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Based on observation, record review and interview the hospital failed to meet the requirements for the Condition of Participation for Governing Body as evidenced by:


1) Failure to follow the Medical Staff By-Laws, which were approved by the Governing Body, as evidenced by: failing to ensure the credentials of the candidates for reappointment to the medical staff were reviewed and recommendations were made to the governing body by the medical staff for 3 of 7 physicians reviewed (S20, S21, S24) and for 3 of 3 nurse practitioners reviewed (S25, S31, S32); failing to ensure a statement of the specific privileges were requested and approved for each member of the medical staff as evidenced by the request of core privileges rather than specific privileges for 6 of 7 physicians reviewed (S19, S21, S22, S23, S24, S26) and 1 of 3 nurse practitioners reviewed (S31); failing to ensure participation of physicians in committee assignments as evidenced by the Medical Director as the only member of the Medical Executive Committee, Utilization Review Committee and Quality Assurance/Performance Improvement Committee and no physician participation in the Pharmacy and Therapeutics Committee, peer review, death review, or blood usage review; and failing to ensure the Medical Staff complied with the Medical Staff By-Laws as evidenced by a medical records delinquency reate of 58% (12 of 20 discharged patient records). (See findings at Tag A0046) and

2) Failure of the hospital Governing Body to ensure all contracted services were provided in a safe and effective manner as evidenced by failing to: maintain a maintenance contract for equipment resulting in 3 of 4 Enteral Pumps and 6 of 6 Venaflow Devices used for patient care not being inspected annually; perform evaluations on all contracted services; failing to ensure the contracted services of Laboratory, Dietary and Radiology had policy and procedures addressing patient care and safety. (See findings at Tag A0084).

Based on observation, record review and interview the hospital failed to meet the requirements of the Condition of Participation for Medical Records as evidenced by:

1) Failure to ensure the hospital had an organized medical records system in place to meet the needs of both a main campus and off-site hospital as evidenced by allocation of inadequate space at either location for the processing and storage of open and closed medical records resulting in storage of medical records in cardboard boxes with an Excel spreadsheet used to locate records. (See findings at Tag A0432) and

2) Failure to ensure medical records were accurately written as evidenced by placing an incorrect date on a chart and continuing with inaccurate dates for the next five consecutive days (Patient #2) and by placing a check mark in the space provided for activity on a restraint form (Patient #3) for 2 of 20 sampled patients; medical records were protected from water damage at the hospital's main campus and off site campus designated for medical records storage as evidenced by storing charts in cardboard boxes on the floor and open metal shelving in a room with a ceiling sprinkler system; and medical records were completed no later than thirty days after discharge resulting in 12 of 20 discharged medical records determined to be incomplete (delinquency rate of 58%) (See findings at Tag A0438);

Based on record review and interview the Governing Body failed to follow the Medical Staff By-Laws, which were approved by the Governing Body, as evidenced by: 1) failing to ensure the credentials of the candidates for reappointment to the medical staff were reviewed and recommendations were made to the governing body by the medical staff for 3 of 7 physicians reviewed (S20, S21, S24) and for 3 of 3 nurse practitioners reviewed (S25, S31, S32); 2) failing to ensure a statement of the specific privileges were requested and approved for each member of the medical staff as evidenced by the request of core privileges rather than specific privileges for 6 of 7 physicians reviewed (S19, S21, S22, S23, S24, S26) and 1 of 3 nurse practitioners reviewed (S31); 3) failing to ensure participation of physicians in committee assignments as evidenced by the Medical Director as the only member of the Medical Executive Committee, Utilization Review Committee and Quality Assurance/Performance Improvement Committee and no physician participation in the Pharmacy and Therapeutics Committee, peer review, death review, or blood usage review and 4) failing to ensure the Medical Staff complied with the Medical Staff By-Laws as evidenced by a medical records delinquency reate of 58% (12 of 20 discharged patient records). . Findings:

1) failing to ensure the credentials of the candidates for reappointment to the medical staff were reviewed and recommendations were made to the governing body by the medical staff Physician S20
Review of Physician S20's credentialing file revealed a "Temporary Application To St. Theresa" was completed by S20 on 09/15/10. Further review revealed one peer reference was received on 10/21/10. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed no documented evidence of the type of action taken to include initial application, reappointment application, provisional review, or allied health professional application. Further review revealed the "Signature Page Medical Staff or Allied Health Appointment" was signed by the Chairman of the Medical Executive Committee on 07/19/11 and by the Chairman of the Governing Board on 07/19/11 for appointment of S20 to the medical staff. There was no documented evidence of an application for appointment, proof of continuing education, a peer review by the Medical Director, and a second reference as required by medical staff bylaws for appointment to the medical staff.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT (Registered Health Information Tech) S7 indicated they have used the completed temporary application when they "roll over" a physician from temporary to active status.

Medical Director S21
Review of Medical Director S21's credentialing file revealed he was reappointed on 07/19/11. Further review revealed S21 submitted a request for core privileges for Internal Medicine on 05/06/11, rather than specific privileges. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed S21's reappointment was granted by the Chairman of the Governing Board on 07/19/11 with no documented evidence of a recommendation from the Medical Executive Committee as required by the medical staff bylaws. Further review revealed no documented evidence of a completed peer review as required by the bylaws.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 confirmed Medical Director S21's credentialing file was not reviewed for recommendation by the Medical Executive Committee (MEC), because the MEC consists of only one physician at present, Medical Director S21, and S21 could not review and recommend his own file.

Physician S24
Review of Physician S24's credentialing file revealed a letter addressed to Physician S24 dated 11/15/10 notifying him of his reappointment to the medical staff on 10/26/10. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed Chairman of the MEC signed the recommendation on 10/26/10, and the Chairman of the Governing Board signed the form on 12/07/10, more than one month after S24 was reappointed. Further review revealed no documented evidence whether the Governing Board Chairman granted, did not grant, deferred, or granted with exceptions the reappointment of S24. There was no documented evidence of proof of continuing education and a peer review by the Medical Director as required by medical staff bylaws for appointment to the medical staff.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 confirmed the above findings for Physician S24.

Nurse Practitioner S25
Review of Nurse Practitioner S25's credentialing file revealed a letter dated 05/01/07 that indicated S25's appointment would end on 04/26/09. Further review revealed S25's reappointment application was signed on 06/21/10. Review of a letter dated 07/08/10 revealed S25's reappointment was approved on 07/06/10. There was no documented evidence S25 had applied for and requested privileges prior to her appointment expiring on 04/26/09. Further review revealed no documented evidence of a collaborative agreement with her supervising physician as required by the bylaws.

In a face-to-face interview on 08/04/11 at 11:10am, RHIT S7 confirmed there was no collaborative agreement for Nurse Practitioner S25, and she did treat patients during the time period from 04/26/09 until 07/06/10 when her appointment had expired.

Nurse Practitioner S31
Review of Nurse Practitioner S31's credentialing file revealed a letter dated 09/08/09 notifying S31 that her appointment would expire on 09/03/10. Further review revealed a letter dated 11/15/10 notifying S31 that her reappointment was effective 10/26/10, 53 days after her appointment had expired. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed Chairman of the MEC signed the recommendation on 10/26/10, and the Chairman of the Governing Board signed on 12/07/10, 41 days after S31 had been notified of her appointment. Further review of the credentialing file revealed no documented evidence of a reappointment application, a collaborative agreement with her supervising physician, and her peer reference was received (11/01/10) after her appointment was made.

Nurse Practitioner S32
Review of Nurse Practitioner S32's credentialing file revealed her appointment had expired on 04/26/09, and her reappointment was not approved until 11/02/09, more than 6 months later. Further review revealed no documented evidence of a collaborative agreement with S32's supervising physician.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 indicated he took over credentialing about 1 1/2 to 2 years ago and had no experience with credentialing prior to this time. S7 further indicated he had read the medical staff bylaws, but he had not "studied" them related to credentialing.

In a face-to-face interview on 08/04/11 at 11:10am, RHIT S7 confirmed the above findings.

Review of the "Credentialing Policy of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Applications for initial appointment and reappointment shall contain a request for specific clinical privileges desired by the individual... The application for Medical Staff membership and all supporting documentation shall be delivered to the Chief Executive Officer or his or her designee. ... (b) Verify and obtain at least two written references on initial appointment and at least one written reference at reappointment, on the applicant. ... (a) Temporary privileges shall not routinely be granted. In extraordinary situations when necessary to avoid undue hardship to a patient, the Hospital CEO, an existing member of the Medical Executive Committee or the Governing Board may grant temporary privileges. This decision will be made on a case-by-case basis. ...Temporary privileges may be granted only after there has been a favorable report, for the clinical privileges requested, from the Medical Director... Temporary privileges shall be granted for a specific period of time as warranted by the situation. In no situation should the initial grant of temporary privilege be for a period of time to exceed one hundred and twenty (120) days. (g) Temporary privileges shall expire at the end of the time period for which they are granted. ...All terms, conditions, requirements, and procedures required for initial appointment must continue to be met and maintained for reappointment. 5.A.1. Qualifications (a) To be eligible for reappointment, an individual must have, during the previous appointment term: ... (2) Completed all continuing medical education requirements as designated by state law ...(b) To be eligible to apply for renewal of clinical privilege, an individual must have performed sufficient procedures, treatments, or therapies in the previous appointment term to enable the Medical Director to assess the individual's current clinical competence for the privilege requested...Each current appointee who is eligible to be reappointed to the Medical Staff shall be responsible for completing a reappointment application form, including a new delineation of privileges. ... Prior to the end of each individual's current appointment period, the Medical Director shall prepare a report and recommendation concerning the individual seeking reappointment. ...The Medical Director shall forward its recommendations and findings to the Medical Executive Committee. ... If the recommendation of the Medical Executive Committee is favorable, it shall be submitted to the Governing Board. All recommendations to reappoint must also recommend the clinical privileges to be granted. ... Within 120 days of receipt of the recommendation from the Medical Executive Committee, or prior to expiration of appointment, the Governing Board shall: (1) Reappoint the individual and grant renewed clinical privileges as recommended; or (2) Refer the matter back to the Medical Director... or (3) Reject the recommendation. ... Confidentiality and Peer Review Protection 8.a: Confidentiality and Reporting Actions taken and recommendations made pursuant to this policy shall be treated as confidential... 8.B: Peer Review Protection (a) All minutes, reports, recommendations, communications, and actions made or taken pursuant to this policy are deemed to be covered by the provisions of any applicable peer review statute...".

Review of the "Policy on Licensed Allied Health Practitioners of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Licensed allied health practitioners who are permitted to practice in the Hospital shall be classified as either "Licensed Independent Practitioners" or "Dependent Practitioners." ..."Dependent Practitioners" shall include licensed allied health practitioners who are authorized to function in the Hospital as employees of, or under direct supervision of, a physician(s) appointed to the Medical Staff and are granted a defined scope of practice by the Governing Board. ...A current listing of the types of licensed allied health practitioners functioning within the Hospital as Dependent Practitioners is attached to this policy as Appendix B. ...Provide a copy of collaborative agreement when applicable or when a collaborative agreement is required by law. ... A completed application form, with copies of all required documents must be returned to the Chief Executive Officer within thirty (30) days after receipt of the same if the individual desires further consideration...The Chief Executive Officer will review the application... A completed application shall be forwarded to the Medical Director. Thereafter, the Medical Director shall report to the Medical Executive Committee regarding the applicant's qualifications for the clinical privilege or scope of practice requested. ... the Medical Executive Committee shall report its recommendations to the Governing Board for final action. ...Appendix B Those licensed allied health practitioners currently practicing as Dependent Practitioners at St. Theresa Specialty Hospital are as follows: ... Nurse Practitioners...".

2) failing to ensure a statement of the specific privileges were requested and approved for each member of the medical staff as evidenced by the request of core privileges rather than specific privileges
Physician S19
Review of Physician S19s credentialing file revealed she requested and had approved core privileges for internal medicine, rather than specific privileges.

Medical Director S21
Review of Medical Director S21's credentialing file revealed core privileges for internal medicine was requested by S21 on 05/06/11. Further review revealed no documented evidence S21's request had been reviewed by the Medical Executive Committee and a recommendation made to the Governing Board.

Physician S22
Review of Physician S22s credentialing file revealed she requested and had approved core privileges for palliative care, rather than specific privileges.

Physician 23
Review of Physician S23s credentialing file revealed she requested and had approved core privileges for internal medicine, rather than specific privileges.

Physician S24
Review of Physician S24's credentialing file revealed he requested and had approved core privileges for internal medicine and infectious disease, rather than specific privileges.

Physician S26
Review of Physician S26's credentialing file revealed he requested and had approved core privileges for internal medicine and pulmonary disease, rather than specific privileges.

Nurse Practitioner S31
Review of Nurse Practitioner S31's credentialing file revealed she had requested core privileges for treatment and management of diseases in the adult patient, rather than specific privileges.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 confirmed Medical Director S21's credentialing file was not reviewed for recommendation by the Medical Executive Committee (MEC), because the MEC consists of only one physician at present, Medical Director S21, and S21 could not review and recommend his own privileges. S7 confirmed they were currently using core privileges. S7 indicated he took over credentialing about 1 1/2 to 2 years ago and had no experience with credentialing prior to this time. S7 further indicated he had read the medical staff bylaws, but he had not "studied" them related to credentialing.

Review of the "Credentialing Policy of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Applications for initial appointment and reappointment shall contain a request for specific clinical privileges desired by the individual... Each individual who has been appointed to the Medical Staff shall be entitled to exercise only those clinical privilege specifically granted by the Governing Board. ...Each current appointee who is eligible to be reappointed to the Medical Staff shall be responsible for completing a reappointment application form, including a new delineation of privileges...".

Review of the "Policy on Licensed Allied Health Practitioners of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Licensed allied health practitioners who are permitted to practice in the Hospital shall be classified as either "Licensed Independent Practitioners" or "Dependent Practitioners." ..."Dependent Practitioners" shall include licensed allied health practitioners who are authorized to function in the Hospital as employees of, or under direct supervision of, a physician(s) appointed to the Medical Staff and are granted a defined scope of practice by the Governing Board. ...The applicant shall indicate on the application the clinical privilege or scope of practice which he or she is requesting. ...the Medical Director shall report to the Medical Executive Committee regarding the applicant's qualifications for the clinical privilege or scope of practice requested. ... the Medical Executive Committee shall report its recommendations to the Governing Board for final action...".

3) failing to ensure participation of physicians in committee assignments
The hospital could not submit any documented evidence of peer review performed by a physician, review of blood usage or death reviews, or of Utilization Committee Meeting Minutes.

Review of the Medical Executive Committee and the Quality Assurance/Performance Improvement meeting minutes for 2010 and 2011 revealed the only the Medical Director participated on the committee.

Review of the Pharmacy & Therapeutics Committee meeting minutes revealed the last meeting was held in 2010.

This was confirmed by S1 Administrator and S21 Medical Director on 08/05/11.


4) failing to ensure the Medical Staff complied with the Medical Staff By-Laws
Review of the statistical data submitted to the Quality Management Department concerning the medical records delinquency rate revealed 12 of 20 discharged charts were incomplete after thirty days for a non-compiance rate of 58%. Further review of the meeting minutes of the "Committee of the Whole" dated 07/19/11 revealed... "Issue: Delinquent Medical Records' Discussion: Delinquent records exceeded the 50% threshold for the past four months; Action/Follow-up: Two charts need to be closed administratively due to unavailability of physicians (one has moved and is unable to be located and one expired). CEO and Medical Director completed process...". Further review of the minutes revealed no documented evidence of any further action to be taken.

In a face to face interview on 08/02 11 at 11:00am S7 RHIT indicated no corrective action had been implemented by Administration or the Governing Body concerning the medical records delinquency rate.

In a face to face interview on 08/05/11 at 2:15pm MD S21 Medical Director indicated he was aware of the medical delinquency problem with the medical staff. Further S21 indicated the hospital was experiencing difficulty generating interest in practicing at the hospital and when you come down hard on the physicians for not completing records, they tend not to want to admit patients.

Review of the "Rules and Regulations of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff and Chairman of the Governing Board with no documented evidence of the date they were signed, revealed, in part, "...The attending physician shall complete the medical record at the time of the patient's discharge, to include progress notes, final diagnosis and discharge summary. ... If the medical record is incomplete thirty (30) days after discharge, a written notice shall be sent to the physician by the Administrator notifying him that he has seven (7) days to complete the medical records or his admitting privileges will be suspended. The clinical privileges of any individual shall be deemed to be automatically relinquished for failure to complete medical records in accordance with applicable regulations governing the same, after notification by the Hospital of such delinquency and failure to complete the medical records within the seven day period. This relinquishment shall continue until all records of the individual's patients are no longer delinquent. Failure to complete the medical records that caused relinquishment of clinical privileges within 30 days from the relinquishment of such privileges shall constitute a voluntary resignation form the Medical Staff. Reinstatement of privileges shall be automatic upon completion of records and the Medical Records Director shall inform the Admitting Office. The Medical Records Director shall be responsible for analyzing medical records for the purpose of administering this rule. Three such suspensions of admitting privileges within any twelve (12) month period shall be sufficient cause for disciplinary action by the Executive Committee...".

Based on record review and interview the hospital failed to follow its policy and procedure for their budget as evidenced by failing to include capital expenditures for a three year period in their annual operating budget. Findings:

Review of the annual budget submitted by the hospital as the one currently in use revealed no documented evidence that the capital expenditures for at least a three year period was included.

In a face to face interview on 08/05/11 at 12:15pm S1 Administrator/CEO (Chief Administrative Officer) verified the budget did not include capital expenditures because the hospital did not have any. However when explaining the construction site located in the middle front of the hospital S1 indicated that was in preparation for Phase III of the hospital.

Review of the By-Laws of the Governing Body, dated 02/11 and submitted as the one currently in use, revealed.... "3.9-17 Establishing through the CFO (Chief Financial Officer) an annual operating budget that is prepared according to generally accepted accounting principles to include all anticipated income and expenses and to provide for a three (3) year plan for capital expenditures with appropriate input and consideration by the Hospital's Medical Staff and Administration".

