HospitalInspections.org

Based on document review and interview the facility failed to ensure appropriate provision of services were met as evidenced by:

1. The facility failed to have an annual review of patient care policies, failed to provide specific policies for Surgical Services and failed to include a professional outside member of the professional review committee. (see C272)

2. The facility failed to enforce rules for documentation, handling, and dispensating of controlled drugs for patient use. (see C276)

Based on document review and interview the facility failed to have an annual review of patient care policies, failed to have an existing professional review committee and failed to include a professional outside member to a professional review committee resulting in the failure to remain current with standards of practice. Findings include:

On 1/29/19 at approximately 1435 during document review it was revealed the facility did not have an annual review of policies and had failed to have a group of professional personnel that included an outside professional member to review policies. On 1/29/19 at 1440 during an interview with staff A, the above findings were verified.

On 1/29/19 at 1445 during an interview with the Chief Executive Officer /Chief Nursing Officer Staff A stated, "Our policies are not up to date, I am currently working on them. There is not really a professional review committee at this time..." When queried further whether policies were reviewed annually and if there were specific policies for specialty areas such as the operating room, more specifically in regard to proper handling, administration, documentation and accurate accounting of controlled substances, Staff A stated, " No the policies have not been reviewed annually, and we don't have a policy specific for the operating room for controlled substances."

On 1/29/19 policy received prior to exit "Subject: Controlled Substances, Effective 1996, Revision; 05/16..." stated on page 2 section 11 "The procedure used in the operating suite is somewhat different. a. At the start of the day, the inventory of each controlled substance is counted and documented on the OR Controlled Drug Inventory. b. As a controlled substance is administered to a patient, the dose given and any wastage are documented on the OR Controlled Drug Inventory. c. At the end of the day the inventory is again counted and documented on OR Controlled Drug Inventory. d. The opening and closing inventories are signed and co-signed by a witness. e. The OR staff will periodically requisition replacement quantities from the pharmacy, it is at that time the pharmacy technician gowns up to replenish the inventory and document the addition of stock to the OR Controlled Drug Inventory. f. When the sheets are filled up they shall be kept for a period of 5 years
12. ALL written records are returned to the pharmacy for verification.

Based on observation, policy review and interview the facility failed to ensure accountablity procedures and an accurate record system were utilized for documentation, handling, and dispensing of drugs for patient use in the surgical services /procedure area, resulting in the potential to adversely affect all surgical patients seen at this facility for surgery/procedures that required administration of medication and the diversion of controlled medications. Findings include:

On 1/29/19 at 1145, a document review was conducted of the controlled substance logs. The document titled "OR C2 Controlled Drug Inventory," dated 9/13/19 through 1/24/19 revealed 49 of 63 patients had some form of documentation noted under the heading, "Fentanyl 50 mcg/ml, 2 ml amp" column. Of the 49 with documentation under the fentanyl column, all 49 had no clear dosage or wasted amount, in the "given/added/waste" column, there were zero mcg dosage or ml amounts documented. Rather there was a 1, 2, 4 and 8, noted in the "given/ added" column. In 40 of 49 patients the documentation was a "1" in the "given/ added" column, three patients had a "2", four patients had a "4", and one patient had an "8". Documentation of waste was noted in five of the patients, but the amount or dosage was not documented (if "1" was representative of 1 ml or 50 mcg, there should have been a "1" in the wasted column given the ampule is a 2 ml/ 100 mcg amp). Seven of 49 patients had no date in the "date" column and 40 of 49 had no count in the "vial balance" column. All the above noted findings were confirmed with the CEO/CNO Staff A, the contracted pharmacist Staff D and the pharmacy technician Staff E. In addition, Staff A, D and E were unable to confirm staff signatures on the "Controlled Drug Inventory log in the "employee signature" column.

