HospitalInspections.org

Based on the facility's Performance Improvement Plan, Quality/Risk Management (QRM) committee meeting minutes, facility policies and procedures, incident reports, governing body meeting minutes, and staff interview, the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program for 10 of 10 months reviewed (August 2009 through July 2010), by failure to provide an ongoing quality assessment program (Refer to A264 and A265); failure to assess the processes of care and services provided (Refer to A267); failure to provide an ongoing program of data collection and analysis (Refer to A273, A275 and A276); failure to provide an effective system for tracking and investigating adverse patient events and implement corrective action to prevent reoccurrence (Refer to A288); failure to maintain an effective ongoing performance assessment and improvement process which allowed for the measurement and/or success of actions taken to improve performance (Refer to A291); and failure to implement an ongoing quality assessment and performance improvement program to improve patient safety and health outcomes (Refer to A310). Failure to develop and implement an effective quality assessment and performance improvement placed patients at potential risk for avoidable complications and/or negative outcomes associated/contributed to the care/services received.

Based on observation, interview and record review, the hospital failed to maintain the building in compliance with the Life Safety Code to ensure the safety of patients. Refer to the CMS-2567 K tags for Life Safety Code.

Based on record review, review of a professional reference, policy and procedure review, review of the facility's Infection Control Program, reports, logs, and committee meeting minutes, and staff interview, the facility failed to implement an active infection control program for the prevention, control, and investigation of infections and communicable diseases by failing to implement a system to identify, report, investigate, and control infections and communicable diseases for all patients and personnel (Refer to A749) and failed to maintain a complete log of all incidents of infections among patients and personnel (Refer to A750) for 7 of 7 months reviewed (January 2010-July 2010). Failure to implement an active, effective ongoing infection control program to address infection control issues/problems and take corrective action has the potential for infections to go unreported, to spread or to reoccur, thus affecting the health of all patients, personnel, and visitors of the facility.

Based on review of medical staff bylaws, and medical staff credential files, the governing board reappointed 1 of 1 physicians requiring reappointment (physician #4) without evidence/verification of competency through the facility's peer review/case review process. Failure to verify competency as part of the medical staff appointment/reappointment process allows areas in need of improvement to remain unrecognized and place patients at risk for avoidable consequences/problems associated with the care/services provided.

Findings include:

Review of medical staff bylaws (approved 2009) occurred July 26-29, 2010, and stated: Page 22, Section 13.02 Processing of Application, B. "If an applicant for reappointment holds delineated clinical privileges in more than one clinical service, reappointment review shall include attestation from each Medical Director of applicant's demonstration of satisfactory clinical performance . . . The Credentialing & Peer Review Committee shall provide to the Medical Director information concerning the Staff member and their pattern of performance and professional judgement. Information shall include: 1. Clinical and/or technical skills. . . . 3. Utilization, quality and risk management data. . . . "

Review of Physician #4's credentialing file occurred on 07/28/10, and showed the governing board approved reappointment to the active medical staff on 07/07/09. The file also showed the physician (#4) had experienced action by the State Board of Medical Examiners in 2008 for over prescribing drugs to children. The board of medical examiners removed the action against the physician's (#4) license within a few months following the physician's completion of mandatory education.

The physician's file lacked evidence of demonstrated competency and performance through peer review/case review at the time of the approved reappointment in July 2009.

Based on review of minutes of the governing board meetings, minutes of medical staff meetings, medical staff bylaws, minutes of the facility's "Quality and Risk Management Committee (QRMC)", and staff interview, the governing board failed to ensure the medical staff enforced it's approved bylaws and maintained accountability to the governing board for the quality of care provided patients during 12 of 12 months reviewed (August 2009 through July 2010). The governing board's failure to ensure medical staff accountability for the approved bylaws and quality of care/services provided did not allow the governing board the opportunity for oversight and input into the care/services provided patients, take appropriate action(s) to improve patient care and safety, and monitor the medical staff's progress towards improved patient care.

Findings include:

Review of medical staff bylaws (approved 2009) occurred July 26-29, 2010, and stated: Page 33, "Quality Improvement/Safety Risk Management/Ethics Committee. The Quality Improvement/Risk Management Committee shall provide oversight of quality management and continuous improvement of health outcomes of the patient care services rendered in the Hospital. . . . Duties and Responsibilities include: 1. Assist in improvement of patient care through review, discussion and support of departmental performance improvement programs. 2. Discuss, assess, and make recommendations regarding intra and interdepartmental problems in quality assessment /quality improvement and risk management. 3. Periodically review and approve the Clinical Standards of Care and the Nursing Standards of Care. 4. Monitor the hospital-wide program for incident identification and reporting. 5. Oversee the development and implementation of mechanisms for timely evaluation of incidents which involve actual or potential risk in patient care. 6. Identify trends among the incidents and refer incident and trend summaries to appropriate committees when further action is necessary. 7. Oversee implementation of actions taken to correct problems in patient care and to reduce identified risks. 8. Participate in the activities of the Hospital Quality Improvement/Risk Management Program including risk management education and integration of risk management with performance improvement and credentialing. Submit with the annual report a list of the cases reviewed and findings of the reviews. 9. Report to the MEC [Medical Executive Committee] at a minimum of quarterly. 10. Participate in the Governing Board's annual Review of Hospital Performance Improvement Program. Membership shall be multidisciplinary and include administration, medical and affiliate staff.
Page 35, Pharmacy and Therapeutics and Infection Control Committee. The Committee shall be responsible for the surveillance of inadvertent hospital infection potentials, the review and analysis of actual infections, the promotion of a preventative and corrective program designed to minimize infection hazards, and the supervision of infection control in all phases of the Hospital activities. The Committee functions are performed by the Nursing Department in cooperation with the Medical and Affiliate staff, Administration, Pharmacy services and Individuals. The Committee shall be responsible for the development and surveillance of all drug utilization policies and practices within the Hospital in order to assure optimal clinical results and a minimum potential for hazard. The Committee shall assist in the formulation of board professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, safety procedures and all other matters relating to drugs in the Hospital. It shall also perform the following specific functions: . . . The committee shall submit a written report to the board of Governors quarterly. . . "

Review of the QRMC meeting minutes occurred on 07/28/10, and showed the committee met monthly from August 2009 through July 2010. The minutes lacked evidence a member of the medical staff participated or attended any of the twelve meetings reviewed.

During an interview at 9:45 a.m. on 07/29/10 with a QRMC management staff member (#8), the staff member verified a physician/medical staff member did not attend QRMC meetings, and stated, "We are trying to get a physician to agree to become involved and attend the meetings."

Review of the minutes of medical staff meetings provided by the facility showed the medical staff met 05/10/10, 03/09/10, 01/12/10, 11/10/09, and 09/29/09. The minutes lacked the following:
* Evidence of review, discussion and support of departmental performance improvement programs, including formulation of recommendations regarding identified problems.
* Evidence of monitoring the hospital-wide program for incident identification and reporting, including oversight of timely evaluation of incidents which involve actual or potential risk in patient care.
* Evidence of identification of trends among incidents and referral for further action as indicated.
* Evidence of oversight in the implementation of actions taken to correct problems in patient care and reduce identified risks.
* Evidence of submission of an annual report of cases reviewed.
* Evidence of functioning Pharmacy and Therapeutics and Infection Control Committee.

Review of the minutes of governing board meetings provided by the facility showed, from August 2009 through July 29, 2010, the governing board met on 07/2/10, 05/10/10, 04/19/10, 03/30/10, and 01/12/10. Minutes of these meetings lacked:
* Participation by the medical staff in the the "Governing Boards's annual Review of Hospital Performance Improvement Program."
* Evidence the medical staff reported and/or appraised the governing board of the quality of care provided.
* Evidence of quarterly reports from the Pharmacy and Therapeutics and Infection Control Committee.

During an interview at approximately 8:30 a.m. on 07/29/10 with an administrative staff member (#9) for purposes of reviewing the above findings and allowing the facility to provide additional information. The staff member indicated the facility's Pharmacy and Therapeutics and Infection Control Committee had not been active due to the lack of finding a pharmacist and a physician who would assume duties/responsibilities on the committee. The facility did not provide additional information.

Based on information received from a complainant, review of facility records, and staff interview, the facility failed to respond in a timely manner to a request for copies of a patient medical record, nor did the facility communicate to the patient's representative specific reasons prohibiting the release of the medical record for 1 of 1 patients reviewed (Patient #24). Failure of the facility to provide requested medical record information to Patient #24's representative resulted in a violation of the patient's right to timely access of their medical record for a period exceeding at least twenty-two months.

Findings include:

Information received by the Division from a complainant alleged the facility failed to provide, in a timely and satisfactory manner, the requested copy of Patient #24's medical record.

Review of the documentation provided by the facility (Patient Relations Communication Form) showed Patient #24's representative initially called the facility on 09/03/08 and requested a copy of a specific form filed with the county, "as well as [Patient #24's] entire chart." The facility faxed the requestor a Release of Information Form on 09/03/08. The facility's records showed a signed "Authorization For Release of Information" returned to the facility by the requestor on 09/03/08, specifying the facility could communicate the information by, "written," or "Fax," but not "Verbal" means.

Copies of e-mail communications among facility staff members showed the facility did not send the requested medical record to the requestor, but rather to "another provider who sees [Patient #24], who could then review the copies with [the requestor]." Documentation provided by the facility provided no evidence the facility obtained the consent/authorization of the requestor to send/release the record to another provider, or the requestor's agreement to verbally receive the information through the other provider.

Facility records showed no follow-up by the facility with the requestor following the above referenced review of the record, and no indication of the requestors request for "copies of the entire chart" had been satisfied through the review of the record with the above referenced "other provider."

Facility documentation showed the requestor called the facility on 04/02/09 and requested a copy of Patient #24's hospital discharge summary, and the individual to whom she spoke told the requestor ,"we'd get back to her." On 04/03/09, a facility staff member called the requestor "to confirm her request. I told her that she could try to get a copy from the patient's providers, or the cost would be $20 to obtain from us. She didn't understand why the charges, so I explained our policy to her. . . . "

Facility documentation included a handwritten note from the requestor dated 04/04/09. The note stated, "I will play your game for the time being now, her is my $20.00. Now I want as many papers as I can get and please make sure I have the discharge summary within these papers." The facility's records showed the facility sent the requestor twenty-eight pages of Patient #24's medical record on 04/07/09.

The facility's records lacked evidence of follow-up with the requestor regarding receipt of the twenty-eight pages sent. During an interview with an administrative staff member (#9) on the morning of 07/29/10, the staff member indicated the facility did not mail the information in a manner which would ensure receipt by the requestor, and had not contacted the requestor to ensure receipt and satisfaction with the information submitted.