Based on record review and interview the hospital failed to ensure all contracted services were provided in a safe and effective manner as evidenced by failing to: 1) maintain a maintenance contract for equipment resulting in 3 of 4 Enteral Pumps and 6 of 6 Venaflow Devices used for patient care not being inspected annually; 2) perform evaluations on all contracted services; 3) failing to ensure the contracted services of Laboratory, Dietary and Radiology had policy and procedures addressing patient care and safety. Findings:

1) maintain a maintenance contract for equipment resulting in 3 of 4 Enteral Pumps and 6 of 6 Venaflow Devices used for patient care not being inspected annually
Observations of the Clean Equipment Room on 8/02/2011 at 9:15 a.m., revealed 3 Ross Patrol Enteral Pumps with Safety Inspection Stickers indicated Due Date 3/2010, 2 Venaflow Devices with Stickers indicating Due Date of 3/2010, and 4 Venaflow Devices with no Inspection Sticker.

These findings were confirmed by Registered Nurse S4 in a face to face interview on 8/02/2011 at 9:15 a.m. S4 indicated he (S4) would have Bio-medical Staff S14 explain Biomedical Services at the facility.

In a face to face interview on 8/02/11 at 12:10pm, Biomedical Staff S14 indicated he (S14) had not performed any services for the facility in over a year. S14 indicated he (S14) had made it clear to the facility that they (St. Theresa's) owed him (S14) money and he (S14) would no longer provide any services. S14 indicated he (S14) stopped working for the facility over a year prior to the survey.

In a face to face interview on 08/05/11 at 10:30am S1 Administrator/CEO (Chief Executive Officer) would neither deny or confirm owing money on the Bio-Med contract. Further S1 indicated the hospital signed a contract with another company; however S1 was not able to provide the contract because he (S1) said it was sent to the other company for signature.

Review of the hospital policy titled, "Medical Equipment Management Activities, #252, Revised 10/2008" presented by the hospital as their current policy revealed in part, "Clinical and physical risks are assessed and minimized through inspection, testing and maintenance. Each piece of equipment will have an ID tag and a preventative maintenance tag. All new patient care equipment must be inspected prior to the first use by a Qualified BioMedical Service. . . ."

2) perform evaluations on all contracted services
The hospital could not submit any documentation evaluations were performed on contracted services.

Review of the Quality Assurance/Performance Improvement (QA/PI) Program Committee Meeting Minutes dated 0811/10, 10/10/10 and 07/19/11 revealed no documented evidence contracted services were included in the QA/PI program.

In a face to face interview on 08/05/11 at 12:15pm S1 Administrator verified contract evaluation had not been performed.


3) failing to ensure the contracted services of Laboratory, Dietary and Radiology had policy and procedures addressing patient care and safety.
Review of the Administrative and Clinical Policy and Procedure Manuals submitted as the ones currently in use revealed no documented evidence policies were written to address care and safety issue provided by the contracted services of Laboratory, Dietary and Radiology. This was confirmed by RN S2 DON (Director of Nursing) on 08/05/11 at 11:00am.

Based on record review and interview the hospital failed to develop a list of contracted services. Findings:

The hospital could not submit a list of contracted services used by the hospital. This was confirmed by the S1 Administrator/CEO (Chief Operating Officer) on 08/05/11.

Based on record review and interviews, the hospital failed to implement its grievance process as evidenced by failure to provide prompt resolution of patient grievances for 2 of 3 grievances reviewed (R1, R2). Findings:

Review of the log presented by Director of Quality S11 when the grievance log was requested revealed five complaints (three for the same patient R2) from 08/27/10 through 04/28/11.

Random Patient R1
Review of the "Complaint/Grievance" form dated 08/27/10 at 9:35am and completed by former DON (director of nursing) S50 revealed Random Patient R1's husband complained about the unacceptable behavior of CNA (certified nursing assistant) S30. R1's husband indicated he had asked CNA S30 numerous times on 08/25/10 to place R1 on the bedside commode, and she kept saying she was too busy and would clean R1 after lunch. Further review of the form revealed CNA S30 was removed immediately from the care of Random Patient R1. Further review of the form revealed the question "was issue resolved timely and without need for further investigation" was checked with the answer of "yes".
Review of the investigative findings documented revealed CNA S51 reported his concerns about CNA S30's behavior on 08/26/10. Further review revealed former Contract PTA (physical therapy assistant) S52 was interviewed by former DON S50 on 08/27/10 regarding CNA S30's behavior related to Random Patient R1.
Review of the "Complaint/Grievance" form revealed the investigation started 08/26/10, and there was no documented evidence of the date it was completed, as well as conclusions of review, action taken, the reviewer's signature, the CEO's (chief executive officer) signature, the feedback to patient and family, and the date the written response letter was sent. This was all evidenced by the areas mentioned above being blank.
Review of the documentation under the column titled "Follow-up/Outcome" on the complaint/grievance log revealed "Because of the serious concerns regarding care, as well as the volume of complaints, a counseling session has been scheduled at which the DQM (director of quality management) will be present".

Review of CNA S30's personnel file revealed no documented evidence that a counseling session had taken place. Further review revealed S30 was originally hired 02/01/10, resigned 11/11/10, and was rehired 04/21/11.

In a face-to-face interview on 08/03/11 at 9:35am, Quality Management Director S11 indicated the DCS (Director of Clinical Services) was responsible for handling clinical issues. She further indicated if the DCS was unable to come to a resolution, the DCS would refer it to the CEO. When told by the surveyor that the hospital's patient rights indicated that grievances are given to the Director of Quality, S11 indicated she received them at the end of the process. S11 indicated all of the complaints listed on the log submitted to the surveyor were handled as complaints. When S11 was informed by the surveyor of the regulation's definition of complaint and grievance, S11 indicated they did not interpret the federal regulations as the surveyors had interpreted them.

Random Patient R2
Review of the "Complaint/Grievance" form dated 04/23/11 initiated by DON S2 revealed R2's granddaughter complained of the lack of oral care for her grandmother and that the nurse caring for her grandmother didn't know how to connect the suction canister. Further review revealed the immediate action taken was that DON S2 spoke with the staff and informed them on the practice of and importance of adequate oral hygiene. There was no documented evidence that the nurse's lack of knowledge of how to connect a suction canister had been addressed. Further review revealed the issue was documented as resolved and without need for further investigation. There was no documented evidence of investigation to determine who had not performed oral care, so those individuals could be re-educated.

Review of the "Complaint/Grievance" form dated 04/27/11 initiated by DON S2 revealed Random Patient R2's granddaughter complained that: 1) her grandmother had dried urine on her gown and the underpad beneath her was soaked in urine; 2) there was lack of satisfactory oral care; 3) the intake and output sheet for the night shift of 04/26/11 had not been completed; and 4) the CNAs giving the morning bath had very loud, inappropriate, and personal conversations over her grandmother's body. Further review revealed the immediate action taken was instruction of the CNAs to be respectful of actively dying and all patients when giving a bath and re-instructed CNAs on personal hygiene. There was no documented evidence of investigation to include interviews of staff to determine which staff was responsible for the actions related to the complaints.
Further review revealed no documented evidence of completion of the following sections of the "Complaint/Grievance" form: was issue resolved timely and without need for further investigation; investigative findings; investigation conducted by; conclusions of review / actions taken; reviewer's signature; CEO signature; feedback to Patient and Family; and date written response letter sent to patient and/or family.

Review of the complaint/grievance log revealed a complaint/grievance was issued by Random Patient R2's granddaughter on 04/28/11 regarding creating a peaceful environment by: 1) fixing the outside door that slams constantly; 2) turning off speaker in the room used to page staff members; 3) displaying in the room who was responsible for R2's care each shift; 4) letting family members know the hospital's scope of practice regarding hospice patients; and 5) having the three call buttons functioning (2 of 3 call buttons did not work). Further review revealed no documented evidence a "Complaint/Grievance" form had been initiated by DON S2. Further review revealed no documented evidence that an investigation had been conducted, whether the complaint/grievance had been resolved, and that a written response letter had been sent to the complainant.

In a face-to-face interview on 08/05/11 at 11:08am, Director of Quality S11 indicated if a complaint a truly a grievance, the DON investigates the clinical issues. S11 further indicated if a letter is required to be sent to the complainant, the CEO would write the letter. S11 confirmed that all complaints documented were handled as complaints, and they had none that were viewed as grievances by hospital administration.

In a face-to-face interview on 08/05/11 at 11:15am, DON S2 confirmed no written responses were sent to the complainants for Random Patients R1 and R2.

Review of the hospital policy titled "Patient Complaint and Grievance", number C06-A revised 05/10 and submitted by Director of Quality S11 as their current policy for grievances, revealed, in part, "...5. The hospital staff member receiving the complaint will address the concerns that are appropriate to that individual's area of responsibility, expertise, state practice guidelines. experience, and knowledge and can be addressed immediately... 6. If a complaint cannot be resolved timely by the Hospital staff member, the staff member shall notify his/her supervisor and complete the "Angry Man" complaint form. The form is then forwarded to the Director of Clinical Services (DCS). The DCS will investigate the circumstances surrounding the concern or complaint and review the issues with the DQM and hospital CEO. The Director of Quality Management (DQM) will enter the information in the Complaint/Grievance Log and may participate in the investigation and follow-up process. 7. The investigative process should be completed, corrective action taken, and a written response sent within seven (7) days of receipt of the complaint. If the grievance will not be resolved, or the investigation not completed within seven (7) days, the hospital shall inform the patient or patient's family member/representative, that the hospital is still working to resolve the grievance and will follow-up with a written response in a stated number of days. ... 10. The DQM, along with the CEO, will prepare a written response to the patient's grievance. ... 11. The written response must contain the following: a. A description of the issues raised by the grievance b. A description of the steps taken to investigate the issue c. The date the grievance was resolved and what steps were taken to resolve the grievance. d. The name of the contact person at the hospital that the patient/designee can call with additional questions 12. Written responses to grievances must be reviewed and approved by the Legal Department before they are mailed or delivered to the patient/designee...". Review of the attached "Quality Call (Procedure for filing a complaint)" revealed the listed Director of Clinical Services and CEO were no longer in position, and the Patient Representative was not named with the address being that of the offsite campus rather than the main campus.

Based on record review and interview, the hospital failed to ensure its grievance process included a mechanism for timely referral of patient concerns related to quality of care or premature discharge to the appropriate Utilization and Quality Improvement Organization (QIO). Findings:

Review of the hospital policy titled "Patient Complaint and Grievance", number C06-A revised 05/10 and submitted by Director of Quality S11 as their current policy for grievances, revealed no documented evidence of a process for referring patient concerns related to quality of care or premature discharge to the appropriate Utilization and Quality Improvement Organization.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 indicated she had not read the state licensing and federal certification regulations since she became DON. She could offer no explanation for the grievance process not including the process for referring patient concerns related to quality of care and premature discharge to a QIO.

Based on record review and interview, the hospital failed to ensure patients were informed of their right to participate in developing and implementing their plan of care as evidenced by failure to include this right in the patient rights presented to patients upon admission. Findings:

Review of the "Patient's Rights" included in the admit packet presented by Director of Quality S11 revealed no documented evidence that the right of patients to participate in developing and implementing their plan of care had been included.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 indicated she had not read the state licensing and federal certification regulations since she became DON. She could offer no explanation for the patient rights not including that the patients had the right to participate in developing and implementing their plan of care.

Based on record review and interview, the hospital failed to ensure patients were informed of their right to have a family member of his/her choice or his/her own physician notified promptly of his/her admission as evidenced by failure to include this right in the patient rights presented to patients upon admission. Findings:

Review of the "Patient's Rights" included in the admit packet presented by Director of Quality S11 revealed no documented evidence that the right of patients to have their family member or physician notified promptly of their admission had been included in the patient rights.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 indicated she had not read the state licensing and federal certification regulations since she became DON. She could offer no explanation for the patient rights not including the patient's right to have their family member or physician notified promptly of their admission.

Based on record review and interview, the hospital failed to ensure a physician's order was obtained for the use of Medical Restraints for 3 of 3 sampled patients in restraints out of a total sample of 20 (#3, #5, #15). Findings:

Patient #3
Review of Patient #3's Medical Record revealed the patient was admitted to the hospital on 7/07/2011 with diagnoses that included weakness and fall. Further review revealed a physician's order dated 7/23/2011 at 5:33 a.m. for "Soft wrist restraints to Bilateral Upper Extremities". Review of Restraint Order Sheets "not to exceed 24 hours" for Patient #3 revealed an order sheet for "Left Upper, Right Upper (type of restraint)" with Apply date of 8/02/2011 at 0700 (7:00 a.m.) - 8/03/2011 at 7:00 a.m., Apply date of 8/01/2011 at 7:00 a.m. - 8/02/2011 at 7:00 a.m., 7/31/2011 (no documented time) - 8/1/2011 (no documented time), 7/29/2011 at 7:00 a.m. - 7/30/2011 at 7:00 a.m., and 7/28/2011 - 7:29/2011 with no documented evidence that the orders were taken as verbal and/or telephone orders and no documented signature of a physician.

Patient #5
Review of Patient #5's Medical Record revealed the patient was admitted to the hospital on 7/21/2011 with diagnoses that included Mental Status Changes associated with Hyponatremia and Dehydration. Further review revealed a Restraint Order Sheet "not to exceed 24 hours" for Patient #5 dated 8/02/2011 at 7:00 a.m.- 8/03/2011 at 7:00 a.m. with no documented evidence that the orders were taken as verbal and/or telephone orders and no documented signature of a physician (Initial Physician order for upper extremity restraints 7/31/2011 signed by physician).

During a telephone interview on 8/03/2011 at 8:50 a.m., Charge Nurse S13 indicated the practice on the night shift at the Off Site Campus was to place a Restraint Order Sheet in Patient Medical Records for all patients that had been in Medical Restraints the previous day. S13 indicated Night Shift Nurses would complete the forms with the same orders as the previous day. S13 indicated there would be no order obtained from the physicians. S13 indicated the nurses prepared the forms for the convenience of rounding physicians to sign.

During a face to face interview on 8/03/2011 at 8:50 a.m., Registered Nurse/Charge Nurse S4 indicated Patient #3 and #5 had remained in soft upper extremity restraints on the dates as listed above. S4 indicated there had been no attempts made by the Nursing Staff to contact the Patient's (#3 and #5) physicians to obtain an order to continue soft restraints. S4 indicated the orders were placed in the chart by night shift for physicians to sign upon rounds. S4 indicated physicians did not always sign the forms and nurses did not call the doctors for clarification to ensure the expired order (only good for 24 hours) was to be continued.

Patient #15
Review of Patient #15's medical record revealed he was admitted on 03/24/11 with diagnoses of Alcoholic Hepatitis, Cirrhosis, and Hepatorenal Syndrome. Review of the "Physician's Orders" revealed an order on 03/24/11 at 3:45pm for "soft wrist restraints when family not at bedside". Further review revealed three "Restraint Order Sheet" for right upper restraint (no evidence of type of restraint to be used) dated and timed as "3/25/11 0700 (7:00am) 3/26/11 0700", "3/26/0700 to 3/27/11 0700", and "3/27/11 (0700) 3/28/(0700)". There was no documented evidence of the date and time the physician signed the order to determine that the order for restraints was obtained prior to the application of the restraint.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 could offer no explanation for the restraint orders not including the date and time signed by the physician which would be used to determine that the order was obtained prior to the restraint being applied.

Review of the hospital policy titled, "Restraints and Seclusion R02-N, last revised 12/05/08" presented by the hospital as their current policy, revealed in part, "...Orders for restraints must be renewed on a daily basis. . . If a patient is removed from restraint before the 24 hour time limit and must be returned to restraints within the same 24 hour limit another physician order is required. . ."


25065

Based on record review and interviews, the hospital failed to ensure the nursing staff were trained and demonstrated competency in the application of restraints, monitoring, assessment, and providing care for patients in restraints as evidenced by having 10 of 11 employed nurses' personnel files reviewed (S2, S3, S4, S28, S29, S38, S39, S40, S44, S48) and 2 of 2 contract nurses' personnel files reviewed (S41, S42) with no documented evidence of receiving restraint training and being assessed for competency of restraint application. Findings:

Review of the personnel files of Director of Nursing (DON) S2, RN (registered nurse) S3, RN S4, RN S28, LPN (licensed practical nurse) S29, LPN S38, LPN S39, LPN S40, Contract RN S41 with Company B, Contract RN S42 with Company B, LPN S44, and RN S48 revealed no documented evidence of training in the application of restraints, monitoring, assessment, and providing care for patients in restraints as part of orientation and since being hired or contracted to care for patients.

Review of the medical records of 20 sampled patients revealed Patients #3, #5, and #15 had restraints applied during their hospital stay.

In a face-to-face interview on 08/05/11 at 9:40am, Human Resources Director S9 indicated they had restraint education and an assessment of the application of restraints presented at a skills fair held between 12/13/10 and 12/21/10. S9 further indicated the assessment of competency of the application of restraints was performed by Occupational Therapist (OT) S 46 and Occupational Therapy Assistant (OTA) S47. After review of the personnel files of S46 and S47, S9 confirmed there was no documented evidence of determination of competency of S46 and S47 in the application of restraints. S9 further confirmed there was no documented evidence of restraint training and assessment for competency in the personnel files of DON S2, RN S3, RN S4, RN S28, LPN S29, LPN S38, LPN S39, LPN S40, Contract RN S41, Contract RN S42, LPN S44, and RN S48.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 indicated she couldn't explain why hospital orientation and competency assessments were dropped by the former DON. S2 further indicated she had become DON in April 2011. S2 could offer no explanation for the assessment of competency of restraint application by nurses being performed by an OT and a OTA. S2 indicated she was not aware until about two weeks ago that the hospital was responsible for having the orientation and competency assessment of contract nurses performed by a hospital-employed RN. S2 further indicated she had not read the state licensing and federal certification regulations since becoming DON.

