HospitalInspections.org

Based on observation, record review, and staff interview, the Creston Medical Clinic (CMC) staff failed to ensure that patient care equipment available for patient use contained current expiration dates for 2 of 4 pods in the CMC. The Director of Clinic Services reported an average monthly patient volume of 1840 visits for the CMC.

Failure to ensure patient care equipment that has current expiration dates could potentially result in use of equipment that lacks sterility and potency.

Findings include:

1. During an observation on 10/21/10 at 8:45 AM, with Staff J, CMC Licensed Practical Nurse (LPN) revealed the following expired patient equipment in Pod A procedure room:
- 3 of 3-Insyte IV (intravenous) 18 ga. (gauge) x 1.16 inch expired 3/05
- 1 of 1-Terumo Needle (needle used to draw blood) 21ga x 1inch 100 needles expired 7/06

2. During an observation on 10/21/10 at 9:10 AM, with Staff K, CMC MA (Medical Assistant), revealed the following expired patient equipment in Pod A room 5:
- 1of 1-Hemoccult developer (used to test for blood in a stool specimen) 15 ml (milliliter) ? full expired 4/10
- 2 of 2-Vaseline Petrolatum Packing Strip (used for packing wounds) expired 2/06
- 3 of 3-PVP Iodine swabs (large q-tips saturated in iodine solution) expired 10/08

3. During an observation on 10/21/10 at 9:15 AM, with Staff L, CMC CMA (Certified Medical Assistant), revealed the following expired patient equipment in Pod B room 1:
- 2 of 2-Hemoccult developer 15 ml ? full expired 7/09
- 1 of 1-Curity Plain Packing Strip (used for packing wounds) ? inch expired 8/10
- 1 of 1-Iodoform Packing Strip (used for packing wounds) ? inch expired 12/08

4. A review of the policies for CMC on 10/26/10, revealed the CAH (Critical Access Hospital) administrative staff failed to develop and implement policies related to patient care and to ensure the overall quality and safety of the patient care provided.

5. During an interview on 10/21/10 at 8:45 AM, Staff J showed, nursing staff try to check for expiration dates and verify the expiration dates prior to patient care. I am unsure that I was trained to check for expiration dates.

During an interview on 10/25/10 at 4:05 PM, Director of Clinical Services, revealed that CMC administrative staff lacked a completed set of policies/procedures.

Based on review of documents and staff interview, the Critical Access Hospital (CAH) facilities staff failed to ensure the provision of a written agreement for emergency water and fuel. The CAH identified a census of 12 patients.

Failure to ensure emergency water and fuel available to meet the CAH's critical functions during an emergency/crisis situation could potentially cause a lack of necessary resources to provide adequate patient care during an emergency.

Findings include:

1. A review on 10/19/10 of the policy titled, "Loss of Normal Water Supply", dated 2/92, stated in part. "Policy: Recognizing that water is required to sustain life and is an integral part of providing quality patient care, the hospital has established a procedure for and assigned responsibilities for procuring water for the hospital when the normal water supply is not available or contaminated. It is the policy of this hospital that the hospital CEO (Chief Executive Officer) or his designee will determine the severity of the problem related to the loss of normal water supply and initiate the appropriate procedure. . . ."

A review on 10/19/10 of the policy titled, "Code Brown-Utility Failure", dated 9/08, stated in part. "Policy: Recognizing that Electricity is required to sustain life and is an integral part of providing quality patient care, the hospital has established a procedure for and assigned responsibilities for procuring electricity for the hospital when the normal electricity supply is not available. It is the policy of this hospital that the hospital CEO or his designee will determine the severity of the problem related to the loss of normal electricity supply when the normal electricity supply is not available. . . ."

Review of the documentation lacked evidence of a signed agreement between the CAH and an outside resource.

2. During an interview on 10/19/10 at 10:45 AM, the Assistant Director of Facilities Safety Officer stated the CAH lacked signed contracts for emergency fuel and water.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to develop and implement policies/procedures for the physician's responsibility for periodic review of the CAH's patient records, in conjunction with the mid-level practitioner for 2 of 3 mid-level practitioners. (Practitioners J, K)

The Director of Clinics reported an average of 229 patient visits per month by Practitioner J and an average of 95 patient visits per month by Practitioner K.

Failure of the physician periodic review the CAH's patient records in conjunction with the mid-level practitioner could potentially result in mid-level practitioners misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH's "Quality Improvement Plan" approved by the Board of Trustees on 2/22/10 stated in part. ". . . Activities . . . Peer Reviews which include Medical, Surgical and Emergency case reviews - physicians and midlevels. . . "

Review of CAH policies/procedures on 10/25/10, revealed the CAH administrative staff failed to develop and implement policies/procedures specific to the physician's responsibility for the periodic review of the CAH's patient records, in conjunction with the clinic mid-level practitioners.

2. Review of the Medical Staff Meeting minutes for the 2010 year lacked physician periodic review of the CAH's patient records, in conjunction with the mid-level Practitioners J, K.

3. During an interview on 10/25/10 at 2:50 PM, the Chief Nursing Officer and the Director of Quality Services acknowledged the CAH quality staff failed to develop and implement policies/procedures specific to the physician's responsibility for the periodic review of the CAH's patient records, in conjunction with the clinic mid-level practitioners.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to develop and implement policies/procedures for the mid-level's responsibility for periodic review of the CAH's patient records, in conjunction with the physician, for 2 of 3 mid-level practitioners. (Practitioners J, K)

The Director of Clinics reported an average of 229 patient visits per month by Practitioner J and an average of 95 patient visits per month by Practitioner K.

Failure of the physician periodic review the CAH's patient records in conjunction with the mid-level practitioner could potentially result in mid-level practitioners misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH's "Quality Improvement Plan" approved by the Board of Trustees on 2/22/10 stated in part. " . . . Activities . . . Peer Reviews which include Medical, Surgical and Emergency case reviews - physicians and midlevels. . . "

Review of CAH policies/procedures on 10/25/10, revealed the CAH administrative staff failed to develop and implement policies/procedures specific for the periodic review of the CAH's patient records by the physician in conjunction with the clinic mid-level practitioners.

2. Review of the Medical Staff Meeting minutes for the 2010 year lacked physician periodic review of the CAH's patient records, in conjunction with the mid-level Practitioners J, K.

3. During an interview on 10/25/10 at 2:50 PM, the Chief Nursing Officer and the Director of Quality Services acknowledged the CAH quality staff failed to develop and implement policies/procedures specific for the periodic review of the CAH's patient records by the physician in conjunction with the clinic mid-level practitioners.

Based on observations, review of policies/procedures, documentation, patient medical records, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the CAH pharmacy had a system in place to maintain the pharmacy and its contents in a secure manner; maintain oversight of the security of medications, sample medications, and medication expiration dates in 2 of 2 off-site clinics. (Morning Star Internal Medicine Clinic and Creston Medical Clinic)

1. This determination was evidenced by:

a. The CAH pharmacy staff failed to follow the established policy/procedures for the security the pharmacy and its contents, oversight of sample medications in all areas of the CAH, for the security of medications/sample medications, and for removing expired medications/sample medications. (Refer to C-0271)

b. The CAH Director of Clinic Services failed to develop and implement policies for the Creston Medical Clinic (CMC). The CMC became a member of the CAH system 1/01/10. (Refer to C-0272)

c. The CAH pharmacy staff failed to secure 1 of 1 main Pharmacy and its contents from unauthorized access by an unauthorized non-hospital employee. (Refer to C-0276)

d. The CAH pharmacy staff failed to ensure the secure storage of medications in 2 of 2 off-site clinics (Morning Star Internal Medicine Clinic and Creston Medical Clinic). (Refer to C-0276)

e. The CAH pharmacy staff failed to develop and maintain a system for oversight of all aspects of pharmaceuticals in the CAH including sample drugs (Morning Star Internal Medicine Clinic and the Creston Medical Clinic). (Refer to C-0276)

f. The CAH pharmacy and clinic staff failed to ensure expired medications were not available for patient use in all areas of the CAH (Morning Star Internal Medicine Clinic and Creston Medical Clinic). (Refer to C-0276)

g. The CAH pharmacy staff failed to ensure the notification of the physician when a medication error occurred. (Refer to C-0277)

h. The Critical Access Hospital (CAH) administrative staff failed to ensure the review of patient care policies for the Morning Star Internal Medicine Clinic on an annual basis by the required group of professionals. (Refer to C-0280)

2. The cumulative effect of these systemic failures and deficient practices resulted in the CAH's inability to ensure the health and safety of inpatients and outpatients of the CAH receiving medications, biological, and other pharmaceutical agents and outpatients of its Morning Star Internal Medicine Clinic and Creston Medical Clinic receiving sample medications from the clinics.

I. Based on observation, review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed follow the established policy/procedure ensure the security for 1 (of 1) main Pharmacy and its contents from unauthorized access. Problem identified in the main Pharmacy.

Three of 3 Pharmacists and 4 of 4 Pharmacy Technicians are the only staff members authorized to have a key badge that allowed entry into the CAH's pharmacy.

Failure of CAH staff to follow established policies/procedures related to the security of the main pharmacy and its contents allowed an unauthorized person to enter the pharmacy with an unauthorized key badge. The use of the unauthorized key badge allowed a non-hospital serviceman access to a variety of medications and place CAH staff at risk of harm from an intruder.

Findings include:

1. Observation during a tour of the Pharmacy on 10/21/10 at 3:30 PM with the Director of Pharmacy revealed Serviceman I entered the locked Pharmacy door at approximately 4:07 PM without Pharmacy staff opening the door for the Serviceman. The Serviceman proceeded to check 2 smoke/fire alarm sensors in the Pharmacy. Serviceman I was an unauthorized non-hospital employee who installed the security system and the fire alarm system previously.

The Director of Pharmacy approached Serviceman I and asked how the serviceman was able to enter the locked pharmacy door. Serviceman I stated he used a key badge to enter the Pharmacy. The Director of Pharmacy asked Serviceman I "how did you get key badge access". Serviceman I responded he had given himself key badge access into the pharmacy when he installed the pharmacy security system approximately 8 to 12 months ago.

2. Review of Pharmacy policies/procedures titled "Authorized Access to the Pharmacy", dated 9/1/2004, revealed the following in part. "Policy: Only Authorized Persons Shall Be Allowed in the Pharmacy: Access to the main Pharmacy is limited to the Pharmacist and his/her staff during Pharmacy operating hours. Medical staffs, nursing service, administrative, Environmental Services and other personnel are authorized admission only in conjunction with their duties and under supervision of Pharmacy staff."

Review of Human Resources policies/procedures revealed policy/procedure titled "ID Badges", dated 2/2003, revealed the following in part. "Policy: Greater Regional Medical Center provides to every employee a Photo ID badge, and Emergency Responder badge, and a key badge upon hire to the facility. . . . The key badge may be used by the employee to enter into the facility through a non-public access door assigned to them during regular business hours or after hours. Procedure: . . . On the employee's first day they will receive their ID badge, Emergency Responder badge, and key badge."

