initiate propofol IV at 5 mcg per kg per ml and the titrate parameter was 5 mcg per kg per minute every five minutes to a goal of a Riker Score of "3."

Review of the section of IV/GTT Management showed propofol was titrated up to 15 mcg per kg per minute from 10 mcg per kg per minute on 11/20/14 at 0600 hours.

Review of the section of Neuro (neurological) II of the Daily Assessment Inquiry showed Patient 46's Riker Score was "3" on 11/20/14 at 0500, 0600, and 0800 hours.

Review of the section of the Neuro showed on 11/20/14 at 0600 hours, Patient 46's eye opened spontaneously and the patient was "sedated."

There was no documented evidence to show the rationale for increasing the rate of propofol for Patient 46 on 11/20/14 at 0600 hours.

During an interview and concurrent medical record review with RN D and DON 1 on 11/20/14 at 0915 hours, the RN was asked the reason for increasing the propofol rate for Patient 46 on 11/20/14 at 0600 hours. The RN stated the patient moved around and was fighting with ventilator.

However, the RN confirmed the patient's Riker Score was assessed as 3 and was not changed on 11/20/14 at 0600 hours. When asked, the RN was unable to find documented evidence to show the rationale for increasing the rate of propofol for the patient on 11/20/14 at 0600 hours. The RN stated he expected nursing staff to assess the patient, document the reason for an increase in the rate of propofol, and reassess the patient when the rate of propofol was increased.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's P&P was implemented for one of 58 sampled patients (Patient 12) when nursing staff failed to label an IV site and a bag of IV fluid for Patient 12. This failure could lead to poor outcome for this patient.

Findings:

Review of the hospital's P&P titled Intravenous Therapy: Adult approved 3/5/13, showed all IV sites must be labeled with date, time, and nurse's initials indicating when it was initially placed. All IV solutions must be labeled with date, time, and the nurse's initials indicating when initially started.

An initial tour round was conducted on 11/17/14 at 0920 hours, on the Medical Surgical Unit, accompanied by DON 1.

Patient 12 was observed receiving normal saline IV running at 75 ml per hour. The 1000 ml normal saline bag was not labeled with the date, time, and nurse's initial.

Observation of the patient's IV site on the patient's right forearm did not show the site was labeled with date, time, and a nurse's initial.

The DON confirmed the above observations and stated the bag of normal saline and the IV site should be labeled and dated.

Based on interview and record review, the hospital failed to ensure a complete and accurate medical records for eight of 58 sampled patients (Patients 2, 3, 4, 5, 6, 14, 39, and 47). This had the potential to negatively impact patients' medically fragile health status.

Findings:

1. Review of Patient 2's medical record on 11/17/14, showed the admitting forms contained signatures with an accompanying handwritten date of 10/17/14. The admitting form pages bore a sticker indicating the date of the patient's admission was 11/16/14. The handwriting of the date appeared to correspond to the witness who also signed as a staff member.

Patient 2's record also contained the name of a Significant Other on the patient information section of her admitting data sheet. The Patient Notification of Admission Acknowledgement form contained a section to fill in which family members or representative could be notified of the admission and a separate section to fill in the contact information regarding the physician and whether the patient wanted the physician to be notified of her admission.

No information was filled in on the pre-printed area for family member or representative notification. The section for physician information indicated that the physician should be contacted but contained the contact information of the significant other in lieu of the physician information.

During an interview with the Coordinator Perinatal on 11/17/14 at 1300 hours, she stated the Admitting department had, in error, written the significant other's name in the space for the doctor to be notified.

2. The names of Patients 3, 4, and 5 were found in the hospital's EMR, with documentation of CT scans performed on 11/1/14. The reports of the CT scans of Patients 3, 4, and 5 showed each received a CT scan of the abdomen and pelvis with and without IV contrast on 11/1/14 between 1329 and 1521 hours, after presenting in the ED of the hospital.

The reports of the scans identified the location of the imaging as the hospital; however, the images of the scans reviewed in the hospital's Radiology suite on 11/20/14, showed the imaging center name of the outside provider in Suite 13, not the hospital's name.

During an interview with the HIM Director on 11/19/14 at 1100 hours, he stated he did not have access to the radiology imaging system.




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3. The hospital's P&P titled Protocol For Enteral Nutrition (Adult) (File Under: T-01, Review Date: 3/11)" showed "IV. Procedure; A. Ordering and Labeling; 1. Enteral nutrition requires an order by a practitioner. 2. The order is entered into the computer by nursing personnel. On computer order screen, select nutritional services, and then select tube feeding. Under comments, type in feeding instructions, which must include name of formula, volume or rate of administration, and feeding schedule if bolus feeding is ordered ..."

Listed under references for the development of this policy and procedure included, "A. A.S.P.E.N. Enteral Nutrition Practice Recommendations, 2009..." According to that reference source, "Patient-specific EN [enteral nutrition] orders should include four elements: 1) patient demographics, 2) formula type, 3) delivery site/device, and 4) administration method and rate ..."

On 11/19/14 at 1050 hours, Patient 39's medical record was reviewed. Patient 39 was admitted to the hospital on 11/11/4. Per the EMR, RD 5 completed a nutrition "routine follow-up" for Patient 39 on 11/17/14.

The nutrition assessment form in the EMR had a category titled Evaluation of Assessment Data that noted "s/p (status post) ngt feeds (nasogastric tube feeding as a method to provide nutrition) changed per nephrologist (a doctor specializing in kidney disease), however, tf (tube feeding) as rx (prescribed) will exceed nutritional needs ..."

The same nutrition assessment form had a category titled "Nutrition Route" that indicated "NGT/OGT (nasogastric tube/oral gastric tube)." RD 5 stated the EMR had a pop-up screen that had the NGT/OGT combined as an option to select from, which is why the "Nutrition Route" indicated "NGT/OGT" versus clear communication on one or the other route.

The same nutrition assessment under "Nutrition Recommendations" noted, "1. Decrease Novasource Renal to 30 ml/hr ..."

At that time, RD 5 stated under the physician's order for tube feeding, the tube feeding order would include specifying access and placement (delivery site).

However, RD 5 and the DNS reviewed the physician's order entered on 11/17/14, into the EMR. The staff stated the order indicated, "TF (tube feeding) Formula Novasource Renal decrease rate to 30 ml/hr." RD 5 and DNS both confirmed the physician's order for 11/17/14, had not specified access and placement for the tube feeding.

On 11/20/14 at 1346 hours, RN 6 reviewed the physician's order for tube feeding entered into the EMR on 11/17/14. RN 6 verified the order did not specify access/placement. RN 6 stated other tube feeding orders specified the access/route; the EMR had the capability to do so. RN 6 acknowledged it should have been done.


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4. Review of Patient 14's medical record was initiated on 11/17/14. The patient was admitted to the Observation Unit on 11/16/14.

a. Review of the Rapid Response Team Event Record dated 11/17/14, showed the Rapid Response Team initiated at 0135 hours. The Stroke Team initiated at 0142 hours; EKG was completed.

Further review of Patient 14's medical record showed an EKG completed on 11/17/14 at 0158 hours, was filed into the patient's medical record. However, the patient's name was not entered on this EKG.

During an interview and concurrent medical record review with DON 1 and RN B on 11/17/14 at 1115 hours, staff confirmed the finding.

b. Review of the hospital's P&P titled In-House Code Stroke-Rapid Response Team reviewed 11/13, showed all documentation is to be entered on the Rapid Response Team Event Record.

Review of the Rapid Response Team Event Record showed the section of "vial signs taken within 4 hours PRIOR to Team call" was left blank.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 0830 hours, the DON confirmed the Rapid Response Team Event Record was not completed.

5. Review of Patient 47's medical record was initiated on 11/19/14. The patient was admitted to the hospital on 5/10/14.

a. Review of the Trauma Services History & Physical dated 5/10/14 at 0700 hours, showed the following:

* The section of the initial vital signs was left blank.

* The section of the problem list was left blank.

* The section for admission was left blank.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 0830 hours, the DON confirmed the above findings.


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6. On 11/19/14, Patient 6's closed medical record review showed the patient had two MRI procedures done on 10/31 and 11/3/14. Review of the medical record showed the following:

* On 10/31/14, nursing staff documented Patient 6 left the nursing unit for an MRI at 1405 hours. However, the radiologist report showed the procedure was conducted at 0600 hours, eight hours earlier.

* On 11/3/14, nursing staff documented Patient 6 left for the MRI procedure at 0624 hours. However, the radiologist report showed the MRI procedure was conducted at 0800 hours. In addition, the MRI screening questionnaire showed the MRI technician signed the form at 1030 hours, two and a half hours after the MRI was done.

On 11/20/14 at 0830 hours, an interview was initiated with the Director of Radiology. The Director stated the MRI technologist should review and sign the MRI Screening Questionnaire prior to the procedure to see if any follow-up should be done.

The medical record showing different times of the MRI procedures done on 10/31 and 11/3/14, was shown to the Director. The Director was unable to state how there were two different times for the MRI procedures conducted on 10/31 and 11/3/14. The Director stated he would investigate and respond later.

On 11/20/14 at 0856 hours, an interview and concurrent medical record review was conducted with RNs Y and M. When asked when the MRI was done for Patient 6 on 10/31 and 11/3/14, RN Y reviewed the medical record and confirmed there were two different times for the MRI procedures done on 10/31/14. RN Y stated a Ticket to Ride form (hand off communication form used when a patient was transported to other departments for procedures) would show the time nursing staff handed off the patient to the transporter to be transferred to the Radiology Department.

On 11/20/14 at 1135 hours, the Director of the Radiology Department verified Patient 6 left the nurses' station at 1350 hours and returned at 1442 hours, as documented on Ticket to Ride dated 10/31/14.

On 10/20/14 at 1350 hours, an interview was conducted with the Office Coordinator System Support Staff of the Radiology department. The Coordinator stated the Director of Radiology Department asked her to explain the different times of the MRI procedures done on 10/31 and 11/3/14, for Patient 6. The Coordinator stated on 10/31/14, Patient 6 went to an outside provider in an adjacent medical office building, Suite 13, for the MRI. The MRI technician could not access the hospital's medical record system, so the EMR system used the time of order as the time of the procedure, at 0600 hours.

When asked about the accurate time of both procedures on 10/31 and 11/3/14, the Coordinator reviewed the medical record and stated the MRI procedures were done about 1400 hours on 10/31/14, and at 1036 hours on 11/3/14. Regarding the MRI procedure conducted on 11/3/14, she could not answer how the radiologist's report showed the time of the MRI procedure was at 0800 hours, while it was actually done at 1036 hours.

Based on interview and record review, the hospital failed to ensure an entry in the medical record for one of 58 sampled patients was completed with date, time, and signature.

Findings:

Review of Patient 47's medical record was initiated on 11/19/14. The patient was admitted to the hospital on 5/10/14.

Review of the Trauma Services History & Physical dated 5/10/14 at 0700 hours, showed the Final Diagnosis section was not dated, timed, and the physician's signature was left blank.

During an interview and concurrent medical record review with DON 1 on 11/20/14 at 0830 hours, the DON confirmed the above finding.

Based on record review and interview, the hospital failed to ensure the accuracy of the medical records for five of 58 sampled patients (Patients 1, 14, 21, 29, and 55) when telephone physician's orders did not contain the date and time written and were not authenticated timely. This failure had a potential for miscommunication among staff and compromising patient safety and quality of care.

Findings:

The hospital's P&P Physician/Practitioners Orders review dated 5/13, showed "...All orders must be authenticated, dated and time by the prescribing practitioner within 48 hours ..."

1. On 11/17/14 at 1435 hours, Patient 21's medical record was reviewed with RD 4 and the DNS.

In the paper medical record, in the physician orders on 11/11/14, was a bright green sticker labeled as "Nutrition Services Department. The RD: [name of RD 4] recommends: ...2) Add Novasource Renal 1 can BID..." The bottom of the green sticker had the following pre-printed information, "MD: Please check one box and sign to initiate order." Next to that sentence was a blank box next to "Institute recommendation(s), and another blank box next to "Not approved." The same sticker had a designated location for date, time, and physician signature, all of which were left blank.

Review of Patient 21's EMR indicated a nurse entered the order into the EMR as a telephone order. The EMR dated 11/11/14, indicated "Description; ...Nutritional Supplement Novasource Renal, Frequency; PRN, Start; 11/11/14, Stop; 11/17/14, Note; Lunch & Dinner -start dinner 11/11."

Both the DNS and RD 4 stated the RD's recommendation green sticker dated 11/11/14, recommending the Novasource Renal was not dated, timed, and signed by a physician as required since the physician ordered the Novasource via a telephone order.

On 11/18/14 at 1508 hours, the DNS stated she requested the hospital's IT staff to review the EMR telephone order to see if it was authenticated by a physician. The DNS stated the IT staff reported the order was not been authenticated by a physician. The DNS stated the hospital's P&P required the telephone order for the nutrition supplement of Novasource BID be authenticated by the physician within 48 hours.

On 11/20/14 at 1155 hours, a clinical nurse analyst from the IT Department confirmed the telephone order for Novasource renal BID ordered on 11/11/14, for Patient 21 was not authenticated by the prescribing practitioner.

2. On 11/19/14 at 1258 hours, Patient 55's medical record was reviewed with the DNS and RD 4.

Review of the physician's orders in the paper medical record showed an order dated 10/30/14, with a bright green sticker dated 10/30/14 at 1200 hours, labeled as "Nutrition Services Department. The RD [name of RD 4] recommends: ...2) Add Novasource Renal 1 can BID [twice a day]..." The bottom of the green sticker showed the following pre-printed information: "MD: Please check one box and sign to initiate order." Next to that sentence a check mark was placed in the box next to "Institute recommendation(s)." The sticker showed the name of the physician and "T.O. [name of physician]/name of nurse" was written.

The DNS and RD 4 stated the above telephone order was entered into Patient 55's medical record by a nurse on 10/30/14. The DNS and RD 4 confirmed the telephone entered into the EMR for the oral supplement was not authenticated by the ordering practitioner either in the EMR or in the paper medical record.

On 11/20/14 at 1155 hours, the telephone order for the nutrition supplement entered into the EMR on 10/30/14, was reviewed by a clinical nurse analyst from the IT Department. The IT nurse stated "the order has not been authenticated by the ordering practitioner."


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3. Review of the hospital's P&P titled Forms and preprinted Physician Orders dated 4/14, showed under Procedure L.: "Preprinted orders must indicate date, time and signature of the physician..."

On 11/18/14, at 1455 hours, the medical record for Patient 29 was reviewed in the presence of CNS 1. The review showed a signed pre-printed physician's order titled "Radiology/Special Procedures, Post procedure, Biopsy, Paracentesis, Thoracentesis" was not dated and timed.

During the concurrent interview, CNS 1 identified the signature on the preprinted order as the physician. CNS 1 and Charge RN 1 reviewed the orders and acknowledged the signed preprinted order form had no date and no time.


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4. Review of Patient 14's medical record was initiated on 11/17/14. The patient was admitted to the Observation Unit on 11/16/14.

Review of the Combined Home Medication and Inpatient Medication Reconciliation Order Form showed a physician's telephone order was obtained on 11/17/14. The form failed to show the time the physician's telephone order was obtained.

During an interview and concurrent medical record review with DON 1 and RN B on 11/18/14 at 0915 hours, they confirmed the finding. RN B stated the physician's telephone order should be dated and timed.



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5. The EMR of Patient 1 was reviewed on 11/17/14.

Review of the medication orders showed a physician's telephone order was entered in the medical record by RN I. However, there was no evidence the physician countersigned the order.

During the interview with RN I and RN L on 11/17/14 at 0940 hours, they stated they were not sure how to view in the EMR to show if the physician signed off on the telephone medication orders.

Based on observation, record review, and interview, the hospital failed to ensure staff stored medications at temperature ranges in accordance with the manufacturers' directions. The pharmacy freezer temperature range was set outside the manufacturers' recommendations and contrary to the hospital's P&P. This failure had the pontential to result in patients being exposed to medications at other than labeled strength.

Findings:

Review of the hospital's P&P titled Medication Area Inspection dated 7/11, showed "...Freezer temperatures are minus 5 F (minus 15 C) or lower unless otherwise recommended by the manufacturer of products stored..."

Review of the hospital's P&P titled Storage of Medications dated 7/11, showed "Pharmacy staff will inspect all medication areas, no less than every 30 days, ... Freezer temperatures for medications must be maintained between 5 F (minus 15 C) or lower unless otherwise required by the manufacturer of the product ..."

On 11/19/14 at 1505 hours, the main pharmacy freezer was inspected in the presence of the DOP. The thermometer outside the freezer door was observed as 5 degrees F. The DOP stated "the freezer is on the hospital electronic monitoring system (TempSys) and it will alarm when the temperature is outside the set range."

