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Based on record review, staff interviews and facility policy and procedures, it was determined that the facility failed to protect and promote the rights of one (1) of ten (10) patient #1's right to refuse medication which the patient had a known allergy to and resulted in the patient experiencing an allergic reaction requiring medical intervention.
Record review for patient #1 revealed that the patient was admitted to the facility via the emergency department on 8/2/16 with a chief complaint of redness, swelling and pain of the left elbow. Patient #1 had a documented history of hypertension (high blood pressure) uncontrolled diabetes, hypercalcemia (too much calcium in the blood) and acute kidney injury.
The medical record also revealed a physician's report that patient #1 had visited the ED a week prior and was provided pain medication and Keflex (an antibiotic that treats infections) to take by mouth with failed results.
Patient #1 was admitted to the medical unit for treatment of cellulitis (a bacterial skin infection) of the elbow. Review of a recorded list of patient #1's allergies included Vancomycin which caused swelling.
Review of the medical record for patient #1 revealed the documentation by RN #16 that Vancomycin was listed as an allergy on the patient's chart and patient #1 was wearing an allergy band.
Further review of the medical record for patient#1 revealed MD documentation in the patient's hospital summary that it was not clear if patient #1's left elbow cellulitis was improving. Patient #1 was on Clindamycin for presumed MRSA (Methycillin Resistant Staphylococcus Aureus, a bacterial infection that is difficult to treat with antibiotics) infection - today change to IV Vancomycin because the patient has tolerated this in past and will need to be discontinued from the allergy list.
Review of patient #1's record revealed a physician's medication order written on 8/7/16 for Vancomycin 1,000 mg in Sodium Chloride 0.9 % 250 milliliters IVPB (in a vein).
Review of the Medication Administration Record (MAR) revealed that on 8/7/16, at 5:52 p.m. Vancomycin 1,000 mg in sodium chloride 0.9% 250ml / over 60 minutes was signed as being administered by RN#14.
RN #16 documented in the patient's chart on 8/7/16 that patient #1's face was swollen and his/her speech was garbled. He/she checked patient #1's medical record and saw that patient #1 had been given Vancomycin that afternoon.
Further review of the medical record revealed that RN #14 notified physician #6 that patient #1 was experiencing difficulty swallowing and that his/her private part was swollen. Physician #6 wrote an order for NPO (nothing by mouth).
On 8/6/16 at 4:17 p.m. RN #16 documented that he/she received patient #1 after at Cat Scan (specialized x-ray) and patient #1 was unresponsive but became more alert after a rectal temperature was taken. Patient #1's temperature was 92.8 and he/she was provided with a Bair Hugger ( a device used to raise low body temperature).
Patient #1 and his/her family both refused the Vancomycin IV. The family verbalized that the patient had had a bad reaction at home. Physician #6 was aware of the family's concern about the allergy and stated that the patient had had it before.
Review of the medical record revealed that Physician #11 documented that patient #1 had a swollen face and itching hands; that the family had stated that patient #1 had had the same reaction with Vancomycin in the past. The patient was ordered Solumedrol, Benadryl and Pepcid.
During a phone interview on 8/19/16 at 6:24 p.m., MD#6 stated that he/she assumed care of patient #1 on 8/5/16. The patient was treated for cellulitis of the left elbow that was treated with Clindamycin orally. The patient also had a kidney injury and had had multiple admissions. MD#6 also stated that he/she had treated Patient #1 in the past. MD #6 stated further that the patient #1 was given Vancomycin for nine (9) days in the past and that he/she was unaware of an allergy. MD #6 ordered the Vancomycin because he/she knew that Patient #1 had been on it in the past with no reactions. The MD stated that he/she ordered the Vancomycin to run slowly because the patient had tolerated it very well during past hospitalizations. When the patient developed facial swelling the medication was stopped and the patient was treated for the reaction. When asked why he/she did not pre-medicate the patient to counteract an adverse reaction, MD#6 stated that he/she did not order the pre-medications based on his/her knowledge of the patient's past hospitalizations.
During an interview on 8/22/16 a.m., at 11:40 a.m. the Chief Executive Officer (CEO, #15) stated that all staff were being educated/trained about the facility's existing treatment refusal form (regarding the patient's right to refuse medication). He/she stated that staff told him/her that when patients refused medication, nursing staff, as well as physicians, were documenting patients' refusal of medication in the progress notes. Staff were under the assumption that the form that was being used only related to refusal of treatments and procedures. The CEO stated that the information on the form had been changed system-wide to include the wording, 'refusal of medication'.
Further review of patient #1's record failed to reveal evidence that he/she had been offered or had signed a medication refusal form.
During an interview in a conference room on 8/22/16 at 1:00 p.m., RN #16 stated that Vancomycin was ordered for Patient#1. The patient's sibling said the patient could not take Vancomycin.
RN#16 then told Physician #6 about the last time the patient had Vancomycin and had a bad reaction to it. RN#16 stated further that he/she informed Physician #6 of the patient's sibling's concern and that Physician#6 stated that Patient #1 had had Vancomycin in the past and had not had a reaction to it.
RN#16 further stated that physician #6 said he/she would review the patient's record. The physician later returned and stated that he/she wanted the patient to have the Vancomycin because he/she had had it in the past and had no reaction to it. RN#16 stated that he/she told the family that they could refuse the Vancomycin and they refused it. The following day, RN#16 stated that he/she observed that the patient's speech was "off" compared to the day before. RN#16 reviewed the patient's record and saw that the patient had received the Vancomycin. Patient#1's face was swollen and his/her speech was garbled. RN#16 stated that he/she called the physician who ordered Solumedrol, Benadryl, and Pepcid for the patient's allergic reaction.
During a phone interview with Registered Pharmacist (RP#17) in on 8/22/16 at 1:15 p.m., the RP stated that he/she addressed a consult for Vancomycin dosing for patient #1. The physician's note indicated that he/she was aware the patient had had Vancomycin in April. The physician wanted the patient on Vancomycin because of the infection the patient had. The RP stated that he/she used Pharmacokinetics for dosing of Vancomycin while adhering to lab values and other parameters and dispensed the medication based on the physician's note in the chart.
Review of facility policy # PHC-01-000041 entitled "Consent/Refusal of Treatment" last revised 7/1/15 revealed that 'an adult patient who is conscious and mentally competent has the right to refuse to remain in the hospital and/or to permit medical or surgical treatment /procedures including life- saving treatment/procedures. A competent patient's refusal must be honored. In this event, the physician must explain to the patient the risk associated with refusal, including death (if death is a foreseeable risk) and document such discussion in the progress notes or in the information Refusal or Consent/Treatment form'.

