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The facility's governing body, the legally responsible entity for the conduct of hospital operations, failed to provide oversight of medical staff, radiological services and organ procurement program which resulted in the identification of systemic deficiencies in these areas. In addition, the governing body failed to ensure that the quality assessment and performance improvement program involved all hospital departments and services and reflected the complexity of the hospital's organization and services.

The facility failed to ensure that medical staff requirements were met with regard to the appointment of members to the medical staff and failed to approve the medical staff bylaws. This deficient practice limited the governing body's ability to provide effective oversight of the medical staff. (A 44) ( A340)

The facility's governing body was not involved in the appointment of 2 of 2 medical staff members whose credential files were reviewed. (MD 3 & MD 4). There was no evidence that the governing body approved the appointment of MD 3 and MD 4 to the medical staff. The deficient practice reduced the accountability of the medical staff and limited the facility's ability to identify potential problems in applicants requesting appointment to the medical staff. (A 46) (A 341)

The facility's governing body failed to approve the medical staff bylaws and medical staff rules and regulations. (A 48) (A 354)

The governing body failed to assess and monitor the services provided by their contract providers to ensure the hospital comply with standard or condition of participation requirements. The deficient practice had the potential to allow substandard services to escape scrutiny. (A 83)

The facility's governing body failed to evaluate the quality of each contracted service. There was no evidence that the facility's contract services were incorporated into and evaluated by the hospital wide quality assessment and performance improvement (QAPI) program. The deficient practice limited the facility's ability to identify and correct problems with their contract services. (A 84)

The facility failed to maintain a list of all contracted services including the scope and nature of the services provided. (A 85)

The facility failed to maintain an effective and on-going hospital-wide quality assessment program and failed to incorporate its radiology, laboratory and rehabilitation services into it's quality assessment and performance improvement (QAPI) program. (A 263)

The facility failed to ensure that its medical staff operates under bylaws approved by the governing body. (A 338)

The facility failed to ensure that a qualified radiologist was appointed to supervise it's radiology services and failed to ensure that there were written policies approved by the medical staff to designate which radiological tests require interpretation by a radiologist. (A 528)

The facility failed to ensure that the organ, tissue, and eye procurement requirements were met. (A 884)

The cumulative effects of these systemic problems resulted in the failure of the hospital's governing body to ensure that its patients were provided with safe, effective and quality care.

Based on interview and record review, the facility's governing body failed to ensure that medical staff requirements were met with regard to the appointment of members to the medical staff and failed to approve the medical staff bylaws. This deficient practice limited the governing body's ability to provide effective oversight of the medical staff.

Findings:

Cross reference A-0046, A-0048, A-340 and A-0341.

Based on interview and record review, the facility's governing body was not involved in the appointment of 2 of 2 medical staff members whose credential files were reviewed. (MD 3 & MD 4). There was no evidence that the governing body approved the appointment of MD 3 and MD 4 to the medical staff. The deficient practice reduced the accountability of the medical staff and limited the facility's ability to identify potential problems in applicants requesting appointment to the medical staff.

Findings:

Cross reference A-0341.

Based on interview and record review, the facility's governing body failed to approve the medical staff bylaws and medical staff rules and regulations. This deficient practice limited the governing body's ability to provide effective oversight of the medical staff.

Findings:

On 9/22/11 at 11 a.m., the facility's medical staff bylaws were reviewed. Some of the pages of the medical staff bylaws indicated they had been revised on 1/06 and other pages had a revision date of 3/05. There was a page with areas to be completed to indicate the date the medical staff bylaws were adopted by the medical staff and approved by the governing body. There was also an area for the chief executive officer, the medical director and governing body to sign and date the bylaws. None of these areas had been completed.

A review of the medical staff rules and regulations (revised 9/05) indicated they had not been approved by the governing body.

Administrative Staff 1 who was present during the review, acknowledged that the medical staff bylaws had not approved and signed by the governing body. She stated the governing body was meeting today and would review the medical staff bylaws.

On 9/28/11 at 10:10 a.m., MD 1(director of inpatient psychiatric services) was asked why the medical staff bylaws had not been approved by the governing body. He said "We missed that."

Based on interview and record review, the facility's governing body failed to assess and monitor the services provided by their contract providers to ensure the hospital comply with standard or condition of participation requirements. There was no evidence that contract services were incorporated into and evaluated by the hospital wide quality assessment and performance improvement (QAPI) program. The deficient practice had the potential to allow substandard services to escape scrutiny.

Findings:

On 9/27/11 at 9:40 a.m., the facility's quality assessment and performance improvement (QAPI) program was reviewed with the DOE. When asked how the quality of each contract service was evaluated, she said there was no mechanism in the plan to evaluate contract services. She stated that the facility's contract services were not incorporated into the QAPI program.

A review of the facility's contract radiology services on 9/22/11 and 9/26/11 indicated there was no supervision of the radiology services by a radiologist who was a member of the medical staff and no written policy approved by the medical staff to determine which radiological tests require interpretation by a radiologist. (Cross reference A 546).

Based on interview and record review, the facility's governing body failed to evaluate the quality of each contracted service. There was no evidence that the facility's contract services were incorporated into and evaluated by the hospital wide quality assessment and performance improvement (QAPI) program. The deficient practice limited the facility's ability to identify and correct problems with their contract services.

