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Tag No.: C0276
Based on review of policies, observation, and interview it was determined the facility failed to ensure syringes were labeled, and the receipt and distribution of samples medications were maintained in a manner consistent with current standards of practice and hospital policy in 1 of 1 outpatient clinic toured. These failures had the potential to result in incorrect administration of medications and inadequate pharmacy control in the case of recalled or missing medications. Findings include:
1. Syringes were pre-filled by a nurse and not labeled in accordance with acceptable standards of practice as follows:
The outpatient dermatology clinic was toured on 5/23/12 from 1:40 PM to 3:30 PM. The Outpatient Manager and an LPN who worked in the clinic were present for the tour. During the tour, a plastic tray containing six 3 cc syringes was found. The syringes were not labeled, contained 3 cc of a clear liquid, and had needles attached.
The LPN explained that the syringes contained 1% Xylocaine and that she had pre-filled the syringes in an effort to save time that afternoon. When questioned how others would know the contents of the syringes, she stated the other two staff members knew the syringes contained Xylocaine.
The "Textbook of Basic Nursing," published by Wolters Klewer Health/Lippincott Williams and Wilkins in 2008, stated that all medications must be properly labeled with the patient's name, the medication name and dosage, and the medication expiration date.
The facility failed to ensure all syringes containing medication were labeled in accordance with accepted standards of practice.
2. Records of receipt and distribution of sample medications were not maintained as follows:
The outpatient dermatology clinic was toured on 5/23/12 from 1:40 PM to 3:30 PM. The Outpatient Manager and an LPN who worked in the clinic were present for the tour. Two locked cabinets were noted to contain oral and topical drug samples. The LPN presented a notebook and stated the patient name, the drug sample provided, the lot number and expiration date of the samples provided were to be recorded in the notebook. However, the notebook contained only one entry, dated 5/23/12. She was unable to provide any other entries or past history of samples provided to patients. The LPN stated she did not know where the notebook log entries were.
The outpatient dermatology clinic was revisited on 5/24/12 at 10:00 AM with the Outpatient Manager and the Back Office Manager. During the revisit, 25 different sample medications were noted to be available for distribution to patients.
During an interview on 5/23/12 at 3:30 PM, the Director of Pharmacy Services stated the outpatient clinic was responsible for tracking all medications that were received and distributed at the clinic. He stated he randomly conducted audits of the clinic sample drug log to ensure compliance, but was not able provide documentation to support an audit report or log from the dermatology clinic.
The hospital's policy, "Sample Medications," revised 12/21/10, was reviewed. The policy outlined the procedure to follow regarding sample medications in outpatient locations. According to the policy, each sample medication given to a patient was to be documented in a log with the date, patient name, drug name and strength, quantity, prescriber name, nurse signing out the sample drug, the lot number and expiration date listed on the package. In addition, the policy indicated each sample medication was to be labeled with the directions for use.
The facility failed to ensure the pharmacy adequately maintained control of all medications supplied and distributed in the outpatient clinic.
Tag No.: C0278
Based on staff interview, observation of patient care, and review of hospital policies, it was determined the facility failed to ensure the implementation of procedures to avoid potential transmission of infections and communicable diseases. This directly impacted 1 of 2 patients (#11) whose wound care was observed and 1 of 1 outpatient clinic toured. It had the potential to impact all staff and patients in the facility. Failure to follow policies and standard precautions had the potential to allow for transmission of infections. Findings include:
1. Infection prevention standards were not followed during a wound dressing change as follows:
Patient #11 was a 69 year old male admitted to the facility on 5/15/12 for wound care and antibiotics related to a wound infection following a surgical procedure on his right lower leg. Patient #11's record indicated he had daily dressing changes that were performed by a physical therapist.