The contents of the freezer were IV antibiotics: 153 bags of vancomycin 750 mg/150 ml, 144 bags of vancomycin 1 gm/200 ml, 612 bags of cefazolin 1 gm/50 ml, and 432 bags of Zosyn 3.375 gm/50 ml.

The manufacturers' directions to store these frozen antibiotics at or below minus 4 degrees F or minus 20 degrees C was written on each of the antibiotic packages.

Review of the hospital's electronic monitoring system temperature log showed the main pharmacy freezer temperatures ranged from minus 4.72 degrees F on 11/17/14 at 1538 hours, to 4.70 degrees F on 11/19/14 at 1208 hours. The pharmacy freezer temperature log also showed a range from 5.90 degrees F on 11/19/14 at 1223 hours, to 6.50 degrees F on 11/19/14 at 1508 hours.

During the concurrent interview, the DOP stated the pharmacy did not receive any notice the freezer was out of range; the pager did not alarm and the DOP did not receive an email that the freezer temperature was out of range. The DOP was not aware the pharmacy freezer temperature range was set from minus 58 degrees F to 5 degrees F.

During an interview on 11/19/14 at 1525 hours, the Biomed Department Manager stated the alarm system for the freezer was set to go off only if the freezer temperature was greater than 5 F. Emails would automatically be sent to pharmacy contacts and pharmacy staff would be notified by a dedicated pharmacy pager.

The Manager stated documentation showed the emails were sent; however, he was unable to determine the reason why pharmacy staff did not receive a page and the pharmacy contacts did not receive any email when the hospital electronic monitoring system temperature log showed the freezer temperature had been greater than 5 F since 1223 hours on 11/19/14.

Based on document review and interview, the hospital failed to ensure all controlled substance discrepancies were readily identified and promptly reconciled. The current hospital system did not identify controlled substance losses in a timely manner to minimize the time frame between actual loss to detection and investigation. In addition, the hospital failed implement their P&P to maintain an accurate record on a current basis for each controlled substance loss. These failures had the potential to result in loss or diversion of controlled substances.

Findings:

Review of the hospital's P&P titled Controlled Substances: Pharmacy dated 7/11, showed "...WMCSA (the hospital) will maintain complete and accurate records on a current basis for each controlled substance purchased, received, stored, distributed, dispensed or otherwise disposed of ..."

Review of the hospital's P&P titled Controlled substances: Pyxis Medstations dated 8/11, showed under Discrepancies - Resolution or Consequences: 1. The staff resolves discrepancies occurring in the Pyxis Medstations (automated drug dispensing cabinet) before the end of the shift from the time the discrepancy is discovered or within 72 hours if it cannot be resolved. This includes both nursing and pharmacy.

On 11/19/14 at 1345 hours, the controlled substance discrepancies record was reviewed in the presence of the DOP. Four unresolved discrepancies were noted in the last six months as follows:

* One tablet of acetaminophen/hydrocodone 325 mg/5 mg (drug used for severe pain) was documented missing in pyxis medstation on 5/24/14. Pharmacy identified this discrepancy on 5/27/14 (three days later), and initiated an investigation. The day the discrepancy was declared unresolvable was not documented.

* One tablet of alprazolam 0.25 mg (drug used to treat anxiety and panic disorder) was documented missing in pyxis medstation on 8/7/14. Pharmacy identified this discrepancy and initiated an investigation on 8/12/14 (five days later). The discrepancy was declared on unresolvable on 8/27/14.

* Three tablets of hydromorphone 4 mg (drug used to treat severe pain) were documented missing in pyxis medstation on 8/17/14. It was declared unresolvable on 8/22/14 (five days later).

* One syringe of morphine 4 mg/1 ml injection (drug used to treat severe pain) was documented missing in pyxis medstation on 10/24/14. This discrepancy was identified by Pharmacy on 11/06/14 (14 days later), and declared unresolvable.

During the concurrent interview, the DOP explained the investigations were done but was unable to provide adequate documentation to support the investigations were comprehensive.

During the interview on 11/20/14 at 1330 hours, the DON acknowledged the discrepancies. The DON stated they were investigated but did not provide adequate documentation to support the investigations.

Based on observation, document review, and interview, the hospital failed to ensure reagents were not stored with medications. This had the potential for cross contamination.

Findings:

Review of the hospital's P&P titled Storage of Medications dated 7/11, showed "...Pharmacy staff will inspect all medication storage areas, no less than every 30 days... Medications to be stored in refrigerators and freezers shall be stored in refrigerators and freezers designated solely for medications. Storage of food, chemicals, reagents, and patient specimens shall be prohibited from being stored in this storage area ..."

On 11/17/15 at 1355 hours, the ICU medication refrigerator was inspected in the presence of the DOP and ICU Interim Manager. Two vials of urine dipstick control solutions were found stored next to the IV medications in the ICU medication refrigerator.

During the concurrent interview, the DOP and ICU Interim Manager acknowledged the two vials of urine dipstick control solutions should not be stored with the IV medications in the medication refrigerator.

Based on observation, document review, and interview, the hospital failed to ensure outdated medications and biologicals were not available for patient's use. This had the potential for medication misuse.

Findings:

Review of the hospital's P&P titled Storage of Medications dated 7/11, showed "...Pharmacy staff will inspect all medication storage areas, no less than every 30 days... Medications to be stored in refrigerators and freezers shall be stored in refrigerators and freezers designated solely for medications. Storage of food, chemicals, reagents, and patient specimens shall be prohibited from being stored in this storage area ...The hospital shall remove all expired, damaged and/or contaminated medications and store them separately from medications available for administration ..."

Review of the hospital's P&P titled Medication Area Inspection dated 7/11, showed "..Outdated and deteriorated medications are returned immediately to the Pharmacy for proper disposal..."

1. On 11/17/14 at 0920 hours, the main pharmacy was inspected in the presence of the DOP and Clinical Manager. During the inspection of unit dose medications, two tablets of escitalopram 5 mg (drug used to treat depression and generalized anxiety disorder) which had expired in 8/14, were found.

The DOP acknowledged the expired tablets.

2. On 11/19/14 at 1415 hours, the OR medication storage area was inspected in the presence of the DOP, OR Director, and OR Staff Educator. A packet of lidocaine hydrochloride (anesthetic) topical solution 4% which had expired in 5/14, was found in the OR medication room.

The DOP, OR Director, and OR staff Educator acknowledged the expired medication. The DOP stated pharmacy staff inspected the medication room two weeks prior and did not find any expired medication.



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3. Review of the hospital's P&P titled Crash Cart revised 12/11, showed staff should check all drawers are locked with a blue lock and have a current expiration date. If not, staff should request a cart exchange.

On 11/17/14 at 1007 hours, inspection of the neonatal crash cart in LDR unit was initiated with the Unit Manager, RN L. RN L stated nurses on the unit would check the crash cart once per day.

The log showed the crash cart was last checked on 11/16/14 at 2100 hours. When asked how staff checked the crash cart, RN L stated staff checked the outside posted labels to ensure none of the medications or supplies had expired. The posted labels were made by pharmacy and central supply staff.

Review of the labels from the Central Supply Department showed sterile saline wipes (used for cleansing with a sterile saline solution) had expired in 10/14.

Based on document review and interview, the hospital failed to ensure:
* A P&P was developed to specify procedures for handling controlled substances discrepancies.

* Accurate records of the investigations of the unresolvable controlled substance losses/discrepancies were maintained.

* Controlled substance losses were reported to the appropriate authority in accordance with the State law.

These failures had the potential for the implementation of an effective system or process handling controlled substances discrepancies to be minimized and resulting in controlled substance losses.

Findings:

Review of the hospital's P&P titled Controlled Substances: Pharmacy dated 7/11, showed "...WMCSA (the hospital) will maintain complete and accurate records on a current basis for each controlled substance purchased, received, stored, distributed, dispensed or otherwise disposed of..."

On 11/19/14 at 1345 hours, the controlled substance discrepancies record was reviewed in the presence of the DOP. The following four unresolved discrepancies were noted in the last six months:

* One tablet of acetaminophen/hydrocodone 325 mg/5 mg (a schedule II controlled drug with a high potential for abuse) was documented missing from the automated medication dispensing system on 5/24/14.

* One tablet of alprazolam 0.25 mg (a controlled drug with a potential for abuse) was documented missing from the automated medication dispensing system on 8/7/14.

* Three tablets of hydromorphone 4 mg (a schedule II controlled drug with a high potential for abuse) was documented missing from the automated medication dispensing system on 8/17/14.

* One syringe of morphine 4 mg/1 ml injection (a schedule II controlled drug with a high potential for abuse) was documented from the automated medication dispensing system on 10/24/14.

Two of the above discrepancies had no documentation of an investigation done while the others had incomplete investigations and documentation.

During the concurrent interview, the DOP explained the investigation done but acknowledged the hospital's current P&P did not specify the procedures for handling controlled substances discrepancies.

During an interview on 11/20/14 at 1330 hours, the DON stated extensive investigation was initiated on one of the discrepancies; however, she was unable to provide adequate documentation for the investigation.

During an interview on 11/20/14 at 1430 hours, the DOP stated the above controlled substances losses were not reported to the State Board of Pharmacy.

The State law requires "Reporting drug loss: The owner (in this case the hospital) shall report to the Board within thirty (30) days of discovery of any loss of the controlled substances, including their amounts and strengths."

Based on observation, interview and record review, the hospital failed to ensure radiological services for MRI and CT were provided to patients in a safe setting when the hospital entered into a business agreement with an outside provider in an adjacent medical office building, Suite 13 to provide MRI and CT services to hospital patients when those services were not available in house either due to breakdown of the machines or availably as evidenced by:

* The hospital failed to ensure the P&P developed as instructions to CT Technologists and Radiologists and the P&P for the Code Blue Team Response to emergencies in Suite 13 were signed off by the Department Director and Medical Director of Radiology and were reviewed and approved by the GB prior to the initiating the process.

* No P&P was provided to show criteria was developed to guide staff in determining the appropriateness of the patients deemed safe for transport to Suite 13 for testing.

* The hospital failed to ensure a P&P was developed to address the MRI process in Suite 13.

* The hospital failed to ensure Suite 13 was maintained for fire safety.

These failures had the potential for substandard health outcomes to the patients in the hospital.

Findings:

1. During a tour of the hospital's onsite CT suite on 11/18/14, the CT Supervisor was interviewed about the provision of backup services when the primary CT scanner was busy or not working. The Supervisor stated there was a second CT scanner used in Suite 13 in the medical office building adjacent to the hospital.

On 11/19/14 at 0845 hours, the Director of Radiology stated the hospital no longer had a Mobile CT unit as backup to the in house CT scanner. The Director stated the mobile unit was only used a few times a month. At the end of October 2014, the hospital began using Suite 13 in the medical office building adjacent to the hospital, owned by a radiologist on staff at the hospital. The Director stated the hospital did not lease the space but reimbursed per scan. The Director stated only CT scans were provided in Suite 13.

Review of the maintenance reports for the primary CT scanner showed service was performed on the CT scanner due to functional problems on 7/21, 7/28, 8/25, 10/1, 10/15, 10/21, and 11/6/14. The service records indicated a total of 14.5 hours of service time spent repairing the CT scanner from 7/21 through 11/6/14.


A tour of Suite 13 in the adjacent medical office building was conducted on 11/19/14 at 0900 hours, accompanied by the Director of Radiology, Director of Facilities, and Nursing Director of Trauma. The route to Suite 13 CT building showed two elevators were available for use. The elevator identified by staff for use for a patient on a guerney appeared to be too small to accommodate a patient gurney and medical personnel with equipment and supplies. The elevator measured 77 square inches and required the guerney to enter and then turn to the side. The planned entry door on the lower level did not have a badge access feature to allow entry after the building was locked.

The medical building was attached to the main hospital building by a concrete overhang. It was approximately 90 paces from the hospital exit to Suite 13. Patients entered the Suite through the main waiting room. The services offered in the radiology suite were listed on the sign as CT, MRI, x-ray, mammogram, and ultrasound.

Observation of the CT scanner room showed an Adult and a Pediatric Crash cart present for emergencies. The Director of Trauma stated the crash carts were previously in the Mobile CT unit, maintained, and checked daily by hospital staff. The Director stated the hospital's Code Blue Team would respond to any emergency. Drills showed the response time of the team was three to five minutes.

The Director of Radiology stated the hospital's CT Techs operated the equipment as the scanner was the same as the scanner in the hospital. When asked how the rooms were cleaned between patients, the Director stated the CT Techs wiped down the equipment and tables; the hospital's EVS personnel would clean the room only if there were an instance of body fluid spill; otherwise, the building maintenance cleaned daily.

When asked how the safety of the building and the safety of the CT equipment were ensured, the Director stated the owner of the CT equipment was in charge of the maintenance of equipment. The Director stated he viewed the physicist's report for safety, but he did not have a copy. The Director stated the Patient Safety Officer would conduct EOC rounds for Suite 13.

The contractor's CT Tech was interviewed during the tour regarding hospital patients who obtained CT scans in the Suite 13 imaging center. The Tech stated he was the only CT Tech in the imaging center. When asked if he recognized names of hospital patients in the CT scanner's database, the Tech stated there were three names that did not appear to be Suite 13 imaging center patients. The three names (Patients 3, 4, and 5) were copied from the list of names on the imaging center CT scanner monitor.

Additional observations of Suite 13 showed the following:

* The corridor door to the Ultra Sound Room was impeded from closing with a kick stop in use.

* The corridor door to the mammography room was impeded from closing with a rubber wedge under the door.

* The blue and white fire extinguisher was sitting on the floor unsecured. The date on the label was 8/13/13 (expired 8/13/14), with no monthly inspections.

* There were three fire extinguishers that were installed on 6/16/14, with no monthly inspections since the installation.

* There was a four plug extension cord in use in the CT Scan Room.

In a concurrent interview, the Safety Officer stated the four plug extension cord did not meet the UL waiver requirements.

During an interview during the tour, the Director of Facilities stated the owner of Suite 13 was responsible for the inspections and maintenance of their suite.

During the observation of Suite 13, documented evidence of the monthly 30 second test and annual 90 minute test of all of the exit signs in Suite 13, monthly testing of the fire alarm system, evidence of annual testing and maintenance of the fire alarm system, and annual certification of the fire alarm control panel in Suite 13 were not available.

On 11/19/14, during an interview at 0938 hours, the Director of Facilities stated there was no annual testing and certification of the fire alarm system. The Director stated the hospital was not responsible for Suite 13.

An interview was conducted with the CEO, CNO, COO, Director of Radiology, and Director of Facilities on 11/19/14 at 1030 hours. The survey team verbalized concerns with the safety of using Suite 13 as a backup CT scanner for the hospital.

Documentation was requested to show the maintenance and safety of the building and maintenance of the equipment. The P&Ps for the contracted service and the business contract was also requested for review.

The CEO stated the hospital would cease using the CT scanner in Suite 13 at this time.

On 11/19/14, the names of Patients 3, 4, and 5 were found in the hospital's EMR with documentation of CT scans performed on 11/1/14. The reports of the CT scans of Patients 3, 4, and 5 showed each received a CT scan of the abdomen and pelvis with and without IV contrast on 11/1/14 between 1329 and 1521 hours, after presenting in the ED of the hospital. The reports of the scans identified the location as the hospital; however, the images of the scans, reviewed in the hospital radiology suite on 11/20/14, showed the imaging center name, not the hospital's name.

2. The requested P&Ps were provided for review on 11/19/14.

a. The P&P titled CT Downtime Policy and Protocol showed a revision date of 11/14. The areas for signatures of approval by the Department Director and MD Director were blank.

The policy showed in the event the 16 Slice CT Scanner goes down, CT staff will utilize the CT scanner located in Suite 13 and send the images to the radiologist. The ED, House Supervisor, trauma surgeon on call, and Department Director will be immediately notified and thereafter the CT Downtime protocol should be followed.

The policy showed there are no limitations to scanning with the use of the scanner in Suite 13 and "all CT imaging can be performed during the downtime of the in-house scanner."

Further review of the policy did not show documentation the hospital's CT Techs would operate the CT Scanner.

b. The P&P titled Code Blue Team Response for use of the CT Scanner in Suite 13 was dated 10/14. The areas for signatures of approval by the Department Director and MD Director were blank.

The stated purpose of the P&P was to provide rapid appropriate treatment to any person requiring emergency care in in the CT Scan unit located in Suite 13.

The P&P showed after normal hours of operation the CT Tech would be accompanied by security personnel. The designated Code Blue Team would respond to all situations.

However, there were no P&Ps provided to show criteria was developed to guide staff in determining the appropriateness of patients deemed safe for transport to Suite 13 for testing.