3. Review of documentation provided by Human Resources Officer on 10/25/10 at 11:55 AM, revealed a report titled "Door Access Granted" to the Pharmacy for 10/2/10 to 10/25/10 that showed Serviceman I, a non-hospital employee, entered the Pharmacy via key badge access on 10/21/10 at 4:04 PM.

Serviceman I possessed a key badge with user number 9998, which allowed him/her to enter all areas of the hospital including the main Pharmacy.

4. During an interview on 10/21/10 at 4:10 PM, the Director of Pharmacy stated he/she was not aware that Serviceman I had key badge access to the main Pharmacy. The Director of Pharmacy further clarified that only the Pharmacists and Pharmacy Technicians have key badge access to the main Pharmacy.

During an interview on 10/25/10 at 11:55 AM, the Human Resource Officer reported being the person responsible for issuing the key badges to employees. The Director of Pharmacy approved which employees have key badge access to the pharmacy. The Human Resource Officer stated the hospital did not issue key badge access to the pharmacy to Serviceman I, a non-hospital employee, and was unaware Serviceman I had given himself key badge access to the pharmacy at the time of the installation of the key badge security system to the pharmacy.


II. Based on observation, review of policies/procedures, documentation, patient medical records, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed to follow established policies/procedures to track and account for the receipt and distribution of sample medications subject to oversight by the pharmacy at 2 of 2 clinics. (Morning Star Internal Medicine Clinic and the Creston Medical Clinic)

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and 1840 patient visits per month for the Creston Medical Clinic. The Director of Clinics reported an average of 8 patients per month received sample medications in the Morning Star Internal Medicine Clinic and an average of 5 patients per month received sample medications in the Creston Medical Clinic.

Failure of CAH staff to follow established policies/procedures related to the pharmacy oversight of sample medications resulted in expired sample medications being available for physicians and mid-level providers to give to patients, and the potential for theft of medications by unauthorized persons.

Findings include:

1. Observation during tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 8:35 AM with Staff A, a clinic Licensed Practical Nurse (LPN), revealed 1 of 1 sample medication room that contained approximately 460 boxes of prescription medication samples. Categories of sample medications in the room were medications to control blood pressure, prevent stroke, treat cardiac conditions, replace hormones, treat mood disorders, and treat and manage diabetes.

Observations during tour of the Creston Medical Clinic on 10/21/10 at 8:00 AM with Director of Clinic Services revealed 3 of 3 sample medication rooms that lacked any mechanisms to lock the doors, and 3 of 3 unlocked refrigerators in a common hallway used by clinic staff and patients.

Three of 3 sample medication rooms each measured 6 foot 4 inches by 8 foot 9 inches and contained the following.

Pod A sample medication room contained 16 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications for smoking cessation, treat gastro-intestinal problems, treat mood disorders, replace hormones, treat and manage diabetes, treat cardiac conditions, and treat respiratory and allergy problems.

Pod B sample medication room contained 12 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications to treat mood disorders, treat Alzheimers, treat urinary retention, treat prenatal conditions, treat high cholesterol problems, treat and manage diabetes, treat cardiac conditions, treat respiratory problems, and treat and manage bone density problems.

Pod C sample medication room contained 10 shelves of sample medications, copy machine, coffee pot, and Christmas decorations. Categories of sample medications in the room were medications to treat and manage diabetes, treat cardiac conditions, treat respiratory problems, treat high cholesterol problems, treat mood disorders, treat and control pain, treat urinary retention, replace hormones, treat and manage bone density problems, treat gastro-intestinal problems, treat Alzheimers, and treat and manage sleep problems.

2. Review of Pharmacy policies/procedures revealed policy/procedure titled "Drug Procurement/Inventory Control", dated 9/1/2004, revealed in part. "Policy: Responsibility for control of medications within this hospital rests with the Pharmacy Department. Policies and procedures are designed to ensure the safe and accurate dispensing of medications throughout the hospital. These policies will be approved by the Pharmacy and Therapeutics Committee. Procedure: Acquisition: The Pharmacy Department is responsible for the acquisition of pharmaceuticals for this hospital. The Pharmacist is responsible for specification as to quality, quantity and source of supply all drugs used in the hospital. . . ."

Review of Pharmacy policies/procedures revealed policy/procedure titled "Drug Samples", dated 9/1/2004, revealed in part. ". . . In the interest of effective control, and to comply with federal law, the distribution of drug samples within the confines of Greater Community Hospital is forbidden. Samples found within the facility will be confiscated by the Pharmacy Department and discarded appropriately. . ."

Review of Pharmacy policies/procedures revealed policy/procedure titled "Medication Management Program", dated 9/1/2004, revealed in part. "Policy: The Pharmacy and Therapeutics Committee (MORS), acting on behalf of the medical staff, shall implement a Medication Management Assessment and Evaluation Program to provide a system to ensure medication use within the organization is conducted in a safe and optimal manner. The Medication Management Assessment and Evaluation program requires the routine evaluation of literature for new technologies and best practices that have been demonstrated to enhance safety in other organizations to determine if these practices are conducted successfully within the organization or if they should be implemented to improve the medication management system. The Medication Management Assessment and Evaluation Program identify risk points (including medication errors and adverse drug reactions) and identify areas to improve patient safety as well as the overall use of medications throughout the organization. . . . For the purposes of this program the definition of medication includes: . . . Sample medications. . . . The Pharmacy and Therapeutic Committee (MORS) will maintain oversight for the Medication Management Assessment and Evaluation Program. . . The Pharmacy Department provides fundamental functions as well as key oversight responsibilities and activities in the system of medication management. . . Storage of medications. . . ."

Review of Pharmacy policies/procedures revealed policy/procedure titled "Pharmacy and Therapeutics Committee", dated 9/1/2004, revealed in part. "Policy: The Pharmacy and Therapeutics Committee exists as part of the hospital medical staff committee: Medical/Obstetrics/Radiology/Special Services (MORS). This committee is selected under the guidance of the medical staff, and it is also a policy and procedure recommending body to the medical staff and administration of the hospital on all matters related to the use of medications. . . . Functions and Scope: . . . To monitor implementation of the written policies and procedures and make recommendations for improvement. The Pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementation of procedures. . . ."

On 10/21/10 at 9:45 AM, the surveyor requested a policy/procedure delineating the clinic's process for managing sample medications in the Morning Star Internal Medicine Clinic, Staff A provided a document titled "Pharmaceutical Representatives", dated 4/1/2009. The document only addressed dates and times that clinic providers were available to see drug representatives and/or receive sample medications. The document lacked a system to log, track, or monitor the expiration dates of the sample medications stored at the clinic or the patient receiving the sample medications.

Review of the Morning Star Internal Medicine Clinic policy/procedure titled "Pharmaceutical Representatives" showed it lacked a system that tracked and accounted for sample medications received in the clinic, dispensed to patients, including the lot numbers of sample medications, and expiration dates.

Review of the Morning Star Internal Medicine Clinic and Creston Medical Clinic policy/procedure manuals revealed the clinic administrative staff, in conjunction with pharmacy staff, failed to develop and implement policies/procedures that delineated a system to track and account for medications received in the clinic, dispensed to patients, including lot numbers of sample medications, or expiration dates.

3. Review of the Director of Pharmacy job description, dated 9/1/2004 revealed the following in part.
a. "Statement of Purpose - Responsible for directing, coordinating and controlling the operation of the Pharmacy Department; ensures compliance with patient care quality standards and current concepts in Pharmaceutical Care and: directs and controls the purchase and inventory maintenance of all pharmaceuticals and related substances/supplies; directs and participates in the department's planning, revenue analysis, budgeting, education and human resource management activities.

b. Major Tasks, Duties and Responsibilities

Directs, coordinates and controls the overall operation of Pharmacy Services, with and emphasis on all aspects of Pharmaceutical Care. . .

Directs and coordinates the integration of the Pharmacy Department ' s functions with other aspects of overall patient care. . . .

Works closely with the nursing and medical staff and other clinical department heads in addressing pharmaceutical services issues and to support the maintenance of high-quality patient/Pharmaceutical Care. . . .

Directs the pharmacy's quality assessment and improvement activities and ensures compliance with patient care and medical practice standards. . . .

Oversees the storage and distribution of all pharmaceutical items and ensures compliance by departmental locations and patient care units with established inventory control standards and procedures and federal and state regulations. . . ."

4. Review of the Medical/Obstetric/Radiology/Special Services (MORS) Meeting minutes from 1/8/09 through 7/1/10 showed the members failed to address the development and implementation of policies and procedures that would include a system to track and account for the receipt and distribution of sample drugs in the Morning Star Internal Medicine Clinic and Creston Medical Clinic.

The Morning Star Internal Medicine Clinic became part of the CAH on 11/30/07. The Creston Medical Clinic became part of the CAH on 1/1/10.

5. The CAH lacked a system for the pharmacy to follow the flow of pharmaceuticals from all CAH locations, including the entry of sample medications into the clinics through dispensation/administration. Neither the pharmacy staff nor the clinic staff maintained documentation of the sample medications stored in the Morning Star Internal Medicine Clinic or the Creston Medical Clinic.

6. Review of a random sample of closed patient medical records in the Morning Star Internal Medicine Clinic revealed the following:
a. Patient # 1; medical record showed Patient # 1 received 28 doses of Diovan 320/25 on 6/22/10.

b. Patient # 2; medical record showed Patient # 2 received 2 samples doses of Actonel on 6/24/10.

c. Patient # 3; medical record showed Patient # 2 received 4 boxes of samples of Micardis 40 mg and 2 boxes of samples of Micardis 80 mg on 9/20/09.

7. During an interview on 10/21/10 at 9:20 AM, Staff A stated that clinic staff/provider do not always write in the patient ' s medical record that the patient received sample medications. Staff A further stated that if the staff write in the patient's medical record that the patient received sample medications, the documentation would not include the lot number or expiration date of any sample medication given to the patient.

During an interview on 10/21/10 at 9:55 AM, Practitioner A stated he/she does not always include in the dictation that the patient received sample medications during the patient's clinic visit and does not document the lot number or expiration date of any sample medication given to the patient.

During an interview on 10/21/10 at 3:30 PM, The Director of Pharmacy acknowledged the Pharmacy Department failed to maintain oversight of the Morning Star Internal Medicine Clinic and Creston Medical Clinic Pharmaceuticals since the clinics became a part of the CAH. The Morning Star Internal Medicine Clinic became a part of the CAH on 11/30/2007 and the Creston Medical Clinic became a part of the CAH on 1/1/2010.

The Director of Pharmacy stated that the Pharmacy policies/procedures lacked changes to include the practices for the use of sample medications in the clinics. The Director of Pharmacy also stated the Pharmacy Department staff failed to monitor for secure drug storage or expired medications in the clinics.