Information in the facility's records showed receipt of a letter from the requestor dated May 5, 2010. The letter stated, "We [sic] writing to request a copy of [Patient #24's] medical file or files from your establishment. There was files released to his therapist in the end of 08 and we did request our own copies at this time and received nothing. We just left another message on 4-29-10 at medical records and still have not had a return call so we are now doing this in writing. . . . we know we will probably have to pay for this and this is not the problem please bill me or whatever it is that you do."

Facility records showed the facility did not address the above request for nearly a month until a handwritten note stated, "6/3-1004 [10:04 a.m.] left msg [message] to rtn [return] call." The next evidence of contact by the facility to the requestor occurred in a letter dated June 16, 2010 (forty-two days after the requestors May 5, 2010 letter/request) and stated, "We have received your request for the medical record for [Patient #24]. I have been unable to contact you by telephone at [number] to discuss your request. Our records indicate that we responded to your request for records dated April 4, 2009 by sending a total of 28 pages of documentation on April 7, 2009. The charge of $20.00 was paid to our Medical Records Department . . . In the event you did not receive these 28 pages of documentation we would be happy to reprocess your request. Please notify us if this is the case. . . "

A response letter from the requestor dated June 21, 2010 stated, "Yes, you are right, I was charged $20.00 for some medical records but these are the medical records you sent to his therapist and told her to discuss them with us. I have been asking for my own copy of [Patient #24's] medical records and this just seems to be such a problem Why is that? What is even more sad it took you 30 days to respond to my last request. You people need to pick up the pace when it comes to certain things. Again, I want my own copies of [Patient #24's] medical records . . . "

Facility records showed no further contact/response to the requestor until a letter dated July 27, 2010. The letter stated, "We have received your request for information and I apologize for the delay in responding. . . . in order to fulfill this obligation as a healthcare facility, we do need some additional information from you in order to fulfill your request . . . I have enclosed a Authorization for Release of Information. We need to have this form completed, with the following information; 1) The individual to release the information to, including complete address and phone number. 2) The specific information to be released or obtained. 3) The purpose of Release. 4) A signature of the Legal Guardian . . . In addition to the information and signature on this form, we will need written proof of guardianship or custodial parental status, including who is the medical decision maker . . . "

The facility's documentation/records lacked evidence the facility had questioned the requestors legal right to the information prior to the July 27, 2010, nor do the records show evidence the facility ever informed the requestor of a specific reason(s) why she could not have access to the record.

Review of facility records showed the requestor as the legal representative and medical decision maker for Patient #24 during the patient's hospitalization in August 2008 (the hospitalization records authorized for release by the requestor on 09/03/08, repeatedly requested, and paid for).

The lack of timely response and follow-up regarding the initial request on 09/03/08 for a "Written or Faxed copy" of Patient #24's "entire medical record," resulted in twenty-three month delay and a continuing unresolved violation of the patient's right for timely access to medical information.

Based on review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", review of facility incident reports, and staff interview, the facility failed to provide an ongoing program of data collection, and failed to analyze data collected to improve patient health and safety outcomes for 10 of 10 months reviewed (September 2009 through June 2010). Failure to provide an ongoing program of data collection and analysis placed all patients at risk for adverse/negative outcomes/consequences as a result of unidentified and/or uncorrected problems affecting patient quality care and safety.

Findings include:

Review of the facility's "Performance Improvement Policy," review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement," and review of facility incident reports occurred July 26-29, 2010. Review of the referenced information showed the facility lacked an effective and ongoing process of data collection, analysis of data, and identification of deficient practices or areas in need of improvement to ensure patient safety and the provision of quality care. Refer to A265 and A267.

Based on review of medical staff bylaws, minutes of medical staff, governing board, and Quality and Risk Management Committee (QRMC) meeting minutes, and staff interview, the medical staff failed to organize and maintain accountability for the quality of patient care in the manner prescribed in the governing board approved bylaws during 12 of 12 months reviewed (August 2009 through July 2010). The medical staff's failure to organize consistent with the approved bylaws, and maintain accountability to the governing board for the quality of care provided, placed patients at risk for unresolved problems and potential adverse consequences in areas in need of improvement in the provision of patient safety and quality of care.

Findings include:

Review of medical staff bylaws, medical staff, governing board, and QRMC meeting minutes occurred July 26-29, 2010. As stipulated in the May 2009 governing board approved medical staff bylaws, the minutes of the meetings lacked evidence the medical staff had established committees and carried out the functional responsibilities of the committees, including reporting information relative to the quality of care being provided to the governing board. Refer to A49.

Based on review of medical staff bylaws, and medical staff credential files, the medical staff recommended and the governing board reappointed 1 of 1 physicians reviewed (physician #4) without evidence/verification of competency through the facility's peer review/case review process. Failure to verify competency as part of the medical staff appointment/reappointment process allows areas in need of improvement to remain unrecognized and place patients at risk for avoidable consequences/problems associated with the care/services provided.

Findings include:

Review of medical staff bylaws and medical staff credential files occurred on July 26-29, 2010, and showed the medical staff recommended reappointment of Physician #4 on 07/07/09, and the governing board approved the reappointment on the same date. The file lacked evidence the recommendation for reappointment of Physician #4 included verification of performance/competency through peer review/case review. Refer to A46.

Based on record review, review of incident reports, review of facility policy, and staff interview, the facility failed to ensure nursing staff supervised, implemented, and evaluated a plan of care regarding falls for 1 of 2 closed records (Patient #17) reviewed. Failure to established an individualized nursing plan of care for the patient pertaining to fall prevention does not provide staff with the necessary information to prevent further falls from occurring.

Findings include:

Review of the facility policy titled "Scope of Services and Plan for Provision of Care" occurred on 07/29/10. This policy, dated 05/12/10, stated, "Purpose: This policy describes the scope of services offered by RPSPC [initials of facility] and overall plan for delivery of patient care . . . Care Planning: Based on initial assessment, an initial treatment plan is developed within three days of admission. Treatment goals and therapeutic interventions are recommended. The plan is updated at least every seven days thereafter. Integration and coordination of care among departments and disciplines is carried out through daily multidisciplinary treatment planning sessions, as well as documentation in the medical record and unit or departmental meetings . . . ."

Review of Patient #17's closed medical record occurred on July 28-29, 2010. The facility admitted Patient #17 on 02/11/10 with a diagnosis of major recurrent depression and discharged her to a skilled nursing facility on 03/25/10.

Review of Patient #17's Nursing Admission Assessment, completed by a licensed nurse, identified the patient at "Moderate Risk" for falls related to exhibiting dizziness, weakness, and impaired gait while walking, independent with dressing and toileting, and urinary abnormalities of incontinence "with coughing."

Review of Patient #17's Nursing Care Plan, dated 02/11/10, included a nursing diagnosis of "At risk for falls r/t [related to] unsteady gait" with an expected outcome of "Pt [patient] to [not] sustain fall while IP [inpatient]", and interventions of "1. Staff to monitor ambulation, 2. Pt to verbalized any lightheadedness, fatigue [and] any need for assistive devices, 3. PT [physical therapy] as ordered."

Review of facility incident reports from July 2009-July 2010 identified Patient #17 experienced falls on March 17 and 19, 2010.

The incident report, dated 03/17/10, identified Patient #17 fell at 2:45 a.m. when getting up to use the bathroom and sustained a laceration/skin tear to her right lower leg. Contributing factors/causes noted by staff to this fall, as listed on the incident report, include patient activity as "pt was using the BR [bathroom] when ambulating, pt didn't use walker [and] fell." The facility's "Action Plan to Prevent Reoccurrence," as documented on the incident report included, "Pt continues to be on fall precautions, discuss [with] staff importance of monitoring pt closely when ambulating [and] remind pt to ambulate with walker. Discussed [with] pt importance of using walker to ambulate [and] ask staff for assistance PRN [as needed]."

During interview on 07/29/10 at 10:00 a.m., an administrative nurse (#1) stated she expected nursing staff to complete a Nursing Follow-Up Assessment (the name of the facility's nursing assessment form completed following a patient occurrence necessitating 24 hour follow-up), for all falls sustained by patients.

Review of Patient #17's medical record identified nursing staff assessed Patient #17 on 03/17/10 at 3:15 a.m. This note stated, "Writer notified pt had fallen in bathroom. Pt found on floor in bathroom, had fallen onto knees. Pt was incontinent [and] had a laceration/skin tear on [right] lower leg. Dressing applied to wound. Vitals . . . Pt did not [complain of] pain, 'doesn't hurt, I'm fine.' A [alert] [and] O [oriented] x 3. No head wounds noted. Cleaned pt up [and] assisted to bed. Pt had not used walker to get up to bathroom. MD [medical doctor] on-call notified." Patient #17's medical record lacked any further follow-up assessments pertaining to this fall. Patient #17's medical record lacked documentation of a completed Nursing Follow-Up Assessment for the fall sustained on 03/17/10.

During interview on 07/29/10 at 10:00 a.m., an administrative nurse (#1) confirmed Patient #17's record lacked evidence of follow-up assessments pertaining to the 03/17/10.

Patient #17's incident report, dated 03/17/10, identified the patient fell and sustained a laceration/skin tear to her right lower leg. Patient #17's medical record failed to include a follow-up assessment of Patient #17's injury to her right lower leg and interventions implemented in response to prevent further falls from occurring. Failure to revise Patient #17's plan of care following the fall on March 17, specifically interventions to prevent further falls, may have contributed to the patient sustaining an additional fall on March 19. Facility nursing staff failed to revise Patient #17's plan of care to prevent further falls and/or serious injury in the event of further falls.

- Review of Patient #7, #8, #9, #10, and #11's records occurred July 27-29, 2010 and identified:
* Patient #7's inpatient record review identified the facility admitted the patient on 07/15/10 at 9:30 p.m. The record included an RBTO for admission orders. The record identified five additional physician/provider orders which included one RBTO and four RBVO's.
* Patient #8's inpatient record review identified the facility admitted the patient on 07/01/10 at 9:00 p.m. The record included RBTO's for admission orders. The record identified 10 additional physician/provider orders which included two RBTO's and eight RBVO's.
* Patient #9's inpatient record review identified the facility admitted the patient on 07/15/10. The record included an RBTO for admission orders. The record identified six additional physician/provider orders which included two RBTO's and four RBVO's.
* Patient #10's inpatient record review identified the facility admitted the patient on 07/20/10. The record included an RBTO for admission orders. The record identified four additional physician/provider orders which included RBVO's.
* Patient #11's inpatient record review identified the facility admitted the patient on 07/24/10. The record identified one RBTO and three RBVO's.

