HospitalInspections.org

Based on the manner and degree of deficiencies cited, the hospital failed to be in compliance with the Condition of Participation of Governing Body. The hospital failed to have an effective governing body legally responsible for the conduct of the hospital as an institution that ensured that all patient requirements were met.

The facility failed to meet the following standards under the Condition of Participation of Governing Body:

A 0049 Medical Staff Accountability
The governing body of the facility failed to ensure that medications philosophy of the medical staff, with regards to the general formulary limitations, and in the area of pain management, were evaluated relative to negative impacts on patient care. In addition, the medical staff failed to ensure that the pharmacy services had adequate facilities and resources to provide medications timely and to conduct the various monitoring oversight functions within the department to ensure consistent quality in pharmacy services.

A 0083 Contracted Services
The facility failed to ensure services furnished under contract complied with all applicable conditions of participation and standards for the contracted services. The failure created the potential for a negative patient outcome.

A 0084 Contracted Services
The governing body of the facility failed to ensure the contracted services had internal quality assurance activities to track performance failures. The findings created the potential for negative patient outcome.

A 0085 Contracted Services
The governing body failed to ensure the hospital maintained a complete list of all contracted services, as required.

In addition, the Governing Body of the facility failed to ensure the following other Conditions of Participations were met:

Tag A 0263 - Condition of Quality Assurance/Performance Improvement (QAPI)

Tag A 0490 - Condition of Pharmaceutical Services

The governing body of the facility failed to ensure the following standard under the Condition of Participation of Physical Environment was met:

Tag A 0722 - Facilities
The governing body of the facility failed to ensure adequate space and facilities for the pharmacy to operate effectively and maintain all pharmacy standards for medication storage and preparation areas.

Based medical record reviews, staff/physician interviews and review of facility documents, the the governing body of the facility failed to ensure that medications philosophy of the medical staff, with regards to the general formulary limitations, and in the area of pain management, were evaluated relative to negative impacts on patient care. In addition, the medical staff failed to ensure that the pharmacy services had adequate facilities and resources to provide medications timely and to conduct the various monitoring oversight functions within the department to ensure consistent quality in pharmacy services.

The findings were:

1. Review on 5/18/11 of the facility's governing body bylaws revealed the following, in pertinent parts:
"...Article XIII
Quality of Professional Services.
...2. Accountability of the Medical Staff and Other Professional Staffs.
The Board shall require that the Medical Staff and other professional staffs contribute to assessment and continuous improvement of patient care quality, and establish and implement the following policies, procedures, and practices:
a. All patients with the same medical issues shall receive the same level and quality of care.
b. The Medical Staff, through its defined functions and with concurrence of the Facility Administration, shall (i) conduct ongoing assessment of the quality of professional care in the Facility based upon the medical records of patients (ii) make and implement recommendations for improving such care and (iii) periodically report such activities and their results in writing to the Board..."

2. Review on 5/18/11 of the facility's medical staff bylaws revealed the following, in pertinent parts:
"...ARTICLE 2
PURPOSE AND RESPONSIBILITIES
2.1 PURPOSES.
The purposes of the Medical Staff are:
2.1.1 to ensure that all patients receiving treatment from the Facility receive quality patient care that is provided in a highly ethical manner and that is commensurate with locally available resources;...
2.1.3 to serve as the primary means for accountability to the Board for the quality and appropriateness of the professional performance...and to strive for quality patient care efficiently delivered and maintained consistent with locally available resources and to the degree reasonably possible as determined by the state of the healing arts in the community;
2.1.4 to provide a means through which the Medical Staff may participate in the policy making and planning process, medication management and patient safety...
ARTICLE 11
COMMITTEES AND FUNCTIONS...
11.2.2 Duties: The duties of the MEC (Medical Executive Committee) shall be to:
(c) account to the Board and the Staff for the overall quality, uniformity, and efficiency of medical care rendered to patients;...
(k) make recommendations to the Board on medical administrative and Facility management matters, particularly as they relate to patient care;...
11.4.7 Pharmacy and Therapeutics (Committee).
The duties involved in this function are to:
(a) perform an objective evaluation of the clinical use of all drugs in the Facility to reduce practice variations, errors and misuse;
(b) establish and implement a well controlled formulary to help control drug use in the Facility, and make recommendations as to which drugs should be added to and deleted from the formulary;
(c) monitor and evaluate the prophylactic, therapeutic, and empiric use of drugs, and evaluate all significant untoward reactions to drugs in an effort to ensure that drugs are provided appropriately, safely, and effectively;...
(f) assist in the formulation of and approve all professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, safety procedures, ordering and transcribing, preparing and dispensing, administration and monitoring, and other matters related to drugs in the Facility;.."

Reference the Tags A 0490 Condition of Pharmacy Services, A 0491 Pharmacy Administrator, A 0493 Pharmacy Personnel, A 0511 Formulary System and A 0722 Facilities (under the Condition of Physical Environment) for findings related to the administrative oversight of the department, lack of personnel, formulary system problems and inadequate facilities for the Pharmacy Department.

Based on staff interviews, observation and review of facility documents, the governing body of the facility failed to ensure services furnished under contract complied with all applicable conditions of participation and standards for the contracted services. The failure created the potential for a negative patient outcome.

The findings were:

On 5/16/2011, a request was made for a list of current services provided by contract. On 5/16/2011, a red binder labeled "Contract Compliance Documentation" was provided to the surveyors. The binder contained a piece of paper in the front of the binder that was titled "Contracts - Patient Care; Verification of Regulatory Compliance." The list had five contractors: an ambulance service, a pharmacy service company, a dietary service company, a hospital, and a laboratory. An additional request was made for a complete list of current services provided by contract on 5/16/2011 at approximately 4:45 p.m. On 5/17/2011 at approximately 8:15 a.m., a manila folder was provided to the surveyors that contained a list of the same five contractors as well as 15 doctors that were contracted with the facility for various programs/services. On 5/18/2011 at approximately 8:15 a.m., another list of contracted services titled "Master Service Contracts List" was provided to the surveyors. The list contained the contractors from the previous two lists as well as the doctors from the second list. The list contained other contracts the facility had in place, but did not reflect services identified as being provided by contract previously during the survey, such as preventative equipment maintenance, consulting services with the Director of Nursing, oxygen supply, point of care laboratory supplies, food supply, and medication supply. When asked, the Performance Improvement Manager stated that the list most recently provided was on an administrative assistant's computer who was on vacation.

