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Based on interview and document reviews, the hospital failed to ensure that its grievance process resolution letters included the date that the grievance processes were completed for 5 of 5 grievances reviewed for sampled patients (Patient 22, 23, 24, 25 and 26). This failure created a risk for all patients and/or families that submitted grievances to the hospital to be dissatisfied with the actions taken on their behalf to resolve their grievances.

Findings:

On October 16, 2013, a review of the patient grievances filed by patients and/or family members related to quality of care and treatment concerns were conducted and noted the following:

a. For Patient 22, the grievance resolution letter was generated on July 8, 2013. It did not include the grievance process completion date.

b. For Patient 23, the grievance resolution letter was generated on August 6, 2013. It did not include the grievance process completion date.

c. For Patient 24, the grievance resolution letter was generated on October 10, 2013. It did not include the grievance process completion date.

d. For Patient 25, the grievance resolution letter was generated on October 7, 2013. It did not include the grievance process completion date.

e. For Patient 26, the grievance resolution letter was generated on September 16, 2013. It did not include the grievance process completion date.

On October 16, 2013 at 2:55 PM, an interview was conducted with the Director of Risk Management/Privacy Officer. The Director of Risk Management/Privacy Officer stated the hospital's practice was to generate the grievance process resolution letters on the date the grievance process was completed. She reviewed the grievance process resolution letters that were sent to Patients 22, 23, 24, 25 and 26, and confirmed that the grievance process resolution letters that were sent to the patients did not include the date that the grievance processes were completed.

A review of the hospital's policy and procedure (P&P), titled, "Handling of Patient Grievances and Complaints" , dated October 2012 was conducted. The P&P included the following:

"It is the policy of (hospital's name) to implement practices consistent with regulatory standards to manage patient concerns related to care and services they receive. It is also the organization ' s policy to assure that patient or family member grievances or complaints are communicated in a timely, reasonable and consistent manner to the appropriate departments for investigation, problem resolution and follow-up."

Processing a Grievance: 6). "The resolution letter will be sent upon completion of the investigation. The written communication will include: c). The results of the grievance process, and d). The date of the completion of the resolution."

Based on observation, interview and record review, the hospital failed to ensure that 1 of 35 sampled patients (Patient 17) had the capacity (mental ability) to make decisions to refuse or request treatment while hospitalized. The hospital allowed Patient 17 to sign consent to receive vaccinations and to accept the Conditions of Admission. This failure had the potential to result in the facility to allow any patients that did not have the capacity to receive and understand information to make informed decisions for health care.

Findings:

1a. On October 14, 2013, a review of Patient 17's medical record was conducted with the registered nurse (RN ) 7 and the Intensive Care Unit Supervisor (RN 4).

A review of the Inpatient/Outpatient Admission Record was conducted. On October 11, 2013, Patient 17 was admitted to the hospital with diagnoses that included opiate (drug) overdose and encephalopathy (a brain disease).

A review of the hospital's Conditions of Admission (COA) forms for Patient 17 was conducted. The COA forms were not signed by the patient on admission.

A review of the History and Physical (H&P) evaluation, dated October 11, 2013 was conducted. It noted that Patient 17 was awake, but not alert and oriented. The assessment also noted that the patient had altered mental status with encephalopathy suspected due to opioid overdose.

A review of the nursing admission assessment completed on October 11, 2013 at 8:18 PM was conducted. The nursing assessment noted that the patient's neurological status was not within normal limits. The Neurological Assessment documentation noted that Patient 17 had short and long term memory deficits, inconsistently followed directions, and slurred speech. The nursing staff also noted that the patient was anxious/agitated/restless.

A review of the Influenza and Pneumonia Vaccine Screening and Administration Form, dated October 11, 2013 at 10:40 PM was conducted. It showed that Patient 17 signed the document, (signing the form should indicate that the patient had the mental capacity to understand the risks, benefits and alternatives to the proposed treatment offered). Patient 17 received one dose of the Pneumococcal Polysaccharide Vaccine 0.5 (ml) milliliters, intramuscularly (administered within a muscle) on October 12, 2013 at 9:47 PM.

On October 14, 2013 at 1:55 PM, an interview was conducted with RN 7, who was Patient 17's primary nurse for the day shift (7 AM to 7 PM). She stated that the patient did not have the mental capacity to make informed decisions. RN 7 stated that the patient required a sitter (one direct care staff person at the patient's side at all times) due to the patient's statement that she heard voices that told her to harm herself.

On October 14, 2013 at 2:15 PM, an interview was conducted with the Intensive Care Unit Supervisor. When asked why the patient's COA was not completed on admission, the Intensive Care Unit Supervisor stated that Patient 17 did not have the mental capacity to make informed decisions, according to the H&P evaluation and nursing assessments that were completed on October 11, 2013. The Intensive Care Unit Supervisor stated the Patient Access Department would have the patient sign the COA forms when the patient regained the capacity to make informed decisions. She stated that the patient should not have been allowed to make an informed decision to receive the Pneumococcal Polysaccharide Vaccine.

On October 14, 2013 at 3 PM, Patient 17 was observed in bed. She had a 1 to 1 sitter at her bedside. Patient 17 was interviewed. The patient did not have the mental capacity to make her needs known.

1b. On October 18, 2013, a review of the Patient 17's COA forms were conducted with the Intensive Care Unit Supervisor. The forms were signed by the patient and witnessed by a Patient Access Department employee on October 14, 2013 at 5:30 PM.

A review of the nursing assessment, dated October 14, 2013 was conducted. The nursing assessment noted that the patient's neurological status (mental capacity) was not within normal limits.

On October 14, 2013 at 1:55 PM, an interview was conducted with RN 7, who was Patient 17's primary nurse for the day shift (7 AM to 7 PM). She stated that the patient did not have the mental capacity to make informed decisions. RN 7 stated that the patient required a sitter (one direct care staff person at the patient's side at all times) due to the patient's statement that she heard voices that told her to harm herself.

On October 18, 2013 at 11:30 AM, the Intensive Care Unit Supervisor acknowledged that Patient 17 did not have the mental capacity to make informed decisions on October 14, 2013.

On October 18, 2013 at 2:30 PM, an interview was conducted with the Manager of Patient Access Department. She stated that the employee who obtained and witnessed the patient's signature on the COA forms dated October 14, 2013 at 5:30 PM, did not verify the patient's mental capacity with a license nurse prior to obtaining the patient ' s signature.

Based on interview and record review the hospital failed to ensure that 1 of 35 sampled patients (Patient 11) had a physician ' s order for physical restraints before the patient was placed in physical restraints. This failure had the potential for all patient ' s to be placed in unnecessary restraints.

Findings:

A review of Patient 11's medical record on October 15, 2013 showed that the patient was admitted to the hospital on September 19, 2013 with diagnoses of chronic obstructive pulmonary disease (a chronic disease of the lungs causing shortness of breath and difficulty breathing) and pneumonia.

A review of the Nurse's Notes dated from October 11, 2013, showed that Patient 11 was in soft wrist restraints due to not following commands and touching his endotracheal tube (a breathing tube).

A review of the physician orders dated October 11, 2013 at 10:00 AM showed a large green sticker with check-off boxes for the physician to indicate the type of restraint and the purpose for the restraint. The sticker had a space for the physician to sign, date and time the order. In this case the physician had signed, dated and timed the restraint order sticker but did not check-off any of the boxes to indicate the type of restraint or the purpose for the restraint.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, RN 3 acknowledged that a restraint order needs to be renewed by the physician every 24 hours. RN 3 verified that the restraint order sticker dated October 11, 2013, was incomplete as the physician did not indicate with any check-off boxes the type of restraint to be used or the purpose for the restraint.

Based on interview and record review, the hospital failed to ensure that 1 of 35 sampled patients (Patient 16) had effective and timely pain management interventions. Patient 16 complained of pain on two separate occasions without a nursing intervention to ensure effective pain control. This failure had the potential for all patients that received care and services at the hospital to experience ineffective pain management. In addition, this failure had the potential to result in a delay in the healing process and/or a decline in the patients' overall health status.

Findings:

On October 15, 2013, a review of Patient 16's medical record was conducted with registered nurse (RN) 6 and RN 8. Patient 16 presented to the Emergency Department (ED) on October 14, 2013 with complaints of dizziness and an unsteady gait.

A review of the ED assessments conducted on October 14, 2013 at 5:15 PM and again at 5:48 PM, noted that Patient 16 had head pain that was rated a 6 on the 0 to 10 intensity pain scale (0 equals no pain and 10 equals worst pain possible).

A review of the physician orders was conducted with RN 6. The orders showed that the patient had pain medications (Tylenol and Norco) ordered, but they were not administered.
A review of the nursing documentation dated October 14, 2013, was conducted with RN 6 and RN 8. The documentation failed to show that the patient refused pain management interventions.

On October 15, 2013 at 1:25 PM, RN 6 and RN 8 verified that the medical record did not include documented evidence to show that pain management interventions were implemented to provide effective pain relief for the patient at 5:15 PM and/or 5:48 PM. RN 6 and RN 8 stated that Patient 16 should have been offered pain management interventions. They also stated that if Patient 16 was offered, but refused a pain relief intervention the nurses' documentation should have reflected the patient's refusal.

The hospital's policy and procedure (P&P) titled, "Pain Assessment and Management," dated December 2012, noted the following:
"To ensure caring and appropriate treatment for patients in all age groups who have pain or the potential to experience pain. " " Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." "Our approach to effective pain management for our patients is based on the ABCDE model: A). ask the patient about his/her pain frequently and assess the pain systematically. B). Believe the patient and family in their reports of pain and what relieves it. C). Choose pain control options appropriate for the patient, family and setting. D). Deliver interventions in a timely manner. E). Evaluate the effectiveness of the treatment, taking into consideration the patient's goal for pain relief and explain to patients and families that effective pain management is their right."

"Assessment- the most reliable indicator of pain is the patient's self-report. Pain assessment and documentation will occur on admission, with new onset of pain."

"Pain is assessed in all patients using scales that are appropriate to the patient's cognitive ability, cultural background, and growth and development level." 1). Adults and children greater than four years old. A). The 0-10 Intensity Scale is the scale commonly used for patients to rate their pain. 0 equals no pain and 10 equal the worst pain a patient has ever experienced."

Based on interview and record review, the facility failed to ensure that individualized nursing care plans were developed and implemented based on the patients' assessments, for 5 of 35 sampled patients (Patients 1, 2, 13, 16 and 17).

