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Based on review of Medical Staff Bylaws, meeting minutes, and interview with facility staff (EMP), it was determined the facility failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients.

Findings include:

Review of Medical staff Bylaws dated last revised July 8, 2009, revealed "Article 1. Section 2: Preamble ... 6. The Medical Staff is responsible for the quality of professional services provided by individuals with clinical privileges and is accountable to the Governing Body which by law is the Secretary of Public Welfare. ... Section 5: Responsibilities 1. The Medical Staff has the responsibility for the quality of medical care delivered to patients...7. The Medical Staff is responsible for engaging in performance improvement activities and for the measurement, assessment and improvement of patient care and patient satisfaction."

Review of Joint Directors and Executive Meeting minutes revealed no documented evidence of quality assessment with regard to effectiveness of services or performance improvement measures implemented evaluated by Medical staff and reported to the Governing Body.

Interview with EMP1 on October 8, 2010, at approximately 10:30 AM confirmed that departments do not provide any reporting of evaluation of program effectiveness or quality improvement measures.

Interview with OTH1 on October 8, 2010 at approximately 1:00PM confirmed that there was no mechanism in place to evaluate the services provided by each department.

Cross Reference 482.12(c) Care of Patient

Based on review of medical staff rules and regulations, facility policy, medical records (MR), and interview with facility staff (EMP), it was determined the facility failed to ensure specific patient care requirements were met for nine of 13 medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9).

Findings include:

Review of the facility's Medical Staff Rules and Regulations, last revised March 19, 2010, revealed "Section III Patient Management (Psychiatric Hospital) Evaluation and Documentation Each patient shall be evaluated and a progress note written at least weekly for the first two months and then monthly thereafter. Non psychiatric physicians shall evaluate patient's condition and write a progress note at least weekly for patients with acute medical problems and monthly for chronic conditions. Annual re-evaluation, including physical/neurological examination and lab studies, shall be completed and documented prior to anniversary date or within 365 days from the last evaluation. ... Physical Examination The physical examination shall be completed within twenty-four (24) hours of admission and therefore annually. Psychiatric Assessment The Psychiatric assessment shall be completed within sixty (60) hours of admission and thereafter annually. Psychiatric Individual Comprehensive Treatment Plan (ICTP) Initiated within seventy-two (72) hours of admission, at least every thirty (30) days thereafter, or more often if indicated. ... E. As the Treatment Team Leader, a physician is responsible for the direction and facilitation of the treatment Team and for implementation of the patient's ICTP."

Review of the facility's policy "Individualized Comprehensive Treatment Plan" effective October 1, 2008, revealed "Purpose: To provide active, effective treatment, continuity of care, and discharge planning to facilitate the patient's return to the community."

Review of the facility's policy "Admission, Assessment and Treatment and Annual Update," effective January 2, 2009, revealed "A. Psychiatry ... 2. The psychiatrist conducting the psychiatric interview will complete the psychiatric portion of the Initial/Annual Comprehensive Assessment up to ten (10) days prior to the formulation of the annual ICTP."

Review of the facility's policy "Recognition and Response to Changes In a Patient's Condition", dated effective date January 1, 2009, "Policy Statement: All staff is responsible for recognizing and communicating any perceived acute change in a patient's condition. ... 6. Medical Staff ... Psychiatrists and Medical Physicians are required to perform detailed evaluations of patients on admission, annually, and when their condition acutely changes (A-089). The medical staff, in concert with the nursing staff, is required to complete the multiple screening risk forms on admission, annually, and with a change in the patient's condition."

Review of medical records revealed that the ICTP remained the same every month for four months and greater with no changes in goals or interventions for MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8 and MR9.

Review of MR2 revealed no medical history and physical completed for the August 2010 annual update and no monthly medical update for September 2010 for the identified chronic obstructive pulmonary disease diagnosis.

Review of MR3 revealed that the patient had a 30 pound (lbs.) weight gain (140 lb. to 176 lbs.) from August 2010 to September 2010. The patient's weight was 173 lbs. for October 2010. There was no documented evidence that the physician had changed the diet to a therapeutic diet as of October 8, 2010.