There was no indication on any of the three lists provided that the contracts were assigned to a person or department responsible for review, monitoring and evaluation to determine the effectiveness of the contract. There was no process in place to ensure all hospital clinical contracts were assessed and information forwarded to the Governing Body to ensure performance and quality of services provided met all required standards and applicable conditions of participation. No documentation was available for review that would reflect this activity.

Based on review of the facility's policies/procedures, staff interviews and review of facility documents, the governing body of the facility failed to ensure the contracted services had internal quality assurance activities to track performance failures. The findings created the potential for negative patient outcome.

The findings were:

A review of the facility's policies/procedures revealed that a policy titled "Contractual Services" last reviewed and revised 6/10 stated, in pertinent parts:
" ...Contract Review
4) The Governing Board will review each new contract or agreement for referral to assure that the services are:
a) Required by Cedar Springs;
b) Meet community standards for quality and safety of care;
c) Are provided in an effective manner; and
d) Are tracked by mechanism to identify and report problems in these services.
Quality Review
5) The organization Medical Executive/PI Committee will evaluate the effectiveness of any patient services regularly referred or contracted for.
6) Results of service evaluation, which impact upon patient care, will also be communicated to the CEO and to the Governing Board."

On 5/16/2011, a request was made for a list of current services provided by contract. On 5/16/2011, a red binder labeled "Contract Compliance Documentation" was provided to the surveyors. The binder contained a piece of paper in the front of the binder that was titled "Contracts - Patient Care; Verification of Regulatory Compliance." The list had five contractors: an ambulance service, a pharmacy service company, a dietary service company, a hospital, and a laboratory. An additional request was made for a complete list of current services provided by contract on 5/16/2011 at approximately 4:45 p.m. On 5/17/2011 at approximately 8:15 a.m., a manila folder was provided to the surveyors that contained a list of the same five contractors as well as 15 doctors that were contracted with the facility for various programs/services. On 5/18/2011 at approximately 8:15 a.m., another list of contracted services titled "Master Service Contracts List" was provided to the surveyors. The list contained the contractors from the previous two lists as well as the doctors from the second list. The list contained other contracts the facility had in place, but did not reflect services identified as being provided by contract previously during the survey, such as preventative equipment maintenance, consulting services with the Director of Nursing, oxygen supply, point of care laboratory supplies, food supply, and medication supply. When asked, the Performance Improvement Manager stated that the list most recently provided was on an administrative assistant's computer who was on vacation.

An interview with the facility's Performance Improvement Manager 5/17/2011 at approximately 9:27 a.m., revealed that the facility's contracted services "all have their own performance measurements" and that the services provided "in house" by a contractor were "to collect data and bring to us."

A review of the facility's Performance Improvement Committee and Governing Board minutes revealed that the facility's contracted radiology and laboratory were not discussed, nor was data available/trended by the facility's Quality Assessment and Performance Improvement program.

There was no indication on any of the three lists provided that the contracts were assigned to a person or department responsible for review, monitoring and evaluation to determine the effectiveness of the contract. There was no process in place to ensure all hospital clinical contracts were assessed and information forwarded to the Governing Body to ensure performance and quality of services provided met all required standards and applicable conditions of participation. No documentation was available for review that would reflect this activity.

Based on a review of staff documents and staff interviews, the governing body failed to ensure the hospital maintained a complete list of all contracted services, as required.

The findings were:

On 5/16/2011, a request was made for a list of current services provided by contract. On 5/16/2011, a red binder labeled "Contract Compliance Documentation" was provided to the surveyors. The binder contained a piece of paper in the front of the binder that was titled "Contracts - Patient Care; Verification of Regulatory Compliance." The list had five contractors: an ambulance service, a pharmacy service company, a dietary service company, a hospital, and a laboratory. An additional request was made for a complete list of current services provided by contract on 5/16/2011 at approximately 4:45 p.m. On 5/17/2011 at approximately 8:15 a.m., a manila folder was provided to the surveyors that contained a list of the same five contractors as well as 15 doctors that were contracted with the facility for various programs/services. On 5/18/2011 at approximately 8:15 a.m., another list of contracted services titled "Master Service Contracts List" was provided to the surveyors. The list contained the contractors from the previous two lists as well as the doctors from the second list. The list contained other contracts the facility had in place, but did not reflect services identified as being provided by contract previously during the survey, such as preventative equipment maintenance, consulting services with the Director of Nursing, oxygen supply, point of care laboratory supplies, food supply, and medication supply. When asked, the Performance Improvement Manager stated that the list most recently provided was on an administrative assistant's computer who was on vacation.

Based on medical record review, staff interview, and review of the facility's policies/procedures the facility failed to ensure that each patient had the right to make informed decisions regarding his or her care. Specifically, the facility failed to allow sample patient #20 refuse treatment in the form of medication without documented legal reasoning why the patient could not be afforded such rights.