Findings:

On 9/22/11 at 12:40 p.m., during a tour of the facility's radiology department, the DOE (director of education) stated the facility used mobile radiology services (outside provider)after hours and when the facility's own radiology technician was on leave.

During an interview on 9/26/11 at 11:55 a.m., Administrative Staff 1 was asked for a list of the facility's contracted services. She said " We have no list of contract services but we only have lab., radiology and linen contract services."

On 9/27/11 at 9:40 a.m., the facility's quality assessment and performance improvement (QAPI) program was reviewed with the DOE. When asked how the quality of each contract service was evaluated, she said there was no mechanism in the plan to evaluate contract services. She stated that the facility's contract services were not incorporated into the QAPI program.

In addition, during an interview on 9/27/11 at 3:15 p.m., the DHR (director of human resources) also stated that all new hire physicals, drug screens and vaccinations were provided by an outside occupational health clinic (Concentra).

Based on interview and record review, the facility failed to maintain a list of all contracted services including the scope and nature of the services provided.

Findings:

On 9/22/11 at 12:40 p.m., during a tour of the facility's radiology department, the DOE (director of education) stated the facility used mobile radiology services after hours and when the facility's own radiology technician was on leave. She said x-rays taken by the facility's radiology technician are transmitted digitally to a radiologist at a local hospital who reads the x-ray and notifies the facility of the result. When asked if the facility had a contract with the radiologist she said she would have to check.

During an interview on 9/26/11 at 11:55 a.m., Administrative Staff 1 was asked for a list of the facility's contracted services. She said " We have no list of contract services but we only have lab., radiology and linen contract services.

Facility staff provided copies of the contract with the laboratory (Muirlab) and the mobile radiology services (Community Mobile Diagnostics) but no copy of the linen services contract so the surveyor was unable to determine the scope and nature of the services provided by the linen service.

On 9/26/11 at 12:30 p.m., the DOE stated she could not locate a contract with the radiologist who reads the facility's x-rays. There was no documentation of the scope and nature of the services provided by the radiologist.

During an interview on 9/27/11 at 3:15 p.m., the DHR (director of human resources) stated that all new hire physicals, drug screens and vaccinations were provided by an outside occupational health clinic (Concentra). When asked if the facility had a contract with the occupational clinic she said she would have to "follow up on that."

On 9/28/11 at 9:55 a.m., the DHR stated the facility's agreement with the occupational clinic was "not really a contract but was a protocol process." She said the facility had been using the services of the occupational clinic for a least ten years but had "no formal contract" with the clinic.

Based on interview and record review, the facility failed to indicate in their policy and procedure the provision of written notice to the patient or it's legal representative, about the results or decisions of filed grievances/complaints.

Findings:

In an interview on 9/28/11 at 11:05 AM, the Administrator said the Compliments/Complaints forms were available to patients or their representatives and written on the form was, they will receive a written notice. She acknowledged that not all patients or their representatives will fill out the complaint form and will see the information about receiving a written notice for every complaints they filed.

Review of the Compliments/Complaints form that the patients or family members fill out if they have any concerns or complaints indicated "Feel free to use this form.." The form has spaces for date and time of occurrence, description of occurrence, staff involved, patient involved and name address of person submitting the complaint "(this will allow us to provide you with a written response)."

Review of the facility's 11/09 Grievance/Complaint Process indicated, "The patient / authorized representative will be informed of the findings of the investigation as well as any corrective action recommended within 10 days of the submission of the Report."

The policy and procedure did not clearly indicate that a written notice will be provided to the complainant or it's legal representative about the results/decisions of complaint they filed.

Based on interview and record review, the facility failed to ensure the restraint policy and procedure included the death reporting requirements by CMS.

Findings:

Review of the facility's 09/2006 "Physical Restraints for Safety and Treatment, Acute Psych." did not include any statement about the reporting requirements.

Review of the facility's 9/2009 "Restraint and Seclusion for Behaviors, Acute Psych" indicated "...Any death while in restraints must be reported to CMS, FDA and California Department of Public Health."

Both of the facility's policy and procedure did not include the specified requirements by CMS including, to report death of a patient while on restraint, death that occurred within 24 hours after the restraint was removed and one week after the restraint was removed if the facility found that the death was directly or indirectly related to the restraint used. Also, the policy and procedure did not include the mode of reporting by telephone and timeframe of when the report should be submitted which is no later than the close of the next business day following the knowledge of the patient's death.

In an interview on 9/27/11 at 2:00 PM, the Administrator said the facility's restraint policy and procedure did not include the CMS requirement for reporting and that it will be included in the revised policy and procedure.

