Bringing transparency to federal inspections
Tag No.: C0276
Based on observation and interview, the hospital failed to ensure the secure storage and disposal of discarded and residual amounts of narcotics. This had the potential to contribute to narcotic diversion.
Findings:
During an observation on 7/10/12 with the Medical Surgical Manager (MSM) at 9 AM of the medication room in the medical surgical unit, a two gallon white plastic container with a blue top was noted. The container was labelled, "PharmaSafety (TM)," from the company, "Kendall." The container had a round, yellow rubber - like flap opening in the top, approximately 3 to 4 inches in diameter, that could be easily opened to gain access to the contents. The container was resting on top of a supply cart, and was not secured, mounted to a wall, or locked in any way. Picking up and looking inside, the two gallon container was noted to be approximately 2/3 full of used but intact medication vials, syringes, tubing, and whole tablets, and capsules of oral medications. There were no visible chemical agents or liquids inside the container to decompose or dissolve the intact tablets and capsules. There was visible residual leftover liquid visible in many of the medication vials and syringes. There was no 'funnel' or other type of deterring device to prevent retrieval, or simply dumping out, the contents.
During an interview with the MSM on 7/10/12 at 9 AM, she indicated someone could reach into the container and pull contents out, "if they wanted to."
During an interview with the Director of the Pharmacy (DPH) on 7/10/12 at 11:30, regarding the PharmaSafety (TM) container, he indicated the one noted in the medical surgical medication room should have been secured to the wall. When asked what system is in place to ensure staff with access to the medication room does not empty and divert the contents for unauthorized use, the DPH stated, "The security is the locked doors (to the medication room itself). At some point you have to start trusting people."
During an interview with Registered Nurse 1 on 7/11/12 at 2 PM, she stated if the PharmaSafety (TM) container was full, she would call housekeeping to dispose of it.
During an interview with Housekeeper (HK) 1 on 7/11/12 at 2:30 PM, she stated she was familiar with the PharmaSafety (TM) container from the medication room, and described it and the contents normally found therein. HK 1 stated she had personally transported these containers away from the medication room in the past, and so had the janitors, depending on who was less busy at the time of the call. HK 1 stated if she gets the container, she places the container in a plastic trash bag and carries it to a janitor, who then places it in biohazard container. HK 1 stated the PharmaSafety (TM) containers are always unlocked or unsealed, and there are no inventory sheets, nothing is signed, with no other control systems in place that she was aware of.
During a concurrent observation and interview with the MSM on 7/12/12 at 11 AM in the medication room of the medical surgical unit, she confirmed the disposal practice described by HK 1, and also stated there was no inventory system or tracking of the container once it goes to housekeeping and/or janitorial services. The MSM also stated there was no system in place to prevent or track the possible practice of dumping out or retrieving the many leftover medication vials and diverting all the residual amounts up to make a usable dose(s) for unauthorized use.
The contents of the PharmaSafety (TM) container were observed with the MSM, through the lid. The contents filled approximately 2/3 of the two gallon container, and the following, partial, list of items were identified and verified with the MSM:
1. A used, 2-ounce syringe of Dilaudid (a very strong narcotic pain reliever) with tubing attached, and with visible residual liquid inside.
2. Used Dilaudid syringes, with residual amounts left over inside.
3. Dozens of left over medication vials with residual amounts visible, some narcotic.
4. Several intact tablets and capsules of medication.
Tag No.: C0278
Based on observation, interview, and record reviews, the hospital failed to provide a safe environment consistent with nationally recognized infection control precautions, to avoid sources and transmission of infections and communicable disease, as evidenced by the hospital's failure to have effective systems in place to ensure:
A. Surgical instruments were sterilized in accordance with nationally accepted infection control standards when scissors were not sterilized in the open position;
B. A safe and sanitary emergency room environment;
C. A safe and sanitary medical surgical nursing environment.
Findings:
1. During an initial tour of the Emergency Department with the Quality Improvement Advisor and Registered Nurse House Supervisor (RNHS) on 7/09/12, at 10 AM, the following was observed:
A. In the clean utility room of the Emergency Department: Five scissors in peel pouches, (peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. Peel pouches are used primarily when visibility of the instrument is critical for its effective use), which indicated the instruments had undergone the sterilization process. All five scissors were closed during the sterilization process, not allowing the inner surfaces to be sterilized.