The findings were:

A review of the facility's policies/procedures revealed the following, in pertinent parts:
A policy titled "Use of Emergency Psychotropic Medication" last revised 09/01 stated, in pertinent parts:
...1) To provide a process in which to administer medication to a patient in an emergency situation in order to prevent:
a) Imminent danger to the life of the patient because of the patient's present condition ...
b) Imminent physical or emotional harm to another because of threats, attempts or other acts towards the individual.
c) The patient's life is in imminent danger to toxicity arising from the patient's use or abuse of another medication/substance.
d) Severe debilitation/decompensation of mental health symptoms which may be life threatening ...
2) In the event that the criteria of an emergency situation are met, the unit/staff nurse will notify the attending psychiatrist or medical director for the order.
3) The reason for the use of the specific medication will be documented in the client's medical record stating the necessity of the order, the failure of less intrusive forms of interventions, if any, and the subsequent response by the patient necessitating the use of the emergency medication.
4) This information will be documented each time an emergency order is used, and a new order will be obtained for each use ..."
A policy titled "Involuntary Medication/Administration of Emergency Medication when Patient has Refused" last revised 9/10 stated, in pertinent parts:
" ...3) Involuntary Medication - administration of a psychiatric medication by the order of a licensed physician without the patient's consent. Emergency psychiatric medication(s) may be ordered up to 24 hours without consent under a psychiatric emergency condition ...
...2) If not currently in place, the psychiatrist will initiate a 72-hour hold or a Short-Term Certification ...
...13) No psychiatric medications will be administered without the person's consent until a court order is received authorizing involuntary use, except under emergency conditions ..."

A review of the facility's medical records revealed the following, in pertinent parts:
Sample patient #20 was admitted to the hospital on 4/17/2011 from another acute care hospital on a 72-hour hold for bipolar disorder symptoms and possible schizophrenia. On 4/20/2011, according to the Daily Progress Flow Sheet, the patient signed into the facility voluntarily. The patient's record contained an additional 72-hour hold dated the date of transfer to another psychiatric hospital on 4/29/2011.

On 4/20/2011 at approximately 4:00 a.m., the patient was exhibiting symptoms of agitation and an order was received for emergency medications of Haldol and Ativan (an antipsychotic and an anti-anxiety medication) injections which were administered to the patient at approximately 5:15 a.m. The patient remained on a voluntary status and no 72-hour hold or Short-Term Certification were written. On 4/20/2011 at approximately 4:50 p.m., an additional order for emergency medications of Geodon and Ativan (an antipsychotic and an anti-anxiety medication) injections, which were administered to the patient at approximately 5:05 p.m.

On 4/22/2011 at approximately 9:55 p.m., an order was written for Geodon and Ativan injections without indication that the medications were for an emergency condition. The "Daily Progress Flow Sheet" contained a narrative from 4/22/2011 at approximately 11:00 p.m., which stated that the patient "had a rough day" and that "his/her moods were up and down. S/he was loud and irritated. S/he needed to be redirected several times by staff." The medications were given at approximately 10:30 p.m.

On 4/23/2011 at approximately 8:30 a.m., an order was written for Thorazine (an antipsychotic) injections every 12 hours as needed for agitation without indication that the medications were for an emergency condition. Doses of Thorazine injections were given on 4/23/2011 at approximately 8:50 a.m., on 4/26/2011 at approximately 4:30 p.m., and on 4/27/2011 at approximately 4:00 p.m.

At no point after the initial 72-hour hold expired, was the patient placed on another hold or placed on a Short-Term Certification.

An interview with the facility's Director of Nursing on 5/19/2011 at approximately 11:45 a.m., revealed that after having the ability to review sample patient #20's record, s/he concluded that the patient was voluntary and should not have been given emergency medications without a hold or certification, which s/he stated was not in the record.

Based on review of the facility's documents, staff interview, and the facility's policies/procedures, the facility failed to be in compliance with the Condition of Participation of Quality Assessment and Performance Improvement (QAPI). The facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven QAPI program. Specifically, the facility failed to ensure that the QAPI program involved all hospital departments and services (including those services furnished under contract or arrangement).

The findings were:

A review of the facility's policies/procedures revealed the following, in pertinent parts:
A policy titled "Performance Improvement Plan" last revised 1/08 stated the following, in pertinent part:
" ...The hospital shall fulfill its responsibilities to patients, their families, professionals, support staff, and the community through continuous and systematic assessment and improvement of hospital/department systems and processes, including contracted services used to assist in providing quality care ..."

A policy titled "Contractual Services" last reviewed and revised 6/10 stated the following, in pertinent part:
" ...Contract Review
4) The Governing Board will review each new contract or agreement for referral to assure that the services are:
a) Required by Cedar Springs;
b) Meet community standards for quality and safety of care;
c) Are provided in an effective manner; and
d) Are tracked by mechanism to identify and report problems in these services.
Quality Review
5) The organization Medical Executive/PI Committee will evaluate the effectiveness of any patient services regularly referred or contracted for.
6) Results of service evaluation, which impact upon patient care, will also be communicated to the CEO and to the Governing Board."

An interview with the facility's Performance Improvement Manager on 5/19/2011 at approximately 9:30 a.m., revealed that the facility did not include all departments into the facility's QAPI program. S/he stated that the contracted laboratory was included into the QAPI program through nursing audits of medical records for "timely" results, but was not evaluated in any other way. S/he stated that the contracted Radiology was not evaluated by the facility. S/he stated that the facility's contracted pharmacy reported to the facility on two performance improvement projects: one that tracked how often medications were sent from the pharmacy in the "most ready to administer form" and one in which the facility tracked how often expiration dates were "noted on vials appropriately." S/he stated that the facility relied on nursing incident reports of delayed medications or dispensing errors to evaluate the effectiveness of the pharmacy services rather than any proactive measures that sought to gather data on the effectiveness of the pharmacy.

Based on staff interview, review of the facility's documentation, and medical record review, the facility failed to ensure that performance improvement activities tracked medical errors and adverse patient events effectively. Specifically, the facility relied on staff incident reporting to identify possible medical errors rather than employing other methods in addition such as retrospective medical record reviews.

The findings were:

According to the U.S. Food and Drug Administration (most recently in a "Safety Alert" issued on 1/13/2011), the maximum acetaminophen daily dose should not exceed 4 grams of acetaminophen in a 24 hour period.

