HospitalInspections.org

26611

Based on interview and record review, the hospital's governing body failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Program reflected the complexity of the hospital's organization and services. The QAPI Program did not develop indicators to review contract services to ensure they were safe, effective, and provided services which facilitated the hospital's compliance with all applicable conditions of participation and standards for the contracted services.

Findings:

On 3/29.16 at 10 am, the hospital's Quality Improvement Plan was reviewed with the Director of Quality Assurance (DQA). The plan read, "The Board (of Trustees, GB) will also receive and evaluate reports from the Administration and Medical Staff who have responsibility to address the quality of patient care and safety through the organization."

When asked to review the quality program for contracted services, DQA stated that they had not yet develop indicators for the contracted services.

On 3/30/16 at 9:30 am, the Chief Executive Officer confirmed that they had not developed a quality program to measure the safety and effectiveness of contracted services.

26611

Based on interview and record review, the hospital's governing body failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Program reflected the complexity of the hospital's organization and services. The QAPI Program did not develop indicators to review contract services to ensure they were safe, effective, and provided services which facilitated the hospital's compliance with all applicable conditions of participation and standards for the contracted services.

Findings:

On 3/29.16 at 10 am, the hospital's Quality Improvement Plan (QIP) was reviewed with the Director of Quality Assurance (DQA). The QIP read, "The Board (of Trustees, GB) will also receive and evaluate reports from the Administration and Medical Staff who have responsibility to address the quality of patient care and safety through the organization."

When asked to review the quality program for contracted services, DQA stated they had not yet develop indicators for the contracted services.

On 3/30/16 at 9:30 am, the Chief Executive Officer confirmed that they had not developed a quality program to measure the safety and effectiveness of contracted services.

Based on observation, interview, and record review, the facility failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice as evidenced by:

1. Hospital policies for the safe administration of medication to infants were not followed for nine of ten medication doses reviewed. (Patients 45, 46, and 47) Refer to A 450, finding, 1a-c.

2. Medication administration policies for patient controlled analgesia (PCA, allows a patient to administer small amounts of pain medication through the vein as needed) were not followed for the monitoring of two of two sampled PCA patients. (Patients 4 and 5). Refer to A 405, finding 2 a-b.

3. Pain reassessments were not done for two of two patients reviewed requiring as needed (prn) pain medication. (Patients 1 and 6) Refer to A 405, findings 3 a-b.

4. Hospital policies for the safe administration of intravenous (IV - through the vein) insulin (for controlling blood sugar) was not followed for one of one sampled IV insulin patient. (Patient 7) Refer to A 405, finding 4.

5. Medications were handled with bare hands during medication administration for one of three patients. (Patient 2) Refer to A 749, finding 8.

6. Medications were administered without proper hand hygiene for one of three patients observed during medication administration. (Patient 1) Refer to A 749, finding 9.

The cumulative effect of these systemic problems had the potential to compromise the health of patients, cause injury or harm to patients due to inaccurate patient assessments, cross contamination, infection, and improper medication preparation and administration; and resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Nursing Services.

25755

Based on observation, interview and record review facility failed to implement policies and procedures for safe administration of drugs and monitoring of patients when:

1. Independent double checks were not performed for 9 of 10 pediatric doses administered to newborn infants. This failure had the potential for medication errors to adversely impact an infant's health.

2. PCA (patient controlled analgesia; it allows a patient to self-administer small amounts of pain medications through the vein as needed) monitoring was not done for two of two sampled patients (Patients 4 and 5) in accordance with hospital policy. This failure had the potential of not detecting serious adverse effects from medications including over sedation and respiratory depression.

3. Pain reassessment was not done for two of two sampled patients (Patients 1 and 6) after treating with as needed pain medication. This failure had the potential of exposing patients to continued discomfort and pain.

4. Independent double checks were not done on IV (intravenous, injected through the vein) insulin (for controlling blood sugars) infusions for one sampled patient (Patient 7) per facility policy. This failure had the potential of exposing patients to medication errors leading to low blood sugars and coma.

Findings:

1. On 3/30/16, a review of five patient records was conducted.

a. Patient 1's medical record was reviewed. Patient 1's date of birth was 3/25/16. The medical record indicated he was given an injection of aquamephyton (Vitamin K - given to newborn babies for blood clotting. It is given to prevent a serious disease called hemorrhagic disease of the newborn), erythromycin eye ointment (erythromycin, an antibiotic to prevent a newborn's eyes from being infected with gonorrhea), and a Hepatitis B vaccine.