Observation at a nurse's station on 07/27/10 at 8:20 a.m., revealed a conversation between a nursing staff member and a medical provider. Observation showed the nursing staff member took verbal orders from the physician and recorded the orders in a patient's medical record.

Observation at a nurse's station on 07/27/10 at 4:20 p.m., revealed a telephone conversation between a nursing staff member and a medical provider. Observation showed the nursing staff member took admission orders over the telephone from the provider and recorded the orders in a patient's medical record.

During interview on the afternoon of 07/28/10, two administrative nursing staff members (#1 and #2) agreed the facility should use verbal orders infrequently. The staff members shared awareness of a pattern of utilizing verbal orders frequently and stated administrative staff are aware of the problem.




21202

- Review of Patient #1, #2, and #5's records occurred July 26-29, 2010 and identified:
*Patient #1's inpatient record identified the facility admitted the patient on 07/13/10. The record included a RBTO for admission. The record included four additional RBVO's, dated July 13, 14, 15, 17, and 21, 2010.
*Patient #5's record identified the facility admitted the patient to "residential" level of care on 07/14/10. The record included three RBVO's, dated July 14, 15, and 22, 2010.
*Patient #2's record included a RBVO for admission dated 07/14/10.


17256

Based on observation, record review, review of facility policy, and staff interview, the facility failed to ensure the use of verbal and telephone orders occurred infrequently for 13 of 16 sampled active patients (Patients #1, #2, #5, #7, #8, #9, #10, #11, #12, #13, #14, #15, and #16). The use of verbal orders poses an increased risk of miscommunication that could contribute to an error, resulting in a patient adverse event.

Findings include:

Review of the facility policy titled "Medication Orders from Medical Staff" occurred on 07/28/10. The policy, dated 05/12/08, stated:
". . . This policy and procedure established a process for ordering medications for patients . . . It is the policy . . . to take steps to reduce the potential for error or misinterpretation when orders are written or verbally communicated. The following standards are in place to minimize the risk of medication errors . . . The hospital will minimize the use of verbal and telephone medication orders. . . .
Procedures
A. Origin of Medication Orders
1. The medical staff may write the medication order on the Physicians [sic] Order Sheet in the patient's medical record when making rounds on the units.
2. The medical staff may give the RN/LPN [nurse] a verbal order to write. Always read the order back to the medical staff to confirm the order. Once the order is written it should be signed by the medical staff to confirm the order . . .
3. The medical staff may give a telephone order to the RN/LPN. The order should always be read back to the medical staff member to confirm the order was heard and written correctly. . . .
* All orders should be written by the medical staff member whenever possible to decrease the chance of medication errors. . . ."

- Review of a sample of patient medical records identified the frequent use of verbal and telephone orders. These included:
* Patient #12's inpatient record review occurred on July 26-28, 2010. The record identified the facility admitted the patient on 07/12/10 at 10:30 p.m. and discharged the patient on 07/26/10. The record included read-back telephone orders (RBTO) for admission orders. The record included 14 additional physician/provider orders which included four RBTO's and nine read-back verbal orders (RBVO).
* Patient #13's inpatient record review occurred on July 26-27, 2010. The record identified the facility admitted the patient on 07/20/10 at 9:30 p.m. The record included RBTO for admission orders. The record included a RBTO on 07/23/10, and one RBVO on 07/22/10, one RBVO on 07/26/10 and two RBVO's on 07/27/10.
* Patient #14's inpatient record review occurred on 07/27/10. The facility admitted the patient on 07/20/10. The record included two RBVO's on 07/27/10.
* Patient #15's inpatient record review occurred on July 26-27, 2010. The facility admitted the patient on 07/13/10. The record included RBTO for admission orders, a RBVO on 07/19/10, and two RBVO's on 07/26/10.
* Patient #16's inpatient record review occurred on July 27-28, 2010. The facility admitted the patient on 07/09/10. The record included a RBTO dated 07/13/10, and RBVOs on 07/18/10, 07/19/10, 07/26/10 and 07/27/10.
* Patient #12's inpatient "boarding/partial hospitalization" record review occurred on 07/28/10. The facility admitted the patient admitted on 07/26/10. The record included a RBTO for admission orders and a RBVO on 07/27/10.

Based on review of a professional reference, policy and procedure review, record review, and staff interview, the facility failed to document whether patients received informed consent in the medical record from the health care practitioner responsible for conducting the outpatient procedure for 4 of 4 active outpatient records reviewed (Patient #3, #6, #21, and #22). Failure of the facility to ensure the health care practitioner performing the outpatient ECT procedure obtained written, signed informed consent from Patient #3, #6, #21 and #22 limited each of these patients right to fully consent to this form of treatment.

Findings include:

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process, and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, page 942, stated, ". . . Prior to any surgical procedure, informed consent is required from the client or legal guardian. Informed consent implies that the client has been informed and involved in decisions affecting his or her health. The surgeon is responsible for obtaining the informed consent by providing the following information to the client or legal guardian: The nature of and the reason for the surgery; All available options and the risks associated with each option; The risks of the surgical procedure and its potential outcomes; The right to refuse consent or later withdraw consent. The surgeon documents the informed consent conversation with the client or legal guardian in the preoperative progress note. . . ."

Review of facility policy titled "Informed Consent" occurred 07/29/10. This policy, undated, stated, "It is the policy of RPSPC [initials of facility] that every patient has the right to 'informed consent' which means that the patient has the right to an explanation of diagnostic/therapeutic intervention by a physician/provider . . . It is necessary that patient consent be obtained prior to the medical/surgical treatment. The consent must be informed: that is, the patient must understand the nature and purpose of the proposed treatment, the risks, benefits, and alternatives of what he/she is consenting. When consent is required: . . . G. Electroconvulsive therapy. . . . Responsibility: A. Physician performing procedure. Physicians are responsible for: 1. Providing the patient with appropriate information in terms/language he/she understands. Describing the planned procedure will include . . . Diagnosis of illness being treated; Nature/purpose of the proposed treatment; Risk/consequences of treatment; Benefits of the proposed treatment and probability/likelihood of successful outcome; Feasible alternatives used; Prognosis if no treatment is rendered; Patient given an opportunity to ask questions and that all questions have been answered to the patient's satisfaction. 2. Ensuring documentation of all above elements of the informed consent discussed with the patient/legal representative. B. . . . Non-physician health care providers are responsible for: . . . 2. Reviewing the appropriate consent form and /or the supplemental documentation in the medical record. The following information must be included in the record: . . . Coverage of the elements of a valid consent within physician discussion . . . 4. Contacting the physician and department where the treatment/surgery/procedure is to take place if a signed consent is not present in the medical record and/or the information in #2 is not evident in the medical record. . . ."

Review of facility policy titled "Electroconvulsive Therapy: Prior to test" occurred 07/29/10. This policy, revised 12/08/09, stated, ". . . Written, signed, informed consent shall be obtained prior to the ECT [electroconvulsive therapy] procedure. . . ."

Review of facility policy titled "Electro Convulsive Therapy" occurred on 07/29/10. This policy, undated, stated, ". . . Due to the nature of the treatment and potential risks involved it is of great importance that certain procedures be understood and implemented so that safety is ensured and consent is documented. . . . Informed consent must be obtained from the patient by the treating psychiatrist and documented in the progress notes. . . ."

- Review of Patient #21's outpatient record occurred July 28-29, 2010 and identified the facility admitted the patient on 07/26/10 for the first ECT treatment. Record review lacked documentation the health care practitioner performing the ECT, obtained informed consent from Patient #21 prior to initiating the ECT treatment.

- Review of Patient #22's outpatient record occurred July 28-29, 2010 and identified the facility admitted the patient on 06/09/10 for the first ECT treatment. Record review lacked documentation the health care practitioner performing the ECT obtained informed consent from Patient #22 prior to initiating the first ECT treatment.


21202


- Review of Patient #3's inpatient record occurred on July 26-29, 2010 and identified the facility admitted the patient on 07/15/10 with a diagnosis of major depressive disorder. A physicians's order dated 07/10/10, stated "ECT ASAP [as soon as possible]." Patient #3's ECT record identified she received ECT treatments on July 23, 26, and 28, 2010. Record review lacked documentation by the health care practitioner performing the ECT obtained informed consent from Patient #3 prior to initiating the first ECT treatment.

- Review of Patient #6's outpatient record occurred on July 28-29, 2010 and identified a diagnosis of recurrent severe depression. Record review identified Patient #6 received 24 ECT treatments at the facility from 11/27/09 through 07/19/10. Patient #6's ECT record lacked documentation by the health care practitioner performing the ECT obtained informed consent from Patient #6 prior to initialing the first ECT treatment in November of 2009.

During an interview on 07/28/10 at 4:40 p.m., an administrative nurse (#1) confirmed Patient #3, #6, #21 and #22 records lack evidence the physician obtained informed consent from these patients prior to the initiation of the first ECT treatment.

Based on observation, review of policy and procedure, review of professional references, review of facility records, and staff interview, the facility failed to monitor the temperature of 1 of 1 medication refrigerator in the outpatient procedure room. Failure to monitor the temperature of the medication refrigerator has the potential for the facility to store medications outside the acceptable range and risk the stability of the medication.

Findings include:

Review of the facility policy titled "Refrigerator Temperature & [and] Cleaning for Medication Storage Units" occurred on 07/29/10. This policy, undated, stated, "Purpose: This policy establishes the procedure to ensure that medications are stored in a sanitary environment that maintains infection control standards and that the temperature is within safe limits to promote the potency of medication. . . . Policy: It is the policy of [name of facility] that the medication refrigerators will be cleansed on a weekly basis and that the temperature of the refrigerators is checked and documented two times daily. . . . Responsibilities: . . . B. Night shift Registered Nurse: Responsible for monthly medication room audits to make sure medications are stored properly and in the right temperature. C. Night shift Registered Nurse: Responsible to check the temperatures in the 2 refrigerators in the ECT [electroconvulsive therapy] Department on the night shift. Procedures: A. Refrigerator Temperatures: 1. The refrigerator temperature should be maintained at a temperature of 34-40 degrees at all times. 2. The temperature will be documented on the Temperature Log for each month. 3. The temperature log will be audited by the Infection Control Team. 4. Upon completion for the month the log will be given to the Director of Nursing to store. . . ."

