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Based on records review and interview, the facility failed to provide information regarding the health status of patients possibly exposed to Hepatitis C and HIV. This resulted in the patients/representative possibly not making an informed decision due to lack of information being provided by facility.


Findings:


The complaint survey was related to a Registered Nurse (RN) that worked at the hospital from September 2017 to May 2018. The allegation received involved the RN reusing the same medication filled syringe on multiple patients during the shift. Those patients that received care from this nurse included Hepatitis C and HIV positive patients.


Upon entering the facility, the Director of Quality confirmed the nurse confessed to using the same medication filled syringe on multiple patients. The nurse stated, this started about 6 weeks prior to him being noticed by colleagues. This nurse also confessed that he used the same needle and syringe on several different patients until the needle was dull, usually at the end of the day. The facility placed this nurse on administrative leave three days after the nurse manager was informed of incident. The nurse resigned next day.


Record review and interviews showed, the hospital had identified 186 patients that were potentially exposed to Hepatitis and HIV. The hospital leadership decided to contact potentially exposed patients and request testing. These patients was initially contacted by phone. A script was used to inform patients about the recall. The final script was written and approved by a QAPI committee that included the hospital Safety Department, Infection Prevention Department, Infectious Disease Department, Chief Medical Officer, Chief Nursing Officer, CEO, Legal Department, and Health Systems Director.


When it was time to explain purpose of call the script stated, "We recently had a lapse in protocol at W.W. Hastings Hospital and are providing testing to any patient that this might affect. You have been identified as needing laboratory screening at our facility. We would like to offer this service as a precautionary measure. We would like to order some lab tests for you. Do you have a minute to talk with me about how to get tested?" The script did not inform the patients the laboratory testing requested was for Hepatitis and HIV test. The patient would have had to ask caller (from the hospital) what tests were being requested to know this information.


On 7/18/18, Patient #1 was interviewed. The patient stated that she received a phone call about a lapse in protocol. She had blood testing done and the hospital called her with the results. The hospital never told her what blood tests were done. When Patient #1 asked for more information, she stated, the hospital wouldn't elaborate. Patient #1 also stated during the interview that she still have a lot of questions.


On 7/18/18, Patient # 2 was interviewed. He stated that he received a phone call from the hospital about a lapse in protocol and urged laboratory testing. He declined testing because he did not understand what was being told to him. Patient #2 stated, he found out what tests were being done and why through the local media/news afterwards.


On 718/18, Patient #3 was interviewed. She stated, she received a phone call from the hospital nurse about a lapse in protocol and requested she get "tested as soon as possible". She went to an approved clinic for laboratory blood testing. She was told it would take 3 days to receive results. Patient #3 stated, no one called her with the results for two weeks. After two weeks, Patient #3 called facility to find out the test results but could not get results after multiple transfer to departments. The patient became upset and Cherokee Nation Tribe was notified with her complaint. Patient #3 stated, after talking to a Cherokee Nation representative, the facility called her with Hepatitis and HIV tests results within the same day.


On 717/18 at 9:50 am, an interview with Infection Control Officer was conducted. The Infection Control Officer stated that she made calls to patients requesting blood testing to be done urgently. Unless the patient asked her what specific laboratory tests were being requested she did not inform patient. The hospital was specifically requesting Hepatitis and HIV testing. The Infection Control Officer was part of committee that created the script.


On 7/17/18, an interview with the Chief Medical Officer (CMO) was conducted. She confirmed that she was on the committee that approved the final script for the call. The CMO reviewed a copy of the script during interview and confirmed she felt the script had sufficient information for patients to make an informed decision.


Per record review and interview with Infection Prevention Officer on July 18, 2018, if the hospital could not get in touch with patients via phone, the local public health nurse was contacted to make a home visit.


On 7/18/18, an interview with Public Health Nurse Supervisor 1 (PHN 1) was conducted. PHN 1 confirmed that she used the script that was provided from the hospital. The script did not state what laboratory tests were needed to be done. PHN stated, she did not know "what was going on at the hospital until it hit the news". PHN1 was concerned if patients understood terminology used in script such as "lapse in protocol".