The facility failed to maintain an effective and on-going hospital-wide quality assessment program when:

The facility failed to document that its governing body had approved the frequency and detail of data collection for its psychotropic medication use project. The deficient practice reduced the governing body's leadership role regarding quality assessment and performance improvement (QAPI). (A 277)

The facility failed to incorporate its radiology, laboratory and rehabilitation services into it's quality assessment and performance improvement (QAPI) program. The deficient practice sidestepped regulatory expectations that all hospital services be included in QAPI efforts and eliminated mechanisms by which the radiology, laboratory and rehabilitation departments could reach its maximum potential. (A 298)

The facility failed to make an accurate determination of the number of distinct performance improvement (PI) projects it was conducting. The deficient practice eliminated a mechanism by which the facility leadership could know what projects were underway and prioritize it efforts. (A 317)

There was no evidence that the facility's contract services were incorporated into and evaluated by the hospital wide quality assessment and performance improvement (QAPI) program. The deficient practice limited the facility's ability to identify and correct problems with their contract services. (A 84)

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

Based on interview and record review, the facility failed to document that its governing body had approved the frequency and detail of data collection for its psychotropic medication use project. The deficient practice reduced the governing body's leadership role regarding quality assessment and performance improvement (QAPI).

Findings:

On 9/27/11 at 9:25 a.m., the facility's quality assessment and performance improvement (QAPI) program was reviewed with the DOE (director of education). She said the facility was monitoring the use of psychotropic medications as part of it's quality program. The surveyor requested documentation that the psychotropic medication project had been approved by the facility's governing body. The DOE stated she would look for the requested information.

On 9/27/11 at 10:30 a.m., the DOE presented the minutes from the Quality Improvement/Quality Management Committee Meeting of 7/26/11. Under the heading "QI Project in Process" was listed "Psychotropics".

The facility was unable to provide documentation that the governing body had approved the frequency and detail of data collection for their psychotropic medication use project.

Based on interview and record review, the facility failed to incorporate its radiology, laboratory and rehabilitation services into it's quality assessment and performance improvement (QAPI) program. The deficient practice sidestepped regulatory expectations that all hospital services be included in QAPI efforts and eliminated mechanisms by which the radiology, laboratory and rehabilitation departments could reach its maximum potential.

Findings:

On 9/27/11 at 9:40 a.m., the facility's quality assessment and performance improvement (QAPI) program was reviewed with the DOE. When asked how the quality of the facility's radiology and laboratory contract service was evaluated, she said there was no mechanism in the plan to evaluate contract services. She stated that the facility's radiology and laboratory services were not incorporated into the QAPI program. There was no documentation of performance indicators or performance improvement projects for the radiology or laboratory services.

On 9/28/11 at 9:20 a.m., the ADR (assistant director of rehabilitation) was interviewed regarding the department's improvement projects. She stated the department was working on developing a "time management group" and developing clearer documentation forms. However, she said these were internal projects and were not incorporated into the facility wide QAPI program. She stated the rehabilitation department had no formal list of quality projects for 2011.

Based on interview and record review, the facility failed to make an accurate determination of the number of distinct performance improvement (PI) projects it was conducting. The deficient practice eliminated a mechanism by which the facility leadership could know what projects were underway and prioritize it efforts.

Findings:

During an interview on 9/27/11 at 9:15 a.m., the surveyor requested a summary of the facility's performance indicators. The DOE (director of education) stated the facility looked at many indicators including seclusion rates, falls, infection control issues and the use of psychotropic medication.

The facility's quality improvement program was reviewed with the DOE and indicated the following:
Data Review
The QI committee will be responsible in reviewing a variety of quality of care data to assess the facility's current performance and to identify opportunities for improvement. Committee members will be assigned responsibility for presenting data for the QI committee.

This was followed by a list including "Quality of Care Report, Infection Control, Nutritional Services and Pharmacy Report."

The DOE stated these areas were broken down into subgroups including pain management and falls. She said that the facility was looking at all these projects on an ongoing basis. The DOE stated there was no list enumerating the exact number of performance improvement projects the facility was conducting.

The facility failed to ensure that its medical staff operates under bylaws approved by the governing body as evidence by:

The facility failed to enforce its bylaws for two of two practitioners whose credentials files were reviewed (MD 1 & MD 2). MD 1 and MD 2 had no reappraisals for reappointment and had no approval for reappointment by the medical committee and the governing body. The deficient practice limited the efficacy of the medical staff reappointment process. (A 340)

The medical staff failed to ensure that credentials of two candidates for medical staff membership were examined and failed to make recommendations to the governing body for the appointment of the candidates (MD 3 & MD 4). There was no evidence that MD 3 and MD 4 were formally appointed by the governing body. The deficient practice reduced the accountability of the medical staff and limited the facility's ability to identify potential problems in applicants requesting appointment to the medical staff. (A 341)

The governing body failed to approve the medical staff bylaws and medical staff rules and regulations. This deficient practice limited the governing body's ability to provide effective oversight of the medical staff. ( A 354)

The cumulative effect of these systemic failure resulted in the facility's inability to provide quality medical care to patients.

Based on interview and record review, the facility failed to enforce its bylaws for two of two practitioners whose credentials files were reviewed (MD 1 & MD 2). MD 1 and MD 2 had no reapraisals for reappointment and had no approval for reappointment by the medical committee and the governing body. The deficient practice limited the efficacy of the medical staff reappointment process.