During a tour of the Outpatient ECT Department, on 07/28/10 at 4:40 p.m. with an administrative staff member (#1), observation showed a refrigerator located within the ECT procedure room which contained multiple medications used for anesthesia, and a thermometer used to monitor the temperature of the refrigerator. Observation of the thermometer showed a temperature of 42 degrees Farenheit (F). Medications located within this refrigerator included the following temperature sensitive medications:
*1 partially used vial of Brevital Sodium (a medication used as intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures). The medication vial lacked a label which contained the date staff opened the medication. Recommendations from the 2008 Physician's Desk Reference (PDR), pages 1737-1738, identified storage of this medication at a controlled room temperature of 68-77 degrees F.
*3 syringes of Hepatitis B vaccine. Recommendations from the 2008 PDR, pages 3178-3180, identified storage of this medication at 36-46 degrees F and do not freeze.
*11 vials of Succinylcholine (a medication used as anesthesia to relax skeletal muscles during surgery/procedures, and to reduce muscle contractions in electrically-induced convulsions). Stability and storage information from Turkoski, Lance, and Bonfiglio, "Drug Information Handbook for Nursing, including Assessment, Administration, Monitoring Guidelines, and Patient Education", 8th ed., 2007, Lexi-Comp Inc., Ohio, Pages 1149-1151, stated, ". . . Refrigerate at . . . (36 [degrees] F to 46 [degrees] F); however, remains stable for [less than or equal to] 3 months unrefrigerated . . ."
*18 vials of Rocuronium Bromide (a medication used as anesthesia to relax skeletal muscles during surgery/procedure). Stability and storage information from Turkoski, Lance, and Bonfiglio, "Drug Information Handbook for Nursing, including Assessment, Administration, Monitoring Guidelines, and Patient Education", 8th ed., 2007, Lexi-Comp Inc., Ohio, Pages 1098-1099, stated, ". . . Store under refrigeration (2 [degrees] to 8 [degrees] C [Celsius]), do not freeze . . ."
*13 vials of Midazolam and 1 partially used vial of Midazolam (a medication used for perioperative sedation or conscious sedation prior to procedures/intravenous anesthesia). The partially used vial of Midazolam contained a label which identified 07/10/10 as the date facility staff opened the medication. Stability and storage information from Turkoski, Lance, and Bonfiglio, "Drug Information Handbook for Nursing, including Assessment, Administration, Monitoring Guidelines, and Patient Education", 8th ed., 2007, Lexi-Comp Inc., Ohio, Pages 819-822, stated, ". . . Stable for 24 hours at room temperature/refrigeration . . ."
*2 partially used vials of Labetalol (a medication used to treat high blood pressure). One vial contained a label which identified 07/01/10 as the date facility staff opened the medication, and the other vial contained a label which identified 07/10/10 as the date facility staff opened the medication. Stability and storage information from Turkoski, Lance, and Bonfiglio, "Drug Information Handbook for Nursing, including Assessment, Administration, Monitoring Guidelines, and Patient Education", 8th ed., 2007, Lexi-Comp Inc., Ohio, Pages 700-702, stated, ". . . Labetalol should be stored at room temperature or under refrigeration and should be protected from light and freezing. . . ."

During interview on 07/28/10 at 4:50 p.m., when asked if facility staff record and monitor the temperature of the refrigerator, an administrative staff member (#1) stated it's the nursing staff's responsibility to check the temperature on a daily basis and record it on the form located on top of the refrigerator.

Observation of the top of the refrigerator showed a form labeled "Refrigerator Temperature Log" for the month of July. Review of the form/log identified only two temperature recordings for the entire month (42 degrees F on 07/26/10 and 42 degrees F on 07/27/10).

During interview on 07/28/10 at 4:55 p.m., an administrative staff member (#1) stated staff use the ECT department on Monday, Wednesday, and Fridays for scheduled ECT procedures. The staff member (#1) stated the nursing staff scheduled to work in the ECT department must check and record the refrigerator temperature only on the days staff use the department. The administrative staff member (#1) confirmed the nursing staff neglected to record temperature readings on the log for July.

On the morning of 07/29/10, when survey staff asked to review the ECT refrigerator temperature logs for the past six months, the facility provided no further information. During interview on 07/29/10 at 9:00 a.m., an administrative staff member (#1) stated the facility started monitoring the ECT refrigerator temperature in July, 2010.

Review of facility medication error reports from January 2009 to June 2010, occurred July 26-29, 2010. An error report dated, 05/11/09, indicated the certified registered nurse anesthetist (CRNA) administered Brevital to a patient for an ECT treatment. The report identified after administration of the above medication, the CRNA noticed the expected result associated with the medication did not occur. The documentation indicated the CRNA then administered another dose of Brevital from a different vial with a different lot number and achieved the appropriate result. Review of the report showed the facility provided the pharmacy with the vial and lot number of the Brevital for investigation.

The failure to properly store medications according to professional recommendations, and ensure the stability of medications, has the potential to cause the patient harm in the event the medication loses it's effectiveness.

Based on observation, review of hospital construction standards, and staff interview, the facility failed to ensure a call system is available and accessible to patients and staff for 1 of 1 procedure room, and 1 of 1 pre-operative/recovery room in the Outpatient Electroconvulsive Therapy (ECT) Department. The lack of a call light system poses a safety hazard to patients and staff, if during the course of care/treatment, patients or staff are unable to summon assistance for an emergency.

Findings include:

The 1992-93 "Guidelines for Construction and Equipment of Hospital and Medical Facilities", section 7. General Hospital, part 7.32 Electrical Standards, 7.32.G Nurses Calling System, stated, "In patient areas, each patient room shall be served by at least one calling station for two-way voice communication. Each bed shall be provided with a call device. . . . Calls shall activate a visible signal in the corridor at the patient's door . . . and at the nursing station of the nursing unit. . . . In rooms containing two or more calling stations, indicating lights shall be provided at each station. Nurses calling systems at each calling station shall be equipped with an indicating light which remains lighted as long as the voice circuit is operating. . . . Provisions for emergency calls will also be needed in outpatient and treatment areas where patients may be subject to incapacitation. . . . A staff emergency assistance system for staff to summon additional assistance shall be provided in each operating . . . recovery . . . special procedure rooms . . . out-patient surgery, admission and discharge areas, and areas for mental patients . . . anterooms and toilet rooms serving them, communal toilet . . . therapy, exam, and treatment rooms. This system shall annunciate at the nurse station with back-up to another staffed area from which assistance can be summoned. . . ."

A tour of the Outpatient ECT Department took place on 07/28/10 at 4:40 p.m. with an administrative staff member (#1). Observation showed the lack of a call light system, including call devices, and an emergency assistance system in the pre-procedure/recovery room, and the lack of an emergency assistance system in the procedure room.

During an interview on 07/28/10 at 5:05 p.m., an administrative staff member (#1) confirmed the lack of a call light and emergency assistance system in the pre-procedure/recovery and procedure room, and stated nursing staff used the telephone when they required any assistance.

Based on observation, interview and record review, the hospital failed to meet the applicable provisions of the Life Safety Code. Refer to the CMS-2567 K tags for Life Safety Code.

Based on record review, review of a professional reference, policy and procedure review, review of the facility's Infection Control Program, reports, logs, and committee meeting minutes review, and staff interview, the facility failed to implement a system to identify, report, investigate, and control infections and communicable diseases for all patients and personnel of the facility for 7 of 7 months reviewed (January 2010-July 2010). Failure to implement an active ongoing infection control program and to establish a method to address infection control issues/problems and take corrective action has the potential for infections to go unreported, to spread or reoccur, thus affecting the health of all patients, personnel, and visitors of the facility.

Findings include:

The Centers for Medicare and Medicaid Services (CMS) has outlined the standards of practice for establishing and maintaining an active tracking program to identify, investigate, report, control, and prevent patient and employee infections and communicable diseases. The system should include all incidents of infections including both healthcare-associated infections and community-acquired infections. The facility should identify measures for the assessment of infections in patients and staff along with measures to prevent infection. The infection control officer(s) is responsible for developing this system. Part of this responsibility includes important activities such as mitigating risks associated with patient infections upon admission, mitigating risks contributing to healthcare-associated infections, conducting active surveillance, monitoring compliance with the infection control program, and evaluating the effectiveness of the program. Facilities need to provide a safe, sanitary environment for patients and staff. The success of this will depend on the development, implementation, and evaluation of a hospital-wide infection prevention and control program that includes collaboration with administrative, clinical, and non-patient care staff and their departments.

Review of facility policy titled "Infection Control Program" occurred 07/29/10. This policy, revised 10/30/09, stated, "The mission of the Infection Control (IC) Program is to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases and to develop, implement and maintain a program for the identifying, reporting, investigation and control of infections and communicable diseases. The infection control program is an active surveillance program that includes specific measures for early detection, reporting, investigation and controlling of infections and communicable diseases. . . . Assessment includes information gathered from . . . infection tracking . . . follow through and resolution of infection tracking . . . data retention for IC Team review . . . The DON [director of nursing] is responsible to carry out the daily functions of the infection control program. . . . The DON is also responsible for routine reporting of infection control data to the IC Committee. The Infection Control Team . . . meets monthly and is the working group for analysis of data gathered. Data consists of patient and employee infections/communicable disease . . . Information is forwarded to the IC Committee. . . . The Infection Control Committee provides oversight for the infection control program . . . The IC Team works in collaboration and with direction of the IC Committee and QRM [quality and risk management] Committee to investigate and control trends reported. . . ."

Review of facility policy titled "Infection Control Team" occurred on 07/29/10. This policy, undated, stated, ". . . The Infection Control Team is responsible for: 1. The investigation, control and prevention of infection. 2. The review and approval of infection control policies and procedures. . . . It is the responsibility of the Infection Control Team to complete monthly and quarterly reports for the Director of Nursing who reports to the Pharmacy, Therapeutics, and Infection Control Committee. . . ."

Review of facility policy titled "Infection Control Guidelines of the Infection Control Officer/Committee" occurred on 07/29/10. This policy, undated, stated, ". . . The staff members who work with infection control perform seven major functions at the [name of facility]. These include: 1. Surveillance - active detection, reporting and analyzing the occurrence of nosocomial infections in patients and staff. The data is collected and evaluated in order to identify sources, patterns, and trends as well as making recommendations to prevent recurrences. . . . 2. Infection investigation/research - all infections will be reviewed and analyzed by the infection control team. Clusters of infections are investigated in order to identify potential problems. . . . Research will be conducted as directed by the Infection Control Committee/Quality and Risk Management Committee to determine efficacy of treatment when patterns and trends of infection are noted. . . . 4. Education . . ."