For Patients 1 and 2, the hospital failed to develop individualized nursing care plans, with interventions/approaches, based on the patients' assessments. This failure had the potential to result in, the patients to not have received the care and treatment necessary to resolve identified health concerns based on their assessments.

For Patient 13, the hospital failed to develop a comprehensive and individualized nursing care plan, with interventions/approaches, for pain. This failure had the potential for Patient 13 to not receive nursing care and interventions necessary to resolve identified pain concerns.

For Patient 16, the hospital failed to develop a plan of care that reflected the patient's pain management need that was identified when the patient presented to the hospital. This failure had the potential to contribute to ineffective pain management for the patient.

For Patient 17, the hospital failed to follow the plan of care for nutritional deficit that was identified on the patient's day of admission to the hospital. This failure had the potential for the patient's overall health status to decline.

Findings:

1. During a review of the medical record for Patient 1, on October 14, 2013, the "Admission Record" noted that Patient 1 was admitted to the hospital on October 13, 2013, with the diagnoses that included asthma (a chronic disease in which the airway becomes inflamed and narrowed restricting the passage of oxygenated air) and pneumonia (a bacterial, viral or fungal infection of one or both lungs in which the air sacs may fill with fluid or pus, causing difficulty breathing).

During a review of the medical record for Patient 1, the "Pediatric Admission Assessment" dated October 13, 2013, was completed by Registered Nurse 1 (RN 1), on October 13, 2013 at 3:00 AM. The assessment noted that Patient 1 had intercostal retractions (the muscles between the ribs as they are pulled in, when a person is having difficulty breathing), nasal flaring (the widening of the nostrils when breathing is difficult), and crackles (bubbling sounds, usually caused by fluid in the airway, that are heard within the lungs) in both lungs with wheezing (a high-pitched whistling sound associated with labored breathing). The assessment also noted that Patient 1 was pale in color and had a dry cough.

During a review of Patient 1's medical record, the care plan titled "Gas Exchange, Impaired" dated October 13, 2013, initiated by RN 1, noted the goals of "Absence of Hypoxia (a condition in which the body is deprived of oxygen)" with the target date of October 16, 2013. Further review of the care plan showed that RN 1 did not document interventions/approaches to be implemented in order to prevent the occurrence of hypoxia.

During a review of the hospital's policy and procedure titled "Documentation" dated January 1998 (revised December 2012), was reviewed on October 14, 2013. The policy and procedure noted the following:

"Patient Plan of Care:"

"Each patient will have an individualized Plan of Care, which will be initiated upon admission, based upon the nursing assessment of the patient's needs, strengths, limitations and goals, in conjunction with the medical plan."

"The Plan of Care will include, the patient's needs/problems and health care provider's approaches/solutions..."

During an interview on October 14, 2013 at 2:05 PM, with Registered Nurse 2 (RN 2) and the Pediatric Unit Manager (Manager 1), RN 2 verified that Patient 1 was admitted to the hospital on October 13, 2013 with diagnoses of asthma and pneumonia. RN 2 verified that the medical record included a nursing care plan for the problem of "Gas Exchange, Impaired" that did not include interventions.

RN 2 and Manager 1 stated the care plan should have included interventions. RN 2 verified that the care plan should have been updated and/or reviewed by any licensed staff caring for Patient 1, based on the patient's status.

2. During review of the medical record for Patient 2, on October 14, 2013, the "Admission Record" noted that Patient 2 was, admitted to the hospital on October 13, 2013, with the diagnosis of bronchitis (inflammation of the airway passages between the nose and the lungs, caused by a respiratory infection or exposure to an irritant).

During a review of the medical record for Patient 2, the " Pediatric Admission Assessment " dated October 13, 2013 at 9:00 PM, was completed by RN 1. The assessment noted that Patient 2 had nasal congestion with thick yellow secretions.

During a review of Patient 2's medical record, the nursing care plan titled "Airway Clearance, Ineffective" dated October 13, 2013, noted the goals of "Lung Sounds Return to Baseline", with the target date of October 14, 2013. Further review of the nursing care plan showed that there was no documented evidence of interventions/ approaches that would be implemented to achieve the goal.

During further review of the medical record, the nursing care plan titled "Gas Exchange, Impaired " dated October 13, 2013, initiated by RN 1, noted the goals of "Absence of Hypoxia" manifested by the absence of cyanosis (bluish coloring of the skin due to the lack oxygen in the blood stream) and having a blood oxygenation levels within normal limits. The target date on the care plan was October 14, 2013. Further review of the care plan showed there was no documented evidence of interventions/ approaches that would be implemented to achieve the goals.

During an interview on October 14, 2013 at 2:20 P.M., with RN 2 and Manager 1, RN 2 verified that Patient 2 was admitted to the hospital on October 13, 2013 with the diagnosis of bronchitis. RN 2 verified that the medical record showed that RN 1 had nursing care plans for the problems of "Airway Clearance, Ineffective" and "Gas Exchange, Impaired" , that were initiated on October 13, 2013. RN 2 verified that the nursing care plans had no documented interventions/approaches as of October 14, 2013 at 2:20 P.M. RN 2 and Manager 1 verified that the nursing care plans should have documented interventions/approaches towards resolving the identified problems.



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3. During review of the medical record for Patient 13, on October 14, 2013, the Admission Record noted that Patient 13 was admitted to the hospital on October 7, 2013, with the diagnoses that included chest pain and congestive heart failure (a condition in which the heart cannot pump enough blood to the rest of the body).

During a review of the medical record for Patient 13, the Electronic Medication Administration Record (eMAR) dated October 9, 2013 at 11:57 AM, noted that Patient 13 had leg pain, rated as an 8 (the intensity pain scale of 0 to 10, with 0 being no pain and 10 being the worst pain). Patient 13 was given morphine sulfate 2 milligrams, intravenous (in the vein) pain medication. Further record review of the eMAR, dated October 9, 2013 at 4:01 PM, and noted that Patient 13 had generalized pain based on the patient ' s non-verbal behavior, no pain scale used. Patient 13 was given a second dose of morphine sulfate 2 milligrams, intravenous (in the vein) pain medication.

During a review of Patient 13's medical record noted that there was no nursing care plan specific for pain management, with no interventions/approaches addressing the problem of pain.

During an interview on October 14, 2013 at 2:05 PM, with Registered Nurse 9 (RN 9) and the Chief Nursing Officer (CNO) verified that an identified patient problem should have documented a nursing care plan with individualized interventions/approaches. RN 9 verified that there was no specific nursing care plan regarding Patient 13's complaints of pain.



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4. On October 15, 2013, a review of Patient 16's medical record was conducted with Registered Nurse (RN) 6 and RN 8. Patient 16 presented to the Emergency Department (ED) on October 14, 2013 with complaints of dizziness and an unsteady gait.

A review of the ED nursing assessments completed on October 14, 2013 at 5:15 PM and again at 5:48 PM, noted that Patient 16 had head pain that was rated a 6 on the 0 to 10 intensity pain scale (0 equals no pain and 10 equals worst pain possible).

A review of the medical record failed to show documented evidence that a nursing plan of care for pain management was developed for Patient 16.

On October 15, 2013 at 1:30 PM, an interview with RN 6 and RN 8 confirmed that a nursing plan of care for pain management was not developed for Patient 16.

On October 15, 2013 at 1:45 PM, an interview was conducted with the CNO. The CNO stated that the nursing staff had 24 hours to develop a plan of care that reflected the patient's needs.

A review of the hospital ' s policy and procedure titled "Documentation" dated January 1998 (revised December 2012), was reviewed on October 15, 2013. The policy and procedure noted the following:

"Patient Plan of Care:"

"Each patient will have an individualized Plan of Care, which will be initiated upon admission, based upon the nursing assessment of the patient's needs, strengths, limitations and goals, in conjunction with the medical plan."

"The Plan of Care will include, the patient's needs/problems and health care provider's approaches/solutions..."

5. On October 14, 2013, a review of Patient 17's medical record was conducted with Registered Nurse (RN) 7 and the Intensive Care Unit Supervisor (RN 4).

A review of the Inpatient/Outpatient Admission Record was conducted and noted that on October 11, 2013, Patient 17 was admitted to the hospital with diagnoses that included opiate (drug) overdose and encephalopathy (a brain disease).

A review of the nursing plan of care for nutritional deficit dated October 11, 2013 indicated that the nursing interventions included: promote adequate nutrition and collaborate with the dietician. The patient's goals were to have adequate nutritional intake.

A review of the " Intensive Care Unit Nutritional Intake " documents noted that Patient 17's nutritional intake was less than or equal to 25 percent per meal, as follows:

October 11, 2013 - the physician ' s admission order noted that the patient to have nothing by mouth, " NPO. "

October 11, 2013 - The Nutritional Intake record noted that the patient had 0% food intake.

October 12, 2013 - the physician order noted that Patient 17 to have a clear liquid diet.

October 12, 2013 - The Nutritional Intake record noted that the patient had 0% food intake.

October 13, 2013 - the physician order noted that Patient 17 to advance to a cardiac diet (low fat and low salt foods)

October 13, 2013 - The Nutritional Intake record noted that the patient had 0% food intake.

October 14, 2013- no new diet ordered and the patient continued on a cardiac diet.

October 14, 2013 - The Nutritional Intake record noted that the patient had 0% food intake.

A review of the Dietary Nutrition Assessment, dated October 12, 2013 was conducted. The assessment noted that the patient had poor oral (by mouth) intake of food and that the patient was confused. The interventions included: monitor the patient's bowel movements and oral intake. The dietician's recommendations included: if the patient was unable to tolerate oral intake, consider nutrition support to meet needs. The patient's goals included bowel movements, meet nutritional needs, tolerate oral diet and follow up in one to three days.

On October 16, 2013 at 3:00 PM an interview was conducted with RN 12. She reviewed the patient ' s meal intake percentages since the date of admission and confirmed that the patient had low oral intake. RN 17 was unable to locate documented evidence in Patient 17's medical record to show that the physician or the dietician was informed of the patient's low oral intake.

On October 18, 2013 at 11:15 AM, an interview was conducted with the Registered Dietician (RD), who completed the Dietary Nutrition Assessment, dated October 12, 2013. The RD stated that she was not aware that the patient had been eating less than or equal to 25% of the meals after the initial Dietary Nutrition Assessment. The RD stated that if she had been made aware that Patient 17 ' s intake was less than 25%, she would have reassessed the patient ' s nutritional needs and made recommendations. The RD stated that she did not reassess Patient 17 until October 16, 2013 and at that time she made recommendations.