On 7/18/18, an interview with Public Health Nurse Supervisor 2 (PHN 2) was conducted. PHN2 confirmed that she used the script that was provided by the hospital to inform patients that laboratory tests were being requested by the hospital.

Based on interviews and record reviews, the hospital Nursing Services failed to have a comprehensive Nurse Training Program that address Pharmacy Compounding Medication and Nursing Preceptor program. This failed practice have the potential to affect all inpatients and out patients and receive care on a daily basis.


Findings:


On 7/17/18, at approximately 10:30AM, an interview with the the Training and Education Coordinators and the Nurse Residency Program Coordinator were conducted. During the interview, both coordinators stated that the medication training in the program did not cover compounding medications. The training covered basic medication administration reviews and a medication knowledge test. Neither of the Coordinators were sure who in the hospital is responsbile for providing this training


On 7/17/18, the Director of Quality was interviewed concerning the Nurse Training Program. The Director stated that she is developing a new program and it will have more guidance and specific goals for the RN intern and their preceptors. When asked if the program includes compounding medication, the Director stated "No".


On 7/18/18, at 8:15 AM, an observation and interview were conducted in the Operating Room (OR) areas. A new Registered Nurse (RN) employed in the OR was observed and interviewed. During the interview, the new RN stated that she just started working on 7/16/2018. She indicated that she started the orientation on the same day (7/16/18). The RN stated that her "boss" was on vacation and she did not have a preceptor so she was just learning the computer and following staff around to see what the flow is in the OR. The new RN stated that she did not have an organized orientation plan and she did not understood what her role would be in each area (OR, Pre-Surgical and Post Surgical).


On 7/18/18, a confidential interview was conducted with one RN. During the interview the RN stated that there is a lack of information and clear expectation during the RN Residency Program. The RN stated that sometimes the primary preceptor may not be present on a shift that the nurse resident is. Many times this results in no experienced RN volunteering to take responsibility of the nurse resident for the shift. The RN indicated during the OR rotation there was no primary preceptor available. This nurse felt as a result he/she was not comfortable to ask questions and too many mistakes were made.


The complaint allegation surveyed by the Centers for Medicare & Medicaid Services surveyors was based on one RN working in the OR who was reusing needles to prepare medications on piggy bags and/or Intra Venous (IV) medication administration. This incident resulted into a massive recall of patients under his care. The hospital tested the patients for Hepatitis B, C, and HIV. Record review of the RN during the internship program indicated that his performance was not always at acceptable standards of care. However, the RN completed the RN Residency and a position was offered him to work in the OR.


On 7/17/18, at 0845AM, an interview with the OR Clinical Supervisor was conducted. When ask about a nurse mixing Zantac and Reglan in 100 ml of NS and was reusing the same syringe and needle all day "until it became dull" the supervisor stated, " He was trying to be faster and more efficient." He had been in the perioperative setting for 5 days when the practice was reported.


The supervisor indicated that the RN was offered a job by Pre-Anesthesia Testing (this is a new department and has not opened yet). There would be no hands on care. "He was still an ok nurse".


When asked about the RN performance, the OR supervisor stated, "he had a big interest in the OR. Quite a variance in reviews. Some of the variance could be due to the political stuff involved - he is an important person in this town".


The supervisor also stated that the RN involve in the incident was assigned to a very competent preceptor nurse during his nurse residency program. She felt the nurse was determined and competent, so he was given a patient assignment during residency.


When asked about training in compounding medication in the OR or nursing orientation the supervisor had no response.


On 7/17/18, at 2:30PM, the Human Resources Director and the Human Resources Manager were interviewed. When ask how they select potential RNs, they stated they ask the Chief Nurse Officer to provide preceptor recommendations. The Director stated that they don't read all the evaluations. This surveyor asked specifically about the RN involved in the complaint, the manager stated, "We thought it will work for him because he wanted to work in the OR".