Review of facility policy titled "Infection Control Surveillance" occurred on 07/29/10. This policy, revised 06/12/08, stated, "This policy established measures put into place for assessing and identifying employees, patients, and visitors at risk for infections and communicable diseases. . . . I. The infection control team member conducts daily surveillance of HAI's [health care associated infections] and monitor for identification, treatment, resolution and prevention of communicable disease/infection. . . . IV. Sources used for determining patients at risk for infections and communicable disease: A. infection control surveillance rounds checklist. B. review of culture reports and other pertinent lab data. C. nurse assessment. D. chart review . . . G. physician consultation. H. communicable disease/infection report tool. . . . It is the responsibility of the infection control team member to conduct surveillance of infections among patients and employees. . . . The infection control team member investigates all infections and/or communicable diseases identified on the communicable disease/infection report tool. . . . Following the investigation the infection control team member will record the findings on the communicable disease and infections log . . . All communicable disease ad [sic] infections are discussed and analyzed by the IC team . . . Data from the log will be given to the Quality Manager and prepared for the QRM committee for tracking trends and corrective action as necessary. . . ."

- Patient #7's active inpatient record, reviewed on July 27-29, 2010, identified the facility admitted the patient on 07/15/10. Review of the skin section on the "Nursing Admission Assessment" form indicated open areas and drainage on Patient #7's lower legs. A "Nursing Progress Note", dated 07/16/10 at 12:38 p.m., stated, "Pt. [patient] was observed to have red, elevated patches on her lower legs. The patches are discharging a clear fluid in some areas. Pt. says that they are itchy et [and] that she acquired the 'poison ivy' as she called it when she ran into the bushes . . . Dr. [doctor] notified. Writer applied bandages to the areas where the discharge was et encouraged pt. not to scratch or touch the areas et to use good handwashing."

Documentation on Patient #7's "Medical Consultation" exam, dated 07/16/10, revealed a rash to lower extremities, which contained red, elevated patches and clear, straw-colored fluid. The examining physician identified the rash as allergic contact dermatitis. The exam also revealed Patient #7 reported a sore throat. A "Psychiatric Progress Note", dated 07/20/10, stated, ". . . Subjective Data: . . . Staff report that she has not been feeling well . . . Mental Status: . . . She reports that she is just not feeling as well as she would like to. A couple of the kids in the unit have had this, it is quite possible that it is that. This writer does not believe that is the side effect related to her current medications at the present time. . . ."

Review of Patient #7's "Physician Orders", dated 07/16/10 at 2:48 p.m., stated, "May use Aveeno calamine cream from home topical to legs [bilateral] prn [as needed] itching - Contact Dermatitis. Apply bandaide [sic] to any blisters that burst. Cepacol lozenges po [by mouth] q [every] 2 [hours] prn sore throat." The record showed nursing staff initiated a nursing care plan on 07/16/10 listing the problems: altered skin integrity related to contact dermatitis and altered comfort related to sore throat. Review of the care plan revealed no further documentation regarding the above problems.

Record review lacked documentation of follow-up regarding the signs and symptoms Patient #7 experienced and lacked documentation staff reported the signs and symptoms to the infection control nurse/officer for further investigation, monitoring, and recommendations.

- Patient #9's active inpatient record, reviewed on July 27-29, 2010, identified the facility admitted the patient on 07/15/10. Review of the "Nursing Admission Assessment" form indicated Patient #9 reported a cough for the last few days. Documentation on Patient #9's "Medical Consultation" exam, dated 07/16/10, revealed a productive cough with purulent sputum, mild shortness of breath, sore throat, nasal congestion, mild runny nose, and swollen neck lymph nodes. The examining physician identified the symptoms as an upper respiratory infection, likely viral, and to rule out strep. Review of Patient #7's "Physician Orders", dated 07/16/10 at 2:02 p.m., stated, "Halls cough drops q 2 [hours] prn cough. Chloroseptic [sic] spray . . . q 4 [hours] prn sore throat. Rapid Strep, may be tomorrow."

Review of a "Psychiatric Progress Note", dated 07/20/10, stated, ". . . Subjective Data: . . . Today, he complained about having a cough and how he felt the cough was not allowing him to sleep. Reassured him we would have him see the family medicine people perhaps for a cough medicine . . . Plan: . . . We will refer the patient to the family medicine group to ascertain possible need for cough syrup to address nocturnal cough . . ." A physician order, dated 07/20/10 at 9:00 a.m., stated, "Cough syrup 30 cc [cubic centimeter] po q 4-6 [hours] prn for cough . . ." Review of a "Nursing Progress Note", dated 07/26/10 at 10:10 a.m., stated, "Pt. stated that his [right] ear feels tender in some places. He described it as feeling 'full' et that it 'hurts when I swallow.' . . . FP [family practitioner] notified." Another nursing progress note, dated 07/26/10 at 8:00 p.m., stated, "Pt continues to have a barking cough et is c/o [complaining of] [right] ear pain. Pt takes Robitussin 30 cc prn for cough et uses chloraseptic spray et states some relief from medication. . . . FP notified. Encouraged pt to drink fluids et to utilize medications et use good handwashing to [decrease] germs. . . ."

Record review lacked evidence of the strep culture result and whether staff collected and submitted a strep culture to the laboratory. The record identified Patient #9 continued to participate in group therapy with other patients until 07/23/10. The record showed nursing staff initiated a nursing care plan on 07/16/10 listing the problem: altered comfort related to sore throat. Review of the care plan revealed no further documentation regarding the problem. Record review lacked documentation of follow-up regarding the signs and symptoms Patient #9 experienced and lacked documentation staff reported the signs and symptoms to the infection control nurse/officer for further investigation, monitoring, and recommendations.

Upon request on July 28-29, 2010, the facility staff provided no additional information regarding Patient #9's physician order for a strep test or lab results.

During interview on 07/28/10 at 8:50 a.m., a nursing staff member (#3) stated staff did not report Patient #7 and Patient #9's signs and symptoms of possible infection and stated staff report patient infections/or possible infections if a provider orders an antibiotic. The staff member (#3) stated nursing staff complete an infection report form if a provider places a patient on an antibiotic. Staff then give the form to the infection control nurse.

-Patient #18's closed medical record, reviewed on 07/28/10, identified the facility admitted the patient on 04/07/10 and discharged the patient to partial hospitalization on 04/22/10. Patient #18's medical diagnoses included post traumatic stress disorder, major depression, and factitious disorder. Patient #18's medical record included a culture and sensitivity report from a left wrist wound, dated 04/21/10, stating moderate growth of "Enterococcus species."

Review of Patient #18's Discharge Summary from the above hospital stay identified Patient #18 "probably self-inflicted" fecal matter into the open wound thus subjecting herself to an infection.

Review of Patient #18's Nursing Progress Notes identified nursing staff completed daily skin assessments from April 07-22, 2010 and documented the patient's skin integrity as:
*April 07 - " . . . patient has MRSA [methicillin resistant staphylococcal aureus] by hx [history]. Reviewed admission hx that patient has no open areas . . . She has been free from MRSA since Sept [September] 2009
*April 10 - ". . . no new open areas were noted . . . ."
*April 11 - "Pt skin assessed, no open areas noted . . . .
*April 13 - "Pt [patient] skin observed- [no] areas of breakdown noticed. Does have small area above brace on rt [right] hand that is red. Will monitor."
*April 15 - "Skin assessed . . . [No] open areas noted . . . ."
*April 16 - "Skin assessed . . . [No] open areas observed . . . ."
*April 17 - "No new areas of skin breakdown noted - [no] open or red areas- does have wound on lt [left] wrist . . . was cultured earlier in the day."
*April 21 - "Skin was assessed . . . Pt has open area on [left] wrist that continues to have sangious [sic] drainage - scant amount . . . ."
*April 22 - "Skin was assessed . . . Pt has an open area on [left] wrist that is reddened [and] bruised. Pt denied causing bruising (purple/blue) on wrist. Staff mentioned to pt that skin wasn't bruised yesterday evening during skin assessment . . . The [left] wrist had scant yellow drainage . . . ."

Review of the facility's infection control log from April 2010 lacked evidence nursing staff informed the infection control nurse of Patient #18's draining left wrist wound.

During interview on 07/29/10 at 10:00 a.m., an administrative nurse (#1) confirmed the facility's infection control program and log failed to identify Patient #18's wound infection.

The January - June 2010 facility infection control reports and log, reviewed on July 26-28, 2010, lacked evidence the facility identified and recognized infections of inpatients, outpatients, and personnel of the facility. The reports and log revealed the facility lacked the inclusion of personnel and only tracked infections when providers placed patients on an antibiotic. Review of the infection report forms identified incomplete documentation in the follow up section, including the lack of review by Infection Control Team and Committee, Quality Risk Management, and recommendations.

The reports lacked evidence of causative factors, investigation, tracking and trending for patterns, and corrective action taken to address the problems of infections and prevent future problems. The reports did not indicate facility staff implemented the facility infection control plan and surveillance policy. Review of the forms identified the facility failed to implement a system to identify, analyze, prevent, and decrease the spread of infections to provide a safe environment for patients.

The January, March, May, and June, 2010 infection control meeting minutes, reviewed on July 26-28, 2010, lacked evidence the members discussed or addressed the incidents of infection within the facility.

During interview on 07/28/10 at 10:00 a.m., an administrative nurse (#1) stated she obtained information from the infection control reports to track and identify infections of inpatients. The administrative nurse (#1) confirmed the infection control nurse only tracked or followed patients identified as receiving an antibiotic.

During interview on 07/28/10 at 10:00 a.m., two administrative nurses (#1 and #2) verified the facility had no infection control log for personnel or patients other than the log of identified patients with antibiotics. The nurses (#1 and #2) could not provide information or evidence of documented surveillance of infection for Patient's #7 and #9. The administrative nurse (#1) verified the facility had no documentation regarding infection control on these patients.

The administrative nurses (#1 and #2) could not provide additional information or evidence of documented causes/effects/factors, further investigation, tracking and trending, corrective action, or education for the incidents of infections among patients in the facility. When asked if the facility established a benchmark for infections, the administrative nurses (#1 and #2) confirmed the facility had not. The nurses (#1 and #2) revealed the facility lacked an active and effective infection control system or process at this time, confirmed the lack of discussion of infections at the infection control committee meetings, and stated an awareness of the problem.


21202

Based on review of facility infection control reports and log, policy and procedure review, and staff interview, the facility failed to maintain a complete log of all incidents of infections among patients and personnel for the past seven months (January 2010-July 2010). Failure to ensure the development and maintenance of a complete infection control log, which included all patients and personnel of the facility, has the potential for infections to go unreported, limiting the facility's ability to control and prevent infections.