Based on interview and record review, the hospital failed to ensure that 8 of 35 sampled patients (Patients 8, 9, 10, 11, 12, 13, 19 and 20), in a universe of 191, had all of their physician orders authenticated (with the name, date and time) of the ordering practitioner, within 48 hours. This failure had the potential for errors in transcription and the potential to affect the patients ' treatment and safety.

Findings:

Record review, on October 14, 2013, of the hospital's medical staff bylaws, dated December 14, 2011 noted the "...basic responsibilities of medical staff membership...include...2.5.4: preparing and completing in timely fashion, medical records for all the patients to whom the member is responsible for providing care in the hospital;..."

1. A review of Patient 12's physician orders on October 14, 2013 at about 3:00 PM, showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 10, 2013 at 7:00 PM an order for potassium and intravenous (into the vein) fluids.

October 11, 2013 at 5:00 PM an order for an orthopedic consultation of both knees, rheumatology consult of both knees and a change to the intravenous medications.

October 11, 2013 at 7:00 PM an order to discontinue use of the indwelling urinary catheter (a tube in the bladder), laboratory tests, change the drip rate of TPN (total parenteral nutrition) and begin a soft diet.

In an interview with RN 5 on October 14, 2013 at 3:25 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

2. A review of Patient 13's physician orders on October 14, 2013 at about 1:45 PM showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 9, 2013 at 5:20 PM an order for discontinued use of the indwelling urinary catheter and a consultation with a urologist.

October 12, 2013 at 4:16 PM an order for continued use of medications.

In an interview with RN 9 on October 14, 2013 at 1:45 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

3. A review of Patient 19's physician orders on October 16, 2013 at about 11:00 AM showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 12, 2013 at 8:00 PM an order for an injection of medication.

In an interview with RN 10 on October 16, 2013 at 11:20 AM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

4. A review of Patient 20's physician orders on October 16, 2013 at about 10:30 AM showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 9, 2013 at 7:59 PM an order for medication to be given on an as needed basis.

October10, 2013 at 5:00 PM an order for blood sugar checks and for an injection of insulin.

In an interview with RN 11 on October 16, 2013 at 10:50 AM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.



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5. A review of Patient 10's physician orders on October 14, 2013 showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 11, 2013 at 2:40 AM an order to discontinue an intravenous (into the vein) medication.

October 11, 2013 at 10:45 AM an order titled "Medication Titration Order Set".

October 10, 2013 at 5:50 PM an order titled "Medication Titration Order Set."

October 10, 2013 at 6:15 AM an order intravenous medication.

In an interview with RN 4 on October 14, 2013 at 3:50 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

6. A review of Patient 8's physician orders on October 15, 2013 showed the following verbal/telephone orders that were signed by the physician but not dated or timed when the physician signed the orders:

October 12, 2013 at 8:30 AM an order for intravenous fluids and medications, to cancel the nasogastric tube and to hold all oral medications.

October 12, 2013 at 5:40 PM an order for laboratory tests and a blood transfusion.

In an interview with RN 4 on October 14, 2013 at 3:50 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

7. A review of Patient 9's physician orders on October 15, 2013 showed the following verbal/telephone orders that were signed by the physician but not dated or timed when the physician signed the orders:

October 12, 2013 at 4:00 PM an order for intravenous fluids and diabetic medication.

October 12, 2013 at 6:19 AM an order for a consult and diabetic medication.

October 12, 2013 at 8:30 AM an order for blood sugar checks, laboratory tests and a Dietician consult.

Further review of Patient 9's physician verbal/telephone orders showed the following orders that were not signed, dated or timed within 48 hours:

October 11, 2013 at 9:35 AM an order for potassium and intravenous fluids.

October 12, 2013 at 7:30 PM an order for oral fluids and potassium.

October 12, 2013 at 10:20 PM an order for an intravenous medication.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, he acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

8. A review of Patient 11's physician orders on October 15, 2013 showed the following verbal/telephone orders that were signed by the physician but not dated or timed when the physician signed the orders:

October 7, 2013 at 9:30 PM an order form titled "Adult Pre-Op CABG Pre-Printed Orders."

October 8, 2013 at 6:50 PM an order to discontinue an intravenous medication.

October 8, 2013 at 7:00 PM an order form titled "Medication Titration Order Set."

October 8, 2013 (no time) an order form titled "Adult-ICU Post-Thoracotomy (incision into the chest) Pre-Printed Orders."

October 8, 2013 at 10:00 AM an order to obtain the patient's consent for a procedure.

October 8, 2013 at 11:40 AM an order to change a central line (a long tube placed in a large vein).

October 8, 2013 at 9:30 AM an order to hold a medication due to possible surgery.

October 11, 2013 at 10:30 AM an order for a laboratory test and a change in the patient's ventilator (breathing machine) settings.

October 11, 2013 at 10:45 AM an order to return to the previous ventilator settings.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, he acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

Based on interview and record review the hospital failed to ensure that 1 of 35 sampled patients (Patient 11) had a medical history and physical completed and documented in the medical record 24 hours after the patient's admission to the hospital. This failure had the potential to result in the patient's care team providing care that was not indicated or harmful for the patient's medical conditions.

Findings:

A review of Patient 11's medical record on October 15, 2013, showed that the patient was admitted to the hospital on September 19, 2013, with diagnoses of chronic obstructive pulmonary disease (a chronic disease of the lungs causing shortness of breath and difficulty breathing) and pneumonia.

A review of Patient 11's History and Physical showed that the physician dictated the report on September 23, 2013, 4 days after the patient was admitted.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, RN 3 acknowledged that the physician's History and Physical was not dictated and documented within 24 hours of the patient's admission and should have been.

A review of the hospital's Medical Staff Bylaws approved on December 14, 2011 showed the following under "Basic Responsibilities of Medical Staff Membership":

"2.5.4 preparing and completing in timely fashion medical records for all the patients to whom the member is responsible for providing care in the hospital;..."

Based on interviews and record review, the hospital failed to ensure a complete and accurate medical record was maintained for 1 of 35 sampled patients (Patient 19). This failure had the potential to affectthe health and safety of the patient.

Findings:

During a record review, on October 16, 2013, of Patient 19 ' s medical record noted that the patient underwent two invasive procedures (a part of the body is entered with a puncture or incision) on October 5, 2013, performed by a physician. An arterial line was inserted (a thin catheter inserted into an artery to monitor the blood pressure) and a Quinton catheter was inserted (a catheter for temporary access for dialysis or infusion of medicine).

Further record review of Patient 19 ' s medical record noted that there was no physician's documentation of the October 5, 2013 procedures.

A record review, on October 16, 2013, of the hospital's medical staff bylaws, dated December 14, 2011 noted the "...basic responsibilities of medical staff membership...include...2.5.4 preparing and completing in timely fashion, medical records for all the patients to whom the member is responsible for providing care in the hospital;..."


During an interview, on October 17, 2013 at 1:10 pm, with the Chief Nursing Officer (CNO), she verified that there was no physician's procedure note regarding the October 5, 2013 arterial line insertion and the Quinton catheter insertion.

Based on interview and record review, the hospital failed to ensure that only authorized personnel had access to the automated drug delivery system. The system, PYXIS, contained routine medications and controlled medications, such as narcotics. The hospital failed to follow its policy and procedure to remove three employees who no longer worked for the hospital. This failure had the potential for all licensed staff, who no longer work for the hospital, to access medications, including controlled medications and had the potential for drug diversion to occur in the hospital.

Findings:

In an interview with the Pharmacy Director (PD) on October 17, 2013 at approximately 9:50 AM, the PD stated that he receives an e-mail from Human Resources listing any employees that were terminated. The PD stated that the pharmacy department was responsible to deactivate in the PYXIS the employees ' names that no longer work for the hospital.

A review on October 17, 2013, of the list of "Users" for the hospital's automated drug delivery system, PYXIS, was reviewed and compared with a list of terminated employees.

The comparison of the two lists showed that there were three employees who were active in the PYXIS list that were no longer working at the hospital.

In an interview with the Pharmacy Manager (PM) on October 18, 2013 at 10:20 AM, the PM stated that she would have to check on the employee names to see if the three former employees were still active.

In a follow-up interview with the PM on October 18, 2013 at 2:10 PM, she acknowledged that there were three employees that should have been deactivated in the PYXIS users list.


In a review of a hospital policy and procedure titled
"Termination/Resignation" with an effective date of May 2012 showed the following under "Procedure" section:

"...The department director or designee should insure (ensure):
h. Completes Pyxis User Addition/Deletion/Modify Request and submits to Pharmacy to request deletion of Pyxis user access."

In a review of a hospital policy and procedure titled "Pyxis Med-Stations Anesthesia Machines" with an origination date of September 2000 showed the following under "Professional Codes " :

"3. Maintenance and entry of user IDs and user privileges will be performed by Pharmacy.

5. Pharmacy is notified of terminations for code removal by Human Resources."

Based on observation and interview, the hospital failed to ensure that 2 of 10 Labor and Delivery Rooms did not have expired ready to use infant formula. This failure had the potential to result in a decrease in the nutritive value resulting from the ingesting of formula past the manufacturer's "use by" calendar date.

Findings:

During a general tour of the Labor and Delivery Unit on October 14, 2013 at 3:10 PM with Director of Women and Child Services (DWCS), the following was observed:

1. Six bottles of Enfamil Premium Newborn Ready to Use Formula with the expiration date of October 1, 2013, were observed in Labor and Delivery Room (LDR) 6.

2. One bottle of Similac Advance ready to use formula with the expiration date of September 1, 2013, was observed in LDR 5.

During an interview with the DWCS on October 14, 2013 at 3:37 PM, the DWCS verified that the bottles of ready to use infant formula in the Labor and Delivery Rooms were available for patient use. The DWCS verified that the above listed bottles of ready to use formula observed in LDR 5 and LDR 6 and had expired according to the manufacturer's "use by" date.