In a face-to-face interview on 08/05/11 at 2:05pm, Medical Director S21 could offer no explanation for the nursing staff not being trained on restraints. S21 indicated he would "bring it to the table to discuss corrections for quality of care, because this shouldn't suffer through changes in leadership".

Review of the hospital policy titled "Restraints and Seclusion", policy number R02-N revised 12/05/08 and presented by Director of Quality S11 as their current policy for restraints, revealed, in part, "...Staff Training: Registered nurses are trained in the assessment of restraint need, the restraint order process, time frames for and processes of reassessments. Staff with direct patient care is trained in alternatives to restraints, applying restraints, monitoring restrained patients, and releasing patients from restraints. Training is provided in initial orientation and annual inservice training including the practical application of principles and the use of various restraint devices to minimize danger to patients and staff...".

Based on record review and interviews, the hospital failed to ensure the nursing staff were trained and demonstrated competency in the techniques to identify staff and patient behaviors, events, and environmental factors that could trigger situations that require the use of a restraint as evidenced by having 10 of 11 employed nurses' personnel files reviewed (S2, S3, S4, S28, S29, S38, S39, S40, S44, S48) and 2 of 2 contract nurses' personnel files reviewed (S41, S42) with no documented evidence of receiving training on such techniques. Findings:

Review of the personnel files of Director of Nursing (DON) S2, RN (registered nurse) S3, RN S4, RN S28, LPN (licensed practical nurse) S29, LPN S38, LPN S39, LPN S40, Contract RN S41 with Company B, Contract RN S42 with Company B, LPN S44, and RN S48 revealed no documented evidence of training in the techniques to identify staff and patient behaviors, events, and environmental factors that could trigger situations that require the use of a restraint as part of orientation and since being hired or contracted to care for patients.

Review of the medical records of 20 sampled patients revealed Patients #3, #5, and #15 had restraints applied during their hospital stay.

In a face-to-face interview on 08/05/11 at 9:40am, Human Resources Director S9 indicated they had restraint education and an assessment of the application of restraints presented at a skills fair held between 12/13/10 and 12/21/10. S9 confirmed there was no documented evidence of training in the techniques to identify staff and patient behaviors, events, and environmental factors that could trigger situations that require the use of a restraint in the personnel files of DON S2, RN S3, RN S4, RN S28, LPN S29, LPN S38, LPN S39, LPN S40, Contract RN S41, Contract RN S42, LPN S44, and RN S48.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 indicated she couldn't explain why hospital orientation and competency assessments were dropped by the former DON. S2 further indicated she had become DON in April 2011. S2 could offer no explanation for the entire staff not having training on all aspects of restraint use according to hospital policy. S2 indicated she was not aware until about two weeks ago that the hospital was responsible for having the orientation and competency assessment of contract nurses performed by a hospital-employed RN. S2 further indicated she had not read the state licensing and federal certification regulations since becoming DON.

Review of the hospital policy titled "Restraints and Seclusion", policy number R02-N revised 12/05/08 and presented by Director of Quality S11 as their current policy for restraints, revealed, in part, "...Staff Training: Registered nurses are trained in the assessment of restraint need, the restraint order process, time frames for and processes of reassessments. Staff with direct patient care is trained in alternatives to restraints, applying restraints, monitoring restrained patients, and releasing patients from restraints. Training is provided in initial orientation and annual inservice training including the practical application of principles and the use of various restraint devices to minimize danger to patients and staff...".

Based on record review and interviews, the hospital failed to ensure the nursing staff were trained and demonstrated competency in the use of nonphysical intervention skills as evidenced by having 10 of 11 employed nurses' personnel files reviewed (S2, S3, S4, S28, S29, S38, S39, S40, S44, S48) and 2 of 2 contract nurses' personnel files reviewed (S41, S42) with no documented evidence of receiving training on the use of nonphysical intervention skills. Findings:

Review of the personnel files of Director of Nursing (DON) S2, RN (registered nurse) S3, RN S4, RN S28, LPN (licensed practical nurse) S29, LPN S38, LPN S39, LPN S40, Contract RN S41 with Company B, Contract RN S42 with Company B, LPN S44, and RN S48 revealed no documented evidence of training in the use of nonphysical intervention skills as part of orientation and since being hired or contracted to care for patients.

Review of the medical records of 20 sampled patients revealed Patients #3, #5, and #15 had restraints applied during their hospital stay.

In a face-to-face interview on 08/05/11 at 9:40am, Human Resources Director S9 indicated they had restraint education and an assessment of the application of restraints presented at a skills fair held between 12/13/10 and 12/21/10. S9 confirmed there was no documented evidence of training in the use of nonphysical intervention skills in the personnel files of DON S2, RN S3, RN S4, RN S28, LPN S29, LPN S38, LPN S39, LPN S40, Contract RN S41, Contract RN S42, LPN S44, and RN S48.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 indicated she couldn't explain why hospital orientation and competency assessments were dropped by the former DON. S2 further indicated she had become DON in April 2011. S2 could offer no explanation for the entire staff not having training on all aspects of restraint use including the use of nonphysical intervention skills according to hospital policy. S2 indicated she was not aware until about two weeks ago that the hospital was responsible for having the orientation and competency assessment of contract nurses performed by a hospital-employed RN. S2 further indicated she had not read the state licensing and federal certification regulations since becoming DON.

Review of the hospital policy titled "Restraints and Seclusion", policy number R02-N revised 12/05/08 and presented by Director of Quality S11 as their current policy for restraints, revealed, in part, "...Staff Training: Registered nurses are trained in the assessment of restraint need, the restraint order process, time frames for and processes of reassessments. Staff with direct patient care is trained in alternatives to restraints, applying restraints, monitoring restrained patients, and releasing patients from restraints. Training is provided in initial orientation and annual inservice training including the practical application of principles and the use of various restraint devices to minimize danger to patients and staff...".

Based on record review and interviews, the hospital failed to ensure the nursing staff were certified in the use of cardiopulmonary resuscitations evidenced by having 4 of 11 employed nurses reviewed (S2, S29, S39, S40) with no documented evidence of current CPR (cardiopulmonary resuscitation) certification. Findings:

Review of the personnel files of Director of Nursing (DON) S2, LPN (licensed practical nurse) S29, LPN S39, and LPN S40 revealed no documented evidence of current CPR certification.

Review of the medical records of 20 sampled patients revealed Patients #3, #5, and #15 had restraints applied during their hospital stay.

In a face-to-face interview on 08/05/11 at 9:40am, Human Resources Director S9 confirmed DON S2, LPN S29, LPN S39, and LPN S40 did not have current CPR certification.

Review of the LPN and RN (registered nurse) job descriptions revealed CPR certification was required as a position qualification.

Based on record review and interviews, the hospital failed to ensure the individuals who provided staff training of restraint use, application, and monitoring had been trained and experienced in techniques used to address patients' behaviors as evidenced by having no documented evidence of such training and experience by the two individuals who provided training (S46, S47). Findings:

In a face-to-face interview on 08/05/11 at 9:40am, Human Resources Director S9 indicated a skills fair was held between 12/13/10 to 12/21/10, and restraint education and assessment of the application of restraints was part of the skills fair. S9 further indicated Occupational Therapist (OT) S46 and Occupational Therapy Assistant (OTA) S47 presented the education and performed the competency assessments.

Review of the personnel files of OT S46 and OTA S47 revealed no documented evidence of orientation to, training, or experience in techniques used to address patients' behaviors. Further review revealed no documented evidence that S46 and S47 had been assessed and determined to be competent in the application of restraints or the monitoring of patients in restraints.

Review of the medical records of 20 sampled patients revealed Patients #3, #5, and #15 had restraints applied during their hospital stay.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 indicated she couldn't explain why hospital orientation and competency assessments were dropped by the former DON. S2 further indicated she had become DON in April 2011. S2 could offer no explanation for the assessment of competency of restraint application by nurses being performed by an OT and a OTA.

Review of the hospital policy titled "Restraints and Seclusion", policy number R02-N revised 12/05/08 and presented by Director of Quality S11 as their current policy for restraints, revealed, in part, "...Staff Training: Registered nurses are trained in the assessment of restraint need, the restraint order process, time frames for and processes of reassessments. Staff with direct patient care is trained in alternatives to restraints, applying restraints, monitoring restrained patients, and releasing patients from restraints. Training is provided in initial orientation and annual inservice training including the practical application of principles and the use of various restraint devices to minimize danger to patients and staff...".

Based on record review and interview the hospital failed to ensure the death of a patient that occurred within 24 hours after the patient had been removed from restraints was reported to CMS (Center for Medicare Services) for 1 of 1 patients review that died within 24 hours of being released from restraints out of a total sample of 20 (Patient #8). Findings:

Review of Patient #8's medical record revealed the patient was admitted to the hospital on 1/10/2011 with diagnoses that included Respiratory Failure and Pneumonia. Review of Physician signed orders dated 1/10/2011 at 1440 (2:40 p.m.) revealed in part, "Restraints-bilateral wrist". Review of Restraint Order Sheet dated 2/2/11 (no documented time) revealed in part, "Type of Restraint: Left Upper, Right Upper, Clinical Justification for Restraint Use: Unable to understand the need for treatment, Unable to understand the seriousness of condition, Poor Judgment. . . Expected Duration: 24 hours". Review of Patient #8's Discharge Summary dictated 2/28/2011 revealed in part, "On 2/03/2011 the patient's (#8) status was worsening. . . The patient's(#8) DNR (Do Not Resuscitate) status continued to be followed. At 1710 (5:10 p.m.), the patient lost vital signs. . . The patient was declared deceased. . ." Review of Patient #8's "Medical Restraint Record and Plan of Care" flow sheet revealed Patient #8 remained in soft cloth wrist restraints to both the right and left arm from 7:00 a.m. on 2/02/2011 through 6:00 a.m. on 2/03/2011 (11 hours and 10 minutes before Patient #8 lost vital signs on 2/03/2011 at 5:10 p.m). Further review of the entire medical record revealed no documented evidence as to whether the restraints remained in place after the last documented assessment on 2/03/2011 at 6:00 a.m. or were discontinued. Review of Patient #8's entire medical record revealed no documented evidence that CMS had been notified when a patient died within 24 hours of being released from a restraint or died while in restraints (unclear documentation as to whether the patient's restraints were removed or remained in place on 2/03/2011 at 6:00 a.m.).

During a face to face interview on 8/03/2011 at 10:00 a.m., Registered Nurse/Charge Nurse S4 indicated it had never been his practice to notify CMS when a patient had died in restraints or had been in restraints 24 hours prior to death. S4 confirmed there was no documented evidence in the Medical Record for Patient #8 to indicate that CMS had been notified.

During a telephone interview on 8/03/2011 at 9:55 a.m., Quality Manager S11 indicated the hospital would only report deaths in restraints or within 24 hours of release from restraints if the restraints had been used for Behavioral Purposes. S11 indicated if restraints had been used as Medical Restraints, there would have been no report to CMS. S11 confirmed there had been no report made to CMS regarding Patient #8's death 11 hours after the last documented use of restraints.

Review of the hospital policy titled, "Restraints and Seclusion, R02-N, last revised 12/05/08" presented by the hospital as their current policy revealed in part, "Death as a result of Seclusion or Restraint: The hospital will report to CMS 1) any death that occurs while a patient is restrained, 2) any death that occurs within 24 hours after the patient has been removed from restraints. . ."

Based on record review and interviews, the medical staff failed to ensure the credentials of the candidates for reappointment to the medical staff were reviewed and recommendations were made to the governing body for 3 of 7 physicians reviewed (S20, S21, S24) and for 3 of 3 nurse practitioners reviewed (S25, S31, S32). Findings:

Physician S20
Review of Physician S20's credentialing file revealed a "Temporary Application To St. Theresa" was completed by S20 on 09/15/10. Further review revealed one peer reference was received on 10/21/10. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed no documented evidence of the type of action taken to include initial application, reappointment application, provisional review, or allied health professional application. Further review revealed the "Signature Page Medical Staff or Allied Health Appointment" was signed by the Chairman of the Medical Executive Committee on 07/19/11 and by the Chairman of the Governing Board on 07/19/11 for appointment of S20 to the medical staff. There was no documented evidence of an application for appointment, proof of continuing education, a peer review by the Medical Director, and a second reference as required by medical staff bylaws for appointment to the medical staff.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT (Registered Health Information Tech) S7 indicated they have used the completed temporary application when they "roll over" a physician from temporary to active status.

Medical Director S21
Review of Medical Director S21's credentialing file revealed he was reappointed on 07/19/11. Further review revealed S21 submitted a request for core privileges for Internal Medicine on 05/06/11, rather than specific privileges. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed S21's reappointment was granted by the Chairman of the Governing Board on 07/19/11 with no documented evidence of a recommendation from the Medical Executive Committee as required by the medical staff bylaws. Further review revealed no documented evidence of a completed peer review as required by the bylaws.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 confirmed Medical Director S21's credentialing file was not reviewed for recommendation by the Medical Executive Committee (MEC), because the MEC consists of only one physician at present, Medical Director S21, and S21 could not review and recommend his own file.

Physician S24
Review of Physician S24's credentialing file revealed a letter addressed to Physician S24 dated 11/15/10 notifying him of his reappointment to the medical staff on 10/26/10. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed Chairman of the MEC signed the recommendation on 10/26/10, and the Chairman of the Governing Board signed the form on 12/07/10, more than one month after S24 was reappointed. Further review revealed no documented evidence whether the Governing Board Chairman granted, did not grant, deferred, or granted with exceptions the reappointment of S24. There was no documented evidence of proof of continuing education and a peer review by the Medical Director as required by medical staff bylaws for appointment to the medical staff.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 confirmed the above findings for Physician S24.

Nurse Practitioner S25
Review of Nurse Practitioner S25's credentialing file revealed a letter dated 05/01/07 that indicated S25's appointment would end on 04/26/09. Further review revealed S25's reappointment application was signed on 06/21/10. Review of a letter dated 07/08/10 revealed S25's reappointment was approved on 07/06/10. There was no documented evidence S25 had applied for and requested privileges prior to her appointment expiring on 04/26/09. Further review revealed no documented evidence of a collaborative agreement with her supervising physician as required by the bylaws.

In a face-to-face interview on 08/04/11 at 11:10am, RHIT S7 confirmed there was no collaborative agreement for Nurse Practitioner S25, and she did treat patients during the time period from 04/26/09 until 07/06/10 when her appointment had expired.

Nurse Practitioner S31
Review of Nurse Practitioner S31's credentialing file revealed a letter dated 09/08/09 notifying S31 that her appointment would expire on 09/03/10. Further review revealed a letter dated 11/15/10 notifying S31 that her reappointment was effective 10/26/10, 53 days after her appointment had expired. Review of the "Signature Page Medical Staff or Allied Health Appointment" revealed Chairman of the MEC signed the recommendation on 10/26/10, and the Chairman of the Governing Board signed on 12/07/10, 41 days after S31 had been notified of her appointment. Further review of the credentialing file revealed no documented evidence of a reappointment application, a collaborative agreement with her supervising physician, and her peer reference was received (11/01/10) after her appointment was made.

Nurse Practitioner S32
Review of Nurse Practitioner S32's credentialing file revealed her appointment had expired on 04/26/09, and her reappointment was not approved until 11/02/09, more than 6 months later. Further review revealed no documented evidence of a collaborative agreement with S32's supervising physician.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 indicated he took over credentialing about 1 1/2 to 2 years ago and had no experience with credentialing prior to this time. S7 further indicated he had read the medical staff bylaws, but he had not "studied" them related to credentialing.

In a face-to-face interview on 08/04/11 at 11:10am, RHIT S7 confirmed the above findings.

Review of the "Credentialing Policy of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Applications for initial appointment and reappointment shall contain a request for specific clinical privileges desired by the individual... The application for Medical Staff membership and all supporting documentation shall be delivered to the Chief Executive Officer or his or her designee. ... (b) Verify and obtain at least two written references on initial appointment and at least one written reference at reappointment, on the applicant. ... (a) Temporary privileges shall not routinely be granted. In extraordinary situations when necessary to avoid undue hardship to a patient, the Hospital CEO, an existing member of the Medical Executive Committee or the Governing Board may grant temporary privileges. This decision will be made on a case-by-case basis. ...Temporary privileges may be granted only after there has been a favorable report, for the clinical privileges requested, from the Medical Director... Temporary privileges shall be granted for a specific period of time as warranted by the situation. In no situation should the initial grant of temporary privilege be for a period of time to exceed one hundred and twenty (120) days. (g) Temporary privileges shall expire at the end of the time period for which they are granted. ...All terms, conditions, requirements, and procedures required for initial appointment must continue to be met and maintained for reappointment. 5.A.1. Qualifications (a) To be eligible for reappointment, an individual must have, during the previous appointment term: ... (2) Completed all continuing medical education requirements as designated by state law ...(b) To be eligible to apply for renewal of clinical privilege, an individual must have performed sufficient procedures, treatments, or therapies in the previous appointment term to enable the Medical Director to assess the individual's current clinical competence for the privilege requested...Each current appointee who is eligible to be reappointed to the Medical Staff shall be responsible for completing a reappointment application form, including a new delineation of privileges. ... Prior to the end of each individual's current appointment period, the Medical Director shall prepare a report and recommendation concerning the individual seeking reappointment. ...The Medical Director shall forward its recommendations and findings to the Medical Executive Committee. ... If the recommendation of the Medical Executive Committee is favorable, it shall be submitted to the Governing Board. All recommendations to reappoint must also recommend the clinical privileges to be granted. ... Within 120 days of receipt of the recommendation from the Medical Executive Committee, or prior to expiration of appointment, the Governing Board shall: (1) Reappoint the individual and grant renewed clinical privileges as recommended; or (2) Refer the matter back to the Medical Director... or (3) Reject the recommendation. ... Confidentiality and Peer Review Protection 8.a: Confidentiality and Reporting Actions taken and recommendations made pursuant to this policy shall be treated as confidential... 8.B: Peer Review Protection (a) All minutes, reports, recommendations, communications, and actions made or taken pursuant to this policy are deemed to be covered by the provisions of any applicable peer review statute...".