During the tour of Suite 13 on 11/19/14 at 0900 hours, the Nursing Director of Trauma stated if the patient undergoing a CT required cardiac monitoring, an RN would accompany the Tech in transporting the patient from the hospital to Suite 13. When asked if a licensed nurse accompanied unmonitored patients, the Director stated no, just a CT Tech.

3. No P&P was provided to address the care of hospital patients undergoing MRI testing in Suite 13.

On 11/20/14, during a review of the MRI log for 10/31/14, the log contained data showing six MRIs for three patients (Patients 6, 7, and 8) who had an MRI with the location identified as "SNA-NWKS8 Radiology Front Desk." The other MRIs performed on that date had the location identified as "WMC MR GE Trailer."

During a review of the medical record of Patient 6 on 11/20/14, the record indicated there was a plan on 10/31/14, to have Patient 6's MRI performed in Suite 13.

Review of Patient 6's MRI screening questionnaire for an MRI scan done in Suite 13 on 10/31/14, showed the radiology staff of the outside provider failed to show documentation the hospital's P&P was implemented regarding follow-up with an identified contraindication listed on the screening questionnaire. Cross reference to A0535.

4. The business contract for the hospital's use of the CT scanner was provided for review on 11/19/14.

The "Services Agreement" showed the "Agreement was entered into as of the later of October 31, 2014 or the date this Agreement has been duly executed by both parties (the "effective date")."

Under the heading for "Hospitals Obligations", it showed the hospital would provide all equipment, facilities, supplies, utilities, and services, including laundry, linen and janitorial services," as the Hospital deemed necessary.

Exhibit A- Description of Duties and Responsibilities showed the following:

* The "hospital will have access to the Group's MRI and CT Suite..." and delineated the fees for each of the scans.

* Group will assign a liaison to participate with the Hospital's Life Safety Program; such duties include but are not limited to participation in EOC round no less than two times per year; reporting all safety issues at Suite 13 to the Hospital's Safety Officer; participation in all Hospital Safety Initiatives.

* Group is required to provide Fire Sprinkler testing and Egress Lighting Testing annually to the Hospital's Director of Facilities.

* Group is required to provide all Inspection and Testing documentation to the Hospital's Director of Facilities.

Review of the page 12, the signature page showed the CEO signed the contract on 11/19/14, the same day as the contract was requested for review by the surveyors. The signature of the owner of the suite was not dated.

The survey team met with the CEO, CNO, COO, and Director of Medical Staff on 11/20/14 at 1330 hours.

The CEO was informed there was no documentation in the GB Meeting minutes of the board's review/approval of the use of Suite 13 as the backup CT Scanner for the hospital. The CEO stated the GB had not reviewed for this as they were not meeting until the end of this month. The CEO stated the use of Suite 13 happened very quickly when their CT Mobile unit was removed unexpectedly on 10/31/04. The CEO stated she made an emergency decision. The CEO stated there was discussion with the Trauma surgeons, however, that Suite 13 not be used for unstable trauma patients.

The contract for Suite 13 was discussed. The CEO was asked why the contract was not signed until yesterday, 11/19/14, even though the patients were scanned beginning on 10/31/04. The CEO stated she had the contract but had not gotten around to signing it.

The CEO was asked why the surveyors were told only CT scans were done in Suite 13; the survey team found five patients had undergone MRI scans in Suite 13 since 10/31/14, and the contract included MRI scans. The CEO stated she did not realize the contract included MRI scans.

The CEO confirmed Suite 13's owner was unable to provide documentation of fire safety in the building; EOC rounds were not conducted by hospital staff prior to and during the use of Suite 13 for the hospital's patients.

The CEO was asked if criteria were developed to guide staff in determining the appropriateness of the patients deemed safe for transport to Suite 13 for testing. The CEO confirmed criteria for this was not developed.

When asked, the CEO stated the two P&Ps developed to address the use of Suite 13 were not reviewed and approved by the GB as the board had not met as yet.

When informed the elevator used to transport patients by gurney to Suite 13 was not large enough, the CEO stated that was the only elevator available.

Based on interview and document review, the hospital failed to ensure the radiology staff of a contracted outside provider implemented the hospital's P&P regarding follow-up with an identified contraindication listed on the MRI screening questionnaire for one of 58 sampled patients (Patient 6). This failure could pose the potential for injury during an MRI procedure.

Findings:

Review of the hospital's P&P titled MRI Services revised 8/12, showed the following:

- If the radiology staff had any question regarding an ordered examination during the screening process, they would contact the patient, nurse or ordering physician directly to clarify.

- If the MRI technologist had any question or concern, she/he would review the order with the radiologist for clarification and appropriate instructions prior to beginning the exam.

- The patient should be pre-screened for any MRI contraindications (i.e., pacemakers, aneurysm clips and contraindications to the use of MRI contrast agents).

On 11/19/14, Patient 6's closed medical record review showed the patient had two MRI procedures done on 10/31 and 11/3/14, while in the hospital.

The MRI Screening Questionnaire for the procedure date of 10/31/14, showed nursing staff checked "Yes" for the question if Patient 6 had shrapnel, bullets, or any other metal in the body and documented "surgery metal hook" on the patient's right wrist. There was no signature of the MRI technologist on the form.

On 11/20/14 at 0830 hours, an interview was initiated with the Director of Radiology. The Director confirmed the MRI procedure was conducted on 10/31/14, for Patient 6 at an outside provider in an adjacent medical office building, Suite 13. For the question of when the MRI technologist should sign the MRI screening questionnaire, the Director stated the MRI technologist should review and sign the form prior to the procedure to see if any follow-up should be done.

Patient 6's above questionnaire was shown to the Director. The Director stated in this case, per the hospital's P&P, the MRI technologist should inform the radiologist for follow-up. The Director explained sometimes, the physician ordered an additional radiology procedure to check the type and size of the metal part to determine if it was safe for the patient to have the MRI procedure.

The Director was asked to provide documented evidence to show the MRI technologist's follow-up of the identified surgical metal hook in Patient 6's right wrist prior to the procedure. The Director stated he would review the document and respond later.

On 11/20/14 at 0856 hours, an interview and concurrent medical record review was conducted with RNs Y and M. When asked what nursing responsibility was when Patient 6 was identified with a surgical metal hook in the body prior to the MRI, RN Y stated the nurse would fax the screening form to the Radiology Department who would follow up. When asked, the RN could not locate any documentation of follow-up of the surgical metal hook for Patient 6 prior to the MRI procedure conducted on 10/31/14.

On 11/20/14 at 1310 hours, another interview was conducted with the Director of Radiology. The Director stated the outside provider, Suite 13's MRI technologist stated he called the nurse who stated the surgery was done in the past couple of years; the implanted metal part would be titanium and there would be no risk from titanium.

The Director was asked for documented evidence to support the MRI technologist's above verbal statement. There was no documented evidence provided.

Based on observation, interview, and record review, the hospital failed to ensure nursing and laboratory staff in the ED followed the hospital's P&P for providing results of STAT laboratory tests (high priority laboratory tests are needed immediately in order to manage medical emergencies) within 30 minutes for one of 58 sampled patients (Patient 17). This had the potential for a delay in detecting and treating the medical problems for this patient.

Findings:

On 11/20/14, medical record review for Patient 17 was initiated. Patient 17 presented to the hospital's ED on 11/17/14, with a chief of complaint of altered level of consciousness.

Review of a physician's order dated 11/17/14 at 0843 hours, showed an order to obtain STAT labs for Magnesium and Troponin (test used to help diagnose of heart attack), CKMG with index (cardiac marker), CPK total (cardiac marker), CMP, and CBC for Patient 17.

Review of the laboratory Detail dated 11/17/14, showed Patient 17's blood was collected on 11/17/14 at 1020 hours.

The final results of the lab tests were not available to the physician until 11/17/14 at 1036 hours, approximately two hours after the physician ordered STAT orders. Review of the laboratory results showed the final results as follows:

* The RBC count was low at 3.46 M/uL ( normal count is 3.63 - 5.22 M/uL).
* The hemoglobin level was low at 7.7 ( normal range is 11.2-15.7 g/dL).
* The hematocrit level was low at 24.0 ( normal range is 34.1-44.9 %).
* The platelet count was high at 467 (normal range is 182-369 K/uL).
* The sodium count was low at 131 (normal range is 136-145 mmok/L).
* The BUN level was high at 27 (normal range is 7-18 mg/dL).
* The creatinine level was high at 1.2 (normal range is 0.6-1.0 mg/dL).
* The total protein level was high at 8.3 (normal range is 6.4-8.2 g/dL).
* The critical value for CKMB was 10.9 (normal range is 0-3.5 ng/mL).

RN S was interviewed on 11/17/14 at 1100 hours. After reviewing Patient 17's lab results on the computer, she stated the lab results were reported after the 30 minutes turnaround time. RN S stated the lab was paged three times to draw the patient's blood.

During an interview with the RN Director of Trauma on 11/17/14 at 0830 hours, she stated the hospital's P&P for STAT labs showed the expected time was 30 minutes.

During an interview with Phlebotomist 1 on 11/17/14 at 1020 hours, he stated he was not notified by laboratory personnel to draw Patient 17's STAT labs. Phlebotomist 1 stated if he received a STAT lab order he needed to draw the blood in less than 30 minutes.

Based on interview and record review, the hospital failed ensure the protocol for potentially tainted blood was fully implemented for one of 58 sampled patients (Patient 9) when there was inadequate documentation to confirm the physician read the notification or contacted the patient, resulting in the increased risk of a poor health outcome for this patient.

Findings:

The hospital's Blood Bank Lookback Protocol revised 8/17/04, was reviewed on 11/18/14. The stated purpose of the policy showed the actions to be taken when a blood supplier notified the hospital of a problem or recall. Documentation showed upon notification in writing from the blood supplier of a potentially tainted blood product, if the unit was transfused, the patient's physician should be notified as soon as possible that the patient was transfused with a unit of blood from a donor who subsequently seroconverted (the development of antibodies to a particular antigen [infectious organism]).

The protocol showed if the physician can not be reached or refuses to contact the recipient, three attempts must be made by the transfusion service to contact the recipient. The policy read, "The transfusion service is ultimately responsible for notifying the recipient including basic explanation to the recipient and referral for counseling, and shall document the notification or attempts to notify the attending physician or the recipient."

Review of the laboratory records showed on 3/21/12, the hospital received notification potentially tainted blood was provided to Patient 9. In response, a certified letter was sent to Patient 9's physician's address of record. However, there was no documentation to show if the physician actually read the letter, if he was willing or able to contact the patient, and there was no documentation to show patient contact was attempted or occurred.

During an interview with the Blood Bank Supervisor on 11/18/14 at 0910 hours, the Supervisor stated contacted the physician by phone to ensure the notification was received; however, she did not document the contact. The Supervisor concurred there was no documentation in the file to show the patient was actually contacted regarding the potentially tainted blood.

Based on observation, interview, and record review the hospital failed to ensure:

1. The Director of Food and Dietetic Services was available full-time to the dietary department at the hospital.

2. Raw poultry was stored properly.

3. A dating system for thawing meat was developed to ensure the meat was cooked in a timely manner for food safety.

4. A consistent system for dating and labeling of food, and for removing expired food.

5. To maintain the planned par level of the hospital's food supply to be used in the event of a disaster.

Failure to ensure safe food handling and sanitation practices had the potential to place the highly susceptible patients at risk for developing a foodborne illness.

In addition, the hospital failed to ensure the emergency food supply was maintained to meet the nutritional needs of patients in the event of a disaster.

"Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1)Immunocompromised; preschool age children, or older adults; and (2) Obtaining FOOD at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center. FDA Food Code 2013.

Findings:

1. On 11/17/14 at 0922 hours, the DNS stated she worked at the hospital "a little over 50% of the time since this one is bigger." The DNS stated she was the Director of Nutrition Services at a "sister" hospital as well.

On 11/17/14 at 1030 hours, the COO confirmed the DNS was the person to whom the hospital's GB delegated the responsibility and authority as responsible for the daily management of dietary services. The COO acknowledged the DNS was not full-time to the hospital in that capacity.

According to the job description of the DNS, the DNS reported to the COO. Documentation showed the "position directs the Nutritional Services department and all related food service activities within the medical center..., Qualifications:...11. Must have a working knowledge of every aspect of foodservice operations including: ...Regulatory requirements including...CDPH [California Department of Public Health], CMS [Centers for Medicaid/Medical Services]..." The DNS job description was signed by the DNS on 8/24/14.

2. The hospital's P&P titled Food Preparation, Production And Service 800-825 reviewed 2/11, indicated, "Purpose: To define the department standards for safe food preparation and production ..., Procedure; 1. Frozen foods are thawed correctly: ...Frozen products to be thawed are placed in drip pans of sufficient size and depth on the lower shelves of the refrigerator to prevent cross-contamination..., 3...Raw foods in marinade are stored below ready-to-eat foods.

On 11/17/14 at 1010 hours, a joint observation with the DNS was conducted. Inside the kitchen a reach-in refrigerator stored a pan of raw poultry on a shelf directly over a shelf that stored a pan of ready to eat jello. At that time, FW 1 observed the pan of raw chicken and stated, "I am going to cook the chicken today for a chicken salad." FW 1 was asked if the raw chicken should be stored over jello, and she stated, "No."

3. The hospital's P&P titled Food Preparation, Production And Service 800-825 reviewed 2/11," indicated, "Purpose: To define the department standards for safe food preparation and production ..., Procedure; 1. Frozen foods are thawed correctly:...Thawed foods are prepped and cooked in timely manner ..."

On 11/17/14 at 0935 hours, a joint observation with the DNS was conducted. Inside the kitchen a walk-in refrigerator stored a large box of meat on the lower shelf. Cook 2 stated the large box of meat was tri-tip. Cook 2 stated it was the hospital's policy for meat to be in the thawed state for five days.

Cook 2 was asked if the product was dated to show when the thawing process began. Cook 2 stated "This just came in from the vendor on Saturday and it was put in the refrigerator because our normal stocker was not here. We were short staffed." Cook 2 stated the meat should have been dated with a label indicating when the thawing process began; indicating a "use by" date.

During the same observation, another large pan of meat was noted thawing inside a walk-in refrigerator. Cook 2 stated, "That is angus beef." Cook 2 stated the pan of thawing angus beef was not dated once the thawing process began as it should have been.

Cook 2 stated, "The angus beef was taken out of the freezer last Thursday and put in the refrigerator to thaw. We have four to five days to thaw." The DNS confirmed dietary staff should place a label indicating the date the thawing process began in order to ensure the thawed raw meat was cooked in accordance with safe food handling practices.

4. The hospital's P&P titled Labeling And Dating 800-817, reviewed 2/11, indicated, "Purpose; To assure freshness and safety of food served to patients, staff and visitors, Policy; Foods will be labeled and dated for freshness and food safety. Procedure; 1. Nutrition Services staff use "first in, first out" (FIFO) to rotate refrigerated, frozen and dry foods in order that the oldest inventory is used first. 2. Foods that are past the manufacturers "use-by" or expiration date are discarded..., 4. Opened packages of food are stored tightly covered, labeled with name of product (if product name is not easily visible), date product was opened, and date of shelf life expiration. (Refer to Attachment A.)" Attachment A showed "Shelf Life of Food Products" that contained limited shelf life guidance for dietary staff.

a. On 11/17/14 at 0927 hours, the dry food storage room of the kitchen was toured. The following was observed:

* A large clear bin of uncooked pasta was labeled on the bin "10/3/14, Use by 10/17/14." During interview, Cook 2 stated, "That shouldn't be here." Cook 2 was asked the hospital's expectation for the shelf life of the opened, uncooked pasta. Cook 2 stated, "6 months." Cook 2 stated the label on the bin was likely for something else and was not changed to reflect the stored contents.

* A second large bin of stored uncooked pasta was not labeled with a date. Cook 2 stated the bin of pasta should have been labeled with a "Use by" date.

* A bin of multiple unopened bags of uncooked pasta were not dated with a use by date.

* A large bin of dry, uncooked lentils was observed. Cook 2 read the label that indicated "Date 10/14/14, Use by 11/14/14." Cook 2 stated generally dry foods were good for six months, such as the lentils; however, when asked the cook was not able to explain why the product was dated to be used within one month.

* Two large unopened cans of pineapple were observed with a hand written date of "12" indicating year of 2012. FW 3 stated, "I write the date on the cans when we receive them. That date should be 2014, not 2012."

b. On 11/17/14 at 0945 hours, the walk-in freezer was observed. Meat wrapped in a plastic wrap was noted as labeled "Use by 10/12/14." Cook 2 stated, "This is meatloaf, and that is an expired date. This should have been thrown out."

On 11/17/14 at 1030 hours, during an interview, the DNS acknowledged the Dietary Department's labeling and dating system was not clear and consistently implemented by dietary staff and the shelf-life of foods policy was not clear to dietary staff.