The Hospital failed to provide an active program for the prevention, control, and investigation of infections and communicable diseases that maintains a sanitary environment, when:

1. Surgical staff wore masks outside of the OR (operating room). (Refer to 749 #1.)

2. Surgical caps did not cover hair. (Refer to 749 #2.)

3. Dust was observed on a vent in the OR. (Refer to 749 #3.)

4. Endoscope (medical instrument used for diagnostic examination and surgical procedures) reprocessing steps were omitted or inadequate. (Refer to 749 #4.)
a. The alcohol flush was not in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility. (Refer to 749 #4.a.)
b. Disinfectant test strips were not used in accordance with manufactures guidelines. (Refer to 749 #4.b.)
c. Leak tests were not performed. (Refer to 749 #4.c.)
d. Endoscopes were not stored in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility. (Refer to 749 #4.d.)
e. Endoscopes were not washed in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility. (Refer to 749 #4.e.)

5. LMAs (laryngeal mask, an airway device) were not reprocessed or stored in accordance with manufacturer's guidelines. (Refer to 749 #5.)

6. Laryngoscopes (medical instrument used when examining the larynx [an organ in the neck that contains the vocal cords]) were not stored in a manner to prevent recontamination. (Refer to 749 #6.)

7. A surgical instrument marking tape was not used in accordance with manufacturer's guidelines. (Refer to 749 #7.)

The cumulative, systemic effects of these problems compromised the facility's ability to ensure the provision of quality health care in a safe environment in accordance with this Condition of Participation.

Based on observation, document review, and staff interview, the Hospital failed to maintain a system for controlling sources of infections in a universe of 191 patients, in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when:

1. Surgical staff wore masks outside of the OR (operating room).

2. Surgical caps did not cover hair.

3. Dust was observed on a vent in the OR.

4. Endoscope (medical instrument used for diagnostic examination and surgical procedures) reprocessing steps were omitted or inadequate.
a. The alcohol flush was not in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility.
b. Disinfectant test strips were not used in accordance with manufactures guidelines.
c. Leak tests were not performed.
d. Endoscopes were not stored in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility.
e. Endoscopes were not washed in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility.

5. LMAs (laryngeal mask, an airway device) were not reprocessed or stored in accordance with manufacturer's guidelines.

6. Laryngoscopes (medical instrument used when examining the larynx [an organ in the neck that contains the vocal cords]) were not stored in a manner to prevent recontamination.

7. A surgical instrument marking tape was not used in accordance with manufacturer's guidelines.

These failures had the potential to increase the risk for contamination and infections resulting in a delay in the healing process and/or a decline in health status for patients receiving surgical services in the hospital.

Findings:

1. From October 15, 2013 till October 17, 2013, during intermittent observations, 9 surgical staff were observed wearing masks, hung from the neck, outside of an Operating Room.

During an interview on October 15, 2013, at 11:42 AM, the ICP (Infection Control Preventionist), stated the facility follows AORN (Association of Perioperative Registered Nurses) for their nationally recognized infection control guidelines in the OR.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):
"A fresh, clean surgical mask should be worn for every procedure (in the OR). The mask should be replaced and discarded whenever it becomes wet or soiled.
Masks should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal (nose and throat region) airway. The contaminated mask may cross-contaminate the surgical attire top.
Surgical masks should be discarded after each procedure."

2. From October 15, 2013 till October 17, 2013, during intermittent observations, 3 surgical staff were observed wearing head cover that did not completely cover hair, including sideburns and the nape of the neck, when in surgical semirestricted and restricted areas.

During an interview on October 15, 2013, at 11:42 AM, the ICP (Infection Control Preventionist) stated the facility follows AORN (Association of Perioperative Registered Nurses) for their nationally recognized infection control guidelines in the OR.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):
"All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas.
Head coverings contain skin squames (flakes) and hair shed from the scalp. It is important to prevent shed skin squames from falling onto the sterile field. Although group A streptococcus (a type of bacteria) is isolated in less than 1% of surgical site infections, it is a serious cause of SSIs (surgical site infestions) and can be carried on the scalp.
Human hair can be a site of pathogenic (disease producing) bacteria such as MRSA (Methicillin-Resistant Staphylococcus Aureus is a bacteria that is resistant to many antibiotics).
A clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin should be worn. The head cover or hood should be designed to minimize microbial dispersal.
Hair acts as a filter when it is uncovered and collects bacteria in proportion to its length, waviness, and oiliness. Studies have shown that Staphylococcus aureus and Staphylococcus epidermidis have a tendency to colonize hair...Head coverings designed to contain hair and scalp skin will minimize microbial dispersal. Skull caps may fail to contain the side hair above and in front of the ears and hair at the nape of the neck."


3. On October 15, 2013, at 11:45 AM, during observation and concurrent interview, dust was observed on an air vent in OR #6. The ICP (Infection Control Preventionist) confirmed the presence of dust and stated that the surface should be cleaned daily.

During an interview on October 15, 2013, at 11:42 AM, the ICP stated the facility follows AORN (Association of Perioperative Registered Nurses) for their nationally recognized infection control guidelines in the OR.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013):
"The patient should be provided a clean, safe environment. Cleanliness means the absence of visible dust...

All horizontal surfaces in the OR should be damp dusted before the first scheduled surgical procedure of the day.

Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers among other things.

Growth of bacteria and fungus has been found in dust.

Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day."


4. On October 15, 2013, at 2:10 PM, during observation and concurrent interview in the Gastroenterology (referring to stomach, intestines and their associated organs) Laboratory, GI Tech 1 stated that endoscopes are initially cleaned with First Step (endoscope pre-cleaning kit) then reprocessed, and 5 mL (milliliter) of alcohol with 10-20 mL of air is manually flushed.

During an interview on October 15, 2013, at 3:18 PM, the ICP (Infection Control Preventionist) stated the facility conducts annual endoscope competency evaluation in accordance with SGNA (Society of Gastroenterology Nurses and Associates) guidelines.

On October 15, 2013, at 2:10 PM, during observation and concurrent interview in the Gastroenterology Laboratory, GI Tech 1, demonstrated cleaning of an endoscope that included the following:

Suctioned water from a small bowl then, with only the tip of the endoscope in the bowl of water, indicated that bubbles came from the tip of the endoscope and affirmed this was a leak test. Opened First Step and wiped endoscope with the First Step sponge then suctioned the fluid from the First Step package. Brushed the channels with the endoscope on top of a cart, not submerged. Suctioned water from a small bowl. Placed the endoscope in a Custom Ultrasonics endoscope reprocessor.

GI Tech 1, stated that 5-10mL of 70% isopropyl alcohol with 10-20mL of air is manually flushed through the endoscope at the end of the reprocessor cycle and that the endoscope may be reused immediately.

A leak test was not performed and the endoscope was not soaked / brushed in a detergent or enzymatic detergent.

According to document review, St. Mary Medical Center Endoscope Cultures, the last comprehensive cultures occurred November, 2010.

According to document review, Competency Checklist: Annual Position Title: GI tech, the last endoscope cleaning competency for GI Tech 1, occurred November, 2010.

a. According to Olympus (endoscope manufacturer) Instructions provided by the facility:
"Precautions. Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure the endoscope...must undergo thorough manual cleaning followed by high-level disinfection or sterilization...Be sure to perform a leakage test on the endoscope prior to manual cleaning, and do not use the endoscope if a leak is detected.
Non-sterile water rinse and alcohol flush...flush 90mL of the alcohol through the air/water and suction channels respectively..."

According to Olympus, the endoscope manufacturer, Internet-based instructions, Cleaning, Disinfection and Sterilization, Reprocessing Instructions, Alcohol Flush. 70% ethyl or isopropyl alcohol is used to promote drying of the endoscope's channels and inhibits the growth of microorganisms.

According to SGNA (Society of Gastroenterology Nurses and Associates), Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012):

According to the SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012):
"70% isopropyl alcohol is used to assist in drying the interior channel surfaces...Note that drying the endoscope after every reprocessing cycle, both between patient procedures and before storage is a requisite practice crucial to the prevention of bacterial transmission and nosocomial (originating in a hospital) infection. Drying is as important to the prevention of disease transmission and nosocomial infection as cleaning and high level disinfection."

b. On October 15, 2013, at 2:20 PM, during observation and concurrent interview, Surgical Tech 1, was observed testing the minimum effective concentration of the disinfectant solution with a test strip. Surgical Tech 1, dipped a test strip in the solution, waited 45 seconds, held it to the strength scale on the bottle of strips, and stated the disinfectant passed. The instructions on the test strips indicated that the results are to be read 90 seconds after removal from the solution.

On October 17, 2013, at 10:50 AM, during observation and concurrent interview, Sterile Processing Tech 1, was observed testing the minimum effective concentration of the disinfectant solution with a test strip. Sterile Processing Tech 1, dipped a test strip in the solution then held it to the strength scale on the bottle of strips. When asked for the time between dipping a test strip and comparing the result to the strength scale, Sterile Processing Tech 1, said the strip can be read immediately. The instructions on the test strips indicated that the results are to be read 75 seconds after removal from the solution.

c. According to St. Joseph Health, St. Mary, Policy and Procedure, Cleaning / Disinfecting of Endoscopy Equipment (Origination Date 03/1997):
"Attach the scope to the manual mechanical leak testing machine following manufacturer's instructions."

According to Olympus (endoscope manufacturer) Instructions provided by the facility:
"Leakage testing. After precleaning, perform leakage testing on the endoscope to ensure that it is waterproof. Equipment needed. Leakage tester...During leakage testing, a continuous series of air bubbles emerging from a location on the endoscope indicates a leak at that location...Fill a basin with clean water. Use a basin which is at least 40 cm by 40 cm (centimeter) in size and deep enough to allow the endoscope to be completely immersed...With the leakage tester connected, immerse the endoscope in the water and observe for approximately 30 seconds while angulating the bending section..."

According to SGNA, Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012):
"Attach the leak tester and pressurize the scope before submerging it in clear water...With the pressurized endoscope completely submerged, flex the distal portion of the scope in all directions, observing for bubbles."

On October 17, 2013, at 1:10 PM, during a phone interview with a Custom Ultrasonics (endoscope reprocessor manufacturer) representative, the representative stated that the System 83 Plus does not perform a leak test.

d. On October 17, 2013, at 10:17 AM, during observation and concurrent interview in the Gastroenterology Laboratory, endoscope light source connectors were observed in a storage cabinet in a non-vertical position.