Review of the "Policy on Licensed Allied Health Practitioners of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Licensed allied health practitioners who are permitted to practice in the Hospital shall be classified as either "Licensed Independent Practitioners" or "Dependent Practitioners." ..."Dependent Practitioners" shall include licensed allied health practitioners who are authorized to function in the Hospital as employees of, or under direct supervision of, a physician(s) appointed to the Medical Staff and are granted a defined scope of practice by the Governing Board. ...A current listing of the types of licensed allied health practitioners functioning within the Hospital as Dependent Practitioners is attached to this policy as Appendix B. ...Provide a copy of collaborative agreement when applicable or when a collaborative agreement is required by law. ... A completed application form, with copies of all required documents must be returned to the Chief Executive Officer within thirty (30) days after receipt of the same if the individual desires further consideration...The Chief Executive Officer will review the application... A completed application shall be forwarded to the Medical Director. Thereafter, the Medical Director shall report to the Medical Executive Committee regarding the applicant's qualifications for the clinical privilege or scope of practice requested. ... the Medical Executive Committee shall report its recommendations to the Governing Board for final action. ...Appendix B Those licensed allied health practitioners currently practicing as Dependent Practitioners at St. Theresa Specialty Hospital are as follows: ... Nurse Practitioners...".

Based on record review and interviews, the hospital failed to ensure a statement of the specific privileges were requested and approved for each member of the medical staff as evidenced by the request of core privileges rather than specific privileges for 6 of 7 physicians reviewed (S19, S21, S22, S23, S24, S26) and 1 of 3 nurse practitioners reviewed (S31). Findings:

Physician S19
Review of Physician S19s credentialing file revealed she requested and had approved core privileges for internal medicine, rather than specific privileges.

Medical Director S21
Review of Medical Director S21's credentialing file revealed core privileges for internal medicine was requested by S21 on 05/06/11. Further review revealed no documented evidence S21's request had been reviewed by the Medical Executive Committee and a recommendation made to the Governing Board.

Physician S22
Review of Physician S22s credentialing file revealed she requested and had approved core privileges for palliative care, rather than specific privileges.

Physician 23
Review of Physician S23s credentialing file revealed she requested and had approved core privileges for internal medicine, rather than specific privileges.

Physician S24
Review of Physician S24's credentialing file revealed he requested and had approved core privileges for internal medicine and infectious disease, rather than specific privileges.

Physician S26
Review of Physician S26's credentialing file revealed he requested and had approved core privileges for internal medicine and pulmonary disease, rather than specific privileges.

Nurse Practitioner S31
Review of Nurse Practitioner S31's credentialing file revealed she had requested core privileges for treatment and management of diseases in the adult patient, rather than specific privileges.

In a face-to-face interview on 08/04/11 at 10:10am, RHIT S7 confirmed Medical Director S21's credentialing file was not reviewed for recommendation by the Medical Executive Committee (MEC), because the MEC consists of only one physician at present, Medical Director S21, and S21 could not review and recommend his own privileges. S7 confirmed they were currently using core privileges. S7 indicated he took over credentialing about 1 1/2 to 2 years ago and had no experience with credentialing prior to this time. S7 further indicated he had read the medical staff bylaws, but he had not "studied" them related to credentialing.

Review of the "Credentialing Policy of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Applications for initial appointment and reappointment shall contain a request for specific clinical privileges desired by the individual... Each individual who has been appointed to the Medical Staff shall be entitled to exercise only those clinical privilege specifically granted by the Governing Board. ...Each current appointee who is eligible to be reappointed to the Medical Staff shall be responsible for completing a reappointment application form, including a new delineation of privileges...".

Review of the "Policy on Licensed Allied Health Practitioners of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and the Chairman of the Board of Directors with no documented evidence of the date it was signed, revealed, in part, "...Licensed allied health practitioners who are permitted to practice in the Hospital shall be classified as either "Licensed Independent Practitioners" or "Dependent Practitioners." ..."Dependent Practitioners" shall include licensed allied health practitioners who are authorized to function in the Hospital as employees of, or under direct supervision of, a physician(s) appointed to the Medical Staff and are granted a defined scope of practice by the Governing Board. ...The applicant shall indicate on the application the clinical privilege or scope of practice which he or she is requesting. ...the Medical Director shall report to the Medical Executive Committee regarding the applicant's qualifications for the clinical privilege or scope of practice requested. ... the Medical Executive Committee shall report its recommendations to the Governing Board for final action...".

Based on record review and interview, the hospital failed to ensure a medical history and physical examination (H&P) was completed and documented on the medical record within 24 hours of admission for 5 of 20 sampled patients (#6, #11, #12, #15, #20). Findings:

Patient #6
Review of the medical record for Patient #6 revealed he was admitted to the facility on 07/29/11 on with a non healing wound on his right foot. Further review of the medical record revealed no documented evidence a H&P (History and Physical) had been performed and filed in #6's medical record.

In a face to face interview on 08/02/11 at 1:30pm RN S4 Charge Nurse verified there was no history and physical in Patient #6's medical record. Further S4 indicated the H&P should have been in the chart and signed off within 24 hours.

Patient #11
Review of Patient #11's medical record revealed she was admitted on 07/31/11 with a diagnosis of breast cancer.
Review of Patient #11's H&P revealed it was the H&P from an admit to another facility dictated on 09/15/10. There was no documented evidence that a H&P had been performed for Patient #11's admission to St. Theresa Specialty Hospital.

Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 with diagnoses of Osteomyelitis requiring intravenous antibiotic therapy and physical therapy and severe endstage Multiple Sclerosis.
Review of Patient #12's H&P revealed no documented evidence of the date the H&P was dictated, the date the H&P was transcribed, and the date and time the H&P was signed by Physician S49. Further review revealed two blanks left by the transcriptionist had not been completed by S49 when he signed the H&P.

Patient #15
Review of Patient #15's medical record revealed he was admitted on 03/24/11 with diagnoses of Alcoholic Hepatitis, Cirrhosis, and Hepatorenal Syndrome.
Review of Patient #15's H&P revealed it was dictated and transcribed on 03/28/11, 48 hours after admission.

In a face-to-face interview on 08/05/11 at 2:05pm, Medical Director S21 indicated he was aware of the problem of not having patient H&Ps completed within 24 hours of admission. S21 further indicated he had given the directive that no patient was to be admitted without a transfer summary dictated for the physician to update the following day.

Patient #20
Review of the medical record of Patient #20 revealed he was admitted to the main campus of St Theresa for inpatient hospice care on 07/26/11. Further review of the medical record revealed no documented evidence an H&P (History and Physical) had been performed and filed in the medical record except for a Provider Note dated 06/06/11 from another hospital in the community.

In a face to face interview on 08/01/11 at 12:30pm RN S2 DON (Director of Nursing) indicated the only H&P info was the provider note of 06/06/01 and the even though the patient was hospice, an updated history and physical was required.

Review of the "Rules and Regulations of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff and Chairman of the Governing Board with no documented evidence of the date they were signed, revealed, in part, "...Medical Records ... 2. Medical History and Physical Examination: Each patient shall receive a history and physical examination completed no more than thirty (30) days before or twenty-four (24) hours after admission and documentation must be placed in the patient's medical record within twenty-four (24) hours of admission. When a history and physical examination is recorded prior to admission, a physical examination of the patient must be completed for any changes in the patient's condition and documented in the patient's medical record within twenty-four (24) hours of admission...".

Based on record review and interview the hospital failed to ensure History and Physical Exams performed within 30 days prior to the patient's admission were updated within 24 hours of admission to the hospital for 3 of 20 sampled patients (#2, #3, 6). Findings:

Patient #2
Review of Patient #2's Medical Record revealed the patient was admitted to the hospital on 7/29/2011. Further review revealed a History and Physical Examination located in the Medical Record with the date of 7/24/2011 (5 days prior to the patient's admission to the hospital. Review of the entire medical record on 8/02/2011 revealed no documented evidence of an updated History and Physical Notation.

Patient #3
Review of Patient #3's Medical Record revealed the patient was admitted to the hospital on 7/07/2011. Further review revealed a History and Physical Examination located in the medical Record with the date of 7/03/2011 (4 days prior to admission). Review of the Patient #3's Medical Record revealed a History and Physical Update form dated 7/19/2011 (12 days after the patient was admitted to the hospital).

Patient #6
Review of the medical record for Patient #6 revealed he was admitted to the facility on 07/29/11 on with a non healing wound on his right foot. With continued review of the medical record revealed there was no History and Physical in the patient's chart.

In a face to face interview on 08/02/11 at 1:30pm RN S4 Charge Nurse verified there was no history and physical in Patient #6's medical record. Further S4 indicated the H&P should have been in the chart and signed off within 24 hours.

Patient #20
Review of the medical record of Patient #20 revealed he was admitted to the main campus of St Theresa for inpatient hospice care on 07/26/11. Further review of the medical record revealed no consents for treatment were in the chart and no history and physical was in the medical record except for a Provider Note dated 06/06/11 from another hospital in the community.

In a face to face interview on 08/01/11 at 12:30pm RN S2 DON (Director of Nursing) indicated all patients including hospice patients are required to have an updated history and physical. Further S2 indicated History and Physical on the patient they had was what the hospice faxed to the hospital.

During face to face interviews on 8/02/2011 at 3:15 p.m. and 3:28 p.m., Registered Nurse S4 indicated the hospital had an ongoing problem with getting physicians to comply with updating History and Physical Exams that had been initially done within 30 days prior to the patient's admission to the hospital. S4 indicated the physician's should update their History and Physical Exams within 24 hours of the patient's admission.

Review of the "Rules and Regulations of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff and the Chairman of the Governing Board with no documented evidence of the date it was signed, revealed, in part, "...C. Medical Records ...2. Medical History and Physical Examination: Each patient shall receive a history and physical examination completed no more than thirty (30) days before or twenty-four (24) hours after admission and documentation must be placed in the patient's medical record within twenty-four (24) hours of admission. When a history and physical examination is recorded prior to admission, a physical examination of the patient must be completed for any changes in the patient's condition and documented in the patient's medical record within twenty-four (24) hours of admission...".

Based on record review and interviews, the hospital failed to ensure the RN (registered nurse) supervised and evaluated the nursing care for each patient as evidenced by: 1) failure of the RN to assess patients' weights and/or vital signs as ordered for 7 of 20 sampled patients (#2, #5, #9, #12, #16, #17, #20); 2) failure of the RN to assess patients who experience a change in condition for 2 of 20 sampled patients (#12, #13); 3) failure of the RN to assess wounds weekly as per policy for 1 of 4 patients with wounds from a total sample of 20 patients (#12); and 4) failure of the RN to assess a patient in restraints as per hospital policy for 1 of 3 patients reviewed with restraints from a total of 20 sampled patients (#15). Findings:

1) Failure of the RN to assess patients' weights and/or vital signs as ordered:
Patient #2:
Review of Patient #2's medical record revealed the patient was admitted to the hospital on 7/29/2011. Further review revealed no documented evidence that Patient #2 had ever been weighed.

Patient #5:
Review of Patient #5's medical record revealed the patient was admitted to the hospital on 7/21/2011 with diagnoses that included C Diff and Colitis. Further review revealed physician's orders dated 7/21/2011 at 1500 (3:00 p.m.) for "Weigh on Admission and every Daily Day (as written)". Review of Patient #5's medical record revealed no documented evidence that the patient was weighed on 7/29/2011, 7/30/2011, and 7/30/2011.

These findings were confirmed by Registered Nurse S4 on 8/02/2011 at 1400 (2:00 p.m.) and 1515 (3:15 p.m.) in face to face interviews. S4 further indicated the hospital scale at the Off Site Campus had recently been broken and no patients at the Off Site Campus were weighed during that time. S4 indicated he (S4) could not recall the specific dates and had no documentation of the dates when the scale had been broken. S4 indicated the hospital had not obtained an alternate scale for use during the time the hospital's scale was broken. S4 indicated the hospital policy for weighing patients upon admission and physician's orders for weighing patients should have been followed. S4 further indicated the Initial Assessment of New Patients should include the patient's weight for reference in regards to future weight loss or weight gain.

Patient #9
Review of the medical record for Patient #9 revealed she was admitted to the hospital on 06/22/11 with the diagnoses of Vent Wean and Respiratory Failure. Review of the Admission Orders dated 06/22/11 revealed a physician's order to weigh on admission and every 7 days.

Review of her Graphic Vital Signs, Weights, I &O Flow sheet dated 7/06/11 to 08/03/11 revealed her weight on 07/11/11 was 182.1 # and on 07/25/11 her weight was 209#. There were no other weights documented on the flow sheet.

In a face to face interview on 08/03/11 at 1:45pm RN S4 Charge Nurse verified there were no more weights for Patient #9, and the weights were not obtained as ordered by the physician.

Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 with diagnoses of Osteomyelitis requiring intravenous antibiotic therapy and physical therapy and severe endstage Multiple Sclerosis.
Review of Patient #12's "Admission Orders" received by telephone order on 05/18/11 at 4:00pm revealed an order to weigh on admission and weekly and to check vital signs every 4 hours.
Review of Patient #12's "Admission Database", "24 Hour Patient Record", and "Graphic Vital Signs, Weights, I&O (intake and output), Flowsheet" revealed no documented evidence Patient #12 was weighed upon admit and weekly as ordered.
Review of Patient #12's "24 Hour Patient Record" and "Graphic Vital Signs, Weights, I&O, Flowsheet" revealed no documented evidence Patient #12's vital signs were taken as ordered on 05/19/11 at 4:00am, on 05/20/11 at 12:00am, 4:00am, 12:00pm, and 4:00pm, on 05/27/11 at 12:00pm and 4:00pm, and on 05/30/11 at 12:00pm.

Patient #16
Review of the medical record for Patient #16 revealed a 54 year old male admitted 07/28/11 to the hospital for urosepsis. Review of the Admission Orders 07/28/11 revealed an order for weekly weights.
Review of the "24 Hour Patient Record" and "Graphic Vital Signs, Weights, I&O, Flowsheet" for Patient #16 revealed no documented evidence a weight had been assessed on admit or weekly thereafter.

Patient #17
Review of Patient #17's medical record revealed a 65 year old female admitted to the hospital on 06/16/11 for hepatic encephalopathy and vertebral osteomyelitis. Review of the Admission Orders dated/timed 06/16/11 at 1540 (3:40pm) revealed an order for weekly weights.
Review of the "Graphic Sheet" for Patient #17 revealed no documented evidence a weight was recorded as scheduled weekly for 06/23/11.

Patient #20
Review of Patient #20's medical record revealed a 64 year old female admitted to the hospital on 04/21/11 for further treatment of a left groin wound. Review of the Admission Orders dated/timed 04/21/11 at 0100 (1:00am) revealed an order for daily weights.
Review of Patient #20's "Graphic Sheet" revealed no documented evidence Patient #20's weight had been obtained for 04/23/11.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 could offer no explanation for the patients' weight and vital signs not being assessed by the RN.

2) Failure of the RN to assess patients who experience a change in condition:
Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 with diagnoses of Osteomyelitis requiring intravenous antibiotic therapy and physical therapy and severe endstage Multiple Sclerosis.
Review of Patient #12's "24 Hour Patient Record" for 05/20/11 revealed LPN (licensed practical nurse) S40 documented that a family member reported Patient #12 to possibly be having a seizure at 9:30am. Further review revealed S40 documented "pt (patient) with slight tremors". There was no documented evidence LPN S40 reported the seizure activity to a RN, and there was no documented evidence of a RN's assessment.
Review of Patient #12's "24 Hour Patient Record" for 05/24/11 revealed LPN S44 documented at 11:27am that Patient #12 was short of breath and had possibly aspirated. Further review revealed no documented evidence LPN S44 reported the change in condition of Patient #12 to a RN, and there was no documented evidence of an assessment by a RN. Review of Patient #12's "24 Hour Patient Record" for 05/25/11 revealed LPN S39 documented at 8:45am that Patient #12's family member reported that they thought she had aspirated. Further review revealed no documented evidence LPN S39 reported the possible aspiration of Patient #12 to a RN for assessment.

Patient #13
Review of Patient #13's medical record revealed an admit date of 06/24/11 with diagnoses of diabetic foot ulcer with infection, cellulitis, and concern for osteomyelitis.
Review of Patient #13's "24 Hour Patient Record" revealed LPN S43 documented Patient #13's blood sugar was 47 on 06/28/11 at 3:45am and "pt stated he would eat a candy bar". Review of Patient #13's physician's orders revealed a blood glucose of less than 60 mg/dl (milligrams per deciliter) was to be treated with 4 ounces of orange juice or 4 Glucose tablets if the patient was alert, and the blood glucose was to be rechecked every 15 minutes with the treatment repeated if the glucose was less than 80 mg/dl. There was no documented evidence LPN S43 reported this change in condition to a RN for assessment.
Review of Patient #13's "24 Hour Patient Record" for 06/30/11 revealed RN S48 documented at 4:30pm that Patient #13's blood sugar was 56 mg/dl. Further review revealed no documented evidence RN S48 treated the hypoglycemia according to physician orders and reassessed the blood sugar every 15 minutes.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 could offer no explanation for the LPN not reporting changes in patients' condition for a RN to perform an assessment.

Review of the hospital policy titled "Change in Patient Condition", policy number C41-N revised 07/11 and presented by DON S2 as their current policy for treatment of a change in condition, revealed, in part, "...A complete head to toe assessment will be performed along with consultation as appropriate among the clinical team. It is the responsibility of the charge nurse to ensure that the process to assess the patient occurs in a timely fashion, and to gather relevant data. ... It is the Charge Nurse's responsibility to notify the attending physician. ... The complete assessment should appear on the nursing flow sheet. A brief note in the progress notes by the charge nurse should summarize the episode and verify physician notification". Review of the entire policy revealed no documented evidence that the head to toe assessment must be performed by a RN.