5. The hospital's P&P titled Emergency Management Plan 700-701, reviewed 4/02, indicated, "Purpose: To explain the process by which Nutrition Services will provide for the nutritional needs of patients, hospital staff and visitors in the event of an internal or external emergency."

On 11/17/14 at 1306 hours, the DNS stated the hospital's "Emergency Management Plan" consisted of maintaining emergency food supplies for four days.

According to the hospital's Emergency Management Plan, "In the event of loss of electricity, gas or water supply, the Department Director has established a four-day disaster menu based on foods which require minimal or no preparation and may be served at room temperature. The department food supplies and emergency stock is inventoried biannually in February and August. Inventory reports are submitted to the Director of Materials Management and copies are kept on file in the department. "

The Emergency Management Plan included a "Disaster Food Supply Stock Level" inventory list. In a concurrent observation of the disaster food supply that was stored in the dry food storage room in the kitchen, the DNS stated, "We are short on the par levels of disaster food supply. We have been using the disaster food supply in our daily operations for about one week."

The DNS acknowledged the disaster food supply should have been maintained at the planned par levels at all times. The DNS stated, "A new person was assigned to do the ordering, and it is a one- time occurrence that we are short on our disaster food due to training issues. "

In a concurrent observation of the disaster food supply, the DNS stated the following food items were not maintained at par level as planned in accordance with the 4-Day Disaster Menu and the Disaster Food Supply Stock Level:

* Par level of 30 cases of assorted Juice, 4 ounces- the hospital had 10 cases of the juice.
* Par level of 17 cases of assorted dry cereal - the hospital had eight cases of the cereal.
* Par level of four bags of dry milk - the hospital had three bags of dry milk.
* Par level of 60 # 10 sized cans of chili con carne - The hospital had zero cans of chili con carne.
* Par level of 14 #10 cans of three bean salad - The hospital had zero cans of three bean salad.
* Par level of 14 #10 cans of kidney beans - The hospital had zero cans of kidney beans.
* Par level of six cases of canned tuna - The hospital had three cases of canned tuna
* Par level of one box of low sodium crackers (planned for the cardiac [heart] and renal [kidney] diets) - The hospital lacked the box of low sodium crackers.
* Par level of five boxes of graham crackers - The hospital had one box of graham crackers.
* Par level of six boxes of peanut butter - The hospital had zero boxes of peanut butter.
* Par level of four boxes of Jelly - The hospital had two boxes of jelly.

Based on interview and record review, the hospital failed to ensure the nutritional supplements for two of 58 sampled patients (Patients 40 and 55) were documented as given to the patients as ordered by the practitioner responsible for the care of the patient and the orders were clearly understood by the hospital staff.

In addition, the hospital failed to ensure that the nutrition care plans were detailed to reflect specific nutrition interventions planned for Patients 40 and 55 to address identified nutrition concerns in accordance with hospital P&P when ordered oral nutrition supplements entered via the EMR were not clearly understood by health care team members; implementation of a physician's order for a specific oral nutrition supplement and the percentage of consumption of the specific ordered nutrition supplement was not documented; monitoring for the effectiveness of interventions, dietary intake and nutritional status was not documented; and individualized, specific nutrition interventions were not documented on the nutrition care plan.

Lack of documentation of ordered nutritional supplements and lack of specific individualized nutrition care plans created a barrier to the multidisciplinary healthcare team responsible for monitoring the dietary intake and nutritional status of patients.

Findings:

Review of the hospital's P&P titled Interdisciplinary Nutrition Care Plan (File Under: 2200-2205) reviewed 10/10, indicated, "Purpose; To explain how Registered Dietitians communicate and coordinate the patients' nutrition care plan with the interdisciplinary team. Policy; Following nutritional assessment of the patient at nutrition risk, Clinical Dietitians document identified nutrition problems, desired outcome and intervention in the patient's electronic health record ..."

Review of the hospital's P&P titled Interdisciplinary Plan of Care (File Under: Doc-19) reviewed 8/11, indicated, "Purpose; To list priority patient problems, and identify interventions which direct and communicate the plan of care to the interdisciplinary team. To evaluate progression towards expected outcomes, in collaboration with the patient and family..., Policy; F. The Interdisciplinary Plan of Care will be individualized, providing the patient with care, treatment, and services according to his/her individualized plan of care..., 3. To discontinue an intervention: Enter the date (month/day) and initials in the "DC" column, or adjacent to the intervention indicating which intervention is discontinued..."

1. On 11/19/14 at 1244 hours, Patient 40's medical record was reviewed with the DNS and RN 7. Patient 40 was admitted to the hospital on 10/29/14.

a. According to the physician's order notes in the paper medical record, RD 8 provided recommendations to the physician that included Boost Plus, 1 carton at breakfast daily.

The DNS verified a telephone order from the physician was placed in the EMR to implement the recommendation for the nutrition supplement Boost Plus on 11/5/2014.

RN 7 was asked how the nurses documented the order for Boost Plus was implemented for Patient 40. After review of the physician's order for Boost Plus in Patient 40's EMR, RN 7 stated, "The order for Boost Plus is prn [as needed]. So it is when she [the patient] wanted it. We would document that in the nurses' notes."

According to the DNS, the Boost Plus supplement order was for daily at breakfast. This was authenticated by a physician's signature in the paper medical record. However, the order for Boost Plus entered into the EMR indicated, "Nutritional Supplement Boost Plus PRN and under "Detail Note" it indicated "1 carton at breakfast."

The order for Boost Plus as entered into the EMR was understood by the nurse as a PRN order, not a daily order.

b. Review of Patient 40's nutrition care plan showed RD 8 initiated the nutrition care plan on the same day RD 8 provided recommendations that included the Boost Plus 1 carton at breakfast. The nutrition care plan dated 11/5/14, was developed to address "Suboptimal oral nutrient intake r/t [regards to] poor appetite/nausea." However, the nutrition care plan failed to list specific individualized nutrition interventions to address an identified nutrition concern, such as the Boost Plus 1 carton daily at breakfast.

In addition, on 11/5/14, RD 8 recommended snacks be given to Patient 40 at 1400 and 2000 hours, as well as yogurt at breakfast. These recommendations were not detailed in Patient 40's nutrition care plan.

2. On 11/19/14 at 1258 hours, Patient 55's medical record was reviewed with the DNS and RD 4.

a. Review of the physician's orders in the paper medical record showed an order dated 10/30/14, with a bright green sticker dated 10/30/14 at 1200 hours, labeled as "Nutrition Services Department. The RD [name of RD 4] recommends:...2) Add Novasource Renal 1 can BID [twice a day]..." The bottom of the green sticker showed the following pre-printed information: "MD: Please check one box and sign to initiate order." Next to that sentence a check mark was placed in the box next to "Institute recommendation(s)." The sticker showed the name of the physician and "T.O. [name of physician]/name of nurse" was written.

The DNS and RD 4 stated the above telephone order from the physician was entered into Patient 55's EMR by a nurse on 10/30/14.

During Patient 55's medical record review RN 9 was asked how the nursing staff documented the implementation of the physician's order for the oral nutrition supplement Novasource Renal, 1 can BID for Patient 55. RN 9 stated the order was "PRN, so if they want it." RN 9 stated if the patient drank the Novasource Renal she would document consumption on the "Intake/Output Inquiry" in the EMR under the Intake section indicating "Oral."

RN 9 reviewed Patient 55's Intake/Output Inquiry dated 11/19/14. For breakfast there was no specific documentation to show Novasource Renal was implemented at breakfast. T he section under "Oral" was blank. Documentation showed "breakfast %" with a note of "75." RN 9 confirmed nursing staff would not document the specific oral supplement ordered and would include the supplement under "oral." RN 9 explained oral intake could be any liquid provided on the breakfast tray.

At this time, three other nursing staff members present, RN 6, RN 10, and RN 11, verified they also would document an ordered oral nutrition supplement in the same manner; they would not specify the name of the oral nutrition supplement or the specific percentage of the ordered nutrition supplement the patient consumed.

On 11/19/14 at 1315 hours, RD 4, who recommended the Novasource Renal 1 can BID for Patient 55 on 10/30/14, was asked during an interview why the order appeared as "PRN" in the EMR as understood by RN 9. RD 4 reviewed the EMR order for Novasource Renal BID and noted it was entered into the EMR a couple of different times and in different ways.

RD 4 stated when the order was entered into the EMR there was an automatic pop-up with three options that consisted of PRN, meal, or once. Since the order was BID, it was hospital staff's practice to select PRN but to then utilize the "Detail Note" section to clarify breakfast and dinner.

At this time RD 4, the DNS, RN 6, RN 9, RN 10, and RN 11 all acknowledged the physician's order for the oral nutrition supplement for Patient 55 was unclear and there was not a clear system in place to document the physician's order for the oral nutrition supplement was implemented for Patient 55.

b. Review of Patient's 55 current nutrition care plan titled "Suboptimal oral nutrient intake regards to poor appetite/nausea, reactivated 11/14/14," showed to maintain 75% or better intake of meals and tolerance of oral diet. Additional documentation dated 11/19/14, showed to encourage/supervise/assist with meals, provide a pleasant, relaxing environment during meal times, allow the patient to eat at their own pace, and monitor the percentage intake of meals.

DNS and RD 4 were asked to review Patient 55's nutrition care plan. The staff verified the care plan lacked detailed specific nutrition interventions that were provided to the patient. The staff acknowledged this could be a barrier to clearly communicating specific interventions to the interdisciplinary team that were, or should be, provided and monitored for effectiveness in regards to the identified problem(s).

Based on observation, interview, and record review, the hospital failed to ensure facility and equipment used for patient care were maintained to ensure the safety of patients and staff as evidenced by:

1. Failed to maintain their emergency lighting units. This was evidenced by the failure to perform monthly and annual test for the emergency lights in Suite 105, and by emergency lights that failed to illuminate in the offsite building Suite 105 and the Main Hospital. This could leave the rooms in darkness during a power outage. This affected one of seven floors in the Main Hospital and Ambulatory Surgery Suite 105. Cross reference to A0702, example #1.

2. Failed to maintain their exit signs in the offsite building Suites 105 and 13. This was evidenced by the failure to perform monthly and annual tests on their exit signs equipped with an internal emergency power supply source, and by exit signs that failed to illuminate when tested. This could result in a delay in evacuation due to limited exit sign visibility. This affected Suite 105 under the hospital's license and Suite 13 contractual services. Cross reference to A0702, example #2.

3. Failed to provide written documentation of weekly visual inspections of the emergency generator for 52 of 52 weeks for offsite building Suite 105 and one of 52 weeks for the Main Hospital. This could result in loss of power in the event of a power failure. This affected two of two offsite buildings. Cross reference to A0702, example #3.

4. Failed to maintain their emergency generator. This was evidenced by no EPS system connected to the facility in Suite 105. The building was unoccupied. This affected one of two offsite buildings. Cross reference to A0702, example #4.

5. Failed to maintain their automatic sprinkler system and enforce the contractual agreement with Suite 13 in an offsite building. This was evidenced by the five year certification that failed in the main hospital, by no quarterly testing of offsite building Suite 105 and by no quarterly testing of Suite 13 per contractual agreement. This could result in the failure of the sprinkler system in the event of a fire. This affected seven of seven floors in the Main Hospital and the offsite building Suites 105 and 13. Cross reference to A0710, example #1.

6. Failed to maintain the fire alarm system. This was evidenced by expired batteries in five of seven Fire Alarm Control Panels in the Main Hospital, by expired batteries in offsite building Suite 105, by no monthly testing in Suite 105 and offsite building Suite 13, and by no annual certification for Suite 105 and Suite 13. This could result in the fire alarm system not functioning as designed in the event of a fire. This affected two of two buildings, the Main Hospital and the offsite building. Cross reference to A0710, example #2.

7. Failed to maintain the integrity of the common two hour fire rated construction. This was evidenced by no separation wall. This could result in the reduction in staffs ability to protect in place due to smoke and fire. This affected the offsite building Suite 105, unoccupied, in one of two buildings. Cross reference to A0710, example #3.

8. Failed to ensure the facility and equipment were maintained at an acceptable level of safety and quality in the Surgical Services and SPD following the manufacturer's instructions; equipment was repaired when broken; weekly maintenance was done consistently for one piece of laboratory testing equipment; and PM was done on patient care equipment timely and in the Cardiac Rehab gym. Cross reference to A0724.

9. Failed to ensure weekly maintenance was performed for one lab processor. Cross reference to A0725.

10. Failed to ensure the humidity levels in the sterile processing area and surgical services area were maintained properly to provide a safe environment for patients receiving surgical care, increasing potential for the risk of fire. Cross reference to A0726.

11. Failed to ensure the QAPI provided oversight of a new service performed under contract in the imaging center adjacent to the hospital. Cross reference to A0308.

12. Failed to ensure environment of care rounds were documented as completed and reported and incorporated into the QAPI program. Cross reference to A0273, example #1.

The cumulative effect of these failings resulted in the hospital's inability to provide quality healthcare in a safe and sanitary environment creating the increased risk of poor health outcomes for the hospital's patients.

Based on observation, interview, and record review, the hospital failed to ensure emergency power and lighting was available in the hospital and the offsite building Suite 105 as evidenced by:

1. Failed to maintain their emergency lighting units. This was evidenced by the failure to perform monthly and annual test for the emergency lights in Suite 105, and by emergency lights that failed to illuminate in the offsite building Suite 105 and the Main Hospital. This could leave the rooms in darkness during a power outage. This affected one of seven floors in the Main Hospital and Ambulatory Surgery Suite 105.

2. Failed to maintain their exit signs in the offsite building Suites 105 and 13. This was evidenced by the failure to perform monthly and annual tests on their exit signs equipped with an internal emergency power supply source, and by exit signs that failed to illuminate when tested. This could result in a delay in evacuation due to limited exit sign visibility. This affected Suite 105 under the hospital's license and Suite 13 contractual services.

3. Failed to provide written documentation of weekly visual inspections of the emergency generator for 52 of 52 weeks for offsite building Suite 105 and one of 52 weeks for the Main Hospital. This could result in loss of power in the event of a power failure. This affected two of two offsite buildings.

4. Failed to maintain their emergency generator. This was evidenced by no EPS system connected to the facility in Suite 105. The building was unoccupied. This affected one of two offsite buildings.

Findings:

1. Review of the NFPA 101, Life Safety Code, 2000 Edition, 7.9.3 Periodic Testing of Emergency Lighting Equipment showed:

A Functional test shall be conducted on every required emergency lighting system at 30-day intervals for not less than 30 seconds. An annual test shall be conducted on every required battery-powered emergency lighting system for not less than 1.5 hours. Equipment shall be fully operational for the duration of the test. Written records of visual inspections and tests shall be kept by the owner for inspection by the authority having jurisdiction.

During a tour of the facility with the Director of Facilities, Safety Officer, and Bio Med Engineer Manager on 11/18/14, the facility emergency lighting units were observed and tested, testing documents were requested, and a staff person was interviewed.

a. 11/18/14, Suite 105

* At 0841 hours, three of three emergency lights in the hallway were not illuminating when the test button was pressed.

* At 0845 hours, two of two emergency lights in two ORs were not illuminating when the test button was pressed.

* At 0848 hours, there was no documented evidence of testing the five emergency lights monthly for 30 seconds and annually for 90 minutes for Suite 105.

* At 0855 hours, the emergency light in the north stairwell was not illuminating when the test button was pressed.

* At 0858 hours, the Director of Facilities stated during an interview that there had not been any testing of the emergency lights for approximately 12 years since the building suite was unoccupied during that time.

b. 11/18/14, Main Hospital

* At 1247 hours, the emergency light in Operating Room 1 was not illuminating when the test button was pressed. The emergency light was last tested during the month of October 2014.

2. Review of the NFPA 101, Life Safety Code, 2000 Edition showed:

7.10.9.2 Exit signs connected to or provided with a battery-operated emergency illumination source, where required in 7.10.4, shall be tested and maintained in accordance with 7.9.3.

7.9.3 Periodic Testing of Emergency Lighting Equipment-
A Functional test shall be conducted on every required emergency lighting system at 30-day intervals for not less than 30 seconds. An annual test shall be conducted on every required battery-powered emergency lighting system for not less than 1.5 hours. Equipment shall be fully operational for the duration of the test. Written records of visual inspections and tests shall be kept by the owner for inspection by the authority having jurisdiction.

During a tour of the facility with the Director of Facilities, the Safety Officer, and the Bio Med Engineer Manager on 11/18 through 11/19/14, the exit signs were tested, exit sign testing documents were requested, the contractual agreement was reviewed, and a staff member was interviewed.

a. 11/18/14, Suite 105

* At 0832 hours, the exit sign to the main entrance was not illuminating when the test button was pressed.