A wound dressing change was observed on 5/23/12 at 10:20 AM. The Physical Therapist brought a plastic tote with her into the room and placed it on a towel that partially covered the bedside table. The bedside table also held a patient water mug with straw and personal items. The Physical Therapist took dressing supplies from the plastic tote and placed them on the towel. Patient #11 had two lower leg wounds on his right leg. Each dressing was changed separately. The first dressing was removed and discarded. The Physical Therapist reached into the plastic tote with dressing supplies and took out a small square retractable measuring tape. She extended the tape measure, placed it against Patient #11's leg wound to measure, then retracted it and placed it back into the plastic tote. She then took sterile gauze and poured sterile normal saline on the gauze. With her gloved hands, she folded the gauze and squeezed the excess fluid out, then cleansed the wound bed with the moistened gauze. After cleansing the wound, the Physical Therapist debrided the wound with a curette. The gloves had not been changed after touching the measuring tape, leg, normal saline container, and gauze package, thus the moistened gauze was contaminated before cleaning the wounds. The same method of measuring and cleaning the second wound on Patient #11's leg was observed.
A policy, "Dressing Change Procedure in Rehab Services," revised 3/02/12, stated wounds were to be cleaned with sterile normal saline and debrided using sterile gauze and instruments as needed.
After the dressing change was completed, the Physical Therapist was questioned about the plastic tote that contained dressing change supplies. She stated the plastic tote was stored in the physical therapy department on a shelf. She stated she would replace supplies and send the scissors to be cleaned and sterilized. The Physical Therapist confirmed there was no name or tag on the tote to ensure it was only used by Patient #11. The Physical Therapist was unable to describe how the retractable measuring tape would be cleaned and stated she did not know how others cleaned it. The Physical Therapist confirmed she had squeezed out the gauze using dirty gloves and stated she did not realize she had potentially contaminated the wound in doing so.
A wound was changed without using aseptic technique in accordance with hospital policy. Contaminated wound dressing change supplies were returned to the physical therapy department prior to being sanitized.
2. The outpatient dermatology clinic stored soiled instruments and staff food in the same location as follows:
The outpatient dermatology clinic was toured on 5/23/12 from 1:40 PM to 3:30 PM. The Outpatient Manager and an LPN who worked in the clinic were present for the tour. The LPN described the movement of patients through the clinic, procedures performed, and identified work areas. She stated the work area that contained a sink, refrigerator, counters, computers and phone was the nursing station. The LPN stated the sink was designated as a "dirty" sink, for washing used instruments. However, on the left back corner next to the sink were two bottles of personal hand soap, one bottle of personal hand lotion, and a bottle of hand sanitizer. There was a paper towel dispenser mounted on the wall behind the sink. When asked where the staff washed their hands, she pointed to the sink that she had stated was the designated dirty sink.
To the left of the sink, under the counter, was a small refrigerator. There was a sign designating the refrigerator as "Staff Food Only." To the right on the counter beside the sink, was a covered metal tray. The LPN stated the instruments used in the clinic were placed in the tray and sent to the hospital for processing and sterilization. Below the dirty instrument tray, a drawer was noted to have pre-filled and unlabeled 3 cc syringes for patient use, a container of flavored drink concentrate, deodorant, toothbrush, hand lotion, and plastic bags with "biohazard" labels.
The Outpatient Manager participated in the tour and confirmed the sink area held personal hand cleaning and moisturizing products as well as being designated by the LPN as a "dirty" sink. When questioned about the proximity of the staff refrigerator to the dirty sink and instruments, as well as personal use items and food, the Outpatient Manager stated he was not aware the instruments were brought out to that area.
The facility failed to separate clean and dirty areas to maintain sanitation.
3. Staff failed to practice hand hygiene in accordance with standards of practice as follows:
The outpatient dermatology clinic was toured on 5/23/12 from 1:40 PM to 3:30 PM. The Outpatient Manager and an LPN who worked in the clinic were present for the tour. During the tour, an LPN working with clinic patients was observed carrying soiled instruments from a patient exam room to the nurse's station. The LPN rinsed the instruments off in the sink and then placed them in a covered metal tray on the counter next to the sink. The LPN removed her gloves, then walked down the corridor to a desk area and opened a file box, as if looking for something. She returned to the nursing station and opened a laptop computer, typed on the keyboard, closed the laptop, then returned to the desk area. The LPN reached into her right pocket, removed keys, opened a locked cabinet, took something out and locked the cabinet. The LPN then opened the door to a patient exam room and entered the room. She did not use hand sanitizer or wash her hands after removing her gloves and prior to the next task.