3) Failure of the RN to assess wounds weekly as per policy:
Review of Patient #12's "Photographic Wound Documentation" revealed wounds to the right ischium, left hip, left ischium, perineum, and right heel were assessed by RN S36 on 05/19/11. Further review revealed the left hip and left ischium wounds were assessed as resolving stage III pressure ulcers. Further review revealed the next RN assessment of Patient #12's wound was performed on 05/28/11, 9 days after the previous assessment rather than weekly as per policy. Further review revealed Patient #12's left hip and left ischium wounds were assessed by RN S36 as resolved Stage II wounds rather than Stage III as previously assessed.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 could offer no explanation for the wound assessments not being performed weekly as per hospital policy.

Review of the hospital policy titled "Skin Care, Assessment and Maintenance of", policy number S02-N revised 12/06/08 and present in the clinical manual provided by DON S2 as containing the current policies, revealed, in part, "...The effectiveness of all wound care treatment will be reassessed on a weekly basis. ... Rounds will include measurement weekly and photographic documentation every other week of all wounds. ... Documentation will become a permanent part of the patient record. The status of the wounds will be compared to wound status documentation from previous wound rounds...".

4) Failure of the RN to assess a patient in restraints as per hospital policy:
Review of Patient #15's medical record revealed he was admitted on 03/24/11 with diagnoses of Alcoholic Hepatitis, Cirrhosis, and Hepatorenal Syndrome. Further review revealed he was restrained from 03/25/11 at 8:00pm until 6:00pm on 03/27/11.
Review of the "Medical Restraint Record and Plan of Care", with no documented evidence of the date ( record review determined it was 03/25/11), no documented evidence of the type of restraints applied. Further review revealed no documented evidence of an assessment every 2 hours from 8:00pm through 6:00am on 03/26/11 of Patient #15's need for fluids/food, use of the bedpan/urinal and direct observation every hour.
Review of the "Medical Restraint Record and Plan of Care" for 03/26/11 revealed no documented evidence of an assessment by direct observation of Patient #15 every hour as required by the hospital flowsheet.
Review of the "Medical Restraint Record and Plan of Care" for 03/27/11 revealed no documented evidence of an assessment every 2 hours from 7:00am through 6:00pm of Patient #15's need for fluids/food and use of the bedpan/urinal.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 could offer no explanation for the RNs not assuring the assessment of patients in restraints was performed according to hospital policy.

Review of the hospital policy titled "Restraints and Seclusion", policy number R02-N revised 12/05/08 and presented as the current policy for restraints by DON S2, revealed, in part, "...The initial assessment must be performed by physician, Licensed Independent Practitioner or Registered Nurse. ...Interdisciplinary Team Member documentation must: ... State observations/interventions/findings from periodic observations, to include: safety, comfort, mobility, skin integrity, food/hydration and toileting to include removal of restraints at least 10 minutes every 2 hours or more often...".

25065

Based on record review and interview, the hospital failed to ensure: 1) the nursing staff developed and kept current a nursing care plan as evidenced by: a) failing to develop and implement a plan of care for a patient admitted with an infected sternal wound (#16); b) failure to have an individualized patient care plan that provided interventions to meet the needs of the patient and that had measurable goals for 3 of 20 sampled patients (#12, #13, #18) and c) failure to revise the patient's care plan with changes in the patient's condition for 3 of 20 sampled patients related to seizures (#12), decreases in blood sugar (#13), aspiration (#12), respiratory failure (#19) and/or panic lab levels (#13) and 2) the physician's orders were implemented for 9 of 20 sampled patients for medications (#11), vital signs (#12), labs (#12, #18), weights (#2, #5, #9, #12, #16, #17, #20), wound care (#12), and/or treatment of low blood sugar (#13). Findings:

1) Failure to develop and keep current a nursing care plan as evidenced by:
a. Failure to develop or implement a plan of care for a patient admitted with an infected sternal wound
Review of the medical record for Patient #16 revealed a 54 year old male admitted 07/28/11 to the hospital for urosepsis.

Review of the nursing notes for Patient #16 revealed: 07/29/11 was refusing to eat due to the food being unappetizing and 07/30/11 continues to refuse to eat and also refusing nebulizer treatments and wound dressing changes.

Review of the medical record for Patient #16 revealed no documented evidence a plan of care was developed for #16.

In a face to face interview on 08/05/11 at 10:30am RN S53 Charge Nurse, after reviewing Patient #16's chart, verified a plan of care was not developed for this patient.


b) Failure to have an individualized patient care plan that provided interventions to meet the needs of the patient and that had measurable goals:
Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 with diagnoses of Osteomyelitis requiring intravenous antibiotic therapy and physical therapy and severe endstage Multiple Sclerosis. She was discharged on 06/04/11.
Review of Patient #12's "Plan of Care" revealed the patient problem of potential for infection related to invasive lines, incisions/wounds, and a suprapubic catheter had been identified on 05/18/11. Further review revealed no documented evidence that interventions and expected outcomes had been addressed and whether the problem had resolved by the time of discharge on 06/04/11. Further review revealed the problem of alteration in elimination related to the foley catheter had been identified on 05/18/11. Further review revealed no documented evidence that interventions and expected outcomes had been addressed and whether the problem had resolved by the time of discharge on 06/04/11.
Review of Patient #12's "Plan of Care" revealed the following patient problems were identified on 05/19/11: Self-care deficit related to decreased strength and endurance - interventions identified were to encourage family involvement; expected outcomes were patient will assist within potential with care and patient care needs will be met during the hospitalization. There was no documented evidence how the goals would be measured to determine if the interventions needed to be revised or to determine if the goals were met. Further review revealed no documented evidence that the problem had resolved by the time of discharge on 06/04/11; Alteration in skin integrity related to a wound - interventions identified were assess/document skin condition on admit and throughout stay, specialty bed/overlay, and wound care evaluation; expected outcome was that the patient skin integrity will be maintained or improved during hospitalization. There was no documented evidence how the goal would be measured to determine if the skin integrity was maintained or improved. Further review revealed no documented evidence that the problem had resolved by the time of discharge on 06/04/11; Alteration in mental status related to orientation - there was no documented evidence that the problem had resolved by the time of discharge on 06/04/11.
There was no documented evidence Patient #12's care plan had been reviewed weekly at an interdisciplinary team meeting as required by hospital policy.

Patient #13
Review of Patient #13's medical record revealed an admit date of 06/24/11 with diagnoses of diabetic foot ulcer with infection, cellulitis, and concern for osteomyelitis.
Review of Patient #13's "Plan of Care" revealed the patient problem of knowledge deficit related to a new diagnosis was identified on 06/24/11. Further review revealed the nursing intervention was patient education with no documented evidence of the topics of education to be provided by the nursing staff. Further review revealed the expected outcome was "patient/family will verbalize and/or demonstrate understanding of ____". Further review revealed no documented evidence of what was to be verbalized or demonstrated in order to determine when the goal was met. Further review revealed the patient problems of alteration in comfort related to pain, potential for infection related to invasive lines, and alteration in skin integrity related to wounds had been identified with no documented evidence of the date of assessment, and there was no documented evidence that the problems had been resolved by the time of discharge on 07/02/11.
There was no documented evidence Patient #13's care plan had been reviewed weekly at an interdisciplinary team meeting as required by hospital policy.

Patient #18
Review of the medical record for Patient #18 revealed a 62 year old male admitted to the hospital on 05/13/11 for a sternal wound infection with a history of DM (Diabetes Mellitus), Hypertension, Hyperlipidemia, and COPD (Chronic Obstructive Pulmonary Disease).

Review of the Physician's Orders for Patient #18 dated 05/13/11 revealed daily weights, contact isolation, I&O, Therapeutic Diet of Mechanical Soft with nectar thick liquids, no straws, Glucerna 60ml/hr hold if residual greater than 50ml, wound vac, oxygen 3 liter per nasal cannula, blood pressure parameters, SCD (Sequential Compression Devices) and pain management regime.

Review of the Plan of Care for Patient #18 dated 05/13/11 the following identified problems, expected outcomes and interventions: Knowledge deficit related to new diagnosis - no documented expected outcomes or interventions; Alteration in sensory perception related to: no further documentation noted; Potential for infection related to (no further documentation of what attributed to the potential (i.e. invasive lines, Foley catheter, etc), potential for infection will be reduced throughout hospitalization and assess for s/s of infection; Alteration in tissue perfusion related to decreased cardiac output, no expected outcomes documented and telemetry would be monitored; Actual alteration in skin integrity related to a wound and knowledge deficit with no documented expected outcomes or interventions. Further review of the Plan of Care revealed no documented evidence any of the physician identified problems were addressed in the Plan of Care.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 could offer no explanation for the patients' care plans not being individualized and not having measurable goals in order to determine when the patients' expected outcome had been met.

Review of the hospital policy titled "Nursing Care Plan, number N02-N revised 12/08/08 and filed in the clinical policy manual submitted by DON S2 as their current policy and procedure manual, revealed, in part, "...Purpose: To provide a mechanism for initiating and updating the Nursing Care Plan. Procedure: 1. A personalized Nursing Care plan is initiated within twenty-four hours of admission for each patient. 2. The Nursing Care Plan is updated with any change in patient status. 3. The Nursing Care Plan is brought to Interdisciplinary Team Meeting weekly by the charge nurse for review and update".

c) Failure to revise the patient's care plan with changes in the patient's condition:
Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 with diagnoses of Osteomyelitis requiring intravenous antibiotic therapy and physical therapy and severe endstage Multiple Sclerosis.
Review of Patient #12's "24 Hour Patient Record" revealed she had seizure activity on 05/20/11 at 9:30am and possible aspiration on 05/24/11 at 11:27am and 05/25/11 at 8:45am.
Review of Patient #12's "Plan of Care" revealed no documented evidence the plan of care was revised with Patient #12's change of condition related to seizures and aspiration.

Patient #13
Review of Patient #13's medical record revealed an admit date of 06/24/11 with diagnoses of diabetic foot ulcer with infection, cellulitis, and concern for Osteomyelitis.
Review of Patient #13's "24 Hour Patient Record" revealed a drop in blood sugar to 47 on 06/28/11 at 3:45am and to 56 on 06/30/11 at 4:30pm. Review of the lab reports revealed Patient #13 had a panic potassium level of 5.6meq/l (milliequivalents per liter) on 06/27/11 at 7:56am. Review of Patient #13's "Plan of Care" revealed no documented evidence the care plan was revised to reflect the change in Patient #13's condition related to blood sugars and potassium level.

Patient #19
Review of the medical record for Patient #19 revealed a 54 year old female admitted to the hospital on 04/21/11 for an infected left groin wound. Further review revealed Patient #19 had a history of CHF (Congestive Heart Failure), Hypertension, DM (Diabetes Mellitus), and Atrial Fibrillation.

Review of the Physician's Orders for Patient #19 revealed the following: 04/21/11 - Daily weights, 1000ml fluid restriction therapeutic diet of 2000 calorie ADA with hs (hour of sleep) snack, dietary consult, elevate HOB (Head of Bed), I&O (Intake and Output), Foley catheter, Telemetry, CPAP, and medications with parameters for Blood Pressure (Clonidine).

Review of the Nursing Notes for Patient #19 dated 04/22/11 revealed problems with elevated blood pressure 205/78. Further review revealed Patient #19 was becoming sleepy and oxygen saturation was dropping.

Review of the Plan of Care dated 04/21/11 for Patient #19 revealed the following identified problems, expected outcomes and interventions: Actual infection related to incision/wounds - Patient will show improvement of s/s (signs and symptoms) of infection by discharge - assess for s/s of infection; Weakness- patient will be provided a safe environment to reduce potential for injury during hospitalization - Fall precautions; and Potential for alteration in skin integrity related to decreased mobility and a wound, Patient skin integrity will be maintained or improved during hospitalization, Assess/document skin condition on admit and throughout stay, wound care evaluation and turn/reposition schedule. Further review of the care plan revealed no documented evidence included the identified nutritional, cardiac or respiratory problems identified by the physician on admit or that the plan of care was updated to reflect the change in condition.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 could offer no explanation for the patients' care plans not being updated when the patient's condition changed.

Review of the hospital policy titled "Nursing Care Plan, number N02-N revised 12/08/08 and filed in the clinical policy manual submitted by DON S2 as their current policy and procedure manual, revealed, in part, "...Purpose: To provide a mechanism for initiating and updating the Nursing Care Plan. Procedure: ...2. The Nursing Care Plan is updated with any change in patient status. 3. The Nursing Care Plan is brought to Interdisciplinary Team Meeting weekly by the charge nurse for review and update".

2) Physician's orders were implemented:
Medication
Patient #11
Review of Patient #11's medical record revealed she was admitted on 07/31/11 with a diagnosis of breast cancer.

Review of Patient #11's "Physician's Orders" of 07/31/11 revealed an order for Dexamethasone 4 mg (milligrams) one by mouth every morning, Neurontin 100 mg one by mouth three times a day, and Methadone 10 mg one by mouth three times a day.
Review of Patient #11's "Medication Administration Record" for 07/31/11 revealed Dexamethasone 4 mg was administered on 07/31/11 at 6:30pm. Further review revealed no documented evidence of a clarification order to administer the Dexamethasone in the evening rather than in the morning.

Labs
Patient #12
Review of Patient #12's "Physician's Orders" dated 05/19/11 at 5:20pm revealed an order for a Hemoglobin A1C in the morning. Review of the lab results revealed no documented evidence that a Hemoglobin A1C was drawn on 05/20/11 as ordered. Further review of the lab reports for Patient #12 revealed results of Vitamin B12, Folate, Thyroid Stimulating Hormone, Thyroxine (T4), Free, complete blood count with differential and platelets, and a comprehensive metabolic panel drawn on 05/20/11, Vitamin B12, Folate, Thyroid Stimulating Hormone, Thyroxine (T4), Free, complete blood count with differential and platelets, and a comprehensive metabolic panel drawn on 05/21/11, and a basic metabolic panel and a complete blood count with differential and platelets drawn on 05/26/11. Further review revealed no documented evidence of a physician's order for the labs drawn on 05/20/11, 05/21/11, and 05/26/11.

Patient #18
Review of the medical record for Patient #18 revealed a 62 year old male admitted to the hospital for a sternal wound infection. Review of the Physician's Orders revealed 05/16/11 (no time documented) an order for a BMP in the AM. Review of the lab results revealed no documented evidence blood was drawn and a BMP performed on 05/17/11.

Weights
Patient #2:
Review of Patient #2's medical record revealed the patient was admitted to the hospital on 7/29/2011. Further review revealed no documented evidence that Patient #2 had ever been weighed.

Patient #5:
Review of Patient #5's medical record revealed the patient was admitted to the hospital on 7/21/2011 with diagnoses that included C Diff and Colitis. Further review revealed physician's orders dated 7/21/2011 at 1500 (3:00 p.m.) for "Weigh on Admission and every Daily Day (as written)". Review of Patient #5's medical record revealed no documented evidence that the patient was weighed on 7/29/2011, 7/30/2011, and 7/30/2011.

These findings were confirmed by Registered Nurse S4 on 8/02/2011 at 1400 (2:00 p.m.) and 1515 (3:15 p.m.) in face to face interviews. S4 further indicated the hospital scale at the Off Site Campus had recently been broken and no patients at the Off Site Campus were weighed during that time. S4 indicated he (S4) could not recall the specific dates and had no documentation of the dates when the scale had been broken. S4 indicated the hospital had not obtained an alternate scale for use during the time the hospital's scale was broken. S4 indicated the hospital policy for weighing patients upon admission and physician's orders for weighing patients should have been followed. S4 further indicated the Initial Assessment of New Patients should include the patient's weight for reference in regards to future weight loss or weight gain.

Patient #9
Review of the medical record for Patient #9 revealed she was admitted to the hospital on 06/22/11 with the diagnoses of Vent Wean and Respiratory Failure. Review of the Admission Orders dated 06/22/11 revealed a physician's order to weigh on admission and every 7 days.

Review of her Graphic Vital Signs, Weights, I &O Flow sheet dated 7/06/11 to 08/03/11 revealed her weight on 07/11/11 was 182.1 # and on 07/25/11 her weight was 209#. There were no other weights documented on the flow sheet.

In a face to face interview on 08/03/11 at 1:45pm RN S4 Charge Nurse verified there were no more weights for Patient #9 and the weights were not obtained as ordered by the physician.

Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 with diagnoses of Osteomyelitis requiring intravenous antibiotic therapy and physical therapy and severe endstage Multiple Sclerosis.
Review of Patient #12's "Admission Orders" received by telephone order on 05/18/11 at 4:00pm revealed an order to weigh on admission and weekly and to check vital signs every 4 hours.
Review of Patient #12's "Admission Database", "24 Hour Patient Record", and "Graphic Vital Signs, Weights, I&O (intake and output), Flowsheet" revealed no documented evidence Patient #12 was weighed upon admit and weekly as ordered.
Review of Patient #12's "24 Hour Patient Record" and "Graphic Vital Signs, Weights, I&O, Flowsheet" revealed no documented evidence Patient #12's vital signs were taken as ordered on 05/19/11 at 4:00am, on 05/20/11 at 12:00am, 4:00am, 12:00pm, and 4:00pm, on 05/27/11 at 12:00pm and 4:00pm, and on 05/30/11 at 12:00pm.

Patient #16
Review of the medical record for Patient #16 revealed a 54 year old male admitted 07/28/11 to the hospital for urosepsis. Review of the Admission Orders 07/28/11 revealed an order for weekly weights.

Review of the "24 Hour Patient Record" and "Graphic Vital Signs, Weights, I&O, Flowsheet" for Patient #16 revealed no documented evidence a weight had been assessed on admit or weekly thereafter.

Patient #17
Review of Patient #17's medical record revealed a 65 year old female admitted to the hospital on 06/16/11 for hepatic encephalopathy and vertebral Osteomyelitis. Review of the Admission Orders dated/timed 06/16/11 at 1540 (3:40pm) revealed an order for weekly weights.

Review of the "Graphic Sheet" for Patient #17 revealed no documented evidence the weight was recorded as scheduled for the week of 06/23/11.