During an interview with the RNHS, on 7/12/12 at 10:15 AM, she stated that all unopened instruments in sterile packages would be reprocessed before use.
The 2012 Perioperative Standards and Recommended Practices published by AORN (Association of periOperative Registered Nurses) was reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces ..."
Failure of the hospital to sterilize instruments in accordance with nationally accepted infection control guidelines placed surgical patients at risk for exposure to serious life-threatening infectious agents.
B. In the clean utility room of the Emergency Department, the following was found: Four boxes of partially used laboratory tubes (tubes used to collect blood specimens for testing) that indicated outdates of 2/12/12; two packages of double-action wire cutters in sterile packages that indicated sterile outdates of 7/13/11 and 1/24/12; one gallon of "Cidex-Plus 28 day solution," with an expiration date of 3/23/09, was stored on a shelf with various packages of dressings, including a box of eye pad dressings. The one gallon bottle read, "Hazardous to Humans." "The MSDS, (Material Safety Data Sheet) for the product indicated, "This product may cause skin, eye, and respiratory irritation." It further indicated that, "eye and skin protection are recommended," (chemical resistant gloves and masks). The RNHS stated, "We will get rid of all these products, and I don't know what the Cidex is for, but it shouldn't be kept here."
C. In the clean utility room of the second floor Medical Surgical unit, the following was found: One chest tube insertion sterile kit indicating an expiration date of 6/2012, (sterility cannot be guaranteed after an expiration date has passed). One trochanter, (a surgical instrument used for insertion of chest tubes) had an outdate of 9/12/11, and three trochanters had outdates of 4/2012. The plastic bag which contained the kit also contained two bottles of Lidocaine (medication used for numbing skin) which were outdated on 7/1/12. During a concurrent interview with the Nurse Manager, she stated, "Yes, these are outdated and I'll pull them from the shelf."
These failures placed patients at risk of coming into contact with disease causing organisms, and at risk of coming into contact with hazardous chemicals.
Tag No.: C0298
3. The clinical record for Patient 5 was reviewed on 7/10/12, at 2 PM, with RN 2. The record titled, "Patient Care Plan Report," initiated 7/9/12, read, "Altered Skin Integrity (Pressure Ulcer) (Actual) related to immobility, Evidenced by compromised skin integrity."
This care plan problem was followed by four (4) goals and eighteen (18) interventions related to the presence of an actual pressure sore on Patient 5. The problem, goals, and interventions were all initiated by RN 3 on 7/9/12 at 3:58 AM, and then evaluated by three different RNs four more times:
On 7/09/12 at 3:11 PM
On 7/10/12 at 00:38 AM
On 7/10/12 at 11:14 AM
On 7/10/12 at 12:57 PM
During an interview with RN 2 on 7/10/12 at 3 PM, she stated, according to the clinical record, Patient 5 had no pressure sore.
The "Daily Focus Assessment Report," dated 7/9/12 at 8:15 PM, read that a skin assessment for Patient 5 indicated his skin was "clear," and under "signs/symptoms" was the word "none."
The hospital policy and procedure titled "Plan of Care Using Clinical Care Station," dated 2/12/12, indicated, "1. The Plan of Care must be initiated by an RN (Registered Nurse) within 24 hours of admission, and by other disciplines at the time of problem identification., 4. The Plan of Care will be evaluated every 24 hours, and 5. The Plan of Care will be individualized according to the patient's diagnosis and comorbid conditions."
28741
Based on interview and record review, the hospital failed to develop an accurate and individualized plan of care for three of 20 sampled patients (2, 16, and 5), which had the potential:
1. For Patient 2 to receive inconsistent care regarding gastrointestinal diagnoses;
2. For Patient 16 to not receiving appropriate interventions for nausea and vomiting;
3. For Patient 5 to receive unnecessary treatments/interventions for a problem the patient did not have.
Findings:
1. The clinical record for Patient 2 was reviewed on 7/11/12. The patient was admitted on 7/6/12 for failure to gain weight, with a history of laryngomalacia (a softening of the tissues of the larynx) and a gastrostomy tube (GT-a surgical opening into the stomach for the purpose of nutrition). The physician's history and physical indicated the GT had been placed when the patient was two months old and the patient's mother was not sure if she had been correctly mixing the tube feeding formula for his feedings.