According to SGNA, Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012):
"Endoscopes should be stored in a manner that will protect it from contamination. Hang the endoscope in a vertical position to facilitate drying...Note that drying the endoscope after every reprocessing cycle, both between patient procedures and before storage is a requisite practice crucial to the prevention of bacterial transmission and nosocomial infection. Drying is as important to the prevention of disease transmission and nosocomial infection as cleaning and high level disinfection"

According to Olympus, the endoscope manufacturer, Internet-based instructions "Cleaning, Disinfection and Sterilization. Reprocessing Instructions. Storage. The endoscope must be dry before storage. Wet equipment promotes the growth of microorganisms and presents an infection control risk. Hang the endoscope in a storage cabinet."

e. On October 17, 2013, at 8:00 AM, during a phone interview with a Cygnus Medical product representative (First Step manufacturer), the representative stated that First Step is for initial cleaning and does not replace soaking the endoscope in a detergent or enzymatic detergent and manual brushing.

On October 17, 2013, at 1:10 PM, during a phone interview with a Custom Ultrasonics (endoscope reprocessor manufacturer) representative, the representative stated that the System 83 Plus is not cleared by the FDA or endorsed by the manufacturer to replace the detergent or enzymatic detergent soak with manual brushing after bedside cleaning.

According to Olympus (endoscope manufacturer) Instructions provided by the facility:
"Detergent solution. Use a medical-grade, low-foaming, neutral pH detergent or enzymatic detergent and follow the manufacturer's dilution and temperature recommendations.
Cleaning, Disinfection and Sterilization Procedures...insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.
Manual cleaning. After completing the leakage test, perform manual cleaning...prepare the following...Detergent solution...Clean water...Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer. Use a basin which is at least 40cm by 40cm in size and deep enough to allow the endoscope to be completely immersed...Brushing the channels...To avoid splattering detergent solution when the channel cleaning brush...is pulled out, keep the endoscope submerged...Aspirating detergent solution into the instrument channel and the suction channels...aspirate detergent solution for approximately 30 seconds...Flushing detergent solution in the air/water channels...Inject 90mL of detergent solution into the air/water channel...Soaking the endoscope and all reprocessing equipment in detergent solution...Soak the endoscope and all reprocessing equipment for the amount of time and the temperature and concentration recommended by the detergent manufacturer...Place the endoscope and all reprocessing equipment in clean water and gently agitate to thoroughly rinse...Removing detergent solution from all channels...Attach the 30mL syringe to the air/water channel port of the injection tube and inject 90mL of clean water into the air/water channel."

According to Custom Ultrasonics, System 83 Plus (Washer/Disinfector) Operator's Manual, provided by the facility:
"The System 83 Plus (Washer/Disinfector) is designed to compliment, not replace, manual precleaning...A water filtration system is used."

According to SGNA, Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2012):
"Manual cleaning of endoscopes is necessary prior to automated or manual disinfection. This is the most important step in removing the microbial burden from an endoscope. Retained debris may inactivate or interfere with the capability of the active ingredient of the chemical solution to effectively kill and/or inactivate microorganisms...Fill a sink or basin with freshly-made solution of water and a medical grade, low-foaming, neutral pH detergent formulated for endoscopes that may or may not contain enzymes... Immerse the endoscope...The endoscope should be submerged in the detergent solution when performing all subsequent cleaning steps to prevent splashing of contaminated fluid and aerosolization of bioburden...Brush all accessible endoscope channels including the body, insertion tube and the umbilicus of the endoscope...After each passage, rinse the brush in the detergent solution, removing any visible debris before retracting and reinserting it... Soak the endoscope and its internal channels for the period of time specified by the label, if using an enzymatic detergent. Note: All steps should be completed sequentially and immediately following the procedure."


5. On October 16, 2013, at 12:00 PM, during observation and concurrent interview in Labor & Delivery OR #1, 4 LMAs (laryngeal mask, an airway device) were observed in a cart. An LMAs sterile peel pack was open and no LMA or its sterile peel pack indicated the date of purchase or first use, or the number of times reprocessed, confirmed by the ICP (Infection Control Preventionist).

According to St. Joseph Health, St. Mary, Policy and Procedure, Equipment, Care and Management, Peri-Operative Services (Origination Date 03/1981):
"Purpose: To render the equipment used for anesthesia free from contamination.
Wash and sterilize the following reusable items after each patient use as follows: LMA...the LMA will be removed placed in a peel sack and sealed."

According to "LMA ProSeal Instructions For Use" provided by the facility:
"Precautions: A 40-Use record card is supplied with every device to record the number and date of usage. Completion of the record card validates the warranty of the device."

"Manufacturer's Warranty: The LMA ProSeal is reusable...for forty (40) uses or a period of one (1) year from date of purchase (whichever is earlier)..."

"Warning: With proper cleaning, sterilization and handling, the LMA ProSeal can be safely used 40 times. Continued use beyond 40 uses is not recommended as degradation of the components may occur, resulting in impaired performance or abrupt failure of the device."


According to LMA North America Inc., "The 40 Use Tracking Program," (January 2004) retrieved from http://www.lmana.com/pwpcontrol.php?pwpID=6405:
"The Laryngeal Mask Company, our manufacturer, warrants reusable LMA products against manufacturing defects for 40 uses or a period of one (1) year from date of invoice, whichever comes first...Our packaging is clearly labeled in several places with a do-not-exceed 40 use symbol."


6. On October 15, 2013, at 11:45 AM, during observation and concurrent interview, an assembled and uncovered laryngoscope blade and handle (intubation [placement of a flexible plastic tube into the windpipe] supplies) was observed on top of a cart in OR #6. The ICP (Infection Control Preventionist) confirmed the assembled and uncovered laryngoscope and stated "I wouldn't expect to see this."

According to St. Joseph Health, St. Mary, Policy and Procedure, Equipment, Care and Management, Peri-Operative Services (Origination Date 03/1981):
"Purpose: To render the equipment used for anesthesia free from contamination.
Wash and sterilize the following reusable items after each patient use as follows: 1. Laryngoscope blades"

According to St. Joseph Health, St. Mary, Policy and Procedure, Care and Maintenance of Laryngoscope Blades and Handles (Origination Date 05/2013):
"Procedure: Items will then be peel packed and sterilized...
Regulatory Reference LNC-AFL-07-09"

According to LNC-AFL-07-09:
"The blade and handle should be packaged and steam sterilized unless it is contraindicated in the laryngoscope's reprocessing instructions...If the laryngoscope is to be stored prior to use, transport it to where it is to be stored, using care to prevent re-contamination and damage prior to and during storage...To avoid bacterial colonization, it is recommended that the blade and handle not be stored in a closed carrying case, container, or kit."

7. On October 15, 2013, at 12:00 PM, during observation and concurrent interview with the ICP (Infection Control Preventionist), in the sterile reprocessing area, a tray contained instruments with surgical identification tape. Creases, chips, and lifting of the tape were noted. No documented monitoring of the surgical identification tape was provided by the facility.

According to "Key Surgical Identification Tape Applications Instructions" provided by the facility:
"Overlap once...Replace when necessary."


According to "Key Surgical Identification Tape Application Instructions"

"Tape should lay flat without gaps

Inspect tape each time the instrument is processed

Replace tape when it starts to chip, flake, or lift off the instrument."

Based on interview and document reviews, the hospital failed to ensure that its grievance process resolution letters included the date that the grievance processes were completed for 5 of 5 grievances reviewed for sampled patients (Patient 22, 23, 24, 25 and 26). This failure created a risk for all patients and/or families that submitted grievances to the hospital to be dissatisfied with the actions taken on their behalf to resolve their grievances.

Findings:

On October 16, 2013, a review of the patient grievances filed by patients and/or family members related to quality of care and treatment concerns were conducted and noted the following:

a. For Patient 22, the grievance resolution letter was generated on July 8, 2013. It did not include the grievance process completion date.

b. For Patient 23, the grievance resolution letter was generated on August 6, 2013. It did not include the grievance process completion date.

c. For Patient 24, the grievance resolution letter was generated on October 10, 2013. It did not include the grievance process completion date.

d. For Patient 25, the grievance resolution letter was generated on October 7, 2013. It did not include the grievance process completion date.

e. For Patient 26, the grievance resolution letter was generated on September 16, 2013. It did not include the grievance process completion date.

On October 16, 2013 at 2:55 PM, an interview was conducted with the Director of Risk Management/Privacy Officer. The Director of Risk Management/Privacy Officer stated the hospital's practice was to generate the grievance process resolution letters on the date the grievance process was completed. She reviewed the grievance process resolution letters that were sent to Patients 22, 23, 24, 25 and 26, and confirmed that the grievance process resolution letters that were sent to the patients did not include the date that the grievance processes were completed.

A review of the hospital's policy and procedure (P&P), titled, "Handling of Patient Grievances and Complaints" , dated October 2012 was conducted. The P&P included the following:

"It is the policy of (hospital's name) to implement practices consistent with regulatory standards to manage patient concerns related to care and services they receive. It is also the organization ' s policy to assure that patient or family member grievances or complaints are communicated in a timely, reasonable and consistent manner to the appropriate departments for investigation, problem resolution and follow-up."

Processing a Grievance: 6). "The resolution letter will be sent upon completion of the investigation. The written communication will include: c). The results of the grievance process, and d). The date of the completion of the resolution."

Based on observation, interview and record review, the hospital failed to ensure that 1 of 35 sampled patients (Patient 17) had the capacity (mental ability) to make decisions to refuse or request treatment while hospitalized. The hospital allowed Patient 17 to sign consent to receive vaccinations and to accept the Conditions of Admission. This failure had the potential to result in the facility to allow any patients that did not have the capacity to receive and understand information to make informed decisions for health care.

Findings:

1a. On October 14, 2013, a review of Patient 17's medical record was conducted with the registered nurse (RN ) 7 and the Intensive Care Unit Supervisor (RN 4).

A review of the Inpatient/Outpatient Admission Record was conducted. On October 11, 2013, Patient 17 was admitted to the hospital with diagnoses that included opiate (drug) overdose and encephalopathy (a brain disease).

A review of the hospital's Conditions of Admission (COA) forms for Patient 17 was conducted. The COA forms were not signed by the patient on admission.

A review of the History and Physical (H&P) evaluation, dated October 11, 2013 was conducted. It noted that Patient 17 was awake, but not alert and oriented. The assessment also noted that the patient had altered mental status with encephalopathy suspected due to opioid overdose.

A review of the nursing admission assessment completed on October 11, 2013 at 8:18 PM was conducted. The nursing assessment noted that the patient's neurological status was not within normal limits. The Neurological Assessment documentation noted that Patient 17 had short and long term memory deficits, inconsistently followed directions, and slurred speech. The nursing staff also noted that the patient was anxious/agitated/restless.