The Outpatient Manager participated in the tour and also observed that the LPN did not use hand hygiene after removing her gloves and prior to moving to the next task.
According to the CDC's "Guideline for Hand Hygiene in Health-Care Settings," from 10/25/02, hand washing or hand antisepsis should be performed before and after direct contact with patients, after removing gloves, and after contact with inanimate objects near a patient.
The facility did not ensure staff compliance with infection control standards.
Tag No.: C0297
Based on review of hospital policies and medical records, and staff interviews, it was determined the facility failed to ensure verbal orders were authenticated for 1 of 1 patient (#13) whose procedure was observed in IR. The lack of authenticated orders made it difficult to determine if orders were executed per physician order. Findings include:
A policy titled "Telephone, Verbal and Written Orders for Medication," approved 9/23/11, stated, "The prescribing practitioner must sign the written record of the verbal/telephone order within 24 hours of giving the order." This was not done in the following example:
1. Patient #13 was a 73 year old male admitted 5/22/12 for an ultrasound guided femoral angioplasty and was observed in IR from 1:15 PM to 3:15 PM. During the procedure the physician gave verbal orders for administration of the following medications:
- 2:40 PM - 25 mcg Fentanyl IV and 1 mg Versed IV
- 3:04 PM - 1 mg Versed IV and 7,000 units Heparin IV
Patient #13's record was reviewed following the procedure. The verbal orders had been documented by the RN under the section of the procedure report titled "IV Information Medication Events-M." However, the verbal orders were not co-signed by the physician.
The Quality Assistant was interviewed 5/24/12 at 11:05 AM. He reviewed Patient #13's record and agreed the verbal orders had not been co-signed by the physician. He stated for all patients in IR the physician signed a post-procedure note, which included the total amounts of medications given, but did not sign the verbal orders for the individual doses of medication administered during the procedure.
Verbal orders were not authenticated by the physician for IR procedures.
Tag No.: C0298
Based on review of policies and medical records, and interview it was determined the facility failed to ensure a comprehensive nursing care plan was developed for 6 of 20 inpatients (#5, #6, #7, #11, #14, and #15) whose records were reviewed. Failure to develop a nursing care plan inclusive of all pertinent nursing needs had the potential to negatively impact the continuity of patient care. Findings include:
The hospital's "Patient Care Plans" policy, effective 4/13/12, was reviewed. According to the policy, "The plan of care/problem list shall be individualized, based on the diagnosis, nursing care treatments and medical treatments, patient assessment and personal goals of the patient and his/her family."
Nursing care plans were incomplete as follows:
1. Patient #7 was an 86 year old female admitted to the hospital on 5/19/12 for treatment related to shortness of breath and pneumonia. The H&P, completed by the physician on 5/19/12, indicated Patient #7 used a pain pump to manage chronic low back pain and scoliosis. In addition, the physician documented Patient #7 had a history of chronic obstructive pulmonary disease.
Patient #7's "Patient Care Plan Report," initiated 5/20/12 at 3:16 PM, included goals, interventions, and monitoring for activity intolerance, fall risk, change in physiologic status, and knowledge deficit. In addition, the Physical Therapist created a POC to address the physical therapy goals and interventions regarding Patient #7's activity intolerance.
The POC did not address Patient #7's altered respiratory status or her chronic pain. The nursing care plan, therefore, did not include goals and interventions related to these diagnoses or allow for documentation of Patient #7's response to the interventions utilized.
The Quality Assistant was interviewed on 5/21/12 at 2:20 PM. He reviewed Patient #7's POC and confirmed it did not address nursing care treatment needs related to respiratory or pain status.
Patient #7's nursing care plan was not comprehensive to include respiratory or pain goals and interventions.
