HospitalInspections.org

Based on staff interview and review of policies, patient records, meeting minutes, credentials files, and state hospital licensure rules, it was determined the CAH failed to ensure an organizational structure was in place sufficient to 1) provide safe and effective care to patients and 2) ensure all Conditions of Participation were met. This resulted in the inability of the CAH to develop systematic approaches to patient care and to respond to identified problems. The findings include:

1. Refer to C241 as it relates to the failure of the Governing Body to assume full responsibility for determining, implementing, and monitoring policies governing the CAH's operation.

2. Refer to C-270, Condition of Participation: Provision of Services and related standard level deficiencies as they relate to the failure of the Governing Body to ensure patients received appropriate care and services.

3. Refer to C-330, Condition of Participation: Periodic Evaluation and Quality Assurance Review and related standard level deficiencies as they relate to failure of the Governing Body to ensure a data driven QA program was developed and implemented.

The cumulative effect of these negative systemic practices limited the capacity of the CAH to furnish services of an adequate level or quality.



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Based on staff interview and review of policies, patient records, meeting minutes, credentials files, and state hospital licensure rules, it was determined the Governing Body failed to assume full responsibility for determining, implementing, and monitoring policies governing the CAH's operation. This lack of oversight directly impacted the care of 1 of 1 patient (#9) reviewed who was treated by a provider operating under a restricted license and had the potential to impact all patients seeking medical services at the CAH. The failure of the Governing Body to ensure policies were developed and to monitor care in relation to those policies resulted in a lack of direction to staff. The findings include:

1. The CEO was interviewed on 6/16/10 at 8:55 AM. He stated the hospital's Board of Trustees met on 5/17/10 following the 5/05/10 survey. He stated the hospital did not have the recertification survey report at the time of the meeting (CMS Form 2567). Draft minutes of the 5/17/10 board meeting stated the recertification survey had taken place. The minutes stated the hospital had received one serious citation related to "the condition of participation on sterilization of scopes." The minutes did not mention the deficiencies related to Organizational Structure or Quality Assurance. The CEO stated the board had not met since receiving the survey report.

In the same interview, the CEO stated the QI Coordinator had met with members of the QI Committee individually but he said the Committee as a whole had not met since the survey. The CEO stated the medical staff met shortly after the survey and before the hospital had received the survey report. The CEO stated none of the above entities had met following the receipt of the survey report to discuss the findings of the report, to review hospital systems, and to develop a plan of correction.

The Governing Body failed to ensure persons responsible for the operation of the hospital had met and reviewed operations in order to correct identified deficiencies.

2. Idaho state licensure requirements at IDAPA 16.03.14.350.03 require the hospital to form a Pharmacy and Therapeutics Committee composed of members of the medical staff, the Director of Pharmaceutical Services, the DON, hospital administration and other health disciplines as necessary to develop written policies and procedures for medication use. While the hospital had a Pharmacy and Therapeutics Committee which met monthly in conjunction with the Medical Staff meetings, the Governing Body of the hospital did not ensure a pharmacist was included on the committee.

Five monthly Medical Staff meeting minutes between 1/13/10 and 5/12/10 were reviewed. None of these minutes listed the pharmacist was in attendance. The pharmacist was interviewed on 6/16/10 at 10:20 AM. He stated he was not a part of the Pharmacy and Therapeutics Committee and did not attend the meetings. He further stated he did not review medication errors that occurred at the hospital. He said he did not oversee the use of IV medications and solutions at the hospital. He stated he did not review areas of the hospital where medications were stored, except for the pharmacy.

The Governing Body failed to ensure the pharmacist participated as a member of the Pharmacy and Therapeutics Committee. The Governing Body failed to ensure the pharmacist had oversight of medications and IV solutions at the hospital.

3. The Governing Body failed to ensure an effective system to identify and prevent medication/prescription errors had been developed and implemented.

The hospital had identified only 2 medication/prescription errors between 10/20/09 and 6/14/10, the start of the follow-up survey. Surveyors identified 10 medication/prescription errors between 6/11/10 and 6/17/10.

The QI Coordinator was was interviewed on 6/16/10 at 9:45 AM. She stated a system to actively search for medication errors had not been developed. She stated the Pharmacy Technician conducted some medical record reviews. She acknowledged the Pharmacy Technician did not have a medical background and had not been trained to identify medication errors.

The Governing Body failed to develop a system to prevent medication errors.

4. The Governing Body failed to restrict the practice of 1 of 1 Allied Medical Staff member (Staff I) with a restricted license.