On 3/30/16 at 10:36 am, during a concurrent interview and record review the obstetrical (OB) Clinical Coordinator was asked to locate the documentation that a second licensed staff member verified the pediatric doses before they were administered. After reviewing the medical record, the OB Clinical Coordinator stated "It's not documented."

b. Patient 2's medical record was reviewed. Patient 2's date of birth was 3/28/15. The medical record indicated he was given an injection of aquamephyton and erythromycin eye ointment.

On 3/30/16 at 10:36 am, during a concurrent interview and record review the OB Clinical Coordinator was asked to locate the documentation that a second licensed staff member verified the pediatric doses before they were administered.

A record titled, "Newborn Interdisciplinary Plan of Care/Flowsheet was reviewed. Above the date and times the two medications were administered, was a space for two signatures. The space for the verification by another licensed staff was blank. The Clinical Coordinator verified that there was no documentation that the pediatric doses were verified before they were administered to Patient 2.

c. Patient 3's medical record was reviewed. Patient 3's date of birth was 3/26/16. The medical record indicated he was given an injection of aquamephyton, erythromycin eye ointment, and an injection of hepatitis B vaccine.

During an interview conducted with the Clinical Coordinator of OB on 3/30/16 at 10:36 am, she verified that the hepatitis B vaccine had documentation that the pediatric dose was verified prior to administration, but the erythromycin eye ointment and the aquamephyton had not.

Patient 4's medical record was reviewed. Patient 4's date of birth was 3/29/16. The medical record indicated she was given an injection of aquamephyton and a dose of erythromycin eye ointment.

A record titled, "Newborn Interdisciplinary Plan of Care/Flowsheet was reviewed. Above the date and times the two medications were administered, was a space for two signatures. The space for the verification by another licensed staff was blank.

The Clinical Coordinator verified that there was no documentation that the pediatric doses of the aquamephyton or the erythromycin eye ointment were verified before they were administered to Patient 4.

A hospital policy and procedure titled, "High Alert Medication Management, dated 2/16, was reviewed. The Purpose of the policy indicated that "Some medications have an increased risk of causing harm when used in error. This policy is to help bring awareness to these medications and reduce the risk of error from occurring.

Procedure: The following are categories of medications and specific medications that require special precautions in handling during all phases of medication management processes, which may include, but are not limited to ... employing independent double checks when necessary: Pediatric dose."

A second hospital policy and procedure titled, "Bar Code Medication Administration", with a revision date of 2/2016, was reviewed. The purpose is to define policies and procedures to assure the safe administration of medication and to delineate the persons and circumstances under which they are administered within the hospital.

"Witnessing of high risk and pediatric medications will be done visually and compared to the prescribed order in Bar Code Medication Administration. Documentation not will reflect licensed staff's electronic signature/initial to this witness.

"High Alert Medications Requiring Double-Check Co-Signatures:
Pediatric Dosages".

On 3/30/16 at 10:43 am, OB Registered Nurse (RN) 1 was interviewed. She was asked what the procedure was for administering medications to infants. OB RN 1 stated that she scanned the baby's medications, and identification, verified that it was the correct medication, and verified the medication with another nurse. The expectation was that we were supposed to verify the dosages routinely, it was done in the Electronic Medical Record. OB RN 1 reviewed the Newborn Interdisciplinary Plan of Care/ Foresheet for Patient 2. The medications were given two days ago. The verifying signature was blank. "I can't tell you why I didn't do it with that one."


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31580

2a. Review of Patient 4's clinical record with RN Mgr C, indicated that Patient 4 was admitted to the hospital on 3/8/16, and her physician orders, dated 3/9/16, included Dilaudid (hydromorphone a narcotic for pain) PCA with a continuous rate of 0.12 milligram (mg)/hour and a demand dose (dose when patient self-administers) of 0.1 mg.
Review of hospital policy "Patient Controlled Analgesia," dated 8/2013, indicated "Vital signs are to be every hour x (for) 4 hours, and then every 4 hours and more frequently as needed. Respirations and sedation score will be recorded on the vital sign sheet every 2 hours."
Review of Patient 4's PCA record indicated that the Dilaudid PCA was initiated on 3/9/16 at 7:50 pm Patient 4's respiration rate, sedation scale and pain score after initiating the PCA were recorded on 3/10/16 at 6:20 am (over 10 hours later).

During an interview on 3/29/16 at 1:50 pm RN Mgr C confirmed that Patient 4's respiration and sedation were not monitored per policy.