2. Patient #15 was an 86 year old male admitted to the hospital on 4/26/12 for an incision and debridement of a wound on his right calf, which was to be completed on 4/27/12. He was discharged on 4/30/12.
Patient #15's "Patient Care Plan Report," initiated 4/26/12 at 2:12 PM, included goals, interventions, and monitoring for safety, pain, change in physiological status, and knowledge deficit. In addition, the POC addressed skin integrity. However, the POC did not differentiate between goals, interventions, and monitoring of IV sites, the surgical wound, and overall skin integrity. The POC did not include information relating to prescribed wound care of the surgical site.
The Quality Assistant was interviewed on 5/23/12 at 3:15 PM. He reviewed Patient #15's medical record and confirmed the POC did not contain specific goals and interventions related to wound care.
Patient #15's nursing care plan was not comprehensive to include specific goals and interventions for wound care.
3. Patient #14 was a 62 year old female admitted to the hospital on 4/26/12 for care after a fall at home. She was discharged on 4/30/12. The physician completed an H&P on 4/26/12, and documented Patient #14 suffered from acute renal failure and had a history of chronic pain syndrome and Parkinson's Disease. The physician documented Patient #14 had limited range of motion, bruising, and abrasions on her right side as a result of her fall. In addition, he ordered a physical therapy assessment and treatment to improve Patient #14's safety and mobility.
A nursing assessment, completed by an RN on 4/27/12 at 11:02 AM, indicated Patient #14 stated her shoulder and wrist ached, but that the abrasions to her cheek and knee felt much better with a dressing over them. A subsequent wound evaluation by the Physical Therapist was documented on 4/27/12 at 11:21 AM. The Physical Therapist documented the size and description of the wound and indicated a Mepilex Border was to be used for the abrasion on Patient #14's cheek and knee and was to be changed twice a week.
Patient #14's "Patient Care Plan Report," initiated 4/26/12 at 8:37 PM, included goals, interventions, and monitoring for change in physiological status, knowledge deficit, pain, safety, and skin integrity. However, the POC did not include goals and interventions related to the physical therapy evaluation and Patient #14's impaired mobility. In addition, the POC did not address the nursing care treatment needs for wound assessments or dressing changes.
The Quality Assistant was interviewed on 5/23/12 at 3:15 PM. He reviewed Patient #14's medical record and confirmed the POC did not address activity level or impaired mobility or the wound care to be provided and monitored.
Patient #14's nursing care plan was not comprehensive to include goals and interventions related to impaired mobility or wound care.
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4. Patient #5 was a 64 year old female admitted to the hospital on 5/21/12 for treatment related to confusion and low sodium levels. The "Patient Care Plan Report," initiated 5/21/12 at 2:26 PM, included nursing diagnoses related to knowledge deficit, skin integrity, safety, and change in physiologic status. Interventions included reeducating as needed due to occasional confusion and bed alarm on in case unable to use call light. It did not address the admitting diagnosis of confusion, such as assessing for orientation and neurological status.
The Assistant CNO was interviewed 5/24/12 at 10:15 AM. She reviewed Patient #5's care plan and stated it did not address the admitting diagnosis of confusion and should have.
Patient #5's care plan was not developed to address the admitting diagnosis.
5. Patient #6 was a 22 year old female admitted to the hospital on 5/20/12 for attempted suicide through overdose. The "Patient Care Plan Report," initiated 5/21/12 at 2:46 AM, included nursing diagnoses related to safety, knowledge deficit, and change in physiologic status. Interventions included 1:1 observation, monitoring vital signs and intake/output, and neurological checks every 3 hours. It did not address the psychological or emotional needs, such as assessing for suicidal ideation, life changes, and support systems.
The Assistant CNO was interviewed 5/24/12 at 10:15 AM. She reviewed Patient #6's care plan and stated it did not address issues related to the admitting diagnosis of suicide attempt and should have.
Patient #6's care plan was not developed to address the admitting diagnosis.
