HospitalInspections.org

Based on observation, interview and record review, the hospital's governing body failed to ensure the hospital's compliance with the Federal requirements set forth in the Medicare Conditions of Participation (CoP) as follows:

Findings:

1. The hospital failed to ensure its governing body provided a comprehensive evaluation of the safety and effectiveness of hemodialysis services as provided to hospital patients under a contractual agreement by an outside provider. (Cross reference A-083; A-084)

2. The governing body failed to ensure the hospital's compliance with patient's rights provision, advance directive, right to receive care in a safe setting and the use of restraints in accordance with the physician's orders. (Cross reference A-115, A-117; A-132; A-144; A-166; A-168)

3. The governing body failed to ensure the hospital's compliance with the ongoing evaluation and implementation of an effective Quality Assurance and Performance (QAPI) program. (Cross reference A- 263; A-267; A-288; A-290)

4. The governing body failed to ensure the nursing services were provided in accordance with acceptable standards of practice to ensure the health and safety of patients, (Cross reference A-385; A-395; A- 396; A-398; A-457; A-467)

5. The governing body failed to ensure pharmaceutical services carried out its full and complete oversight of the services provided to ensure the health and safety of patients. (Cross reference A-490; A-491; A-500; A-501; A-507)

6. The governing body failed to ensure the hospital's compliance with the implementation of an active infection control program and the implementation of its policies and procedures to prevent the transmission of infections, particularly on patients receiving hemodialysis treatments and patients diagnosed with infectious diseases. (Cross reference A-747; A-748; A-749)

Based on observation, interview, record review and document review, the hospital failed to promote the patients's rights as follows:

1. The hospital failed to provide patient's rights information prior to providing care to patients. (Cross reference A-117)

2. The hospital failed to ensure information relative to advance directives for health care were provided to patients. (Cross-reference A-132)

3. The hospital failed to ensure the provision for a safe environment to ensure the patient's health and safety. (Cross reference A-144)

4. The hospital failed to ensure the patient's nursing care plan included the use of bilateral wrist restraints and a hand mitten. (Cross reference A-166)

5. The hospital failed to ensure physician orders were obtained prior to the application of bilateral wrist restraints and a hand mitten. (Cross reference A-168).

The cumulative effect of these practices resulted in the failure of the facility to deliver the statutory mandated compliance with the Condition of Participation for Patient's Rights.

Based on observation, interview, record review and document review, the facility failed to ensure the implementation of an effective quality assessment and performance improvement program (QAPI), to include the ongoing evaluation of all the services provided to 16 of 16 dialysis patients, including the provision for hemodialysis as provided to patients by an outside provider under a written agreement with the hospital.
Findings:
1. The facility failed to ensure that their QA Program collected, measured, and analyzed data on the completion of serologic testing for the determination of all dialysis patients' Hepatitis B (an infectious viral illness that causes inflammation of the liver) status. Serologic tests for the determination of Hepatitis B were not completed on 14 of 16 hemodialysis patients. (Cross reference A-267; A-748 #1)
2. The facility failed to ensure that their QA Program monitored the effectiveness of infection control and safety practices used by the contracted dialysis service. Dialysis nurses did not clean and disinfect dialysis machines in between use for patients with unknown Hepatitis B status. (Cross reference A-748 #2 & 3)
3. The facility failed to ensure that their QA Program monitored the staffs' compliance related to infection control practices that prevents the spread of infectious diseases. Staff did not implement the facility's contact precaution policy and procedure. (Cross reference A-749)
4. The facility failed to ensure that their QA Program monitored the effectiveness of the implementation of safety measures while providing hemodialysis treatments. Hoses connecting the water source (faucet) to the dialysis machine and the patient were not safely secured to prevent accidents. One patient receiving hemodialysis treatment was left unattended while dialysis treatment was in progress. (Cross reference A-263)
5. The facility failed to ensure that their QA program included the ongoing evaluation of nursing services related to the patient use of restraints and Total Parenteral Nutrition (TPN) administration. (Cross reference A-166; A-395; A-396 and A-748)
The cumulative effect of these systemic practices and issues resulted in the failure of the facility to deliver statutorily mandated compliance with the Condition of Participation for the Quality Assessment and Performance Improvement.

Based on observation, interview, record review and document review, the hospital failed to ensure nursing services were provided in accordance with the hospital's policy and acceptable standards of practice to ensure the health and safety of patients.

Findings:

1. The hospital failed to ensure that 16 of 16 patients receiving hemodialysis treatments had documented evidence of Hepatitis B screening, to include the 3 serological tests as required by the hospital's policy, prior to the initiation of hemodialysis treatments. (Cross reference A-395 #1)

2. The hospital failed to ensure that the nursing services provided included the ongoing evaluation of the dialysis nurses' compliance with the hospital's policy, relative to the cleaning and disinfection of dialysis machines inbetween patients with unknown Hepatitis B status. The failure to comply with the policy could potentially result to the transfer of Hepatitis B infection from one patient to another. (Cross reference A-395; A-398; A-
748)

3. The hospital failed to ensure the nursing services compliance with the patient safety policy. (Cross reference A-144).

4. The hospital failed to ensure the ongoing evaluation of the nursing care and safety needs of a patient receiving total parenteral nutrition (TPN). (Cross reference A-395; A-396)

5. The hospital failed to ensure the nursing services provided included the evaluation of the use of restraints, including the physician's orders allowing the use of restraints. (Cross reference A-168)

Based on observation, interview, record review and document review, the hospital failed to implement an active infection control surveillance program to include the ongoing evaluation of hemodialysis services, as provided to 16 patients requiring hemodialysis treatments (procedure which involved the removal of chemical substances from the blood by passing it through tubes made of semi-permeable membranes.)

Findings:

1. The hospital's policy requirement for the monthly attendance of a representative from the dialysis provider in the monthly Quality Assurance and Performance Improvement (QAPI), was not followed. A representative from the dialysis provider did not attend the meeting for 4 consecutive months, during the previous 6 months from January 2011 to June 2011. There was also the lack of attendance and active participation of a representative from the dialysis provider during the monthly infection control committee meetings from January 2011 to June 2011. Hence, infection control issues related to the Hepatitis B serological assay screening to confirm the 16 hemodialysis patients exposure to Hepatitis B infection were not identified, evaluated and acted upon. (Cross reference A-748; A-749)

2. The hospital failed to implement its policy and procedure relative to the cleaning, bleach treatment and heat disinfection of dialysis machines used inbetween patients, particularly those patients whose Hepatitis B status had not been confirmed, based on the 3 serologic test results for Hepatitis B. (A-748).

3. The hospital's failure to ensure that a comprehensive evaluation of the dialysis provider's compliance with infection control policies and procedures to ensure the health and safety of patients. (Cross reference A-084).

Based on the above findings, an Immediate Jeopardy (IJ) situation in which the hospital's non-compliance with the Condition of Participation for Infection Control, that could have caused or was likely to cause serious injury to patients, was declared by the survey team on 7/15/11 at 1:50 P.M. The survey team had a meeting with the following hospital staff in attendance: Chief Operating Officer (CEO), Regional CEO, Dialysis Nurse Coordinator, Chief Nursing Officer, Director of Quality and Risk Management.

The immediate corrective actions in response to the Immediate Jeopardy situation was submitted and implemented by the facility beginning on 7/15/11 at 5:30 P.M. The survey was extended through 7/19/11 to further validate the facility's compliance and full implementation of their plan of correction.

The facility's failure resulted in a potential for Hepatitis B exposure of a patient with unknown Hepatitis B status, to a patient that was susceptible to Hepatitis B infection. The cumulative effect of these system problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for infection control, and the failure to provide care in a safe environment.

Based on interview and document review, the facility failed to ensure that only the governing body had authority to grant temporary privileges to the medical staff to provide care in the facility.

Findings:

A review of the Medical Staff Bylaws was conducted on 7/12/11 at 10:45 A.M. The bylaws specified, "The Governing Board shall ultimately be responsible for granting membership and Privileges (provided, however, that these functions may be delegated to the Chief of Staff (COS) and Chief Executive Officer (CEO) with respect to requests for temporary Privileges)."

A review of the Medical Staff Roster was conducted on 7/12/11 at 10:47 A.M. The roster indicated that none of the Medical Staff had temporary privileges.

An interview with the Chief Executive Officer, a member of the Governing Board, was conducted on 7/12/11 at 10:48 A.M. She stated that temporary privileges were not commonly granted. She said currently there were no Medical Staff with temporary privileges. She acknowledged that the Medical Staff Bylaws delegated granting temporary privileges to Medical Staff by the COS and CEO during emergency situations, for example a patient who required care from a specialist that was not a member of the Medical Staff. She also acknowledged that the Governing Board was not involved in the granting of temporary privileges in accordance with the regulation.

Based on interview and document review, the facility failed to ensure that its governing body provided a comprehensive evaluation of the contracted dialysis service, to ensure that hemodialysis treatments were provided in a safe and effective manner, for 16 of 16 sampled hemodialysis patients (Patients1 to16).

Definition:
Hemodialysis is the removal of chemical substances from the blood by passing it through tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

Findings:

On 7/13/11 at 8:00 A.M., a review of the facility's contract for dialysis services was conducted. The contract was first established on 3/6/06 and was last amended on 1/7/10. The written agreement indicated that the following responsibilities will be carried out: "Whenever patients are receiving Services (hemodialysis), Company (contracted dialysis agency) shall provide on duty at least one (1) nurse currently licensed in the Hospital's state and experienced in rendering Services, to oversee the provision of Services and such additional Staff to maintain an appropriate patient/staff ratio. The Staff shall monitor and regulate the Services in conformity with Physician's orders and the patient's condition. The duties and responsibilities of the Staff providing Services hereunder are set forth in Exhibit 3.10." The written agreement did not include a statement indicating that the facility retained professional and administrative responsibility for the services provided.

A review of the facility's policy and procedure related to Hepatitis B revealed that the required screening for Hepatitis B was not fully implemented as written.

A review of the facility's policy and procedure relative to the cleaning and disinfection of hemodialysis machines was not implemented as written.

The dialysis nursing staff's compliance with the policies and procedures related to dialysis and patient safety was also not implemented.

Involvement and active participation of the dialysis representative in monthly quality assurance and performance improvement (QAPI) and infection control meetings, was not evident.

On 7/13/11 at 8:15 A.M., and interview was conducted with the facility's Chief Executive Officer (CEO). The CEO confirmed that the contract was still in effect. The CEO acknowledged that terms regarding the facilities retained professional and administrative responsibilities were missing. The CEO stated, "We need to review and update this contract."

The facility's governing body failed to evaluate the safety and effectiveness of the contracted dialysis services which impacted the quality of services rendered to hemodialysis patients.

Based on observation, interview, record and document review, the facility's governing body failed to ensure that contracted dialysis services were provided in a safe and effective manner, for 16 of 16 sampled patients (Patients 1 to 16) receiving hemodialysis treatment.

Sixteen of the hospital's 69 patients (7/12/11 census) required hemodialysis treatments as provided under a written agreement (contract) by an outside entity.

Definition:
Hemodialysis is the removal of chemical substances from the blood by passing it through the tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

Findings:

1. A review of the hospital's policy and procedure relative to hepatitis surveillance and infection control measures, revealed a policy statement whereby control measures would be implemented to minimize the spread of hepatitis (inflammation of the liver) infections in the dialysis setting. In order to reduce the risk of transmission of Hepatitis B (caused by Hepatitis B virus transmitted through blood) among patients, all new patients should be tested prior to or at the time of the initial hemodialysis treatment. The patient's Hepatitis B serologic status should have included the following: (a) Hepatitis B Surface antigen (b) Total Hepatitis B Core Antibody (c) Hepatitis B Surface Antibody.

If the results of the above tests were not known at the time of inpatient hemodialysis treatment, the patient should be treated as a suspect patient for Hepatitis B infection. Documentation of the patient's hepatitis serologic tests as specified above would remain in the patient's current active medical record.

On 7/15/11 at 10:20 A.M., an interview was conducted with the dialysis nurse coordinator (RN 2). She confirmed the above policy and indicated they have 16 patients requiring hemodialysis treatment onsite. A joint review of all 16 patients medical records were done to validate if each patient had all the three serological test results as required. It was determined that 14 of 16 patients currently receiving hemodialysis treatment did not have documented test results for Total Hepatitis B Core Antibody Screening. Fourteen of 16 patients receiving hemodialysis treatment did not have the documentation of test results for Hepatitis B Surface Antibody. One of 16 patients did not have the test result for Hepatitis B antigen. It was essential to have all the 3 serological markers identified to determine if the patient had been infected with acute or chronic Hepatitis B.

On 7/15/11 at 10:30 A.M., an interview was conducted with the infection control director. She confirmed her involvement in the ongoing surveillance of all infections at the facility, including the review and implementation of infection control policies and procedures. However, the lack of compliance with the required Hepatitis B screening of all hemodialysis patients was not identified.

2. A review of the hospital's policy on infection control and isolation measures for known or unknown Hepatitis B Surface Antigen Positive patients showed a policy statement whereby the hospital would provide additional infection control measures for the care of known or unknown Hepatitis B Surface Antigen positive patient.

Patients whose Hepatitis B Surface Antigens were unknown would be considered infected with Hepatitis B until determined otherwise by the physician. While hospitalized, each Hepatitis B antigen positive patient would undergo dialysis in a separate room and use a separate dialysis system, equipment, instrument and supplies. The internal pathway of the hemodialysis delivery system (machine) would be cleaned using bleach and heat disinfection. The external surfaces would be thoroughly cleaned with 1:100 bleach solution after every treatment.