A review of the facility's medical records revealed the following, in pertinent parts:
Patient #23 was admitted to the facility on 4/26/2011 and was transferred to another out-of-state hospital on 5/4/2011. The patient had multiple chronic pain diagnoses and was placed on Vicodin for pain. The Medication Administration Record (MAR) for the patient reflected that the patient was ordered Vicodin 5/500 (5 mg of hydrocodone and 500 mg of acetaminophen in each tablet) two tablets every four hours as needed for pain, not to exceed eight tablets (four doses) in a 24 hour period. The MAR included entries from nursing staff for administration of two tablets of Vicodin on 4/27/11 at approximately 12:30 a.m., 4:45 a.m., 8:30 a.m., 12:30 p.m., and 5:30 p.m. (for a total of five doses, including 5000 mg of acetaminophen).

An interview with the facility's Director of Nursing (DON) on 5/18/2011 at approximately 1:35 p.m., confirmed that sample patient #23's record reflected the administration of 5 grams of acetaminophen (a 1 gram overdose of the maximum recommended daily dosage). S/he stated that the pharmacy department received a copy of each patient's MARs at the end of each week or if a MAR was copied or when the patient discharges from the hospital.

An interview with the facility's pharmacist on 5/18/2011 at approximately 1:45 p.m., revealed that the MAR was used by the pharmacy for charges and was not reviewed in any manner for possible medication errors, such as an overdose of acetaminophen.

A review of the facility's internal quality documents revealed that within the previous 12 months, the facility's Quality Assessment and Performance Improvement program performed two performance improvement projects with the pharmacy: one that tracked how often medication were sent from the pharmacy in the "most ready to administer form" and one in which the facility tracked how often expiration dates were "noted on vials appropriately." The facility did not have documentation of tracking of medication errors or adverse patient events other than from internal incident reports (which did not include sample patient #23). Reports of medical records audits that were performed by nursing staff on patient units did not include areas for staff to identify medication errors or adverse patient events, rather the form indicated that medical record reviews included for medications: presence of consents, documentation of effectiveness of first doses, double signatures when required, AIMS testing when indicated, presence of RN/LPN initials where indicated, and signatures on MARs.

In summary, the facility relied on staff to report medical errors or adverse patient events and therefore was unable to accurately track the actual occurrence of medication errors, or adverse patient events. Furthermore, the reports that were generated did not include analysis or follow-up that occurred including the identification of any patterns that may have existed.

Based medical record reviews, staff/physician interviews and review of facility documents, the medical staff organization of the facility failed to ensure that medications philosophy of the medical staff and the hospital, with regards to the general formulary limitations, and in the area of pain management, were evaluated relative to negative impacts on patient care. In addition, the medical staff failed to ensure that the pharmacy services had adequate facilities and resources to provide medications timely and to conduct the various monitoring oversight functions within the department to ensure consistent quality in pharmacy services.

The findings were:

1. Review on 5/18/11 of the facility's medical staff bylaws revealed the following, in pertinent parts:
"...ARTICLE 2
PURPOSE AND RESPONSIBILITIES
2.1 PURPOSES.
The purposes of the Medical Staff are:
2.1.1 to ensure that all patients receiving treatment from the Facility receive quality patient care that is provided in a highly ethical manner and that is commensurate with locally available resources;...
2.1.3 to serve as the primary means for accountability to the Board for the quality and appropriateness of the professional performance...and to strive for quality patient care efficiently delivered and maintained consistent with locally available resources and to the degree reasonably possible as determined by the state of the healing arts in the community;
2.1.4 to provide a means through which the Medical Staff may participate in the policy making and planning process, medication management and patient safety...
ARTICLE 11
COMMITTEES AND FUNCTIONS...
11.2.2 Duties: The duties of the MEC (Medical Executive Committee) shall be to:
(c) account to the Board and the Staff for the overall quality, uniformity, and efficiency of medical care rendered to patients;...
(k) make recommendations to the Board on medical administrative and Facility management matters, particularly as they relate to patient care;...
11.4.7 Pharmacy and Therapeutics (Committee).
The duties involved in this function are to:
(a) perform an objective evaluation of the clinical use of all drugs in the Facility to reduce practice variations, errors and misuse;
(b) establish and implement a well controlled formulary to help control drug use in the Facility, and make recommendations as to which drugs should be added to and deleted from the formulary;
(c) monitor and evaluate the prophylactic, therapeutic, and empiric use of drugs, and evaluate all significant untoward reactions to drugs in an effort to ensure that drugs are provided appropriately, safely, and effectively;...
(f) assist in the formulation of and approve all professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, safety procedures, ordering and transcribing, preparing and dispensing, administration and monitoring, and other matters related to drugs in the Facility;.."

Reference the Tags A 0490 Condition of Pharmacy Services, A 0491 Pharmacy Administrator, A 0493 Pharmacy Personnel, A 0511 Formulary System and A 0722 Facilities (under the Condition of Physical Environment) for findings related to the administrative oversight of the department, lack of personnel, formulary system problems and inadequate facilities for the Pharmacy Department.

Based on staff interviews and reviews of medical records and other facility documents, the nursing department of the facility failed to ensure that nurses adequately assessed pain and documented the effectiveness of medication for pain management. In addition, the nursing department failed to employ auditing methods to identify medication administration errors. The department relied only on reported medication errors to identify medication administration problems.

The findings were:

1. Reference Tag A 131 for findings related to nursing administering multiple doses of psychotropic medications to a voluntary patient (sample patient #20) without his/her consent.

2. Reference Tag A 0286 Quality Assurance/Performance Improvement Tracking for findings related to the failure of the nursing department to institute auditing methods to identify nursing care problems, including medication administration errors.

3. Reference Tag 0404 Medication Administration for findings related to the nursing staff failure to consistently and adequately assess patients for pain and document effectiveness of pain medications administered for sample patients #14, and #23.