Review of MR5 revealed a physician's order for August 13, 2010, to "increase Benadryl to 50 mg. (milligrams) po (per os - by mouth) q (every) 0830; 75 mg. po q 2030 and 25 mg. po q 1630 for 10 days then resume Benadryl 25 mg. po tid (three times a day)." There was no documentation by the physician as to why there was a medication change. Nursing monthly documentation noted the medication change but no reason why the medication was changed.

Review of MR10 revealed no documentation of completed monthly psychiatric progress notes for February and March of 2010.

Interview with EMP1 on October 8, 2010, at approximately 10:30 AM confirmed that MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8 and MR9 did not contain the required updates and that there was no change in the goals or interventions from month to month. EMP1 further confirmed that MR3 and MR4 did not have the required yearly medical history completed and MR10 was missing monthly physician and psychiatric notes.

Interview with EMP3 on October 8, 2010, at 10:00 confirmed that the treatment team documentation had changed since the computerized care plan began approximately two years previous. EMP3 further confirmed that the dates on the care plans were changed month to month but not the goals or the interventions, even if the interventions utilized were unsuccessful.

Interview with Patient 1 (PT1) on October 8, 2010, at approximately 11:00 AM confirmed "there were no therapeutic activities provided for the patients on weekends, except that the Recreation Hall was open on Saturday mornings." PT1 stated that "if the weather was bad the patients couldn't go."

Interview with OTH2 on October 7, 2010 confirmed that there were two occupational therapists on the weekends. If there was inclement weather, the occupational therapists would go to two departments to provide activities, usually the departments were there were more aggressive patients. OTH 2 further confirmed that there were no formal group activities provide for the patients on weekends.

Cross Reference 482.12(a)(5) Medical Staff - Accountability

Based on review of the facility's Performance Improvement Plan, meeting minutes, and interview with facility staff (EMP), it was determined the facility failed to demonstrate evidence of an ongoing hospital wide data-driven quality assessment and performance improvement program that involved all hospital departments and services.

Findings include:

Review of the facility's "Performance Improvement/Risk Management Plan," last revised January 2010, revealed "Scope of Care and Services. The Performance Improvement/ Risk Management Program Plan encompasses all standards of consumer care and treatment. This includes clinical, as well as non clinical aspects of care and treatment. ... Leadership ... The hospital leadership supports the Performance Improvement/Risk Management Program Plan by ensuring it's department directors will do the following:
Report data using statistical quality control
Develop indicators for ongoing monitoring
Document strategic plans for performance improvement efforts in committee/department minutes."

Review of the Joint Directors and Executive Meeting minutes revealed no documented evidence of quality assessment with regard to the effectiveness of services or performance improvement measures implemented, evaluated by Medical staff and reported to Governing Body.

Interview with EMP1 on October 8, 2010, at approximately 10:00 AM confirmed there was no documented evidence of reports by department directors, no evidence of specific performance improvement projects, and no documented evidence of ongoing monitors.

Interview with EMP2 on October 7, 2010, at 10:00 AM confirmed there were no active quality performances in place for Social Service and no documented evidence of reporting data as defined in the risk management plan.

Interview with EMP4 on October 7, 2010, at 2:00 PM confirmed there was no documentation of performance improvement projects or established criteria for measurement of Pharmacy processes.

Based on review of facility documents,and interview with facility staff (EMP), it was determined the facility failed to implement timely preventative actions and mechanisms following the death of a patient as a result of toxic drug levels (MR6).