* At 0851 hours, the east exit sign near the back entrance was not illuminating when the test button was pressed.

b. 11/19/14, Suites 105 and 13

* At 0909 hours, there was no documented evidence of monthly 30 second tests and an annual 90 minute test for all of the exit signs in Suite 105 and Suite 13.

* At 0918 hours, the contractual agreement read in part that the contractual Suite 13 would provide all inspection and testing documentation to the hospital's Director of Facilities.

c. 11/20/14, Suites 105, and 13

* At 0903 hours, the Director of Facilities said that there was no documented testing of the exit signs for Suites 105 and 13.

3. Review of the NFPA 101, Life Safety Code, 2000 Edition showed:

9.1.3 Emergency Generators. Emergency generators, where required for compliance with this Code, shall be tested and maintained in accordance with NFPA 110, Standard for Emergency and Standby Power Systems.

NFPA 99, Health Care Facilities, 1999 Edition
3-4.4.1 Maintenance and Testing of Essential Electrical System.
3-4.4.1.1 Maintenance and Testing of Alternate Power Source and Transfer Switches.
(a) Maintenance of Alternate Power Source. The generator set or other alternate power source and associated equipment, including all appurtenant parts, shall be so maintained as to be capable of supplying service within the shortest time one or more transfer switches. One transfer switch shall practicable and within the 10-second interval specified in 3-4.1.1.8 and 3-4.3.1. Maintenance shall be performed in accordance with NFPA 110, Standard for Emergency and Standby Power Systems, Chapter 6.
(b) Inspection and Testing.
1.* Test Criteria. Generator sets shall be tested twelve (12) times a year with testing intervals between not less than 20 days or exceeding 40 days .Generator sets serving emergency and equipment systems shall be in accordance with NFPA 110, Standard for Emergency and Standby Power Systems, be installed and connected to the alternate power source Chapter 6.
2. Test Conditions. The scheduled test under load conditions shall include a complete simulated cold start and appropriate automatic and manual transfer of all essential electrical system loads.
3. Test Personnel. The scheduled tests shall be conducted by competent personnel. The tests are needed to keep the machines ready to function and, in addition, serve to detect causes of malfunction and to train personnel in operating procedures.

NFPA 110, Standard for Emergency and Standby Power Systems, 1999 Edition
6-4 Operational Inspection and Testing.
6-4.1* Level 1 and Level 2 EPSSs, including all appurtenant components, shall be inspected weekly and shall be exercised under load at least monthly.
Exception: If the generator set is used for standby power or for peak load shaving, such use shall be recorded and shall be permitted to be substituted for scheduled operations and testing of the generator set, provided the appropriate data are recorded.
6-4.2* Generator sets in Level 1 and Level 2 service shall be exercised at least once monthly, for a minimum of 30 minutes, using one of the following methods:
(a) Under operating temperature conditions or at not less than 30 percent of the EPS nameplate rating
(b) Loading that maintains the minimum exhaust gas temperatures as recommended by the manufacturer. The date and time of day for required testing shall be decided by the owner, based on facility operations.

During document review with the Director of Facilities, the Safety Officer, and the Bio Med Engineer Manager on 11/19/14, the generator maintenance records were reviewed, and staff was interviewed.

a. Main Hospital

* At 1312 hours, there was no documented evidence of weekly inspections since 11/5/14. There was no record for the week of 11/12/14.

b. 11/20/14, Suite 105

* At 0852 hours, there was no documented evidence of testing the EPS system in suite 105 for 12 of 12 months and weekly inspections for 52 of 52 weeks.

* At 0854 hours, the Director of Facilities stated during an interview that they did not have records for the EPS system in suite 105 since it had been unoccupied for the past several years.

4. Review of the NFPA 101, Life Safety Code, 2000 Edition showed:

9.1.3 Emergency Generators. Emergency generators, where required for compliance with this Code, shall be tested and maintained in accordance with NFPA 110, Standard for Emergency and Standby Power Systems.

NFPA 110, Standard for Emergency and Standby Power Systems, 1999 Edition
6-4 Operational Inspection and Testing.
6-4.1* Level 1 and Level 2 EPSSs, including all appurtenant components, shall be inspected weekly and shall be exercised under load at least monthly.
Exception: If the generator set is used for standby power or for peak load shaving, such use shall be recorded and shall be permitted to be substituted for scheduled operations and testing of the generator set, provided the appropriate data are recorded.
6-4.2* Generator sets in Level 1 and Level 2 service shall be exercised at least once monthly, for a minimum of 30 minutes, using one of the following methods:
(a) Under operating temperature conditions or at not less than 30 percent of the EPS nameplate rating
(b) Loading that maintains the minimum exhaust gas temperatures as recommended by the manufacturer. The date and time of day for required testing shall be decided by the owner, based on facility operations.

NFPA 99, Standard for Health Care Facilities, 1999 Edition
3-4.2.2.2 Emergency System. 6. Blood, bone, and tissue banks
(a) General. Those functions of patient care depending on lighting or appliances that are permitted to be connected to the emergency system are divided into two mandatory branches, described in 3-4.2.2.2(b) and (c).
+All ac-powered support and accessory equipment necessary to the operation of the EPS shall be supplied from the load side of the automatic transfer switch(es), or the output terminals of the EPS, ahead of the main EPS overcurrent protection, as necessary, to ensure continuity of the EPSS operation and performance. (NFPA 110: 5-12.5)

During document review with the Director of Facilities, Safety Officer, and Bio Med Engineer Manager on 11/20/14, the facility's emergency EPS system was examined and a staff person was interviewed.

a. 11/20/14, Suite 105

* At 0851 hours, the batteries to the EPS system were disconnected and did not provide emergency power in the event of a power failure.

* At 0854 hours, the Director of Facilities said during an interview, that they did not have records for the EPS system in Suite 105 since it had been unoccupied for the past several years.

Based on observation, interview, and record review, the hospital failed to meet the applicable provisions of the Life Safety Code of the NFPA as evidenced by:

1. Failed to maintain their automatic sprinkler system and enforce the contractual agreement with Suite 13 in an offsite building. This was evidenced by the five year certification that failed in the main hospital, by no quarterly testing of offsite building Suite 105 and by no quarterly testing of Suite 13 per contractual agreement. This could result in the failure of the sprinkler system in the event of a fire. This affected seven of seven floors in the Main Hospital and the offsite building Suites 105 and 13.

2. Failed to maintain the fire alarm system. This was evidenced by expired batteries in five of seven Fire Alarm Control Panels in the Main Hospital, by expired batteries in offsite building Suite 105, by no monthly testing in Suite 105 and offsite building Suite 13, and by no annual certification for Suite 105 and Suite 13. This could result in the fire alarm system not functioning as designed in the event of a fire. This affected two of two buildings, the Main Hospital and the offsite building.

3. Failed to maintain the integrity of the common two hour fire rated construction. This was evidenced by no separation wall. This could result in the reduction in staffs ability to protect in place due to smoke and fire. This affected the offsite building Suite 105, unoccupied, in one of two buildings.

Findings:

1. The NFPA 101, Life Safety Code, 2000 Edition, 19.7.6 Maintenance and Testing. (See 4.6.12.) showed:

4.6.1.2 Any requirements that are essential for the safety of building occupants and that are not specifically provided for by this Code shall be determined by the authority having jurisdiction.

9.7.5 Maintenance and Testing. All automatic sprinkler and standpipe systems required by this Code shall be inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems.

NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 1998 Edition
1-4.2 The responsibility for properly maintaining a water-based fire protection system shall be that of the owner(s) of the property. By means of periodic inspections, tests, and maintenance, the equipment shall be shown to be in good operating condition, or any defects or impairments shall be revealed.
Inspection, testing, and maintenance shall be implemented in accordance with procedures meeting or exceeding those established in this document and in accordance with the manufacturer's instructions. These tasks shall be performed by personnel who have developed competence through training and experience.
Exception: Where the owner is not the occupant, the owner shall be permitted to pass on the authority for inspecting, testing, and maintaining the fire protection systems to the occupant, management firm, or managing individual through specific provisions in the lease, written use agreement, or management contract.

During document review with the Director of Facilities, the Safety Officer, and the Bio Med Engineer Manager on 11/19/14 through 11/20/14, the sprinkler system certification and testing documents were reviewed, and a staff person was interviewed.

a. 11/19/14, Suites 105 and 13

* At 0912 hours, there was no documented evidence of quarterly testing of the sprinkler system in suite 105 under the facilities license, and Suite 13 contracted services.

* At 0914 hours, the contractual agreement read in part on page A, number 3, Group is required to provide fire sprinkler testing.

b. 11/19/14, Main Hospital

* At 1343 hours, the facilities documented evidence of the five year certification indicated that it failed during testing on 12/31/13. The test indicated the dry pipe was leaking and failed. The dry pipe allows for water to be pumped to each floor by the fire department during a fire emergency.

c. 11/20/14

* At 1411 hours, the Safety Officer said during an interview, that the facility was in the process of securing a contract to have the dry pipe replaced. The job was being evaluated by a few companies for bid. The facility was informed of the waiver process during the exit interview.

2. NFPA 101, Life Safety Code, 2000 Edition, 9.6.1.4 showed:
A fire alarm system required for life safety shall be installed, tested, and maintained in accordance with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm Code, unless an existing installation, which shall be permitted to be continued in use, subject to the approval of the authority having jurisdiction.

NFPA 72, National Fire Alarm Code, 1999 Edition,
7-3.2, requires sealed lead acid batteries to be replaced every four years.
7-3.2* Testing. Testing shall be performed in accordance with the schedules in Chapter 7 or more often if required by the authority having jurisdiction. If automatic testing is performed at least weekly by a remotely monitored fire alarm control unit specifically listed for the application, the manual testing frequency shall be permitted to be extended to annual.

Table 7-3.2 shall apply.
Exception: Devices or equipment that are inaccessible for safety considerations (for example, continuous process operations, energized electrical equipment, radiation, and excessive height) shall be tested during scheduled shutdowns if approved by the authority having jurisdiction but shall not be tested more than every 18 months.
Table 7-3.2 Testing Frequencies
6. Batteries - Fire Alarm Systems
d. Sealed Lead-Acid Type
1. Charger Test (Replace battery every 4 years.)

Table 7-3.2, Testing Frequencies, Item 23 - requires the system be tested monthly with the Monitoring/Supervising Station.

During a tour of the facility with the Director of Facilities, Safety Officer, and Bio Med Engineer Manager on 11/17/14 through 11/19/14, the Fire Alarm system components were observed, testing documents were requested, and a staff person was interviewed.

a. 11/17/14, Main Hospital

* At 0949 hours, the two batteries in the fire alarm control panel on the 7th floor were dated 3/2/10, and expired on 3/2/14.

* At 1038 hours, the two batteries in the fire alarm control panel on the 5th floor were dated 3/2/10 and expired on 3/2/14.

* At 1319 hours, the two batteries in the fire alarm control panel on the 3rd floor were dated 3/2/10 and expired on 3/2/14.

* At 1341 hours, the two batteries in the fire alarm control panel on the 2nd floor were dated 3/2/10 and expired on 3/2/14.

* At 1445 hours, the two batteries in the fire alarm control panel on the 1st floor were dated 3/2/10 and expired on 3/2/14.

b. 11/18/14, Main Hospital

* At 0914 hours, the two batteries in the Main fire alarm control panel in the Plant Operations shop were dated 3/2/10 and expired on 3/2/14.

c. 11/19/14, Suite 13

* At 0912 hours, there was no documented evidence of annual testing and maintenance of fire alarm system.

d. 11/20/14, Suite 105

* At 0922 hours, the two batteries in the fire alarm control panel in Suite 105 were undated, approximately 1/4 of the batteries were covered with green corrosion that was piled approximately 1 inch above the batteries, battery acid was leaking down the positive side of the batteries on to the control panel, and the battery wires were covered with corrosion.

* At 0857 hours, there was no documented evidence on monthly testing of the fire alarm system in Suites 105 and 13.

* At 0959 hours, there was no documented evidence of an annual certification of the fire alarm control panel in Suites 105 and 13.

* At 0938 hours, the Director of Facilities stated during an interview that there was no annual testing and certification of the fire alarm system in Suite 105 and that the facility was not responsible for Suite 13.

3. NFPA 101, Life Safety Code, 2000 Edition:

19.1.1.4.1 Additions. Additions shall be separated from any existing structure not conforming to the provisions within Chapter 19 by a fire barrier having not less than a 2-hour fire resistance rating and constructed of materials as required for the addition. (See 4.6.11 and 4.6.6.)

19.1.1.4.2 Communicating openings in dividing fire barriers required by 19.1.1.4.1 shall be permitted only in corridors and shall be protected by approved self-closing fire doors. (See also Section 8.2.)

8.2.3.2.3.1 Every opening in a fire barrier shall be protected to limit the spread of fire and restrict the movement of smoke from one side of the fire barrier to the other. The fire protection rating for opening protective's shall be as follows:
(1) 2-hour fire barrier - 1 1/2-hour fire protection rating
(2) 1-hour fire barrier - 1-hour fire protection rating where used for vertical openings or exit enclosures, or 3/4-hour fire protection rating where used for other than vertical openings or exit enclosures, unless a lesser fire protection rating is specified by Chapter 7 or Chapters 11 through 42.

8.2.2.1 Where required by Chapters 12 through 42, every building shall be divided into compartments to limit the spread of fire and restrict the movement of smoke.

8.2.2.2* Fire compartments shall be formed with fire barriers that are continuous from outside wall to outside wall, from one fire barrier to another, or a combination thereof, including continuity through all concealed spaces, such as those found above a ceiling, including interstitial spaces. Walls used as fire barriers shall comply with Chapter 3 of NFPA 221, Standard for Fire Walls and Fire Barrier Walls. The NFPA 221 limitation on percentage width of openings shall not apply.

Exception: A fire barrier required for an occupied space below an interstitial space shall not be required to extend through the interstitial space, provided that the construction assembly forming the bottom of the interstitial space has a fire resistance rating not less than that of the fire barrier.

During a tour of the facility with the Bio Med Engineer Manager on 11/20/14, the fire rated construction was observed, and a staff person was interviewed.

Suite 105

* At 0922 hours, there was no separation wall/door/partition between Suite 105 (on the facilities License) and Suite 109 (separate business).

* At 0923 hours, the Bio Med Manager stated during an interview that there was no separation between Suites 105 and 109.

Based on observation, interview, and record review, the hospital failed to ensure the facility and equipment were maintained at an acceptable level of safety and quality as evidenced by:

1. In the Surgical Services and SPD, sterilizers were not maintained following the manufacturer's instructions and repaired when broken. In addition, the equipment was not in a sanitary and functioning condition.

2. Weekly maintenance was not done during one week for one piece of laboratory testing equipment.

3. In the Cardiac Rehab gym, weight machines showed cracks in the material covering the benches.

4. A patient's bathroom air vent was full of lint. The toilet seat was stained, the faucet had heavy calcium deposits, and the floor grout was rusty.

5. PM of a suction machine was overdue.

6. PM of blood pressure machine was overdue.

Findings:

1.a. On 11/17/14 at 0932 hours, the SPD was toured with the SPD Manager. The following was identified:

* Two sterilizers, 3 and 4 were observed with heavy brown and green colored minerals deposited on the sterile chamber.

The SPD Manager stated those two sterilizers were used every day for sterilizing of hospital surgical instruments. Both sterilizers had been there for a long time. The SPD's night shift staff was responsible for cleaning the sterilizers on Friday nights, but the staff did not document this.

The SPD Manager stated the brown and green colored residues were there for a long time. The Manager could not recall a process of cleaning the residues.

Review of the manufacturer's manual for Sterilizers 3 and 4 showed "the customer is responsible for required, daily, weekly and monthly preventive maintenance. The manual listed daily, weekly, monthly, every three months, and every six months preventive maintenance for the sterilizers."

* Six of six loading carts were observed with visible rusty and adhesive tape. In a concurrent interview, SPD Techs 2 and 3 stated the loading carts were used every day and staff disinfected carts daily. Staff was aware of the rust on the carts.

b. The hospital's P&P titled Equipment - Cleaning &Decontamination of SPD revised 6/14, showed staff is to report all broken or defective equipment to the Bio-Medical Department.

On 11/18/14 at 1042 hours, during a tour in the surgical services area, Sterilizer 3 in OR core was observed with a broken door gasket.

The Director of Perioperative Services stated OR staff or SPD staff operated this sterilizer. The Biomedical Engineering Department was responsible for preventive maintenance.

An interview with the Biomedical Engineer showed the repair or replacement of the gasket was based on an as needed situation; however, there was no documented evidence of a request for repair.

c. The hospital's P&P titled Autoclave Malfunction and/or Repair, reviewed 6/14, showed all the SPD staff and OR staff should repeat and document all daily quality controls after a repair of an autoclave unit. The procedure showed the Bio-Medical Department and the SPD Manager should be called when the autoclave appears to malfunction; for example, if the cycle did not complete or was aborted due to malfunction. The Bio-Med or SPD Manager will attempt to trouble shoot the equipment problem.