Based on review of medical records, policies and procedures, other facility documents and staff interviews, the hospital failed to ensure that all medications were prepared and administered by nurses in accordance with state and federal laws, orders of the practitioners responsible for the patients' care and acceptable standards of practice. Specifically, the nursing staff failed to ensure that nursing staff followed maximum 24-hour dosage guidelines and physician orders for administration of a pain medication containing acetaminophen to sample patient #23. In addition, the nursing failed to follow state and federal laws when they administered multiple doses of psychotropic medications to a voluntary patient (sample patient #20) without his/her consent. Finally, the nursing staff failed to consistently and adequately assess patients for pain and document effectiveness of pain medications administered.

The findings were:

1. Reference Tag A 286 for findings related to nursing failure to follow maximum 24-hour dosage guidelines and physician orders for administration of a pain medication containing acetaminophen to sample patient #23.

2. Reference Tag A 131 for findings related to nursing administering multiple doses of psychotropic medications to a voluntary patient (sample patient #20) without his/her consent.

3. Review of the medical records for sample patients #14, and #23 revealed that the patient had chronic pain issues in addition to their psychiatric conditions. Review of the records revealed that use of a "1 to 10" pain scale to document pain and effectiveness of pain medication was not consistently utilized when documenting pain for these patients. During an interview with the director of nursing on 5/17/11 at approximately 1:15 p.m., s/he acknowledged that the nursing department did not have a form or commonly utilized pain assessment policy and procedure. S/he stated that s/he had identified this problem. S/he stated that she was working on a pain assessment policy/procedure and would be working with nursing to standardize pain assessment documentation using the standard "1 to 10" pain scale in the future.

Based on facility tour, staff interview and review of the facility's policies/procedures the facility failed to ensure that unauthorized individuals could not gain access to or alter patient records.

The findings were:

A tour of the medical records department was conducted with the Health Information Services (HIS) Director on 5/19/2011 at approximately 9:05 a.m. The facility stored all medical records on-site. Long-term storage areas for medical records consisted of two rooms. Upon request the rooms were toured and revealed that for each room, the doors were unlocked prior to the HIS Director's entry with the surveyor. There were no staff members present in either of the two rooms. Interview at the time of the observation confirmed that both doors were currently unlocked and were so prior to the tour. S/he stated that a staff member from the HIS department would come in the morning and unlock the doors as s/he would pull old records for the new admissions from the previous night from the two rooms when s/he came in to the department in the morning. The HIS Director confirmed that the doors were unlocked without constant monitoring, and that no other security measures were in place to protect the records from unauthorized access.

A subsequent tour at approximately 10:00 a.m. revealed that both doors were locked.

A review of the facility's policies/procedures revealed that a policy titled "Access to Health Information Service Department" last revised/reviewed 03/11 stated, in pertinent parts,
"Due to the confidential nature of patient medical records, access to the Health Information Services, previously known as the Medical Records Department, is limited..."

Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Pharmaceutical Services. The facility failed to ensure that the pharmacy services met the needs of the patients.

The facility failed to meet the following standards under the Condition of Pharmaceutical Services:

Tag A 0491 Pharmacy Administrator
The facility failed to ensure that the pharmacy was administered in accordance with acceptable professional principles, including accurate formulary and appropriate drug storage.

Tag A 0493 Pharmacy Personnel
The hospital failed to ensure that the pharmacy was adequately staffed to ensure timely/quality pharmaceutical services. The inadequate staffing contributed to failures to monitor orders for off-formulary medications that were to be supplied by the patients, reported delays in filling prescriptions and other medication administration errors. The inadequate pharmacy staffing also contributed to a failure to engage in other monitoring activities to identify medication administration/order fulfillment problems and address them ensure medication administration safety in the facility.

Tag A 0511 Formulary System
The hospital failed to ensure that the formulary system, which was limited and relied heavily on use of patients' own medications and samples, assured quality pharmaceuticals that met the needs of the patients. In addition, the hospital failed to ensure the formulary accurately reflected what was stocked by the pharmacy, so that nursing staff and physicians would be aware of whether a particular medication was available or considered "non-formulary," requiring use of the patient's own medication, application for a non-formulary approval or substitution with another medication.

In addition, the facility failed to meet the following standard under the Condition of Physical Environment:

Tag A 0722 Facilities
The facility failed to ensure adequate space and facilities for the pharmacy to operate effectively and maintain all pharmacy standards for medication storage and preparation areas.

Based on review of medical records, facility documents, staff interviews and tours/observations, the facility failed to ensure that the pharmacy was administered in accordance with acceptable professional principles, including accurate formulary and appropriate drug storage.

The findings were:

1. Review of previous state board of pharmacy inspection reports for 2011 and 2009, revealed the following findings, in pertinent parts:
"12/15/09
...To be corrected:
...3) Per reg 5.01.3(c)(3), there shall be sufficient shelf, drawers and or cabinet space for proper storage of prescription drugs - do not store prescription drugs directly on the floor..."

"4/5/11
...Deficiencies To Be Corrected and Comments:
...2) Pharmacy needs to be cleaned/organized."

2. During a tour of the pharmacy on 5/17/11 at approximately 11 a.m., it was observed that in the small main room of the pharmacy, two plastic boxes of medications were sitting on the floor. The pharmacist stated that the medications had been delivered and were waiting to to be placed in stock on the shelves.