Findings include:

Review of the facility's postmortem committee meeting minutes and root cause analysis of a patient death (MR6) revealed the event occurred in October of 2005. The Committee concluded Luvox (an anti-depressant) resulted in toxic Thorazine (an anti-psychotic) levels which were contributory to the patient's death. The pharmacy was to consider regulatory steps or possibly banning the use of Luvox at facility. Also Topamax (an anti-convulsive) guidelines were to be developed and implemented. The coroners's report listed the cause of death as "Chlorpromazine Poisoning. "

Interview with EMP4 revealed that the contracted pharmacy in 2005 at the time of the patient's death was no longer contracted by the facility. An in house, full time pharmacist was implemented beginning January of 2008. High Alert Medications for both Luvox and Topamax were presented. There were no dates to indicate when these alerts were implemented. EMP4 was not involved with the root cause at the time of the death and was unsure of the timeliness of the pharmacy mechanisms to prevent further occurrences.

Review of the High Alert Medication for Luvox revealed the medication was not banned from use in the facility until July of 2006.

Interview with OTH1 on October 7, 2010, at approximately 11:00 AM revealed "it was very difficult with the contracted pharmacy service, not enough onsite oversight. This is why we went with an in house pharmacy."

Based on review of facility documents and interview with facility staff (EMP), it was determined the facility failed to demonstrate evidence of an ongoing hospital wide data-driven quality assessment and performance improvement program that involved all hospital departments and services.

Findings include:

Review of the facility's "Performance Improvement/Risk Management Plan," last revised January 2010, revealed "Scope of Care and Services. The Performance Improvement/ Risk Management Program Plan encompasses all standards of consumer care and treatment. This includes clinical, as well as non clinical aspects of care and treatment. ... Leadership ... The hospital leadership supports the Performance Improvement/Risk Management Program Plan by ensuring its department directors will do the following:
Report data using statistical quality control
Develop indicators for ongoing monitoring
Document strategic plans for performance improvement efforts in committee/department minutes."

Interview with EMP1 on October 8, 2010, at approximately 10:00 AM confirmed there was no documented evidence of reports by department directors, no evidence of specific performance improvement projects and no documented evidence of ongoing monitors.

Interview with EMP3 on October 7, 2010, at 10:00 AM confirmed there were no active quality performances in place for Social Service and no documented evidence of reporting data as defined in the risk management plan

Interview with EMP4 on October 7, 2010, at 2:00 PM confirmed there was no documentation of performance improvement projects or established criteria for measurement of Pharmacy processes.


Cross Reference 482.21 QAPI

Based on review of Medical Staff Bylaws, Performance Improvement Plan, meeting minutes, and interview with facility staff (EMP), it was determined the facility failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients.

Findings include:

Review of the facility's "Medical Staff Bylaws," dated last revised July 8, 2009, revealed "Article 1. Section 2: Preamble ... 6. The Medical Staff is responsible for the quality of professional services provided by individuals with clinical privileges and is accountable to the Governing Body which by law is the Secretary of Public Welfare. ... Section 5: Responsibilities 1. The Medical Staff has the responsibility for the quality of medical care delivered to patients. ... 7. The Medical Staff is responsible for engaging in performance improvement activities and for the measurement, assessment and improvement of patient care and patient satisfaction."

Review of the facility's "Performance Improvement/Risk Management Plan," last revised January 2010, revealed "Scope of Care and Services. The Performance Improvement/ Risk Management Program Plan encompasses all standards of consumer care and treatment. This includes clinical, as well as non clinical aspects of care and treatment. ... Leadership ... The hospital leadership supports the Performance Improvement/Risk Management Program Plan by ensuring its department directors will do the following:
Report data using statistical quality control
Develop indicators for ongoing monitoring
Document strategic plans for performance improvement efforts in committee/department minutes."

Review of Joint Directors and Executive Meeting minutes revealed no documented evidence of quality assessment with regard to effectiveness of services or performance improvement measures implemented and evaluated by Medical staff and reported to Governing Body.

Interview with EMP1 on October 8, 2010, at approximately 10:30 AM confirmed that departments do not provide any reporting of evaluation of program effectiveness or quality improvement measures.

Interview with EMP2 on October 7, 2010 at 10:00 AM confirmed there were no active quality performances in place for Social Service and no documented evidence of reporting data as defined in the risk management plan

Interview with EMP4 on October 7, 2010, at 2:00 PM confirmed there was no documentation of performance improvement projects or established criteria for measurement of Pharmacy processes.