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6. Patient #11 was a 62 year old male admitted to the hospital on 4/15/12 for wound care and antibiotics related to cellulitis of his right leg.
Patient #11's "Patient Care Plan Report," initiated 5/15/12, and last updated 5/22/12 at 12:20 PM, included goals, interventions, and monitoring for safety, pain, change in physiological status, and knowledge deficit. In addition, the POC addressed skin integrity. However, the POC did not differentiate between goals, interventions, and monitoring of IV sites, the surgical wound, and overall skin integrity. The POC did not include information relating to prescribed wound care of the surgical site.
In an interview on 5/23/12 at 10:25 AM, the Physical Therapist that was preparing to change Patient #11's dressing stated there were no specifically outlined instructions for his wound care. She stated "Every patient is unique and we use our best judgement in determining what type of wound care is provided at the time of the dressing change." The Physical Therapist stated she did not enter dressing change information into the patient plan of care.
In an interview on 5/23/12 at 11:20 AM, the DOMS/MNS reviewed Patient #11's medical record and confirmed the POC did not contain specific goals and interventions related to wound care.
Patient #11's nursing care plan was not comprehensive to include specific goals and interventions for wound care.
Tag No.: C0304
Based on record review, policy review, and staff interview, it was determined the facility failed to ensure a consent for admission and treatment was obtained and placed in each newborn patient record for 3 of 3 newborns (#2, #4, and #16) whose records were reviewed. This resulted in treatment and procedures completed without parental consent, as well as, an incomplete medical record. Findings include:
The facility's "Conditions of Admission to Bingham Memorial Hospital," revised 12/08/11, included sections for medical and surgical consent, release of information, and the financial agreement. Under the medical and surgical consent portion, the patient signed consent for "services which may be performed during this hospitalization...and which may include but are not limited to laboratory procedures, radiology procedures, diagnostic procedures...medical, nursing or surgical treatments or procedures..." The form included a section to be signed by the patient or guardian.
A policy, "Consent for Treatment," revised 4/11/12, included a section titled "CONSENT AND MINORS," which stated "...either the parent(s) or an appropriately designated legal guardian must give consent to medical treatment."
The following newborn records did not contain consent for treatment:
a. Patient #16 was a female infant, born 3/21/12 and admitted to the nursery with respiratory distress. Her medical record documented she was transported to a referral facility for higher level of care on 3/23/12. Immediately upon delivery Patient #16 was placed on oxygen and started on antibiotics. Her record indicated she had daily blood tests and X-rays performed. There was no consent for treatment in her record.
During an interview on 5/23/12 at 9:00 AM, the DOMS/MNS reviewed Patient #16's record and confirmed there was no consent for treatment.
b. Patient #2 was a female infant, born 5/19/12 and admitted to the nursery for routine newborn care. Her medical record documented blood tests were done to assess blood sugar levels, and Vitamin K and Erythromycin were administered shortly after birth. Before discharge from the hospital on 5/21/12, Patient #2 had a hearing test, as well as, a blood test for newborn metabolic screening. There was no consent for treatment in her record.
During an interview on 5/21/12 at 3:30 PM, the DOMS/MNS reviewed Patient #2's record and confirmed there was no consent for treatment.
c. Patient #4 was a female infant, born 5/21/12 and admitted to the nursery for routine newborn care. Her medical record documented she had received Vitamin K and Erythromycin which were given shortly after birth. There was no consent for treatment in her record.
During an interview on 5/21/12 at 3:45 PM, the DOMS/MNS reviewed Patient #4's record and confirmed there was no consent. She confirmed it was not hospital procedure to obtain a separate consent for admission and treatment for newborn infants.
During an interview on 5/23/12 at 1:00 PM, the CNO confirmed that once a newborn infant was delivered, the newborn was assigned his/her own medical record number and a separate patient chart was generated for the newborn. She stated it was her understanding the general consent for admission and treatment signed by the mother before delivery covered the baby as an implied consent.
The facility did not ensure consent for admission and treatment was signed and placed in each newborn patient's medical record.