During a phone interview with RN#4 at 11:24 a.m., on 8/22/16 he/she stated that during the on-coming (change of shift) report, there was no mention that the patient had refused Vancomycin. There was also no notation in patient #1's Rover (portable, hand held device used by medical staff to retrieve and record patients medical record information) from Pharmacy that provided information about the patient's allergies. In order to check for allergies, one must check the list in the patient's record or Rover. RN#4 further stated that he/she got the Vancomycin from the Accu-dose machine. RN#4 stated that he/she told the patient that he/she had two medications to hang and one was an antibiotic. The patient's mother was in the room and did not say anything. RN#6 stated further that he/she did not notice that the patient having any swelling or respiratory distress. RN#4 stated that had he/she known the patient was allergic to the medication, he/she would not have given it.
Review of facility's policy #2000 entitled "Rights and Responsibilities of Patients" last revised 8/14 revealed:
-All patients have the right to considerate, respectful care at all times and under all circumstances, with recognition of their personal dignity and autonomy.
- Patients or their surrogates/family have the right to refuse care, treatment or services according to the laws of Georgia.
Review of facility Medical Staff Rules and Regulations revealed the following:
-The patient and family/significant other as directed by the patient will participate in the development and implementation of his/her plan of care.
-the patient also has the right to designate a decision maker in case the patient is incapable of understanding a proposed treatment, and procedure or is unable to communicate his/her wishes regarding care.
- the patient has the right to refuse treatment as permitted by law.
Review of facility policy # PFH 2076 entitled "Medication Administration", last reviewed 10/15 revealed:
- Patients would be informed as to why the medication is being given.
- food and drug interaction would be discussed.
- patients would be alerted of significant side effects.
Review of policy # PHC-01000041 entitled "Consent/Refusal of Treatment, last revised 7/1/15 revealed:
-An adult patient who is conscious and mentally competent has the right to refuse to remain in the hospital and/or to permit medical or surgical treatment/procedures, including life-saving treatment /procedures.
-A competent patient's refusal must be honored.
Review of Quality Review data for 2016, failed to reveal evidence that a complaint had been received regarding this patient's care.
Review of Credential staff and Personnel files revealed that all had required orientation and qualification for employment.