Staff I was a NP. Her credentials file contained a letter from the Board of Nursing, dated 11/06/07, which stated she was not allowed access to prescribe or dispense controlled substances and/or scheduled drugs. Her privileges had not been modified. The privilege list did not state how scheduled medications would be ordered if needed.

The inability to order scheduled medication led to confusion. Patient #9's medical record documented a 58 year-old female who was brought to the ER on 6/11/10 after a fall from a horse. She complained of severe pain in her right upper leg. She was examined by Staff I. An order by Staff I on the "ER PROVIDER ORDER AND DOCUMENTATION RECORD", that was undated and untimed, stated "MS [morphine sulfate] 4 mg X 2." The order stated Staff J, another NP, had approved the order. Staff J had not signed the order. The medical record stated morphine was administered to Patient #9 at 8:02 PM and at 8:40 PM on 6/11/10.

During an interview with the DON on 6/17/10 at 11:15 AM, she verified the record of Patient #9 and the morphine order. She stated Staff I had a restricted license and was unable to prescribe narcotics. The DON stated there was an unwritten arrangement with the medical and nursing staff in which staff were instructed to call the back up physician or other nurse practitioner for narcotics orders. The DON stated, in the case of Patient #9, it was not documented that communication with another provider was made.

The Chief of the Medical Staff was interviewed on 6/22/10 at 10:20 AM. He stated he thought Staff I was not allowed to write orders for scheduled medications. He stated nurses would have to obtain an order from another provider. He said he did not know if a specific procedure to do this had been developed.

The Governing Body failed to define Staff I's practice and identify how nursing staff could obtain valid orders for scheduled medications.



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Based on review of policies, staff interview, and review of medical records, it was determined the CAH failed to ensure services were provided in accordance with written policies and procedures. This resulted in the inability of the CAH to provide consistent services based on sound practices. The findings include:

1. Refer to C271 as it relates to the failure of the CAH to ensure services were provided in accordance with written policies.

2. Refer to C276 as it relates to the failure of the CAH to follow established standards of practice in the management of medications.

The cumulative effect of these negative systemic practices limited the capacity of the CAH to furnish services of an adequate level or quality.

Based on staff interview, review of medical records and hospital policies, it was determined the CAH failed to ensure services were furnished in accordance with appropriate written policies. Staff failed to follow written policies related to the writing complete medication orders, documenting services provided to patients, the provision of IV therapy, and ensuring orders were accurately written. This directly impacted 10 of 15 ER and OP department patients (#1, #2, #4, #5, #6, #7, #9, #12, #14, and #15), whose records were reviewed. This resulted in the inability of the hospital to ensure effective care was provided in accordance with appropriate orders from practitioners. The findings include:

1.Staff failed to write complete orders in accordance with written policy.

A policy titled "Telephone, Verbal, and Written orders for Medication," dated 5/15/10, stated orders "would include the following criteria:

-Date and time the order is prescribed
-The name of the individual prescribing the drug and his/her licensure
-The generic and brand name of the drug
-Drug dosage
-Quantity and/or duration
-Route drug is to be administered
-Frequency of administration
-Age and weight of the patient when appropriate.
-The reason the drug was ordered for the patient
-Specific indications for use, as indicated
-Name and level of licensure of the individual receiving and documenting the order."

Staff failed to follow this policy and wrote incomplete orders including:

a. Patient #6's medical record documented a 92 year-old female who presented to the ER on 6/14/10 at 3:10 PM. She complained of chest and back pain. The "EMERGENCY ROOM RECORD" dated 6/14/10 and generated at the time of the visit, stated "Toradol 30 mg IM, Phenergan 50 mg IM, GI Cocktail po." (A GI cocktail is a mixture of ingredients to calm an upset stomach. Usually the major ingredient is a Maalox-type antacid.) This appeared to be written by Staff H, a RN. It was not clear that this was an order. The medications were simply listed on the form with no date or time or signature. It did not state when the medications were to be given. The Toradol and Promethazine were documented as given at 3:15 PM. The GI Cocktail was documented at 3:30 PM

Staff H, the RN who cared for Patient #6, was interviewed on 6/17/10 at 10:10 AM. She stated she gave the medications to Patient #6. She confirmed a complete order for the medications was not present in the medical record. She stated the NP rushed up from the clinic, saw Patient #6, and rushed back to the clinic. Staff H stated she did not know what the hospital's policy was regarding complete medical orders.