On 11/17/14, documentation entitled "WMCSA/SPD Sterrad Sterilization" was reviewed with the SPD Manager. The documentation showed on 11/10/14 at 2227 hours, Sterilizer 1 ran a load of instrument sterilization and the load was "canceled."

A printed strip attached on the document indicated "cycle canceled, cancel stage: chamber pumpdown 1." The printed strip contained a list for how to trouble shoot and included steps from A to E and a space for documenting "Validated by:" However, the "Validated by" area was left blank.

Further review of the log for Sterilizer 1 showed the sterilizer was operated on the following day for a regular testing. There was no documented evidence the trouble shooting steps were completed by the SPD staff.

In a concurrent interview with SPD Manager, the Manager stated most of the SPD staff acknowledged the problem of the cancellation was due to the sterilizer overheating, the machine needed to rest. The SPD Manager was aware of the manufacturer's instructions for trouble shooting steps, but they did not do.

d. On 11/17/14 at 1010 hours, the SPD decontamination area was toured with the SPD Manager. At that time an Automated Multi-chamber Washer/Disinfector was operating.

The Washer had four sections. Each section had a window on each side. Three of four windows were covered with white material which blocked all the vision of the window.

The Manager opened the window and the white material fell off like snowflakes. The Manager stated the white material was water minerals deposits. The Manager had to use heavy chemical to descale the deposits weekly and had been doing this for months.

The Manager believed this had to do with the hardness of the water. The hospital had a contracted services company which performed water softening services; however, the Manager was not sure the service was scheduled or when was the last time of the service.

e. The hospital's P&P titled Cannulated Sonic Instrument Cleaning, Use of reviewed 6/14, showed the routine maintenance of the ultrasonic cleaner is to clean the cleaner on a daily basis or if instrument are grossly contaminated clean after each use, inspecting the outer case, basket, drain tap and filter. Empty the tank as necessary to fill with clean liquid.

On 11/17/14 at 1010 hours, during the tour in the SPD Decontamination area, an ultrasonic cleaner was noted with a rusty tank and wire basket for instruments. The Manager stated the cleaner was moved from the OR and was used infrequently.

f. On 11/18/14 at 1120 hours, an auto instrument washer was found in the surgical services decontamination room. According to the SPD Manager this unit was operated as a backup washer for the SPD services.

The Teflon track located on two sides of the machine to secure the machine to the wall was broken. The SPD Manager stated he was not aware of it.

7. On 11/18/14 at 1330 hours, the GI Lab was toured with the Manager of Perioperative Services. The following was identified:

* In GI Lab 2, a key board connected to the GI machine was missing the tab cover for three keys. During an interview, Endoscopy Tech 1 stated she used the keyboard this morning. The Tech acknowledged the missing key covers. The Tech stated they did not use those keys very often.

* In GI Lab 3, the plastic surface on the top of the GI cart had two lines of cracked fissures. A vital signs monitor was placed on the surface. Endoscopy Tech 1 stated this GI cart was the mobile unit for GI cases for the hospital inpatients in use in multiple areas of the hospital. The Tech was not aware of the surface of the cart broken.

In addition, the door of the bottom drawer of the GI cart was rusted stopping the door from closing completely.

c. In the Endoscopy processing room, clean EGD scopes and colon scopes were hanging in the racks in two closets. The cover surfaces of the bottom and the back of the closets were cracked. A towel was placed on the bottom on the closet.

Endoscopy Tech 1 removed the towel during the interview with the surveyor. Endoscopy Tech 1 stated she was aware a towel should not be place under the scopes creating the possibility of the towel touching and scratching the lens of the scope.


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2. During an interview with the Lab Supervisor on 11/18/14 at 1030 hours, she stated weekly maintenance was to be done on the lab processors. The maintenance records for the Vitros Eci 2 immunodiagnostic system (machine to provide test results on components of the immune system) were requested. Review of the record for the previous week showed it was not completed.

The Lab Supervisor stated the weekly maintenance was not performed on the machine in error.


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3. The Cardiac Rehab area was toured on 11/18/14 at 0900 hours, with the Director of Trauma and the Director of Cardiology. The unit housed gym equipment which the Directors stated was used by Cardiac Rehab patients and was also available to hospital staff at certain hours.

Observation of the weight machines showed cracks in the material covering the benches of three of the machines. In addition, the arm supports of the abdominal crunch machine had a foam/porous material edged with black tape.

The Director of Cardiology stated the cracks in the material covering the machines was noted on EOC rounds and work orders had been submitted but had not yet been addressed.


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4. During a tour of of the 6th floor with RNs B and M on 11/17/14 at 1330 hours, a patient's bathroom air vent was full of lint. The toilet seat was stained with brownish discoloration, the faucet was surrounded by calcium deposits, and the floor grout was rusty. Both RNs acknowledged the bathroom was not maintained.





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5. An inspection of a crash cart in Medical/Surgical Unit was conducted on 11/17/14 at 0920 hours, accompanied by DON 1. The suction machine showed a sticker indicating PM was due on 8/14. The DON confirmed the PM was overdue.
6. On 11/18/14 at 0910 hours in Medical/Surgical Unit, a blood pressure machine showed a sticker indicating PM was due on 6/14. DON 1 confirmed the PM was overdue.

Based on interview and record review, the laboratory failed to ensure weekly maintenance was performed for one lab processor, creating the increased risk of poor equipment performance for that machine.

Findings:

During an interview with the Lab Supervisor on 11/18/14 at 1030 hours, the Supervisor stated weekly maintenance was done on the lab processors. The maintenance records for the Vitros Eci 2 lab processor were requested. Review of the records did not show maintenance for the previous week was completed.

During a continuing interview with the Lab Supervisor, the Supervisor stated the weekly maintenance was not performed on the machine in error.

Based on record review and interview, the hospital failed to ensure the humidity levels in the sterile processing area and surgical services area were maintained properly to provide a safe environment for patients receiving surgical care, increasing the potential for the risk of fire.

Findings:

According to AORN 2013, Recommended Practices for a Safe Environment of Care, Recommendation V.b. stated, "Low humidity increases the risk of electrostatic charge, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust."

Review of the hospital's P&P titled Temperature and Humidity Monitoring, revised 8/1/13, showed humidity and relative humidity would be monitored daily and maintained between 30% to 60% with humidity in the perioperative suite, including ORs and sterile processing. The temperature and humidity are to be recorded on the Temperature Record and Humidity Record for every operative area every 24 hours by a designated person.

If humidity is out of range submit a work order and call Engineering immediately. Document on log under ACTION TAKEN the work order was placed. If Engineering is unable to correct humidity or temperature the department director/designee is notified immediately. Document in the "ACTION TAKEN" column what you did about the temperature or humidity being out of range. Leave column blank if temperatures and humidity are with in normal range.

The hospital's humidity documentation, Operating Room Suite Daily Humidity Record was reviewed. The documentation notification showed the definition of the humidity range as 30% to 60%.

The documentation for November 2014, showed the following:

1. In the SPD:

* 11//16/14, the decontamination room humidity was less than 30%; Problem: low humidity 22%; Action Taken: lower temperature; and Resolution Achieved: was left blank.

* 11//16 and 11/17/14, SPD workroom: the humidity was less than 30%; Problem, Action taken, and Resolution Achieved were left blank.

* 11//16 and 11/17/14, Decontamination room: the humidity was less than 30%; Problem: low humidity 22% and 19%, Action Taken: lower temperature; and Resolution Achieved: was left blank.

2. In 11 of 11 ORs:

* OR 1: 11/6, humidity: 24%; 11/8, humidity: 28%; and 11/12 humidity: 12%.

* OR 2: 11/6, humidity: 24%; 11/17, humidity: 10%; and 11/18, humidity: 20%.

* OR 3: 11/6, humidity: 26%; 11/17; humidity: 12%; 11/18; and humidity: 20%.

* OR 4: 11/6, humidity: 23%; 11/17, humidity: 10%; and 11/18 humidity: 20%.

* OR 5: 11/6, humidity: 24%; 11/8, humidity: 26%; 11/17, humidity: 10%; and 11/18, humidity: 20%.

* OR 6: 11/6, humidity: 23%; 11/8, humidity: 25%; 11/17, humidity: 12%; and 11/18, humidity: 20%.

* OR 7: 11/6, humidity: 24%; 11/8, humidity: 28%; 11/17, humidity: 12%; and 11/18, humidity: 20%.

* OR 8: 11/6, humidity: 22%; 11/8, humidity: 25%; 11/17, humidity: 10%; and 11/18, humidity: 20%.

* OR 9: 11/6, humidity: 24%; 11/17, humidity 10%; and 11/18, humidity: 20%.

* OR 10: 11/6, humidity: 22%; 11/8, humidity: 24%; 11/17, humidity: 10%; and 11/18, humidity: 18%.

* OR 11: 11/6, humidity: 23%; 11/17, humidity: 10%; and 11/18, humidity: 20%.

On 11/19/14 at 1400 hours, the Director of Perioperative Services stated on 11/17/14, the OR staff monitored and documented the ORs' humidity levels were below 30% and notified the Engineering Department. The Director further stated the ORs with the humidity levels below 30% were used for surgical procedures.

On 11/19/14 at 1422 hours, during an interview, the Director of Facilities reviewed the engineer's shift report documentation from 11/16/14 at 2300 hours to 11/17/14 at 1400 hours. Documentation showed the engineers acknowledged the humidity levels below 30% in the hospital various areas, including the ORs.

The Director was unable to locate documentation of a communication from the facility department to surgical services regarding the humidity levels out of range. There was no documented evidence of work orders generated for 11/17/14, when the OR reported humidity levels below 30%.

Based on observation, interview, and record review, the hospital failed to provide a sanitary environment and an active infection control program as evidenced by:

1. The hospital was unable to provide documentation of specific qualification of its infection control practitioners. Cross reference to A0748.

2. The hospital failed to develop a system for identifying, reporting, investigating, and controlling the infections and communicable diseases of patients and personnel. Cross reference to A0749.

3. The hospital failed to ensure the CEO and CNO implemented and maintained an effective infection control program. Cross reference to A0756.

4. Surveillance hand hygiene data appeared inaccurate and there was no documentation provided to indicate the hospital was in the process of improving data gathering regarding hand hygiene. Cross reference to A0273, example #2.

The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe and sanitary environment creating the increased risk of poor health outcomes for the hospital's patients.

Based on interview and record review, the hospital failed to provide information regarding the qualifications of the designated infection control specialists in the hospital. This failure had the potential to affect the hospital's infection control program.

Findings:

A list of personnel files was submitted to the hospital at the time of the entrance conference with administration on 11/17/14. Included in the list were the hospital's designated medical staff and nursing Infection Control Preventionists.

During a review of the personnel files on 11/20/14 at 1030 hours, with the HR Manager, the files for the Clinical Performance Improvement Director and the physician as the designated medical staff and nursing Infection Control Preventionists were not included in the files presented. The HR Manager stated the file for the Performance Improvement Director needed to come from a sister facility and should be available later in the day. The HR Manager stated the records for the Infection Control Physician would be provided by another department.

Upon exiting the facility on 11/20/14, the surveyor was not provided with the requested information to show the designated infection control staff was qualified through education, training, experience, or certification.

Based on observation, interview, and record review, the hospital failed to develop a system for identifying, reporting, investigating, and controlling the infections and communicable diseases of patients and personnel as evidenced by:

1. Failed to implement the infection control program plan for 2013, to evaluate and plan interventions for assessed high priority risk of admission of patients with MDRO infections.

2. Failed to show documentation of data from the infection control EOC rounds was recorded and reported.

3. Hospital staff were unable to verbalize the correct dwell/wet times for disinfectants used in an isolation room, GI lab, OR, and Newborn Nursery Unit.

4. The hospital's P&P for the frequency of the change out of closed system suction catheters did not match the current practice by the staff.

5. Expired supplies were found on the neurosurgical cart available for patient use in sterile procedures.

6. Patient equipment was not dated and maintained in a sanitary condition.

7. The GI Lab counter top and GI cart surface were noted with lines of cracked fissures. EVS staff did not disinfect the GI Lab counter top with proper time.


8. Equipment in the OR was not disinfected with proper time.

9. The metal parts of multiple pieces of furniture and equipment in an OR were corroded and rusted. The surface of a cart used for medication preparation had opened cracks.

10. The HLD of reusable lens used for eye surgeries was conducted in the Surgical Services Decontamination room where trash was stored. Equipment in the room was dirty and rusted.

11. Staff in the OR, Radiology suite, and Ultrasound did not perform HLD of probes and scopes per the hospital's P&P.

12. Staff in the SPD, GI lab, and OR Decontamination room did not mix the enzymatic detergents per the manufacturer's directions.

13. Hospital staff did not perform hand hygiene per the hospital's P&P during observations on the Critical Care Unit, 6th floor, and ED.

14. Observations of the hospital environment showed multiple instances of cracked surfaces, rusted equipment, water damage, chipped paint, and dirty and dusty build-up.

15. Directions on the temperature monitoring log for breast milk storage were not in accordance with hospital policy, resulting in breast milk refrigeration storage temperatures exceeding hospital policy.

16. Physician screening for TB was incomplete for four of eight physician files reviewed.

17. Equipment in the Newborn Nursery Unit was not disinfected with proper time.

18. Failed to develop and implement action plans for possible staff exposure to infectious airborne diseases.

These failures increased the risk of spread of the infections and diseases to the patients in hospital.

Findings:

1. On 11/19/14, review of the hospital's infection control program and plan dated January to December 2013, showed, "The hospital evaluates the effectiveness of its infection control plan annually and whenever risks were significantly changed." The highest priority risk assessed was "admission of patients with MDRO posing the risk of horizontal transmission."

On 11/20/14, during the surveyors' meeting with the infection control committee at 0900 hours, the committee was asked which HAI organism was the most prevalent according to the current year's surveillance. None of the infection control committee members were able to identify the most prevalent HAI organism.

When asked which of the reportable diseases to the Public Health had the highest incidence, there was also no reply by the committee. The hospital's 2014 HAI surveillance and the reportable diseases data as collected by members of the infection control committee were presented. The committee was then asked if there were interventions planned for the collected data. The only response was from the Director of Clinical Performance Improvement who stated, "You caught us in a bad time."

2. The hospital's Organization-wide Infection Prevention and Control Program and Plan 2014 dated 4/23/14, read in part, "Reports of infection surveillance, prevention, and control information are provided to the appropriate staff within the hospital"....."Surveillance is performed and included (but is not limited to): ...v. Conducting or facilitation infection control environmental and isolation rounds."

During an interview with the CNO on 11/19/14 at 1430 hours, she stated the Infection Preventionist attended the EOC rounds and reported to the EOC Committee. The CNO stated she was not sure how the EOC rounds were reported to the MEC.

The quarterly EOC/Safety Committee Minutes from 2013 and 2014 were reviewed. The minutes contained reports about functional issues involving the physical plant and equipment and patient safety issues but did not contain infection control EOC information.

During an interview with the Patient Safety Officer on 11/19/14 at 1445 hours, he stated he coordinated the EOC rounds; the Infection Preventionist usually attended EOC rounds but was an ad hoc member and reported to her own committee.

During an interview with RN K from the Quality Department on 11/19/14 at 1420 hours, she stated the Infection Preventionist reported to the Clinical Monitoring Committee.

During an interview with the Infection Preventionist on 11/19/14 at 1425 hours, she stated the Infection Control Department presented to the Clinical Monitoring Committee.

The minutes of the Clinical Monitoring Committee for 2013 and 2014, were reviewed. There was no evidence of infection control EOC rounds data found.

During a second interview with the Infection Preventionist on 11/20/14 at 0900 hours, she stated the infection control EOC data should have been in the EOC minutes and should be in the Clinical Monitoring Committee minutes.

3. The interventions listed on the Infection Control report (January - December 2013) included EVS staff trained in proper cleaning of isolation rooms and use of disinfectants.

On 11/17/14 at 1500 hours, during the initial tour of the Neuro Observation Unit on the 4th floor, Housekeeping staff was observed cleaning an isolation room. When asked, EVS 5 was unable to state the type of isolation provided in the room, such as airborne precautions (signified by a blue card), droplet precautions (green card), contact precautions (yellow card), and standard precautions (pink card).

Unable to determine the need to wear a mask or not, EVS 5 stated she wore a mask, gown, and glove to clean every isolation room. When asked about the contact time on surfaces for the disinfectant used, EVS 5 stated surfaces needed to stay wet for 25 minutes for all isolation rooms, except those signified by the white card (C-difficille, cause of infectious diarrhea due to a type of spore-forming bacteria). EVS 5 stated she used bleach on isolation rooms with a white card.