The Director of Pharmacy stated he/she was not aware the sample medication rooms in the Creston Medical Clinic lacked any mechanism to lock the doors and that non-hospital contract persons cleaned the Creston Medical Clinic after clinic business hours. The Director of Pharmacy acknowledged he/she was aware that sample medications were kept in the clinics as clinic staff would periodically bring expired sample medications to the pharmacy for proper disposal. The Director of Pharmacy stated he/she was not aware of any documentation in the clinics to follow the flow of pharmaceuticals from all CAH locations, including the entry of sample medications into the clinics through dispensation/administration. The pharmacy failed to maintain records of the sample drugs stored in the Morning Star Internal Medicine Clinic or the Creston Medical Clinic.


III. Based on observation, review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed to follow the established policies/procedures to ensure the secure storage of medications in 2 of 2 off-site clinics in accordance with policies/procedures (Morning Star Internal Medicine Clinic and Creston Medical Clinic).

The Director of Clinic Services reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and an average of 1840 patient visits per month for the Creston Medical Clinic.

Failure of CAH staff to follow established policies/procedures related to the security of all medications/sample medications resulted in the potential theft of medications by unauthorized persons.

Findings include:

1. Observations during tour of the Creston Medical Clinic on 10/21/10 at 8:00 AM with Director of Clinic Services revealed 3 of 3 sample medication rooms that lacked any mechanisms to lock the doors, and 3 of 3 unlocked refrigerators in a common hallway used by clinic staff and patients.

Three of 3 sample medication rooms each measured 6 foot 4 inches by 8 foot 9 inches and contained the following.

Pod A sample medication room contained 16 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications for smoking cessation, treat gastro-intestinal problems, treat mood disorders, replace hormones, treat and manage diabetes, treat cardiac conditions, and treat respiratory and allergy problems.

Pod B sample medication room contained 12 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications to treat mood disorders, treat Alzheimers, treat urinary retention, treat prenatal conditions, treat high cholesterol problems, treat and manage diabetes, treat cardiac conditions, treat respiratory problems, and treat and manage bone density problems.

Pod C sample medication room contained 10 shelves of sample medications, copy machine, coffee pot, and Christmas decorations. Categories of sample medications in the room were medications to treat and manage diabetes, treat cardiac conditions, treat respiratory problems, treat high cholesterol problems, treat mood disorders, treat and control pain, treat urinary retention, replace hormones, treat and manage bone density problems, treat gastro-intestinal problems, treat Alzheimers, and treat and manage sleep problems.

The 3 of 3 unlocked dorm-size refrigerators contained vaccines.

Observations during tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 10:45 AM with Staff D, Clinic LPN, revealed 1 of 1 unlocked dorm-size refrigerator in a common hallway used by clinic staff and patients. The unlocked refrigerator contained vaccines, and medications to treat and manage diabetes.

2. Review of Pharmacy policies/procedures titled "Drug Procurement/Inventory Control", dated 9/1/2004, revealed the following in part. "Policy: Responsibility for control of medications within this hospital rests with the Pharmacy Department. Policies and procedures are designed to ensure the safe and accurate dispensing of medications throughout the hospital. . . . Procedure: . . . Medications are stored in a secure manner. . . ."

Review of the Morning Star Internal Medicine Clinic and the Creston Medical Clinic policy/procedure manuals revealed the clinic administrative staff failed to develop and implement policies/procedures that delineated a process to ensure the security of medications in the clinic.

3. During an interview on 10/21/10 at 8:10 AM, the Director of Clinic Services stated non-hospital private contracted persons are responsible for cleaning the Creston Medical Clinic after business hours. Cleaning included vacuuming, dusting, and emptying trash throughout the clinic including the sample medication rooms. The Director of Clinic Services verified the lack of clinic staff present when the non-hospital private contracted persons performed cleaning activities in the clinic and could have access to unsecured medications in the unlocked sample medication rooms and unlocked refrigerators.

During an interview on 10/21/10 at 10:45 AM, Staff D, a clinic LPN, acknowledged 1 of 1 unlocked refrigerator in the Morning Star Internal Medicine Clinic containing medications available to clinic staff and patients.

During an interview on 10/21/10 at 3:30 PM, the Director of Pharmacy stated he/she was not aware of security of medication concerns in the clinics, specifically the lack of locks on the doors of the sample medication rooms in the Creston Medical Clinic. The Director of Pharmacy further stated he/she was not aware of a private contract service to clean the Creston Medical Clinic after business hours, potentially making the medications available to unauthorized persons. The Director of Pharmacy also stated he/she went to the Creston Medical Clinic on 1/10/10 to make a suggestion of how to consolidate 3 refrigerators into 1 and gave the Director of Clinic Services a quote to accomplish the consolidation. The Director of Pharmacy stated he/she had not heard anything further from the Director of Clinic Services about needing assistance for the clinics.


IV. Based on observation, record review, and staff interview the Critical Access Hospital (CAH) pharmacy staff failed to follow the established policy/procedures for the removal of expired medications/sample medications, for the security of medications/sample medications, and oversight of sample medications in 2 of 2 off-sight clinic areas (Morning Star Internal Medicine Clinic and Creston Medical Clinic)

Failure of CAH staff to follow established policies/procedures related to ensure all medications including sample medications checked for expiration dates could potentially expose patients to expired medications that may be harmful to the patient or have diminished effectiveness.

Findings include:

1. Observation during tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 8:35 AM with Staff A, Clinic Licensed Practical Nurse (LPN), revealed 1 of 1 sample medication room that contained approximately 460 boxes of sample medications.

Observation during a tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 8:35 AM with Staff A, Clinic LPN, revealed the following representative sample of expired sample medications available for patient use:
- 2 of 20 boxes (20 capsules) of Aggrenox 25 mg/200 mg capsules (10 capsules/box) with expiration date of 5/2010
- 5 of 20 boxes (50 capsules) of Aggrenox 25mg/200mg capsules (10 capsules/box) with expiration date of 7/2010
- 2 of 2 bottles ( 14 tablets) of Effient 10 mg (7 tablets/bottle) with expiration date of 2/2010
- 1 of 1 packet (7 tablets) of Altace 2.5 mg tablets (7 tablets/packet) with expiration date of 9/2009
- 2 of 2 bottles (14 tablets) of Atacand HCT 32/12.5 mg (7 tablets/bottle) with expiration date of 7/2010
- 8 of 12 bottles (56 tablets) of Azor 10 mg/20 mg (7 tablets/bottle) with expiration date of 5/2010
- 4 of 8 bottles (28 tablets) of Azor 5 mg/20 mg (7 tablets/bottle) with expiration date of 5/2010
- 4 of 8 bottles (28 tablets) of Azor 5 mg/40 mg (7 tablets/bottle) with expiration date of 9/2010
- 4 of 4 bottles (28 tablets) of Azor 10 mg/40 mg (7 tablets/bottle) with expiration date of 9/2010
- 5 of 20 packets (35 tablets) of Hyzaar 50/12.5 mg (7 tablets/bottle) with expiration date of 3/2010
- 3 of 4 boxes (90 tablets) of Mycardis HCT 80 mg/12.5 mg (30 tablets/box) with expiration date of 4/2010
- 1 of 4 boxes (30 tablets) of Mycardis HCT 80 mg/12.5 mg (30 tablets/box) with expiration date of 6/2010
- 1 of 1 boxes (7 tablets) of Mycardis HCT 80 mg/12.5 mg (7 tablets/box) with expiration date of 2/2010
- 1 of 5 boxes (7 tablets) of Avapro 300 mg (7 tablets/box) with expiration date of 5/2010
- 2 of 23 boxes (8 tablets) of Seroquel 200 mg (4 tablets/box) with expiration date of 2/2010
- 20 of 146 cards (140 tablets) of Pristiq 50 mg (7 tablets/card) with expiration date of 6/2010
- 1 of 3 boxes (28 tablets) of Synthroid 88 mcg (28 tablets/box) with expiration date of 28 July 2010
- 2 of 3 boxes (56 tablets) of Synthroid 88 mcg (28 tablets/box) with expiration date of 2 June 2010
- 2 of 2 boxes (56 tablets) of Synthroid 137 mcg (28 tablets/box) with expiration date of 14 July 2010
- 2 of 2 boxes (56 tablets) of Synthroid 150 mcg (28 tablets/box) with expiration date of 17 June 2010
- 2 of 2 boxes (56 tablets) of Synthroid 200 mcg (28 tablets/box) with expiration date of 19 June 2010
- 1 of 1 packet (5 tablets) of Prempro 0.625 mg/2.5 mg (5 tablets/packet) with expiration date of 4/2010.

Observation during a tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 10:50 AM with Staff D, Clinic LPN, revealed 1 of 1 refrigerator that contained expired medications available for patient use:
- 1 sample vial - 10 ml - of Humalog Insulin 100 u/ml (opened 7/20/2009) with expiration date of 7/2010
- 4 of 4 sample Symlin 5 ml vials - 0.6 mg/ml with expiration date of 4/2009
- 2 of 3 sample Victoza injectable pens - 18 mg/3ml with expiration date of 2/2009
- 1 of 3 sample Victoza injectable pens - 18 mg/3ml with expiration date of 3/2009
- 29 of 49 vials Sterile Diluent for Merck and Company live virus vaccines (sterile water) with expiration date of March 2010
- 20 of 49 vials Sterile Diluent for Merck and Company live virus vaccines (sterile water) with expiration date of April 2010

Observation during a tour of Creston Medical Clinic POD A on 10/21/10 at 8:45 AM with Staff J, a clinic LPN, revealed the following with expired medications available for patient use:
a. POD A Procedure room:
- 1 of 1 bottle of Zephiran benzalkonium chloride (topical antiseptic solution) 1:750 8oz. ? bottle remaining with expiration date of 9/07
- 26 of 26 packets of Triple Antibiotic ointment (topical antibiotic) 0.9gm (gram) individual unit dose with expiration date of 3/10
- 1 of 1 - 500 ml (milliliter) 0.9% Na Cl (Sodium Chloride) IV (Intravenous) bag with expiration date of 7/07
- 10 of 10 Ammonia Inhalant Capsules (breakable capsule used for fainting) with expiration date of 9/09
- 1 of 1 Gentamaicin Sulfate Ophthalmic Ointment tube (antibiotic ointment used in the eye) 0.3% with expiration 7/10
b. POD A room 5:
- 1 of 1 bottle of A/B optic drops (antibiotic drops for the eye) 15 ml with expiration date of 9/09
- 1 of 1 bottle of Betadine (topical antiseptic solution) 8oz. ? remaining with expiration date of 4/10
- 1 of 1 bottle of S.T. 37 (first aid antiseptic/oral pain relief solution) 8oz. ? remaining with expiration date of 3/08

Observation during a tour of Creston Medical Clinic POD B on 10/21/10 at 9:15 AM with Staff K, a Medical Assistant (MA), revealed the following with expired medications available for patient use:
a. POD B room 1:
- 1 of 1 bottle of Benzoin Compound Tincture (oral mucosal protection) 2oz full bottle with expiration date of 9/10
- 5 of 5 bottles of SurClens (topical cleansing solution) 20 ml with expiration date of 3/09

b. POD B shot area:
- 1 of 1 bottle of Zephiran benzalkonium chloride (topical antiseptic solution) 1:750 8oz. ? bottle remaining with expiration date of 10/08

2. On 10/21/10 at 9:45 AM, the surveyor requested a policy/procedure delineating the clinic's process for managing sample medications in the Morning Star Internal Medicine Clinic, Staff A provided a document titled "Pharmaceutical Representatives", dated 4/1/2009. The document only addressed dates and times that clinic providers were available to see drug representatives and/or receive sample medications. The document lacked a system to log, track, or monitor the expiration dates of the sample medications stored at the clinic.

Review of Pharmacy policy/procedure titled "Unusable and Outdated Drugs", dated 9/1/2004, revealed the following in part. "Policy: All discontinued patient drugs; outdated drugs, contaminated drugs, improperly stored drugs with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal. . . . Procedure: All drug storage areas of the hospital will be inspected, including Surgery, Pyxis MedStations and other patient care unit stock areas if applicable, for outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels. The Pharmacy staff member conducting the inspection will remove all these types of drugs from the area. . . ."

Review of the Morning Star Internal Medicine Clinic and the Creston Medical Clinic policy/procedure manuals revealed the clinic staff failed to develop and implement policies/procedures that delineated a process for monitoring the expiration dates of medications available for patient use.

3. During an interview on 10/21/10 at 9:45 AM, Staff A, a clinic LPN, stated the nursing staff check sample medication expiration dates "daily and haphazardly". Staff A further clarified that clinic staff always check the expiration dates prior to the patient receiving the medication. When nursing staff find expired medications, they place the expired medications in a yellow container and take them to the Pharmacy for proper disposal.

During an interview on 10/21/10 at 10:50 AM, Staff H, a clinic LPN, stated he/she checked the refrigerator earlier this morning for expired medications. At the time Staff H checked for expired medications, Staff H reported he/she found the insulin they were looking for was expired. The surveyor showed Staff H the expired medications found in the refrigerator by the surveyor on 10/21/10 at 10:45 AM. Staff H then stated he/she was in a hurry this morning and failed to check all of the medications in the refrigerator for expiration dates. Staff H stated he/she did not know how often staff were supposed to check for expired medications.

During an interview on 10/21/10 at 10:55 AM, Staff D, a clinic LPN, acknowledged the clinic lacked a policy/procedure that addressed sample medications or to check the expiration dates of sample medications/medications.

During an interview on 10/21/10 at 8:45 AM, Staff J, a clinic LPN, stated nursing staff try to check for expiration dates prior to patient care. Staff J acknowledged he/she were unsure that they received training to check for expired medications.

During an interview with Staff F, Pharmacy Technician, Staff G, Pharmacy Technician, and the Director of Pharmacy, on 10/25/10 at 11:20 AM, Staff F and G both stated that they had not checked for any expired medications in the clinics.

The Director of Pharmacy stated, "The Pharmacy Technicians have never been told to go there [to the clinics]" to check for expired medications. The Director of Pharmacy acknowledged the pharmacy policy/procedure addressed pharmacy staff was responsible for the inspection of drug storage areas and the removal of expired medications throughout the hospital.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) Director of Clinic Services failed to develop and implement policies for the Creston Medical Clinic (CMC). The CMC became a member of the CAH system 1/01/10. The Director of Clinic Services reported an average monthly patient volume of 1840 visits for the CMC.

Failure to develop and implement policies for the clinics potentially resulted in inadequate patient care and the lack of staff direction for proper patient care.

Findings include:

1. A review of the policies for CMC on 10/26/10, revealed the CAH administrative staff failed to develop and implement policies related to patient care and to ensure the overall quality and safety of the patient care provided.

A review of the policy titled "CAH Advisory Committee" dated 8/10, stated in part. "...Policy: Hospital clinical policies are developed with the advice of a group of professional personnel that includes one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff; and at least one member of the group is not a member of the CAH staff ..."

2. A review of Quality Improvement Meeting minutes from 11/2009 - 9/2010 included policy review for various areas of the hospital. The minutes lacked policy development and review for the CMC.

3. During an interview on 10/25/10 at 4:05 PM, Director of Clinical Services, revealed that the CMC lacked a completed set of policies/procedures.

During an interview on 10/26/10 at 2:40 PM, the Chief Nursing Officer acknowledged that CMC policies/procedures lacked approval by the committee responsible for the development and review of CAH policies/procedures, to include the required group of professionals.

I. Based on observation, review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed to secure 1 (of 1) main Pharmacy and its contents from unauthorized access in accordance with policies/procedures. Problem identified in the main Pharmacy.

Three of 3 Pharmacists and 4 of 4 Pharmacy Technicians are the only staff members authorized to have a key badge that allowed entry into the CAH's pharmacy.

Failure of CAH staff to secure the main pharmacy and its contents allowed an unauthorized person to enter the pharmacy with an unauthorized key badge. The use of the unauthorized key badge allowed a non-hospital serviceman access to a variety of medications and place the CAH staff of harm from an intruder.

Findings include:

1. Observation during tour of the Pharmacy on 10/21/10 at 3:30 PM with the Director of Pharmacy revealed, Serviceman I entered the locked Pharmacy door at approximately 4:07 PM without Pharmacy staff opening the door for the Serviceman. The Serviceman proceeded to check 2 smoke/fire alarm sensors in the Pharmacy. Serviceman I was an unauthorized non-hospital employee who installed the security system and the fire alarm system previously.

The Director of Pharmacy approached Serviceman I and asked how they were able to enter the locked pharmacy door. Serviceman I stated he used his key badge to enter the Pharmacy. The Director of Pharmacy asked Serviceman I "how did you get key badge access". Serviceman I responded he had given himself key badge access into the pharmacy when he installed the pharmacy security system approximately 8 to 12 months ago.

2. Review of Pharmacy policies/procedures titled "Authorized Access to the Pharmacy", dated 9/1/2004, revealed the following in part. "Policy: Only Authorized Persons Shall Be Allowed in the Pharmacy: Access to the main Pharmacy is limited to the Pharmacist and his/her staff during Pharmacy operating hours. Medical staffs, nursing service, administrative, Environmental Services and other personnel are authorized admission only in conjunction with their duties and under supervision of Pharmacy staff."

Review of Human Resources policies/procedures revealed policy/procedure titled "ID Badges", dated 2/2003, revealed the following in part. "Policy: Greater Regional Medical Center provides to every employee a Photo ID badge, and Emergency Responder badge, and a key badge upon hire to the facility. . . . The key badge may be used by the employee to enter into the facility through a non-public access door assigned to them during regular business hours or after hours. Procedure: . . . On the employee's first day they will receive their ID badge, Emergency Responder badge, and key badge."

3. Review of documentation provided by Human Resources Officer on 10/25/10 at 11:55 AM, revealed a report titled "Door Access Granted" to the Pharmacy for 10/2/10 to 10/25/10 that showed Serviceman I, a non-hospital employee, entered the Pharmacy via key badge access on 10/21/10 at 4:04 PM.

Serviceman I possessed a key badge with user number 9998, which allowed him/her to enter all areas of the hospital including the main Pharmacy.

4. During an interview on 10/21/10 at 4:10 PM, the Director of Pharmacy stated he/she was not aware that Serviceman I had key badge access to the main Pharmacy. The Director of Pharmacy further clarified that only the Pharmacists and Pharmacy Technicians have key badge access to the main Pharmacy.

During an interview on 10/25/10 at 11:55 AM, the Human Resource Officer reported being the person responsible for issuing the key badges to employees. The Director of Pharmacy approved which employees have key badge access to the pharmacy. The Human Resource Officer stated the hospital did not issue key badge access to the pharmacy to Serviceman I, a non-hospital employee, and was unaware Serviceman I had given himself key badge access to the pharmacy at the time of the installation of the key badge security system to the pharmacy.


II. Based on observation, review of policies/procedures, documentation, patient medical records, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed to develop and maintain a system to track and account for the receipt and distribution of sample drugs through a process developed in cooperation with the Pharmacy and Therapeutics Committee, subject to oversight by the pharmacy. Problem identified in the Morning Star Internal Medicine Clinic and the Creston Medical Clinic.

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and 1840 patient visits per month for the Creston Medical Clinic. The Director of Clinics reported an average of 8 patients per month received sample medications in the Morning Star Internal Medicine Clinic and an average of 5 patients per month received sample medications in the Creston Medical Clinic.

Failure of pharmacy staff to provide oversight of sample medications resulted in expired medications being available for physicians and mid-level providers to give to patients, and the potential theft of medications by unauthorized persons.

Findings include:

1. Observation during tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 8:35 AM with Staff A, a clinic Licensed Practical Nurse (LPN), revealed 1 of 1 sample medication room that contained approximately 460 boxes of sample medications. Categories of sample medications included in the room were to control blood pressure, prevent stroke, treat cardiac conditions, replace hormones, treat mood disorders, and treat and manage diabetes.

Observations during tour of the Creston Medical Clinic on 10/21/10 at 8:00 AM with Director of Clinic Services revealed 3 of 3 sample medication rooms that lacked any mechanisms to lock the doors, and 3 of 3 unlocked refrigerators in a common hallway used by clinic staff and patients.

Three of 3 sample medication rooms each measured 6 foot 4 inches by 8 foot 9 inches and contained the following.

Pod A sample medication room contained 16 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications for smoking cessation, treat gastro-intestinal problems, treat mood disorders, replace hormones, treat and manage diabetes, treat cardiac conditions, and treat respiratory and allergy problems.

Pod B sample medication room contained 12 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications to treat mood disorders, treat Alzheimers, treat urinary retention, treat prenatal conditions, treat high cholesterol problems, treat and manage diabetes, treat cardiac conditions, treat respiratory problems, and treat and manage bone density problems.

Pod C sample medication room contained 10 shelves of sample medications, copy machine, coffee pot, and Christmas decorations. Categories of sample medications in the room were medications to treat and manage diabetes, treat cardiac conditions, treat respiratory problems, treat high cholesterol problems, treat mood disorders, treat and control pain, treat urinary retention, replace hormones, treat and manage bone density problems, treat gastro-intestinal problems, treat Alzheimers, and treat and manage sleep problems.

2. Review of Pharmacy policies/procedures revealed policy/procedure titled "Drug Procurement/Inventory Control", dated 9/1/2004, revealed in part. "Policy: Responsibility for control of medications within this hospital rests with the Pharmacy Department. Policies and procedures are designed to ensure the safe and accurate dispensing of medications throughout the hospital. These policies will be approved by the Pharmacy and Therapeutics Committee. Procedure: Acquisition: The Pharmacy Department is responsible for the acquisition of pharmaceuticals for this hospital. The Pharmacist is responsible for specification as to quality, quantity and source of supply all drugs used in the hospital. . . ."

Review of Pharmacy policies/procedures revealed policy/procedure titled, "Drug Samples", dated 9/1/2004, revealed in part. ". . . In the interest of effective control, and to comply with federal law, the distribution of drug samples within the confines of Greater Community Hospital is forbidden. Samples found within the facility will be confiscated by the Pharmacy Department and discarded appropriately. . . "

Review of Pharmacy policies/procedures revealed policy/procedure titled "Medication Management Program", dated 9/1/2004, revealed in part. "Policy: The Pharmacy and Therapeutics Committee (MORS), acting on behalf of the medical staff, shall implement a Medication Management Assessment and Evaluation Program to provide a system to ensure medication use within the organization is conducted in a safe and optimal manner. The Medication Management Assessment and Evaluation program requires the routine evaluation of literature for new technologies and best practices that have been demonstrated to enhance safety in other organizations to determine if these practices are conducted successfully within the organization or if they should be implemented to improve the medication management system. The Medication Management Assessment and Evaluation Program identify risk points (including medication errors and adverse drug reactions) and identify areas to improve patient safety as well as the overall use of medications throughout the organization. . . . For the purposes of this program the definition of medication includes: . . . Sample medications. . . . The Pharmacy and Therapeutic Committee (MORS) will maintain oversight for the Medication Management Assessment and Evaluation Program. . . The Pharmacy Department provides fundamental functions as well as key oversight responsibilities and activities in the system of medication management. . . Storage of medications. . . ."

Review of Pharmacy policies/procedures revealed policy/procedure titled "Pharmacy and Therapeutics Committee", dated 9/1/2004, revealed in part. "Policy: The Pharmacy and Therapeutics Committee exists as part of the hospital medical staff committee: Medical/Obstetrics/Radiology/Special Services (MORS). This committee is selected under the guidance of the medical staff, and it is also a policy and procedure recommending body to the medical staff and administration of the hospital on all matters related to the use of medications. . . . Functions and Scope: . . . To monitor implementation of the written policies and procedures and make recommendations for improvement. The Pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementation of procedures. . . ."

On 10/21/10 at 9:45 AM, the surveyor requested a policy/procedure delineating the clinic's process for managing sample medications in the Morning Star Internal Medicine Clinic, Staff A provided a document titled "Pharmaceutical Representatives", dated 4/1/2009. The document only addressed dates and times that clinic providers were available to see drug representatives and/or receive sample medications. The document lacked a system to log, track, or monitor the expiration dates of the sample medications stored at the clinic or the patient receiving the sample medications.

Review of the Morning Star Internal Medicine Clinic policy/procedure titled "Pharmaceutical Representatives" failed to include a system that tracked and accounted for medications received in the clinic, dispensed to patients, including lot numbers of sample medications, or expiration dates.

Review of the Morning Star Internal Medicine Clinic and the Creston Medical Clinic policy/procedure manuals revealed the clinic administrative staff, in conjunction with pharmacy staff, failed to develop and implement policies/procedures that delineated a system that tracked and accounted for medications received in the clinic, dispensed to patients, including lot numbers of sample medications, or expiration dates.

3. Review of the Director of Pharmacy job description, dated 9/1/2004 revealed the following in part.
a. "Statement of Purpose - Responsible for directing, coordinating and controlling the operation of the Pharmacy Department; ensures compliance with patient care quality standards and current concepts in Pharmaceutical Care and: directs and controls the purchase and inventory maintenance of all pharmaceuticals and related substances/supplies; directs and participates in the department's planning, revenue analysis, budgeting, education and human resource management activities.

b. Major Tasks, Duties and Responsibilities

Directs, coordinates and controls the overall operation of Pharmacy Services, with and emphasis on all aspects of Pharmaceutical Care

Directs and coordinates the integration of the Pharmacy Department's functions with other aspects of overall patient care. . . .

Works closely with the nursing and medical staff and other clinical department heads in addressing pharmaceutical services issues and to support the maintenance of high-quality patient/Pharmaceutical Care. . . .

Directs the pharmacy's quality assessment and improvement activities and ensures compliance with patient care and medical practice standards. . . .

Oversees the storage and distribution of all pharmaceutical items and ensures compliance by departmental locations and patient care units with established inventory control standards and procedures and federal and state regulations. . . ."

4. Review of the Medical/Obstetric/Radiology/Special Services (MORS) Meeting minutes from 1/8/09 through 7/1/10 failed to address the development and implementation of policies and procedures that would include a system to track and account for the receipt and distribution of sample drugs in the Morning Star Internal Medicine Clinic and Creston Medical Clinic.

The Morning Star Internal Medicine Clinic became part of the CAH on 11/30/07. The Creston Medical Clinic became part of the CAH on 1/1/10.

5. The CAH lacked a system for the pharmacy to follow the flow of pharmaceuticals from all CAH locations, including the entry of sample medications into the clinics through dispensation/administration. Neither the pharmacy staff nor the clinic staff maintained documentation of the sample medications stored in the Morning Star Internal Medicine Clinic or the Creston Medical Clinic.

6. Review of a random sample of closed patient medical records in the Morning Star Internal Medicine Clinic revealed the following:
a. Patient # 1; medical record showed Patient # 1 received 28 doses of Diovan 320/25 on 6/22/10.

b. Patient # 2; medical record showed Patient # 2 received 2 samples doses of Actonel on 6/24/10.

c. Patient # 3; medical record showed Patient # 2 received 4 boxes of samples of Micardis 40 mg and 2 boxes of samples of Micardis 80 mg on 9/20/09.

7. During an interview on 10/21/10 at 9:20 AM, Staff A stated that clinic staff/provider do not always write in the patient's medical record that the patient received sample medications. Staff A further stated that if the staff write in the patient's medical record that the patient received sample medications, the documentation would not include the lot number or expiration date of any sample medication given to the patient.

During an interview on 10/21/10 at 9:55 AM, Practitioner A stated he/she does not always include in the dictation that the patient received sample medications during the patient's clinic visit and does not document the lot number or expiration date of any sample medication given to the patient.

During an interview on 10/21/10 at 3:30 PM, The Director of Pharmacy acknowledged the Pharmacy Department failed to maintain oversight of the Morning Star Internal Medicine Clinic and Creston Medical Clinic Pharmaceuticals since the clinics became a part of the CAH. The Morning Star Internal Medicine Clinic became a part of the CAH on 11/30/2007 and the Creston Medical Clinic became a part of the CAH on 1/1/2010.

The Director of Pharmacy stated that the Pharmacy policies/procedures lacked changes to include the practices for the use of sample medications in the clinics. The Director of Pharmacy also stated the Pharmacy Department staff failed to monitor for secure drug storage or expired medications in the clinics.

The Director of Pharmacy stated he/she was not aware the sample medication rooms in the Creston Medical Clinic lacked any mechanism to lock the doors and that non-hospital contract persons cleaned the Creston Medical Clinic after clinic business hours. The Director of Pharmacy acknowledged he/she was aware that sample medications were kept in the clinics as clinic staff would periodically bring expired sample medications to the pharmacy for proper disposal. The Director of Pharmacy stated he/she was not aware of any documentation in the clinics to follow the flow of pharmaceuticals from all CAH locations, including the entry of sample medications into the clinics through dispensation/administration. The pharmacy failed to maintain records of the sample drugs stored in the Morning Star Internal Medicine Clinic or the Creston Medical Clinic.


III. Based on observation, review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed to ensure the secure storage of medications in 2 of 2 off-site clinics in accordance with policies/procedures (Morning Star Internal Medicine Clinic and Creston Medical Clinic).

The Director of Clinic Services reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and an average of 1840 patient visits per month for the Creston Medical Clinic.

Failure of CAH staff to secure all medications/sample medications resulted in the potential theft of medications by unauthorized persons.

Findings include:

1. Observations during tour of the Creston Medical Clinic on 10/21/10 at 8:00 AM with Director of Clinic Services revealed 3 of 3 sample medication rooms that lacked any mechanisms to lock the doors, and 3 of 3 unlocked refrigerators in a common hallway used by clinic staff and patients.

Three of 3 sample medication rooms each measured 6 foot 4 inches by 8 foot 9 inches and contained the following.

Pod A sample medication room contained 16 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications for smoking cessation, treat gastro-intestinal problems, treat mood disorders, replace hormones, treat and manage diabetes, treat cardiac conditions, and treat respiratory and allergy problems.

Pod B sample medication room contained 12 shelves of sample medications, copy machine, and coffee pot. Categories of sample medications in the room were medications to treat mood disorders, treat Alzheimers, treat urinary retention, treat prenatal conditions, treat high cholesterol problems, treat and manage diabetes, treat cardiac conditions, treat respiratory problems, and treat and manage bone density problems.

Pod C sample medication room contained 10 shelves of sample medications, copy machine, coffee pot, and Christmas decorations. Categories of sample medications in the room were medications to treat and manage diabetes, treat cardiac conditions, treat respiratory problems, treat high cholesterol problems, treat mood disorders, treat and control pain, treat urinary retention, replace hormones, treat and manage bone density problems, treat gastro-intestinal problems, treat Alzheimers, and treat and manage sleep problems.

The 3 of 3 unlocked dorm-size refrigerators contained vaccines.

Observations during tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 10:45 AM with Staff D, Clinic LPN, revealed 1 of 1 unlocked dorm-size refrigerator in a common hallway used by clinic staff and patients. The unlocked refrigerator contained vaccines, and medications to treat and manage diabetes.

2. Review of Pharmacy policies/procedures titled "Drug Procurement/Inventory Control", dated 9/1/2004, revealed the following in part. "Policy: Responsibility for control of medications within this hospital rests with the Pharmacy Department. Policies and procedures are designed to ensure the safe and accurate dispensing of medications throughout the hospital. . . . Procedure: . . . Medications are stored in a secure manner. . . ."

Review of the Morning Star Internal Medicine Clinic and Creston Medical Clinic policy/procedure manuals revealed the clinic administrative staff failed to develop and implement policies/procedures that delineated a process to ensure the security of medications in the clinic.

3. During an interview on 10/21/10 at 8:10 AM, the Director of Clinic Services stated non-hospital private contracted persons are responsible for cleaning the Creston Medical Clinic after business hours. Cleaning included vacuuming, dusting, and emptying trash throughout the clinic including the sample medication rooms. The Director of Clinic Services verified the lack of clinic staff present when the non-hospital private contracted persons performed cleaning activities in the clinic and could have access to unsecured medications in the unlocked sample medication rooms and unlocked refrigerators.

During an interview on 10/21/10 at 10:45 AM, Staff D, Clinic LPN, acknowledged 1 of 1 unlocked refrigerator in the Morning Star Internal Medicine Clinic containing medications available to clinic staff and patients.

During an interview on 10/21/10 at 3:30 PM, the Director of Pharmacy stated he/she was not aware of security of medication concerns in the clinics, specifically the lack of locks on the doors of the sample medication rooms in the Creston Medical Clinic. The Director of Pharmacy further stated he/she was not aware of a private contract service to clean the Creston Medical Clinic after business hours, potentially making the medications available to unauthorized persons. The Director of Pharmacy also stated he/she went to the Creston Medical Clinic on 1/10/10 to make a suggestion of how to consolidate 3 refrigerators into 1 and gave the Director of Clinic Services a quote to accomplish the consolidation. The Director of Pharmacy stated he/she had not heard anything further from the Director of Clinic Services about needing assistance for the clinics.


IV. Based on observations, review of policies/procedures, documentation, closed patient medical records, and staff interviews, the Critical Access Hospital (CAH) pharmacy and clinic staff failed to ensure expired medications were not available for patient use in 2 of 2 off-site clinics (Morning Star Internal Medicine Clinic and Creston Medical Clinic).

The Director of Clinic Services reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and an average of 1840 patient visits per month for the Creston Medical Clinic.

Failure of CAH staff to check all medications including sample medications for expiration dates could potentially expose patients to expired medications that may be harmful to the patient or have diminished effectiveness.

Findings include:

1. Observation during tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 8:35 AM with Staff A, a clinic Licensed Practical Nurse (LPN), revealed 1 of 1 sample medication room that contained approximately 460 boxes of sample medications.

Observation during a tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 8:35 AM with Staff A, a clinic LPN, revealed the following representative sample of expired sample medications available for patient use:
- 2 of 20 boxes (20 capsules) of Aggrenox 25 mg/200 mg capsules (10 capsules/box) with expiration date of 5/2010
- 5 of 20 boxes (50 capsules) of Aggrenox 25mg/200mg capsules (10 capsules/box) with expiration date of 7/2010
- 2 of 2 bottles ( 14 tablets) of Effient 10 mg (7 tablets/bottle) with expiration date of 2/2010
- 1 of 1 packet (7 tablets) of Altace 2.5 mg tablets (7 tablets/packet) with expiration date of 9/2009
- 2 of 2 bottles (14 tablets) of Atacand HCT 32/12.5 mg (7 tablets/bottle) with expiration date of 7/2010
- 8 of 12 bottles (56 tablets) of Azor 10 mg/20 mg (7 tablets/bottle) with expiration date of 5/2010
- 4 of 8 bottles (28 tablets) of Azor 5 mg/20 mg (7 tablets/bottle) with expiration date of 5/2010
- 4 of 8 bottles (28 tablets) of Azor 5 mg/40 mg (7 tablets/bottle) with expiration date of 9/2010
- 4 of 4 bottles (28 tablets) of Azor 10 mg/40 mg (7 tablets/bottle) with expiration date of 9/2010
- 5 of 20 packets (35 tablets) of Hyzaar 50/12.5 mg (7 tablets/bottle) with expiration date of 3/2010
- 3 of 4 boxes (90 tablets) of Mycardis HCT 80 mg/12.5 mg (30 tablets/box) with expiration date of 4/2010
- 1 of 4 boxes (30 tablets) of Mycardis HCT 80 mg/12.5 mg (30 tablets/box) with expiration date of 6/2010
- 1 of 1 boxes (7 tablets) of Mycardis HCT 80 mg/12.5 mg (7 tablets/box) with expiration date of 2/2010
- 1 of 5 boxes (7 tablets) of Avapro 300 mg (7 tablets/box) with expiration date of 5/2010
- 2 of 23 boxes (8 tablets) of Seroquel 200 mg (4 tablets/box) with expiration date of 2/2010
- 20 of 146 cards (140 tablets) of Pristiq 50 mg (7 tablets/card) with expiration date of 6/2010
- 1 of 3 boxes (28 tablets) of Synthroid 88 mcg (28 tablets/box) with expiration date of 28 July 2010
- 2 of 3 boxes (56 tablets) of Synthroid 88 mcg (28 tablets/box) with expiration date of 2 June 2010
- 2 of 2 boxes (56 tablets) of Synthroid 137 mcg (28 tablets/box) with expiration date of 14 July 2010
- 2 of 2 boxes (56 tablets) of Synthroid 150 mcg (28 tablets/box) with expiration date of 17 June 2010
- 2 of 2 boxes (56 tablets) of Synthroid 200 mcg (28 tablets/box) with expiration date of 19 June 2010
- 1 of 1 packet (5 tablets) of Prempro 0.625 mg/2.5 mg (5 tablets/packet) with expiration date of 4/2010.

Observation during a tour of the Morning Star Internal Medicine Clinic on 10/21/10 at 10:50 AM with Staff D, a clinic LPN, revealed 1 of 1 refrigerator that contained expired medications available for patient use:
- 1 sample vial - 10 ml - of Humalog Insulin 100 u/ml (opened 7/20/2009) with expiration date of 7/2010
- 4 of 4 sample Symlin 5 ml vials - 0.6 mg/ml with expiration date of 4/2009
- 2 of 3 sample Victoza injectable pens - 18 mg/3ml with expiration date of 2/2009
- 1 of 3 sample Victoza injectable pens - 18 mg/3ml with expiration date of 3/2009
- 29 of 49 vials Sterile Diluent for Merck and Company live virus vaccines (sterile water) with expiration date of March 2010
- 20 of 49 vials Sterile Diluent for Merck and Company live virus vaccines (sterile water) with expiration date of April 2010

Observation during a tour of 2 of 2 areas in Creston Medical Clinic POD A on 10/21/10 at 8:45 AM with Staff J, a clinic LPN, revealed the following with expired medications available for patient use:
a. POD A Procedure room:
- 1 of 1 bottle of Zephiran benzalkonium chloride (topical antiseptic solution) 1:750 8oz. ? bottle remaining with expiration date of 9/07
- 26 of 26 packets of Triple Antibiotic ointment (topical antibiotic) 0.9gm (gram) individual unit dose with expiration date of 3/10
- 1 of 1 - 500 ml (milliliter) 0.9% Na Cl (Sodium Chloride) IV (Intravenous) bag with expiration date of 7/07
- 10 of 10 Ammonia Inhalant Capsules (breakable capsule used for fainting) with expiration date of 9/09
- 1 of 1 Gentamaicin Sulfate Ophthalmic Ointment tube (antibiotic ointment used in the eye) 0.3% with expiration 7/10

b. POD A room 5:
- 1 of 1 bottle of A/B optic drops (antibiotic drops for the eye) 15 ml with expiration date of 9/09
- 1 of 1 bottle of Betadine (topical antiseptic solution) 8oz. ? remaining with expiration date of 4/10
- 1 of 1 bottle of S.T. 37 (first aid antiseptic/oral pain relief solution) 8oz. ? remaining with expiration date of 3/08

Observation during a tour of 2 of 2 areas in Creston Medical Clinic POD B on 10/21/10 at 9:15 AM with Staff K, a Medical Assistant (MA), revealed the following with expired medications available for patient use:
a. POD B room 1:
- 1 of 1 bottle of Benzoin Compound Tincture (oral mucosal protection) 2oz full bottle with expiration date of 9/10
- 5 of 5 bottles of SurClens (topical cleansing solution) 20 ml with expiration date of 3/09

b. POD B shot area:
- 1 of 1 bottle of Zephiran benzalkonium chloride (topical antiseptic solution) 1:750 8oz. ? bottle remaining with expiration date of 10/08

2. On 10/21/10 at 9:45 AM, the surveyor requested a policy/procedure delineating the clinic's process for managing sample medications in the Morning Star Internal Medicine Clinic, Staff A provided a document titled "Pharmaceutical Representatives", dated 4/1/2009. The document only addressed dates and times that clinic providers were available to see drug representatives and/or receive sample medications. The document lacked a system to log, track, or monitor the expiration dates of the sample medications stored at the clinic.

Review of Pharmacy policy/procedure titled "Unusable and Outdated Drugs", dated 9/1/2004, revealed the following in part. "Policy: All discontinued patient drugs; outdated drugs, contaminated drugs, improperly stored drugs with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal. . . . Procedure: All drug storage areas of the hospital will be inspected, including Surgery, Pyxis MedStations and other patient care unit stock areas if applicable, for outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels. The Pharmacy staff member conducting the inspection will remove all these types of drugs from the area. . . ."

Review of the Morning Star Internal Medicine Clinic and the Creston Medical Clinic policy/procedure manuals revealed the clinic administrative staff failed to develop and implement policies/procedures that delineated a process for monitoring the expiration dates of medications available for patient use.

3. During an interview on 10/21/10 at 9:45 AM, Staff A stated the nursing staff check sample medication expiration dates "daily and haphazardly". Staff A further clarified that clinic staff always check the expiration dates prior to the patient receiving the medication. When nursing staff find expired medications, they place the expired medications in a yellow container and take them to Pharmacy for proper disposal.

During an interview on 10/21/10 at 10:50 AM, Staff H, a clinic LPN, stated he/she checked the refrigerator earlier this morning for expired medications. At the time Staff H checked for expired medications, Staff H reported he/she found the insulin they were looking for was expired. The surveyor showed Staff H the expired medications found in the refrigerator by the surveyor on 10/21/10 at 10:45 AM. Staff H then stated he/she was in a hurry this morning and failed to check all of the medications in the refrigerator for expiration dates. Staff H stated he/she did not know how often staff were supposed to check for expired medications.

During an interview on 10/21/10 at 10:55 AM, Staff D, a clinic LPN, acknowledged the clinic lacked a policy/procedure that addressed sample medications or to check the expiration dates of sample medications/medications.

During an interview on 10/21/10 at 8:45 AM, Staff J, a clinic LPN, stated nursing staff try to check for expiration dates prior to patient care. Staff J acknowledged he/she were unsure that they received training to check for expired medications.

During an interview with Staff F, Pharmacy Technician; Staff G, Pharmacy Technician; and the Director of Pharmacy, on 10/25/10 at 11:20 AM, Staff F and G both stated that they had not checked for any expired medications in the clinics.

The Director of Pharmacy stated, "The Pharmacy Technicians have never been told to go there [to the clinics]" to check for expired medications. The Director of Pharmacy acknowledged the Pharmacy policy/procedure addressed pharmacy staff was responsible for the inspection of drug storage areas and the removal of expired medications throughout the hospital.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) pharmacy staff failed to ensure physician notification for the occurrence of a medication error for 12 of 20 medication errors reviewed. The CAH reported a census of 12 patients.

Failure to notify the physician of medication errors could potentially result in life threatening conditions, or other related health conditions that could lead to serious harm.

Findings include:

1. Review of the Quality Improvement policy/procedure titled "Medication Errors", dated 7/10, revealed the following in part. "Medication Errors: The findings related to the incident will be written by the physician, who is notified of all medication errors immediately ..."