A review of the Influenza and Pneumonia Vaccine Screening and Administration Form, dated October 11, 2013 at 10:40 PM was conducted. It showed that Patient 17 signed the document, (signing the form should indicate that the patient had the mental capacity to understand the risks, benefits and alternatives to the proposed treatment offered). Patient 17 received one dose of the Pneumococcal Polysaccharide Vaccine 0.5 (ml) milliliters, intramuscularly (administered within a muscle) on October 12, 2013 at 9:47 PM.

On October 14, 2013 at 1:55 PM, an interview was conducted with RN 7, who was Patient 17's primary nurse for the day shift (7 AM to 7 PM). She stated that the patient did not have the mental capacity to make informed decisions. RN 7 stated that the patient required a sitter (one direct care staff person at the patient's side at all times) due to the patient's statement that she heard voices that told her to harm herself.

On October 14, 2013 at 2:15 PM, an interview was conducted with the Intensive Care Unit Supervisor. When asked why the patient's COA was not completed on admission, the Intensive Care Unit Supervisor stated that Patient 17 did not have the mental capacity to make informed decisions, according to the H&P evaluation and nursing assessments that were completed on October 11, 2013. The Intensive Care Unit Supervisor stated the Patient Access Department would have the patient sign the COA forms when the patient regained the capacity to make informed decisions. She stated that the patient should not have been allowed to make an informed decision to receive the Pneumococcal Polysaccharide Vaccine.

On October 14, 2013 at 3 PM, Patient 17 was observed in bed. She had a 1 to 1 sitter at her bedside. Patient 17 was interviewed. The patient did not have the mental capacity to make her needs known.

1b. On October 18, 2013, a review of the Patient 17's COA forms were conducted with the Intensive Care Unit Supervisor. The forms were signed by the patient and witnessed by a Patient Access Department employee on October 14, 2013 at 5:30 PM.

A review of the nursing assessment, dated October 14, 2013 was conducted. The nursing assessment noted that the patient's neurological status (mental capacity) was not within normal limits.

On October 14, 2013 at 1:55 PM, an interview was conducted with RN 7, who was Patient 17's primary nurse for the day shift (7 AM to 7 PM). She stated that the patient did not have the mental capacity to make informed decisions. RN 7 stated that the patient required a sitter (one direct care staff person at the patient's side at all times) due to the patient's statement that she heard voices that told her to harm herself.

On October 18, 2013 at 11:30 AM, the Intensive Care Unit Supervisor acknowledged that Patient 17 did not have the mental capacity to make informed decisions on October 14, 2013.

On October 18, 2013 at 2:30 PM, an interview was conducted with the Manager of Patient Access Department. She stated that the employee who obtained and witnessed the patient's signature on the COA forms dated October 14, 2013 at 5:30 PM, did not verify the patient's mental capacity with a license nurse prior to obtaining the patient ' s signature.

Based on interview and record review the hospital failed to ensure that 1 of 35 sampled patients (Patient 11) had a physician ' s order for physical restraints before the patient was placed in physical restraints. This failure had the potential for all patient ' s to be placed in unnecessary restraints.

Findings:

A review of Patient 11's medical record on October 15, 2013 showed that the patient was admitted to the hospital on September 19, 2013 with diagnoses of chronic obstructive pulmonary disease (a chronic disease of the lungs causing shortness of breath and difficulty breathing) and pneumonia.

A review of the Nurse's Notes dated from October 11, 2013, showed that Patient 11 was in soft wrist restraints due to not following commands and touching his endotracheal tube (a breathing tube).

A review of the physician orders dated October 11, 2013 at 10:00 AM showed a large green sticker with check-off boxes for the physician to indicate the type of restraint and the purpose for the restraint. The sticker had a space for the physician to sign, date and time the order. In this case the physician had signed, dated and timed the restraint order sticker but did not check-off any of the boxes to indicate the type of restraint or the purpose for the restraint.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, RN 3 acknowledged that a restraint order needs to be renewed by the physician every 24 hours. RN 3 verified that the restraint order sticker dated October 11, 2013, was incomplete as the physician did not indicate with any check-off boxes the type of restraint to be used or the purpose for the restraint.

Based on interview and record review, the hospital failed to ensure that 1 of 35 sampled patients (Patient 16) had effective and timely pain management interventions. Patient 16 complained of pain on two separate occasions without a nursing intervention to ensure effective pain control. This failure had the potential for all patients that received care and services at the hospital to experience ineffective pain management. In addition, this failure had the potential to result in a delay in the healing process and/or a decline in the patients' overall health status.

Findings:

On October 15, 2013, a review of Patient 16's medical record was conducted with registered nurse (RN) 6 and RN 8. Patient 16 presented to the Emergency Department (ED) on October 14, 2013 with complaints of dizziness and an unsteady gait.

A review of the ED assessments conducted on October 14, 2013 at 5:15 PM and again at 5:48 PM, noted that Patient 16 had head pain that was rated a 6 on the 0 to 10 intensity pain scale (0 equals no pain and 10 equals worst pain possible).

A review of the physician orders was conducted with RN 6. The orders showed that the patient had pain medications (Tylenol and Norco) ordered, but they were not administered.
A review of the nursing documentation dated October 14, 2013, was conducted with RN 6 and RN 8. The documentation failed to show that the patient refused pain management interventions.

On October 15, 2013 at 1:25 PM, RN 6 and RN 8 verified that the medical record did not include documented evidence to show that pain management interventions were implemented to provide effective pain relief for the patient at 5:15 PM and/or 5:48 PM. RN 6 and RN 8 stated that Patient 16 should have been offered pain management interventions. They also stated that if Patient 16 was offered, but refused a pain relief intervention the nurses' documentation should have reflected the patient's refusal.

The hospital's policy and procedure (P&P) titled, "Pain Assessment and Management," dated December 2012, noted the following:
"To ensure caring and appropriate treatment for patients in all age groups who have pain or the potential to experience pain. " " Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." "Our approach to effective pain management for our patients is based on the ABCDE model: A). ask the patient about his/her pain frequently and assess the pain systematically. B). Believe the patient and family in their reports of pain and what relieves it. C). Choose pain control options appropriate for the patient, family and setting. D). Deliver interventions in a timely manner. E). Evaluate the effectiveness of the treatment, taking into consideration the patient's goal for pain relief and explain to patients and families that effective pain management is their right."

"Assessment- the most reliable indicator of pain is the patient's self-report. Pain assessment and documentation will occur on admission, with new onset of pain."

"Pain is assessed in all patients using scales that are appropriate to the patient's cognitive ability, cultural background, and growth and development level." 1). Adults and children greater than four years old. A). The 0-10 Intensity Scale is the scale commonly used for patients to rate their pain. 0 equals no pain and 10 equal the worst pain a patient has ever experienced."

Based on interview and record review, the facility failed to ensure that individualized nursing care plans were developed and implemented based on the patients' assessments, for 5 of 35 sampled patients (Patients 1, 2, 13, 16 and 17).

For Patients 1 and 2, the hospital failed to develop individualized nursing care plans, with interventions/approaches, based on the patients' assessments. This failure had the potential to result in, the patients to not have received the care and treatment necessary to resolve identified health concerns based on their assessments.

For Patient 13, the hospital failed to develop a comprehensive and individualized nursing care plan, with interventions/approaches, for pain. This failure had the potential for Patient 13 to not receive nursing care and interventions necessary to resolve identified pain concerns.

For Patient 16, the hospital failed to develop a plan of care that reflected the patient's pain management need that was identified when the patient presented to the hospital. This failure had the potential to contribute to ineffective pain management for the patient.

For Patient 17, the hospital failed to follow the plan of care for nutritional deficit that was identified on the patient's day of admission to the hospital. This failure had the potential for the patient's overall health status to decline.

Findings:

1. During a review of the medical record for Patient 1, on October 14, 2013, the "Admission Record" noted that Patient 1 was admitted to the hospital on October 13, 2013, with the diagnoses that included asthma (a chronic disease in which the airway becomes inflamed and narrowed restricting the passage of oxygenated air) and pneumonia (a bacterial, viral or fungal infection of one or both lungs in which the air sacs may fill with fluid or pus, causing difficulty breathing).

During a review of the medical record for Patient 1, the "Pediatric Admission Assessment" dated October 13, 2013, was completed by Registered Nurse 1 (RN 1), on October 13, 2013 at 3:00 AM. The assessment noted that Patient 1 had intercostal retractions (the muscles between the ribs as they are pulled in, when a person is having difficulty breathing), nasal flaring (the widening of the nostrils when breathing is difficult), and crackles (bubbling sounds, usually caused by fluid in the airway, that are heard within the lungs) in both lungs with wheezing (a high-pitched whistling sound associated with labored breathing). The assessment also noted that Patient 1 was pale in color and had a dry cough.

During a review of Patient 1's medical record, the care plan titled "Gas Exchange, Impaired" dated October 13, 2013, initiated by RN 1, noted the goals of "Absence of Hypoxia (a condition in which the body is deprived of oxygen)" with the target date of October 16, 2013. Further review of the care plan showed that RN 1 did not document interventions/approaches to be implemented in order to prevent the occurrence of hypoxia.

During a review of the hospital's policy and procedure titled "Documentation" dated January 1998 (revised December 2012), was reviewed on October 14, 2013. The policy and procedure noted the following:

"Patient Plan of Care:"

"Each patient will have an individualized Plan of Care, which will be initiated upon admission, based upon the nursing assessment of the patient's needs, strengths, limitations and goals, in conjunction with the medical plan."

"The Plan of Care will include, the patient's needs/problems and health care provider's approaches/solutions..."

During an interview on October 14, 2013 at 2:05 PM, with Registered Nurse 2 (RN 2) and the Pediatric Unit Manager (Manager 1), RN 2 verified that Patient 1 was admitted to the hospital on October 13, 2013 with diagnoses of asthma and pneumonia. RN 2 verified that the medical record included a nursing care plan for the problem of "Gas Exchange, Impaired" that did not include interventions.

RN 2 and Manager 1 stated the care plan should have included interventions. RN 2 verified that the care plan should have been updated and/or reviewed by any licensed staff caring for Patient 1, based on the patient's status.

2. During review of the medical record for Patient 2, on October 14, 2013, the "Admission Record" noted that Patient 2 was, admitted to the hospital on October 13, 2013, with the diagnosis of bronchitis (inflammation of the airway passages between the nose and the lungs, caused by a respiratory infection or exposure to an irritant).