Review of the manufacturer's label on the disinfectant used by EVS 5 regarding contact time showed 25 minutes was the length of time needed to rinse the eyes if contaminated. However, the dwell/contact time for the disinfectant was 10 minutes for fungi, bacteria, and viruses.

4. On 11/20/14, review of the hospital's P&P for Suction-Closed System for the Ballard Trach Care Closed Suction Catheter for RTs and RNs approved on 7/15/11, showed the system was a method to remove secretions while maintaining ventilation and reducing potential contamination. The system would be changed every 24 hours from the initiation or change of the device and as necessary for contamination or malfunction. The procedure included placing a 24-hour change-out sticker over the suction valve.

On 11/17/14 at 0930 hours, during an initial tour of the ICU, a patient connected to a ventilator was observed. The patient's closed suction system did not have a sticker to show when it should be changed.

When asked, RNs X and C and the Charge nurse stated they did not know when the system was initiated and when it should be changed.

Four additional ventilated ICU patients were reviewed via a computer accessible to RTs only.

Patient 56's suction catheter was initiated on 11/11/14, and was changed on 11/14/14, within 72 hours.

Patient 57's suction catheter was initiated on 11/15/14, and was due for change on 11/18/14.

However, Patient 39's suction catheter was initiated on 11/3/14, and was not changed up to 11/17/14.

Patient 58's suction catheter was changed after two days only, from 11/13 to 11/15/14, within 48 hours.

On 11/17/14 at 1030 hours, the Director of the Respiratory Department stated catheters lasted 72 hours before requiring change out. The Director of Respiratory stated their current practice did not reflect the current P&P. The size 14 French catheters could last 72 hours while the size 12 French or smaller suction catheters used in NICU were changed every 24 hours. The Director stated stickers should be attached to the tubing to determine its duration.

5. On 11/17/14 at 1030 hours, the ICU was toured with the ICU Director. The following was observed:

a. The neurosurgical cart was inspected. The rolling cart contained all the medical and surgical equipment to insert ventriculostomies (to drain the crebrospinal fluid) and intracranial pressure monitors (to measure brain pressure) requiring strict sterility. Two expired vials of sodium chloride were found in drawer 1 of the cart.

b. The wound cart was inspected. A bottle of stomahesive powder for wound dressings available for patient use showed an expiration date of 10/14.

6. On 11/17/14 at 1330 hours, the Telemetry Unit on 6th floor was toured with RNs B and M. The following was observed:

a. In a patient room, an irrigation set (to flush nasogastric tubes) was found with no date when it was initially used. RNs B and M acknowledged the disposable equipment should be dated.

b. In a patient bathroom an air vent was noted full of lint. The toilet seat was stained with brownish discoloration. The faucet was surrounded by white calcium appearing deposits and the floor grout was rusty. The RNs acknowledged the findings.


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7. On 11/18/14 at 1330 hours, the GI Lab was toured with the Manager of Perioperative Services. The following was identified:

a. In GI Lab 3, the plastic surface on the top of the GI cart had two lines of cracked fissures. A vital signs monitor was placed on the surface. Endoscopy Tech 1 stated this GI cart was the mobile unit for GI cases for the hospital inpatients and was being used in multiple areas of the hospital. The Tech was not aware the surface of the cart was broken and would be difficult to keep clean.

b. During the cleaning observation, EVS staff applied a disinfectant to the counter. The counter remained wet for only four and half minutes. When asked, the EVS staff stated the wet time for the disinfectant was 10 minutes.

8. On 11/18/14 at 0930 hours, during a tour of the OR, Housekeeping 1 was observed cleaning between cases. Housekeeping 1 wiped down the front and back pads of the OR table and placed the pads back immediately after wiping. In a concurrent interview, Housekeeping 1 stated the disinfectant Quat required a wet time of 10 minutes.

9. On 11/18/14 at 0948 hours, one of 11 ORs was observed for a surgical procedure. A service cart located in the room showed the plastic surface was noted with lines of cracked fissures. The circulating RN used the surface to prepared the medications.

In the OR, the metal parts of most of the furniture were corroded and rusted; for example: two surgeons chairs, a patient positioning head rest, linen hampers, kick buckets, cautery machine, back table, and instrument carts. During a concurrent interview, the Director of Perioperative Services stated those items were aged furniture.

On 11/19/14 at 1125 hours, during an interview, the EVS Director stated EVS Services staff stated they were aware of the corrosive surfaces in the surgical services area and the proper way to disinfect the corrosive surfaces was discussed as a concern. They stated staff cleaned the items "as is."

10. A tour of the Surgical Services Decontamination Room was conducted on 11/18/14 at 1100 hours.

A HLD container with Wavicide was on a counter in the room. According to the SPD Manager, the SPD staff and Perioperative Staff performed disinfection of reuseable vitroctomy lens with HLD Wavicide in this room.

The vitroctomy lens were then taken to the operating sterile field after disinfection for eye surgery.

During the observation of the room, two EVS staff were working to sort two wheeled bins containing bags of trash. Observation of the ceiling vent in the room that was adjacent to an instrument autowasher had visible debris and dust.

When asked about the HLD done in a room with trash, the Manager acknowledged the disinfection process was performed in a contaminated environment. The Manger stated the staff locked the room during the disinfection process to eliminate traffic for infection prevention. However, the Manager acknowledged the room was a contaminated environment used for storage of trash.

On 11/20/14 at 1300 hours, the Surgical Services Decontamination Room was again toured. Further observation of the room showed the metal rails holding the ceiling tiles were rusted, the metal wheels on all the carts and the sink were rusted, the floor along the wall under the sink had a dirt build-up, and the wall covering was pulling away from the bottom of the wall on both sides of the entry door.

11.a. Review of the hospital's P&P titled Glutaralehyde (Wavicide) for High Level Disinfection (HLD) reviewed 4/14, showed the procedure for rinsing indicated, following immersion in HLD for 45 minutes, all items must be thoroughly rinsed. The rinsing process included rinsing of the probe with sterile water for a minimum of three times. Each rinse should be a minimum of one minute (but maximum five minutes) in duration, and a large volume of fresh sterile water must be used for each rinse.

On 11/18/14 at 1120 hours, the Anesthesia Tech was interviewed regarding the HLD of used Transesophageal probes (probe containing an ultrasound transducer at its tip that is passed into the patient's esophagus allowing images and Doppler evaluation which can be recorded).

The Anesthesia Tech stated after the scopes were immersed in the Wavicide for 50 minutes, she removed the scope from the HLD container and soaked the scope in the sink filled with sterile water and repeated three times. On the third time, the scope would be soaked for 10 minutes.

b. The hospital's P&P titled Cleaning of Transducers reviewed 12/13, read in part, "Transvag [transvaginal] probes are first cleaned with Transeptic spray, dried, and then immersed in Wavicide solution for a minimum of 45 minutes."

During a tour of the radiology suite on 11/17/14 at 1245 hours, the documentation of vaginal ultrasound probe high level disinfection was reviewed. The documentation form contained columns to indicate the time the probe was put in the disinfectant and the time it was removed.

The documentation showed two instances on 11/12/14, when the times the probe was placed in the disinfectant was recorded, but not the time it was removed.

During an interview with the Ultrasound Supervisor on 11/17/14 at 1115 hours, she stated the ultrasound technician forgot to record the time the probes were removed.

12. According to CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, for cleaning surgical instruments, a neutral or near-neutral pH detergent solution commonly is used because such solutions generally provide the best material compatibility profile and good soil removal. Enzyme solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label.

Review of the enzymatic agent used by the hospital, "Medline Dual Enzymatic Detergent" showed the manufacturer's instructions for this agent were to add warm water at 90-110 degrees F. Use one ounce (equivalent to 30 ml) of the detergent mix with one gallon of water.

a. During a tour of the SPD on 11/17/14 at 1010 hours, SPD Tech 1 was observed and interviewed for decontamination of instruments. SPD Tech 1 stated she did not monitor the water temperature for mixing the enzymatic agent. The amount of water put in the sink for mixing the detergent needed to reach the line marked in the sink. SPD Tech 1 stated she added six pumps of the enzymatic agent. TheTech was unable to state the exact amount of "one pump." There was no measurement tool available.

During two observations, when SPD Tech 1 added the water to mix the enzymatic detergent, the amount of water did not fill up to the marked line on the sink. SPD Tech 1 stated the stopper on the bottom of the sink was not working.

b. During a tour of the GI Lab on 11/17/14 at 1320 hours, Endoscopy Tech 1 was interviewed regarding the mixing of enzymatic detergents for cleaning dirty endoscopes. The Tech stated she did not monitor the water temperatures for mixing with the enzymatic agent.

c. During a tour of the OR Decontamination room on 11/18/14 at 1120 hours, during an interview, the Anesthesia Tech stated she used the enzymatic agent to decontaminate used flexible scopes. The Anesthesia Tech stated she did not monitor the temperatures of the mixing water.


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13. Review of the hospital's Infection Control Orientation curriculum showed hand hygiene was the single most effective way to prevent the spread of infection and should be performed before and after each patient contact and before and after wearing gloves.

Review of the hospital's P&P IC.4.6.1 titled Infection Control revised 1/14, showed for isolation patients a gown and gloves should be worn. Gloves are to be removed before leaving the patient's environment and hands disinfected immediately with an antimicrobial agent. After glove removal and hand disinfection, ensure that hands do not touch potentially contaminated environmental surfaces or items in the patient's room to avoid transfer of microorganisms to other patient's or environments.

The hospital's P&P IC4.2.2 titled Infection Control, Gown Technique in an Isolation Room revised 6/11, showed gown ties are to be fastened securely so that the gown fits snugly and clothing is covered. The attached page showing a example of safe donning and removal of gowns showed to fasten the gown in back at neck and waist.

a. On 11/17/14 at 0930 hours and on 11/18/14 at 0850 hours, during the observations of the Critical Care Units with the Director of Critical Care and RN C, the following was observed:

* RN G was in a contact isolation room providing care to the patient. The RN's protective gown was not secured at the neck allowing the gown to fall down over her shoulders, exposing the front of her nursing uniform as she bent over the patient to provide care. The RN kept pulling the gown up to cover the top of her uniform with the gloves she was using to provide care to the patient.

* At 1030 hours, an RN left a patient room, still wearing the gloves used to care for the patient. The RN walked across the hallway and disposed of the gloves in a trash container at the nurses' station. After removing the gloves the RN used her hands to brush her hair away from her face and talked to another staff member prior to performing hand hygiene.

* At 1100 hours, the family member of a patient on contact isolation was seen removing their gown and gloves, but did not perform hand hygiene prior to leaving.

b. On 11/18/14 at 1350 hours with RN M on the 6th floor, an RN was observed in a contact isolation room. The RN removed his PPE and performed hand hygiene. After stepping outside the room, the RN took a cleaning cloth to disinfect the movable computer and station outside the door.

After disinfecting the computer, the RN stepped back into the isolation room and lifted the lid on the trash container, where used gowns and gloves were placed, with his bare hand. The RN did not perform hand hygiene after touching the lid on the trash container and left the area pushing the computer cart.

c. On 11/17/14 from 0900 to 1130 hours, the following observations were made in the ED during an observation of RN N preparing and administering IV medications for Patient 15.

RN N repeatedly failed to perform hand hygiene. The RN touched the computer and patient equipment and did not sanitize or wash his hands before or after the procedure.

At approximately 1000 hours, RN N was observed computer charting next to the patient's bed in the ED. RN N went to the medication cart to prepare a medication for IV administration. RN N walked to the patient's bedside holding the syringe with his bare hands. Without sanitizing or washing his hands again and donning gloves, he administered the IV medication via Patient 15's IV access port without previously scrubbing it with alcohol.

RN N then interrupted the medication administration and asked Patient 15 to hold the syringe with medication so he could obtain the patient's blood pressure. RN N picked up a blood pressure cuff, which was on the floor with his bare hands, obtained the blood pressure, and finished the medication administration.

When informed on 11/17/14 at 1030 hours of the sequence of observations made of RN N during the provision of care for Patient 15, the Director of Trauma confirmed RN N's infection control techniques were a clear disregard of basic infection control practices and standards of nursing practice.

14. During the observations of the hospital environment, the following was observed:

a. On 11/17/14, in the CCU/ICU, the laminated covering on the counter tops at the nurses' stations and patient rooms had missing areas of laminate exposing the porous wood underneath. There were penetrations in the walls in the patient rooms, exposing the porous wallboard underneath.

The paint on door frames was chipped off exposing the metal underneath and the outer laminate covering on the doors had missing areas exposing the porous wood underneath. The caulk under the towel dispensers mounted next to the sinks had water damage. Around the edges of the floors and in the corners was a dirt build-up.

The air tube stations had chipped paint exposing the metal underneath and rusty areas in the metal.

Dust was observed in the intake vents.

The cabinet under the sink in a patient room had water damage which cracked the bottom of the cabinet; there was dirt around the edges and in the corners and a large rust area. The remainder of the cabinet doors under the sinks were secured and could not be observed.

b. On the 6th floor, the air tube stations had chipped paint, exposing the metal underneath and rusty areas in the metal.

In the shower room, there was a one piece metal sink and cabinet combination attached to the wall. The cabinet was painted white and there were areas where the paint was chipped off and a rusted area on the front. On the faucet was a build-up of a white substance.

The same type of sink was found in patient rooms. The paint on the side of the cabinets had bubbled due to water damage. A build-up of a white substance was noted on the handles, and there was a dirt build-up on the floor under the sinks.

Wall covering was peeling away from the base of a wall.

On 11/20/14 at 0900 hours, a meeting was held with hospital personnel to discuss infection control issues. The Director of Facilities was asked if the secured cabinets under the sinks in the facility were opened and inspected for possible water damage and mold. The Director stated they were inspected on a regular basis during the EOC rounds; if any issues were found they would be corrected.

The surveyor requested a copy of documentation of issues found during EOC rounds regarding the undersink areas. The Director stated there were no check off sheets to show when areas were inspected or if any issues were found. If an issue was found a work order was submitted. The only tracking method presently was to go through all the work orders. There was no method to be able to track and trend the environmental issues found.

c. On 11/19/14 at 1100 hours, observation of the contracted dialysis service storage room was done with the Director of Trauma. Observation of the three dialysis machines stored in the room showed the reverse osmosis system mounted the to the back of the machines had rusted metal parts, a white build-up on areas of the equipment and dirt at the base of the system. A rubber glove placed over the ends of the machine hoses contained drainage from the hoses. The outside of the gloves was wet and dripping fluid.

d. On 11/19/14 at at 1020 hours, observation of the laundry area used to clean the cloths and mop heads for Environmental Services was done with EVS 2.

The washing machines had rusted areas on the sides and in the back. The areas of rust on the back of the washers had weakened the metal and there were holes in the rusted areas. There was a white build-up on sides and top of machines, powdered soap build-up around the area where soap was placed in the washer and water on floor behind one machine. The faucet behind the machine was dripping and the sink where cleaners were mixed was rusty. There was rust on front and sides of the dryer and dust build-up was noted on lines behind dryer.

e. On 11/18/14 at 1430 hours, a portable x-ray machine used throughout the hospital in patient rooms had chipped off paint in many areas exposing the metal underneath. The large rubber covered cords were dirty.

f. On 11/19/14 at 1330 hours, observation of the adult crash cart in the MRI/CT Suite of the outside provider, Suite 13 showed the handles of the cart were loose and wrapped with a white medical tape. The tape was dirty.


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g. On 11/17/14 at approximately 0945 hours, a tour to the ED Trauma Room accompanied by the Director of Critical Care Unit was conducted. The Trauma suite had no patients at this time and had been cleaned after its last use.

There was only one available handwashing sink in the suite; it was located near the exit door. Observation of the interior of the sink showed spills of blood and a used splint from the previous patient.

During an interview with Housekeeping 1 on 11/17/14 at 0945 hours, she confirmed she had cleaned and sanitized the Trauma Room.

During an interview with the Director of Trauma on 11/17/14 at 0950 hours, she stated the handwashing sink should not be used for discarding body fluids as it considered potentially contaminated.

h. According to the USA Food and Drug Administration: Refrigerator Strategies: Keeping Food Safe, take steps to make sure your refrigerated foods stay as safe as possible. Wipe up spills immediately. This helps reduce the growth of the Listeria bacteria (which can grow at refrigerated temperatures).

On 11/28/14 at 1100 hours, an observation was made of the patient refrigerator in the ED nurses' station accompanied by the Critical Care Director.

The refrigerator contained soft drinks, milk, and orange juice. The refrigerator was observed with yellowish stains, yellow food/drink spills, and food particles.