Review of the Pharmacy policy/procedure titled "Medication Errors", dated 9/04, stated in part. "When a medication error occurs, the following should occur in this order: Notify the physician and evaluate the patient ..."

2. Review of the medication errors from April to September 2010 revealed 12 of 20 medication errors lacked physician notification at the time the error occurred.

Review of the "Medication Related Error" form, undated, showed in bold print "Physician notified? Yes No Date and time physician notified:"

2. During an interview on 10/26/10 at 1:47 PM, the Director of Quality Services stated the nurses receive education in the use of the Medication Related Error form during their orientation to the nursing floor, receive instruction to completely fill out the form, and notify the physician at the time the medication error occurred. After the physician signs the form, the Chief Nursing Officer (CNO) and the Director of Quality Services review the form, and follow up with the appropriate individual. The Director of Quality of Services stated when he/she reviewed the Medication Related Error form, he/she does not concentrate on immediate notification of the physician.

During an interview on 10/26/10 at 1:54 PM, Staff B, staff nurse, stated that when the nurses make or find a medication error, a Medication Related Error form is completed. The nurses make the decision of physician notification based on the severity of the medication error. The lack of physician notification at the time of the error resulted in physician notification at his/her next visit to the nursing unit. Nursing orientation to the nursing floor included training on the use of the Medication Related Error form.

Based on review of policies/procedures, documentation, and staff interview the Critical Access Hospital (CAH) administrative staff failed to ensure the review of patient care policies for the Morning Star Internal Medicine Clinic on an annual basis by the required group of professionals including a physician, nurse practitioner, and one member who is not a member of the CAH. The Director of Clinic Services reported an average monthly patient volume of 800 visits for the Morning Star Internal Medicine Clinic.

Failure to review the patient care policies on annual basis by the required group of professionals could potentially result in the policies failing to meet the needs of the patient and community.

Findings include:

1. Review of the policy titled "CAH Advisory Committee", dated 8/10, revealed in part. "Policy: Hospital clinical policies are developed with the advice of a group of professional personnel that includes one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff; and at least one member of the group is not a member of the CAH staff ..."

The policy failed to address that the required group of professionals reviewed the policy/procedures annually.

2. Review of the cover sheet for the Morning Star Internal Medicine policy/procedure manual on 10/26/10, revealed a review date of 3/2009 by the required group of professionals.

3. During an interview on 10/26/10 at 2:40 PM, Chief Nursing Officer (CNO) acknowledged the Morning Star Internal Medicine Clinic policies/procedures lacked annual review by the required group of professionals as required by the regulations.

Based on record review and staff interview the Critical Access Hospital (CAH) failed to integrate the Creston Medical Clinic (CMC) and Morning Star Internal Medicine Clinic patient medical records into the hospital medical record system.

The CAH reported a census of 12 patients.

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and 1840 patient visits per month for the Creston Medical Clinic.

Failure to integrate the CMC and Morning Star Internal Medicine Clinic patient medical records into the hospital medical record system could potentially result in a loss of communication in the care of the patient.

Findings include:

1. A review of CMC and Morning Star Internal Medicine Clinic policy/procedure manuals on 10/25/10, revealed the CAH administrative staff failed to identify a method of communication between outpatient services and inpatient services allowing for the integration of patient information.

2. During an interview on 10/25/10 at 3:40 PM, Staff E, Emergency Department staff nurse, revealed when the clinic physician dictates an office note it shows up in the computer. When the physician sees a patient at the end of his/her work day on Friday and does not dictate a note, there is no way of knowing what took place at the office visit until the dictation is completed at a later time. The Emergency Department has no access to the patient medical records at the CMC and the Morning Star Internal Medicine Clinic after hours, on the weekends, or on a holiday.

During an interview on 10/21/10 at 10:00 AM, Director of Clinic services revealed the patient clinical records of the CMC are not a part of the hospital medical records. The physician writes orders to admit a patient to the hospital and patients are cross-referenced in the hospital computer system to alert the hospital of clinic involvement.

During an interview on 10/25/10 at 3:44 PM, Staff C, Licensed Practical Nurse (LPN) phone nurse at the CMC, revealed no hospital staff has access to patient medical records after hours, on the weekends, or on a holiday. When the physician sees a patient at the end of his/her work day on Friday and does not dictate a note, there is no way of knowing what took place at the office visit until the dictation is completed at a later time.

During an interview on 10/26/10 at 3:42 PM, Staff D, LPN at the Morning Star Internal Medicine Clinic, revealed no hospital staff has access to patient medical records after hours, on the weekends, or on a holiday. When the physician sees a patient at the end of his/her work day on Friday and does not dictate a note, there is no way of knowing what took place at the office visit until the dictation is completed at a later time.

Based on observations, review of policies/procedures, and staff interview, the Critical Access Hospital (CAH) failed to secure and maintain the confidentiality of medical records for the 1 of 1 laboratory and 1 of 2 off-site clinics. [Creston Medical Clinic (CMC)]

The CAH reported a census of 12 patients.

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and 1840 patient visits per month for the Creston Medical Clinic.

Failure to secure and maintain the confidentiality of the medical records could potentially result in unauthorized use of patient's information.

Findings include:

1. Observation during a tour of the laboratory on 10/20/10 at 3:15 PM with the Laboratory Director, revealed in the reception area 1 of 1 open file bin on top of the counter that contained approximately 1,000 physician orders for patient labs including diagnoses. The open file bin lacked any mechanism to secure the patient records.

Additional observation in the laboratory revealed 2 of 2 open rolling file cabinets in the reception area that contained approximately 2,000 patient lab results for January 1, 2010 to present. The open file bin lacked any mechanism to secure the patient records.

Additional observation in the clean area of the laboratory revealed 2 of 2 drawers that contained approximately 3,000 patient lab results per drawer for the calendar years of 2008 and 2009. The drawers lacked any mechanism to secure the patient records.

Observation during a tour of the CMC on 10/21/10 at 8:45 AM, with Staff M, CMC MLT (Medical laboratory technologist), revealed an unlocked EKG (Electrocardiogram) room with 1 of 1 unlocked 3 drawer file cabinet that contained approximately 520 unsecured patient medical records.

Additional observation in the CMC on 10/21/10 at 9:10 AM, with Staff K, CMC MA (Medical Assistant) revealed 1 of 1 unlocked 3 drawer file cabinet in Pod A hallway that contained approximately 65 unsecured patient medical records.

Additional observation in the CMC on 10/21/10 at 9:10 AM, with the Director of Clinic Services, revealed 1 of 1 open medical record storage room that contained approximately 32,000 unsecured patient medical records.

2. Review of the CAH policy/procedure on 10/25/10 titled, "Confidentiality", dated 10/1/04, stated in part. ". . . Background: All information, regardless of where it is handled or stored (e.g. in computers, file cabinets, desks, fax machines, voice-mail, etc.) must be protected from unauthorized access, modification, disclosure, and/or destruction ....Non-Information User or Users. Individuals who have not been granted authorization and who typically do not require access to protected health information as it pertains to their specific job duties ....Secure area. An area not accessible to unauthorized persons or an area where the information is attended by an authorized person. Examples include: nursing stations, private offices, work areas, monitored by a staff member or receptionist, most employee-only areas, secure buildings."

During an interview on 10/25/10 at 4:05 PM, the Director of Clinical Services, revealed that CMC administrative staff lacked a completed set of policies/procedures that addressed confidentiality of patient medical records in the CMC.

3. During an interview on 10/20/10 at 3:15 PM, the Laboratory Director verified the unsecured patient medical records in the open file bin and rolling file cabinets in the laboratory reception area, and in the drawers in the clean area of the laboratory. Housekeeping cleans the laboratory after staff leave for the day. Housekeeping has a key to the laboratory.

During an interview with 10/20/10 at 4:05 PM, Staff N, housekeeper, stated he cleaned the laboratory during the 3 to 11 PM shift, at times laboratory personnel are not always present. When laboratory personnel are not present, Staff N stated he entered the lab by using the code to unlock the door.

During an interview on 10/21/10 at 8:45 AM, Staff M, CMC MLT, reported the EKG room always remained unlocked. Housekeeping cleans the CMC after business hours when the clinic is closed.

During an interview on 10/21/10 at 9:10 AM, Staff K, CMC MA, reported the lack of a key to lock the 3-drawer file cabinet that contained patient medical records. Housekeeping cleans the room when the clinic is closed.

During an interview on 10/21/10 at 8:45 AM, the Director of the Clinic Services stated a private contracted cleaning service cleaned the CMC after business hours when the clinic is closed. The responsibilities of the private company included vacuuming, dusting, and trash removal for Pod A, B, C, D, and the medical record storage room.

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure delineation of privileges in the surgical area for 1 of 1 ophthalmology technician assisting the ophthalmologist during surgery. The Director of Surgery Services reported the ophthalmology technician assisted with 6-8 surgical procedures a month.

Failure to ensure delineation of privileges for the ophthalmology technician could potentially result in unauthorized individuals assisting with surgical procedures that could put the patient at risk for surgical complications or the loss of vision.

Findings include:

1. Review of the practitioner privilege information kept in the surgery area lacked delineation of privileges for Practitioner L, ophthalmology technician.

Review of the operating room logbook revealed Practitioner L, assisted Practitioner B, ophthalmologist, with 6 ophthalmology surgical cases on 10/7/10 and 3 ophthalmology surgical cases on 8/5/10 in the last 3 months reviewed.

Review of a document, provided by the Executive Assistant and kept in administration, titled, "Allied Health Professions Information Form", showed Practitioner L signed an application on 7/09/02. The application included an uncompleted "Physician's Employee-Licensed Job Description/Description of Services". The cover letter accompanying the "Allied Health Professions Information Form" showed the date reviewed by the Chief Nursing Officer on 1/10/03 and the date reviewed by the Executive Medical Staff on 3/18/03.

The application lacked completed and current requested/approved privileges by the governing body to assist the ophthalmologist during surgical procedures at the CAH.

2. Review of the Medical Staff Bylaws, approved by the Board of Trustees on November 24, 2008, revealed in part. "The Associate Staff consists of those non-physician practitioners who hold clinical privileges at the Hospital. . . The nature of the Associate Staff member's privileges, including admitting or co-admitting privileges and any limitations or restrictions on privileges, shall be determined under the criteria for clinical privileges. . . CLINICAL PRIVILEGES. . . Privileges to practice at the hospital are granted by the Board following recommendations of the Medical Staff. . . A practitioner may exercise only those clinical privileges specifically granted by these bylaws. . . DURATION OF APPOINTMENT. Each regular appointment or reappointment to the medical staff and each grant of privileges will be for a period terminating on the next December 31st of an even-numbered year. . . ."

3. During an interview on 10/19/10 at 3:20 PM, the Director of Surgical Services acknowledged the lack of delineated privileges for Practitioner L in the surgical area. The Director of Surgical Services stated Practitioner L accompanies and assists Practitioner B during ophthalmology surgical procedures at the CAH monthly.