b. Patient #7's medical record documented a 62 year-old female who presented to the ER on 6/12/10 at 5:17 PM. She complained of difficulty breathing. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD", written by Staff J, a NP, and dated 6/12/10, stated Patient #7 had "bad" upper respiratory symptoms for 4 days. The form stated Patient #7 had a history of chronic obstructive pulmonary disease and said she "can't talk for periods because can't catch breath." The form stated "Duoneb svn-tx." This was not noted as an order by Nurse K, the RN who examined Patient #7. The time it was written was not noted. The number of ampules to be given was not documented. The form did not state if the drug should be administered immediately or if it could be postponed. The Duoneb was documented as administered at 7:40 PM, 2 hours and 23 minutes after Patient #7 arrived at the ER.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He reviewed Patient #7's medical record and stated the failure to write a complete order and administer Duoneb in a timely manner constituted a medication error.

c. Patient #7 returned to the ER on 6/14/10 at 2:47 PM, complaining of shortness of breath and cough. The "EMERGENCY ROOM RECORD" stated Patient #7 received "Prednisone 40 mg 2 pills" at 3:15 PM. An order for the Prednisone was not documented in the medical record.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He reviewed Patient #7's medical record and confirmed the lack of a medication order.

d. Patient #5, an 88 year-old female was seen as an OP on 6/14/10 at 11:53 AM, for left leg and hip pain. A verbal order was given to Staff H, a RN, by Patient #5's physician for Decadron (a steroid), and Toradol (an anti-inflammatory). The verbal order was untimed, and was not signed by the physician.

In an interview with Staff H, the RN, on 6/17/10 at 10:10 AM, she confirmed Patient #5's orders were incomplete.

e. Patient #9, a 58 year-old female was brought to the ER on 6/11/10 after a fall from a horse. She reported she had severe pain in her right upper leg. An entry by Staff I, a NP, on the "ER PROVIDER ORDER AND DOCUMENTATION RECORD" was undated and untimed. It read "MS 4 mg X 2, [Staff J, another NP] approved." There was no signature by Staff J. Patient #9's record also documented IV fluids had been administered, although there was no order for the IV fluids.

An interview with the CAH's pharmacist was completed on 6/16/10 at 10:30 AM. He reviewed Patient #9's medication order. He indicated since the order was not complete it would be considered a medication error.

f. Patient #12, a 16 year-old male came to the ER on 6/13/10 at 7:50 PM with severe sore throat pain. The record stated he was evaluated by Staff I, a NP. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD" stated "Amoxicillin 1 gm PO now." The order was not dated, timed, or signed. It was not clear whether the nurse or the practitioner had written the order. The order was not noted by a nurse, although the medication was documented as given at 8:05 PM.

In an interview on 6/17/10 at 11:15 AM, the DON reviewed the record of Patient #12 and confirmed the documentation.

In an interview on 6/16/10 at 10:30 AM, the CAH's pharmacist reviewed Patient #12's medication order. He stated since the order was not dated, signed or timed, it would be considered a medication error.

g. Patient #15, a 12 year-old male came to the ER on 6/16/10 with complaints of a sore throat. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD" had a verbal order from Staff I, a NP, that was undated and untimed, for "Azithromycin 200/5 ml-PO Now, give 5 ml, then dispense remainder of bottle with instructions to take 2.5 ml every day X 4 days."

In an interview on 6/17/10 at 11:15 AM, the DON reviewed the record of Patient #15 and stated the nurse was responsible for ensuring the record was complete, which would include the time and date on the orders. The DON stated the record for Patient #15 documented the NP had seen the patient. She stated the CAH had a difficult time with the providers writing their own orders.

h. Patient #14, a 42 year-old female, came to the ER on 6/15/10, with a complaint of right sided headache for 2 hours. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD" had an order from Staff I, a NP, that was undated and untimed, for "Flexeril 10 mg PO Now," and "dispense Flexeril 10 mg X 2 tabs to take home."

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #14's medication order. He stated the since the order was not dated or timed, it would be considered a medication error.

In an interview on 6/17/10 at 11:15 AM, the DON reviewed the record and confirmed the medication order entry for Patient #14. The DON stated the nurse was responsible for ensuring the record was complete, which would include the time and date on the orders. The DON stated the problem of complete documentation has been an ongoing problem with both the providers and nursing staff. The DON said the policy of the CAH was to minimize verbal orders when the provider was available and present.

The hospital failed to ensure complete orders were written and signed.

2. Practitioners failed to document examinations of patients in accordance with written policy. Examples include:

a. Patient #6's medical record documented a 92 year-old female who presented to the ER on 6/14/10 at 3:10 PM. She complained of chest and back pain. The "EMERGENCY ROOM RECORD," stated Patient #6 received Toradol 30 mg and Promethazine 50 mg by injection at 3:15 PM. The record stated she received a "GI Cocktail" at 3:30 PM. The "EMERGENCY ROOM RECORD" stated Patient #6 was discharged at 4:30 PM. The "EMERGENCY ROOM RECORD" stated Patient #6 was examined by Staff J, a NP, but did not state a time. Documentation of the examination by the NP was not present in the medical record as of 6/17/10.