Patient #20
Review of Patient #20's medical record revealed a 64 year old female admitted to the hospital on 04/21/11 for further treatment of a left groin wound. Review of the Admission Orders dated/timed 04/21/11 at 0100 (1:00am) revealed an order for daily weights.

Review of Patient #20's "Graphic Sheet" revealed no documented evidence Patient #20's weight had been obtained for 04/23/11.

Wound Care
Patient #12
Review of Patient 12's "Physician's Orders" dated 05/18/11 at 3:00pm revealed an order for Dakin's 1/4 strength solution topical daily, with no documented evidence where this was to be applied, and Xenaderm ointment topically twice a day to perineum and left hip. Review of the "24 Hour Patient Record", the "Nursing Wound Documentation", and the "Medication Administration Record" revealed no documented evidence wound care was performed as ordered to the left ischium on 05/23/11 and 05/24/11, to the left hip on 05/23/11 and 05/24/11, to the right lateral hip on 05/24/11, to the right ischium on 05/23/11 and 05/24/11, and to the right posterior hip on 05/23/11 and 05/24/11.

Low Blood Sugar
Patient #13
Review of Patient #13's medical record revealed an admit date of 06/24/11 with diagnoses of diabetic foot ulcer with infection, cellulitis, and concern for Osteomyelitis.
Review of Patient #13's "Physician's Protocol Orders Standard Subcutaneous Insulin" dated 06/24/11 at 3:15pm revealed an order as follows: "5. Blood glucose less than 60 mg/dl (milligrams per deciliter) A. If patient alert and not NPO (nothing by mouth) give 4 oz. (ounces) of orange juice or 4 Glucose Tablets B. If patient is NPO or unresponsive give 1/2 amp (ampoule) D50 (dextrose 50) IV (intravenous) Push STAT. Continue to recheck blood glucose every 15 minutes and repeat above if glucose is less than 80 mg/dl".

Review of Patient #13's "24 Hour Patient Record" for 06/27/11 (includes 06/27/11 from 7:00am through 7:00am on 06/28/11) revealed an entry by LPN (licensed practical nurse) S43 at 3:45am of "CBG 47 (capillary blood glucose) - Pt (patient) stated he would eat a candy bar". Review of the "24 Hour Patient Record" and the "Medication Administration Record" revealed no documented evidence Patient #13 was given 4 ounces of orange juice or 4 Glucose tablets as ordered. Further review revealed no documented evidence his blood sugar was checked every 15 minutes as ordered.

Review of Patient #13's "24 Hour Patient Record" for 06/30/11 revealed an entry at 4:30pm by RN (registered nurse) S48 of "...current CBG is 56 mg/dl, asymptomatic of hypoglycemic episode @ (at) present". Review of the "24 Hour Patient Record" and the "Medication Administration Record" revealed no documented evidence Patient #13 was given 4 ounces of orange juice or 4 Glucose tablets as ordered. Further review revealed no documented evidence his blood sugar was checked every 15 minutes as ordered.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 could offer no explanation for
the nursing staff not following physician's orders for weights, vital signs, medications, wound care, labs, and treatment of hypoglycemia.

Review of the hospital policy titled, "Assessment and Reassessment of Patient AO3-G, last revised 12/1/08" presented by the hospital as their current policy revealed in part, "Scope of Assessment by Nursing: The initial assessment is the analysis of data collected and determination of the patient problems/needs by the nurse upon admission. . . Biophysical. Nutritional screening is initiated within 24 hours of admission. . . Basic, initial screening,/assessment criteria considers: 2. Low body weight for height. . ."

Based on record review and interviews, the hospital failed to ensure the nursing care of patients was assigned to nursing staff who were determined to be competent as evidenced by failure to have documented evidence of nursing staff competency 10 of 11 nurses' personnel files reviewed (S2, S3, S4, S28, S29, S38, S39, S40, S44, S48). Findings:

Review of the personnel files of Director of Nursing (DON) S2, RN (registered nurse) S3, RN S4, RN S28, LPN (licensed practical nurse) S29, LPN S38, LPN S39, LPN S40, LPN S44, and RN S48 revealed no documented evidence of orientation and assessment of competency.

In a face-to-face interview on 08/05/11 at 9:40am, Human Resources Director S9 confirmed there was no documented evidence of determination of competency for DON S2, RN S3, RN S4, RN S28, LPN S29, LPN S38, LPN S39, LPN S40, LPN S44, and RN S48.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 indicated she couldn't explain why hospital orientation and competency assessments were dropped by the former DON. S2 further indicated she had become DON in April 2011. S2 further indicated she had not read the state licensing and federal certification regulations since becoming DON.

Based on record review and interviews, the hospital failed to ensure that 2 of 2 contracted registered nurses (RN) whose personnel files were reviewed had been oriented and an evaluation of their clinical activities had been conducted by a hospital-employed RN (S41, S42). Findings:

Review of the employee files presented by Human Resource Director S9 for Contract RN S41 with Company B and Contract RN S42 with Company B revealed no documented evidence that they had been oriented to the hospital policies and procedures by a hospital-employed RN. Further review revealed no documented evidence S41's and S42's clinical activities had been evaluated by a hospital-employed RN.

In a face-to-face interview on 08/05/11 at 10:40am, DON S2 indicated she couldn't explain why hospital orientation and competency assessments were dropped by the former DON. S2 further indicated she had become DON in April 2011. S2 indicated she was not aware until about two weeks ago that the hospital was responsible for having the orientation and competency assessment of contract nurses performed by a hospital-employed RN. S2 further indicated she had not read the state licensing and federal certification regulations since becoming DON.

Based on observation, record review and interview the hospital failed to have an organized medical records system in place to meet the needs of both a main campus and off-site hospital as evidenced by allocation of inadequate space at either location for the processing and storage of open and closed medical records resulting in storage of medical records in cardboard boxes with an Excel spreadsheet used to locate records. Findings:

Observation on 08/02/11 at 11:45am of the room located in the business office of the main campus and designated as the "Medical Records Department" revealed two open medical shelves, a desk and approximately twenty cardboard boxes stacked four high and stored on the floor.

In a face to face interview on 08/02/11 at 11:45am RHIT S7 indicated the medical records department is presently located at the offsite campus of Hospital "a"; however should be located at the main campus of the hospital. Further S7 indicated at the present time neither site has adequate space for a department, but because the higher patient census is at the offsite, the medical records department is there. S7 indicated after a patient was discharged and the medical record was completed and closed, it was stored in a cardboard box. Further S7 indicated an Excel Spreadsheet was made in order to be able to locate charts as needed. S7 indicated he is the only one with the key to medical records and must be called to retrieve a record in either location.

Based on record review and interview the hospital failed to ensure: 1) medical records were accurately written as evidenced by placing an incorrect date on a chart continuing with an inaccurate date for the next five consecutive days (Patient #2) and by placing a check mark in the space provided for activity on a restraint form (Patient #3) for 2 of 20 sampled patients; 2) medical records were protected from water damage at the hospital's main campus and off site campus designated for medical records storage as evidenced by storing charts in cardboard boxes on the floor and open metal shelving in a building with a leaking roof on the main campus; and 3) medical records were completed no later than thirty days after discharge resulting in 12 of 20 discharged charts determined incomplete ( non-compliance rate of greater than 58%) . Findings:

1) medical records were accurately written
Review of Patient #2's medical record revealed the patient was admitted to the hospital on 7/29/2011 at 2300 (11:00 p.m.) with Nursing Documentation dated 7/30/2011 at 0010 (12:10 a.m.) indicated" Pt (patient) arrive to room. . ." Review of Patient #2's graphic record revealed vital signs documented on 7/29/2011 at 12:00 a.m., 4:00 a.m., 8:00 a.m., 12:00 p.m., 4:00 p.m, and 8:00 p.m. when the patient did not arrive to the room until 7/30/2011 at 12:10 a.m. for admission.

During a face to face interview on 8/02/2011 at 1515 (3:15 p.m.), Registered Nurse S4 confirmed the above findings. S4 indicated there were 5 sets of vital signs documented on Patient #2 prior to the patient ever arriving on the unit. S4 indicated it appeared as though the nursing staff charted the wrong date on the graphic; however, they continued to chart sequential dates with vital signs following the initial date of 7/29/2011 and it would be difficult to tell if any of the dates/times on the vital sign graphic were accurate.

Review of Patient #3's Medical Record revealed two Medical Restraint Record and Plan of Care form with no documented date on either page. Both Medical Restraint Records revealed check marks located in the section for "R= Reposition, E= Exercise, O-= OOB (out of bed), B = Back to bed." One form had check marks placed at 7:00 a.m., 9:00 a.m., 11:00 a.m., 1:00 p.m., 3:00 p.m, and 5:00 p.m. The other form had check marks placed at 7:00 a.m., 9:00 a.m., 11:00 a.m., 1:00 p.m., 3:00 p.m, 5:00 p.m., 7:00 p.m., 9:00 p.m., 11:00 p.m., 1:00 a.m., 3:00 a.m, and 5:00 a.m. Neither undated/un-timed Medical Restraint Record documented a "R, E, O, or B"

During a face to face interview on 8/02/2011 at 1528 (3:28 p.m.), Registered Nurse S4 indicated the nursing staff should use the appropriate symbol on the Medical Restraint Record to indicated what service was being provided; either R= Reposition, E= Exercise, O-= OOB (out of bed), B = Back to bed. S4 indicated the nurses placing a check mark on the form without the correct symbol would not revealed what service had been provided to the patient.

2) medical records were protected from water damage
An observation was made on 08/02/11 at 11 a.m. of the Medical Record Department at the off - site campus of the hospital. The Medical Records Department had sprinkler heads in the ceiling to protect the department from fire. Observed were 4 large wooden shelves with open fronts with medical charts on the shelves.

An interview was conducted with S7 RHIT on 08/02/11 at 11 a.m. He stated the department had water sprinklers to protect the records from fire. He further stated that the shelving would not protect the records from water damage.

Observation on 08/02/11 at 11:45am of the office in the Business Department designated as Medical Records revealed an area with a large window, sprinkler heads, a desk, and two metal open shelves with medical records laying (not filed) on the shelves. Further review revealed rows of cardboard boxes stacked 3-4 high with medical records.

In a face to face interview on 08/02/11 at 08/02/11 at 11:45am S7 RHIT indicated this room was where all of the purged files were stored. Further S7 indicated he had developed an Excel Spreadsheet in order to assist him in locating any requested medical record. S7 indicated the medical records are not protected from fire or water damage due to the window, sprinklers and the presently leaking roof at the main campus.

3) medical records were completed no later than thirty days after discharge resulting in 12 of 20 discharged charts determined incomplete ( non-compliance rate of greater than 58%) .

Review of the statistical data submitted to the Quality Management Department concerning the medical records delinquency rate revealed 12 of 20 discharged charts were incomplete after thirty days for a non-compiance rate of 58%. Further review of the meeting minutes of the "Committee of the Whole" dated 07/19/11 revealed... "Issue: Delinquent Medical Records' Discussion: Delinquent records exceeded the 50% threshold for the past four months; Action/Follow-up: Two charts need to be closed administratively due to unavailability of physicians (one has moved and is unable to be located and one expired). CEO and Medical Director completed process...". Further review of the minutes revealed no documented evidence of any further action to be taken.

In a face to face interview on 08/02 11 at 11:00am S7 RHIT indicated no corrective action had been implemented by Administration or the Governing Body concerning the medical records delinquency rate.

In a face to face interview on 08/05/11 at 2:15pm MD S21 Medical Director indicated he was aware of the medical delinquency problem with the medical staff. Further S21 indicated the hospital was experiencing difficulty generating interest in practicing at the hospital and when you come down hard on the physicians for not completing records, they tend not to want to admit patients.

Review of the "Rules and Regulations of the Medical Staff of St. Theresa Specialty Hospital", signed by the Chief of Staff and Chairman of the Governing Board with no documented evidence of the date they were signed, revealed, in part, "...The attending physician shall complete the medical record at the time of the patient's discharge, to include progress notes, final diagnosis and discharge summary. ... If the medical record is incomplete thirty (30) days after discharge, a written notice shall be sent to the physician by the Administrator notifying him that he has seven (7) days to complete the medical records or his admitting privileges will be suspended. The clinical privileges of any individual shall be deemed to be automatically relinquished for failure to complete medical records in accordance with applicable regulations governing the same, after notification by the Hospital of such delinquency and failure to complete the medical records within the seven day period. This relinquishment shall continue until all records of the individual's patients are no longer delinquent. Failure to complete the medical records that caused relinquishment of clinical privileges within 30 days from the relinquishment of such privileges shall constitute a voluntary resignation form the Medical Staff. Reinstatement of privileges shall be automatic upon completion of records and the Medical Records Director shall inform the Admitting Office. The Medical Records Director shall be responsible for analyzing medical records for the purpose of administering this rule. Three such suspensions of admitting privileges within any twelve (12) month period shall be sufficient cause for disciplinary action by the Executive Committee...".

Based on observation and interview the hospital failed to securely maintain the confidentiality of medical records as evidenced by storing the medical records of discharged patients in a file drawer in the Nurses' Medication Room. The key to the Nurses' Medication room was contained on the master key chain hanging in the Nurses' station and accessible to all nursing and housekeeping staff. Findings:

An observation was made on 08/01/11 at 10:00 a.m. of six patient's medical records in an unlocked metal file cabinet in the medication room on the main campus of the hospital.

In a face to face interview on 08/01/11 at 10:00am S3/RN Charge Nurse indicated the medical records in the metal cabinet were medical records of patients that were discharged on the weekend. S3/RN Charge Nurse indicated S7 RHIT would pick the medical records up today, 08/01/11. S3/RN Charge Nurse indicated the Medication Room was locked by a combination lock and only medical staff had access.

An observation was made on 08/01/11 at 10:25am of S2/DON (Director of Nursing) obtaining the master key ring that was hanging in the nurse's station and unlocking the medication room with a key on the master key ring. An interview was conducted with S2/DON and S3/RN Charge Nurse at that time and both indicated they were unaware the medication room key was on the master key ring, which was kept unsecured in the nurses' station. S3/RN verified the medical records in the unlocked metal cabinet in the medication room were unsecured.

Based on record review and interview the hospital failed to ensure a pharmacist was responsible for supervising and coordinating all the activities of the pharmacy as evidenced by failing to ensure a Pharmacy and Therapeutic Committee Meeting was held since the last documented date of March 18, 2010. Findings:

Review of the hospital's Pharmacy and Therapeutic Committee Meeting minutes revealed the last meeting was conducted 3/18/2010 (1 year and 4 months prior to the survey).

During a face to face interview on 8/03/2011 at 10:45 a.m., Pharmacist S12 indicated there had been no Pharmacy and Therapeutic Meeting since last documented on March 18, 2010. S12 indicated she was a prn (as needed) pharmacist; however, review of all data regarding Pharmacy and Therapeutic Meetings indicated the last one was held over a year ago. S12 had no explanation as to why the meetings had stopped. S12 indicated the Pharmacy Director S5 was on vacation and not available at the time.

Review of the "Medical Staff Bylaws of St. Theresa Specialty Hospital", signed by the Chief of Staff on 07/18/11 and signed by the Chairman of the Governing Board with no documented evidence of the date it was signed, revealed, in part, "...Infection Control and Pharmacy & (and) Therapeutics Function: The Infection Control and Pharmacy & Therapeutics Function may include: recommending and implementing, subject to approval by the Medical Executive Committee, plans, policies and procedures for maintaining quality, including mechanisms to: ... Assist in the formulation of professional practices and policies related to the evaluation, appraisal, selection, procurement, storage, distribution, use, safety procedures, and all other matters relating to drugs in the Hospital, including antibiotic usage; (9) Advise the Medical Staff and pharmaceutical service on matters pertaining to the choice of available drugs; ... (14) Maintain a record of all activities relating to pharmacy and therapeutics functions and submit periodic reports and recommendations to the Medical Executive Committee concerning those activities...".

Based on record review and interview the hospital failed to ensure pharmacy developed and implemented a policy that included a mechanism for reviewing all medications; outside of those administered during an emergency, were reviewed for appropriateness by a pharmacist before the first dose was dispensed for 1 of 1 policy reviewed regarding pharmacy's review of medications (Policy 06-13). Findings:

Review of the hospital policy titled, "After Hours access to Medication, 06.13, last revised 3/2010" presented by the hospital as their current policy revealed in part, "The charge nurse will be responsible for reading all new orders and obtaining enough medication from the cabinet to address the immediate patient care need until the pharmacy re-opens. All orders dispensed through the cabinet will be verified by a pharmacist immediately after opening the next day."

During a face to face interview on 8/03/2011 at 10:45 a.m., Pharmacist S12 indicated the only hospital policy that addressed pharmacist's review of medications was Policy 06.13. S12 indicated the policy indicated Pharmacy would review medications when they (Pharmacists) returned the following day. S12 indicated the hours of operation of the hospital's pharmacy was Monday through Friday 9 a.m. until 5 p.m. and Saturday/Sunday 9 a.m. until 1 p.m. S12 indicated pharmacists would stay later if a new patient arrival was expected. S12 indicated review of medications indicated in Policy 06.13 was regarding medications that may have been taken by nursing staff from the night cabinet for after hours needs, which would include new medication orders. S12 indicated that she (S12) relied on her memory regarding possible drug interactions between a patient's established drug regiment and newly ordered medications, were nursing staff to call her after hours, when she was the pharmacist on call. S12 indicated there was no formal procedure/policy regarding having a pharmacist review medications for appropriateness prior to the first administered dose.

Based on observation and interview the hospital failed to ensure all narcotics were secured as evidenced by being stored in an unlocked medicine cart in the nurses' medication room accessible by all nursing staff by a key kept on a key ring located at the nurses' station. Findings:

Observation on 08/03/11 at 10:00am of the Nurses' Medication Room revealed an open medication cart located at the back of the room containing the following: Morphine Sulfate 200mg 8 packages of 10 pills each and Morphine Sulfate 30mg 5 packages of 3 tablets each for hospice Patient #11 and Hydrocodone App 7.5/750 tablets two thirty count blister packs for Random hospice patient R16.