During an interview on 10/26/10 at 9:20 AM, the Executive Assistant stated Practitioner L is a visiting nurse, and "has not been put through the credentialing process."

Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the periodic evaluation of its total CAH program included the number of patients served and the volume of services for 1 of 1 applicable off-site clinic. (Morning Star Internal Medicine Clinic)

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic.

Failure to include the periodic evaluation of it total CAH program could result in failure to identify potential changes needed in services provided.

Findings include:

1. Review of Administration policies/procedures revealed policy/procedure titled "Annual Program Evaluation", dated reviewed/revised 1/10, revealed in part. "Purpose: To determine if the utilization of services was appropriate, the established policies were followed, and to determine if changes are needed. . . . Procedure: The review in each of the following areas will take place at least once a year: a) Utilization Review information on number of patients served and volume of services. . . ."

2. Review of the "Critical Access Hospital Annual Report", dated July 1, 2008 to June 30, 2009, failed to include the number of patients served and the volume of services for the Morning Star Internal Medicine Clinic.

3. During an interview on 10/26/10 at 2:40 PM, the Chief Nursing Officer acknowledged the annual evaluation of the CAH total program evaluation lacked evidence to include the number of patients served and the volume of services for the Morning Star Internal Medicine Clinic.

Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the periodic evaluation of its total CAH program included a review of a representative sample of both active and closed clinical records for 1 of 1 applicable off-site clinic. (Morning Star Internal Medicine Clinic)

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic.

Failure to include the periodic evaluation of it total CAH program could result in failure to identify potential changes needed in services provided.

Findings include:

1. Review of Administration policies/procedures revealed policy/procedure titled "Annual Program Evaluation", dated reviewed/revised 1/10, revealed in part. ". . . . Procedure: The review in each of the following areas will take place at least once a year: . . . b) Clinical Record review (minimum sample of 10% of the records will be reviewed). . ."

2. Review of the "Critical Access Hospital Annual Report", dated July 1, 2008 to June 30, 2009, revealed the report failed to include a review of a representative sample of both active and closed clinical records for the Morning Star Internal Medicine Clinic.

3. During an interview on 10/26/10 at 2:40 PM, the Chief Nursing Officer acknowledged the annual evaluation of the CAH total program evaluation lacked evidence to include a review of a representative sample of both active and closed clinical records for the Morning Star Internal Medicine Clinic.

Based on review of the Quality Improvement Plan, Quality Improvement activities, documentation, and staff interviews, the Critical Access Hospital (CAH) quality staff failed to ensure an effective quality assurance program in place. The CAH lacked pharmacy oversight of the security of medications, sample medications, and medication expiration dates in 2 of 2 off-site locations. (Morning Star Internal Medicine Clinic and Creston Medical Clinic)

The Director of Clinics reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and 1840 patient visits per month for the Creston Medical Clinic. The Director of Clinics reported an average of 8 patients per month received sample medications in the Morning Star Internal Medicine Clinic and an average of 5 patients per month received sample medications in the Creston Medical Clinic.

Failure to ensure an effective quality assurance program to evaluate the ongoing monitoring and data collection for problem prevention, identification, and data analysis regarding pharmacy oversight for all pharmaceuticals in the CAH:
a. resulted in expired medications being available for physicians and mid-level providers to give to patients, and the potential theft of medications by unauthorized persons
b. resulted in the potential theft of medications by unauthorized persons
c. could potentially expose patients to expired medications that may be harmful to the patient or have diminished effectiveness.

Findings include:

1. Review of the CAH's "Quality Improvement Plan" approved by the Board of Trustees on 2/22/10 stated in part.

a. ". . . Through the collection of data, GRMC [Greater Regional Medical Center] will determine what is important to our customers, analyze the medical center's performance and take actions to improve performance. . .

b. The QI [Quality Improvement] Committee has approved the following goals for the program: . . . Promote improvement in patient care through ongoing, process change and measurement of outcomes. . .

c. The governing board is the final authority and ultimately responsible for the facility-wide, comprehensive Quality Improvement Program. They may review and approve or require changes in all facets of the program operations. They will receive for review and comment reports on all program activities and findings. . .

d. Department and Service Directors are responsible for the operation of the required quality improvement functions for their respective areas. They are scheduled to attend and report at the QI Committee quarterly. Department Directors are required to submit their written reports using a standard format which includes the area of study or opportunity for improvement, benchmarks/goals and reporting of outcomes for each quality improvement activity. . . "

2. The Quality Improvement Meeting minutes from February 11, 2009 through September 8, 2010 lacked documentation of ongoing monitoring and data collection for problem prevention, identification, and data analysis regarding pharmacy oversight for the security of medications, sample medications, and medication expiration dates in the Morning Star Internal Medicine Clinic and Creston Medical Clinic. The pharmacy quality indicators failed to change in the past 2 years to include monitoring activities of all pharmaceuticals in the CAH including the Morning Star Internal Medicine Clinic and the Creston Medical Clinic.

3. The Pharmacy Director Job description responsibilities, dated 9/1/2004, stated in part. ". . . Directs the pharmacy's quality assessment and improvement activities and ensures compliance with patient care and medical practice standards. . . ."

4. During an interview on 10/25/10 at 2:35 PM, the Director of Quality Services stated the pharmacy failed to report to the quality committee on any monitoring activities regarding medications in the clinics since January 2010.

The Director of Quality Services further stated that some departments kept the same quality monitors even when the lack of problems were identified and those departments need to change the indicators that they are monitoring.

During an interview on 10/26/10 at 4:25 PM, the Director of Pharmacy acknowledged the pharmacy failed to report to the quality committee on any monitoring activities regarding medications in the clinics since January 2010.

During an interview on 10/21/10 at 3:30 PM, The Director of Pharmacy acknowledged the Pharmacy Department failed to maintain oversight of the Morning Star Internal Medicine Clinic and Creston Medical Clinic Pharmaceuticals since the clinics became a part of the CAH. The Morning Star Internal Medicine Clinic became a part of the CAH on 11/30/2007 and the Creston Medical Clinic became a part of the CAH on 1/1/2010.

The Director of Pharmacy further acknowledged the pharmacy has monitored the same indicators for quite some time and should reevaluate what they are monitoring so new potential concerns could be evaluated.

Based on review of the Quality Improvement Plan, Quality Improvement activities, and staff interviews, the Critical Access Hospital (CAH) quality staff failed to ensure the evaluation of all patient care services provided for 1 of 2 off-site locations. (Creston Medical Clinic)

The Director of Clinic Services reported an average of 1840 patient visits per month for the Creston Medical Clinic.

Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substandard care.

Findings include:

1. Review of the CAH's "Quality Improvement Plan" approved by the Board of Trustees on 2/22/10 stated in part. ". . . Department and Service Directors are responsible for the operation of the required quality improvement functions for their respective areas. They are scheduled to attend and report at the QI Committee quarterly. . . Medical center departments/supportive services will complete ongoing monitoring and evaluations. The director of each department is responsible for including the department's activities in the monitoring and evaluation process . . Creston Medical Clinic.

2. The Quality Improvement Meeting minutes from January 13, 2010 through September 8, 2010 lacked evidence the Creston Medical Clinic monitored, evaluated and reported quality improvement activities regarding patient care services for the Creston Medical Clinic.

3. During an interview on 10/25/10 at 2:35 PM, the Director of Quality Services acknowledged the Creston Medical Clinic failed to submit quality reports since merging with the CAH in January 2010.

During an interview on 10/25/10 at 4:05 PM, the Director of Clinic Services stated Creston Medical Clinic has not participated in the quality improvement process since becoming a part of the CAH on 1/1/10. The Director of Clinic Services stated the plan is to do so retrospectively.

During an interview on 10/26/10 at 11:44 AM, the Chief Executive Officer stated the schedule for quality reporting included all clinics report to quality, but Creston Medical Clinic has failed to report since becoming a part of the CAH.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access (CAH) administrative staff failed to ensure a physician at the CAH evaluated the quality and appropriateness of the diagnoses and treatment of patient care furnished by 2 of 3 mid-level practitioners. (Practitioners J, K)

The Director of Clinic Services reported an average of 800 patient visits per month for the Morning Star Internal Medicine Clinic and an average of 1840 patient visits per month for the Creston Medical Clinic.

Failure to ensure the physicians evaluated the quality and appropriateness of the diagnosis and treatment of patient care furnished by the mid-level practitioners could potentially result in mid-level practitioners misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of the CAH's "Quality Improvement Plan" approved by the Board of Trustees on 2/22/10 stated in part. ". . . Activities . . . Peer Reviews which include Medical, Surgical and Emergency case reviews - physicians and midlevels. . . "

2. Review of Quality Improvement Committee Meeting minutes and Medical Staff Meeting minutes for the year of 2010 lacked evidence of evaluation of the quality and appropriateness of the diagnosis and treatment furnished by mid-level practitioners (Practitioners J, K) by a physician at the CAH.

3. During an interview on 10/21/10 at 8:15 AM, Practitioner I, a clinic physician, acknowledged the lack of evaluation of the quality and appropriateness of the diagnosis and appropriateness of the diagnosis and treatment furnished by mid-level practitioner (Practitioner K) by a physician at the CAH.

During an interview on 10/25/10 at 2:35 PM, the Director of Quality Services acknowledged the lack of evaluation of the quality and appropriateness of the diagnosis and treatment furnished by mid-level practitioners (Practitioners J, K) by a physician at the CAH.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to include all practitioners that provided care and services to the CAH patients, in their external peer review process for 7 of 10 applicable practitioners. (Practitioners B, C, D, E, F, G, H) The CAH reported a census of 12 patients.

Failure to ensure an external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH could potentially result in medical staff members misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. A review of CAH policies/procedures on 10/25/10, revealed the CAH administrative staff failed to develop and implement policies/procedures related to the evaluation of the quality and appropriateness of diagnoses and treatment provided to the CAH patients furnished by doctors at the CAH.

During an interview on 10/25/10 at 2:35 PM, the Director of Quality Services acknowledged the CAH quality staff failed to develop a policy/procedure that addressed the evaluation of the quality and appropriateness of diagnoses and treatment provided to the CAH patients furnished by doctors at the CAH.

2. Review of peer review documentation for the past credentialing period of 2 years revealed the CAH staff failed to include all Practitioners (Practitioners B, C, D, E, F, G, H) in the CAH's external peer review process.

3. During an interview on 10/26/10 at 8:00 AM, the Director of Quality Services stated the CAH quality staff only send out records of patients cared by active medical staff members and not specialty physicians including those that have provided surgical care to the patients at the CAH. The Director of Quality Services acknowledged the CAH quality staff failed to send out records for Practitioners B, C, D, E, F, G, H for external peer review for the last credentialing period. The Director of Quality Services verified Practitioners B, C, D, E, F, G, H had provided services to patients of the CAH during the last credentialing period.