The HIM Director was interviewed on 6/17/10 at 11:00 AM. She reviewed Patient #6's medical record. She stated the NP who examined Patient #6 had not dictated an examination note.

b. Patient #7's medical record documented a 62 year-old female who presented to the ER on 6/14/10 at 2:47 PM complaining of shortness of breath and cough. The "EMERGENCY ROOM RECORD" stated Patient #7 received "Prednisone 40 mg 2 pills" at 3:15 PM. The "EMERGENCY ROOM RECORD" stated a "provider" examined Patient #7 at 3:05 PM. Documentation of the examination by the provider was not present in the medical record as of 6/17/10.

The HIM Director was interviewed on 6/17/10 at 11:00 AM. She reviewed Patient #7's medical record. She stated Staff J, the NP who examined Patient #7, had not dictated an examination note.

c. Patient #12 was a 16 year-old male who came to the ER on 6/13/10 at 7:50 PM, with severe sore throat pain. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD" did not contain notes or a provider signature, although the "EMERGENCY ROOM RECORD" dated 6/13/10, indicated the provider (Staff I, a NP) had arrived at 7:56 PM to assess Patient #12.

In an interview on 6/17/10 at 11:15 AM, the DON reviewed the record and confirmed Patient #12 had no evidence of dictation or written notes by Staff I.

d. Patient #14 was a 42 year-old female who came to the ER on 6/15/10 with a complaint of right sided headache for 2 hours. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD," undated and untimed, had a note entry of assessment by Staff I, a NP. It stated "Muscle tension headache, plan: Flexeril 10 one, TID PRN." Documentation was not present that the NP had examined Patient #14 or that she had dictated a note of her examination.

In an interview on 6/17/10 at 11:15 AM, the DON reviewed the record. She confirmed an appropriate note of the NP's findings was not documented. The DON stated Staff I often dictated notes for ER visits, but said there was no evidence a note had been dictated.

Practitioners did not document assessments of patients.

3. The CAH failed to follow written policies related to monitoring and assessment of outpatients.

The policy "Medication Administration," dated 5/15/10, stated all patients receiving a medication in the outpatient department will be monitored for 15 minutes following the administration of the medication to check for adverse reactions. The policy did not reference any exceptions to the 15 minute rule. Patients were not monitored for the required time frames. Examples include:

a. Patient #1 was a 66 year-old male, who received daily antibiotic therapy for osteomyelitis (an infection involving the bone) in his heel. On 6/13/10 Patient #1's infusion of Cubicin and Invanz (both antibiotics) was started at 8:10 AM. The record indicated the infusion was completed at 8:40 AM, and Patient #1 was discharged at 8:50 AM, which was 10 minutes after the infusion was completed.

In an interview on 6/16/10 at 11:00 AM with Staff B, a RN, she confirmed Patient #1 was discharged 10 minutes after the antibiotic was completed. She stated the infusion for Patient #1 infused over 30 minutes, and as he had been receiving the medication on a daily basis, she felt he no longer required the 15 minute evaluation.

b. Patient #2, a 28 year-old male received daily antibiotic therapy for a salivary gland infection. On 6/11/10, Patient #2's infusion of Invanz was started at 5:15 PM. There was no documentation of the time the infusion was completed. The record stated Patient #2 was discharged at 5:45 PM.

In an interview on 6/16/10 at 11:00 AM with Staff B, a RN, she confirmed she did not document when the antibiotic was completed. She stated the medication for Patient #2 infused over 30 minutes, and as he had been receiving the medication on a daily basis, she felt he no longer required the 15 minute evaluation.

On 6/13/10 Patient #2's medical record stated the infusion of Invanz was completed at 5:30 PM, and he was discharged at 5:35 PM, 5 minutes after the infusion was completed.

In an interview on 6/16/10 at 11:00 AM with Staff B, the RN, she stated Patient #2 had been receiving the medication on a daily basis, and she felt he no longer required the 15 minute evaluation.

The CAH staff failed to monitor patients that had received medications, for 15 minutes as required in the medication administration policy.



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4. The policy "Verbal and Written Orders, General," not dated, and the policy "Telephone, Verbal and Written Orders for Medication," not dated, stated nursing staff would utilize the read back process and repeat the orders in their entirety to the prescribing practitioners to prevent miscommunication. The policies did not specify how nursing staff were to document this read back process.