In a face to face interview on 08/01/11 at 10:20am RN S3 Nurse Manager indicated the medication cart should be locked at all times. Further S3 indicated the cart is used to store the drugs for the hospice patients only because most of these patients have their own medications.

Based on observation, record review, and interview, the hospital failed to ensure only authorized personnel had access to locked areas containing medications by having a key to the medication room on a key ring attached to a hook under the nursing station desk. Findings:

Observation on 08/01/11 at 10:25am revealed S2/Director of Nursing (DON) reaching under the nursing station desk to obtain a set of master keys on a large key ring that was attached to a hook under the desk. Further observation revealed S2/DON using one of the attached keys to open the locked medication room.

In a face-to-face interview on 08/01/11 at 10:25am, S2/DON confirmed the key to the medication room should not be kept on a master key ring that was accessible to all staff. S2/DON indicated that she did not know the key to the medication room was on that key ring.

Based on observation, record review, and interview, the hospital failed to ensure outdated supplies were not available for patient use located in the medication room at the main campus and in 1 of 1 Medication Room at the off site campus. Findings:

Observation on 08/01/11 at 10:02am of the medication room at the main campus, with DON (director of nursing) S2 present, revealed the following discharged patients' medications stored on the shelf with those of current inpatients:
Haloperidol oral solution 2 mg/ml (milligrams per milliliters) for Random Patient 12 who discharged on 07/15/11;
Haloperidol oral solution 2 mg/ml for Random Patient 13 who was discharged on 07/15/11;
Lactulose solution 10g/15ml (grams per milliliter) for Random Patient R14 who was discharged on 07/29/11; and
Q-Dryl 12.5/5ml elixir for Random Patient R15 who was discharged on 07/25/11.

In a face-to-face interview on 08/01/11 at 10:05am, DON S2 indicated the hospice agency had not been coming in a timely manner to remove their discharged patients' medications. S2 further indicated the unusable medication should not have been stored with current inpatient medications.

Observations on 8/02/2011 at 10:20 a.m. revealed the following Medications to be held in a locked cabinet in the Medication Room at the offsite campus:
Patient #18 (Admit 05/13/11 and Discharge 05/26/11) Provintal, Benadryl, Excedrin in a clear sealed bag (amount unknown/ seal left in place)
Patient #R3 (Admit 10/07/2009 and Discharge 10/30/09): Blister Packs of Medication labeled with the name of Patient #R3 and the facility where Patient #R3 resided prior to admission/discharge from St. Theresa's. Lexapro three tablets, Allupurinol 100 milligrams 10 tablets, Clonodine 0.1 milligrams 10 tablets, Gabapentin 200 milligrams 11 tablets, Nexium 40 milligrams 8 tablets, Lanoxin 0.125 milligrams 3 tablets, Levothroxine 0.1/100 6 tablets, Lasix 20 milligrams 3 tablets, Lexapro 10 milligrams 30 tablets, Tricor 145 milligrams 5 tablets, Folic Acid 1 milligram 4 tablets, Lasix 20 milligrams 3 tablets, Amlodipine 10 milligrams 9 tablets, Amitiza 24 milligrams 6 tablets
Patient #R4 (Admit 6/10/10 and Discharge 7/19/2010): Bottle of Gabapentin 60 milligrams 20 tablets
Patient #R5 (Admit 4/09/2010 and Discharge 4/29/2010): Traclear 62.5 milligrams 20 tablets
Patient #R6 (Admit 10/06/2010 and Discharge 11/04/2010): Isentress 400 milligrams 60 tablets, Keletran 200/50 milligram tablets 120 tablets

These findings were confirmed in a face to face interview with Registered Nurse S4 on 8/02/2011 at 10:20 a.m. S4 further indicated the medications belonged to patients that had been discharged from the facility. S4 indicated the medications should have been returned to the patients and/or responsible party at the time of discharge. S4 indicated he had no explanation as to why the medications remained held in the locked cabinet in the Medication Room.

Observation of the shelves located in the back of the medication room revealed two 100mL bottles of 0.25% Acetic Acid with the patient label and indication for use partially removed.

In a face to face interview on 08/01/11 at 10:20am RN S3 Nurse Manager indicated the bottles should have been discarded when the patients were discharged.

Review of the hospital policy titled, "Disposition of Expired Medication, # 06.05" presented by the hospital as current revealed in part, "The pharmacy director or designee shall be responsible for assigning pharmacy associates to inspect for expired medications in the pharmacy and other areas throughout the facility monthly. . . There are no outdated or deteriorated drugs, devices, or related materials...".


25065

Based on record review and interview the hospital failed to ensure policies and procedures were developed for patient safety of the contracted radiological procedures performed in the hospital. Findings:

Review of the Clinical and Administrative Policy and Procedure Manuals submitted as the ones presently in use revealed no documented evidence any policies were developed related to radiology procedures performed in the hospital.

In a face to face interview on 08/03/11 at 10:30am S11 QM (Quality Management) Director, after review of the Clinical and Administrative Manual there were no policies for Radiology procedures.

Based on interview the hospital failed to have a credentialed Radiologist on staff . Findings:

Review of the list of all credentialed physician revealed no documented evidence a radiologist was on listed as on staff at the hospital.

In a face to face interview on 08/05/11 at 12:15pm S1 Administrator/CEO (Chief Executive Officer) verified there was no MD credentialed for Radiology for the contracted services for the main campus or off-site.

Based on observations, record review, and interview, the hospital failed to develop policies and procedures to ensure the services provided by the contracted lab were adequate to meet the needs of the patients as evidenced by having expired lab tubes available for use. Findings:

Observations on 8/02/2011 at 10:05 a.m., revealed 94 purple top lab tubes with the expiration date of 2/2011, 3 gold top tubes with the expiration date of 6/2011, and 26 red top tubes with the expiration date of 2011 to be located in the Medication Room at the Off Site Campus.

Record review revealed no documented evidence of policies and procedures related to the provision of services/supplies by the contracted lab.

These findings were confirmed by Registered Nurse S4 in a face to face interview on 8/02/2011 at 10:05 a.m. S4 further indicated the expired tubes should have been discarded. S4 indicated expired supplies had been addressed in the policy titled, "Disposition of Expired Medication" in regards to Pharmacy inspections; however, he (S4) had been unable to find any policy addressing expired supplies other than the monthly inspections by pharmacy."

Based on interviews the facility failed to employ a full-time dietary manager responsible for supervising and directing daily food services resulting in food being stored and/or served out of the accepted temperature parameters. Findings:

Review of the Personnel List for the hospital revealed no documented evidence a dietary manager was employed by the hospital.

Review of the Food Temperature Log for the main campus, performed by employees of Company "c" revealed the following food temperatures on the serving line were documented for 06/23/11 through 07/03/11; 07/07/11, 07/19/11, 07/21/11, 07/26/11 through 07/31/11 and 08/01/11 through 08/02/11 . Further review of the temperature log revealed the hot food temperatures were above 140 degrees Fahrenheit for the following dates and meals: 06/24/11 dinner meal (meat, starch, vegetable; 06/25/11 dinner meal (regular and chopped meat); 06/27/11 dinner meal (regular meat); 06/29/11 dinner meal (vegetable); 07/01/11 breakfast (grits); 07/02/11 Lunch (regular meat, regular starch and regular starch puree) and Dinner (pureed vegetable); 07/03/11 Breakfast (grits); 07/07/11 Lunch (regular and pureed meat); 07/26/11 Breakfast (regular and pureed meat, regular and pureed starch) Lunch (regular and chopped meat, pureed starch, regular and pureed vegetable) Dinner (regular and chopped meat, starch, vegetable); 07/28/11 Breakfast (pureed meat regular and pureed starch) Lunch (regular and pureed meat, regular and pureed starch, regular and pureed vegetable); 07/30/11 Lunch (all meats, pureed starch); 08/01/11 Breakfast (chopped and pureed meat, grits, pureed biscuits, pureed eggs) Lunch (all meat, regular and chopped starch, all vegetables) Dinner (chopped meat, pureed vegetable) and 08/03/11 Breakfast (all meat, all starches, biscuit and eggs) Lunch (regular meat). Further review of the logs revealed no documented evidence test trays were performed to monitor the temperature when served to the patients.

Review of the Food and Nutrition Services Test Tray Evaluation used by the off-site campus revealed a test tray was performed on the following days: 05/10/11, 05/19/11, 05/24/11, 05/31/11, 06/02/11, 06/06/11, 06/09/11, 07/05/11, 07/12/11, 07/14/11, 07/19/11, 07/21/11, 07/26/11, 07/28/11 and 08/02/11. In addition all temperatures milk 50 degrees, cold entree 50 degrees, hot entree 120 degrees, starch 120 degrees, cold beverage 50 degrees and hot beverage 120 degrees were documented the same for every date tested.

Review of the Louisiana State Regulation 9383 C. revealed.... Hot foods shall leave the kitchen or steam table at or above 140-F., and cold foods at or below 41-F In-room delivery temperatures shall be maintained at 120-F or above for hot foods and 50-F or below for cold items, except for milk which shall be stored at 41-F. Food shall be transported to the patients' rooms in a manner that protects it from contamination, while maintaining required temperatures.

An interview was conducted with RN S4 Charge Nurse at St Theresa's off campus site on 08/03/11 at 9:30 a.m. He stated S18 Dietary Hostess was not an employee of St. Theresa's, but an employee of Company "a". He further stated that St. Theresa does not have a Dietary Manager on their staff.

An interview was conducted with S1Administrator at 08/04/11 at 10 a.m. He stated he did not have anyone who was a full time employee of St. Theresa that supervised the dietary services of the hospital.

In a face to face interview on 08/03/11 at 9:15am Dietary Hostess S18 employed by Company "a" indicated her duties were to make sure the patients at St. Theresa's off campus site received the food they needed and they ordered. Further S18 indicated it is her responsibility to find out what food they like, keep the snack area supplied with snacks, and twice a week perform a test tray and tests the food temperatures.

In a face to face interview on 08/03/11 at 9:30am RN S4 Charge Nurse at St Theresa's off campus site verified S18 Dietary Hostess was not an employee of St. Theresa's, but an employee of Company "a" . S4 further indicated that St. Theresa did not have a Dietary Manager on their staff.

Based on observation and interview the hospital failed to have a system in place to ensure the physical plant was maintained to assure the safety and well being of patients as evidenced by: 1) overgrown weeds and grass throughout the physical plant; 2) unsecured old construction site containing pilings and cement blocks; 3) continued unresolved roofing issues resulting in leaking water in patient care areas, stained tiles throughout the hospital and a black substance build-up on ceiling tiles necessitating a survey by the Office of Public Health; 4) unsecured electrical room that contained electrical panels on the wall labeled as "high voltage"; 5) rooms ready for occupancy with trash in receptacles, linen in closets, soiled bathroom floors and toilet bowls, sink with dirt and hair present, and window sills with dust and dried bugs present. Findings:

1) Overgrown weeds and grass throughout the physical plant
Observation on 08/01/11 at 9:00am of the outside ground of the hospital revealed tall grass and weeds surrounding the entire hospital grounds. Surveyors walked in the grass which revealed unleveled ground which could possibly cause a person to fall due to not being able to visualize the uneven areas.

In a face to face interview on 08/01/11 at 11:00am Maintenance S54 indicated it had been raining and that he was only one person and could do only so much. According to the personnel list submitted as accurate by the hospital revealed a Materials Manager, Materials Tech, Maintenance Manager and Maintenance Assistant assigned the responsibility for the main campus and the off-site.

2) unsecured old construction site containing pilings and cement blocks
Observation on 08/01/11 at 9:00am of the outside ground of the hospital revealed the following:
tall grass surrounding the entire hospital grounds; an unsecured construction site located in the front middle section of the hospital grounds with pilings sticking approximately two feet above ground and partially obscured by grass and weeds and large stacked sections of cement blocks used for foundation purposes; large pieces of twisted metal in the middle of the yard between the generator room and the hospital; and three garbage cans turned on the side and laying on the ground in this same area.

In a face to face interview on 08/05/11 at 2:00pm S1 Administrator indicated the old construction site should have a fence around it for safety. Further S1 indicated it was his understanding the materials were for use in Phase III of the hospital.

3) continued unresolved roofing issues resulting in leaking water in patient care areas, stained tiles throughout the hospital and a black substance build-up on ceiling tiles
Observation on 08/01/11 at 10:00am of the patient care areas of the hospital revealed the following:
Physical Therapy Room - active leaking from the tiles noted; brown stains on the floor in two locations in the room, one of which was directly under the active leak; black substance on water-stained ceiling tiles throughout the room.
Unoccupied Rooms - Room "b" - visible dust on the top of the closet, black substance of the handrails of the bed, broken light cover above the bed, and the bio-hazard container sharps container to the filled line; Room "c" - ceiling tile with black substance near the metal vent and a hole in the wall above the bathroom door with a protruding pipe; Crash cart in hallway near the Nurses' Station - top of the cart, screen of the AED, and the supplies were covered with visible dust, Rooms "e and "f" - water stained tiles; Room "g" - six ceiling tiles missing; and Hallway "a" - twelve stained and sagging ceiling tiles.

In a face to face interview on 08/01/11 at 9:20am S1 Administrator indicated all of this damage had just occurred the previous Thursday (07/28/11) due to the torrential rains the area had experienced. Further S1 indicated the black spots o the ceiling just developed.

4) Unsecured electrical room that contained electrical panels on the wall labeled as "high voltage":
Observation on 08/01/11 at 9:50am revealed an unlocked electrical room across from the nursing station that was accessible to patients, family members, and staff. Further observation revealed electrical panels on the walls in the room that were labeled :high voltage". This observation was confirmed by Director of Quality S11.

5) Rooms ready for occupancy with trash in receptacles, linen in closets, soiled bathroom floors and toilet bowls, sink with dirt and hair present, and window sills with dust and dried bugs present:
Observation on 08/01/11 at 10:45 of room "h" revealed the room was ready for occupancy. Further observation revealed the following: a trash receptacle and a biohazard receptacle both with trash present; the closet with linens and patient gowns; the bathroom with dirt on the floor of the shower stall; the toilet bowl with green residue streaming down the sides; and the floor drain in the bathroom with dried corroded residue.
Observation on 08/01/11 at 10:50am of room "i" revealed the room was ready for occupancy. Further observation revealed the following: the trash receptacle with a glove and paper towels present; the sink with hair and dirt particles present; the window sill with dust and died bugs; the ceiling tile in the room with black and brown substance.
Observation on 08/01/11 at 10:55am of room "j" revealed the room was ready for occupancy. Further observation revealed a large dead roach on the floor and paper towels in the trash receptacle.

All of the above observations were made in the presence of RN (registered nurse) Manager S3.


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Based on observation and interview the hospital failed to have a system in place to ensure: 1) equipment was inspected for electrical safety for 3 of 4 Enteral Pumps and 6 of 6 Venaflow Devices reviewed for Electrical Safety Inspections; 2) ventilators and BiPAP respiratory machines were inspected per manufacturer's recommendations for 2 of 2 ventilators and 1 of 1 BiPAP machines either being used by or available for patient use; 3) supplies used for patient care were safely stored and protected from damage, contamination and/or deterioration. Findings:

1) equipment was inspected for electrical safety for 3 of 4 Enteral Pumps and 6 of 6 Venaflow Devices reviewed for Electrical Safety Inspections;
Observations of the Clean Equipment Room on 8/02/2011 at 9:15 a.m., revealed 3 Ross Patrol Enteral Pumps with Safety Inspection Stickers indicating a Due Date 3/2010, 2 Venaflow Devices with Stickers indicating Due Date of 3/2010, and 4 Venaflow Devices with no Inspection Sticker.

These findings were confirmed by Registered Nurse S4 in a face to face interview on 8/02/2011 at 9:15 a.m. S4 indicated he (S4) would have Biomedical Staff S14 explain Biomedical Services at the facility.

During a face to face interview on 8/02/2011 at 12:10 p.m., Biomedical Staff S14 indicated he (S14) had not performed any services for the facility in over a year. S14 indicated he (S14) had made it clear to the facility that they (St. Theresa's) owed him (S14) money and he (S14) would no longer provide any services. S14 indicated he (S14) stopped working for the facility over a year prior to the survey.

Review of the hospital policy titled, "Medical Equipment Management Activities, #252, Revised 10/2008" presented by the hospital as their current policy revealed in part, "Clinical and physical risks are assessed and minimized through inspection, testing and maintenance. Each piece of equipment will have an ID tag and a preventative maintenance tag. All new patient care equipment must be inspected prior to the first use by a Qualified BioMedical Service. . . ."

2) ventilators and BIPAP respiratory machines were inspected per manufacturer's recommendations
An observation was made at St. Theresa's off site campus respiratory storage area on 08/03/11 at 10:45 a.m. of 1 ventilator (Puritan Bennett 840) and 1 BiPAP machine with S16 Respiratory Manager. The 1 ventilator in the storage area had a preventative maintenance sticker on the side of the machine with a date of 06/01/09 as the last date maintenance was conducted. The BiPAP machine had a preventative maintenance sticker on the side of the machine with a sticker with the last date of preventative maintenance as 09/17/09. The ventilator in use on Patient #9 had a preventative maintenance sticker on the side of the machine, which indicated the last date of preventative maintenance was done on 09/01/09. S16 Respiratory Manager confirmed the dates of the preventative maintenance on the ventilators and BiPAP machine.

Review of the Policy and Procedure for St. Theresa Specialty Hospital Environment of Care, which was provided to the surveyor as the current policy in use, revealed in part, " ... 11. Preventative Maintenance (PM) System All patient related equipment is maintained and checked on a periodic basis by an external contractor. A. A preventive maintenance schedule is maintained for all patient care electrical equipment per manufacture's recommendations. B. All medical equipment obtains a preventive maintenance check per the schedule and then has a sticker placed on it when the check is successfully complete. l Documentation is maintained by the contractor and available thru the business office. C. An inventory as well as maintenance history is kept on each piece of equipment."