Dilaudid carries a boxed warning which is the strongest warning the Food and Drug Administration (FDA) requires a manufacturer to put on a drug, the warning indicated that Schedule II opioid agonists, including Dilaudid have the highest potential for abuse and risk of producing fatal overdose due to respiratory depression.

ISMP, Institute of Safe Medication Practice article titled, "Fatal PCA adverse events continue to happen. Better patient monitoring is essential to prevent harm" dated 5/10/13, indicated, "Hospitals may want to monitor patients more frequently at night, as opioid-induced respiratory depression is more common between midnight and 6 am"

2b. Review of Patient 5's clinical record along with RN Mgr C, indicated that he was admitted to the hospital on 3/18/16 and his physician orders, dated 3/19/16, included Dilaudid PCA with a continuous rate of 0.25 mg/hour and a demand dose of 0.25 mg.

Review of Patient 5's PCA record indicated that the Dilaudid PCA was initiated on 3/19/16 at 2:40 pm. Patient 5's respiration rate, sedation scale and pain score after initiating the PCA were recorded on 3/19/16 at 6:45 pm (4 hours later). The next set of respiration and sedation was documented on 3/20/16 at 4:35 am (10 hours later) and then at 5:40 pm (13 hours later).

During an interview on 3/29/16 at 1:50 pm, RN Mgr C confirmed that Patient 5 was not monitored per policy of every hour for 4 hours an then every 2 hours for respiration and sedation.

3a. Review of Patient 6's clinical record indicated that he was admitted to the facility on 2/23/16 for trauma to the leg. Patient 6's physician orders included Dilaudid 1mg IV on 2/23/16 and increased to 1.5 mg on 2/24/16 every 3 to 4 hours as needed.

Review of the facility policy, "Pain Management," dated 6/2015, indicated "IV and IM medications will have a reassessment after 30 minutes using the "PRN (as needed) effectiveness in BCMA (Bar Code Medication Administration)."

Review of Patient 6's BCMA with RN Mgr C indicated the following doses of Dilaudid were not reassessed after 30 minutes for effectiveness:

- 2/23/16 at 5:32 pm, and 9:02 pm

- 2/24/16 at 12:15 am, 4:19 am, 8; 29 pm, 12:19 am, and 3:35 am

During an interview on 3/29/16 at 10:44 am, RN Mgr C confirmed that Patient 6's above mentioned pain reassessments were not done per policy.

3b. Review of Patient 1's clinical record indicated that she was admitted to the facility on 3/26/16 and her physician orders included Dilaudid IV 0.5mg and 1 mg every 4 hours as needed for pain.

Review of Patient 1's BCMA indicated Dilaudid 1 mg was administered on 3/27/16 at 3:20 am and a reassessment was done at 4:57 am (1.5 hours later) at which point the pain score was documented as 9 (pain scale of 0-10 where 10 being the worst pain).

The following administrations were also not reassessed per policy:

- Dilaudid 0.5 mg administered on 3/28/16 at 8:59 am and reassessed at 10:43 am

-Dilaudid 0.5 mg administered on 3/28/16 at 9:39 pm and reassessed at 11 pm per nurses note and not documented in BCMA per policy.

-Dilaudid 0.5 mg administered on 3/29/16 at 7:52 am and reassessed at 8:59 am.

- Dilaudid 0.5 mg administered on 3/29/16 at 11:58 am and reassessed at 1:58 pm.

During an interview on 3/29/16 at 9:48 am, RN Mgr C acknowledged that Patient 1's pain reassessments were not done after 30 minutes of as needed pain medication as per policy.

4) Review of Patient 7's clinical record indicated that she was admitted to the facility on 2/27/16 and her physician orders dated 2/28/16 included IV insulin infusion (100 units of regular insulin in 100 milliliters of saline solution) per protocol.

Review of Patient 7's insulin infusion flowsheet from the Intensive Care Unit (ICU) indicated that no independent double checks were documented on initiation of the insulin infusion and during rate changes.

During an interview on 3/29/16 at 2:20 pm, RN Mgr C confirmed the lack of double checks on the insulin infusion for Patient 7.

In an interview on 3/29/16 at 2:25 pm, RN Mgr E stated that it was the standard practice amongst nurses not to do double checks for IV insulin infusion on initiation or during rate changes. RN Mgr E stated that double checks were only done on shift changes.

Review of the facility policy, "High Alert Medication Management," dated 2/2016, indicated that insulin IV was identified as a high alert medication. The policy indicated "High alert medications are drugs that have an increased risk of causing significant harm to a patient when used in error. Because of the consequences of an error associated with use of these medications can result in significant patient injury, special precautions shall be employed with their overall management throughout the institution."