Based on record review, staff interview and facility policies and procedures, it was determined that nursing staff failed to initiate medication administration according to physician orders for one (1) of one (1) patient #1 which resulted in the patient's blood sugar dropping to dangerously low levels requiring medical intervention.
Findings include:
Record review for patient #1 revealed that the patient was admitted to the facility via the emergency department on 8/2/16 with a chief complaint of redness, swelling and pain of the left elbow. Patient #1 had a documented history of hypertension (high blood pressure) uncontrolled diabetes, hypercalcemia (too much calcium in the blood) and acute kidney injury.

Review patient #1's admission orders by ED Physician#7 revealed the following:
Insulin Detemir/Levemir (a long- acting insulin used to treat diabetes) injection 80 units, Nightly.

Physician #6's medication orders revealed the following:
Lispro (insulin that lowers the blood sugar (BS) within 15 minutes) 15 units injection. Three (3) times a day with meals. Dose 1-5 units, for blood glucose greater than 140, give:
BS 141-160 -give 1 units
BS 161-190- give 2 units
BS 191-220- give 3 units
BS 251-280- give 4 units
BS greater than 280, Call the doctor and for dosing if the patient was not eating.

Review of a list/summary of the insulin record revealed the following:
On 8/5/16 at 2:49 a.m. BS - 286 Lispro 6 units was administered at 3:03 a.m.
- at 8:02 a.m. 19 units Lispro was given
-10:16 a.m. BS 146, the patient was placed on NPO (nothing by mouth).
-at 11:39 a.m. 16 units Lispro was administered
-at 4:05 p.m. BS 101 Lispro was held
-at 9:46 p.m. 9 units Lispro and 80 units of Detemir/Levemir was administered.
The record revealed that the patient was NPO, 8/5/16 from 8:05 p.m. until 11:57 p.m.
-On 8/6/16
- 5:41 a.m. BS 82
-at 6:10 BS 70
-at 8:30 BS 38 D5 was started on D10 (Dextrose) drip
On 8/6/16
-at 2:03 p.m. BS 165 patient was transferred to ICU on an insulin drip.
-at 3:03 p.m. BS 165 Lispro and Levemir were discontinued.
-at 7:59 a.m. BS 355 Lispro 8 units was given at 10:14 p.m.
On 8/7/16
-at 7:13 a.m. BS 237 Lispro 5 units given
-at 11:21 a.m. BS 272 Lispro 5 units given at 12:31 p.m.
-at 4:04 p.m. BS 213 Lispro 3 units given at 4:56 p.m.

At 2:22 p.m. physician #6 documented that patient #1 had persistent low blood sugars, possibly related to high doses of Levemir, as well as infection. Patient #1 was treated with Dextrose 10 IV until stable.

In an interview with RN #14 at 5:34 p.m. he/she stated that he/she was aware that patient#1 had difficulty swallowing and was NPO the day the head CT was done. RN@14 stated that he/she gave the patient 80 units of insulin and that the patient's insulin would be given according to the order set (the facilities written instructions for insulin administration). The order did not state that the long-acting insulin was to be held.

Review of documents revealed that the facility failed to provide evidence of an order set for patient #1.

Review of facility policy # PFH 2076 entitled "Medication Administration" effective date 9/94, last reviewed 10/15 revealed that:

-Patients would be informed as to why the medication is being given.
-Food and drug interaction would be discussed.
-Patients would be alerted of significant side effects.

Review of unnumbered policy entitled "Medication Management and Storage of Medications" last revised 9/14 revealed that in order to ensure that medications are safely and accurately administered, health care staff who administer medications, with or without supervision, are consistent with laws, regulations, and hospital policy.
-Discuss any unresolved, significant concerns about the medication with the patient's physician/prescriber and or relevant staff involved with the patient's care, treatment and services.

Review of Quality Review data for 2016 failed to reveal evidence that a complaint had been received regarding this patient's care.

Review of Credential staff and Personal Files revealed that all had required orientation and qualifications for employment. All had current competencies and training.