During a review of the medical record for Patient 2, the " Pediatric Admission Assessment " dated October 13, 2013 at 9:00 PM, was completed by RN 1. The assessment noted that Patient 2 had nasal congestion with thick yellow secretions.

During a review of Patient 2's medical record, the nursing care plan titled "Airway Clearance, Ineffective" dated October 13, 2013, noted the goals of "Lung Sounds Return to Baseline", with the target date of October 14, 2013. Further review of the nursing care plan showed that there was no documented evidence of interventions/ approaches that would be implemented to achieve the goal.

During further review of the medical record, the nursing care plan titled "Gas Exchange, Impaired " dated October 13, 2013, initiated by RN 1, noted the goals of "Absence of Hypoxia" manifested by the absence of cyanosis (bluish coloring of the skin due to the lack oxygen in the blood stream) and having a blood oxygenation levels within normal limits. The target date on the care plan was October 14, 2013. Further review of the care plan showed there was no documented evidence of interventions/ approaches that would be implemented to achieve the goals.

During an interview on October 14, 2013 at 2:20 P.M., with RN 2 and Manager 1, RN 2 verified that Patient 2 was admitted to the hospital on October 13, 2013 with the diagnosis of bronchitis. RN 2 verified that the medical record showed that RN 1 had nursing care plans for the problems of "Airway Clearance, Ineffective" and "Gas Exchange, Impaired" , that were initiated on October 13, 2013. RN 2 verified that the nursing care plans had no documented interventions/approaches as of October 14, 2013 at 2:20 P.M. RN 2 and Manager 1 verified that the nursing care plans should have documented interventions/approaches towards resolving the identified problems.



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3. During review of the medical record for Patient 13, on October 14, 2013, the Admission Record noted that Patient 13 was admitted to the hospital on October 7, 2013, with the diagnoses that included chest pain and congestive heart failure (a condition in which the heart cannot pump enough blood to the rest of the body).

During a review of the medical record for Patient 13, the Electronic Medication Administration Record (eMAR) dated October 9, 2013 at 11:57 AM, noted that Patient 13 had leg pain, rated as an 8 (the intensity pain scale of 0 to 10, with 0 being no pain and 10 being the worst pain). Patient 13 was given morphine sulfate 2 milligrams, intravenous (in the vein) pain medication. Further record review of the eMAR, dated October 9, 2013 at 4:01 PM, and noted that Patient 13 had generalized pain based on the patient ' s non-verbal behavior, no pain scale used. Patient 13 was given a second dose of morphine sulfate 2 milligrams, intravenous (in the vein) pain medication.

During a review of Patient 13's medical record noted that there was no nursing care plan specific for pain management, with no interventions/approaches addressing the problem of pain.

During an interview on October 14, 2013 at 2:05 PM, with Registered Nurse 9 (RN 9) and the Chief Nursing Officer (CNO) verified that an identified patient problem should have documented a nursing care plan with individualized interventions/approaches. RN 9 verified that there was no specific nursing care plan regarding Patient 13's complaints of pain.



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4. On October 15, 2013, a review of Patient 16's medical record was conducted with Registered Nurse (RN) 6 and RN 8. Patient 16 presented to the Emergency Department (ED) on October 14, 2013 with complaint

Based on interview and record review, the hospital failed to ensure that 8 of 35 sampled patients (Patients 8, 9, 10, 11, 12, 13, 19 and 20), in a universe of 191, had all of their physician orders authenticated (with the name, date and time) of the ordering practitioner, within 48 hours. This failure had the potential for errors in transcription and the potential to affect the patients ' treatment and safety.

Findings:

Record review, on October 14, 2013, of the hospital's medical staff bylaws, dated December 14, 2011 noted the "...basic responsibilities of medical staff membership...include...2.5.4: preparing and completing in timely fashion, medical records for all the patients to whom the member is responsible for providing care in the hospital;..."

1. A review of Patient 12's physician orders on October 14, 2013 at about 3:00 PM, showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 10, 2013 at 7:00 PM an order for potassium and intravenous (into the vein) fluids.

October 11, 2013 at 5:00 PM an order for an orthopedic consultation of both knees, rheumatology consult of both knees and a change to the intravenous medications.

October 11, 2013 at 7:00 PM an order to discontinue use of the indwelling urinary catheter (a tube in the bladder), laboratory tests, change the drip rate of TPN (total parenteral nutrition) and begin a soft diet.

In an interview with RN 5 on October 14, 2013 at 3:25 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

2. A review of Patient 13's physician orders on October 14, 2013 at about 1:45 PM showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 9, 2013 at 5:20 PM an order for discontinued use of the indwelling urinary catheter and a consultation with a urologist.

October 12, 2013 at 4:16 PM an order for continued use of medications.

In an interview with RN 9 on October 14, 2013 at 1:45 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

3. A review of Patient 19's physician orders on October 16, 2013 at about 11:00 AM showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 12, 2013 at 8:00 PM an order for an injection of medication.

In an interview with RN 10 on October 16, 2013 at 11:20 AM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

4. A review of Patient 20's physician orders on October 16, 2013 at about 10:30 AM showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 9, 2013 at 7:59 PM an order for medication to be given on an as needed basis.

October10, 2013 at 5:00 PM an order for blood sugar checks and for an injection of insulin.

In an interview with RN 11 on October 16, 2013 at 10:50 AM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.



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5. A review of Patient 10's physician orders on October 14, 2013 showed the following verbal/telephone orders that were not signed, dated or timed by the physician within 48 hours:

October 11, 2013 at 2:40 AM an order to discontinue an intravenous (into the vein) medication.

October 11, 2013 at 10:45 AM an order titled "Medication Titration Order Set".

October 10, 2013 at 5:50 PM an order titled "Medication Titration Order Set."

October 10, 2013 at 6:15 AM an order intravenous medication.

In an interview with RN 4 on October 14, 2013 at 3:50 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

6. A review of Patient 8's physician orders on October 15, 2013 showed the following verbal/telephone orders that were signed by the physician but not dated or timed when the physician signed the orders:

October 12, 2013 at 8:30 AM an order for intravenous fluids and medications, to cancel the nasogastric tube and to hold all oral medications.

October 12, 2013 at 5:40 PM an order for laboratory tests and a blood transfusion.

In an interview with RN 4 on October 14, 2013 at 3:50 PM, she acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

7. A review of Patient 9's physician orders on October 15, 2013 showed the following verbal/telephone orders that were signed by the physician but not dated or timed when the physician signed the orders:

October 12, 2013 at 4:00 PM an order for intravenous fluids and diabetic medication.

October 12, 2013 at 6:19 AM an order for a consult and diabetic medication.

October 12, 2013 at 8:30 AM an order for blood sugar checks, laboratory tests and a Dietician consult.

Further review of Patient 9's physician verbal/telephone orders showed the following orders that were not signed, dated or timed within 48 hours:

October 11, 2013 at 9:35 AM an order for potassium and intravenous fluids.

October 12, 2013 at 7:30 PM an order for oral fluids and potassium.

October 12, 2013 at 10:20 PM an order for an intravenous medication.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, he acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

8. A review of Patient 11's physician orders on October 15, 2013 showed the following verbal/telephone orders that were signed by the physician but not dated or timed when the physician signed the orders:

October 7, 2013 at 9:30 PM an order form titled "Adult Pre-Op CABG Pre-Printed Orders."

October 8, 2013 at 6:50 PM an order to discontinue an intravenous medication.

October 8, 2013 at 7:00 PM an order form titled "Medication Titration Order Set."

October 8, 2013 (no time) an order form titled "Adult-ICU Post-Thoracotomy (incision into the chest) Pre-Printed Orders."

October 8, 2013 at 10:00 AM an order to obtain the patient's consent for a procedure.

October 8, 2013 at 11:40 AM an order to change a central line (a long tube placed in a large vein).

October 8, 2013 at 9:30 AM an order to hold a medication due to possible surgery.

October 11, 2013 at 10:30 AM an order for a laboratory test and a change in the patient's ventilator (breathing machine) settings.

October 11, 2013 at 10:45 AM an order to return to the previous ventilator settings.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, he acknowledged that the physician orders should be signed, dated and timed within 48 hours by the physician.

Based on interview and record review the hospital failed to ensure that 1 of 35 sampled patients (Patient 11) had a medical history and physical completed and documented in the medical record 24 hours after the patient's admission to the hospital. This failure had the potential to result in the patient's care team providing care that was not indicated or harmful for the patient's medical conditions.

Findings:

A review of Patient 11's medical record on October 15, 2013, showed that the patient was admitted to the hospital on September 19, 2013, with diagnoses of chronic obstructive pulmonary disease (a chronic disease of the lungs causing shortness of breath and difficulty breathing) and pneumonia.

A review of Patient 11's History and Physical showed that the physician dictated the report on September 23, 2013, 4 days after the patient was admitted.

In an interview with RN 3 on October 15, 2013 at 12:20 PM, RN 3 acknowledged that the physician's History and Physical was not dictated and documented within 24 hours of the patient's admission and should have been.

A review of the hospital's Medical Staff Bylaws approved on December 14, 2011 showed the following under "Basic Responsibilities of Medical Staff Membership":

"2.5.4 preparing and completing in timely fashion medical records for all the patients to whom the member is responsible for providing care in the hospital;..."

Based on interviews and record review, the hospital failed to ensure a complete and accurate medical record was maintained for 1 of 35 sampled patients (Patient 19). This failure had the potential to affectthe health and safety of the patient.

Findings:

During a record review, on October 16, 2013, of Patient 19 ' s medical record noted that the patient underwent two invasive procedures (a part of the body is entered with a puncture or incision) on October 5, 2013, performed by a physician. An arterial line was inserted (a thin catheter inserted into an artery to monitor the blood pressure) and a Quinton catheter was inserted (a catheter for temporary access for dialysis or infusion of medicine).

Further record review of Patient 19 ' s medical record noted that there was no physician's documentation of the October 5, 2013 procedures.

A record review, on October 16, 2013, of the hospital's medical staff bylaws, dated December 14, 2011 noted the "...basic responsibilities of medical staff membership...include...2.5.4 preparing and completing in timely fashion, medical records for all the patients to whom the member is responsible for providing care in the hospital;..."