During a tour of the smaller back room of the pharmacy, the area appeared very crowded with boxes on shelving and some items, such as boxes of unusable drugs were in boxes on the floor awaiting pick-up by a vendor. The room had a counter with a sink on one end and open shelving above the counter/sink. The entire area was approximately 5 feet wide. There were numerous bottles of cleaning supplies, soap, a large opened bottle of mouthwash and a jar of peanut butter sitting on the area behind and to the sides of the small square sink. To the right of the sink was a cleared counter that had a plastic grid for laying out and preparing unit dose packets. The shelves above the sink had the plastic inserts for the unit dose packets. To the right of the counter on the wall was the poster outlining the steps to assemble the unit dose packets. The area appeared to be a work station for preparing unit dose medication. Further observation of the two small room that comprised the pharmacy, revealed that the only sink was the one in the back room near what appeared to be the unit dose preparation area. In addition, the only other work/counter area for preparing medications was in the main room and was a narrow, approximately 5-foot counter, with storage shelves and cabinets above and below the area. When asked if the unit dose medications were prepared at that counter area, the pharmacist stated that they "tried not to use that area," but s/he was unable to confirm that the counter area in the back room was never utilized for unit dose or other medication preparation.

3. During the tour of the pharmacy and during subsequent interviews with the pharmacist, s/he acknowledged that the pharmacy did not have a system for tracking timeliness of patients receiving their own medication (in circumstances where it was being brought into the facility after admission by patient family or friends). In addition, the pharmacist acknowledged that there was not a system in place to track timeliness of medication fulfillment or of processing nonformulary medication requests. S/he stated that the staffing demands did not allow for those kinds of activities.

4. On 5/18/11 at approximately 1 p.m., during a tour of the medication unit on the adult wing, prior to observing a medication administration, the medication nurse confirmed that the pharmacy does not review the medication administration records (MARS) for transcription errors. The medications are transferred from one 7-day MARS to another once a week. The nurse and the accompanying director of nursing confirmed that there was no system for checking for transcription errors other than that "the medication nurses prepared and passed medications for the same patients every day were likely to notice an error."

5. The pharmacist confirmed in a subsequent interview on 5/18/11 at approximately 2 p.m., that s/he did not have the staff time to review all of the copies of the MARS that were sent over to the pharmacy for errors. S/he stated s/he had to rely on the incident/medication error reports to identify problems.

Based on staff interviews and review of facility documents and medical records, the hospital failed to ensure that the pharmacy was adequately staffed to ensure timely/quality pharmaceutical services. The inadequate staffing contributed to failures to monitor orders for off-formulary medications that were to be supplied by the patients, reported delays in filling prescriptions and other medication administration errors. The inadequate pharmacy staffing also contributed to a failure to engage in other monitoring activities to identify medication administration/order fulfillment problems and address them ensure medication administration safety in the facility.

The findings were:

1. Review of the facility policy/procedure titled "Statement of Philosophy and Plan for Professional Services," last revised 6/10 revealed the following, in pertinent parts:
"...PHARMACY
Scope of Services
The Pharmacy's primary purpose is to provide medication services to the acute and residential patients of (the facility). Services are provided through a contract agreement with (a contracted pharmacy service).

One full-time Pharmacist staffs the Pharmacy, as well as a full-time Pharmacy Technician.

The Pharmacy shall provide medication services to the acute units, to (a residential child/adolescent unit), and to other residents as required. These services include but are not limited to planning, organizing, controlling, leadership, risk management, and performance improvement as they relate to medication. The pharmacy shall develop and administer policies and procedures; assume responsibility for all drugs and their distribution; assume responsibility for staffing, pharmacological and pharmacokinetic consults, in-service programs as needed, and coordinate activities with other departments.
...Hours of Operation
A pharmacist is available Monday - Friday, 8 a.m. to 4 p.m. The Pharmacist will be available on-call after hours, 7 days a week..."

2. In an interview of the pharmacist and his/her visiting corporate supervisor during a tour of the pharmacy on 5/17/11 at approximately 11 a.m., it was determined that the pharmacy was staffed with a full-time pharmacist and a part-time pharmacy technician. It was clarified that was the usual staffing. In a subsequent interview, the pharmacist stated that s/he did come in on the weekend days to also fill prescriptions. It was also clarified that the visiting corporate supervisor was a pharmacist licensed in another state, so s/he was available for consultation, but was not able to prepare medications in the pharmacy.

3. During an interview with the director of nursing on 5/17/11 at approximately 1 p.m., s/he acknowledged that there were problems with timely filling of prescriptions that s/he attributed to inadequate staffing. S/he stated that s/he and the chief executive officer had recently met with the pharmacist and his/her corporate supervisor to discuss problems related to the pharmacy, including delays of as much as "3 or 4 hours at times" in filling prescriptions. S/he stated that the meetings had generated a commitment from the pharmacist and his/her supervisor to generate a plan to correct the problem of delays.

4. Review on 5/19/11 of the medical record of sample patient #21 revealed that the patient came into the facility on a mental health hold after threatening to kill his/her military unit and self. Patient had a history of depression, anxiety and post-traumatic stress disorder. The patient had previously been on Seroquel IR (immediate release), but the hospital formulary only had Seroquel XR (extended release), so the physician ordered upon admission "Patient may use own supply of Seroquel IR when brought here." No other psychotropic medication was ordered. The Medication Record revealed the only psychotropic medication ordered was for "Seroquel 100 mg each bedtime for sleep - use patient supply." Review of the medication record revealed that despite the patient being in the hospital for four days, there was not one documented dose of the Seroquel or any other psychotropic medication having been administered. The patient was discharged against medical advice to his/her military unit and commanding officer because there had been no improvement and the patient denied the previous suicidal and homicidal ideation.

5. An interview with the facility's pharmacist on 5/18/2011 at approximately 1:45 p.m., revealed that the MAR was used by the pharmacy for charges and was not reviewed in any manner for possible medication errors or other medication administration system failures.

6. Reference Tag A 286 for further findings related to pharmacy failure to ensure that adequate monitoring systems were in place to address medication administration and that order fulfillment problems were identified and addressed to ensure medication administration safety in the facility.

Based on staff and physician interviews and review of medical records and facility documents, the hospital failed to ensure that the formulary system, which was limited and relied heavily on use of patients' own medications and samples, assured quality pharmaceuticals that met the needs of the patients. In addition, the hospital failed to ensure the formulary accurately reflected what was stocked by the pharmacy, so that nursing staff and physicians would be aware of whether a particular medication was available or considered "non-formulary," requiring use of the patient's own medication, application for a non-formulary approval or substitution with another medication.