On 7/12/11 at 10:30 A.M., a dialysis nurse ( RN 3) was observed applying a dressing to Patient 1's right arm. RN 3 indicated that she had just finished providing hemodialysis treatment to Patient 1 who occupied Bed 1. She then proceeded to push the same hemodialysis machine towards Patient 3, who occupied Bed 3 in the same room. When the surveyor asked RN 3 if she would clean and disinfect the machine first before using the same machine on Patient 3, the nurse stated that she did not have to clean or disinfect the machine because both Patients 1 and 3's serology reports were negative for Hepatitis B antigen. The dialysis nurse coordinator had also confirmed RN 3's statement and validated that no cleaning and disinfecting of the dialysis machine's internal pathway was needed in between Patient 1 and Patient 3. No dialysis machine cleaning and disinfection was observed by the surveyor.

On 7/14/11, Patient 1 and Patient 3 were chosen as sampled patients. The patients' medical records were reviewed with the dialysis nurse coordinator beginning on 7/14/11 at 9:00 A.M.

Patient 1's hemodialysis treatment record dated 7/12/11 showed the patient was dialyzed by a dialysis nurse (RN 3) from 7:00 A.M. to 10:30 A.M. The record showed machine # 7042 was used for the Patient 1's dialysis. The only Hepatitis B screening serology report found in Patient 1's medical record was for Hepatitis B surface antibody which showed a positive test result for Hepatitis B. The serology reports for Hepatitis B antigen and Hepatitis B core antibody were not found in the medical record. It should be noted that per hospital's policy, if the patients' Hepatitis B antigen was unknown, then the patient should be treated as "infected" with the Hepatitis B infection.

Patient 3's hemodialysis record showed the provision of hemodialysis treatment by the same dialysis nurse (RN 3) on 7/12/11 from 12:30 P.M. to 3:30 P.M. The dialysis machine number was 7042, which was the same machine used for Patient 1 on 7/12/11. This was confirmed with interview with the dialysis nurse coordinator on 7/14/11 at 10:20 A.M. Patient 3's medical record only contained the patient's Hepatitis B surface antigen negative result. No other serology reports to indicate that the patient's Hepatitis B core and surface antibodies were found in the record. It should be noted that per hospital policy, patients without these reports should be treated as "unknown" and considered infected and/or susceptible to Hepatitis B.

Record review and interview with the dialysis nurse coordinator on 7/15/11 at 10:20 A.M. confirmed the use of the same dialysis machine on Patient 1 who had a positive Hepatitis B antibody and Patient 3 who had a negative Hepatitis antigen and considered a susceptible patient. RN 3 and the dialysis nurse coordinator confirmed the dialysis machine disinfection was not done in between Patient 1 and Patient 3.

The facility's governing body failed to ensure that the facility's policies and procedures related to infection control and the disinfection of hemodialysis machines were implemented. Comprehensive screening of patients for Hepatitis B (required serology tests) prior to hemodialysis were not performed, obtained and kept in the active medical record. These failures could have potentially resulted in the transfer of infectious diseases such as Hepatitis B.

Based on observation, interview, and record review, the facility failed to provide information on patient's rights prior to providing patient care, for 3 of 30 sampled patients (21, 22, 23).

Findings:

1. On 7/12/11 at 2:00 P.M., joint review of Patient 21's medical record was conducted with the Chief Nursing Executive (CNE). Patient 21 was admitted to the facility on 6/27/11 per the facesheet. The medical record did not contain evidence showing that Patient 21 had been informed of his patient rights. The CNE acknowledged that there was no evidence that Patient 21 had been informed of his patient rights. The CNE stated that the Admissions Department was supposed to provide that information to all patients on admission.

An interview was conducted with the Admission's Director (AD) on 7/12/11 at 2:40 P.M. The AD stated that on admission, all patients or their responsible parties, should have been given a handout that listed 27 patient's rights (i.e. the right to refuse medication and the right to file a grievance). Also provided was information on privacy practices (HIPAA). Medicare patients received information on Medicare payment rights, a document titled "An Important Message From Medicare About Your Rights." Patients were then asked to sign a form titled "Acknowledgment of Receipt of Health Care Information." The receipt form had check boxes to indicate receipt of: "Notice of HIPAA Privacy Practices," "An Important Message From Medicare" and "Patient Rights and Responsibilities." The AD stated that the receipt forms were supposed to be kept in the patients medical records as proof that the patients had been informed or their rights. The AD stated that she had looked everywhere and had found no proof that Patient 21 had ever been advised of his patient's rights. The AD stated, "Maybe he came in at night or on a weekend and we missed him."

An interview was conducted with Patient 21 in his room on 7/13/11 at 10:05 A.M. He stated that he had been hospitalized before and understood what the term "patient rights" meant. Patient 21 stated that he had not been advised of his patient rights on this admission and had not signed the Acknowledgment of Receipt of Health Care Information form.

A review of the facility policy titled "Patients Rights and Responsibility" was conducted on 7/15/11 at 2:40 P.M. The policy stated, "All patients will be informed of their rights and responsibilities."

2. On 7/13/11 at 10:20 A.M., a joint review of Patient 22's medical record was conducted with the Chief Nursing Executive (CNE). Patient 22 was admitted to the facility on 6/29/11 per the facesheet. The medical record did not contain evidence indicating that Patient 22 had been informed of his patient rights on admission. The CNE acknowledged that there was no evidence that Patient 22 had been informed of his patient's rights. The CNE stated that the Admissions Department was supposed to provide that information to all patients.

An interview was conducted with an Admission's Associate (AA) on 7/15/11 at 9:20 A.M. AA stated that Patient 22 should have received a private pay patient's rights packet on admission. AA displayed the packet, which included a handout that listed 27 patient's rights and information on privacy practices (HIPAA). The sample packet included a form titled Acknowledgment of Receipt of Health Care Information. The receipt form had check boxes for: "Notice of HIPAA Privacy Practices," "An Important Message From Medicare" and "Patient Rights and Responsibilities." AA stated that non-Medicare patients were asked to sign the form showing that they had received the information on HIPAA privacy practices and patient rights. AA acknowledged that some patients, including Patient 22, may have been missed.

A review of the facility policy titled "Patients Rights and Responsibility" was conducted on 7/15/11 at 2:40 P.M. The policy stated, "All patients will be informed of their rights and responsibilities."

3. On 7/12/11 at 1:00 P.M., a tour of a medical surgical unit was conducted with the Chief Nursing Executive (CNE). During the tour Patient 23 was observed lying in his bed. Two guards were observed sitting in Patient 23's room.

On 7/13/11 at 11:15 A.M., a joint interview and review of Patient 23's medical record was conducted with the CNE. Patient 23 was admitted to the facility on 6/29/11 per the facesheet. The medical record did not contain evidence showing that Patient 23 had been informed of his patient rights on admission. The CNE looked at the record and acknowledged that there was no evidence that Patient 23 had been informed of his patient's rights. The CNE stated, "He's in custody and prisoners have fewer rights."

A review of the facility policy titled "Patients Rights and Responsibility" was conducted on 7/15/11 at 2:30 P.M. The policy stated, "All patients will be informed of their rights and responsibilities."

A review of the facility policy titled "Care of Forensic (in the custody of law enforcement) Patient" was conducted on 7/15/11 at 2:40 P.M. The policy stated, "Patient Rights and Responsibilities apply to patients in custody, including the right to informed consent and the right to refuse treatment."

Based on interview and record review, the facility failed to ensure that information related to Advance Directives was provided and maintained in the medical record, for 3 of 30 sampled patients (Patients 23, 29, 42).

Definition:
An Advance Directive is a written statement of a person's wishes regarding medical treatment, often including a living will. This legal document is created to ensure health care wishes are carried out should the person be unable to communicate them to a doctor.

Findings:

1. A review of Patient 29's medical record was conducted on 7/13/11 at 9:00 A.M. Patient 29 was admitted to the facility on 7/11/11 per the facesheet. There was no documented evidence to indicate that information regarding Advance Directives was provided to Patient 29.

An interview and joint record review with Registered Nurse (RN 11) was conducted on 7/13/11 at 9:10 A.M. RN 11 stated that Advance Directives were discussed with patients during the admission process, Advance Directive information was provided and the documentation was completed. She acknowledged that Patient 29's medical record did not contain an Advance Directive or documentation to show that information regarding Advance Directives was provided.

An interview and joint record review with the Admissions Associate (AA 11) was conducted on 7/13/11 at 10:25 A.M. AA 11 stated that there was no documentation or record of Patient 29's Advance Directive information being discussed or provided to the patient within 24 hours of admission in accordance with the facility's policy.

A review of the facility's policy entitled "Power of Attorney-Advance Directives" was conducted on 7/13/11. The policy indicated that upon each admission adult inpatients shall be provided with written information on Advance Directives. The policy defined an Advance Directive "... as a Durable Power of Attorney for Health Care, Living Will or Declaration Under Natural Death Act. The policy stipulated that "Documentation will be made in the medical record by the Admissions Department if there is or is not an Advance Directive."

2. A review of Patient 42's medical record was conducted on 7/13/11 at 10:25 A.M. Patient 42 was admitted to the facility on 7/6/11 per the facesheet. There was no documented evidence to show that information regarding Advance Directives was provided to Patient 42.

An interview and joint record review with the Critical Care Director (CCD) was conducted on 7/13/11 at 10:30 A.M. The CCD acknowledged that Patient 42's medical record did not contain documentation or a record of Advance Directive information being provided to the patient in accordance with the facility's policy.

A review of the facility's policy entitled "Power of Attorney- Advance Directives" was conducted on 7/13/11. The policy indicated that upon each admission adult inpatients shall be provided with written information on Advance Directives. The policy defined an Advance Directive "... as a Durable Power of Attorney for Health Care, Living Will or Declaration Under Natural Death Act. The policy stipulated that "Documentation will be made in the medical record by the Admissions Department if there is or is not an Advance Directive."


22932

3. On 7/13/11 at 11:15 A.M., a joint interview and review of Patient 23's medical record was conducted with the Chief Nursing Executive (CNE). There was no documented evidence that information regarding an Advance Directive was provided tor Patient 23. A form titled Resuscitation Status/Advanced Directive Orders (a document indicating who can make patient's treatment choices) was found in the medical record. The form was blank except for Patient 23's name and identification information at the top. The CNE looked at the record and acknowledged that there was no evidence that Patient 23 had been provided information about an Advance Directive. The CNE stated, "He's in custody and prisoners have fewer rights."

A review of the facility policy titled "Care of Forensic (in the custody of law enforcement) Patient" was conducted on 7/15/11 at 2:30 P.M. The policy stated, "Patient Rights and Responsibilities apply to patients in custody, including the... the right to refuse treatment."

A review of the facility's policy entitled "Power of Attorney-Advance Directives" was conducted on 7/13/11. The policy indicated that upon admission adult inpatients shall be provided with written information on Advance Directives. The policy defined an Advance Directive as, "... a Durable Power of Attorney for Health Care, Living Will or Declaration Under Natural Death Act." The policy stipulated that "Documentation will be made in the medical record by the Admissions Department if there is or is not an Advance Directive.

Based on observation, interview and record review, the hospital failed to provide a safe environment for patients, staff and visitors. Unsafe practices were observed, particularly on 2 of 16 sampled patients receiving hemodialysis treatments (Patients 3 and 50). In addition, allergy warning labels were not placed on the medical record covers for 2 of 30 sampled patients per hospital's policy. (Patients 21 and 24).

Definition:
Hemodialysis - is the removal of chemical substances from the blood by passing it through the tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

Findings:

1. On 7/12/11 at 8:50 A.M., a tour and evaluation of 3rd floor patient care unit was done with the director of nursing services. Room X was observed to have 2 patients. Patient 50 ( Bed 1 by the door) was observed to have a hemodialysis machine at his bedside and was receiving hemodialysis treatment. A dialysis nurse (RN 5) was observed sitting next to Patient 50.

Four long drain hoses that were connected to the hemodialysis machine and the water faucet in the bathroom were observed on the floor. The hoses were observed hanging freely, unsecured and unprotected. There was no caution sign or protective covering on the long hoses to alert people to observe caution so no one would trip on the hoses as people entered and exited the room. Two staff were observed walking in and out of the room to attend to the care needs of the patient in Bed 2. A laboratory technician was also observed entering the same room pushing a wheeled cart with laboratory supplies.

On 7/12/11 at 8:56 A.M., an interview was conducted with the dialysis nurse (RN 5) providing treatment to Patient 50. The nurse confirmed the lack of availability of caution signs and/or protective covering that could be utilized to protect the long hoses on the floor.

The staff's failure to implement safety measures, including the use of caution signs to ensure the long hoses were secured and protected could potentially result to accidents. People entering and exiting the room could accidentally trip on the hoses and cause the disconnection of the machine, including the blood tubings that were connected to the patient's blood lines and the hemodialysis machine.

2. On 7/14/11 at 8:40 A.M., during the tour and evaluation of the 3rd floor patient care unit with the director of nursing, Patient 3 was observed receiving her hemodialysis treatment in Room XX. It was noted that the hemodialysis machine was running with blood tubing lines connected to Patient 3. The patient was observed unattended and no dialysis nurse or any other staff was present in the room. Patient 3 was interviewed and asked about the dialysis nurse's whereabouts. The patient replied and stated, " I don't know, she left the room again".

A nurse was then observed entering Patient 3's room about 8 minutes later. She stated that she was the dialysis nurse (RN 7) assigned to Patient 3 and confirmed to be the nurse providing the patient's hemodialysis treatment. When questioned as to why Patient 3 was left unattended during a hemodialysis treatment, she indicated that she had to leave the room to get a normal saline solution. She stated that she had left the patient without asking for another staff to watch the patient in her absence.