Findings include:

Review of facility policy titled "Reporting Employee Infections" occurred 07/29/10. This policy, undated, stated, "This policy establishes a plan to ensure identification and follow-up of potentially contagious infections among employees. . . . Responsibilities: A. HR [human resources] tracks sick calls. B. Infection Control Officer/Nursing Management: Responsible to determine if necessary that an illness is contagious and if an employee should not be caring for patients. C. Supervisor: . . . The supervisor will also report the infection to the Infection Control Officer for tracking purposes. Procedure: . . . 4. Upon receiving information from the employee the supervisor should inform the Infection Control Officer of the employees' illness so it can be tracked within the facility to see if there are trends of other employees or patients getting sick."

Review of facility policy titled "Infection Control Surveillance" occurred on 07/29/10. This policy, revised 06/12/08, stated, "This policy established measures put into place for assessing and identifying employees, patients, and visitors at risk for infections and communicable diseases. . . . IV. Sources used for determining patients at risk for infections and communicable disease: A. infection control surveillance rounds checklist. . . . C. nurse assessment. D. chart review . . . E. self report by employees. . . . G. physician consultation. H. communicable disease/infection report tool. . . . It is the responsibility of the infection control team member to conduct surveillance of infections among patients and employees. . . ."

The facility infection control log (January-June, 2010), reviewed on July 26-28, 2010, lacked evidence the facility identified and recognized infections of all patients (inpatients and outpatients) and personnel of the facility. The log revealed the facility lacked the inclusion of personnel and only tracked infections when patients were placed on an antibiotic.

During interview on 07/28/10 at 10:00 a.m., two administrative nurses (#1 and #2), verified the facility had no infection control log for personnel or patients other than the log of identified patients with antibiotics. The nurses (#1 and #2) confirmed the facility has no infection control log for employees or outpatients. An administrative nurse (#1) stated the facility has a surveillance form to track employee infections, but identified facility staff do not utilize it and reported noncompliance with the process.

Based on review of a professional reference, policy and procedure review, record review, and staff interview, the facility failed to ensure the integration and organization of outpatient services with inpatient services for 1 of 1 active inpatient record reviewed (Patient #3) who currently receives outpatient electroconvulsive therapy (ECT) treatments; failed to ensure licensed health care provider orders for services and treatments provided during outpatient ECT procedures for 3 of 3 active outpatient records reviewed (Patients #6, #21, and #22); and failed to provide and explain discharge instructions following ECT treatments for 3 of 3 active outpatient records reviewed currently receiving outpatient ECT treatments at the facility (Patients #6, #21, and #22).

Failure to integrate outpatient services limits the facility's ability to ensure the continuation of care between different levels of care (an outpatient discharged to inpatient status and/or an outpatient discharged home or to a skilled nursing facility). Failure to provide and explain written discharge instructions to patients has the potential to place the patient at risk of improper care due to the lack of instruction. Failure to ensure the facility discharges patients to a responsible adult hs the potential to put the patient at risk if problems arise.

Findings include:

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process, and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, page 957-958, stated, ". . . The nurse consults the surgeon's postoperative orders to learn the following: food and fluids permitted by mouth, intravenous solutions and intravenous medications, position in bed, medications ordered, laboratory tests, intake and output . . . activity permitted, including ambulation. . . . The nurse also checks the PACU (post anesthesia care unit) record for the following data: Operation performed . . . anesthetic used . . . medications administered in the recovery room . . . Document the client's time of arrival and all assessments. . . ."

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process, and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, pages 127 and 257, stated, ". . . Essential information before discharge includes information about medications, dietary, and activity restrictions, signs of complications that need to be reported to the primary care provider, follow-up appointments and telephone numbers, and where supplies can be obtained. . . . Information needs to be provided verbally and in writing. . . . If the discharge plan is given directly to the client and family, it is imperative that instructions be written in terms that can be readily understood. For example, medications, treatments, and activities should be written in layman's terms, and use of medical abbreviations (such as tid) should be avoided. . . ."

Review of facility policy titled "Electro Convulsive Therapy" occurred 07/29/10. This policy, undated, stated, ". . . ECT may not be prescribed unless the following conditions are met: a. The treatment team has documented in the patient's record that other alternative, less intensive treatment modalities have been discussed and ECT may represent the most effective therapy for the patient. b. The treatment is recommended by the physician and/or psychiatrist. c. The patient has been given a full explanation of the nature and duration of the proposed treatment and why the treatment team is recommending the treatment. . . ."

Review of facility policy titled "Electroconvulsive Therapy: Prior to test" occurred 07/29/10. This policy, revised 12/08/09, stated, ". . . Evening or morning prior to treatment: The nurse will examine the patient's chart to ensure if the necessary orders have been carried out. . . . 1. Physician order for the procedure. . . . Documentation: . . . 4. Time patient left the psychiatric unit (if inpatient) for ECT. 5. Any teaching done."

Review of the facility form titled "ECT Discharge Instructions" occurred on the morning of 07/29/10. This form stated, "ACTIVITY: . . . may feel fatigued the day of your treatment . . . Also, due to the effects of anesthesia as well as ECT we advise against driving or operating equipment the day of the ECT. DISCOMFORT: There is usually minimal physical discomfort after ECT treatment. Some people do experience minor headache, neck or jaw pain. Over the counter relievers such as Tylenol or Motrin are often effective in treating these . . . Please let the doctor doing the treatments know if you are having any discomforts after your treatments. MEMORY LOSS/CONFUSION: ECT can have an effect on attention which some individuals experience as short-term memory loss or slight confusion. This confusion is temporary and will go away. It may take a few hours to feel oriented again. In most patients the memory disturbance goes away within a few days or weeks. Talk with your doctor if you have any further concerns. If confusion is significant, call the psychiatrist immediately. NAUSEA: There may be some nausea after the anesthesia that is used with ECT . . . DIET: There are no restrictions on diet. Next ECT treatment is scheduled for: . . . Due to the effects of anesthesia, you are advised to refrain from important decision making and alcohol intake for 24 hours following your treatment. No driving the remaining part of the day following treatment . . . ."

Review of Patient #3, #6, #21 and #22's active records occurred on July 26-29, 2010.

- Review of Patient #3's inpatient medical record identified the facility admitted the patient on 07/15/10 with a diagnosis of major depressive disorder. Patient #3's inpatient record included a physician's order, dated 07/10/10 for ECT treatments and the patient's outpatient record identified she received ECT treatments on July 23, 26, and 28, 2010. Review of Patient #3's inpatient record lacked evidence/documentation regarding the transfer of Patient #3's care following completion of the outpatient ECT treatments provided and lacked an assessment by nursing staff regarding the patient's toleration of the three outpatient ECT treatments completed on July 23, 26, and 28.

- Review of Patient #6's active outpatient record identified a diagnosis of recurrent severe depression. Patient #6 resides at a skilled nursing facility (SNF) and returns to the facility three times a month for outpatient ECT treatments. Record review identified Patient #6 received 24 ECT treatments at the facility from 11/27/09 through 07/19/10. Review of the record lacked a physician's order for the ECT treatment/procedure at the start of the ECT series. The record lacked documentation of the time the patient left the facility after the ECT treatment, if staff provided discharge instructions and explained instructions to the patient or the staff at the SNF, and if the facility discharge the patient to a responsible adult.

- Review of Patient #21's active outpatient record identified the facility admitted the patient on 07/26/10 for the first ECT treatment. The record lacked a physician's order for the ECT treatment/procedure at the start of the ECT series. The record lacked documentation of the time the patient left the facility after the ECT treatment, if staff provided and explained discharge instructions to the patient, and if the facility discharged the patient to a responsible adult.

- Review of Patient #22's active outpatient record identified the facility admitted the patient on 06/09/10 for the first ECT treatment. The record lacked a physician's order for the ECT treatment/procedure at the start of the ECT series. The record lacked documentation of the time the patient left the facility after the ECT treatment, if staff provided and explained discharge instructions to the patient, and if the facility discharged the patient to a responsible adult.

During an interview on 07/28/10 at 4:40 p.m., an administrative nurse (#1) stated the physician from the clinic calls her when there is a patient needing an ECT, she goes to clinic, reviews the chart to see if patient is "appropriate" for ECT, and lets the referring physician know. An administrative nurse (#1) stated she documents her review as described above in the patient's clinic record, and she considers the clinic record the physician's order for the ECT treatment(s). An administrative nurse (#1) confirmed Patient #6, #21, and #22 outpatient records lacked a physician's order for the initial ECT treatment/procedure. An administrative nurse (#1) confirmed Patient #3's inpatient record lacked evidence of outpatient nursing staff providing a verbal or written transfer of care following the ECT treatments. An administrative nurse (#1) confirmed the records for Patient #6, #21, and #22 lacked written discharge instructions.


21202

Based on review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", review of facility incident reports, and staff interview, the facility failed to provide an ongoing quality assessment program reflecting measurable improvement through the use of indicators established to improve patient health outcomes for 10 of 10 months reviewed (September 2009 through June 2010). Failure to implement an ongoing quality assessment program placed patients at risk for reoccurring negative outcomes/consequences associated with the care/services provided.

Findings include: Refer to A265 and A267.

Based on review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", and staff interview, the facility failed to provide an ongoing quality assessment program reflecting measurable improvement through the use of indicators established to improve patient health outcomes for 10 of 10 months reviewed (September 2009 through June 2010). Failure to provide an ongoing quality assessment program placed all patients at risk for adverse/negative outcomes/consequences as a result of unidentified and/or uncorrected problems affecting patient quality care and safety.