The findings were:

1. Review on 5/17/11 of the Department of Pharmacy Policy #37 titled "Formulary" revealed the following, in pertinent parts:
"...The hospital has a Drug Formulary, which has been developed and approved by the Pharmacy and Therapeutics Committee and approved by the Medical Staff.

The existence of a hospital Drug Formulary does not preclude the use of unlisted drugs requested by physicians, which meet the required standards.

The medications are selected on the basis of patient need and safety and not solely on economics..."

2. Review on 5/17/11 of the Medical Executive Committee Meeting minutes for 3/23/11, revealed the following, in pertinent parts:
"...3.3 Pharmacy Report...Latuda, a new long acting anti-psychotics, was added to the Formulary. The pharmacy has coupons to give patients upon discharge for a free 14-day supply...
Seroquel (a commonly use anti-psychotic medication) continues to be a problem due to the fact that the Hospital is not receiving ample supplies. (The medical director) will ask the doctors to consider other therapies and only use sample dosages that are supplied. Another consideration mentioned was dosing once daily rather than dosing multiple times per day..."
3. Review on 5/19/11 of the medical record of sample patient #21 revealed that the patient came into the facility on a mental health hold after threatening to kill his/her military unit and self. Patient had a history of depression, anxiety and post-traumatic stress disorder. The patient had previously been on Seroquel IR (immediate release), but the hospital formulary only had Seroquel XR (extended release), so the physician ordered upon admission "Patient may use own supply of Seroquel IR when brought here." No other psychotropic medication was ordered. The Medication Record revealed the only psychotropic medication ordered was for "Seroquel 100 mg each bedtime for sleep - use patient supply." Review of the medication record revealed that despite the patient being in the hospital for four days, there was not one documented dose of the Seroquel or any other psychotropic medication having been administered. The patient was discharged against medical advice to his/her military unit and commanding officer because there had been no improvement and the patient denied the previous suicidal and homicidal ideation.

4. Review of medical record of sample patient #5 on 5/19/11 revealed that the patient was admitted with orders for continued use of medications from the patient's own supply. Per review of the form "Medication Reconciliation/Physicians Orders," which was completed at the time of admission on 4/13/11, the patient's own psychotropic medications (Trileptal 150 mg twice daily for mood and Latuda 40 mg every evening for mood) were ordered. Review on 5/18/11 of the formulary (dated 3/11) revealed that Trileptal 150 mg was listed on the formulary and Latuda, per previously referenced medical executive committee meeting minutes, was available through the formulary as of 3/23/11. Despite availability of both medications through the formulary, it appeared that nursing staff were ordered to administer the medication from the patient's own supply.

5. Review of the medical record of sample patient #11 on 5/19/11 revealed that the patient was admitted with orders for continued use of medications from the patient's own supply. Per review of the form "Medication Reconciliation/Physicians Orders," which was completed at the time of admission on 4/1/11 at 2:30 p.m., the patient's won seizure control medication (Keppra 1000 mg four times per day for epilepsy) was ordered. Review of the "Psychiatric Admission Assessment and Work Up" on 5/19/11 revealed the following, in pertinent parts:
"...Current Medications: Current Medications at home, Zyprexa 20 mg p.o. at nighttime, Prozac 10 mg p.o. daily, Keppra 1000 mg p.o. qid (4x/day). These medications were slightly adjusted on hospital admission, with the addition of Ultram to replace home methadone, unknown mg methadone dose taken before. It was anticipated that Keppra would have been in by boyfriend, for continuation here, since this is a non-formulary medication at this hospital, however, he does not have enough gas to bring the medications to this facility..."

Review on 5/18/11 of the formulary (dated 3/11) revealed that Keppra and Ultram were not listed. Although review of the medication administration record revealed that the patient did receive doses of Ultram, no application for a "Nonformulary Drug Requests" was found for that medication and there was no indication that Ultram was provided by the patient.

Review of "Physician's Orders" on 5/19/11, revealed the following, in pertinent parts: "4/2/11 at 11:30 a.m. - 1. Keppra 1000 mg po QID (4x/day) - Submitting non-formulary request for this (unable to access patients home supply) (Seizures)..."

Review on 5/19/11 of the "Nonformulary Drug Requests" for 2011 revealed that an application for Keppra 1000 mg po QID was approved by the medical director on 4/2/11.

Review of the medication administration sheets for the patient revealed that the patient missed 2 doses of Keppra on 4/1/11 (5 p.m., 9 p.m.) and 2 doses on 4/2/11 (9 a.m. and 1 p.m.) because the patient's own medication was not available and then during the time additional time it took to approve the Nonformulary drug request, once it became clear that the patient's own medication was not going to be provided timely.

6. Review of the medical record of sample patient #23 on 5/18/11 revealed that the patient was admitted on 4/26/11 after a suicide attempt, history of depression, with a secondary diagnosis of chronic pain. The chronic pain was previously controlled at home with a combination of Hydromorphone 8 mg po BID (2x/day) for pain, Oxycontin 40 mg po QID (4x/day) for pain, Dilaudid 8 mg po every four hours as needed for pain. All of those medications were discontinued at the time of admission. Vicodin 5/500 2 tablets every four hours as needed for pain (not to exceed eight tablets in 24 hours) on 4/26/11. On 4/30/11, the medical specialist added an order for Toradol 30 mg intramuscular injections BID (2x/day) as needed for pain. Review of the medical record revealed extensive documentation from the nursing staff and physicians that the patient continued to have problems with pain control and spent a lot of time in bed and not participating in activities related to pain complaints.