Interview with OTH1 on October 8, 2010, at approximately 1:00 PM confirmed that there was no mechanism in place to evaluate the services provided by each department.

Interview with EMP3 on October 8, 2010, at 10:00 confirmed that the treatment team documentation had changed since the onset of the computerized care plan began approximately two years previous. EMP 3 further confirmed that the dates on the care plans were changed month to month but not the goals or the interventions, even if the interventions utilized were unsuccessful.

Cross Reference 482.21 QAPI

Based on review of the facility's medical staff rules and regulations, facility policy, medical records (MR), and interview with facility staff (EMP), it was determined the medical staff failed to ensure specific patient care requirements were met for nine of 13 medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, and MR9).

Findings include:

Review of the facility's "Medical Staff Rules and Regulations," last revised March 29, 2010, revealed "Section III Patient Management (Psychiatric Hospital) Evaluation and Documentation Each patient shall be evaluated and a progress note written at least weekly for the first two months and then monthly thereafter. Non psychiatric physicians shall evaluate patient's condition and write a progress note at least weekly for patients with acute medical problems and monthly for chronic conditions. Annual re-evaluation, including physical/neurological examination and lab studies, shall be completed and documented prior to anniversary date or within 365 days from the last evaluation. ... Physical Examination The physical examination shall be completed within twenty-four (24) hours of admission and therefore annually. Psychiatric Assessment The Psychiatric assessment shall be completed within sixty (60) hours of admission and thereafter annually. Psychiatric Individual Comprehensive Treatment Plan (ICTP) Initiated within seventy-two (72) hours of admission, at least every thirty (30) days thereafter, or more often if indicated. ... E. As the Treatment Team Leader, a physician is responsible for the direction and facilitation of the treatment Team and for implementation of the patient's ICTP."

Review of the facility's policy "Individualized Comprehensive Treatment Plan," effective October 1, 2008, revealed "Purpose: To provide active, effective treatment, continuity of care, and discharge planning to facilitate the patient's return to the community."

Review of the facility's policy "Admission, Assessment and Treatment and Annual Update," effective January 2, 2009, revealed "A. Psychiatry ... 2. The psychiatrist conducting the psychiatric interview will complete the psychiatric portion of the Initial/Annual Comprehensive Assessment up to ten (10) days prior to the formulation of the annual ICTP."

Review of the facility's policy "Recognition and Response to Changes In a Patient's Condition", dated effective date January 1, 2009, revealed "Policy Statement: All staff is responsible for recognizing and communicating any perceived acute change in a patient's condition. ... 6. Medical Staff ... Psychiatrists and Medical Physicians are required to perform detailed evaluations of patients on admission, annually, and when their condition acutely changes (A-089). The medical staff, in concert with the nursing staff, is required to complete the multiple screening risk forms on admission, annually, and with a change in the patient's condition."

Review of medical records revealed that the ICTP remained the same every month for four months and greater with no changes in goals or interventions for MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8 and MR9.

Review of MR2 revealed no medical history and physical completed for the August 2010 annual update and no monthly medical update for September 2010 for the identified chronic obstructive pulmonary disease diagnosis.

Review of MR3 revealed that the patient had a 30 pound (lbs.) weight gain (140 lb. to 176 lbs.) from August 2010 to September 2010. The patient's weight was 173 lbs. for October 2010. There was no documented evidence that the physician had changed the diet to a therapeutic diet as of October 8, 2010.

Review of MR5 revealed a physician order for August 13, 2010, to "increase Benadryl to 50 mg. (milligrams) po (per os - by mouth) q (every) 0830; 75 mg. po q 2030 and 25 mg. po q 1630 for 10 days, then resume Benadryl 25 mg. po tid (three times a day)." There was no documentation by the physician as to why there was a medication change. Nursing monthly documentation noted the medication change but no reason why medication was changed

Review of MR10 revealed no completed monthly psychiatric progress notes for February and March of 2010.