During an interview, on October 17, 2013 at 1:10 pm, with the Chief Nursing Officer (CNO), she verified that there was no physician's procedure note regarding the October 5, 2013 arterial line insertion and the Quinton catheter insertion.

Based on interview and record review, the hospital failed to ensure that only authorized personnel had access to the automated drug delivery system. The system, PYXIS, contained routine medications and controlled medications, such as narcotics. The hospital failed to follow its policy and procedure to remove three employees who no longer worked for the hospital. This failure had the potential for all licensed staff, who no longer work for the hospital, to access medications, including controlled medications and had the potential for drug diversion to occur in the hospital.

Findings:

In an interview with the Pharmacy Director (PD) on October 17, 2013 at approximately 9:50 AM, the PD stated that he receives an e-mail from Human Resources listing any employees that were terminated. The PD stated that the pharmacy department was responsible to deactivate in the PYXIS the employees ' names that no longer work for the hospital.

A review on October 17, 2013, of the list of "Users" for the hospital's automated drug delivery system, PYXIS, was reviewed and compared with a list of terminated employees.

The comparison of the two lists showed that there were three employees who were active in the PYXIS list that were no longer working at the hospital.

In an interview with the Pharmacy Manager (PM) on October 18, 2013 at 10:20 AM, the PM stated that she would have to check on the employee names to see if the three former employees were still active.

In a follow-up interview with the PM on October 18, 2013 at 2:10 PM, she acknowledged that there were three employees that should have been deactivated in the PYXIS users list.


In a review of a hospital policy and procedure titled
"Termination/Resignation" with an effective date of May 2012 showed the following under "Procedure" section:

"...The department director or designee should insure (ensure):
h. Completes Pyxis User Addition/Deletion/Modify Request and submits to Pharmacy to request deletion of Pyxis user access."

In a review of a hospital policy and procedure titled "Pyxis Med-Stations Anesthesia Machines" with an origination date of September 2000 showed the following under "Professional Codes " :

"3. Maintenance and entry of user IDs and user privileges will be performed by Pharmacy.

5. Pharmacy is notified of terminations for code removal by Human Resources."

Based on observation and interview, the hospital failed to ensure that 2 of 10 Labor and Delivery Rooms did not have expired ready to use infant formula. This failure had the potential to result in a decrease in the nutritive value resulting from the ingesting of formula past the manufacturer's "use by" calendar date.

Findings:

During a general tour of the Labor and Delivery Unit on October 14, 2013 at 3:10 PM with Director of Women and Child Services (DWCS), the following was observed:

1. Six bottles of Enfamil Premium Newborn Ready to Use Formula with the expiration date of October 1, 2013, were observed in Labor and Delivery Room (LDR) 6.

2. One bottle of Similac Advance ready to use formula with the expiration date of September 1, 2013, was observed in LDR 5.

During an interview with the DWCS on October 14, 2013 at 3:37 PM, the DWCS verified that the bottles of ready to use infant formula in the Labor and Delivery Rooms were available for patient use. The DWCS verified that the above listed bottles of ready to use formula observed in LDR 5 and LDR 6 and had expired according to the manufacturer's "use by" date.

The Hospital failed to provide an active program for the prevention, control, and investigation of infections and communicable diseases that maintains a sanitary environment, when:

1. Surgical staff wore masks outside of the OR (operating room). (Refer to 749 #1.)

2. Surgical caps did not cover hair. (Refer to 749 #2.)

3. Dust was observed on a vent in the OR. (Refer to 749 #3.)

4. Endoscope (medical instrument used for diagnostic examination and surgical procedures) reprocessing steps were omitted or inadequate. (Refer to 749 #4.)
a. The alcohol flush was not in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility. (Refer to 749 #4.a.)
b. Disinfectant test strips were not used in accordance with manufactures guidelines. (Refer to 749 #4.b.)
c. Leak tests were not performed. (Refer to 749 #4.c.)
d. Endoscopes were not stored in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility. (Refer to 749 #4.d.)
e. Endoscopes were not washed in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility. (Refer to 749 #4.e.)

5. LMAs (laryngeal mask, an airway device) were not reprocessed or stored in accordance with manufacturer's guidelines. (Refer to 749 #5.)

6. Laryngoscopes (medical instrument used when examining the larynx [an organ in the neck that contains the vocal cords]) were not stored in a manner to prevent recontamination. (Refer to 749 #6.)

7. A surgical instrument marking tape was not used in accordance with manufacturer's guidelines. (Refer to 749 #7.)

The cumulative, systemic effects of these problems compromised the facility's ability to ensure the provision of quality health care in a safe environment in accordance with this Condition of Participation.

Based on observation, document review, and staff interview, the Hospital failed to maintain a system for controlling sources of infections in a universe of 191 patients, in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and applicable regulations, when:

1. Surgical staff wore masks outside of the OR (operating room).

2. Surgical caps did not cover hair.

3. Dust was observed on a vent in the OR.

4. Endoscope (medical instrument used for diagnostic examination and surgical procedures) reprocessing steps were omitted or inadequate.
a. The alcohol flush was not in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility.
b. Disinfectant test strips were not used in accordance with manufactures guidelines.
c. Leak tests were not performed.
d. Endoscopes were not stored in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility.
e. Endoscopes were not washed in accordance with manufacturer's guidelines or nationally recognized infection control and prevention guidelines adopted by the facility.

5. LMAs (laryngeal mask, an airway device) were not reprocessed or stored in accordance with manufacturer's guidelines.

6. Laryngoscopes (medical instrument used when examining the larynx [an organ in the neck that contains the vocal cords]) were not stored in a manner to prevent recontamination.

7. A surgical instrument marking tape was not used in accordance with manufacturer's guidelines.

These failures had the potential to increase the risk for contamination and infections resulting in a delay in the healing process and/or a decline in health status for patients receiving surgical services in the hospital.

Findings:

1. From October 15, 2013 till October 17, 2013, during intermittent observations, 9 surgical staff were observed wearing masks, hung from the neck, outside of an Operating Room.

During an interview on October 15, 2013, at 11:42 AM, the ICP (Infection Control Preventionist), stated the facility follows AORN (Association of Perioperative Registered Nurses) for their nationally recognized infection control guidelines in the OR.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):
"A fresh, clean surgical mask should be worn for every procedure (in the OR). The mask should be replaced and discarded whenever it becomes wet or soiled.
Masks should not be worn hanging down from the neck. The filter portion of a surgical mask harbors bacteria collected from the nasopharyngeal (nose and throat region) airway. The contaminated mask may cross-contaminate the surgical attire top.
Surgical masks should be discarded after each procedure."

2. From October 15, 2013 till October 17, 2013, during intermittent observations, 3 surgical staff were observed wearing head cover that did not completely cover hair, including sideburns and the nape of the neck, when in surgical semirestricted and restricted areas.

During an interview on October 15, 2013, at 11:42 AM, the ICP (Infection Control Preventionist) stated the facility follows AORN (Association of Perioperative Registered Nurses) for their nationally recognized infection control guidelines in the OR.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Surgical Attire (2013):
"All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas.
Head coverings contain skin squames (flakes) and hair shed from the scalp. It is important to prevent shed skin squames from falling onto the sterile field. Although group A streptococcus (a type of bacteria) is isolated in less than 1% of surgical site infections, it is a serious cause of SSIs (surgical site infestions) and can be carried on the scalp.
Human hair can be a site of pathogenic (disease producing) bacteria such as MRSA (Methicillin-Resistant Staphylococcus Aureus is a bacteria that is resistant to many antibiotics).
A clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin should be worn. The head cover or hood should be designed to minimize microbial dispersal.
Hair acts as a filter when it is uncovered and collects bacteria in proportion to its length, waviness, and oiliness. Studies have shown that Staphylococcus aureus and Staphylococcus epidermidis have a tendency to colonize hair...Head coverings designed to contain hair and scalp skin will minimize microbial dispersal. Skull caps may fail to contain the side hair above and in front of the ears and hair at the nape of the neck."


3. On October 15, 2013, at 11:45 AM, during observation and concurrent interview, dust was observed on an air vent in OR #6. The ICP (Infection Control Preventionist) confirmed the presence of dust and stated that the surface should be cleaned daily.

During an interview on October 15, 2013, at 11:42 AM, the ICP stated the facility follows AORN (Association of Perioperative Registered Nurses) for their nationally recognized infection control guidelines in the OR.

According to the AORN, Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013):
"The patient should be provided a clean, safe environment. Cleanliness means the absence of visible dust...

All horizontal surfaces in the OR should be damp dusted before the first scheduled surgical procedure of the day.

Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers among other things.

Growth of bacteria and fungus has been found in dust.

Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day."


4. On October 15, 2013, at 2:10 PM, during observation and concurrent interview in the Gastroenterology (referring to stomach, intestines and their associated organs) Laboratory, GI Tech 1 stated that endoscopes are initially cleaned with First Step (endoscope pre-cleaning kit) then reprocessed, and 5 mL (milliliter) of alcohol with 10-20 mL of air is manually flushed.

During an interview on October 15, 2013, at 3:18 PM, the ICP (Infection Control Preventionist) stated the facility conducts annual endoscope competency evaluation in accordance with SGNA (Society of Gastroenterology Nurses and Associates) guidelines.

On October 15, 2013, at 2:10 PM, during observation and concurrent interview in the Gastroenterology Laboratory, GI Tech 1, demonstrated cleaning of an endoscope that included the following:

Suctioned water from a small bowl then, with only the tip of the endoscope in the bowl of water, indicated that bubbles came from the tip of the endoscope and affirmed this was a leak test. Opened First Step and wiped endoscope with the First Step sponge then suctioned the fluid from the First Step package. Brushed the channels with the endoscope on top of a cart, not submerged. Suctioned water from a small bowl. Placed the endoscope in a Custom Ultrasonics endoscope reprocessor.

GI Tech 1, stated that 5-10mL of 70% isopropyl alcohol with 10-20mL of air is manually flushed through the endoscope at the end of the reprocessor cycle and that the endoscope may be reused immediately.

A leak test was not performed and the endoscope was not soaked / brushed in a detergent or enzymatic detergent.

According to document review, St. Mary Medical Center Endoscope Cultures, the last comprehensive cultures occurred November, 2010.

According to document review, Competency Checklist: Annual Position Title: GI tech, the last endoscope cleaning competency for GI Tech 1, occurred November, 2010.

a. According to Olympus (endoscope manufacturer) Instructions provided by the facility:
"Precautions. Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient