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Based on a review of medical records and policy and procedures; observation; and staff interview the CAH (Critical Access Hospital) failed to ensure 2 of 41 sampled patients (Patients 32 and 41) received non-formulary medications (medications not stocked in the hospital pharmacy) in accordance with physician's orders. This had the potential to affect all patients admitted to the facility that have orders for non-formulary medications. Facility census was 9 inpatients and 1 swing bed patient.

Findings are:

A. A review of Patient 32's medical record showed that an order for Namenda XR (extended release medication used to help slow down the symptoms of dementia [a loss of intellectual abilities]) was received on 11/19/14 at 1400 (2:00 PM). The order was for "Namenda 14 or 21 XR po daily". A clarification of the Namenda XR order was received on 11/19/14 at 1600 (4:00 PM) from the physician which revealed, "Namenda XR titration pack from clinic as directed: Namenda XR 7 mg (milligrams) po (per mouth) daily x (by) 7 days, then 14 mg po x 7 days, then 21 mg po x 7 days, then 28 mg po".

B. A review of Patient 32's Medication Administration Records (MAR) dated 12/10/14 through 1/8/15, showed an order for Namenda XR 28 mg PO Q (every) day. The MAR indicated that the medication was due to be given at 9:00 AM and it was documented the medication was not given until 11:06 AM.

C. An interview with RN (Registered Nurse)-S on 1/7/15 at 9:35 AM confirmed that Patient 32's Namenda XR had not been given at 9:00 AM as ordered. RN-S stated, "I don't have it available to give right now. I called the pharmacy and they said we have been using samples from the clinic and we ran out. They will need to get more samples from the clinic."

D. Review of Patient 41's medical record showed admission orders on 1/6/15 at 14:15 (2:15 PM) for:
- Provigil (a medication given to promote wakefulness) 200 mg po BID (twice a day);
- Azopt 1% eye drops (an eye drop used to treat glaucoma and other causes of high pressure inside the eye) 1 drop in both eyes BID; and
- Alphagan 1% eye drops (an eye drop that reduces the amount of fluid in the eye, which decreases the pressure inside the eye, used to treat glaucoma or other causes of high pressure inside the eye) 1 drop in both eyes TID (three times a day).

E. An observation of medication pass with RN-J on 1/8/15 at 8:45 AM revealed that Patient 41's Alphagan 1% eye drop, and Azopt 1% eye drop and Provigil medication were not available for administration.

F. An interview with RN-J on 1/8/15 at 8:45 AM revealed, "Those are medications we don't have here. The family was going to bring them in, but didn't. I just asked (Patient 41) if I could call (family) to remind them to bring the meds. " (Patient 41) stated, "No, I probably will go home tomorrow, so will just wait to use them when I get home."

G. Review of Patient 41's Medication Administration Records (MAR) dated 1/6/15 through 1/8/15 revealed that the Provigil, Azopt 1 % and Alphagan 1 % medications had not been administered per physician order due to the medications were non formulary and not available since the 1/6/15 4:15 PM admission. Therefore, as of 3 PM on 1/8/15 (time of exit), Patient 41 missed 4 doses of Azopt 1% eye drops; 5 doses of Alphagan 1 % eye drops and 4 doses of Provigil.

H. An interview with the DON on 1/8/15 at 2:05 PM confirmed that Patient 41's Azopt, Alphagan and Provigil had not been administered since the 1/6/15 admission. The DON stated, "I was here at the time (Patient 41) was admitted, the after hours pharmacy said we did not have those eye drops in our formulary. I asked the physician if we could use (Patient 41's) home eye drops. The physician gave an order to use (Patient 41's) home eye drops. I talked to (Patient 41's) family and asked if they could run home and get the medications, they said that they would bring them in the morning when they came back to visit." "I was not aware that they had not brought the medications in."

I. Review of the Pharmacy Policy revealed:
- "Administration of Medications: Patient's Personal Medications (effective 3/5/12): the pharmacy can authorize use of a patient's personal medication if the pharmacy cannot provide the medication, such as with a non-formulary product"; and
- "Formulary (no effective date indicated on form) revealed, A practitioner may prescribe medications that are not listed in the formulary unless the medical staff has specifically excluded their use in this facility...If a practitioner orders medications that are not in the formulary, a pharmacist will follow the P&T (Pharmacy and Therapeutic) Committee policy, such as contacting the prescriber, dispensing an approved therapeutic equivalent, or other defined process. If after discussion with the prescriber, a non-formulary medication is still required but is unobtainable or the procurement will be delayed, the pharmacy shall notify the practitioner and nursing service".

J. Interview with the DON (Director of Nurses) and the Compliance Officer on 1/8/15 at 2:55 PM revealed, "We don't really have a specific policy that addresses this situation of usage of sample medications for hospital patients or what procedure to use if a patient's family is to bring in home medications that are not on the formulary and do not bring them." The DON stated, "I would expect that the physician would either be notified by the pharmacist or the nurse that the medications were not available and get further orders."