Review of the Manufacture's recommendations on the 840 Ventilator System Operator's Guide revealed in part, Table 7-2: Preventive Maintenance intervals Review of the Manufacture's recommendations on the 840 Ventilator System Operator's Guide revealed in part, Table 7-2: Preventive Maintenance intervals: (Frequency) Every year; (Part) Atmospheric pressure transducer, expiratory valve, flow sensors, and vent inop test;. (Maintenance) Perform calibration/test Must be done by a qualified service technician according to instructions in the 840 Ventilator System Service Manual. (Frequency) Every year; (Part) Entire Ventilator: (Maintenance) Run performance verification. This includes running an electrical safety test and inspecting ventilator for mechanical damage and for label illegibility.

In a face to face interview on 08/03/11 at 1:30pm Respiratory Manager S16 verified there were no preventative maintenance logs on the ventilators and BiPAP machine. Further S16 indicated the preventative maintenance should be done once a year.

3) supplies used for patient care were safely stored and protected from damage, contamination and/or deterioration
Observation on 08/01/11 at 10:30am of the unlocked supply closet located on the main campus revealed 7 boxes of supplies stored on the floor.

Observation on 08/01/11 at 10:45am of the back area of the medication room located on the main campus revealed 4 boxes of paper supplies and 2 pieces of foam stored on the floor. Further review revealed the boxes wee blocking the path to obtain the stored supplies of respiratory and lab.

In a face to face interview on 08/01/11 at 10:50am RN S3 Nurse Manager indicated the supplies should be stored on the shelves and not on the floor.

Observation on 08/02/11 at 9:00am of the supply closet of the off-site campus of the hospital revealed 10 boxes of supplies stored directly on the floor with a total of 41 boxes stacked in the room. Further review revealed it was not possible to access supplies without moving boxes.
This was confirmed by RN S4 Charge Nurse at the time of the observation.

Based on record review and interview the hospital failed to ensure the Infection Control Officer developed a system for monitoring staff practices to ensure: 1) sanitary condition of the Nutrition Refrigerator at the Off Site Campus for 1 of 1 Patient Nutrition Refrigerators Observed (Off Site Campus) for Sanitary Conditions; 2) sanitary condition in the Nutrition Room on the main campus as evidenced by a thick dark brown substance under the ice-machine and on the counter surrounding the machine which is used to supply patients with ice; 3) all equipment used for patient care was clean and ready for use as evidenced by having a nasal cannula tubing laying on the floor by the oxygen cylinders, four hand weights laying on the floor, two water-pics stored under the sink, wrist splint laying on a desk in the Physical Therapy Department and an IV pump laying on the floor in the Nurses' Medication Room; 4) all staff adhered to current CDC guidelines related to TB screening as evidenced by the medical staff failing to be included in the hospital's screening program for 6 of 6 physician files eviewed (S19, S21, S22, S23, S24, S26). Findings:

1) Sanitary condition of the Nutrition Refrigerator at the Off Site Campus for 1 of 1 Patient Nutrition Refrigerators
Observations on 8/02/2011 at 9:40 a.m. revealed the Patient Nutrition Refrigerator to have a bottle of Miracle Whip with an expiration date of 10/28/2009. Further observations revealed a white thick buildup of crusty material at the bottom of their refrigerator and along the door. Further there was a bottle of baby food (bananas) that had been opened with no documented label as to the date and time. it had been opened.

These findings were confirmed by Charge Nurse/Registered Nurse S4 on 8/02/2011 at 9:40 a.m. S4 indicated he was unsure when the Nutrition Refrigerator had been last cleaned. S4 indicated there had never been a time when he had assigned anyone to clean the refrigerator. S4 indicated there was no log to indicate when the refrigerator had been cleaned.

Review of the hospital policy titled, "Patient Nutrition Room, 8.3, last revised 7/02" presented by the hospital as their current policy revealed in part, "Refrigerators must be maintained in a sanitary manner and cleaned weekly. Check daily for outdated food products and discard if outdated. . ."

2) Sanitary condition in the Nutrition Room on the main campus as evidenced by a thick dark brown substance under the ice-machine and on the counter
Observation on 08/01/11 at 10:15am of the Nutrition Room located on main campus of the hospital revealed a thick dark brown substance under the ice-machine and on the counter surrounding the machine which is used to supply patients with ice.

In a face to face interview on 08/01/11 at 10:15am Housekeeper S10 indicated she cleaned the room on Thursday of last week and did not remember seeing the brown substance.

3) All equipment used for patient care was clean and ready for use
Observation on 08/01/11 at 10:45am of the Physical Therapy Room revealed the following: one nasal cannula tubing laying on the floor by the oxygen cylinders, four hand weights laying on the floor, two water-pics stored under the sink, wrist splint laying on a desk, sink with a thick white residue, and visible dust and dirt build-up on the floor.

In a face to face interview on 08/01/11 at 10:45am RN S2 DON (Director of Nursing) indicated she did not know why the physical therapy room was in this condition. Further S2 indicated she knew the room itself was no frequently used by the patients due to the low census of LTAC patients; however when an LTAC patient was in-house and needed PT (Physical Therapy) services, the equipment contained in the room was used. Further S2 indicated she was not sure whether or not it was clean.

In a face to face interview on 08/01/11 at 11:00am RN S9 indicated she made monthly inspections of the physical plant.

Observation on 08/01/11 at 10:50am of the Medication Room revealed an intravenous pump lying on the floor under the desk.

In a face to face interview on 08/01/11 at 10:50am RN S2 DON indicated she did not know if it was clean or dirty; however because it was on the floor it was considered dirty. Further S2 indicated the pump should not be in the room with the medication.

4) All staff adhered to current CDC guidelines related to TB screening
Review of the physician personnel files for MD S19, MD S21, MD S22, MD S23, MD S24, and MD S26 revealed no documented evidenced the physicians were screened for TB within the past year.

In a face to face interview on 0804/11 at 10:20am S7 RHIT indicated he had the responsibility for the credentialing of the physicians. Further S7 indicated all of the physicians who were on staff at the hospital were also on staff at Hospital "a" and were not required to have TB screening at that facility. S7 indicated he was told by someone (unnamed) TB screening for physicians was not necessary. In addition, Administration for the hospital had decided that since we were having a difficult time getting physicians on-board to the hospital, screening would not be pushed.

Review of the " Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 " published by the CDC (Centers for Disease Control) revealed, in part, " ...HCWs (health-care workers) refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to M. tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in TB screening programs. All HCWs who have duties that involve face-to-face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program. The following are HCWs who should be included in a TB screening program: Administrators or managers ...Nurses ...Physicians (assistant, attending, fellow, resident, or intern) ... " .

Based on record review and interview, the hospital failed to ensure the personnel files of 2 of the 3 occupational therapy staff reviewed had evidence of competency as evidenced by failure to have documented evidence of orientation and evaluation of competency as required by hospital policy (S46, S47). Findings:

Review of the "Occupational Therapy Staff Competency: Orientation and Evaluations" revealed the preceptor/manager was responsible for documenting competencies under the "Level of Proficiency" columns indicating the task/paperwork was completed or performed independently, it was performed with assistance, or there was correction needed.

Review of Occupational Therapist (OT) S46's personnel file revealed he was hired on 11/05/09. Review of S46's "Occupational Therapy Staff Competency: Orientation and Evaluations" revealed no documented evidence that S46 had been assessed as competent in the topics of general overview, environment of care, wound care, respiratory, critical thinking, age/population specific, admission/discharge process, education, restraints, cardiac arrest, delegation, supervision, assessment, documentation, evaluation, treatment, communication, weight bearing status, edema management, positioning, bed mobility, turning schedule, therapy/documentation, feeding, grooming, upper body self care, toileting, transfers, supplies, and patient conditions/disease processes as evidenced by the "level of proficiency" column being blank. Further review revealed no documented evidence that a performance review had been conducted after the 90 day introductory period and annually as required by hospital policy.

Review of Occupational Therapy Assistant (OTA) S47's personnel file revealed she was hired on 01/20/10. Review of OTA S47's "Occupational Therapy Staff Competency: Orientation and Evaluations" revealed no documented evidence that S46 had been assessed as competent in the topics of general overview, environment of care, wound care, respiratory, critical thinking, age/population specific, admission/discharge process, education, restraints, cardiac arrest, delegation, assessment, documentation, treatment, communication, weight bearing status, edema management, positioning, bed mobility, turning schedule, therapy/documentation, feeding, grooming, upper body self care, toileting, transfers, supplies, and patient conditions/disease processes as evidenced by the "level of proficiency" column being blank. Further review revealed no documented evidence that a performance review had been conducted after the 90 day introductory period and annually as required by hospital policy.

In a face-to-face interview on 08/05/11 at 9:40am, Director of Human Resources S9 confirmed there was no evidence of evaluation of competency at the introductory period and annually for OT S46 and OTA S47.

Review of the hospital policy titled "Introductory Period", presented by Director of Human Resources S9 as their current policy for orientation, revealed, in part, "...Orientation and Training: During the first 30 days of the introductory period, new employees will participate in general orientation program. ... Performance Review: At the end of the introductory period, supervisors review performance with the new employee and decide whether to change employee classification to regular employee status...".

Review of the hospital policy titled "Performance Reviews", presented by Director of Human Resources S9 as their current policy for performance reviews, revealed, in part, "...Performance reviews will be completed by the supervisor at the completion of the introductory period and annually ... The employee will be given the core competencies and age specific competencies at least 30 days prior to the date of the performance evaluation. ... It is the supervisor's responsibility to see that performance evaluations are completed in a timely manner. ... The original performance evaluation form is kept in the employee's personnel file...".

Based on record review and interview, the hospital failed to ensure physician orders for
physical therapy (#13,#18), speech therapy (#12), and occupational therapy (#18) were implemented for 3 of 6 medical records reviewed with occupational/speech/physical therapy services from a total of 20 sampled patients. Findings:

Patient #12
Review of Patient #12's medical record revealed she was admitted on 05/18/11 for wound care and antibiotic therapy.
Review of Patient #12's "Physician's Orders" revealed an order on 05/24/11 at 11:27am for a speech therapy evaluation for aspiration. Further review revealed an order on 05/27/11, with no documented evidence of the time the telephone order was received, for modified barium swallow study with speech therapist.
Review of Patient #12's entire medical record revealed no documented evidence a speech therapy (ST) evaluation had been performed after it was ordered on 05/24/11. The modified barium swallow was unsuccessfully attempted at an area hospital on 05/30/11, three days after it was ordered and 6 days after the speech therapy evaluation was ordered for evaluation for aspiration.

Patient #13
Review of Patient #13's medical record revealed he was admitted on 06/24/11 with diagnoses of diabetic foot ulcer with infection, cellulitis, and concern for Osteomyelitis. Review of the admission orders revealed an order for PT (physical therapy) to evaluate for wound care. Review of the entire medical record revealed no documented evidence that PT had evaluated Patient #13 as ordered.

Patient #18
Review of the medical record revealed a 62 year old male admitted to the hospital on 05/13/11 for a sternal wound infection. Review of the Admission Orders for Patient #18 dated 05/13/11 revealed an order for Physical Therapy and Occupational Therapy to evaluate and treat.

Review of the Rehabilitation Physician Order Form revealed a written plan completed by the Physical Therapist and Occupational Therapist dated 05/16/11 (no time documented); however there is no evidence the orders had ever been signed by the physician.

Review of the Physicians Orders dated 05/16/11 (no time documented) revealed an order to make sure the patient gets therapies twice a day. Review of the Physician's Orders dated 05/18/11 (no time documented) revealed PT (Physical Therapy) 2 times a day 7 days a week. If this unit cannot provide this therapy please consider transfer to off-site campus at Hospital "a".

Review of the Physical Therapy Treatment Log revealed Patient #16 received physical and occupational therapy once daily from 05/16/11 through 05/25/11.

In a face-to-face interview on 08/05/11 at 10:40am, Director of Nursing (DON) S2 indicated a PT had quit, and it took a couple of months to replace the position. S2 further indicated there was no PT done during that time. S2 indicated she was aware there had been delays with ST evaluations, but she wasn't aware they weren't being done.

In a face-to-face interview on 08/05/11 at 11:15am, DON S2 indicated the charge nurse was responsible to review all physician orders and assure that the orders were carried out. S2 further indicated a copy of the order was to be placed in each discipline's bin, and the charge nurse was to follow-up with each discipline to schedule the evaluation. S2 further indicated she recently found out the the PTs, OTs (occupational therapists), and STs were not getting copies of the assessment packets. S2 indicated the rehab department was supposed to evaluate every patient.

Review of the hospital policy titled "Therapeutic Assessment, Treatment Plan, and Documentation", number A02-RH revised 02/21/00 and filed in the clinical manual presented by DON S2 as their current policies and procedures, revealed, in part, "...All therapy disciplines will be responsible for completing assessments and treatment plans according to procedure, upon physicians referral. ... 1. All patient assessments will be initiated, by the next business day, after receipt of physician's orders, by the appropriate therapy discipline. 2. Each discipline will document their assessment of patient's functional abilities and treatment goals in the Medical Record...".

Based on record review and interview the hospital failed to develop and implement quality indicators for dietary, laboratory, maintenance, rehabilitation services, and housekeeping as evidenced by identified and ongoing problems related to food temperatures not within acceptable temperature standards, laboratory tests performed without orders and laboratory tests not performed with MD orders, equipment used for patient care not routinely tested, rehabilitation services not rendered in a timely manner or not according to MD orders and unclean refrigerators, floor, and nutritional areas. Findings:

See findings at Tags:
A0084 related to dietary;
A0749 related to cleanliness and equipment;
A0396 related to labs; and
A1132 related to Rehabilitation Services

Based on record review and interview the hospital failed to implement corrective action for an ongoing problem of delinquency of medical records.

Review of the Quality Assurance/Performance Improvement data dated 08/11/10 through 07/19/11 revealed as follows:
08/11/10 - Delinquent Medical Records remain above threshold. Actions/Follow-up: Continue to monitor.
10/10/10 - Delinquent Medical Records remain above threshold. Actions/Follow-up: Continue to monitor. No improvement noted despite an RN dictating the summaries for the physicians.
Actions/Follow-up: Actions/Follow-up:Refer to MEC (Medical Executive Committee)
07/19/11 - Delinquent Medical Records exceeded the 50% threshold for the past four months (12 of 20 discharged medical records). No corrective action implemented at this time.

In a face to face interview on 08/02/11 at 12:10pm S7 RHIT indicated the hospital was aware of the problem with the medical records delinquency rate. Further S7 indicated to his knowledge letters have not been sent out concerning delinquency and any kind of suspension if the records were not completed.

In a face to face interview on 08/05/11 at 2:15pm MD S21 Medical Director indicated he was aware of the problem with the delinquency rate; however the hospital was in a hard position. S21 indicated the hospital was having difficult getting staff from Hospital "a" to utilize the main campus. The hospital felt if too much pressure was put on the physicians, it would jeopardize the physicians wanting to practice at this hospital.

Based on record review and interview the hospital failed to ensure medication was administered as ordered by the physician for 2 of 20 sampled Patients (#8, #11). Findings:

Patient #8
Review of Patient #8's Physician Orders dated 7/22/2011 revealed an order for Sucralfate 1 Gram by mouth twice daily. Medication Administration Record review revealed the schedule time for administration was 9:00 a.m. and 9:00 p.m. Review of Patient #8's Medication Administration Record for the date of 7/28/2011 at 9:00 a.m. revealed a circle had been drawn around the administration time with a written notation of "out of stock". Further review revealed the 9:00 a.m. medication had been administered at 1400 (2:00 p.m.). Review of Patient #8's entire medical record revealed no documented evidence that Nursing staff contacted Patient #8's physician to obtain approval for administering the patient's Sucralfate 5 hours after the scheduled does and 7 hours before the next dose was due. Review of physician's orders revealed no documented evidence of an order to administer the 9:00 a.m. scheduled dose of Sucralfate at 1400 (2:00 p.m.).

During a face to face interview on 8/03/2011 at at 1:30 p.m., Registered Nurse S4 confirmed the above findings. S4 indicated hospital policy allows administration of medication one hour before or one hour after the scheduled dose. S4 indicated the nurse should have called the patient's physician prior to administering the medication 5 hours after the scheduled dosage. S4 indicated there was no documented evidence the nurse called the patient's physician or received an order for the late administration of Sucralfate.

Patient #11
Review of Patient #11's medical record revealed she was admitted on 07/31/11 with a diagnosis of breast cancer.
Review of Patient #11's "Physician's Orders" of 07/31/11 revealed an order for Dexamethasone 4 mg (milligrams) one by mouth every morning, Neurontin 100 mg one by mouth three times a day, and Methadone 10 mg one by mouth three times a day.
Review of Patient #11's "Medication Administration Record" for 07/31/11 revealed Dexamethasone 4 mg was administered on 07/31/11 at 6:30pm. Further review revealed no documented evidence of a clarification order to administer the Dexamethasone in the evening rather than in the morning.

In a face-to-face interview on 08/05/11 at 10:40am, DON (director of nursing) S2 could offer no explanation for the nursing staff not following physician's orders for medications.

Review of the hospital policy titled "Medication Administration", number M01-N revised 12/08/08 and filed in the clinical policy manual submitted by DON S2 as their current policy manual, revealed, in part, "...22. Medications are given at the time ordered or within 60 minutes before or 60 minutes after the time designated. 23. Medications will be administered at standard times unless specifically ordered by the physician...".

Review of the hospital policy titled "Medications: Standard", number M02-N revised 12/08/08 and filed in the clinical policy manual submitted by DON S2 as their current policy manual, revealed, in part, "... Purpose: To define hospital-wide routine hours for medication administration ... Daily 1000 (10:00am) ... BID (twice a day) 1000, 2200 (10:00pm) BID diuretic 0730 (7:30am), 1630 (4:30pm) BID diabetic 0730, 1630...".


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