A concurrent interview was conducted on 11/28/14 at 1105 hours with the ED Manager. The Manager stated Housekeeping staff did not have a schedule to clean the patient's refrigerator; the nurses needed to ask them to clean when necessary. The ED Manager could not state the last time the patient's food refrigerator was cleaned.


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i. An initial tour of the Medical/Surgical Unit medication room was conducted on 11/17/14 at 0920 hours, accompanied by DON 1. One 10 ml vial of sterile water, one 500 ml bottle of sterile irrigation water, syringes, and two bags of irrigation solution were observed stored in the bottom shelf.

The bottom shelf was dusty and was very low to the ground. Two bags of irrigation solutions touched a step stool with white dusty and yellow residue. The DON confirmed the observation. The DON stated these items should not be stored in that manner.

j. An inspection of the clean utility room was conducted on 11/17/14 at 1320 hours, in the Observation Unit accompanied by DON 1 and RN A. A closet in the room contained bags of IV fluids. The shelf of the closet was rusty. Multiple bags of IV fluids were stored on the bottom shelf which was directly on the floor. The shelf had a white dusty build-up and white residue. The DON and the RN confirmed the observation.



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k. The Cardiac Rehab area was toured on 11/18/14 at 0900 hours, with the Director of Trauma and Director of Cardiology. The unit housed gym equipment which the Directors stated was used for the Cardiac Rehab patients and was also available to hospital staff at certain hours.

Observation of the weight machines showed cracks in the material covering the benches of three of the machines. In addition, the arm supports of the abdominal crunch machine had a foam/porous material edged with black tape.

The Director of Cardiology stated nursing cleaned the machines with Sani wipes in between patients but was unable to state how the surfaces could be sanitized with cracks in the material covering the benches.




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15. Review of the hospital's P&P titled Comprehensive Breastfeeding, Breast Milk Identification, Storage, And Addition Of Human Milk Fortifier (B-01, Review Date: 07/13)" indicated, "Purpose; B. To provide staff with information regarding the identification and storage of expressed breast milk in the hospital setting..., 6. Fresh expressed milk (never frozen) can be refrigerated up to 48 hours between 35 - 40 degrees F..., 13. Refrigerator will have daily temperature control check and documented on Refrigerator Temperature Log., 14. If at any time refrigerator temperature is not in compliance with temperature stated above all stored breast milk will be discarded as biohazard waste. Engineering will be notified to repair refrigerator."

In addition, the P&P showed "7. Expressed milk can be frozen in the freezing compartment of a deep freeze (-20 degrees C, 0 degrees F) for 12 months.."

On 11/18/14 at 1315 hours, in the NICU, a separate room was observed with a refrigerator/freezer. A freezer compartment with separate doors was used to store breast milk.

Located on the door of the refrigerator was a log entitled Medication-Vaccine-Breast Milk Refrigerator temperature record that indicated, "Definition; Temperature range 36 degrees F to 46 degrees F." Next to those temperatures was a handwritten temperature in a bold black color that indicated "(39 degrees F)."

Concurrently, an observation was conducted of the internal thermometer temperature of the refrigerator storing the breast milk. The Nurse Manager stated, "It reads 41 degrees F." The Nurse Manager stated 41 degrees F was an acceptable temperature in accordance with directions on the breast milk temperature log.

Concurrently, the Director of NICU reviewed the breast milk temperature log posted on the refrigerator. The Director was asked if the documented 41 degrees F temperature was acceptable. The Director of NICU pointed to the directions on the breast milk temperature log that indicated a range of 36 - 46 degrees F, and stated, "Yes, 36 degrees F to 46 degrees F is acceptable." The Director of NICU was asked why there was a handwritten temperature in parenthesis on the log that indicated 39 degree F and she stated, "I don't know."

Review of the breast milk refrigerator temperature log for the month of November 2014, indicated through 11/18/14, there were nine times that staff documented a temperature at 41 degrees F. Review of the breast milk temperature log for the month of October 2014, showed 21 of 31 temperature entries noted were greater than 40 degrees F.

The Medication-Vaccine-Breast Milk Refrigerator temperature record included the following directions on the log, "Definition; Temperature range 36 degrees F to 46 degrees F."

Next to those temperatures was a handwritten temperature in a bold black color that indicated "(39 degrees F)" Guidelines; Enter time & initial in the corresponding box for the observed temperature Twice daily. Initials above or below the double lined box indicates that the temperature is outside the specified range. If the temperature is out of range: 1. Adjust the Temp and document action taken.

Failure to achieve range requires informing Facilities. 2. Notify Facilities and document

Based on observation and interview, the hospital failed to ensure the CEO and CNO implemented and maintained an effective infection control program, creating the risk of substandard health outcomes to the patients in the hospital.

Findings:

1. The hospital's infection control program was not incorporated into the hospital's QAPI program. Data from the infection control EOC rounds was not reported to the QA program. Cross reference to A0273, example #1.

2. Poor hand hygiene practices were observed, hand hygiene data appeared inaccurate, and there was no documentation provided to indicate the hospital was in the process of improving data gathering regarding hand hygiene. Cross reference to A0273, example #2.

3. The infection control program plan for 2013, to evaluate and plan interventions for assessed high priority risk of admission of patients with MDRO infections was not implemented. Cross reference to A0749, example #1.

Based on record review and interview, the hospital failed to ensure one of 58 sampled patients (Patient 47) was provided with a discharge planning evaluation to evaluate the patient's capacity for self-care or of the possibility of the patient being cared for in the environment from which he entered the hospital. The had the potential for immature discharges.

Findings:

Review of the hospital's P&P titled Discharge Planning approved 1/6/14, showed nursing staff are to assess discharge planning needs as part of the initial nursing assessment, refer high-risk patients to Case Management Services, include discharge needs in the plan of care and update as needed, and assist patient in maintaining functional status. Nursing staff are to assess quality parameters for patient stability at discharge and provide consultation to patient and family regarding continuing care need.

Review of Patient 47's medical record was initiated on 11/19/14. The patient was admitted to the hospital on 5/10/14.

Review of the Admission Assessment Inquiry dated 5/10/14 at 0937 hours, showed the following:

* The patient had changed in functional mobility (gait, balance, or transferring difficulties) and had newly identified difficulty in performing ADLs.

* The patient had a history of falls. The patient's upper and/or lower body strength was inadequate for safe mobility. The patient had weight bearing restriction on one or more extremities and was identified as high risk for falls.

* The patient was unable to ambulate.

Review of the Daily Assessment Inquiry showed an entry dated 5/11/14 at 0845 hours, Patient 47 had an initial PT evaluation. The patient required "Contact Guard Assist" for positioning from supine to sitting and from sitting to supine; transferring from bed to chair; and gait. The recommendations included PT treatment twice daily six times a week and once daily on Sunday.

Review of the physician's order signed by a PT on 5/11/14 at 0915 hours, and the physician on 5/11/14, indicated the physician approved the recommended PT treatment plan.

Review of a physician's order dated 5/11/14, showed to discharge the patient home.

Review of Discharge Assessment/Summary Report showed Patient 47 was discharged on 5/11/14 at 1400 hours.

Further review of Patient 47's medical record failed to show documented evidence Patient 47 was assessed for discharge planning needs within 24 hours of admission when the patient was identified having changed in functional mobility and required PT treatment. There was no documented evidence to show nursing staff assessed the patient for continuing care needs when discharged.

An interview and concurrent medical record review was conducted with DON 1 and RN C on 11/19/14 at 1350 hours. There were asked about discharge planning assessments when a patient was admitted. The DON stated nursing staff would initiate a discharge planning assessment when the patient was needed to be referred a Case Manager would be involved. When asked, the DON was unable to find documented evidence to show an assessment of discharge planning needs was initiated within 24 hours of admission for Patient 47 as per hospital's P&P.

Based on interview and document review, the hospital failed to track the readmission rate to determine whether the readmissions were potentially due to problems in discharge planning or the implementation of discharge plan. This failure could cause the hospital being unable to evaluate the effectiveness of discharge planning.

Findings:

On 11/19/14 at 1350 hours, during an interview, the Case Manager stated there was no tracking of the hospital's readmission as part of its review of the discharge planning process.

On 11/19/14, review of the hospital's QAPI documents did not show any data regarding the hospital's assessment of readmissions.

On 11/20/14 at 1110 hours, during a meeting with the QAPI committee, the CNO stated she was not aware of any initiative for tracking unplanned readmissions, and one needed to be started.

Based on record review and interview, the hospital failed to ensure surgical services were provided maintaining high standards of practice as evidenced by:

1. The humidity levels in the sterile processing area and surgical services area were not maintained properly to provide a safe environment for patients receiving surgical care.

2. Air vents were not cleaned in the OR sterile core area and metal parts of multiple pieces of furniture and equipment in an OR room were corroded and rusted. The surface of a cart used for medication preparation had opened cracks.

3. The hospital's P&P was not implemented to have a dedicated RN administering and monitoring moderate sedation for the patients in the Endoscopy Lab with no other duties.

4. The OR was not properly cleaned between cases.

5. High level disinfection of surgical devices was not done in a safe location.

These failures could result in poor quality care of surgical patients and increase in infections.

Findings:

1. According to AORN 2013, Recommended Practices for a Safe Environment of Care, Recommendation V.b. stated, "Low humidity increases the risk of electrostatic charge, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust."

Review of the hospital's P&P titled Temperature and Humidity Monitoring revised on 8/1/13, showed humidity and relative humidity would be monitored daily and maintained between 30% to 60% with humidity in the perioperative suite, including operating rooms and sterile processing. The temperature and humidity are to be recorded on the Temperature Record and Humidity Record for every operative area every 24 hours by a designated person.

If humidity is out of range submit a work order and call Engineering immediately. Document on log under ACTION TAKEN the work order was placed. If Engineering is unable to correct humidity or temperature the department director/designee is notified immediately. Document in the "ACTION TAKEN" column what you did about the temperature or humidity being out of range. Leave column blank if temperatures and humidity are with in normal range.

Review of the hospital's humidity documentation, Operating Room Suite Daily Humidity Record showed the definition of the humidity range as 30% to 60%.

The documentation for November 2014, showed the following for two days in November 2014, humidity was less than 30% in the SPD and five days in 11 of 11 ORs. There was no documentation of action taken to resolve the problem. Cross reference to A0726.

2. On 11/18/14 at 1042 hours, during a tour in the Surgical Services restricted area, the following was noted:

a. The ceiling vent in the OR central core had heavy visible debris. A storage cart was located directly below the vent. The shelf that stored sterile packages and patient positioning devices showed accumulated debris.

b. An accumulation of dust was observed on the outside of unused water supply pipes.

c. On 11/18/14 at 0948 hours, during an observation of one of 11 ORs, the metal parts of multiple pieces of furniture and equipment in an OR room were corroded and rusted. The surface of a cart used for medication preparation had opened cracks. Cross reference to A0749, example #9.

3. The hospital's P&P titled Staffing in the Endoscopy Lab reviewed 4/11, indicated if an ACLS certified RN is administering moderate sedation for the patients in the Endoscopy Lab, the RN should monitor the patients continuously. The monitoring nurse will have no other duties that would restrict him/her from continuous monitoring.

On 11/18/14 at 1330 hours, a GI procedure was observed with the Director Perioperative Services. The GI room light was dimmed as the procedure required. During the procedure, RN V administered operative sedation drugs, Versed and fentanyl throughout the procedure via the patient's IV line.

However, at the same time RN V was observed assisting preparation of lab requisitions for the lab after the GI physician obtained a specimen. RN V turned his back to the vital signs monitor and walked away from the patient's gurney toward the end of the room to pull out the requisition forms from the bottom drawer.

In a concurrent interview, the Director Perioperative Services stated there was only one RN assigned for moderate sedation and circulating in the GI Lab.

4.a. On 11/18/14 at 0930 hours, during a tour of the OR, Housekeeping 1 was observed cleaning between cases. Housekeeping 1 was observed wiping down the front and back pads of the OR table, placing the pads back immediately after wiping, not allowing the pads to dry. In a concurrent interview, Housekeeping 1 stated the disinfectant Quat required a wet time of 10 minutes.

b. On 11/18/14 at 0948 hours, one of 11 ORs was observed for a surgical procedure. A service cart located in the room showed the top plastic surface was cracked with lined open fissures. The circulating RN used the surface for preparing medications.

In the OR room, the metal parts of most of the furniture were corroded and rusted; for example: two surgeons chairs, a patient positioning head rest, linen hampers, kick buckets, cautery machine, back table and instrument carts. During a concurrent interview, the Director of Perioperative Services stated those items were aged furniture.

On 11/19/14 at 1125 hours, during an interview, the EVS Director stated the EVS services staff was aware of the corrosive surfaces in the surgical services area and the proper way to disinfect the corrosive surfaces was discussed as a concern. They cleaned the items "as is."

5. In the surgical services area, the Decontamination Room was toured on 11/18/14 at 1100 hours.

A HLD container with Wavicide was on a counter in the room. According to the SPD Manager, the SPD staff and Perioperative Staff performed disinfection of reuseable vitroctomy lens with HLD Wavicide in this room.

The vitroctomy lens were then taken to the operating sterile field after disinfection for eye surgery.

During the observation of the room, two EVS workers were working to sort two wheeled bins containing bags of trash. Observation of the ceiling vent in the room that was adjacent to an instrument autowasher had visible debris and dust.

When asked about the HLD done in a room with trash, the Manager acknowledged the disinfection process was performed in a contaminated environment. The Manger stated the staff locked the room during the disinfection process to eliminate traffic for infection prevention. However, the Manager acknowledged the room was a contaminated environment used for storage of trash.

On 11/20/14 at 1300 hours, further observation of the OR Decontamination Room was done with RN H. The metal rails holding the ceiling tiles were rusted, the metal wheels on all the carts and the sink were rusted, the floor along the wall under the sink had a dirt buildup, and the wall covering was pulling away from the bottom of the wall on both sides of the entry door.

Based on observation and interview, the hospital failed to ensure a spare tracheostomy tube (a tube inserted into a hole in the neck to windpipe] at the bedside of one of 56 sampled patients (Patient 30). This resulted in the potential for a tracheostomy tube not readily available in the event of accidental dislodgment. In addition, the Respiratory Department failed to update their P&P on in-line suction catheters to reflect their current practice. The failure could result to unsafe practice due to poor infection control measures.
Findings:

1. Review of the Lippincott Manual of Nursing Practice 8th edition, Procedures and Guidelines for Tracheostomy Care, recommended an extra tracheostomy tube be kept at the bedside of a patient with a tracheostomy; in the event of tube dislodgement reinsertion of a new tube may be necessary.

During tour rounds of the Medical Surgical 4th floor accompanied by the Respiratory Therapy Manager on 10/18/14 at 1000 hours, Patient 30 was observed with a tracheostomy tube connected to a mechanic ventilator (machine that replaces spontaneous breathing).

During an interview with the RT 1 on 11/18/14 at 1005 hours, the RT confirmed Patient 30 did not have an emergency tracheostomy tube at bedside. RT 1 stated Patient 30 was admitted last night; they would have to order an extra tube.

During a concurrent interview with the Director of Respiratory Therapy the Director confirmed the above findings. The Director, when asked, stated the RT Department did not have a specific P&P to address tracheostomy care. The Director stated staff referred to Lippincott Nursing Manual for guidance.



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2. On 11/20/14, review of the hospital's P&P for Suction-Closed System for the Ballard Trach Care Closed Suction Catheter for RTs and RNs, approved on 7/15/11, showed, the system was a method to remove secretions while maintaining ventilation and reducing potential contamination.

The system would be changed every 24 hours from the initiation or change of the device and as necessary for contamination or malfunction. The procedure included placing a 24-hour change-out sticker over the suction valve.

On 11/17/14 at 0930 hours, during an initial tour of the ICU, a patient connected to a ventilator was observed. The patient's suction-closed system did not have a sticker to show when it should be changed. When asked, RN X and RN C, the Charge nurse, stated they did not know when the system was initiated and when it should be changed.

Four additional ventilated ICU patients were checked via a computer accessible to RTs only.

Patient 56's suction catheter was initiated on 11/11/14, and was changed on 11/14/14, within 72 hours.

Patient 57's suction catheter was initiated on 11/15/14, and was due for change on 11/18/14.

However, Patient 39's suction catheter was initiated on 11/3/14 and was not changed up to 11/17/14.

Patient 58's suction catheter was changed after two days only, from 11/13/14 to 11/15/14, within 48 hours.

On 11/17/14 at 1030 hours, the Director of the Respiratory Department stated the catheters lasted 72 hours before requiring change out. The Director of Respiratory stated their current practice did not reflect the current P&P. The size 14 French catheters could last 72 hours while the size 12 French or smaller suction catheters used in NICU were changed every 24 hours. The Director stated stickers should be attached to the tubing to determine its duration.