Nursing staff did not document a read back process for verbal and orders, resulting in medication orders which were not accurately written. Examples include:

a. Patient #6's medical record documented a 92 year-old female who presented to the ER on 6/14/10 at 3:10 PM. She complained of chest and back pain. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD," dated 6/14/10, not timed or dated, stated "Toradol 30 mg IM, Phenergan 50 mg IM, GI Cocktail po." (A GI cocktail is a mixture of ingredients to calm an upset stomach. Usually the major ingredient is a Maalox-type antacid.) This was written by the nurse. The documentation did not state the orders had been read back to the prescribing practitioner.

b. Patient #4's medical record documented a 56 year-old female who was seen on 6/14/10 as an outpatient. There was a telephone order written on a Harms Memorial Hospital prescription pad for "Valium, 7 mg, IM". The telephone order did not indicate it was read back to the prescribing physician.

c. Patient #5's medical record documented an 88 year-old female that was seen as an outpatient on 6/14/10 at 11:53 AM for left leg and hip pain. A verbal order was written by Staff H, a RN, for Decadron (a steroid), and Toradol (an anti-inflammatory). The verbal order did not indicate it was read back to the prescribing physician.

d. Patient #15's medical record documented a 12 year-old male that came to the ER on 6/16/10 with complaints of a sore throat. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD," had a verbal order entry from Staff I, a NP, that was undated and untimed, for "Azithromycin 200/5 ml-PO Now, give 5 ml, then dispense remainder of bottle with instructions to take 2.5 ml every day X 4 days." The verbal order did not indicate it was read back to the prescribing physician.

Staff B, the Charge Nurse on duty, was interviewed on 6/24/10 at 8:30 AM. She stated the hospital had not developed a procedure defining how nurses would document the read back process for verbal and telephone orders. She said there was no way to tell if orders had been read back to the prescribing practitioner. She also stated nurses had the capability to record telephone orders from certain telephones. She stated there was no policy directing staff when or how to use this system.

A system had not been developed to document a read back process for verbal and telephone orders.

Based on staff interview and review of medical records and hospital policies, it was determined the CAH failed to ensure rules for the storage, handling, and administration of drugs were developed and implemented. The CAH also failed to ensure the pharmacist maintained oversight of medication policies and drug storage areas. This affected the care of 8 of 15 patients (#4, #5, #6, #7, #9, #12, #14, and #15) whose medical records were reviewed and had the potential to affect all patients at the CAH who received medications. This resulted in the inability of the CAH to accurately provide medications to patients. The findings include:

1. The CAH's policies were insufficient to prevent medication errors. Nine medication/prescription errors were identified by surveyors that occurred between 6/11/10 and 6/17/10. These errors had not identified by CAH staff. The errors included:

a. Patient #6's medical record documented a 92 year old female who presented to the ER on 6/14/10 at 3:10 PM. She complained of chest and back pain. The "EMERGENCY ROOM RECORD" stated Patient #6 received Toradol 30 mg and Promethazine 50 mg by injection at 3:15 PM. The record stated she received a "GI Cocktail" at 3:30 PM. These 3 medications were written by the nurse on an "ER PROVIDER ORDER AND DOCUMENTATION RECORD," dated 6/14/10. The medications were simply listed on the form. The name/signature of the individual who wrote order was missing, as was the date and time it was written. The document did not contain information related to when these medications were to be given or if they could be repeated.

Staff H, the RN who cared for Patient #6, was interviewed on 6:17/10 at 10:10 AM. She stated she gave the medications to Patient #6. She confirmed an order for the medications was not present in the medical record. She stated Staff J, the NP who examined the patient, rushed up from the clinic, saw Patient #6, and rushed back to the clinic. Staff H stated she did not know what the hospital's policy stated regarding complete medical orders.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He reviewed Patient #6's medical record and stated the administration of Toradol, Promethazine and the "GI Cocktail" constituted medication errors.

Nursing staff administered medications to Patient #6 without orders.

b. Patient #7's medical record documented a 62 year old female who presented to the ER on 6/12/10 at 5:17 PM. She complained of difficulty breathing. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD," written by the NP and dated 6/12/10, stated Patient #7 had "bad" upper respiratory symptoms for 4 days. The form stated Patient #7 had a history of chronic obstructive pulmonary disease and said she "can't talk for periods because can't catch breath." The form stated "Duoneb svn-tx." What this meant was not clear. This was not noted as an order by the nurse. The time it was written was not noted. The number of doses to be given was not documented. The route was not documented. The form did not state if the drug should be administered immediately or if it could be postponed.

The inhalation treatment with Duoneb was administered at 7:40 PM on 6/12/10, according to the MAR. The reason for the 2 hour and 23 minute delay was not documented.

Staff B, the nurse on duty when Patient #7 was treated in the ER, was interviewed on 6/16/10 at 11:20 AM. She stated she did not see the order for the Duoneb. She stated if she had seen the order she would have administered it in a timely manner.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He reviewed Patient #7's medical record and stated the failure to write a complete order and administer Duoneb in a timely manner constituted a medication error.

c. A separate medical record documented Patient #7 returned to the ER on 6/14/10 at 2:47 PM complaining of shortness of breath and cough. The "EMERGENCY ROOM RECORD" stated Patient #7 received "Prednisone 40 mg 2 pills" at 3:15 PM. An order for the Prednisone was not documented in the medical record.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He reviewed Patient #7's medical record and confirmed the medication error.

The hospital failed to ensure complete orders were written and failed to provide medication to Patient #7 in a timely manner.


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d. Patient #4, a 56 year-old female was seen on 6/14/10 as an outpatient. There was a telephone order written by an RN on a Harms Memorial Hospital prescription pad for "Valium, 7 mg, IM". The outpatient record documented Patient #4 received Valium 7 mg at 4:20 PM. Patient #4's medical record did not contain a diagnosis or reason for the order. The record did not contain instructions to the nurse regarding how to monitor Patient #4 following the injection.

A policy titled "TELEPHONE, VERBAL, AND WRITTEN ORDERS FOR MEDICATION," dated 5/15/10 included the criteria for orders to contain:

"-Date and time the order is prescribed
-The reason the drug was ordered for the patient"

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #4's medication order and stated it constituted a medication error.

e. Patient #5, an 88 year-old female was seen as an outpatient on 6/14/10 at 11:53 AM for left leg and hip pain. A verbal order was given to Staff H, a RN, by Patient #5's physician for Decadron and Toradol. The verbal order was not dated or timed, and was not signed by the physician.

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #5's medical record. He stated since the order was not dated, timed, or signed, it was a medication error.

f. Patient #9 was a 58 year-old female, brought to the ER on 6/11/10 with severe pain in her right upper leg after falling from a horse. An entry was on the "ER PROVIDER ORDER AND DOCUMENTATION RECORD," that was undated, untimed and unsigned. It read "MS 4 mg X 2," followed by the name of Staff J, a NP, and the word "approved." Patient #9's record also documented IV fluids had been administered, although there was no order for the IV fluids.

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #9's medication order. He stated since the order was not dated, signed or timed, it was a medication error.

g. Patient #12, a 16 year-old male came to the ER on 6/13/10 at 7:50 PM with severe sore throat pain. The "EMERGENCY ROOM RECORD" on page 2, dated 6/13/10, documented Patient #12 received a dose of Amoxicillin (an antibiotic) 1 gram at 8:05 PM. No medication order was documented.

In an interview on 6/17/10 at 11:15 AM, the DON reviewed the record of Patient #12 and confirmed the documentation of medication given. She confirmed the order was not complete.

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #12's medication order. He stated since the order was not dated, signed or timed, it was a medication error.

h. Patient #14, a 42 year-old female came to the ER on 6/15/10 with the complaint of a right-sided headache for 2 hours. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD," had an order entry from Staff I, a NP, that was undated and untimed, for "Flexeril 10 mg PO Now," and "dispense Flexeril 10 mg X 2 tabs to take home."

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #14's medication order. He stated the since the order was not dated or timed, it was a medication error.

i. Patient #15, a 12 year-old male came to the ER on 6/16/10 with a complaint of sore throat. The "ER PROVIDER ORDER AND DOCUMENTATION RECORD," had a verbal order entry from Staff I, a NP, that was undated and untimed, for "Azithromycin 200/5 ml-PO Now, give 5 ml, then dispense remainder of bottle with instructions to take 2.5 ml every day X 4 days." The record documented Staff I performed an assessment and spoke with Patient #15's mother.

In an interview on 6/16/10 at 10:30 AM, the pharmacist reviewed Patient #15's medical record. He stated because the order was not dated or timed, it was a medication error.

The CAH had 2 medication error policies. One was a pharmacy policy, dated 2/15/01, titled "Medication Error Policy and Procedure." It was a 1 page policy that stated "All medication errors that have the potential to cause an adverse reaction with the resident will be reported to the resident's physician or the physician on call in the Emergency Department in the absence of the primary physician within 24 hours." The policy did not define medication errors.

Another policy, not dated, titled "MEDICATION ERRORS-EMERGENCY DEPARTMENT," defined 7 levels of medication errors and types of errors. It was not clear if this policy applied to the entire hospital.

The CAH's policies were inconsistent and failed to prevent medication errors.