On 7/17/17, at 3:30PM, an interview with the hospital Quality Assessment and Performance Improvement Program (QAPI) members was conducted. There were six members representing the program. The RN Residency Program was discussed during this interview. The Director for the QAPI program stated they recently had a visit from their accrediting organization. The hospital was found not in compliance with the Nurse Residency Program. According to the QAPI members, the Nurse Residency Program lacked specific individual goals and the preceptors were not always on the same schedule as the RN resident. The QAPI Director is currently working on a new RN Residency Program that will address measurable individual goals. When asked about the compounding medication training, the QAPI members indicated having no knowledge of the training and the federal regulation that address compounding medications outside the pharmacy.

Based on interview and record reviews, the Pharmaceutical Services failed to follow up with the Nursing Department's excess controlled medication destruction, monitor and train the Nursing Department in Compounding Medication, and failed to assess the environment work space selected in the Operating Room (OR) Department to prepare and mix medications.


On July 17, 2018, at 1:30 PM, the Pharmacy Director and the In-Patient Pharmacist were interviewed. During the interview, both pharmacists indicated that Pharmacy provided each Nursing Unit Manager a weekly report reflecting the inconsistencies with drug destruction. The In-Patient Pharmacist stated that the biggest problem they have is that the nurses are not double signing when control medications are wasted. When asked if the Pharmacy monitors the weekly report to ensure Nursing is capturing these inconsistencies, the In-Patient Pharmacist stated, "No, we just give the Nursing Manager the reports".


On July 17, 2018, the Chief Nurse Officer was interviewed. The Chief Nurse Officer (CNO) indicated that Pharmacy provide the weekly Dose Reconciliation Reports to all the Nurse Managers. The CNO stated that she has a new process in place. Since May 2018, she is reviewing the reports and can see the inconsistency of the nurses not double signing the control medication waste.


According to the CNO, the new process involved each unit nurse manager to review the weekly pharmacy reports. The unit managers review the doctor orders and the medication administration records to ensure the correct dose was administered. When asked if the managers monitored the nurses to ensure two nurses verified the amount of medication wasted, the CNO stated, "no". The pharmaceutical services should have a system in place to reconcile medications that are administered or not administered when pharmacy staff inventories patient medication or restock patient medication.


On July 17, 2018, the nurse manager for the Pre-Operative Unit was interviewed concerning the inconsistent medication waste report. The nurse manager stated the majority of the time the patients can't wait for their pain medication if the patient is going to the OR. Once the Anesthesiologist orders the medication, the patient has to be taken to the OR . The Manager confirmed that the OR nurses are always busy and they don't have time to have a second nurse verify the wasted control drugs. The pharmaceutical services must keep a current and accurate records of the receipt and disposition of all scheduled drugs. The pharmaceutical services is accountable for the control of the distribution, use, and disposition of all scheduled drugs.


Record review of the pharmacy weekly reports provided by the inpatient pharmacist indicated that between January 2018 to April 2018 there were 28 unreconciled waste doses of control medications. The pharmacy weekly reports for July 1-18, 2018 indicated there was 12 unreconciled waste doses control medications. The pharmacy did not provide the reports for May and June 2018. The pharmaceutical services must have a record system in place to track the movement of all scheduled drugs from the point of entry into the hospital to the point of departure either through administration to the patient, destruction or return to the manufacturere. The record system must be capable of readuly identifyng loss or diversion of all controlled substances in such a manner thatit minimizes the time frame between the actual loss or diversion to the time of detection and determination of the extent of the loss or diversion.


Based on the survey, the RN compounding medication was working in the OR at the time of the incident occurred. According to the RN's statement, he was preparing and mixting the "piggy bags" to be administer to patient IV.


On July 18, 2018, at 11:40 am, the CNO provided the Pharmacy Policy and Procedure on Nursing-Sterile Product Preparation and Utilization. According to the policy, it is the responsibility of the In-Patient Pharmacy to mix intravenous admixture during the normal In-Patient Pharmacy working hours. A license nurse will prepare all available admixture requested when the In-Patient Pharmacy is closed. The regullation requires that all compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist. All compounding must be done in accordance with accepted standards of practice.