A Progress Note, dated 5/3/11 (the day prior to discharge), contained the following, in pertinent parts: "...The patient continues to complain about severe pain. S/he has been taking a lot of Toradol shots, and had two yesterday, two the day before and at least one the day before that. S/he is asking for them again, but this will have to be okayed by the medical doctor. S/he did say that s/he gets very depressed because of his/her pain, and we are trying to get him into a VA facility where they may be able to address that more efficiently...The patient does appear to be gradually improving, but is still in a significant amount of pain. S/he was on a much heavier pain regimen prior to arrival here, but we did not have a lot of pain meds that he was taking. We will try to get him into the VA Hospital..."

The Discharge Summary stated the following, in pertinent parts:
"...(Patient) was in a significant amount of pain throughout his/her stay, and in fact, his/her pain issues were his/her primary focus of this admission, rather than the psychiatric issues...(Patient) continued having significant pain issues, and much of the pain medications that s/he was taking prior to coming to the hospital are not available here, and so s/he was not able to get them. This caused (patient) to be in significant amount of pain much of the time. (Patient) stated his/her suicidal thoughts did improve while here, for the most part. For his/her pain s/he was given Toradol as prescribed by the medical doctor, which was twice a day for several days prior to (discharge)...(Patient) was in somewhat better condition, but the main thing that will help him/her right now is getting his/her pain under better control. (The patient) is a lower risk of harm to self, if his pain is not taken care of, that risk increases."

7. During a tour of the pharmacy on 5/17/11 at approximately 11 a.m., it was observed that Vicodin and Percocet were in stock on the shelves in the pharmacy and the pharmacist confirmed that they were available for pain management in the facility. Later review on 5/18/11 of the formulary (dated 3/11) revealed that Percocet was not listed as part of the formulary.

8. Further interview with the pharmacist during the tour on 5/17/11 and during subsequent interviews during the survey, it was determined that the hospital/medical staff had taken a position of limiting pain medication medications utilized in the facility, rather than continuing with the pain medication regimens that patients were being maintained on at home. In addition, the pharmacist confirmed that it was common practice to utilize the patients' own medications and supplementation of the limited formulary with samples of psychotropic medications. S/he stated that this practice reflected the philosophy of the medical staff and was present when s/he began working at the facility. S/he clarified that patient's own medications had to be inspected and approved by the pharmacy prior to administration to the patient. S/he explained the process for getting a medication that was Nonformulary approved. S/he stated that the physician filled out the application, which required the approval of the medical director before the medication could be acquired from an outside pharmacy. When asked if s/he maintained a log of patients' own medications that were ordered, to provide information for review and additions to the formulary, the pharmacist stated that s/he did not. The pharmacist did maintain a copy of each application for Nonformulary medication.

The pharmacist also clarify that medications provided through sample supplies were listed as no charge and did not generate a charge to the patient or his/her insurance carrier. S/he state that the pharmaceutical companies also provided coupons for free or discounted medications that the patient could utilize after discharge.

9. On 5/19/11 at approximately 10 a.m., the medical director was interviewed about the formulary, approval of Nonformulary medications, the frequent practice of utilizing the patients' own medication and the availability of pain medications. S/he confirmed that it was common practice to utilize the patient's own medication, once it had been inspected and approved by the pharmacist. S/he explained that the philosophy of the medical executive committee was that pain medications needed to be limited with some acceptable substitutions to control pain based on recent feedback from local emergency rooms and other clinical information. S/he stated the information indicated increase risk for sudden death with interaction of opiates and other medications, including psychotropic medications. When presented the findings (that the patient had not had good pain control because of a lack of pain control options being available in the formulary) in sample record #23, s/he stated that s/he was surprised by this information and believed that the physician should have been able to get the medication to control the patient's pain. S/he stated that s/he was available to consult with physicians about alternatives when they were limited by the formulary, whether for psychotropics or pain management issues. Finally, the medical director explained the process for application for approval of a Nonformulary medication for a patient. S/he stated that s/he "approved applications everyday" and then qualified that statement by saying it occurred "very frequently."

10. Review on 5/19/11 of the "Nonformulary Drug Requests" for 2011 revealed no applications for January and February, seven applications for March and two for April as of the dates of the survey 5/16/11 through 5/19/11. The findings were:
3/1/11 for Tenex (guanfacine) 0.25 mg liquid for pediatric patient with small body weight. Checked as approved, but not signed by the medical director.

3/11/11 for Seroquel IR 50 mg. Signed by medical director, but not checked for approved or not approved.

3/11/11 for Seroquel IR 50 mg. Requested and signed by medical director, but not checked for approved or not approved.

3/14/11 for Seroquel IR 100 mg. Requested and signed by medical director, but not checked for approved or not approved.

3/21/11 for Seroquel IR 300 mg. Requested and signed by medical director, but not checked for approved or not approved.

3/22/11 for Seroquel IR 50 mg. Requested and signed by medical director, but not checked for approved or not approved.

3/27/11 for Seroquel IR 100 mg. Application on a different form that did not contain medical director approval.

4/2/11 for Keppra 100 mg. Application was signed as approved (sample patient #11).

4/8/11 for Keppra 500 mg. Checked as approved and signed by the medical director.

In summary, the formulary system relied on sample medication and extensive use of the patients' own medication to supplement the limited formulary. In addition, the formulary did not contain an accurate list of all of the medications that were or were not available. The formulary system also provided for a way to access Nonformulary medication through an application process involving approval by the medical director. Although the medical director verbalized his/her impression that the option of application for Nonformulary medication was available and frequently utilized, the review of applications for 2011 revealed that the process was rarely utilized. Reviews of medical records revealed instances of delayed doses of psychotropic and pain medication related to the formulary system and underlying philosophy that was implemented by physicians, nursing staff and pharmacy.

Based on staff interviews and review of facility documents and tours/observations, the facility failed to ensure adequate space and facilities for the pharmacy to operate effectively and maintain all pharmacy standards for medication storage and preparation areas.

The findings were:

Reference Tag 0491 for findings related to the physical condition and limitations of the area in the facility allocated for the Pharmacy Department.