Based on review of the Network Agreement; review of policies and procedures; review of Network hospital's onsite visit reports; and staff interview; the CAH (Critical Access Hospital) failed to ensure that the quality and appropriateness of diagnosis and treatment furnished by doctors of medicine or osteopathy was evaluated on an ongoing basis by the Network Hospital, since only one record was identified for external review by the Network Hospital in the last 3 years. The CAH Medical Staff included 3 Active Staff (physicians who admit and follow patients at the CAH), 36 Consulting Staff (physicians who consult, in diagnosis and treatment but do not admit patients) and 7 Courtesy Staff (physicians who occasionally admit patients but do not wish to become members of Active Staff). This failed practice had the potential to affect all patients treated by active, consulting and courtesy members of the medical staff. The CAH reported 471 acute inpatients and 99 swingbed patients for calendar year 2014.

Findings are:

A. Review of the Network Agreement entered into on November 3, 2011 revealed the following under Quality Assurance:
"A team consisting of QA [Quality Assurance] representatives from each facility will discuss ongoing quality issues related to the network's quality initiative and other initiatives they feel will promote better health care and develop plans for implementation of those initiatives. [Name of Network Hospital] will provide oversight on the network's peer review process schedule. As necessary, and upon request of QA representatives of Brodestone [SIC] Memorial Hospital..., the Brodestone [SIC] Memorial Hospital... Medical Staff, Brodestone [SIC] Memorial Hospital...Administrator/CEO [Chief Executive Officer], or Brodestone [SIC] Memorial Hospital...governing body, peer review assistance may be provided by the network's peer review process or another service under contract with Brodestone [SIC] Memorial Hospital."

(Peer review is the process by which a committee and/or another physician examines the work of a peer and determines whether the physician under review has met accepted standards of care in rendering medical services.)

B. Review of the Quality Improvement/Risk Management procedure regarding the classification system for review of patient care events (last reviewed 9/14) revealed the following:
"A Review Classification (RC) number or rank will be assigned to all reviews of patient care events and Medical Staff Quality Improvement review cases....Ranking of Health Care Provider Events 1-6 rankings as defined per level of severity. All the cases are peer reviewed internally.
Level of Severity Assignment:
1. No problem with the documentation or quality of care.
2. Minor problem with process/documentation, but patient outcome not affected.
3. Problem with process, disease or symptoms unchanged, or delayed in improvement by this problem. There is a potential for adverse outcome.
4. Problem with process. Disease exacerbated, or symptoms caused and/or allowed to progress due to this problem.
5. Problem with process. Longevity and/or functional quality of life shortened or adversely affected by medical action or inaction.
6. Mortality Review:
a. Mortality without opportunity for improvement.
b. Mortality with opportunity for improvement.
c. Unanticipated mortality with opportunity for improvement."
This policy and procedure identified the type of review that should be considered for each of the above severity rankings as follows:
"A finding of category 1 or 2 is reviewed by appropriate department head and action taken as deemed necessary or as suggested by RM [Risk Manager]. Adverse [SIC] findings of 3, 4, 5 or 6 are referred to the appropriate Peer Review Committee for action. Cases ranked 5 or 6 should be considered for external review."

C. Review of the Network Hospital's onsite review reports revealed the following:
Onsite visit dated March 19, 2012:
"Peer Review Process for [Name of the Hospital/CAH Network] Described. Internal and External processes discussed. Facilitate a process with the medical staff for internal peer to peer reviews and create indicators for any issue/situation that might "fall out" for further external review. [Name of the Hospital/CAH Network] offers six free external peer reviews (per facility) per calendar year."
Onsite visit dated November 19, 2014:
"Peer Reviews. [Name of the Compliance Officer] feels they have a good process. Has had good experience using [Name of the Hospital/CAH Network]. Review your indicators and see if any of them need revising which may trigger an external peer review. Always make sure you meet the standards set in your rules and regs/bylaws [regulations/bylaws]. Re: policy for outside peer review. Make sure this policy is generic. List no specifics. You do not want to be too specific that you will never meet an indicator."

D. Interview with the Compliance Officer on 1/8/15 from 1:00 PM to 2:00 PM revealed the following:
- The CAH has an internal peer review process where the Active Staff physicians review all deaths, all adverse outcomes, all traumas, patients leaving against medical advice and all patients that come to the emergency department because of attempted suicide.
- Since 11/3/11 sent one record to the Network Hospital for external peer review.
- Records that are sent out for external peer review would be selected by the physicians or the Compliance Officer.

On 1/8/15 at 3:00 PM the Compliance Officer provided a copy of the Quality Improvement/Risk Management policy and procedure for Review Classification System and indicated that external peer review would be considered for cases ranked at a 5 or 6 and since 11/3/11 no cases reviewed internally received a ranking of 5 or 6.