On July 18, 2018, at 1:45 pm, an interview with the Pharmacy Director and Inpatient Pharmacist was conducted. Both pharmacists confirmed that they do not provide compound medication training to the nurses nor do they monitor the nurses to ensure they are following the compounding medication process established by the Pharmacy Association. The Pharmacy Director stated that the departments that "mix" intravenous medications and prepare 'piggy bags" are the OR/PACU and on occasion the Emergency Department (ED). When asked why In-patient Pharmacist do not prepare the intravenous medications for the OR/PACU and the ED, the In-Patient Pharmacists stated that she is the only Pharmacist for the In-Patient Pharmacy. The Out Patient have approximately 21 Pharmacist because they served over 2,000 prescriptions a day. The Inpatient Pharmacist stated that the Nursing Training Officer, CNO, and Unit managers should be responsible for the weekly medication report and the compounding medication training since this was not considered part of the pharmacist's duties. The regullation requires that all compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist. All compounding must be done in accordance with accepted standards of practice.


On July 18, 2018, at 2:30 pm, the hospital Chief Medical Officer (CMO) was interviewed concerning the Pharmacy Department's not following up with the drug destruction weekly report and the nursing training in compounding medication. The CMO stated she was not aware the pharmacists were not monitoring those reports. The CMO was not informed of the compounding medication training and the federal regulation that addresses compounding.


On July 17, 2018, the hospital Training and Education Coordinators were interviewed. During the interview, both coordinators stated the medication training program did not cover compounding medications. The training covers a basic medication administration reviews and a medication knowledge test.


Record review of the hospital education and training for nurses confirmed compounding medications is not part of training.



On July 17, 2018, at 3:30 pm, an interview with the hospital Quality Assessment and Performance Improvement Program (QAPI) members was conducted. There were six members representing the QAPI Program. The Pharmacy concerns were discussed during this interview. The Director for the QAPI program stated that they had a visit from their accrediting organization. They came to investigate the incident of the RN reusing needles in the OR and PACU area. During that visit, they also found that the Pharmacy did not have any systems in place to trend the weekly Drug Reconciliation Reports. The hospital QAPI representatives are currently working on a plan of correction to address a resolution to the pharmacy deficient practice. When asked about compounding medication training the QAPI members indicated having no knowledge of the training and the federal regulation that address compounding medications outside the pharmacy.

Based on observation, interviews, and record review, the hospital failed to have an effective Infection Control Program. The failed practice placed the patients in the Operating Room, Recovery Room, and Post Operative Room at risk for cross contamination and negative outcomes.


Findings:


Glucometer use:


On 7/18/18, a RN was observed in the preoperative area starting intravenous (IV) therapy. The RN removed one glove (no hand hygiene performed), grabbed a case from a shelf that contained a glucometer with the ungloved hand, removed the glucometer and took to patient's bedside. Next, the RN obtained a blood sample for glucose testing. Finally, the RN took the glucometer across the room to the Post Anesthesia Care Unit (PACU). There RN did not clean or sanitized the glucometer after using it and before taking it to PACU.


Medication administration:


On 7/18/18, at approximately 8:35AM, an observation of the PACU was made. A RN removed a medication from the Omnicell system and prepared it for admnistration. The nurse walked across a busy PACU unit (approximately 15 feet) with an uncovered needle to the patient. After administering the medication, the RN walked back across the busy PACU with the used and uncovered needle to dispose in the sharps container located at the nurse's station. This was the closest sharp box to the nurse, there were no sharp boxes close to the preoperative beds or PACU beds.


Medication mixing/compounding station:


On 7/18/18, an interview was conducted with the hospital Director of Quality Manager. When asked about the medication mixing/compounding station in the OR and PACU area the Director responded, "Its a new medication station".


An observation was made 7/18/18. The medication station area is approximately 24" x 30". There are dividers sectioning part of the cabinet from the rest of the cabinet, a sign posted at the back of the designated area, and sharps container setting in the designated area. No cleaning supplies was observed to clean the designated area. Two RN's were observed attempting to spike the IV fluids in this area. The RN hung the IV on the cabinet door knob above the designated area (there was no IV pole available), spiked the bag and allowed the fluid to run through the tubing into the plastic wrapping; there was no sink available to run the fluids into. The medication station was not cleaned before or after use.