During a concurrent electronic medical record (EMR) review and interview with the Maternal Child Clinical Manager (MCM), on 7/11/12, at 10 AM, the record indicated the patient was receiving GT feedings and nothing by mouth. A care plan for GT care and interventions was not found in the record. The MCM stated the electronic medical record contained care plan templates that nurses select based upon the patient's individual needs, and Patient 2 should have had a nursing care plan for his GT management.
2. The electronic medical record for Patient 16 was reviewed on 7/11/12, with Registered Nurse (RN) 2. The patient was admitted for abdominal pain and nausea and vomiting. A care plan for nausea and vomiting was not found in the EMR. RN 2 confirmed the absence of the care plan and stated the patient should have had a care plan for nausea and vomiting initiated on admission.
The hospital policy and procedure titled "Plan of Care Using Clinical Care Station", dated 2/12/12, indicated, "1. The Plan of Care must be initiated by an RN (Registered Nurse) within 24 hours of admission, and by other disciplines at the time of problem identification., 4. The Plan of Care will be evaluated every 24 hours, and 5. The Plan of Care will be individualized according to the patient's diagnosis and comorbid conditions."
Tag No.: C0304
Based on interview and record review, the hospital failed to obtain properly executed informed consents for two of 20 sampled patients (8 and 10) for blood transfusions. This failure had the potential for patients not to be given the information, consequences and other options before they consented to the treatment.
Findings:
The clinical record for Patient 8 was reviewed on 7/10/12, at 10:40 AM. The "Consent for Transfusion," dated 7/8/12 at 4 PM, indicated, "The following must be completed by the physician." This area was found without a physician's signature or date.
The clinical record for Patient 10 was reviewed on 7/10/12, at 10:40 AM. The "Consent for Transfusion," dated 7/7/12 at 11:45 AM, indicated, "The following must be completed by the physician." This area was found to be without a physician's signature or date.
During an interview with the Health Information Manager (HIM) and Medical Record Analyst (MRA) on 7/10/12, at 11 AM, she reviewed the clinical records and was unable to find documentation of informed consent by the physicians. The MRA stated, "Yes, the doctors are required to provide evidence of informed consent."
The hospital policy and procedure titled, "Consent for Blood Transfusion," dated 2/19/12, indicated in part, "The RRH (hospital name) nursing staff will give the pamphlet, A Patient's Guide to Blood Transfusion, prior to the procedure. The physician will verify same at the bottom of the consent form."
The hospital policy and procedure titled, "Medical Staff Rules and Regulations," dated June 2010, indicated, "INFORMED CONSENT: It shall be the practitioner's responsibility to obtain an informed consent for procedure or treatment from the patient or representative. Evidence of an informed consent should be documented in the medical record by the practitioner."
Tag No.: C0306
2. During a clinical record review on 7/11/12, at 2 PM, for Patient 10, the physicians for the patient had not authenticated the following verbal/telephone orders: two orders dated 7/6/12, and seven orders dated 7/7/12.
3. During a clinical record review on 7/11/12, at 2 PM, for Patient 21, the physician had not authenticated the following verbal/telephone order: one order dated 7/8/12.
The hospital policy and procedure titled "Telephone and Verbal Orders," dated 6/7/12, indicated, "Authentication of Telephone or Verbal Orders - All medication orders shall be authenticated by the physician/LIP (Licensed Independent Practitioner) within 48 hours..."
The "Medical Staff Rules and Regulations," dated November 1987 and revised June 2010, indicated in section 3.3, "All verbal orders must be authenticated within 48 hours."
28741
Based on interview and record review, the hospital failed to ensure verbal or telephone physician's orders were authenticated within 48 hours of when the orders were given to the hospital staff for two of 20 sampled patients (16 and 10), and one random patient (21), which had the potential for transcription errors to adversely affect patient safety.
Findings:
1. During a clinical record review on 7/11/12, for Patient 16, the physicians for the patient had not authenticated the following verbal/telephone orders: three orders dated 7/6/12, and four orders dated 7/7/12.
During an interview with the Health Information Manager and Medical Record Analyst (MRA), on 7/11/12, at 11:40 AM, the MRA stated telephone orders and verbal orders must be physically signed by the physician with 48 hours. She stated, "We count them (unsigned verbal or telephone orders) as a medical record deficiency." When asked about the electronic medical record (EMR) orders, the MRA stated, "The EMR orders are dated and timed when the ordering physician authenticates them." The hard copy records must be signed by the ordering physician within 48 hours. She confirmed the seven telephone orders for Patient 16 had not been authenticated by the physician and would be considered a deficiency.