Findings include:

Review of the Facility's "Performance Improvement Policy" (dated 05/12/2008) occurred July 28-29, 2010, and stated: "[name of facility] is committed to providing the highest level of quality patient services in an optimally safe environment for patients, visitors, and employees. This goal is supported through an organization-wide, data driven, quality assessment and improvement program that reflects all service aspects including contract services . . . Consistent with the established organizational mission and vision, the quality program adheres to the following principles: Reflects the complexity of patient services offered, and establishes priorities for improvement; Measures performance through data collection; . . . Encourages an organizational culture of patient safety, and organizational learning through feedback of quality issues and improvements achieved . . .
Data sources include . . . incident reports, adverse events and complications, patient complaints, . . . internal risk assessments, drug utilization, evaluation reports, . . . criteria-based audit reports, . . . infection control, . . . Information from data analysis is used to make changes that improve performance, patient safety and reduce risk the risk of sentinel events. . . .
The Quality and Risk Management Committee (QRM) is responsible for the on-going direction, coordination, and evaluation of the quality, risk management and patient safety programs. The committee: Assures implementation, monitoring, and evaluation of the goals, indicators, and timeliness set forth in the quality management program; Oversees incident and patient complaint reporting as well as corrective action implemented; reviews high alert incidents; Receives and acts on recommendations from the Quality Improvement Team and other committees . . . Sets priorities for improvement . . . Meets monthly and consists of the Board of Directors, Medical Staff, and Administration. Initiates an annual review of the performance improvement program. . . "

Review of the minutes of QRM committee meetings from August 2009 through June 2010 occurred July 28-29, 2010, and showed the QRM committed did not meet monthly per the above reference plan. No meetings occurred during the months of February 2010 and April 2010. In addition, meeting minutes showed the following:
* Departments/services did not report as scheduled, with no action taken by the QRM committee to ensure data collection and analysis of the data occurred, and areas requiring improvement did not go unidentified.
* Minutes of the September 16, 2009 meeting stated, "Infection Control: Deferred to next month. Medication Management/Pharmacy Services: Deferred to next month. Quality & Risk Management Annual Review: Deferred to next month.
* Minutes of the October 21, 2009 meeting showed Medication Management/Pharmacy Services did not report and again "tabled until next meeting." Minutes also stated "Medication Safety audits weren't completed for this reporting period. Medical Staff Peer Review: This was tabled until next meeting. Quality/Risk Management Plan: This was tabled until next meeting. UR [utilization review]/Admissions and Discharges: This was tabled until next meeting."
* Minutes of the November 18, 2009 meeting showed, "Medication Management/Pharmacy Services: Tabled . . ., Quality and Risk Management Plan: Tabled until next meeting . . . UR/Admission & Discharges: Tabled to next meeting. . . QRM Annual Review: Tabled to next meeting. . . Housekeeping: Tabled to next meeting . . . " In addition, the committee "tabled until next meeting" two contract services due for review, and the committee did not address medical staff peer review "tabled until next meeting" at the time of the 10/21/09 meeting.
* Minutes of the December 16, 2009 meeting showed: "Medication Management/Pharmacy Services: Tabled [each month since September 2009]. . . . UR/Admission & Discharges: [no report/review of quality indicators only a report of the hiring of a full time staff person]. Clinical Therapies: . . reported that insufficient data is available in the reporting period due to a high rate of absenteeism among clinical staff. ECT [electro-convulsive therapy]/Anesthesia: . . . Audits will be updated and current data will be provided at the next meeting. Medical Records Review; This item will be tabled to the the next month . . .
* Minutes of the January 20, 2010 meeting showed Clinical Therapies did not report or submit data not provided at the December 16, 2009 meeting. No data provided by ECT/Anesthesia per 12/16/09 meeting. No Medical Record Review report/data per the committee tabling the item at the 12/16/09 meeting. In addition, No report/data submitted regarding infection control indicators. "Medical Staff Peer Review: . . . will be done next month due to change in staff . . . Medication Management and Pharmacy Services; [no report regarding data submission and quality indicators] we continue to work at identifying a pharmacist member of the Pharmacy Committee. . . " Quality and Risk Management and UR/Admissions did not provide reports relevant to data collection/monitoring/analysis consistent with patient related quality indicators.
* Minutes of the March 31, 2010 meeting showed departments/services scheduled to report for the missed February 2010 meeting did not report at the March meeting. Minutes included, "Medical Staff and Peer Review: Tabled to next meeting. Quality & Risk Management: Tabled to next meeting. Clinical Therapies: Tabled until next reporting period [scheduled to report again in June 2010 - did not report when scheduled in December 2009 and has not reported since]. Medical Record Review: Tabled pending coordination with medical records staff . . . [Did not report as scheduled in December 2009 and had not reported since]."
* Minutes of the May 26, 2010 meeting showed, "Housekeeping: This item tabled to next month. Medical Staff Peer Review: This item tabled to next month. Medication Management and Pharmacy Services: This item tabled to next month."
* Minutes of the June 23, 2010 meeting showed, "Medical Records Review: Tabled to next meeting. Clinical Therapies: . . . reported on results of clinical therapies on 12 charts reviewed in June. . . Action: Continue to monitor. . . . " Review of the information submitted by Clinical Therapies showed the following indicators falling below 90%compliance:
- Nursing assessment completed date of admission - 67% compliance.
- OT (occupational therapy) assessment completed within 3 days - 75% compliance (No OT assessment on 3 charts).
- TR (Therapeutic Recreation) assessment completed within 3 days - 83% compliance.
- Psychosocial completed within 3 days - 59% compliance (1 chart no assessment, 3 charts assessment late).
- Psychiatric evaluation completed within 1 day of admission - 58% compliance (2 missing, 3 not signed).
- Weekly weights are documented on the flow sheet - 50% compliance.
- Behaviors are documented on Behavior Log - 34% compliance.
Review of the facility's "Quality/Risk Management/Safety Committee 2010 Reporting Schedule for Indicators & Process Improvement" occurred July 28-29, 2010, and showed required quarterly scheduled reporting to the committee by all departments/services. The above referenced information showed the lack of departments/services providing quarterly reporting to the committee.
The above referenced data lacked evidence of further analysis of the effects the lack of timely assessments, evaluations, and weight monitoring, had on patient outcome(s) and quality care/services.

Review of the facility's "Quality Performance Measurement Plan" occurred July 28-29, 2010, and lacked established thresholds for indicators being measured/monitored by all departments/services.

During interviews on the morning of 07/29/10 with an administrative staff member (#9) and a quality/risk management staff member (#8) both staff members concurred the existing Quality Performance Program lacked scheduled reporting by all department/services, committee action and follow-up on areas requiring improvement, and establishment of indicators and thresholds/parameters to ensure an acceptable standard of measurement and assurance of quality care and patient safety.

Based on review of the facility's "Performance Improvement Policy", "Patient and Visitor Incident Reporting" policy, review of "Quality and Risk Management Committee" (QRMC) meeting minutes, review of the facility's "Quality Performance Measurement Plan", incident reports, and staff interview, the facility failed to assess the processes of care and services provided through the measurement, tracking of quality indicators and adverse patient events for 10 of 10 months reviewed (September 2009 through June 2010). Failure to provide an ongoing performance improvement program placed all patients at risk for adverse/negative outcomes/consequences as a result of unidentified and/or uncorrected problems affecting patient quality care and safety.

Findings include:

Review of the facility's "Performance Improvement Policy" occurred on July 28-29, 2010, and identified Incident Reports as a source of data collection for use in analysis of the quality of care and safety provided patients. Review of the facility's "Patient and Visitor Incident Reporting" (dated 05/12/2008) policy and procedure occurred July 27-29, 2010, and stated: ". . . Policy. It is the policy of [name of facility] to have a mechanism in place to report and follow-up on all patient and visitor incidents with the purpose of improving the quality of care delivered to patients and to enhance patient/visitor safety through performance improvement. . . . The Patient Incident Report should be completed for patient incidents, with all sections of the form completed legibly. . . . Each completed incident report is routed to the DON [director of nursing] for prompt follow up by the DON or designee. . . .1. The DON or designee completes an Incident Investigation Report . . . within 72 hours of the incident, documenting: a. Contributing causes by people and systems. b. Action plan to prevent reoccurrence of the event. 2. The DON or designee completes an audit of the incident report investigation report using an Incident/Investigation Audit Tool . . . to ensure that the incident report was completed promptly, . . . the investigation was completed promptly, and immediate and follow-up corrective action plans are satisfactory and implemented. . . . The DON reports a summary of incidents and RCA (root cause analysis) processes to the Quality and Risk Management Committee at regular scheduled meetings. Incidents and RCA summaries are reported to the Medical Executive Committee and the Board of Governors through the Quality and Risk Management Committee and included risk reduction recommendations to improve the quality of care. . . . All Directors shall receive and review summarized incident data/analysis from the Quality Committee. Directors shall review the incident analysis with their employees for Performance improvement activities."

Review of QRMC minutes for the months of September 2009 through June 2010 occurred on July 28-29, 2010. Meeting minutes for the ten months reviewed lacked evidence the DON or designee provided summary reports of incidents and root cause analysis processes to the QRM committee during the ten month period.

Review of facility incident reports for the months of January 2010 through June 2010 occurred July 26-29, 2010, and showed a lack of timely completion of incident reports, a lack of timely investigation of incidents, and a lack of timely/appropriate action to prevent reoccurrence of the sentinel events as follows:
* Incident occurred 01/01/10 - "Patient pulled on the window screen until it popped open which broke the screen. Then he opened the window and departed the building to the courtyard." The incident report showed a 01/16/10 "Date of Report" (sixteen days after the incident occurred). The incident report lacked any evidence of investigation of the elopement, including investigation of underlying systems which may have failed/contributed to the possibility for elopement. The "Action Plan to Prevent Reoccurrence" dated 01/18/10 stated: "Pt [patient] placed in low stim [stimulation] et [and] Dr. [doctor] ordered pt to wear no shoes et scrubs. Pt programming in low stim. Maintenance notified about window et window fixed." The action plan lacked assurance the facility would prevent/minimize future elopements of the same type/nature.
* Incident occurred 02/22/10 - "Pt was found in shower with shirt rapped [sic] and tied around neck. Pt was pulled up so shirt could be ripped off of pt neck. Pt was then pulled out of shower to floor and then was applied CPR [cardio-pulmonary resuscitation] with LPN [licensed practical nurse]." The incident report showed no investigation of the incident occurred. The DON signed and identified the following "Action Plan to Prevent Reoccurrence" on 03/15/10 (three weeks after the incident), "Pt's room moved back to low stim. Pt place [sic] on 1:1 safety checks. Neuro checks started et vital signs obtained. Staff informed to monitor pt very close for further related behaviors." The incident report lacked evidence of assessment/investigation of the patient's behavior/condition prior to, and factors contributing to the attempted suicide, including weakness/failure of underlying systems (staffing, communication, training, supervision, availability of critical information, environmental factors, leadership structure, etc.).
* Incident occurred 04/13/10 - " Outside during dinner smoke break. Pt burned self on left arm X 3 [three times] with a cigarette. Pt also scratched self on left arm leaving a reddened superficial scratch. Pt did not notify staff of this incident until 9 p.m." The incident report showed the DON investigated the incident on 07/06/10 (nearly three months later). The incident report showed no investigation of the cause/contributing factors, including investigation of the role underlying systems played in the patient's opportunity to inflict self harm which went unrecognized by staff until the patient informed staff several hours later.