Review of the facility policy, "Bar Code Medication Administration (BCMA)," dated 6/2015, indicated "High Alert Medications Requiring Double-Check Co-Signatures ... Insulin."

Based on interview and document review, the hospital failed to ensure that a medical history and physical examination (H&P) were completed and documented no more than 30 days prior to surgery in three of 27 medical records reviewed. (Patients 30, 31, and 35) This failure placed patients at risk for surgical complications.

Findings:

On 3/29/16, review of the hospital's medical staff rules and regulations, Section II F (i), approved 10/27/15, demonstrated the requirement that an H&P shall be completed and documented "(dictated or entered into the hospital's electronic health record system)" for each patient no more than 30 days before surgery or a procedure requiring anesthesia services.

On 3/29/16, review of hospital policy: History and Physical Documentation Requirements (10/2015) demonstrated that it included the statement, under Procedure, Section 1.d., that an H&P that has been documented over 30 days prior to an admission, invasive procedure or surgery does not meet the requirement for a current H&P and cannot be updated with an interval note. A new H&P was required.

1. Review of Patient 30's record on 3/30/16 at 10:30 am, demonstrated that the preoperative H&P was completed and documented on 2/22/16, 37 days before surgery on 3/30/16.

2. Review of Patient 31's record on 3/30/16 at 10:30 am, demonstrated that the preoperative H&P was completed and documented on 2/22/16, 37 days before surgery on 3/30/16.

3. Review of Patient 35's record on 3/30/16 at 11:00 am, demonstrated that the preoperative H&P was completed and documented on 2/23/16, 36 days before surgery on 3/30/16.

In interview on 3/30/16 at 12:45 pm, Administrative Nurse A acknowledged that the three patients under discussion had been admitted to the procedure room despite the H&P requirements not having been met.


25755

Based on observation, interview, document and record review, the facility failed to ensure policies and procedures were developed and implemented for distribution and control of drugs to ensure patient safety when:

1. Fentanyl (opioid or narcotic for pain) patch order that was contraindicated for one of five sampled patients (Patient 3) was not evaluated appropriately by pharmacy staff. This failure had the potential of exposing the patient to respiratory depression and death.

2. The list of drugs for the malignant hyperthermia (MH, an inherited muscle disorder triggered by certain drugs including succinylcholine and volatile anesthetics that may cause a fast-acting life-threatening crisis) cart did not indicate the location of chilled saline or insulin (to reduce potassium levels in the body).

3. Three emergency crash carts (containing medications and supplies for life threatening emergencies) were observed without a list of contents posted on the outside.

These failures (2 and 3) had the potential of preventing caregivers from quickly finding and using drugs required for resuscitating patients during a medical emergency.

Findings:

1) Review of Patient 3's clinical record with nurse manager (RN Mgr) C indicated that she was admitted to the facility on 2/26/16, with a diagnosis of severe degenerative arthritis (breakdown of cartilage in the joints leading to painful inflammation). Patient 3's list of home medications indicated that she was taking Tylenol (for pain) and ibuprofen (for pain and inflammation).

Review of Patient 3's physician orders dated 2/26/16, indicated an order for hydromorphone (opioid for pain) 0.5 milligrams (mg) every 6 hours as needed and a Fentanyl 12 mcg (micrograms)/hour transdermal (via the skin) patch every 72 hours. Review of Patient 3's medication administration record indicated that Fentanyl 12 mcg patch was administered on 2/26/16 to the right upper arm.

Fentanyl patch is a high potency opioid used for pain and has a boxed warning which is the strongest warning the FDA (food and drug administration) can require a pharmaceutical company to place on the labeling of a prescription drug, or in literature describing it. Following is part of the boxed warning: "Respiratory depression and death may occur with use of Fentanyl transdermal system, even when Fentanyl transdermal system has been used as recommended and not misused or abused ... Fentanyl transdermal system is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including ..., use in non-opioid tolerant patients."

The manufacturer package insert defines opioid tolerance as "Tolerance to an opioid of comparable potency must be established before prescribing Fentanyl transdermal system ... Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine (an opioid) daily, or at least 30 mg of oral Oxycodone (an opioid) daily, or at least 8 mg of oral hydromorphone daily or an desquamates (narcotic equivalence) dose of another opioid for a week or longer."

During an interview on 3/29/16 at 11:45 am, the Director of Pharmacy (DOP) acknowledged that Patient 3 was opioid naïve. DOP stated that there was no intervention noted in Patient 3's record that the pharmacist evaluating the order established opioid tolerance or followed up with the physician with concerns of Patient 3 being opioid naïve.