OR staff:


An observation was made on 7/18/18, at 8:45AM, with staff entering the PACU from the OR with surgical masks tucked under their chins and masks hanging down the front of their scrubs. The same staff was observed returning to the OR with the same masks.


On 7/18/18, at 8:50AM, an observation of the OR staff was made with skull caps worn by staff with hair showing at back of neck and sides of head. There was also an observation of a RN entering the OR with a cup of water for personal use


On 07/18/18, at 9:00AM, a Certified Registered Nurse Anesthetist (CRNA) was observed entering the PACU with a patient. He crossed to the bedside of preoperative patient with his mask hanging around his neck, skull cap in place, and a paper gown on. After his preoperative interview with the patient, he was seen going back through PACU and into the OR with the same gown, mask, and skull cap on.


On 7/18/18, at 9:10AM, an observation was made in the OR/PACU area. The nursing staff was moving patients down the semi-restricted hallway to OR # 4. The semi-restricted hallway was lined on both sides with sterile supplies on open shelving, the shelves were not covered. Patients are taken through the semi-restricted hallway and the transporters were observed brushing against the sterile supplies during transit.


On 7/18/18, an observation of the PACUwas made. There was no hand sanitizer at the patients bedside in preoperative or PACU areas. The OR and PACU staff were observed walking across the room to sanitize their hands.


On 7/18/18, at 0945AM, an interview was conducted with the Director of Quality Management. The Director stated that OR #4 use to be connected to Obstetric (OB) department for their c-section room. That access was now sealed, so the only access to OR #4 is through the semi-restricted area. She did not address covering sterile supplies.


On 7/18/18, at 11:00AM, an observation was made of one RN withdrawing medications from the Omnicell. The RN carried the medications to PACU, went out into the semi-restricted corridor and returned to the preoperative area with medications stuck in his back pocket. The hospital Quality Management was present during this observation.


On 7/18/18, at 11:30AM, an interview was conducted with the hospital Chief Medical Officer (CMO). During the interview the CMO stated that she had talked to anesthesia staff about needing to change gowns and masks between patients.


On 7/18/18, at 12:30PM, an interview with the hospital Quality Assessment and Performance Improvement Program (QAPI) members was conducted. There were six members present. Infection Control practices and the cross-contamination between the OR and the PACU was discussed. The QAPI Director stated that in May 2018 their accrediting organization recommended for the OR/PACU to have an area designated to prepare intravenous medications as it was recommended. However, per the CMO the Pharmacy Director was not part of the committee that picked the designated area. The QAPI members verbalized they were surprised by the OR/PACU staff behaviors. The Chief Medical Officer stated that she had recently provided in-services to address the same issues.


On 7/18/18, 1:40PM, an interview was conducted with the Chief of Anesthesia. He stated he has not received any training on the skull caps or masks hanging around necks. "I wear the bouffant hats". The Chief of Anesthesia stated that he provide anesthesia for approximately 400 cases/month. He stated "I have 2 anesthesiologists and 3 CRNAs and have recently added 3 locum tenens CRNA's".


2016 AORN guidelines:

Traffic patterns should be designed to facilitate movement of patients, personnel, equipment and supplies into, through and out of defined areas within the surgical suite.
Semi-restricted area: The peripheral support areas of the surgical suite. The area may include storage areas for equipment and clean and sterile supplies; work areas for processing instruments ... This area is entered directly from the unrestricted area past a nurses' station or from other areas.

Personnel in the semi-restricted area should wear surgical attire and cover all head and facial hair. Access to the semi-restricted area should be limited to authorized personnel.

Sterilized materials should be labeled and stored in a manner to ensure sterility, and each item should be marked with the sterilization date ...shelf life is dependent on packaging material, storage conditions, transport and handling. Sterile packages should be stored under environmentally controlled conditions ...access to sterile supply areas should be limited to personnel who are trained in handling sterile supplies ...sterile items should be stored in closed cabinets or covered carts. Open shelving may be used if it is located in a secure, environmentally controlled, clean area