In addition to the above referenced sentinel events, review of incident reports showed in excess of fifteen other occurrences without adequate and timely investigation including two sentinel events related to self-inflicted harm with objects obtained/brought into the facility. Each of the incident reports showed no investigation of how the patient obtained or had possession of the object(s) used to self-inflict harm, and no evidence of investigation of the role underlying systems played in the opportunity for the the patients to self-inflict injury. Incidents of this nature included:
* 05/04/10 - "pt cut left inner forearm with the end of a Carmex tube. Tube was found on pt during a search . . . " The incident report showed no investigation. The DON signed the report on 07/22/10 (over eleven weeks later) and entered the following, "Action Plan to Prevent Reoccurrence: Making sure patient doesn't obtain objects and use objects to harm self. Use very through searching when admitting."
* 06/07/10 - "Pt was asked to show staff bellybutton - d/t [due to] reports of she may have pierced et has safety pin in navel. Pt then took safety pin out and started to scratch at left inner forearm. Did pierce naval with safety pin." The incident report lacked investigation and showed the DON signed the incident report and entered the following on 07/13/10 (over five weeks later): "Action Plan to Prevent Reoccurrence: Make sure patients are thoroughly searched before entering the unit."

During an interview with an administrative staff member (#9) on the morning of 07/27/10, the staff member indicated she was aware of the delay and lack of investigation of incidents. The staff member provided a root cause analysis completed for an incident involving a patient not referenced in any of the above incidents.

Although the facility acknowledged awareness of the lack of adequate/thorough and timely investigation of incidents occurring in the facility, the minutes of the QRMC lacked evidence of such awareness, requests for submission of incident reporting data, or evidence the QMRC took action to improve the process. The lack of appropriate action placed patients at continuing risk for harm and /or potential harm.

Based on review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", review of facility incident reports, and staff interview, the facility failed to provide an ongoing program of data collection, and failed to analyze data collected to improve patient health and safety outcomes for 10 of 10 months reviewed (September 2009 through June 2010). Failure to provide an ongoing program of data collection and analysis placed all patients at risk for adverse/negative outcomes/consequences as a result of unidentified and/or uncorrected problems affecting patient quality care and safety.

Findings include:

Review of the facility's "Performance Improvement Policy," review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement," and review of facility incident reports occurred July 26-29, 2010. Review of the referenced information showed the facility lacked an effective and ongoing process of data collection, analysis of data, and identification of deficient practices or areas in need of improvement to ensure patient safety and the provision of quality care. Refer to A265 and A267.

Based on review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", review of facility incident reports, and staff interview, the facility failed to provide an ongoing program of data collection, and failed to analyze data collected to improve patient health and safety outcomes for 10 of 10 months reviewed (September 2009 through June 2010). Failure to provide an ongoing program of data collection and analysis placed all patients at risk for adverse/negative outcomes/consequences as a result of unidentified and/or uncorrected problems affecting patient quality care and safety.

Findings include:

Review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", and review of facility incident reports occurred July 26-29, 2010. Review of the referenced information showed the facility lacked an effective and ongoing process of data collection, analysis of data, and identification of deficient practices or areas in need of improvement to ensure patient safety and the provision of quality care. Refer to A265 and A267.

Based on review of the facility's policies and procedures, review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of facility incident reports, and staff interview, the facility failed to provide an effective program for tracking, and investigating adverse patient events, and failed to implement appropriate/adequate corrective action to prevent reoccurrence for 6 of 6 months of incident reporting reviewed (January 2010 through June 2010) and 10 of 10 months of Quality and Risk Management Committee minutes reviewed (September 2009 through June 2010). Failure to provide an ongoing program of tracking and investigating adverse patient events and failure to implement corrective action(s) placed all patients at risk for adverse/negative outcomes/consequences as a result of unidentified and/or uncorrected problems affecting patient quality care and safety.

Findings include:

Review of the facility's "Performance Improvement Policy," review of "Quality and Risk Management Committee (QRM)" meeting minutes, and review of facility incident reports, occurred July 26-29, 2010. Review of the referenced information showed the facility lacked an effective and ongoing process of tracking and investigating patient incidents and accidents. Refer to A267.

Based on review of the facility's "Performance Improvement Policy", review of "Quality and Risk Management (QMR) committee meeting minutes, review of the facility's "2010 Reporting Schedule for Indicators & Process Improvement", the "Quality Performance Measurement Plan", incident reports, and staff interview, the facility failed to maintain an effective and ongoing performance assessment and improvement process which allowed for the measurement and/or success of actions taken to improve performance for 10 of 10 months reviewed (September 2009 through June 2010). Failure to provide an ongoing program which allowed for measurement and/or success of actions taken to improve performance placed all patients at risk for reoccurrence of adverse/negative outcomes/consequences.

Findings include:

Review of the facility's "Performance Improvement Policy", review of the "2010 Reporting Schedule for Indicators & Process Improvement", review of "Quality and Risk Management Committee (QRM)" meeting minutes, and review of facility incident reports occurred July 26-29, 2010. Review of the referenced information showed the facility lacked an effective and ongoing process of data collection, data analysis, and implementation of appropriate/adequate action to improve performance.

The lack of data collection and submission to the QRM committee resulted in the committee's inability to recognize areas in need of improvement, formulate action plans, and implement monitoring systems to measure success and sustained improvement. Refer to A265 and A267.

Based on review of the facility's "Performance Improvement Policy," review of "Quality and Risk Management Committee (QRM)" meeting minutes, review of facility incident reports, review of governing board meeting minutes, and staff interview, the governing board failed to ensure the facility implemented an ongoing quality assessment and performance improvement program to improve patient safety and health outcomes for 10 of 10 months reviewed (September 2009 through June 2010). Failure of the governing board to provide necessary oversight of the facility's quality assessment/performance improvement program provides for potential failure of the governing board to recognize and act upon areas in need of additional resources and efforts by the board to ensure the safety and quality of care to patients.

Findings include:

Review of the Facility's "Performance Improvement Policy" (dated 05/12/2008) occurred July 28-29, 2010, and stated: ". . . The Quality and Risk Management Committee (QRM) is responsible for the on-going direction, coordination, and evaluation of the quality, risk management and patient safety programs. . . . Meets monthly and consists of the Board of Directors, Medical Staff, and Administration. Initiates an annual review of the performance improvement program. . . A schedule for reporting ongoing monitoring and performance activities to the Board of Governors is generated each year."

Review of the facility's "Patient and Visitor Incident Reporting" (dated 05/12/2008) policy and procedure occurred July 27-29, 2010, and stated: ". . . Incidents and RCA summaries are reported to the Medical Executive Committee and the Board of Governors through the Quality and Risk Management Committee and included risk reduction recommendations to improve the quality of care. . . ."

Review of minutes of the QRM committee occurred July 28-29, 2010, and lacked evidence of an established schedule for submitting reports to the governing board during the months of September 2009 through June 2010.

Review of Board of Governors meetings occurred on 07/27/10, and showed the board met on 07/02/10, 05/10/10, 04/19/10, 03/30/10, and 01/12/10. Minutes of the meetings lacked evidence the QRM committee submitted reports of the ongoing monitoring and performance activities to the governing board. Minutes also lacked evidence of submission of a report of an annual evaluation of the performance improvement program.

During an interview on the morning of 07/29/10 with an administrative staff member (#9) the staff member indicated the facility had not completed and submitted a report of an annual program evaluation.

Based on observation, review of a professional reference, policy and procedure review, record review, and staff interview, the facility failed to ensure nursing staff administered drugs and biologicals in accordance with physician orders and accepted standards of practice for 3 of 3 active outpatient (Patient #3, #21, and #22) records reviewed. Failure to obtain written physician's orders for pre-procedure care that included administration of drugs and biologicals, permitted nursing staff to perform duties outside their scope of practice.

Findings include:

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process, and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, pages 943, 950, & 1461, stated, ". . . The surgeon and/or anesthesiologist orders preoperative diagnostic tests. . . .The nurse's responsibility is to check the orders carefully, to see that they are carried out . . . The nurse checks the surgeon's orders for special requirements . . . the administration of medications, such as insulin . . . the primary care provider is responsible for ordering IV [intravenous] therapy. . . . Before preparing the infusion, the nurse first verifies the primary care provider's order indicating the type of solution, the amount to be administered, the rate of the infusion . . ."

Review of facility policy titled "Medication Orders - Elements of Complete Order" occurred 07/29/10. This policy, undated, stated, "This policy establishes the elements for documentation of a complete medication order in a patient's medical record. . . . Orders for medications are to contain the following elements: Medication name, generic or brand, and specific strength; Dosage . . . Route of administration; Frequency of administration and duration. In addition, the order should include a legible signature of the prescriber and date and time of order. . . . Physicians, nurse practitioners and physician assistants are responsible to use the elements stated above when ordering medications on inpatients and outpatients at the [name of facility]. Nurses and pharmacists are responsible for contacting the ordering prescriber for clarification if any medication order is missing information and/or is unclear. . . ."

Observation of the Outpatient Electroconvulsive Therapy (ECT) Department on 07/28/10 at 1:50 p.m., showed three patients (Patient #3, #21, and #22) prepped for their ECT procedure. Each patient had an intravenous (IV) line, attached to an IV bag that contained Lactated Ringers (a solution administered IV to replenish fluids and electrolytes), placed in their arm. Observation showed a nursing staff member (#3) administered a nebulizer (a device used to administer medication in the form of a mist into the lungs) treatment to Patient #3 prior to the ECT procedure.

Review of Patient #21 and #22's outpatient records occurred July 28-29, 2010. Record review identified no pre-procedure physician orders for drugs and biologicals that included the administration of IV fluids.

Review of Patient #3's outpatient record occurred July 28-29, 2010. Record review identified no pre-procedure physician orders for drugs and biologicals that included the administration of IV fluids and respiratory medication or treatments. Review of the "ECT Pre Procedure Sheet" lacked documentation of the nebulizer treatment the nursing staff member (#3) administered to Patient #3 prior to the procedure.

During interview on 07/28/10 at 4:15 p.m., when asked what physician orders nurses followed to prepare patients for a procedure, nursing staff members (#3 and #4) stated the facility used no physician orders. When asked how nursing staff know what to do to care for a patient (e.g., IV and IV solution, medications, etc.), the staff members (#3 and #4) stated they followed the training and education they received for pre-procedure preparation. The staff members (#3 and #4) indicated the facility did not utilize routine or standing physician orders.

During interview on 07/28/10 at 4:40 p.m., an administrative staff member (#1) stated the facility utilized pre-printed routine or standing orders for ECT procedures. When survey staff asked to review the "routine/standing orders", the staff member (#1) provided a form labeled, "Pre-ECT orders". Review of the form lacked a section for an order of the administration of IV fluids and medications. The administrative staff member (#1) confirmed physicians and nursing staff lacked utilization of the form and indicated an awareness of the problem.