On 1/29/19 at 1030 during the survey, a request was made to interview the OR circulating RN (Operating Room Registered Nurse responsible for coordinating all nursing, patient safety needs, and the needs of the surgical team in the operating room during an invasive or operative procedure) as well as the contracted CRNA (Certified Registered Nurse Anesthetist, an advanced practice Registered Nurses that administer anesthesia and other medication), Staff A stated, "I will try to contact the CRNA , the circulating OR RN is not here today." On 1/29/19 at 1200 second request for information to contact the contracted CRNA and the OR RN, was made, to which Staff A stated, "The CRNA may be available later, the OR RN is not available today." A third request to contact the CRNA was made at 1530, Staff A stated, "have not heard from him yet, he could still be unavailable." The CRNA was not able to be interviewed prior to survey exit.

On 1/29/19 at 1230 during an interview with Staff A she stated she was made aware of issues regarding documentation of controlled substances following a State Licensing survey, "I was not here for the state survey. I was made aware of the December findings, usually I do an investigation and put an action plan in place, but I didn't do that..." Staff A further stated, "I did see the letter from the state surveyor that came in early January, and I sent a copy to the OR supervisor. I didn't follow through like I usually do." Staff A proceeded to state, "The staff really downplayed it." When staff A was asked to view the "OR C2 Controlled Drug Inventory" documents and explain the documentation, Staff A stated, "I have never seen that before and couldn't interpret it. I haven't been a nurse on the floor for a long time." When Staff A was queried regarding the illegible signatures and if she thought the document confirmed the use a single vial (ampule) dose being used on more than one patient, Staff A stated, "I cannot say who signed those ...I can guess that one of the (signatures) is the OR circulating nurse and the other is the contracted CRNA, but I won't confirm that ...Yes, it looks like they used a single vial dose on more than one patient. The whole document needs to be redone..." Staff A continued, "That documentation is unacceptable. I called the pharmacist. He is working retail in town, he said he will come to the hospital as soon as he is done filling an order." At the time of interview, Staff A, was queried regarding any changes, educational in-services conducted, or action plans that were put in place after the letter informing the facility of the state surveyors' findings, received in early January. Staff A stated, "no evidence of education, in-service or action plan is available.

On 1/29/19 at 1300 during an interview with Pharmacist Staff D, he stated, "I am not responsible for the sign out or counts ...that's not what we are contracted for." Staff D visually inspected the documents in question and stated, "the dosage documentation is not an acceptable form of documentation, it should show the actual dosage in mcg/mg to be accurate and should be legible." Staff D was queried regarding the pharmacist's involvement in the verifying accuracy of the controlled substances. Staff D stated, "I don't check their count maybe the Pharmacist who works more with the hospital does and he is not available today ...we don't have anything to do with making sure they document accurately." Staff D looked to Staff E (pharmacy tech) and stated, "do you do anything with this document as far as verifying the count or signatures?" Staff D confirmed that he is not involved with the hospital Quality assurance program but that he or "the pharmacist that works closer with the hospital could be involved. The document is not an acceptable document and needs to be addressed."

On 1/29/19 at 1320 Pharmacy Technician Staff E stated, "I just count and make sure the count is correct." Staff E was queried regarding the missing vial balances on the document. Staff E stated, "I look at the documented balance ...it has always added up. I don't know who signs out or anything to do with wasting or dosage. I add the medication to equal the par level."


On 1/29/19 policy received prior to exit "Subject: Controlled Substances, Effective 1996, Revision; 05/16..." stated on page 2 section 11 "The procedure used in the operating suite is somewhat different. a. At the start of the day, the inventory of each controlled substance is counted and documented on the OR Controlled Drug Inventory. b. As a controlled substance is administered to a patient, the dose given and any wastage are documented on the OR Controlled Drug Inventory. c. At the end of the day the inventory is again counted and documented on OR Controlled Drug Inventory. d. The opening and closing inventories are signed and co-signed by a witness. e. The OR staff will periodically requisition replacement quantities from the pharmacy, it is at that time the pharmacy technician gowns up to replenish the inventory and document the addition of stock to the OR Controlled Drug Inventory. f. When the sheets are filled up they shall be kept for a period of 5 years
12. ALL written records are returned to the pharmacy for verification.