The director of nursing confirmed during the interview on 7/14/11 at 8:49 A.M. that any patient receiving active hemodialysis treatment should not be left unattended at any time during the treatment. The dialysis provider policy indicated patients receiving hemodialysis treatment were to be monitored visually and audibly at all times and patients were not to be left unattended.

The hospital's failure to ensure the dialysis provider staff's adherence to this patient safety policy could potentially result to negative outcomes, particularly if the patient's blood lines got disconnected either accidentally or pulled out intentionally by the patient.




22932

3. On 7/12/11 at 2:00 P.M., a review of Patient 21's medical record was initiated. Patient 21 was admitted to the facility on 6/27/11 per the facesheet. Admission orders dated 6/27/11 indicated that Patient 21 was allergic to iodine; contrast media; codeine (a pain medication); sulfamethorxazole (an antibiotic); and indinavir, nelfinvavir, and efavirnez (medications to treat viral diseases). The Admission History and Physical Examination dated 6/27/11 confirmed the allergy list. Patient 21's medical record did not contain an allergy warning label on the cover.

On 7/12/11 at 2:15 P.M., a joint interview and review of Patient 21's medical record was conducted with the Chief Nursing Executive (CNE). The CNE looked at the record and acknowledged that there should have been an allergy warning label on the cover of Patient 21's medical record.

An interview was conducted with the unit nursing manager (RN 23) on 7/13/11 at 9:30 A.M. RN 23 stated that she was not sure if allergy warning labels had to be placed on medical record covers.

On 7/13/11 at 3:30 P.M. the facility policy and procedure titled "Allergy Identification" was reviewed. The policy indicated, "Allergy warning labels are placed on outside/front of patient's chart."

4. On 7/14/11 at 10:48 A.M., a review of Patient 24's medical record was initiated. Patient 24 was admitted to the facility on 4/27/11 per the facesheet. Admission orders dated 4/27/11 indicated that Patient 24 was allergic to latex gloves, surgical tape and silvadene. Patient 21's medical record did not contain an allergy warning label on the cover.

On 7/14/11 at 11:30 A.M., a joint interview and review of Patient 24's medical record was conducted with the Chief Nursing Executive (CNE). The CNE looked at the record and acknowledged that staff had forgotten to put an allergy warning label on the cover of Patient 24's medical record.

On 7/13/11 at 3:30 P.M., the facility policy and procedure titled "Allergy Identification" was reviewed. The policy indicated, "Allergy warning labels are placed on outside/front of patient's chart."

Based on observation, interview and record review, the hospital failed to ensure the patients' nursing care plans were reviewed and modified, to include the use and monitoring of bilateral wrist restraints and a hand mitten, for 2 of 4 sampled patients using restraints (Patients 52, 30).

Findings:

1. Patient 52 was admitted to the hospital on 6/21/11, for continuing medical care and treatment. Treatment modalities ordered by the physician on admission included the use of a nasogastric tube (a tube inserted through the nose that extends into the stomach) and tube feedings for total nutrition and hydration. The patient, according to the physician notes dated 6/21/11, was described as demented with periods of agitation.

On 7/12/11 at 9:45 A.M., Patient 52 was observed in bed with bilateral wrist restraints. The patient was observed trying to raise his hands, but was unable to because of the wrist restraints. The patient was observed to have a nasogastric tube.

On 7/12/11 at 2:15 P.M., Patient 52's medical record was reviewed with the director of nursing (DON). The DON indicated Patient 52 needed the application of bilateral wrist restraints because of the patient's attempts to remove his nasogastric tube. The patient's medical record showed a telephone order from the physician as written by a licensed nurse on 6/29/11 at 11:30 P.M., " Bilateral soft wrist restraints." On 6/30/11, 7/2/11, 7/3/11, 7/5/11 and 7/8/11, the licensed nurses on 3 different shifts recorded the continuing use of bilateral wrist restraints, on Patient 52's nursing flowsheet record. The nurses recorded the wrist restraints were needed to prevent Patient 52 from pulling out his nasogastric tube.

Patient 52's nursing care plan was reviewed with the DON on 7/12/11, beginning at 2:25 P.M. It was determined that the nursing care interventions to be implemented relative to the use of wrist restraints, were not included in Patient 52's nursing care plan.


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2. A review of Patient 30's medical record was conducted on 7/13/11 at 9:30 A.M. Patient 30 was admitted to the facility on 12/21/10, per the facesheet.

According to Patient 30's Physical Restraints Care Plan initiated on 6/8/11, indicated that on 7/10/11, a soft wrist restraint was applied on the left wrist at times. There was no documented evidence to show that a less restrictive restraint such as a mitten was attempted on Patient 30's left hand.

Patient 30's Medical/Surgical Flowsheets were reviewed on 7/13/11. On 7/8/11 during the night shift documentation for assessment for restraints, the documentation indicated that a left hand mitten was applied on the patient. On 7/9/11 at 8:00 A.M., the assessment documentation for restraints indicated that Patient 30's left hand had a mitten. The following documented assessments dated on 7/10/11 at 8:00 A.M., 7/10/11 during a night shift, 7/11/11 at 7:00 A.M. to 7:30 P.M., 7/11/11 at 8:00 P.M. and 7/12/11 at 7:00 A.M. to 7:30 P.M., all indicated under the restraints section that Patient 30 had a mitten on her left hand.

An interview and joint record review with the Critical Care Director (CCD) was conducted on 7/13/11, at 10:35 A.M. The CCD stated that a soft wrist restraint was initially used on Patient 30 to prevent her from pulling out her tubes. She stated that the nursing staff were now using a mitten on Patient's left hand to distract her from pulling out her tubes. She acknowledged that Patient 14's Physical Restraint Care Plan did not reflect the use of a less restrictive restraint such as a mitten on Patient 30's left hand versus a wrist restraint that was initially applied.

A review of the facility's policy and procedure entitled "Nursing Care Planning" was conducted on 7/15/11. The policy indicated that the plan of care shall reflect the needs applicable to the individual patient. Per the policy, it stipulated that the plan of care be reviewed and updated at least daily by a licensed nurse. The policy indicated that the plan of care provided identification and prioritization of individualized patient needs and serves as a basis for patient care decisions.

Based on observation, interview, record review and document review, the hospital failed to ensure that the use of restraints on 2 of 4 sampled restraint patients, (Patients 52,30), were in accordance with the physician's orders and the hospital's policy on the use of restraints.

Findings:

1. Patient 52 was admitted to the hospital on 6/21/11, for continuing medical care and treatment. Treatment modalities ordered by the physician on admission included the use of a nasogastric tube (a tube inserted through the nose that extends into the stomach) and tube feedings for total nutrition and hydration. The patient, according to the physician notes dated 6/21/11, was described as demented with periods of agitation.

On 7/12/11 at 9:45 A.M., Patient 52 was observed in bed with bilateral wrist restraints. The patient was observed trying to raise his hands, but was unable to because of the wrist restraints. The patient was observed to have a nasogastric tube.

On 7/12/11 at 2:15 P.M., Patient 52's medical record was reviewed with the director of nursing (DON). The DON indicated Patient 52 needed the application of bilateral wrist restraints because of the patient's attempts to remove his nasogastric tube. The patient's medical record revealed a telephone order from the physician as written by a licensed nurse, on 6/29/11 at 11:30 P.M.: " Bilateral soft wrist restraints." The order for the use of bilateral wrist restraints as written by the nurse on 6/29/11, had not been signed and acknowledged by the patient's physician.

On 6/30/11, 7/2/11, 7/3/11, 7/5/11 and 7/8/11, licensed nurses on 3 different shifts recorded in the nursing flowsheets the use of bilateral wrist restraints on Patient 52. The nurses documented that the wrist restraints were needed to prevent Patient 52 from pulling out his nasogastric tube. Again, the use of bilateral wrist restraints as written by the nurses as telephone orders were not authenticated and signed by the physician to validate the physician's approval of the use of restraints.

A review of the hospital's policy and procedure relative to the use of restraints, was conducted with the DON on 7/12/11 at 2:25 P.M. The DON confirmed the lack of physician orders for the use of bilateral wrist restraints for Patient 52 as specified above. The hospital's policy on the use of restraints included a policy statement whereby restraints including the reason for its use, would require a physician's order and approval prior to its use. A 24-hour renewal order for restraints should be obtained from the patient's physician if the use of restraints continued beyond 24 hours.


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2. A review of Patient 30's medical record was conducted on 7/13/11 at 9:35 A.M. Patient 30 was admitted to the facility on 12/21/10 per the facesheet. Patient 30's Medical/Surgical Flowsheets were reviewed on 7/13/11. On 7/8/11 during the night shift assessment for restraints, the documentation indicated that a left hand mitten was applied on the patient. On 7/9/11 at 8:00 A.M., the assessment documentation for restraints indicated that Patient 30's left hand had a mitten. The following assessments dated on 7/10/11 at 8:00 A.M., 7/10/11 during a night shift, 7/11/11 at 7:00 A.M. to 7:30 P.M., 7/11/11 at 8:00 P.M. and 7/12/11 at 7:00 A.M. to 7:30 P.M., all indicated under the restraints section that Patient 14 had a mitten on her left hand.

An interview and joint record review with the Critical Care Director (CCD) was conducted on 7/13/11, at 10:35 A.M. The CCD stated that Patient 30 did not have Patient Restraint Orders for the use of a mitten on the left hand in accordance with the facility's policy on the use restraint, obtaining a physician's order and ensuring that the nursing documentation was complete.

A review of the facility's policy entitled "Restraint of Patients" was conducted on 7/15/11. The policy's definition of a restraint was "... any method of restricting an individual's freedom of movement, physical activity or normal access to the body." According to the policy, a verbal order from the Licensed Independent Practitioner (LIP) must be obtained within 12 hours of the initiation of the restraint; the LIP must write the first order for renewal within 24 hours of initiation of restraint based on a face-to-face assessment of the patient by the LIP; and the LIP must write a renewal order every following calendar day that the restraint is in place, based on his/her face-to-face assessment of the patient.

Based on observation, interview, record review and document review, the hospital failed to ensure the provision of nursing services included the ongoing evaluation and supervision of the nursing staff to ensure the staff's compliance with policies and procedures, safety standards and infection control measures, for on 16 of 16 patients receiving hemodialysis treatments (Patients 1-16); and, 1 of 2 sampled patients receiving TPN administration (Patient 53).

Findings:

Definition:
Hemodialysis is the removal of chemical substances from the blood by passing it through the tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

Findings:

1. A review of the hospital's policy and procedure relative to hepatitis surveillance and infection control measures revealed a policy statement whereby control measures would be implemented to minimize the spread of hepatitis (inflammation of the liver) infections in the dialysis setting. In order to reduce the risk of transmission of Hepatitis B (caused by Hepatitis B virus transmitted through blood) among hemodialysis patients, all new patients should be tested prior to or at the time of the initial hemodialysis treatment. The patient's Hepatitis B serologic status should include the following: (a) Hepatitis B Surface antigen; (b) Total Hepatitis B Core Antibody; (c) Hepatitis B Surface Antibody.

If the results of the above serological diagnostic tests were not known at the time of inpatient hemodialysis treatment, the patient should be treated as a suspect patient for Hepatitis B infection. Documentation of the patient's three hepatitis serologic tests as specified above should remain in the patient's current active medical record.

On 7/15/11 beginning at 10:20 A.M., an interview was conducted with the dialysis nurse coordinator (RN 2). RN 2 confirmed the above policy and indicated they had 16 patients requiring hemodialysis treatment. A joint review of Patients 1 to 16 (16 patients) serologic test results were done to validate if each patient had all the three serological test results as required. It was determined that 14 of 16 patients currently receiving hemodialysis treatment did not have the documented test results for Total Hepatitis B Core Antibody Screening. Fourteen of 16 patients receiving hemodialysis treatment did not have the documentation of test results for Hepatitis B Surface Antibody. One of the 16 patients did not have the test result for Hepatitis B surface antigen. The determination of the above serological markers were essential in determining if the patient had been infected with Hepatitis B.

On 7/15/11 at 10:35 A.M., an interview was conducted with the infection control director. She confirmed her role and involvement in the ongoing surveillance of all infections at the facility, including the review and implementation of infection control policies and procedures. However, the nursing staffs' dialysis provider's lack of compliance with the hospital's policy requirement for the Hepatitis B serological status screening for all patients receiving hemodialysis treatment was not identified and evaluated.

A review of the hospital's policy on infection control and isolation measures for known or unknown Hepatitis B Surface Antigen Positive patients showed a policy statement whereby the hospital would provide additional infection control measures for the care of known or unknown Hepatitis B antigen positive patient.

Patients whose Hepatitis B antigen was unknown would be considered infected with Hepatitis B until determined otherwise by the physician. While hospitalized, each Hepatitis B antigen positive patient would undergo dialysis in a separate room and use a separate dialysis system, equipment, instrument and supplies. The internal pathway of the hemodialysis delivery system (machine) would be cleaned using bleach and heat disinfection. The external surfaces would be thoroughly cleaned with 1:100 bleach solution after every treatment.

On 7/12/11 at 10:30 A.M., a dialysis nurse (RN 3) was observed applying a dressing to Patient 1's right arm. RN 3 indicated that she had just finished providing hemodialysis treatment to Patient 1 who occupied Bed 1. She then proceeded to push the same hemodialysis machine towards Patient 3, who occupied Bed 3 in the same room. When the surveyor asked RN 3 if she would clean and disinfect the machine first before using the same machine on Patient 3, the nurse stated that she did not have to clean or disinfect the machine because both Patients 1 and 3's serology reports were negative for Hepatitis B antigen. The dialysis nurse coordinator had also confirmed RN 3's statement and validated that no cleaning and disinfecting of the dialysis machine's internal pathway was needed inbetween the 2 patients. No dialysis machine cleaning and disinfection was observed by the surveyor after the machine had been used for Patient 1.

On 7/14/11, Patient 1 and Patient 3 were chosen as sampled patients. The patients' medical records were reviewed with the dialysis nurse coordinator beginning on 7/14/11 at 9:00 A.M.

Patient 1's hemodialysis treatment record dated 7/12/11, revealed that the patient was dialyzed by a dialysis nurse (RN 3) from 7:00 A.M. to 10:30 A.M. The record showed machine #7042 was used for the patient's dialysis. The only Hepatitis B screening serology report found in Patient 1's medical record was for Hepatitis B surface antibody which showed a positive test result for Hepatitis B on 7/5/11. RN 2 confirmed that Patient 1's serology reports for Hepatitis B antigen and Hepatitis B core antibody were not found in the medical record. It should be noted that per the hospital's policy, if the patient's Hepatitis B antigen was unknown, then the patient should be suspected for Hepatitis B infection.

Patient 3's hemodialysis record showed the provision of hemodialysis treatment by the same dialysis nurse (RN 3), on 7/12/11 from 12:30 P.M. to 3:30 P.M. The dialysis machine that was used was #7042, which was the same machine used for Patient 1 on 7/12/11. This was confirmed with interview with the dialysis nurse coordinator on 7/14/11 at 10:20 A.M. Patient 3's medical record only contained the patient's Hepatitis B surface antigen negative result. No other serology reports to indicate the patient's Hepatitis B core and surface antibodies were found in the medical record. It should be noted that per hospital policy, patients without these reports should be treated as "unknown" and considered suspect and/or susceptible to Hepatitis B.

Record review and interview with the dialysis nurse coordinator on 7/14/11 at 10:20 A.M., confirmed the use of the same dialysis machine on Patient 1 who had a positive Hepatitis B antibody, and Patient 3 who had a negative Hepatitis antigen and considered a susceptible patient. RN 3 and the dialysis nurse coordinator confirmed the dialysis machine disinfection was not done inbetween Patients 1 and 3 on 7/12/11.

The hospital's failure to ensure the implementation of its infection control policy and procedure relative to patient screening for Hepatitis B, and the policy requirement for the disinfection of hemodialysis machines, could potentially result to transfer of infectious diseases such as Hepatitis B.

2. Patient 53 was admitted to the facility on 3/18/11, for continuing medical care and treatment. The physician's consultation report dated 5/5/11, indicated the patient's complex medical history related to his diabetes mellitus and gastrointestinal problems. The physician had also indicated in his notes the patient's dependency to TPN for majority of the patient's caloric intake. A TPN (Total Parenteral Nutrition) was the administration of nutritionally adequate solution through a catheter onto a vein and was usually given to patients who could not adequately obtain nutrients via the normal digestive route.

On 7/13/11 at 8:45 A.M., Patient 53's medical record was reviewed with registered nurse (RN 2). The physician pre-printed TPN orders dated 6/29/11, included the administration of TPN solution, 1992 ml (milliliter) per day at a rate 83 ml/hr, 3 times a week (Monday, Wednesday and Friday). The TPN solution ordered consisted of dextrose 15%, lipids (fat), sodium, potassium and protein. The pre-printed TPN order included the requirement for the monitoring of Patient 53's blood sugar and the amount of regular insulin to be given to the patient based on a sliding scale parameters. The order was not clarified and completed to indicate the physician's instruction relative to the monitoring of the patient's blood sugar level while receiving TPN. RN 2 confirmed the hospital's policy for nurses to monitor the patient's blood sugar levels every 6 hours while the patient was receiving TPN. A joint record review with RN2 confirmed the lack of the nursing assessment and documentation to indicate the every 6 hours blood sugar readings during TPN administration.

Patient 53's laboratory report dated 7/01/11 at 5:30 A.M. (Monday) showed a high blood sugar reading of 200 (60-120 normal reading). There was no indication of the nursing intervention provided, such as calling the physician regarding the patient's blood sugar of 200. The medical record also showed no indication of nursing assessment relative to the patient's need for insulin administration in light of the patient's diabetic condition and use of TPN. The TPN pre-printed protocol included the monitoring of the blood sugar and administration of insulin when the patient's blood sugar was 200 and above.

The hospital's TPN policy included the need to weigh the patient daily on the same scale at comparable times, and with the same amount of clothing. There was no documentation to reflect the recording and assessment of the patient's daily weight in accordance with the policy.

The hospital's TPN policy should include the patient/family education. The nursing documentation did not include the patient education provided to the patient relative to infection control and prevention of complications.

Based on observation, interview and record review, the hospital failed to ensure that nursing care plans were developed and implemented, for 1 of 2 sampled patients (53) receiving total parenteral nutrition (TPN); and, the facility failed to develop a nursing care plan for saftely, for 1 of 4 sampled patients (28) for with restraints.

Findings:

1. Patient 53 was admitted to the facility on 3/18/11, for continuing treatment and medical care. Treatment modalities ordered by the physician included the administration of total parenteral nutrition (TPN) 1992 ml (milliliter) at 83 ml/hr every Monday, Wednesday and Friday. TPN is the administration of nutritionally adequate solution through a catheter onto a vein and was usually given to patients who could not adequately obtain nutrients via the normal digestive route.

On 7/13/11 at 8:45 A.M., an interview and a joint review of Patient 53's medical record was done with a registered nurse (RN 2). The nurse confirmed the administration of TPN to Patient 53, including the presence and use of a central line intravenous catheter on the patient's right arm to administer the TPN. The nurse also confirmed the need to monitor the patient for potential complications related to TPN administration.

The patient's nursing care plan did not include the nursing care and ongoing assessment of the patient's intravenous site, including the nursing measures to prevent potential complications related to TPN. The monitoring of the patient's blood sugar and weight as required by the hospital's policy for TPN administration was also not included in the nursing care plan. The patient education component related to TPN was also not incorporated into Patient 53's nursing care plan.


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2. A review of Patient 28's medical record was conducted on 7/12/11 at 2:02 P.M. Patient 28, seventy-five years old was admitted to the facility on 7/1/11 per the facesheet. There was no documented evidence in the medical record that a Safety Care Plan was developed upon admission.

An interview and joint record review with the Registered Nurse in charge (RN 13) was conducted on 7/12/11 at 3:00 P.M. RN 13 stated that each patient will have individualized care plans but at a minimum, upon admission the following care plans will be developed: mobility, safety, self care, skin integrity and venous thromboembolism (VTE- is a blood clot that forms within a vein) prophylaxis based on assessment findings and patient needs. RN 13 stated that Patient 28's Safety Care Plan was not initiated on admission in accordance with the facility's policy.

A review of the facility's policy and procedure entitled "Nursing Care Planning" was conducted on 7/15/11. The policy stipulated that the plan of care shall reflect the needs applicable to the individual patient. Per the same policy, it indicated that "... Each patient will have individualized care plans, but at a minimum, the following care plans will be initiated after admission: ... b) Safety ...."

Based on observation, interview, record review and document review, the hospital failed to ensure non-facility employee licensed nurses, such as nurses providing hemodialysis services under a contractual agreement, were adequately supervised and evaluated to ensure the nurses adherence to policies and procedures for the safe and effective care, of 16 of 16 sampled patients receiving hemodialysis treatment. (Patients 1 to 16)

Findings:

Definition: Hemodialysis is the removal of chemical substances from the patient's blood by passing it through the tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

On 7/14/11 , the survey team initiated the evaluation of the facility's hemodialysis services as provided under contract by non-facility employee licensed nurses, to 16 of the facility's 69 patients. The following findings revealed the lack of compliance with the facility's policies and procedures regarding the provision of hemodialysis treatments of the facility's 16 hemodialysis patients.

1. The failure to follow the facility's policy and procedure related to the screening of patients to ensure each patient's serological screening for Hepatitis B was done and documented in the medical records prior to hemodialysis treatments. A review of 14 of 16 patients currently on hemodialysis did not have documented evidence of the serological test results to confirm the patient's Hepatitis B surface antibody and Hepatitis B core antibody. One of the 16 sampled patients did not have the test result to confirm the patient's Hepatitis B antigen status. (Cross Reference A-395; A-748)

2. The failure of the non-facility employee dialysis nurses to implement the hospital's policy and procedure relative to the cleaning, bleach disinfection and heat treatment of hemodialysis machines inbetween patients,particularly those whose Hepatitis B statuses were unknown. On 7/12/11 at 10:30 A.M., observation and interview with the dialysis nurse confirmed the use of the same dialysis machine to dialyze Patient 1 who had a positive Hepatitis B core antibody and Patient 3 whose Hepatitis B surface antigen was negative. This practice could have potentially exposed a susceptible patient to Hepatitis B. (Cross Reference A-395; A-748)

3. The failure of the non-facility employee dialysis nurses to implement safety measures in accordance with the hospital's general patient safety policy. On 7/12/11 at 8:50 A.M., four long drain hoses that connected the dialysis machine to the bathroom water faucet, were observed on the floor, hanging freely, unsecured and unprotected. There was no caution sign or mat used to cover the hoses thus presenting a safety hazard if someone accidentally tripped on the hoses. This could potentially result in the accidental disconnection of the hoses from the dialysis machine and blood tubings that were connected to the patient.

The lack of the nurse's compliance with the facility's policy relative to patient safety by failing to stay with the patient at all times during hemodialysis treatment was also noted during the survey. (Cross Reference A-144)

Observation, record reviews and staff interviews during the 5-day survey confirmed the unsafe care and practices provided to patients requiring hemodialysis treatment. The director of nursing's role and responsibility included the adequate supervision and evaluation of the services provided, including the coordination with the dialysis provider of the clinical activities of non-facility employee nursing personnel.

Based on interview and record review, the hospital failed to ensure all verbal and telephone orders were authenticated by the physician within 48 hours, for 3 of 30 sampled patients (Patients 52, 12, 37).

Findings:

1. On 7/12/11 at 2:15 P.M., Patient 52's medical record was reviewed with the director of nursing (DON). The DON indicated Patient 52 needed the application of bilateral wrist restraints because of the patient's attempts to remove his nasogastric tube. The patient's medical record showed a telephone order from the physician as written by a licensed nurse on 6/29/11 at 11:30 P.M., "Bilateral soft wrist restraints." The telephone order for the use of bilateral wrist restraints as written by the nurse on 6/29/11, had not been signed and authenticated with the physician's approval of the order.

On 6/30/11, 7/2/11, 7/3/11, 7/5/11 and 7/8/11, licensed nurses on 3 different shifts recorded the use of bilateral wrist restraints on Patient 52's nursing flowsheet record. The nurses documented that the wrist restraints were needed to prevent Patient 52 from pulling out his nasogastric tube. Again, the telephone orders for the use of restraints as specified on the above dates (5 days) were not authenticated by the physician.

Patient 52's medical record also showed a verbal order written by a nurse on 6/29/11 at 11:30 P.M., for the drug Ativan 1 mg (milligram) now and Ativan 0.5 mg every 6 hours as needed for agitation. The verbal order for Ativan was not authenticated by the physician within 48 hours to validate the physician's approval of the use of Ativan.

The director of nursing (DON) confirmed during the interview on 7/14/11 at 2:40 P.M. the hospital's failure to comply with the physician authentication of all verbal and telephone orders within 48 hours.


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2. A review of Patient 12's medical record was conducted on 7/12/11 at 3:17 P.M. Patient 12 was admitted to the facility on 5/1/11 per the facesheet.

Patient 12's Doctor's Order and Daily Record For Medical Restraint form dated 7/9/11 with no time documented, indicated that bilateral soft wrist restraints were applied to Patient 12's wrists because the patient was pulling tubes, lines, interfering with dressings, wounds, devices, climbing out of bed and not responding to direction or redirection. The physician's signature section was blank. A sticker with an arrow read "sign here" was found pointed to the physician's signature section.

An interview and joint record review with the Registered Nurse (RN 12) was conducted on 7/12/11 at 3:33 P.M. RN 12 stated that the telephone order dated 7/9/11 for the use of soft wrist restraints on Patient 12 was not authenticated by the physician.

An interview with the Critical Care Director (CCD) was conducted on 7/12/11 at 3:40 P.M. The CCD acknowledged that Patient 12's telephone order for the use of medical restraints should have been signed by the physician for authentication within 48 hours from when it was obtained.

3. On 7/12/11 at 10:27 A.M., Patient 37's medical record was reviewed. On 6/30/11 at 9:30 A.M., there was a verbal telephone order to discontinue Lactulose (a medication to treat constipation).

According to California Code of Federal Regulations, Title 22, Section 70263(g) which stated, "Verbal orders for drugs shall be given only by a person lawfully authorized to prescribe or furnish and shall be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours."

Patient 37's order was not countersigned and it had been 12 days since the ordre was given.

Based on interview and record review, the facility failed to ensure that medical records were complete for 2 of 30 sampled patients (Patients 41 and 22). Patient 41's medical record did not contain the results of a Chest X-Ray that had been ordered by the physician. Patient 22's medical record did not have physician's orders for the oxygen that was administered to Patient 22.

Findings:

1. A review of Patient 41's medical record was conducted on 7/12/11 at 1:45 p.m. The record indicated that Patient 41 was admitted to the facility on 7/2/11, with a diagnosis of acute and chronic respiratory failure. The admission orders indicated that the attending physician had ordered a Chest X-ray on 7/3/11. The record did not contain a Chest X-Ray result and the nursing staff could not find the Chest X-Ray result in the computer.

An interview with the Critical Care Director was conducted on 7/2/11 at 1:46 p.m. She acknowledged that a Chest X-ray was ordered on 7/3/11 and that no Chest X-Ray report was found in the record or in the computer. She stated that the Chest X-Ray order was probably missed and not completed. She stated that her expectation was that the Chest X-Ray should have been completed as per the physician order.


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2. On 7/12/11 at 1:00 P.M., a tour of a medical surgical unit was conducted with the facility's Chief Nursing Executive (CNE). During the tour Patient 22 was observed sitting up in her bed. She was receiving oxygen via a nasal cannula (tubing to the nose) at a rate of 4 liters per minute.

An interview was conducted with a unit nurse (RN 24) on 7/12/11 at 1:08 P.M. She stated that Patient 22 was administered oxygen continuously due to shortness of breath.

On 7/13/11 at 10:20 A.M., a review of Patient 22's medical record was initiated. Patient 22 was admitted to the facility on 6/29/11 per the facesheet. Her diagnoses included COPD (chronic obstructive pulmonary [lung] disease) and pulmonary fibrosis (lung disease that causes shortness of breath), per the Admission Orders dated 6/29/11. The Respiratory Therapy Evaluation dated 7/1/11 recommended, "maintain adequate oxygenation..." The respiratory care plan dated 6/19/11 indicated, "Administer oxygen per order." Patient 22's medical record did not include a physician's orders for oxygen.

An interview and joint record review was conducted with the CNE and the director of respiratory services (RT) on 7/13 at 11:15 A.M. RT looked at Patient 22's medical record and acknowledged that she had been administered oxygen continuously for 14 days without a doctor's order for the medication.

An interview and joint record review was conducted with Patient 22's physician (MD) on 7/13/11 at 11:22 A.M. MD stated, "(Patient 22's name) needs oxygen and is always on it." MD looked at his medication orders and stated, "I missed checking the box for oxygen."

Based on observation, interview, medical record review, document review and policy and procedure review, the hospital failed to ensure that pharmaceutical services carried out its full and complete oversight to meet the needs of the patients in the hospital.

Findings:

1. Pharmaceutical services failed to promote safe medication use by ensuring that physician orders were complete for intravenous norepinephrine and dopamine (medications to treat critically low blood pressure) and provided clear direction to nursing staff on how to execute those orders. (Cross Reference A-500, #1)

2. Pharmaceutical services failed to ensure that the medication order for Levophed (norepinephrine), used to treat critically low blood pressure, was complete and safe to administer to a patient. (Cross reference A-500, #3)

3. Pharmaceutical services failed to ensure that documented competency evaluations related to aseptic technique (procedures performed under sterile conditions) were maintained for two pharmacy technicians whom performed drug preparations and compounding. Also, the hospital failed to ensure that aseptic technique competency evaluations were ongoing and performed per the Pharmacy Technician policy and procedure. (Cross reference A-501)

4. Pharmaceutical services failed to provide the oversight and documentation to follow the flow of non-controlled (prescription medications that do not fall under the category of highly abused or highly addictive). The medications were not completely tracked from entry into the hospital through dispensation and administration to patients throughout the hospital. (Cross reference A-491, #1)

5. Pharmaceutical services failed to enforce its automatic stop order policy for medications (Policy #: 400.640) and to establish a stop order policy for all medications administered in the hospital. (Cross reference A-507)

6. Pharmaceutical services failed to follow their policy and procedure and clarify "as needed" medication orders. Indications for the use of the medication was needed in order to provide clear direction for when to administer the medication for optimum effect and patient safety. (Cross reference A-500, #2)

The cumulative effect of these systemic problems identified resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and document review, the hospital failed to ensure that pharmacy services provided the oversight and documentation to follow the flow of non-controlled medications (prescription medications that do not fall under the category of highly abused or highly addictive), from their entry into the hospital through dispensation and administration to patients throughout the hospital. The hospital also failed to update their policy and procedure for controlled drugs (drugs with the greatest potential for abuse and addiction) policy and procedure. The policy did not include the current procedures that the hospital had in place for dispensing, administration, and documentation of controlled drugs.

Findings:

1. On 7/13/11 at 8:30 A.M., Nurse 31 was observed passing medications to Patients 31 and 32. Nurse 31 did not count the number of tablets/capsules found in the cubicle of the ADC (automated dispensing cabinet). Nurse 31 removed six different medications for Patient 31 and 11 medications for Patient 32 (each cubicle in the ADC contained one medication with a specific dose). During the removal process, there was no documentation that ensured the count of the medications in the ADC cubicle was accurate.

On 7/12/11 at 8:50, an interview was conducted with Nurse 31. Nurse 31 stated that the process to count the quantities of these medications to ensure they were accurate was not required. If counting was required and there was a discrepancy found, then a discrepancy report would be created and would need to be investigated.

On 7/13/11 at 9:05 A.M., during an interview, the Director of Pharmacy Services (DOP), stated, "Pharmacy department does not follow up on medications removed from the ADC unless they are controlled substances. All non-controlled medications do not require nursing to count the tablets. Pharmacy was not providing oversight or documentation for these medications."

On 7/13/11 at 10:05 A.M., the hospital controlled drugs policy and procedure (P & P 22.1011) was reviewed. The policy was last dated and revised in 6/2002. The P and P was outdated and did not include the current procedures the hospital had in place for dispensing, administration, and documentation of controlled drugs.

Without this accountability, nursing staff may remove more medication than ordered as there was no oversight by the pharmacy department. There was no way of knowing if this was occurring, and if the count was inaccurate there was no method for the pharmacy department to be notified (no discrepancy report created) to investigate.

ASHP (American Society of Health-System Pharmacists), a well-known and respected standard of practice, stated in their article entitled, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, 1995, "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital for inpatient and ambulatory patients." The article also states, "Failure to provide any of these services may compromise the overall quality of pharmaceutical care."

Based on interview, medical record review, and document review, the facility failed to
promote safe medication use by ensuring that physician orders were complete for 5 of 30 sampled patients (Patients 22, 23, 33, 34, 35). Patient 33, 34 and 35's orders for intravenous norepinephrine and dopamine (medications to treat critically low blood pressure) did not provided clear directions to nursing staff on how to execute those orders during the month of June 2011.

The hospital approved policies and procedures for the administration of norepinephrine and dopamine that included dosages ranges and allowed nurses to choose and administer a dose based on subjective interpretation of the order rather than on a specific dose. Selecting doses from a range allows for different nurses to administer different doses which may lead to sub-optimum patient care.

Follow their policy and procedure and clarify "as needed" pain medication orders for morphine (potent narcotic pain medication) so there was clear direction describing when to administer the medication to ensure optimum effect and safety for Patient 36.

Ensure that the medication order for Levophed (norepinephrine) was complete and safe to administer to Patient 33 and written in compliance with the California Code of Regulations, Title 22, section 70263(g) which states, "Medication orders shall include the name of the drug, the dosage and frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber."

In addition, the facility failed to ensure that drugs were distributed in accordance with safe standards of practice for 2 of 30 sampled patients (Patients 23, 48). Patient 48 was administered total parenteral nutrition (intravenous nutrition) without testing of triglyceride levels in accordance with the facility's policy. Physician orders for PRN (as needed) drugs for Patient 23 did not include indications for administration of the drugs.

Findings:

1. On 7/13/11, review of three closed medical records for Patients, 33, 34, and 35, revealed that Patients 33 and 34 had orders for intravenous norepinephrine and Patient 35 had orders for intravenous dopamine during the month of June 2011. Patient 33's order was written as the following, "Titrate norepinephrine (Levophed) to 30 micrograms/minute."
Patient 34's order was written as the following, "Titrate norepinephrine (Levophed) to keep systolic blood pressure greater than 90."

Both these patients were dosed according to the hospital's policy and procedure (P & P) entitled, "Levophed (norepinephrine) - Policy # 400.714. The P & P stated under part C, "Start with 8-12 micrograms/minute. Part D stated, "Titrate in 2-4 micrograms/minute increments in 5-10 minute intervals. Adjust to maintain desired BP range."
Patient 35 was dosed according to the hospital's policy and procedure (P & P) entitled, "Dopamine Infusion- Policy # 400.713." The P & P stated under part D subpart a, "To achieve desired blood pressure increase every 3 minutes by 5-10 micrograms/kilograms/minute. Under "b" it stated, "To augment cardiac output increase by 3-10 micrograms/kilograms/minute up to 10 micrograms/kilograms/minute."
California Code of Regulations (CCR) Title 22 section 70263(c)(1) required the P&T committee to develop and implement policies and procedures for the safe use of medications.
Title 22 section 70263(g), "The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber or furnisher."
On 7/13/11 at 2:17 P.M., the DOP stated that range orders for medication doses need to be specific and clear and if they are not, they need to be clarified. Clarification of orders for Patients 33, 34 and 35 was not done.

2. On 7/12/11 at 1:25 P.M., review of the medical record for Patient 36 showed two orders for morphine injection. One order was for morphine 4 milligrams (mg) intravenously and the other was for morphine 2 milligrams intravenously. There was no clarification as to when the nurse would administer the 2 mg dose versus the 4 mg dose.

California Code of Regulations, Title 22, 70263(c)(1) stated, "A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative, and the administrator or his representative. The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementation of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate."

On 7/12/11, review of the policy and procedure for medication administration (policy # 22.528) stated, "If a medication order is not clear the nurse is responsible for clarifying the order with the ordering physician." There was no clarification documented in Patient 36's chart.

3. On 7/13/11 at 11:21 A.M., a closed medical record was reviewed for Patient 33. There was a medication order on 6/30/11 at 4:30 P.M. for Levophed (norepinephrine). Levophed is a medication administered intravenously and used to raise blood pressure when the blood pressure is critically low. The order was written as: "Titrate Levophed up to 30 micrograms/minute." There was no dosage, frequency or route of administration ordered. On 7/13/11 at 2:17 P.M., the DOP stated, "There was no reason he could find why the pharmacy didn't follow up to clarify the order. Even nursing needs clarification to administer this medication." The medication was administered on 6/30/11 at 6:47 P.M. The patient expired 7 hours later.


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4. On 7/13/11 at 9:45 A.M., Patient 48's medical record was reviewed. Patient 48 was admitted to the hospital on 6/24/11. Patient 48's medical record contained a physician's order dated 6/24/11, that indicated, "TPN (total parenteral nutrition) pharmacy to dose." TPN is a way of supplying all the nutritional needs of the body by bypassing the digestive system and dripping nutrient solution directly into a vein.

On 6/24/11 a pharmacist completed a form entitled Adult Parenteral Nutrition Orders and on the form prescribed "Lipid 20% (a fat mixture) 200 mL(milliliters)/day... " The form had a section entitled "TPN day 1 labs: BMP, Phos., Mg, Triglycerides, Prealbumin." The check box area next to the lab section had been left blank.

On 6/29/11 there was another Adult Parenteral Nutrition Orders form completed with a notation of " ...cmp, mg, phos, prealbumin, triglycerides with AM labs; 7/1/11. "

On 7/13/11 at 3:15 P.M., the Clinical Nutrition Manager reviewed Patient 48's medical record and verified that there was not a triglyceride lab value (to determine fat in the blood) in the medical record for Patient 48 prior to the 7/1/11 triglyceride lab value that had been obtained.

The Clinical Nutrition Manager stated she would have expected a triglyceride level to have been obtained prior to the infusion of a 20% lipid fat emulsion to be given daily. She stated that she would have assumed that it was done at another acute hospital where the patient was on TPN. The Clinical Nutrition Manager acknowledged that there was a Registered Dietitian (RD) nutrition assessment completed on 6/25/11 and 6/28/11 in which lipid recommendations for the TPN were provided, without the benefit of knowing the triglyceride level of Patient 48. The Clinical Nutrition Manager repeated that she would have made an assumption that the pharmacist obtained the lab value via a phone conversation with the other acute care hospital that the patient was at prior to admission to the current hospital. The Clinical Nutrition Manager acknowledged that the RD had not been proactive in communicating with other health care team members to obtain a pertinent lab value when assessing tolerance to a TPN with lipids.

On 7/13/11 at 3:30 P.M., Pharmacist 49 reviewed Patient 48's medical record and verified that there was not a triglyceride lab value in the medical record for Patient 48 prior to the triglyceride lab value that was obtained on 7/1/11, 6 days after the patient was receiving 20% intralipids daily via TPN. Pharmacist 49 stated, "The patient should have had a triglyceride lab test done on admission because he was already receiving TPN. The check box for triglycerides [on the Adult Parenteral Nutrition Orders] should have been checked more clearer."

On 7/13/11 at 4:30 P.M., the facility's policy "Monitoring TPN" was reviewed. The policy indicated, "When requested by the physician, the pharmacist will initiate TPN orders, and monitor laboratory values as they relate to TPN formulation..., The pharmacist will ensure that a complete chemistry panel including CMP, Magnesium (an ACP), Phosphorous, Pre-Albumin, and Triglycerides is drawn at the initiation of TPN therapy and at least every 48 hours thereafter or as necessary once patient is stabilized."


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5. On 7/13/11 at 11:05 A.M., a review of Patient 23's medical record was initiated. Patient 23 was admitted to the facility on 6/29/11 per the facesheet. The Admission History and Physical Examination report indicated that Patient 23 diagnoses included diabetes. Physician's orders dated 6/29/11 included: Insta-Glucose (sugary gel to treat low blood sugar) 40%, 15 grams PRN (as needed), and Insta-Glucose 40%, 30 grams PRN

The physician's order did not include clear indications for the use of the two different doses of Insta-Glucose. There was no instruction for when to administer 15 grams of the glucose and when to administer 30 grams of the glucose gel.

On 7/13/11 at 11:15 A.M., a joint interview and review of Patient 23's medical record was conducted with the Chief Nursing Executive (CNE). The CNE looked at the physician's orders and acknowledged that there were no indications for the use of the glucose. She stated, "The doctor should have provided better directions for the administration of this medication."

An interview was conducted with the facility Pharmacy Director (PHRM 21) on 7/13/11 at 3:20 P.M. PHRM 21 stated that there was a policy that provided guidance on the use of glucose gel.

A joint review of the facility policy titled "Hypoglycemia/Low Blood Sugar" dated 4/14/92, was conducted with PHRM and the CNE on 7/13/11 at 3:24 P.M. The policy indicated that for blood glucose levels of 60-80 mg/dl (milligrams/decilitre), with symptoms of hypoglycemia, or for blood glucose levels of 60 mg/dl, with or without symptoms, 15 grams of glucose gel were to be administered. The policy provided no indications for administration of 30 gram doses of Insta-Glucose. PHRM acknowledged that the physician's order for Patient 23's Insta-Glucose administration had needed clarification.

An interview was conducted with Patient 23's physician (MD 21) on 7/13/11 at 3:33 P.M. The physician reviewed Patient 23 orders and stated that he should have indicated the blood sugar levels when each of the glucose doses needed to be administered. MD 21 stated, "Next time I'll provide more guidance for the PRN drugs."

California Code of Regulations, Title 22, 70263(c)(1) indicated, "A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative, and the administrator or his representative. The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals."

6. On 7/13/11 at 11:05 A.M., a review of Patient 22's medical record was initiated. Patient 22 was admitted to the facility on 6/29/11 per the facesheet. The Admission History and Physical Examination indicated that Patient 22's diagnoses included chronic pain. Physician's orders dated 6/29/11 included Morphine Sulfate IR (oral pain medication) 15 milligrams every 4 hours PRN (as needed) for breakthrough pain. There were also orders for Soma (pain medication) 350 milligrams every 6 hours PRN. The physician's order did not include clear indications for the use of the two different pain medications. There was no instruction for when to administer Soma instead of morphine.

On 7/13/11 at 11:15 A.M., a joint interview and review of Patient 22's medical record was conducted with the Chief Nursing Executive (CNE). The CNE looked at the physician's orders and acknowledged that there were no indications for the use of the pain medications. She stated, "The doctor should have made this order clearer."

An interview was conducted with Patient 22's physician (MD 21) on 7/13/11 at 3:33 P.M. The physician reviewed Patient 22's orders and stated that soma was intended for moderate back pain and the morphine was for Patient 22's sever pain. MD 1 stated, "Next time I'll provide more guidance for the PRN drugs."

Based on observation, interview and document review, the hospital failed to ensure that 1 of 3 pharmacy technicians (Pharmacy Technician 31), had documented competency evaluations for aseptic technique in their pharmacy training records file. Also, the hospital failed to ensure that competency evaluations were ongoing for aseptic technique and performed per policy and procedure, for Pharmacy Technicians 32 and 33.

Definition:
Aseptic techniques are procedures performed under sterile conditions. Aseptic techniques are use in the pharmacy to ensure that intravenous medications are compounded for patients with the goal of protecting patients from infection and preventing the spread of germs.

Findings:

On 7/12/11 at 9:23 A.M., an interview and joint review of pharmacy training records was conducted with the Director of Pharmacy Services (DOP). The DOP stated that there were three pharmacy technicians working that day who can compound sterile products during their shift. Sterile products are compounded using a laminar flow hood to ensure sterility. The DOP stated, "The pharmacy technicians have been trained and are competent in aseptic technique."

A Review of Pharmacy Technician 31's aseptic technique exams revealed that an exam was given at a date and time in the past, but this information was not documented on the exam. There was no signature of the grader or certifier which was required at the bottom of the exam.

On 7/12/11 at 9:29 A.M., review of the last aseptic competency exam for Pharmacy Technicians 32 and 33 showed that the last exams were given over two years ago on 6/3/09. The DOP stated, "He was recently hired as DOP approximately 3-4 weeks ago." When asked if there was a policy for how often Pharmacy Technicians were evaluated for aseptic technique competency, he stated, "I don't know." When the DOP was asked if the hospital had a policy and procedure for aseptic technique exams, he stated, "I'm not sure, but I'll look into it immediately."

Based on interview, medical record review, and document review, the hospital failed to enforce its automatic stop order policy for pain medications, for 1 of 30 sampled patients (Patient 33). In addition, the facility failed to establish an effective stop order policy for all medications administered in the hospital.

Findings:

On 7/12/11 at 12:30 P.M., the Director of Pharmacy Services (DOP) stated, "All stop orders in the hospital are considered 'soft' stops." He explained that 'soft stops' meant that the physician was notified and the medication continues until discontinued. The DOP stated, "A note is sent to the floor and placed in the patient's chart to notify the MD (medical Doctor) that they need to continue or stop the medication. If the MD ignores the stop order request, there is no follow up from the pharmacy department." The DOP acknowledged that the medication may continue being administered for days, weeks or months.

According to the hospital's "Stop Order Policy" (Policy #: 400.640), only Scheduled II through V drugs (drugs with high potential for abuse and addiction) and anti-infectives (antibiotics, antifungals, antivirals, ..) have stop orders of 7 days and 10 days respectively. The stop order policy required renewals for the medications to continue. The policy stated, "The attending physician shall be notified prior to discontinuance of such medications. Notifications will be done by the nursing staff. The nursing staff may ask the pharmacist to speak with the physician. Nursing would place the renewal order form on the chart. The sheet should indicate the stop date of the drug and that a renewal was needed. If the physician did not responded within 24 hours he will be contacted by phone by nursing staff."

On 7/12/11 at 1:35 P.M., review of Patient 33's medical record revealed an order for morphine (a schedule II pain medication with a stop order policy of 7 days) 2 milligrams every 1 hour as need for pain. Morphine was ordered on 1/29/10 (over 17 months ago) and had continued without a physician renewing the order. According to the DOP, no follow up was done by the pharmacy department to ensure the stop order policy was enforced. Patient 33 had a second order for morphine 5 milligrams per nasogastric tube (feeding tube that goes down the nose into the stomach) every 4 hours as needed for pain. The order was written on 2/16/10 (over 16 months ago) and not renewed.

California Code of Regulations, Title 22, Section 70263(j) stated, "The hospital shall develop policies limiting the duration of drug therapy in the absence of the prescriber's specific indication of duration of drug therapy or under other circumstances recommended by the pharmacy and therapeutics committee or its equivalent and approved by the executive committee of the medical staff. The limitations shall be established for classes of drugs and/or individual drug entities."

Based on interview and record review, the hospital failed to ensure that one dietary employee washed their hands after handling dirty dishes and before proceeding to handle clean dishes; and, failed to ensure that the walk-in refrigerator was maintained in a sanitary manner; and, failed to ensure that a juice product was dated with a thaw date to ensure shelf-life in accordance with manufacturer's guidelines; and, failed to ensure that the hospital's Disaster Contingency Plan provided detail to hospital staff on providing a therapeutic renal diet in the event of a disaster.

Findings:

1. On 7/14/11 at 8:20 A.M., in the presence of the Food Service Director (FSD), Dietary Aide 46 wore gloves when he ran dirty dishes through the dishmachine. Dietary Aide 46 then changed his gloves and proceeded to handle clean dishes, without washing his hands.
The FSD stated, "He should have washed his hands, but he did change his gloves."

According to the facility's policy, Policy # FS 42.680, "POLICY: It is the policy of the Food Service Department that all employees use proper hand washing techniques while working in the facility. PURPOSE: To reduce the possibility of cross-contamination, ...Wash hands after handling soiled articles..."

2. On 7/12/11 at 8:45 A.M., inside the walk-in refrigerator, a thick build-up of a furry brown substance that covered the light fixture and ceiling in front of the circulating fan was observered. The Food Service Director (FSD) stated that it was her responsibility, or the chef's responsibility to have identified that and reported it to the maintenance department. The FSD stated that the furry brown substance had not been identified and reported.

According to the hospital's policy (Policy # FS 42.210) entitled Infection Control in Food Service Dept./Infection Control Program, "...Purpose: To outline proper procedures to follow for the safe handling of food and supplies and for sanitary environmental practices..., All equipment will be maintained clean and free from dirt and dust."

3. On 7/12/11 at 9:00 A.M., inside a reach-in refrigerator, approximately 100 unopened, thawed 4 ounce cartons of a juice product that were not dated, were observed. On the carton of juice were manufacturer's guidelines that indicated "keep frozen, thaw refrigerate and use within 10 days."

The Food Service Director (FSD) acknowledged that, without a thaw date on the juice product there would not be a mechanism to determine if the product's shelf life was maintained in accordance with manufacturer's instructions. The FSD stated, "Dietary staff should have dated the juice with a thaw date."

The hospital's policy (Policy # FS 42.210) indicated, "...Purpose: To outline proper procedures to follow for the safe handling of food and supplies and for sanitary environmental practices..., Items received will be labeled with arrival date. Once item is opened, product will be labeled with a "USE BY" date..."

4. On 7/12/11 at 10:40 A.M., the hospital's Disaster Contingency Plan (Policy # 42.300) was reviewed with the Clinical Nutrition Manager. The Disaster Contingency Plan was planned to feed patients in the event of a disaster for 4 days.

The Disaster Contingency Plan had a one day planned menu that included fruit juices (orange, apple), 1 cup, Peanut Butter 6 T (tablespoons), 14 Saltine Crackers, 6, Dry cereal, ? cup and 2 cups of milk made from a powder, canned meat, canned fruit ? cup, and it indicated that melted ice cream may be used as a milk drink.

The Disaster Contingency Plan indicated that some of the peanut butter could be substituted with a canned meat. There was an attached list of "DISASTER STOCK PROTEIN SUPPLY" that included a substitute option of chili beans, tuna or cubed beef.

According to the hospital's diet census list there were currently six patients that required a therapeutic renal (kidney) diet, and two patients that required hemodialysis.

When the Clinical Nutrition Manager was asked if the detailed one day menu was the menu that would be served to those patients requiring a renal diet she stated, "I wouldn't want them [hospital staff] to serve milk, and I would want them to serve apple juice, not orange juice. The Clinical Nutrition Manager stated that some of the peanut butter could be substituted. The Clinical Nutrition Manager reviewed the hospital's planned protein substitution list, and stated, "Chili beans should not be given."

The Clinical Nutrition Manager acknowledged that the Disaster Contingency Plan did not provide detailed instruction to hospital staff on what to provide to those patients requiring a therapeutic renal diet in which dialysis could be delayed.

Based on observation, interview and record review, the hospital failed to customize a generic diet manual to be hospital specific.

Findings:

On 7/12/11 at 2:00 P.M., during an interview conducted with the Clinical Nutrition Manager (CNM), the CMN stated that the hospital's routinely prescribed therapeutic diet orders, were defined in a policy and procedure that was located in a binder in the food and nutrition department. The CNM was asked how diabetic diet orders were written, and she stated that physician's prescribe different American Dietetics Association (ADA) calorie levels, or ADA diet.

The hospital's policy entitled Diet Order Clarification that was located in the Food and Nutrition Services Manual indicated that an "ADA diet" was defined by the hospital as "1800 Calorie ADA diet. " The CNM was asked how an 1800 Calorie ADA diet would be implemented in terms of a patient's meal tray. The Clinical Nutrition Manager stated that she would not be able to use the hospital's diet manual which was an on-line ADA Nutrition Care Manual because it was a general guide. The Clinical Nutrition Manager provided a form entitled Diabetic Pattern, that was located in the kitchen, to demonstrate how a variety of diabetic calorie level diets would be used as a guide to prepare a patient's meal.

In addition, located in the kitchen, was a customized "do's and don'ts" for renal diets that had been customized based on the actual menu and food inventory that the hospital used, to guide the dietary department in preparing renal diet orders. Neither the CNM nor the Food Service Director had a formal method for ensuring that a routinely prescribed physician's order such as "renal diet," would be provided 90 grams of protein as defined by the hospital. Neither the Food Service Director nor the Clinical Nutrition Manager could utilize the hospital's diet manual to demonstrate how that diet order would be implemented on a patient's tray to ensure that a patient received 90 grams of protein as the order was defined by the hospital.

The CNM stated that the on-line ADA Nutrition Care Manual was limited to nursing staff, as only nursing supervisor's had access via their e-mail accounts. The Clinical Nutrition Manager acknowledged that the hospital's diet manual was generic and could not be used as a guide to implement and prepare patient trays for a variety of therapeutic diet orders.

According to the hospital's policy (Policy # FS 42.505) entitled Diet Orders, "All diets provided for patients are represented in the current Diet Manual...RESPONSIBILITY: It is the responsibility of the Director of Nutritional Services to maintain a current Diet Manual."

Based on interview and record review, the hospital failed to ensure that the hospital's ice-machines were sanitized in accordance with manufacturer's guidelines.

Findings:

On 7/12/11 at 9:34 A.M., an interview with the Food Service Director (FSD) was conducted. the FSD stated that maintenance staff was responsible for the maintenance and cleaning of the ice-making apparatus of the ice-machine, located in the kitchen.

On 7/12/11, Maintenance Staff 47 was interviewed and was asked to show the surveyor all products that was used for the ice-machine in the kitchen. Maintenance Staff 47 showed one product that was an ice-machine cleaner according to the product label. In the presence of the FSD, Maintenance Staff 47 was asked if there were any other steps, or products that was done for the ice-making apparatus (top part) of the ice-machine, in which he stated, "No." Maintenacne Staff 47 confirmed that he was the one responsbile for cleaning of the ice-machine's in the hospital, and stated that the ice-machine cleaner was the only item that went through the ice-machine tubings for all ice-machine's located in the hospital.

During the same interview, the ice-machine's manufacturer's guidelines were reviewed with Maintenance Staff 47, in the presence of the FSD. According to the ice-machine's manufacturer's guidelines, "The ice machine's water system should be cleaned and sanitized a minimum of twice per year." The manufacturer's guidelines indicated that the ice-machine cleaner was to dissolve mineral build up that formed during the ice making process.

The ice-machine's manufacturer guidelines further indicaed that after the cleaning step, "Go to the next step to sanitize the machine...Mix 2 gallons of Sanitizer solution. Follow local codes for Sanitizer. Note: A possible sanitizing solution may be made by mixing 1 ounce of liquid household bleach with 2 gallons of warm (95-115 degrees .F) potable water."
The Maintenance Staff 47 replied, "Oh." The Maintenance Staff 47 then stated that the dietary staff was the one responsible for sanitizing the top-part of the ice-making apparatus, and that they use the quat sanitizer. The FSD stated that the Food and Nutrition Department was not responsible for sanitizing of the top-part of the ice-machine, and that the maintenance department was responsible for that function.

The hospital's policy (Policy # FS 42.615) entitled Handling Ice and Sanitizing Ice Machine indicated, "Ice will be handled, transported and stored in such a manner as to protect it against contamination...Quarterly, Engineering [maintenance dept.] will clean and service the mechanical end of the ice machine unit according to Manufacturer's Guidelines."

According to the hospital's policy (Policy # IC 100.004) entitled Engineering's Role in Infection Control indicated, "Purpose: To identify the role of Engineering Services in Infection Control...SCOPE OF SERVICE...Maintenance and repair of ice machines."

Based on observation, interview, record review and document review, the hospital failed to ensure the involvement of the staff representing the infection control committee, in the ongoing evaluation and implementation of infection control policies and procedures, particularly to patients requiring hemodialysis treatment. Sixteen of 16 patients (Patients 1 to 16)
requiring hemodialysis treatments did not have documented evidence in their current and active medical records, of all 3 Hepatitis B diagnostic serology reports as required by the hospital's policy.

Definition:
Hemodialysis is the removal of chemical substances from the blood by passing it through the tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

Findings:

1. A review of the hospital's policy and procedure relative to hepatitis surveillance and infection control measures, revealed a policy statement whereby control measures would be implemented to minimize the spread of hepatitis (inflammation of the liver) infections in the dialysis setting. In order to reduce the risk of transmission of Hepatitis B (caused by Hepatitis B virus transmitted through blood) among patients, all new patients should be tested prior to or at the time of the initial hemodialysis treatment. The patient's Hepatitis B serologic status should include the following: (a) Hepatitis B Surface antigen; (b) Total Hepatitis B Core Antibody; (c) Hepatitis B Surface Antibody.

If the results of the above diagnostic serology tests were not known at the time of inpatient hemodialysis treatment, the patient should be treated as a suspect patient for Hepatitis B infection. Documentation of the patient's three hepatitis serologic tests as specified above should remain in the patient's current active medical record.

On 7/15/11 at 10:20 A.M., an interview was conducted with the dialysis nurse coordinator (RN 2) who confirmed the above policy and stated that they have 16 patients requiring hemodialysis treatment onsite. A joint review of all 16 patients serology reports were done to validate if each patient had all the three serological test results as required. It was determined that 14 of 16 patients currently receiving hemodialysis treatment did not have documented test results for Total Hepatitis B Core Antibody Screening. Fourteen of 16 patients receiving hemodialysis treatment did not have the documentation of test results for Hepatitis B Surface Antibody. One of the 16 patients currently receiving hemodialysis did not have the Hepatitis B antigen report in her medical record. The 3 serological markers were essential in determining if the patient had chronic or acute Hepatitis B infection.

On 7/15/11 at 10:35 A.M., an interview was conducted with the infection control director. She confirmed her role and involvement in the ongoing surveillance of all infections at the facility, including the review and implementation of infection control policies and procedures. However, the dialysis provider's lack of compliance with the hospital's policy requirement for the Hepatitis B serological status screening for all patients receiving hemodialysis treatment was not identified.

The ongoing coordination of infection control concerns specific to patients receiving hemodialysis was not addressed and discussed with the dialysis provider during the monthly infection control committee meetings for the previous 6 months (January 2011 to June 2011). The lack of attendance and active participation of a staff representing the dialysis service provider was also confirmed with review of the meeting attendance, agenda and interview with the infection control director.

A review of the hospital's policy on infection control and isolation measures for known or unknown Hepatitis B Surface Antigen Positive patients showed a policy statement whereby the hospital would provide additional infection control measures for the care of known or unknown Hepatitis B Antigen positive patient.

Patients whose Hepatitis B Antigen was unknown would be considered infected with Hepatitis B until determined otherwise by the physician. While hospitalized, each Hepatitis B antigen positive patient would undergo dialysis in a separate room and use a separate dialysis system, equipment, instrument and supplies. The internal pathway of the hemodialysis delivery system (machine) would be cleaned, bleach disinfected and heat treated. The external surfaces of the machine would be thoroughly cleaned with 1:100 bleach solution after every treatment.

On 7/12/11 at 10:30 A.M., a dialysis nurse (RN 3) was observed applying a dressing to Patient 1's right arm. RN 3 indicated that she had just finished providing hemodialysis treatment to Patient 1 who occupied Bed 1. She then proceeded to push the same hemodialysis machine towards Patient 3, who occupied Bed 3 in the same room. When the surveyor asked RN 3 if she would clean and disinfect the machine first before using the same machine on Patient 3, the nurse stated that she did not have to clean or disinfect the machine because both Patient 1 and Patient 3's serology reports for Hepatitis B antigen were negative. The dialysis nurse coordinator had also confirmed RN 3's statement and validated that no cleaning and disinfecting of the dialysis machine's internal pathway was needed in between the 2 patients. No dialysis machine cleaning and disinfection in between patients was observed by the surveyor.

On 7/14/11 beginning at 9:05 A.M., Patient 1's medical record was reviewed with the dialysis nurse coordinator (RN 2). Patient 1's hemodialysis treatment record dated 7/12/11 showed the patient was dialyzed by a dialysis nurse (RN 3) from 7:00 A.M. to 10:30 A.M. The record showed machine #7042 was used for the patient's hemodialysis. The only Hepatitis B screening serology report found in Patient 1's medical record was for Hepatitis B surface antibody which showed a positive test result for Hepatitis B. The serology reports for Hepatitis B antigen and Hepatitis B core antibody were not found in the medical record. It should be noted that per hospital's policy, if the patients' Hepatitis B antigen was unknown, then the patient should be considered a suspect for Hepatitis B infection.

Patient 3's hemodialysis record showed the provision of hemodialysis treatment by the same dialysis nurse (RN 3) on 7/12/11 from 12:30 P.M. to 3:30 P.M. The dialysis machine number was 7042, which was the same machine used for Patient 1 on 7/12/11. This was confirmed with interview with the dialysis nurse coordinator on 7/14/11 at 10:20 A.M. Patient 3's medical record only contained the patient's Hepatitis B surface antigen which showed a negative result. No other serology reports to indicate the patient's Hepatitis B core antibody and Hepatitis B surface antibody were found in the record. It should be noted that per hospital policy, patients without these reports should be treated as "unknown" and considered a suspect for Hepatitis B.

Record review and interview with the dialysis nurse coordinator on 7/14/11 at 10:20 A.M. confirmed the use of the same dialysis machine on Patient 1 who had a positive Hepatitis B antibody and Patient 3 who had a negative Hepatitis antigen and considered a susceptible patient. RN 3 and the dialysis nurse coordinator confirmed that no dialysis machine cleaning and disinfection was done in between the 2 patients.

The hospital's policy for Infection Control in Dialysis setting indicated that the Centers for Disease Control (CDC) recommendations for preventing transmission of infections would be followed when caring for dialysis patients. The recommendations included that the determination of the patient's Hepatitis B serologic status should be known. If the patient's serologic status was not known at the time of admission, testing should be completed.

The hospital's failure to ensure the implementation of its infection control policy and procedure relative to the Hepatitis B screening of patients prior to hemodialysis and the disinfection of hemodialysis machines as required by the hospital's policy could potentially result to transfer of infectious diseases such as Hepatitis B.


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2. On 7/15/11 at 3:00 P.M., a dialysis nurse (RN 27) was observed during Patient 10's dialysis treatment. She stated that she had already completed dialysis treatment for two other patients (Patients 11 and 8). RN 27 stated that she was doing the three patient treatments "back-to-back" using the same dialysis machine (755 E). She stated that she had not needed to completely clean and disinfect the dialysis machine between the three patients because they did not have hepatitis B infections. She stated that the three patient did not have hepatitis B because they all had negative Hepatitis B Surface Antigen tests.

On 7/15/11 at 3:35 P.M., an interview and joint review of Patient 11's medical record was initiated with the director of critical care (RN 21). Patient 11 was admitted to the facility on 7/7/11 per the facesheet. The Admission History and Physical Examination dated 7/7/11, indicated that Patient 11 had end-stage renal (kidney) disease. A laboratory report indicated that Patient 11 had tested negative for Hepatitis B Surface Antigen on 7/8/11, and on 7/13/11. There were no reports indicating that Patient 11 had ever been tested for the antibody to hepatitis B core antigen or the antibody to hepatitis B surface antigen. Dialysis records indicated that Patient 11 was dialyzed using machine number 755 E on 7/15/11. The treatment ended at 10:30 A.M. RN 21 acknowledged that Patient 11's hepatitis B status was unknown at the time of dialysis

On 7/15/11 at 3:48 P.M., an interview and joint review of Patient 8's medical record was initiated with RN 21. Patient 8 was admitted to the facility on 7/11/11, per the facesheet. The Admission History and Physical Examination dated 7/7/11, indicated that Patient 8 had end-stage liver disease and had received a liver transplant on 5/15/11. After transplant she required dialysis due to hepatorenal syndrome (decreased kidney function following liver failure). A laboratory report indicated that Patient 8 had tested negative for Hepatitis B Surface Antigen on 7/12/11 and on 7/13/11. There were no reports indicating that Patient 8 had ever been tested for the antibody to hepatitis B core antigen or the antibody to hepatitis B surface antigen. Dialysis records indicated that Patient 8 was dialyzed using machine number 755 E on 7/15/11. The treatment began at 11:10 A.M. and ended at 2:10 P.M. RN 21 acknowledged that Patient 8's hepatitis B status had been unknown at the time of dialysis and the patient may have been susceptible to hepatitis B infection.

On 7/15/11 at 3:10 P.M., a review of Patient 10's medical record was initiated. Patient 10 was admitted to the facility on 5/7/11, per the facesheet. The Admission History and Physical Examination dated 5/7/11, indicated that Patient 10 had end-stage renal disease. A laboratory report indicated that Patient 10 had been tested for the antibody to Hepatitis B Surface Antigen on 6/22/11. The results was, "Individual is considered not immune." Per the same laboratory report, Patient 10 had tested negative for Hepatitis B Surface Antigen on 6/24/11. There were no reports indicating that Patient 10 had ever been tested for the antibody to hepatitis B core antigen. RN 21 acknowledged that Patient 10's hepatitis B status had been unknown at the time of dialysis and the patient may have been susceptible to hepatitis B infection.

An interview and dialysis machine cleaning demonstration was provided by two lead dialysis nurses (RN 25 and RN 26) on 7/19/11, at 11:15 A.M. Both nurses stated that a complete cleaning and disinfecting of the dialysis machine was needed between patients when the hepatitis B status was unknown. RN 25 stated that the cleaning and disinfection process takes 1 hour and 26 minutes.

A review of the facility Policy and Procedure entitled "Infection Control and Isolation Measures for Known or Unknown Hepatitis B Surface Antigen Positive Patients," was conducted on 7/15/11, at 10:45 A.M. The Policy specified, "Patients whose hepatitis B surface antigen status (HBsAG) is unknown will be suspect for hepatitis B infection until determined otherwise by the physician. The policy further specifies that for unknown Hepatitis B surface antigen status, "Teammates caring for patients with unknown hepatitis B status will not care for susceptible patients at the same time. In situations where the hepatitis B surface antigen status is unknown, the internal pathway of the Hemodialysis delivery system will be cleaned using bleach and heat disinfected and the external surfaces will be thoroughly cleaned with a 1:100 bleach solution after every treatment."

On 7/15/11 at 1:40 P.M. a review of the dialysis policy and procedure titled "Hepatitis Surveillance, Vaccination and Infection Control Measures" was conducted. The policy indicated, "In order to reduce the risk of transmission of Hepatitis B [HBV] among patients, all new patients should be tested prior to or at the time of their initial treatment. Their HBV serologic status (i.e., Hepatitis B Surface antigen [HBsAg], Total Hepatitis B Core Antibody [total anti-HBc or HBcAb], and Hepatitis B Surface Antibody [anti-HBs or HBsAb]) results should be known. If the results of this testing are not known at the time of inpatient treatment, the patient should be treated as a suspect patient for hepatitis B infection."

Beginning on 7/15/11, at 1:50 P.M. a review of the dialysis policy and procedure entitled "Infection Control in the Hospital Dialysis Setting" was conducted. The policy indicated that the Centers for Disease Control (CDC) "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" would be followed when care for all patients.

CDC's "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" dated 4/27/11, was reviewed. Recommendations included: "The HBV serologic status (i.e., HBsAg, total anti-HBc, and anti-HBs) of all patients should be known ...If a patient's HBV serologic status is not known at the time of admission, testing should be completed within 7 days ...Most importantly, staff members who are caring for HBsAg-positive patients should not care for susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another."

Based on observation, interview and record review, the hospital failed to ensure that the infection control committee developed an effective system to identify, investigate and evaluate the dialysis provider's compliance with infection control practices, policies and procedures for 16 of 16 patients requiring hemodialysis treatments (Patients 1 to 16); and 1 of 2 sampled patients requiring contact precautions (Patient 53).

In addition, the hospital failed to ensure that their Infection Prevention and Control Plan (IPCP) included the identification or investigation of the nursing staff's compliance related to infection control policies for hemodialysis patients and dialysis machines.

Findings:

1. Patient 53 was admitted to the hospital on 3/18/11 for continuing treatment and medical care. The physician's orders for diagnostic tests included a nasal swab to detect the presence of MRSA (methicillin -resistant staphylococcus aureus) infection. A laboratory test dated 3/19/11, showed a positive test result for the presence of MRSA on the patient's left nares (nose). In light of the positive MRSA test result, Patient 53 was placed on contact precautions. MRSA infection is an infection caused by a strain of staphylococcus bacteria that is resistant to the antibiotics commonly used to treat ordinary infections. Contact precautions include handwashing and the use of protective equipment such as gowns, gloves and masks to reduce the transmission of microorganisms from one person to another or one site to another.

An infectious disease consultation dated 5/05/11, also confirmed Patient 53's MRSA infection with the physician indicating the possible source as the patient's systemic access site (dialysis Port-A-Cath), skin, as well as the patient's urinary catheter. The patient was treated with antibiotics given intravenously.

On 7/12/11 at 10:00 A.M., a sign was observed posted by the door to Patient 53's room indicating the need to observe contact precautions. The sign included clear instructions for anyone entering the room to wear a gown and a pair of gloves before entering the room. Two custody guards were observed sitting in their chairs inside the patient's room. Both guards were observed to not be wearing any protective equipment such as a gown and gloves, as required. The guards stated that they worked for the Department of Corrections and were there to provide security and physical assistance to a patient in custody. They were required to stay in the patient's room at all times but were not fully aware of the need to wear a gown and gloves, to prevent contamination of their personal clothing (uniforms) when inside the patient's room. One of the guards proceeded to read the sign at the door and acknowledged the instruction. Both guards were provided the gowns and gloves and informed of the need to use them to prevent the direct and indirect transmission of microorganisms.

On 7/12/11 at 10:20 A.M., an interview was conducted with a registered nurse (RN 2) regarding the education provided to the custody guards relative to the hospital's policy on infection control. She indicated that the guards had been previously informed about the need to observe contact precautions for Patient 53. RN2 concurred with the nursing staff's failure to provide the ongoing surveillance of the custody guards compliance with the hospital's infection control practices, particularly when assigned to patients requiring contact precautions.


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2. A review of the Dialysis outside provider's Policy and Procedure (P&P) entitled "Hepatitis Surveillance, Vaccination and Infection Control Measures," was conducted on 7/14/11 at 10:30 A.M.
The P&P specified, "Hepatitis B serological testing requires a physician order. All new patients should be tested prior to or at the time of their initial treatment. Their HBV (Hepatitis B Virus) serologic status [i.e. hepatitis B surface antigen [HbsAG], Total Hepatitis B Core Antibody [anti-HBc or HBcAb] and Hepatitis B Surface Antibody [anti-HBs or HbsAB] results should be known prior to admission for outpatient treatments. If the results of testing are not known at the time of inpatient treatment, the patient should be treated as suspect patient for Hepatitis B infection. Documentation of current laboratory values will be accepted for a patient transferring in from another dialysis facility. Documentation of hepatitis B surface antibodies (HbsAb or anti-HBs) and the hepatitis B total core antibody (total anti-HBc or HbcAb) will remain in the patient's current active medical record. "

A review of the P&P titled "Infection Control and Isolation Measures for Known or Unknown Hepatitis B Surface Antigen Positive Patients" was conducted on 7/15/11 at 10:45 A.M. The Policy specified, "Patients whose hepatitis B surface antigen status (HbsAG) is unknown will be suspect for hepatitis B infection until determined otherwise by the physician." The P&P further specified that for unknown Hepatitis B surface antigen status "Teammates caring for patients with unknown hepatitis B status will not care for susceptible patients at the same time. In situations where the hepatitis B surface antigen status is unknown, the internal pathway of the Hemodialysis delivery system will be cleaned using bleach and heat disinfected and the external surfaces will be thoroughly cleaned with a 1:100 bleach solution after every treatment."

A review of the facility's policy entitled "Infection Prevention and Control Plan" was conducted on 7/15/11. The IPCP's goal was to reduce the risk of acquisition and transmission of Healthcare Associated Infections. The goal included an integrated and collaborative effort by all the departments within the facility which meant that each department, in partnership with the medical staff, will be responsible and held accountable for their role in the IPCP. The plan components included the following: risk assessment, surveillance, structure, opportunity for improvement and annual review process. The IPCP's 2011 surveillance related to device-related infections did not include hemodialysis machines. Per the IPCP, the majority of surveillance activities were priority-directed or targeted in nature and may include diagnoses that were high volume and high risk for infection.

A review of the Infection Control Committee Meetings dated 1/19/11, 2/22/11, 3/16/11, 4/20/11, 5/18/11 and 6/15/11, was conducted. There was no documented evidence to show that a dialysis representative was in attendance.

An interview and joint document review with the Infection Control Director (ICD) was conducted on 7/15/11 at 10:35 A.M. The ICD did not know that the dialysis nurses were not obtaining serologic studies to determine the patients' hepatitis B status which were all required to be kept in the active medical record in accordance with the facility's policy. The ICD did not know that infection control practices related to the disinfecting of dialysis machines were not performed in between patients and for patients that should have been identified as an unknown hepatitis B status patient. She stated that dialysis patients were monitored by infection control for two purposes: central line related infections (permanent versus temporary central lines) and the results of the cultures from the dialysate water. She stated that a dialysis representative did not attend Pharmacy and Therapeutics/Infection Control Committee where data and analysis from the IPCP was reported monthly.

Based on observation, interview, and record review, the facility failed to ensure that a discharge planning evaluation was conducted, for 1of 30 sampled patients (Patient 21). There was no documentation in the record that indicated that Patient 21's discharge needs had been evaluated by a case manager.

Findings:

An interview was conducted with a registered nurse (RN 22) on 7/12/11, at 1:15 P.M. RN 22 stated that Patient 21 had been admitted for wound care. She stated that his wounds were almost healed and he was going to be discharged in a few days.

A review of Patient 21's medical record was conducted on 7/12/11, at 2:00 P.M. Patient 21 was admitted to the facility on 6/27/11, per the facesheet. His diagnoses included chronic kidney disease and open wounds, per the history and physical examination dated 6/27/11. Patient 21 also had Clostridium difficile (C.diff-an infectious disease that causes diarrhea), per an infectious disease consultation report dated 7/2/11.

Patient 21's medical record contained no documentation concerning the patient's discharge planning. The case management Patient Evaluation form was blank except for Patient 21's name and identification information. The Discharge Planning Care Plan form was also blank. There were no case manager notes specific to Patient 21's discharge.

On 7/12/11 at 2:00 P.M., a joint interview and record review was conducted with Patient 21's case manager (CM 21). CM 21 reviewed Patient 21's medical record and acknowledged that he had not completed Patient 21's discharge evaluation and discharge care plan. He stated, "I didn't have time to do it."

On 7/14/11 at 7:40 A.M., the facility policy entitled "Patient Discharge" was reviewed. The policy indicated, "A meaningful, relevant teaching program and discharge plan, which includes arranging for necessary equipment... is initiated upon identification of needs."

Based on observation, interview, record and document review, the facility failed to ensure that their Quality Assurance and Performance Improvement (QAPI) program collected, measured and analyzed data on the completion of serologic testing for the determination of Hepatitis B status prior to the sharing of dialysis equipment, for 14 of 16 dialysis sampled dialysis patients (Patients 1 to 14). Serologic testing was not completed for 14 dialysis patients prior to dialysis treatments.

Definition:
Hemodialysis is the removal of chemical substances from the blood by passing it through the tubes made of semipermeable membranes. This procedure is done to cleanse the blood of patients in whom one or both kidneys are defective or absent.

Findings:

A review of the hospital's policy and procedure relative to hepatitis surveillance and infection control measures, revealed a policy statement whereby control measures would be implemented to minimize the spread of hepatitis (inflammation of the liver) infections in the dialysis setting. In order to reduce the risk of transmission of Hepatitis B (caused by Hepatitis B virus transmitted through blood) among patients, all new patients should be tested prior to or at the time of the initial hemodialysis treatment. The patient's Hepatitis B vaccine (HBV) serologic status should include the following:
(a) Hepatitis B Surface antigen (HBsAG)
(b) Total Hepatitis B Core Antibody
(c) Hepatitis B Surface Antibody.

If the results of the above tests were not known at the time of inpatient hemodialysis treatment, the patient should be treated as a suspect (infected) patient for Hepatitis B infection. Documentation of the patient's hepatitis serologic tests as specified above would remain in the patient's active medical record.

On 7/15/11 at 10:20 A.M., an interview was conducted with the dialysis nurse coordinator (RN 2). ,She confirmed the above policy and indicated that they had 16 patients requiring hemodialysis treatment onsite. A joint review of all 16 patients medical records were done to validate if each patient had all the three serological test results as required. It was determined that 14 of 16 patients currently receiving hemodialysis treatment did not have documented test results for Total Hepatitis B Core Antibody Screening. Fourteen of 16 patients receiving hemodialysis treatment did not have the documentation of test results for Hepatitis B Surface Antibody. The above serological markers were essential in determining if the patient had Hepatitis B- current infection, resolving infection, past infection or chronic infection.

On 7/15/11 at 10:30 A.M., an interview was conducted with the infection control director. She confirmed her involvement in the ongoing surveillance of all infections at the facility, including the review and implementation of infection control policies and procedures. However, the lack of compliance with the required Hepatitis B screening of all hemodialysis patients was not identified.

An interview and joint document review with the Director of Quality Assurance (DQA) was conducted on 7/15/11 at 2:55 P.M. The DQA stated that the dialysis lead nurse (dialysis representative) did not attend Quality Assurance Committee meetings on 11/10, 12/10, 1/11, 2/11 and 3/11. The facility's Acute Facility Quality Assessments completed by the dialysis lead nurse, dated 1/21/11 and 2/22/11, indicated that the dialysis data collected showed 100% compliance with a selected set of infection control and safety standards which did not include compliance with Hepatitis B status determination, disinfecting of machines, and utilizing mats to cover dialysis machines' tubes and hoses. The DQA stated that she did not know about the required serology of tests and maintaining them in the patients' active medical record prior to dialysis treatments, in accordance with the facility's policy and procedure. She acknowledged that she did not know that the dialysis audits which collected data for the facility's QA did not capture essential data related to infection control and safety practices, to ensure patient safety and to prevent the transmission of infection amongst dialysis patients.

Based on interview and administrative document review, the hospital failed to analyze medication errors and adverse drug reactions that were reviewed monthly at the Pharmacy and Therapeutic (P & T) Committee meetings, and implement preventative actions so these events were prevented from reoccurring in the future. This failure could potentially jeopardize the safety of patients by placing them at risk for experiencing preventable medication errors and adverse drug reactions.

Findings:

On 7/14/11 at 8:40 A.M., the minutes of the P & T Committee meetings were discussed with the DOP (director of pharmacy.) For the last six months the P & T Committee meeting minutes addressed concerns with the following hospital findings:
? The number of patients who developed C. Difficile (a bacteria in the intestines) infections associated with antibiotic medications
? The number of patients with high blood potassium levels while taking potassium increasing medications
? The number of patients who developed low blood sugar levels that required intervention
? The number of patients requiring a rescue drug while taking anticoagulant medications
? Various medication errors that included: medications not given, late doses, incorrect doses, extra doses and incorrect times.

On 7/14/11 at 8:48 A.M., the DOP stated, "We have no ongoing projects that look at these areas." The hospital was tracking the occurrences but they were not taking action to prevent them from reoccurring nor did they evaluate changes to eliminate or significantly reduce these adverse events.

Based on interview and document review, the hospital failed to ensure that patients receiving intravenous dopamine and norepinephrine (medications to treat critically low blood pressure), received doses that did not require subjective interpretation by the nursing staff, for 3of 3 patients (Patients 33-35). The hospital failed to take action aimed at preventing this from occurring and ensuring patient safety.

Findings:

On 7/13/11, review of three closed medical records of Patients 33, 34, and 35 revealed that Patients 33 and 34 had orders for intravenous norepinephrine and Patient 35 had orders for intravenous dopamine during the month of June 2011.
Patient 33's order was written as the following, "Titrate norepinephrine (Levophed) to 30 micrograms/minute."
Patient 34's order was written as the following, "Titrate norepinephrine (Levophed) to keep systolic blood pressure greater than 90."
Both these patients were dosed according to the hospital's policy and procedure (P & P) entitled, "Levophed (norepinephrine) - Policy # 400.714. The P & P stated under part C, "Start with 8-12 micrograms/minute. Part D states, "Titrate in 2-4 micrograms/minute increments in 5-10 minute intervals. Adjust to maintain desired BP range."

Patient 35 was dosed according to the hospital's policy and procedure (P & P) entitled, "Dopamine Infusion - Policy # 400.713." The P & P states under part D subpart a, "To achieve desired blood pressure increase every 3 minutes by 5-10icrograms/kilograms/minute. Under "b" it states, "To augment cardiac output increase by 3-10icrograms/kilograms/minute up to 10 micrograms/kilograms/minute."

These orders all required nursing staff to select a dose from a range of doses. Selecting doses from a range allowed for different nurses to administer different doses which could lead to sub-optimum patient care.

On 7/14/11 at 8:48 A.M., an interview was conducted with the director of pharmacy. The director of pharmacy stated, "We have no ongoing projects that look into and track these drugs."