Interview with EMP1 on October 8, 2010, at approximately 10:30 AM confirmed that MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8 and MR9 did not contain the required updates and that there was no change in the goals or interventions from month to month. EMP1 further confirmed that MR3 and MR4 did not have the required yearly medical history completed and MR10 was missing monthly physician and psychiatric notes.

Interview with patient 1 (PT1) on October 8, 2010, at approximately 11:00 AM confirmed that "there were no therapeutic activities provided for the patients on weekends except that the Recreation Hall was open on Saturday mornings. PT1 stated that "if the weather was bad the patients couldn't go."

Interview with OTH2 on October 7, 2010, confirmed that there were two occupational therapists on the weekends and if there was inclement weather the occupational therapists would go to two departments to provide activities, usually the departments were there were more aggressive patients." OTH 2 further confirmed that there were no formal group activities provide for the patients on weekends.

Cross Reference 482.12(c) Care of Patient
Cross Reference 482.12(a)(5) Medical Staff - Accountability

Based on review of medical staff rules and regulations, facility policy, medical records (MR), and interview with facility staff (EMP), it was determined the facility failed to ensure each medical record contained the required documentation to justify continued hospitalization, support the diagnosis and describe the patient's progress and response to medications and services for nine of 13 medical records reviewed.( MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, and MR9).

Findings include:

Review of the facility's "Medical Staff Rules and Regulations," last revised March 19, 2010, revealed "Section III Patient Management (Psychiatric Hospital) Evaluation and Documentation Each patient shall be evaluated and a progress note written at least weekly for the first two months and then monthly thereafter. Non psychiatric physicians shall evaluate patient's condition and write a progress note at least weekly for patients with acute medical problems and monthly for chronic conditions. Annual re-evaluation, including physical/neurological examination and lab studies, shall be completed and documented prior to anniversary date or within 365 days from the last evaluation. ... E. As the Treatment Team Leader, a physician is responsible for the direction and facilitation of the treatment Team and for implementation of the patient's ICTP."

Review of the facility's policy "Individualized Comprehensive Treatment Plan," effective October 1, 2008, revealed "Purpose: To provide active, effective treatment, continuity of care, and discharge planning to facilitate the patient's return to the community."

Review of the facility's policy "Admission, Assessment and Treatment and Annual Update," effective January 2, 2009, revealed "A. Psychiatry ... 2. The psychiatrist conducting the psychiatric interview will complete the psychiatric portion of the Initial/Annual Comprehensive Assessment up to ten (10) days prior to the formulation of the annual ICTP."

Review of medical records revealed that the ICTP remained the same for four months or greater with no changes in goals or interventions for MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8 and MR9.

Review of MR2 revealed no medical history and physical completed for the August 2010 annual update and no monthly medical update for September 2010 for the identified chronic obstructive pulmonary disease diagnosis.

Review of MR3 revealed that the patient had a 30 pound (lbs.) weight gain (140 lb. to 176 lbs.) from August 2010 to September 2010. The patient's weight was 173 lbs. for October 2010. There was no documented evidence that the physician had changed the diet to a therapeutic diet as of October 8, 2010.

Review of MR5 revealed a physician order for August 13, 2010, to "increase Benadryl to 50 mg. (milligrams) po (per os - by mouth) q (every) 0830; 75 mg. po q 2030 and 25 mg. po q 1630 for 10 days, then resume Benadryl 25 mg. po tid (three times a day)." There was no documentation by the physician as to why there was a medication change. Nursing monthly documentation noted the medication change but no reason why medication was changed

Review of MR10 revealed no completed monthly psychiatric progress notes for February and March of 2010.

Interview with EMP1 on October 8, 2010, at approximately 10:30 AM confirmed that MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8 and MR9 did not contain the required updates and that there was no change in the goals or interventions from month to month. EMP1 further confirmed that MR3 and MR4 did not have the required yearly medical history completed and MR10 was missing monthly physician and psychiatric notes.

Interview with patient 1 (PT1) on October 8, 2010, at approximately 11:00 AM confirmed that "there were no therapeutic activities provided for the patients on weekends except that the Recreation Hall was open on Saturday mornings. PT1 stated that "if the weather was bad the patients couldn't go."