Findings:

MD 1's credentials file was reviewed on 9/26/11 at 3 p.m. MD 1 initially applied for appointment to the medical staff on 6/87. MD 1 submitted an application for reappointment to the medical staff on 4/06. There was no documentation that the application for reappointment was approved by the medical executive committee or the governing body. There was no primary source verification of MD 1's license and no query was submitted to the National Practitioner Data Bank. MD 1 had submitted a request for specific privileges but the portion of the form to indicate if the privileges were granted or denied was blank. MD 1 had submitted an application for reappointment on 12/29/08 but there was no documentation that this application had been approved by the medical executive committee and the governing body. There was no other application for reappointment in the file even though the facility's medical staff bylaws required reappointment every two years.

MD 2's credentials file was reviewed and indicated that she initially applied for appointment to the medical staff on 10/26/04. MD 2 was due for reappointment by 10/06 but there was no application submitted until 7/15/07. There was no documentation that the application for reappointment was approved by the medical executive committee or the governing body. There was no query submitted to the National Practitioner Data Bank and the only primary source verification of MD 2's license was done on 9/22/11, the day after the survey started. There was no documentation of the privileges requested by MD 2 and whether these privileges had been granted or denied by the governing body. There was another application for reappointment dated 7/16/09 but there was no documentation that this application had been acted upon by the medical executive committee or the governing body. There was no application for reappointment in 2011 even though the facility's medical staff bylaws required reappointment every two years.

During an interview on 9/26/11, Staff 2 stated she helped with the credential files and the reappointment process. When asked about the lack of documentation in MD 1 and MD 2's credential files, she said "We're behind on that." Administrative Staff 1 who was present stated there had been a change of medical director and a change in the system. She could not explain why the credential files were incomplete and said the staff member who deals with credentialing was on vacation.

A review of the facility's medical staff bylaws indicated the following:

Section 4- Appointments and Reappointments

Initial appointments and Reappointments: Initial appointments and Reappointments to the Medical Staff shall be approved by the Governing Body upon a recommendation from the Medical Executive Committee.

Section 6-The Reappointment Process to Active, Associate or Consultant Status

A. Reappointment to the active, associate or consultant Medical Staff Membership status shall be completed every two (2) years.
C. Information for reapplication shall include at least the following:
15. Evidence of current licensure and DEA registration;
17. Evidence of Continuing Medical Education (CME) and experience that qualify the Member for the Privileges sought on reappointment.
D. At least sixty days prior to the the time of renewal of the Medical Staff Member's membership, the Medical Director shall receive from the Credentials and Privileging Coordinator the reappointment application and all relevant information including results of queries to the National Practitioner Data Bank (NPDB).
F. Based on this and any other pertinent information available to him, the Medical Director/Department Chair shall submit to the Credentialing and Privileging Committee within thirty (30) days a written recommendation concerning the Member's reappointment and Clinical Privileges. When the Medical Director recommends any change, the reason for such recommendation shall be stated and documented.
G. At least thirty (30) days prior to the time of expiration of the Medical Staff Member's current appointment, the Credentialing and Privileging Committee shall meet, review all pertinent information and make a written recommendation to the Medical staff Committee and the Medical Executive Committee.
H. At least thirty (30) days prior to the time of expiration of the Medical Staff Member's current appointment the medical Executive Committee shall review the recommendations of the Credentialing and Privileging Committee and submit a written recommendation to the Governing Body. When any change is recommended, the reason for such recommendation shall be stated and documented.

MD 1 (who is also the director of inpatient psychiatric services) was interviewed on 9/28/11 at 10:10 a.m. He stated the medical records department sends out paperwork to physicians who are due for reappointment. He said reappointment is required every two years. When the packet is complete it is sent to the medical director for review. He said the packet would include verification of licensure, National Practitioner Data Bank query, references, privileges requested and other information required by the medical staff bylaws. The medical director sends a written recommendation to the Credentialing and Privileging Committee regarding the physician's reappointment and clinical privileges. After review by the Credentialing and Privileging Committee, a written recommendation is made to the medical executive committee who then review the information and make a written recommendation to the governing body regarding the reappointment of the physician. The governing body reviews the information and approvals or disapproves the reappointment in writing. When told that the credential files reviewed by the surveyor did not contain the information required by the facility's medical staff bylaws for reappointment and that reappointment's were not being done every two years, he said "That's not good."

Based on interview and record review, the medical staff failed to ensure that credentials of two candidates for medical staff membership were examined and failed to make recommendations to the governing body for the appointment of the candidates (MD 3 & MD 4). There was no evidence that MD 3 and MD 4 were formally appointed by the governing body. The deficient practice reduced the accountability of the medical staff and limited the facility's ability to identify potential problems in applicants requesting appointment to the medical staff.

Findings:

MD 3's credential file was reviewed on 9/26/11 at 3 p.m. There was an initial application for appointment to the medical staff dated 6/27/11. There was no request for clinical privileges, no primary source verification of medical licensure, no National Practitioner Data Bank query and no references of competency. The part of the application for the credentials committee signature and date of approval was blank. There was no documentation that the medical executive committee had reviewed the application and made a recommendation to the governing body regarding MD 3's application.

MD 4's credential file was reviewed on 9/26/11 at 3:30 p.m. There was an initial application for appointment to the medical staff dated 7/28/11. There was no request for clinical privileges, no primary source verification of medical licensure, no National Practitioner Data Bank query and no references of competency. There was documentation that references were requested on 9/7/11 but no follow up had been done. The part of the application for the credentials committee signature and date of approval was blank. There was no documentation that the medical executive committee had reviewed the application and made a recommendation to the governing body regarding MD 4's application.

A review of the facility's Active Staff list indicated that MD 3 and MD 4 were both listed as attending physicians at the facility. However, there was no evidence that MD 3 and MD 4 had been formally appointed by the governing body.

During an interview on 9/26/11, Staff 2 stated she helped with the credential files and the initial appointment process. When asked about the lack of documentation in MD 3 and MD 4's credential files, she said "We're behind on that." Administrative Staff 1 who was present stated there had been a change of medical director and a change in the system. She could not explain why the credential files were incomplete and said the staff member who deals with credentialing was on vacation.

A review of the facility's medical staff bylaws indicated the following:

Section 4- Appointments and Reappointments

Initial appointments and Reappointments: Initial appointments and Reappointments to the Medical Staff shall be approved by the Governing Body upon a recommendation from the Medical Executive Committee.

Section 5- Procedures For Appointment
C. Application Form and Content: The application form shall include, but not be limited to the following:
10. Application data is verified through a primary source at original appointment, reappointment and at renewal of clinical privileges by a letter or secure electronic communication obtained from the appropriate state licensing board. Verification of current licensure through the primary source via secure electronic communication or by telephone is acceptable, if this verification is documented.
13. At least two (2) professional references (letters or documented telephone conversations), from professional colleagues other than family or persons affiliated by marriage, who have personal knowledge of the applicant's recent professional performance, his ethical character, current competence, current health status and his/her ability to work cooperatively with others. The documentation also addresses at least the following two specific aspects of current competence: types and outcomes of medical conditions managed by the applicant as the responsible physician and the applicant's clinical judgement and technical skills;
21. Clinical Privileges desired

E. Submission of Application: Verification. The applicant requesting appointment to this Hospital shall deliver a completed application to the Credentialing and Privileging (C and P) Coordinator on behalf of the Credentialing and Privileging Committee. The C and P Coordinator shall verify the references, licensure, and other qualifications evidence submitted. The Hospital shall submit a query to the National Practitioner Data Bank (NPDB), the American Medical Association (AMA) and applicable state licensing board, the Certification Verification Organization (CVO) if required, in compliance with existing laws and Hospital Policy, for all Medical Staff who are applying for Privileges....

The policy went on to detail how the Credentialing and Privileging Committee (a subcommittee of the Medical Executive Committee) would review the application, the supporting documents and other information available to it "that may be relevant to consideration of the applicant's qualifications for the Medical staff category and Clinical Privileges requested." The medical executive committee would then review the recommendation of the credentialing committee and forward to the medical director a written report and recommendation regarding the medical staff category, clinical privileges to be granted and any special conditions attached to the appointment. This report would be sent to the governing body for approval or disapproval.

Based on interview and record review, the facility's governing body failed to approve the medical staff bylaws and medical staff rules and regulations. This deficient practice limited the governing body's ability to provide effective oversight of the medical staff.

Findings:

On 9/22/11 at 11 a.m., the facility's medical staff bylaws were reviewed. Some of the pages of the medical staff bylaws indicated they had been revised on 1/06 and other pages had a revision date of 3/05. There was a page with areas to be completed to indicate the date the medical staff bylaws were adopted by the medical staff and approved by the governing body. There was also an area for the chief executive officer, the medical director and governing body to sign and date the bylaws. None of these areas had been completed.

A review of the medical staff rules and regulations (revised 9/05) indicated they had not been approved by the governing body.

Administrative Staff 1 who was present during the review, acknowledged that the medical staff bylaws had not approved and signed by the governing body. She stated the governing body was meeting today and would review the medical staff bylaws.

On 9/28/11 at 10:10 a.m., MD 1(director of inpatient psychiatric services) was asked why the medical staff bylaws had not been approved by the governing body. He said "We missed that."

Based on interview and record review, the facility failed to ensure all entries in 6 of 18 sampled medical records (Patient 1, 12, 13, 14, 17 and 18) were dated, timed and authenticated by the person responsible for providing and evaluating the services rendered to the patients. An incomplete entry could create confusion and miscommunication amongst staff providing care and services. The facility also failed to follow it's policy regarding verbal orders. Patient 14's record contained a verbal order for occupational therapy. Patient 17's record contained an untimed verbal order for speech therapy. The verbal order for Patient 14 was received by an individual (occupational therapist) and Patient 17's verbal oprder was received by a speech therapist. Both were unauthorized to receive verbal orders and there was no date or time to indicate when the physician had signed the verbal order. The deficient practice increases the risk of treatment errors.

Findings:

1. Patient 1 was admitted to the facility on 6/29/11 with diagnoses including Schizoaffective Disorder.

Review of the patient's medical record on 9/27/11 indicated that she was discharged from the facility on 7/11/11 with an improved condition. The Discharge Summary was typewritten with the physician's name but had no signature to authenticate that he was the one who dictated the report.

2. Patient 12 was admitted to the facility on 8/19/11 with diagnoses including Schizoaffective Disorder with suicidal ideation.

Patient 12's record reviewed had a typewritten Admission Psychiatric Assessment that had no date and time when the assessment was done and had no signature of the physician who dictated the report.

3. Patient 13 was admitted to the facility on 9/3/11 with diagnoses including Schizoaffective Disorder with paranoia and combative behavior.

Review of records showed a type written psychiatric progress notes dated 9/4/11 that was not signed by the physician.

A hand written Nursing Notes entry on 9/16/11 did not indicate the time the note was written. There was also a hand written Recreation/Activity Therapy notes dated 9/21/11 with no time when the note was written.

4. Patient 14 was admitted to the facility on 8/26/11 with diagnoses including Schizoaffective Disorder with delusional behavior.

Review of the patient's Physician's Order sheet had a verbal order dated 8/31/11. The verbal order was signed by the occupational therapist. There was no time recorded to indicate when the order was made. This was signed by the physician, however, the signature had no time and date when signed.

The hand written nursing notes on 9/17/11 was not timed.

Review of the facility's undated Medical Record Audit indicated, "15. The date, time and legible signature/title are required for all entries in the medical record."


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5. Patient 17's record was reviewed on 9/22/11 at 2 p.m. There were physician progress notes dated 8/15/11, 8/19/11 and 8/28/11 that were not timed. The physician progress note dated 9/1/11 was not timed and there was no physician signature. There was a physician's order to discharge Patient 17 on 9/2/11 but there was no time to indicate when the order was written.

Patient 17 had a verbal order regarding speech therapy that had been received from the physician by a speech therapist. The verbal order was dated 8/26/11 but was not timed. The verbal order had been signed by the physician but there was no date or time to indicate when this was done.

The facility's Telephone and Verbal Physician Orders policy (undated) was reviewed and indicated the following:

Policy
All telephone orders for patients on the acute psychiatric unit will be signed by the attending or on call physician within 24 hours. Verbal orders shall only be accepted in an emergency.
Purpose
To ensure complete, accurate and useful medical records for all patients.
Reference
Medical Staff Rules and Regulations
Procedure
2. The attending/ on call physician will date, time and sign the verbal order within 24 hours.
3. Verbal orders are to only be received in an emergency and then the physician will sign the verbal orders immediately after the emergency.

A review of the facility's Medical Staff Rules and Regulations (revised 9/05) indicated the following:

Orders
1. All patient orders shall be in writing and shall be timed and dated.
3. The following individuals are authorized to accept and transcribe verbal orders: registered nurses, pharmacists (medication only), and dieticians (diet related only). The authorized individual shall write the order, followed by the name of the Medical staff Member, date and time, name and signature of the writer.

During an interview on 9/28/11 at 9:20 a.m., the ADR stated therapists often write verbal orders. She said when the physicians are on the unit, they often review the treatment plan with the therapists and will give them a verbal order. The Medical Staff Rules and Regulations were reviewed with the ADR and she acknowledged that the therapists are not authorized to receive verbal orders.

MD 1 ( director of inpatient psychiatric services) was interviewed on 9/28/11 at 10:10 a.m. He stated that verbal orders should only be used in an emergency and should not be used for routine rehabilitation orders. He also said that rehabilitation staff (therapists) were not authorized to take verbal orders per the facility's Medical Staff Rules and Regulations.

6. A review of Patient 18's record showed there was a discharge order dated 9/7/11 but there was no time to indicate when the order was written.

Based on interview and record review, the facility's verbal order policy did not require a staff member receiving a verbal order to read the order back to the ordering practitioner to verify its accuracy. The failure to include "a read back and verify" process for verbal orders increases the risk of medication and treatment errors.

Findings:

The facility's Telephone and Verbal Physician Orders policy (undated) was reviewed and indicated the following:

Policy
All telephone orders for patients on the acute psychiatric unit will be signed by the attending or on call physician within 24 hours. Verbal orders shall only be accepted in an emergency.
Purpose
To ensure complete, accurate and useful medical records for all patients.
Reference
Medical Staff Rules and Regulations
Procedure
2. The attending/ on call physician will date, time and sign the verbal order within 24 hours.
3. Verbal orders are to only be received in an emergency and then the physician will sign the verbal orders immediately after the emergency.

The policy did not include any requirement that the staff member receiving the verbal order read it back to the ordering practitioner to verify its accuracy.

During an interview on 9/27/11 at 11:10 a.m., RN 1 stated that staff members receiving a verbal order were not required to read it back to the ordering physician to verify its accuracy. She acknowledged the facility's verbal order policy did not include a "read back and verify" process.

Based on observation, interview and record review, the hospital failed to maintain an effective temperature monitoring system to ensure the proper storage of medications that require refrigeration. In addition, the hospital failed to consistently implement the hospital policy and procedure on medication storage to ensure that thermometers used in medication storage refrigerators were calibrated periodically.

Findings:

During an inspection of the medication storage refrigerator in the pharmacy with the hospital Director of Pharmacy (DOP) at approximately 11:45 a.m. on 9/22/11, medications and vaccines were observed inside the refrigerator. The DOP presented an electronic device with no temperature display and explained that the device detected and recorded refrigerator temperature every 12 hours and that he would download the data from the device weekly or monthly and reviewed the refrigerator temperature readings retrospectively. The DOP added that the pharmacy had not been doing daily temperature monitoring since the introduction of the new temperature monitoring device. The DOP acknowledged that out of range refrigerator temperature would be not identified and addressed timely to ensure the proper storage of the medications and vaccines within but until the weekly or monthly data downloading from the device.

The CDC (the Center for Disease Control) publication " Guidelines for Maintaining and Managing the Vaccine Cold Chain " indicated that proper temperature monitoring is crucial to proper cold chain management to ensure the effectiveness of vaccines. Temperatures should be read and documented twice each day, once when the office or clinic opens and once at the end of the day. Thermometers should be placed in a central location in the storage unit, adjacent to the vaccine. Exposure of vaccines to temperatures outside the recommended ranges can affect potency adversely, thereby reducing protection from vaccine-preventable diseases.

During an inspection of the medication storage refrigerator of the acute unit at approximately 2:25 p.m. on 9/22/11, there was no record of the calibration of the refrigerator thermometer to ensure the proper functioning of the device. Charge Nurse 1 stated that she confirmed with the hospital plant operations department that there had not been any calibration of the refrigerator thermometer performed.

A review of the hospital policy and procedure on medication storage indicated that refrigerator thermometers must be calibrated periodically and a log be kept for each calibration.

The facility failed to comply with the Condition of Participation for Radiological Services when it failed to ensure that a qualified radiologist was appointed to supervise it's radiology services and failed to ensure that there were written policies approved by the medical staff to designate which radiological tests require interpretation by a radiologist. (A 546)

The cumulative effects of this systemic failure resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, interview and record review, the facility failed to ensure that a qualified radiologist was appointed to supervise it's radiology services and failed to ensure that there were written policies approved by the medical staff to designate which radiological tests require interpretation by a radiologist. The deficient practices limited the facility's ability to provide radiology services in accordance with acceptable standards of practice.

Findings:

On 9/22/11 at 12:40 p.m., during a tour of the facility's radiology department, the DOE (director of education) stated the facility used mobile radiology services after hours and when the facility's own radiology technician was on leave. She said x-rays taken by the facility's radiology technician are transmitted digitally to a radiologist at a local hospital who reads the x-ray and notifies the facility of the result. There was an expired (10/31/2009) radiology x-ray supervisor and operator certificate posted in the radiology department. The DOE stated the certificate was for the radiologist (MD 5) at the local hospital who reads the x-rays for the facility. When asked if the facility had a contract with the radiologist she said she would have to check.

On 9/26/11 at 12:30 p.m., the DOE stated she could not locate a contract with the radiologist who reads the facility's x-rays. There was no documentation of the scope and nature of the services provided by the radiologist. The DOE submitted an updated radiology x-ray supervisor and operator certificate for MD 5 (expiration date 10/31/2013). When asked if MD 5 was the supervisor of the facility's radiology services, the DOE responded "We keep his license downstairs but I don't know if he is considered the radiology director or supervisor." She stated MD 5 was not a member of the medical staff and the facility did not have a credential file for MD 5.

The facility was asked for written policies approved by the medical staff that designated which radiological tests require interpretation by a radiologist. On 9/28/11 at 8:30 a.m. the facility staff submitted a document titled "(Name of facility) Radiology Department. Routine Views (revised 8/1/2008)." The document listed the various radiologic tests available at the facility but did not indicate which tests required interpretation by a radiologist. There was no indication that this document had been approved by the facility's medical staff.

Based on observation, interview and record review, the facility failed to develop a system to identify, report, prevent and control infections and communicable diseases when:

1. There was clean linen stored in the soiled linen closet, two soiled pillows were placed on a weighing scales which was stored in the soiled linen closet and a shower chair seat was stained and had hair on it.

2. A staff member who was not wearing gloves while putting food on a plate, touched her eyeglasses and face and continued to serve food and handle plates of food without washing or sanitizing her hands.

3. There was no process in place to track whether employees who requested the Hepatitis B vaccination received the vaccination.

4. There was no evidence that the Radiology department was incorporated into the hospital wide infection control program.


Findings:


23107

1. During an observation on 9/21/11 at 10:15 a.m., there were five bedspreads stored on a shelf in the soiled linen closet. RN 1 who was present stated the bedspreads were clean and should be stored in the clean linen closet not the soiled linen closet. There was a weighing scales in the soiled linen closet with two pillows placed on top. RN 1 stated the pillows were soiled and should not have been placed on top of the weighing scales. She stated the weighing scale was stored in the soiled linen closet because of " a shortage of space ." She acknowledged this was an infection control issue. In the unit's shower room there was a shower chair with yellow stains and a hair on the seat. RN 1 acknowledged the finding and stated the shower chairs are usually cleaned by the CNA (certified nursing assistant) after each patient.

2. On 9/21/11 at 12 p.m., staff on K 1 unit were observed preparing food for the acute psychiatric unit patients. A staff member who was putting food on plates without wearing gloves, touched her eyeglasses and face and continued to serve food and handle plates without washing or sanitizing her hands.

During an interview on 9/27/11 at 9:55 a.m., the ICN (Infection Control Nurse) said that staff members should wear gloves when serving food and should wash their hands after touching their face.