2. The pharmacist was not involved in the monitoring and prevention of medication errors.

The pharmacy policy "Medication Error Policy and Procedure," dated 2/15/01, stated all medication errors would be reported to the Compliance Officer and reviewed by the "Pharmacy Review Committee" on a monthly basis. The policy did not specify the pharmacist's role in reviewing medication errors.

An Emergency Department policy titled "Medication Errors," not dated, stated significant medication error reports would be reviewed by the Pharmacy and Therapeutics Committee. It listed 7 levels of medication errors from potential errors up to and including patient death. The accompanying procedure did not specify a role for the pharmacist.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He stated he did not review medication errors at the hospital.

The DON was interviewed on 6/16/10 at 9:45 AM. She stated medication errors were reviewed by the Pharmacy Review Committee. She said she was not part of the committee. Upon further questioning, she stated the Pharmacy Review Committee was a nursing home committee and was not a committee for the hospital.

3. A system had not been developed to check for outdated medications on the nursing unit. Surveyors observed the medication cart and storage area behind the nursing station on 6/17/10 beginning at 2:00 PM. Outdated medications which were observed included:

-medication cart-
Ibuprofen 13 tablets, expired 1/2010
-storage area-
Sodium Chloride vials, expired 5/2005
Epinephrine 1:1000 injectable, expired 5/01/2010
Benadryl injectable, expired 4/2010
Nexium injectable, expired 4/2010

The "Consulting Agreement" for the pharmacist, signed on 1/09/1999, stated the pharmacist was to "Periodically check drugs and drug records in all locations in the hospital where drugs are stored, including but not limited to nursing stations, emergency room, outpatient departments, and operating suites."

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He stated nurses checked for outdated medications on the hospital units. He stated he did not know if there was a system in place to check for outdated medications not in the pharmacy.

4. The CAH did not ensure the pharmacist participated with the medical staff to provide oversight of medication storage and delivery systems.

The policy "Pharmacy and Therapeutics Committee," approved 3/12/03, stated the Pharmacy and Therapeutics Committee consisted of the pharmacist and a member of the medical staff and nursing staff as well as others. The policy stated the Pharmacy and Therapeutics Committee met monthly in conjunction with the Medical Staff meeting.

Five monthly Medical Staff meeting minutes between 1/13/10 and 5/12/10 were reviewed. None of these minutes listed the pharmacist in attendance.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He stated he was not a part of the Pharmacy and Therapeutics Committee. He stated he did not attend Pharmacy and Therapeutics Committee meetings or otherwise formally communicate with the medical staff at the hospital.

5. The pharmacist did not provide oversight of IV medications and solutions stored and administered at the hospital.

Nurses mixed most IV medications administered at the hospital. Review of ER and OP patient records documented administration of IV antibiotics to patients on a daily basis from 6/11/10 to 6/16/10. IV medications documented as administered during that time included Solumedrol (a steroid), Levaquin (an antibiotic), Rocephin (an antibiotic), Toradol (a non-steroidal anti-inflammatory drug), Cubicin (an antibiotic), Invanz (an antibiotic), and Decadron (a steroid).

Pharmacy policies did not address the mixing of IV medications. This was confirmed by interview with the pharmacist on 6/16/10 at 10:20 AM. He stated the DON had oversight of IV medications. He stated he was not involved with the mixing of IV medications.

The DON was interviewed on 6/17/10 at 11:15 AM. She confirmed policies related to the mixing of IV medications had not been developed. She stated staff referred to Mosby's "2010 Intravenous Medications" book for technical assistance such as which IV solutions were incompatible with which medications. However, she said a policy to ensure the competency of nurses to mix and administer IV medications and solutions had not been developed. She stated the CAH did not have a written policy that included guidelines for preparing IV fluids and mixtures for ER, OP, and inpatient administration.

The CAH maintained a small open medication storage and preparation room, approximately 5 feet wide by 6 feet long. In the room against one wall was a medication cart on wheels which was approximately 4 feet high, 2 feet wide, and 2 feet deep. At the opposite wall was a sink with a counter that ran the length of the wall. The counter held a large red bucket-type sharps container, a 4 tier open storage unit with syringes and wrapped supplies, several notebooks, and a small refrigerator for medications that needed to be kept cold. To the right of the wheeled medication cart was a wall mounted locked cabinet with 3 open shelves below it. The shelves held plastic buckets which contained various IV, oral, and topical medications. The medications were labeled, but contained no patient labels, and included both opened containers and unopened vials. The small "U" shaped room could accommodate only one staff member at a time. The open counter area for medication preparation was approximately 14 inches wide by 8 inches deep next to a hand washing sink and in front of the 4 tier open storage unit.