Interview with OTH2 on October 7, 2010, confirmed that there were two occupational therapists on the weekends and if there was inclement weather the occupational therapists would go to two departments to provide activities, usually the departments were there were more aggressive patients." OTH 2 further confirmed that there were no formal group activities provide for the patients on weekends.

Based on review of the facility documents and interview with staff (EMP), it was determined that the facility failed to ensure that policies and procedures to minimize drug errors were developed.

Findings include:

Review of the facility's "Performance Improvement/Risk Management Program Plan", dated revised January 2010, revealed "Department Directors/Committee Responsibilities A. Department Directors Clinical and non-clinical department directors shall develop mechanisms to monitor data related to their functioning, which impacts on current aspects of care, current processes, areas of high risk/high volume, high risk/low volume or problem prone areas. Data will be shared with the appropriate assistant superintendent and/or CPIE (Chief Performance Improvement Executive) for monitoring of overall trends and patterns to indicate need for formation of an Improving Organization Performance (IOP) Team. ... All department directors are responsible for keeping their staff members informed of current IOP Team efforts.

Review of the facility's "Medical Staff Bylaws," dated last revised July 8, 2009, revealed "Article 1. Section 2: Preamble ... 6. The Medical Staff is responsible for the quality of professional services provided by individuals with clinical privileges and is accountable to the Governing Body which by law is the Secretary of Public Welfare. ... Section 5: Responsibilities 1. The Medical Staff has the responsibility for the quality of medical care delivered to patients. ... 7. The Medical Staff is responsible for engaging in performance improvement activities and for the measurement, assessment and improvement of patient care and patient satisfaction."

Review of Joint Directors and Executive Meeting minutes revealed no documented evidence of quality assessment with regard to effectiveness of services or performance improvement measures implemented and evaluated by Medical staff and reported to Governing Body.

Review of Position Description, "Chief Pharmacist" revealed "plans, organizes and supervises the operation of all pharmaceutical services at Clarks Summit State Hospital. ... 1. establishing performance objectives, developing performance standards. ... 3. Participates in the Performance Improvement Program by establishing criteria for measurements of Pharmacy processes, conducting activities and methods to achieve goals, discussing with subordinates methods to improve performance. ... 8. Develops policies and procedures for the Pharmacy Department by reviewing standards of certifying bodies, reviewing and evaluating current policies and procedures, reviewing data from internal audits and revising
the policies in order to provide quality treatments as prescribed by the physicians."

Interview with OTH1 on October 7, 2010, at approximately 1:00 PM revealed that a patient had died of Chlorpromazine poisoning in October of 2005. OTH1 further revealed that a Root Cause Analysis (RCA - a method aimed at identifying the root cause of a problem or incident) had determined that Luvox (an anti-depressant), as well as other medications that the patient was receiving, resulted in toxic Thorazine levels, which contributed to the patient's demise. The pharmacy was to consider regulatory steps or possibly banning the use of Luvox at the facility. Another one of the recommendations stemming from the RCA was to establish High Alert Medications. Luvox was not banned from use at the facility until July of 2006. OTH1 confirmed that there was little clinical oversight of the contracted pharmacy in 2005.

Interview with EMP4 on October 7, 2010, at approximately 2:00 PM revealed there was no documented evidence of a mechanism in place for monitoring toxic levels of medications because of an insufficient number of pharmacists. EMP4 confirmed that there was no documented evidence that physicians were notified when medications where reaching toxic levels. EMP4 stated they were monitoring medication profiles for possible toxicity. EMP4 confirmed that there was no documented evidence that this was occurring. EMP4 stated that this was a tedious process, because it was all completed by hand. EMP4 further confirmed that the Pharmacy and Therapeutic Committee meets monthly to review adverse drug reactions and medication errors. There was no established mechanism for measuring quality indicators in the Pharmacy and reporting the facility's Performance Improvement Committee.

Cross Reference 482.21 QAPI