A review of the facility's " Nutritional Services Department Serving Food" policy indicated the following:

Purpose: To prevent foodborne illness by ensuring all foods are served in a sanitary manner.
Instructions:
4. Wash hands before putting on gloves, ...

The facility's "Nutritional Services Department Washing Hands" policy indicated the following:

Purpose: To prevent foodborne illness by contaminated hands.
Instructions:
7. Wash hands:
During food preparation
After touching hair, face, or body

3. PT 1's personnel record was reviewed on 9/27/11 at 1:40 p.m. PT 1 was hired by the facility on 7/2/09. There was a consent form for Hepatitis B vaccine dated 8/11/09 which PT 1 had signed and checked the box that she wished to receive the Hepatitis B vaccine. PT 1 had written on the form that she had received the vaccine several years ago and would like a blood test to determine if she had developed immunity to the hepatitis B virus. There was a second vaccination consent form dated 9/30/10 on which PT 1 again indicated that she would like to receive the Hepatitis B vaccine. There was no documentation that PT 1 had received the Hepatitis B vaccine or a blood test to determine her immunity despite requesting the vaccine twice.

OT 1's personnel record was reviewed on 9/27/11 at 2:40 p.m. OT 1 was hired by the facility on 4/11/11. There was a consent form for vaccinations dated 4/11/11 that OT 1 had signed and indicated that she wanted to receive the hepatitis B vaccine. There was a report from the facility's contract occupational clinic that showed OT 1 received the first injection of the Hepatitis B vaccine on 5/6/11. There was no documentation that OT 1 had received the second injection of the Hepatitis B which was due on 6/6/11.

During an interview on 9/27/11 at 3:05 p.m., the ICN stated when new hires sign the consent for Hepatitis B vaccination, they are sent to the human resources department who will give the employee an authorization form to go to the contract occupation clinic. She said the infection control policy did not address the drawing of blood to determine if an employee had developed immunity to the Hepatitis B virus. She said "The policy is all employees are offered the Hepatitis vaccine." The ICN stated she did not track which employees had received the Hepatitis B vaccine as requested but "maybe HR (human resources) did."

During an interview on 9/28/11 at 9:55 a.m., the DHR stated when employees go to the contract occupational clinic for the Hepatitis B vaccine, human resources will get a notification indicating the date the injection was given. She said the notifications are received "only if people follow through." When asked if she tracked when employees were due for the second and third Hepatitis B injection, she said "no". She said she could not explain why OT 1 had not received the second Hepatitis B injection which was due on 6/6/11. She stated " We need to do a better job of tracking."

A review of the facility's Infection Control Manual indicated the following:

Hepatitis B Vaccine.

The vaccine series is given in this order:
Initial injection
One month after initial injection
Six months after initial injection

It is the (name of facility)'s responsibility to schedule the initial and follow up injection.

4. During a tour of the radiology department on 9/22/11 at 12:40 p.m., the DOE was asked who was responsible for enforcing infection control standards in the radiology department. She said "I don't know, maybe its (name of infection control nurse)."

During an interview on 9/27/11 at 9:45 a.m., the ICN (infection control nurse) was asked if she provided oversight to the radiology department and was responsible for enforcing infection control standards in the department. She responded "Not really." She said she had no infection control policies specific to the radiology department. She stated "Maybe they have their own policies."

There was no evidence that the radiology department was incorporated into the hospital wide infection control program.

The facility failed to ensure that the organ, tissue, and eye procurement requirements were met when:

The facility failed to develop written policies and procedures to address its organ procurement responsibilities. See (A 885)

The facilityfailed to have a written agreement with an Organ Procurement Organization as required under CMS 482.45(a)(1). See (A 886)

The facility failed to have an agreement with at least one tissue bank and one eye bank as required under CMS 482.45(a)(2). See (887).

The cumulative effects of this systemic failure resulted in the hospitals inability to provide services to tranplant recipients and meet its organ procurement responsibilities.

Based on interview the facility failed to develop written policies and procedures to address its organ procurement responsibilities.

Findings:

During an interview on 9/22/11 at 12:10 p.m., Administrative Staff 1 said she had not been aware of the requirements regarding organ, tissue and eye procurement. She said the facility had no policies and procedures regarding organ procurement.

Based on interview, the facility failed to have a written agreement with an Organ Procurement Organization as required under CMS 482.45(a)(1).

Findings:

On 9/21/11 at 9:35 a.m., a copy of the facility's agreement with an Organ Procurement Organization was requested.

On 9/21/11 at 3:50 p.m., RN 1 stated "We do not have an agreement with an Organ Procurement Organization, my administrator will apply for it."

On 9/22/11 at 12:10 p.m., Administrative Staff 1 confirmed the facility did not have an agreement with an Organ Procurement Organization. She said she had not been aware of the requirements regarding organ, tissue and eye procurement.

Based on interview, the facility failed to have an agreement with at least one tissue bank and one eye bank as required under CMS 482.45(a)(2).

Findings:

During an interview on 9/22/11 at 12:10 p.m., Administrative Staff 1 said she had not been aware of the requirements regarding organ, tissue and eye procurement. She said the facility did not have an agreement with a tissue bank and an eye bank.