In an interview with Staff B, the Charge Nurse on 6/17/10 at 3:30 PM, she explained the above described medication room was the room where all patient medications, IV's, and IV medications were prepared, which also included OP and ER patients. Staff B stated she thought the counter area of 8 inches by 14 inches was an adequate sized area for patient medication preparation. Staff B stated the open plastic buckets of opened and unopened medications without patient names was a stock medication supply to be used as needed, and charged to the patient when used.

The pharmacist was interviewed on 6/16/10 at 10:20 AM. He stated he had not inspected the area to ensure it was adequate for the mixing of IV medications.

IV medications at the CAH were not supported by pharmacist oversight or by CAH policies.

Based on staff interview and review of hospital policies, QI meeting minutes and documents, emergency room registers, and past survey reports, it was determined the CAH failed to ensure a comprehensive Quality Assurance program had been put into effect. This resulted in the inability of the CAH to identify and correct care related issues. The findings include:

Refer to C336 as it relates to the failure of the CAH to ensure an effective quality assurance program had been developed and implemented.

The cumulative effect of these negative systemic practices resulted in the inability of the CAH to provide care of sufficient level or quality.



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Based on staff interview and review of hospital policies, QI meeting minutes and documents, the emergency room register, and past survey reports, it was determined the CAH failed to ensure an effective quality assurance program had been developed and implemented. This resulted in the inability of the CAH to evaluate its programs and make improvements. The findings include:

1. The policy "Quality Improvement," dated 7/22/09, stated the hospital would develop a "...process for continuous quality improvement to evaluate the quality of treatment in the facility. This process will be facility wide, include all departments and contracted services, and will include:

Ongoing monitoring and data collection;
Problem prevention, identification and data analysis;
Identification of corrective actions;
Implementation of corrective actions;
evaluation of corrective actions..."

The "Quality Improvement" policy stated a quality improvement committee would meet at least quarterly to "a. Perform problem identification, assessment and facilitation of improvement activities. b. Coordinate/Integrate QI and compliance activities throughout the hospital. c. Review data received from Department managers." The policy stated the quality improvement coordinator was "Assisting Hospital departments in data collection, analysis and reporting."

The QI Committee meeting minutes for 2010 included minutes dated 1/12/10 and 4/13/10. The minutes for both meetings stated the committee met and discussed quality projects. However, no data was discussed in the minutes. Also, no data was attached to the meeting minutes. Missing data included department specific data and incidents such as falls and medication errors.

The QI Coordinator was was interviewed on 6/15/10 at 2:30 PM. Surveyors requested a copy of the QI plan. She stated a specific QI plan listing quality indicators was not documented. She stated a review of the overall QI plan had not been completed in the past year. She also stated QI data was not available. She stated she was not able to compare data, including incidents, from the past with current data in order to determine if systems were improving.

The QI program for the hospital was not supported by a plan and data.

2. The CMS form 2567, dated 5/05/10, stated it was determined the hospital was not in compliance with the Condition of Participation for Periodic Evaluation and Quality Assurance Review (42 CFR Part 485.641) due to an inadequate QI program. The QI Coordinator was was interviewed on 6/15/10 at 2:30 PM. She stated since the 5/05/10 survey, the QI Committee had not met to review the QI program. She stated the committee was scheduled to meet the following week. She stated she had met with individual members of the committee but she did not have documentation of this.

The hospital failed to evaluate its QI program and take corrective action.

3. The hospital had identified only 2 medication/prescription errors between 10/20/09 and 6/14/10, the start of the follow-up survey. Surveyors identified 10 medication/prescription errors between 6/11/10 and 6/17/10.

The QI Coordinator was interviewed on 6/16/10 at 9:45 AM. She stated a system to actively search for medication errors had not been developed. She stated the pharmacy technician conducted some medical record reviews. She acknowledged the pharmacy technician did not have a medical background and had not been trained to identify medication errors.

The hospital failed to develop and implement an effective system to identify medication errors.

4. The CAH had not developed a system to review cases where an RN conducted the medical screening examination. Occasionally, patients presented to the ER and were examined by an RN instead of another provider. The "EMERGENCY ROOM REGISTER" identified a patient who had presented to the ER on 6/14/10 at 7:47 PM complaining of nausea, vomiting, and diarrhea for the past 5 days. The register stated the patient had been examined by an RN and was discharged home at 8:11 PM.

The Chief of the Medical Staff was interviewed on 6/22/10 at 10:20 AM. He stated a system had not been developed to ensure the cases of patients who were not examined by a physician or mid-level practitioner were reviewed in order to determine if they received an examination that was adequate to identify emergency medical conditions.

The hospital failed to develop systems to review the cases of ER patients who were not examined by physician or mid-level practitioners.



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