In an interview on 3/30/16 at 9:10 am, the DOP stated that there was nothing in the CPOE (computerized physician order entry) that prompted the physicians to evaluate opioid tolerance in a patient before ordering a Fentanyl patch. DOP also stated that there was nothing in the pharmacy program that required opioid tolerance evaluation. DOP stated that other boxed warning drugs had also not been entered into CPOE but they will be working on them.

Review of the facility policy, "Provider Medication Orders" indicated "The pharmacist will contact the provider when clarification of a medication order is needed."

Review of the facility policy, "Black Box Warning," dated 2/2016, indicated "The Pharmacy Director shall receive and review notification of package insert change for any medication, medication-related device or biological. Upon receipt of a change or update to a medication, medication-related device or biological the Pharmacy Director shall ...ensure that any information related to the medication is updated into the hospital's clinical information system. "

2. On 3/28/16 at 1:20 pm tour of the PACU (post anesthesia care unit) showed an emergency cart that was identified by RN Mgr C as the MH cart. The list of drugs on the MH cart did not include the location of chilled saline and insulin.

In a concurrent interview, RN Mgr C indicated the hospital followed MHAUS (Malignant Hyperthermia Association of the United States).

Review of MHAUS crisis management indicated "Cool the patient (using chilled saline) if core temperature is >39°C or less if rapidly rising. Stop cooling when the temperature has decreased to < 38°C."

3. On 3/28/16 at 12:10 am, an adult and a pediatric emergency crash cart was observed in the emergency room (ER) There was no list of contents posted on the outside. In a concurrent interview, ER manager, RN Mgr F confirmed there was no contents list on the adult and pediatric crash carts.

On 3/28/16 at 11:30 am, an adult emergency crash cart was observed in the Intensive Care Unit (ICU) without a contents list on the outside cover. In a concurrent interview, RN Mgr F acknowledged that there was no contents list for the cart on the outside cover.

Review of the facility policy, "Emergency Medicine: Crash Carts," dated 2/2016 indicated, "The contents shall be listed in a log on top of the cart ... "

31580

Based on observation, interview and document review facility failed to ensure that drugs were stored appropriately and unusable drugs were not available for use when:

1) Six expired anesthesia kits (for drug storage) and expired eye drops were stored in the Same Day Surgery department (SDS) medication room.

2) Insulin (to control blood sugars) vials and pens (a method of insulin administration) were stored out of the refrigerator, without a use by date, not in accordance with manufacturer storage instructions and facility policy.

These failures had the potential of exposing patients to contaminated drugs.

Findings:

1. On 3/28/16 at 1:30 pm, an observation of the SDS department medication storage room showed a locked cabinet. In a concurrent interview, the nurse manager RN Mgr B stated that the cabinet contained kits used by anesthesia department for procedures such as endoscopy (a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube).

The contents of the locked cabinet contained six kits with expired drugs in them with expiration dates ranging from 3/1 to 3/9/16. The expired drugs included propofol (anesthetic), succinylcholine and Rocuronium (paralytic agents use in anesthesia), Ketorolac (for pain and inflammation).

In a concurrent interview, Registered Nurse Manager (RN Mgr) B confirmed the drugs in the anesthesia kits were expired.

Review of the pharmacy monthly inspection log for SDS indicated that an inspection was conducted by the pharmacy on 3/7/16 but the expired kits were not identified during the inspection.

Review of the facility policy, "Storage of Pharmaceuticals," dated 12/2015, indicated, "All medication areas shall be devoid of outdated, discontinued, or recalled drugs."

Observation of the SDS medication room refrigerator showed an expired bottle of Tropicamide (used for dilating the eye for examination) with a use by date of 2/18/16. In a concurrent interview RN Mgr B confirmed that the eye drops were expired.

2. On 3/28/16 at 11:50 am, the medication storage room in nursing unit MedSurg 2 was observed. The room contained small containers numbered with patient rooms that were identified by RN Mgr C as cassettes containing patient specific medications. The contents of the cassettes included two Lantus (insulin) pens and two Humalog (insulin) vials that were stored without a use by date. In a concurrent interview, RN Mgr C acknowledged that the insulins were not dated after removing them from the refrigerator.

Review of the manufacturer specifications for Lantus and Humalog storage indicated to store unopened pens and vials in the refrigerator and opened pens and vials could be stored at room temperature for up to 28 days.

Review of the facility policy, "Insulin Glargine (Lantus Solostar prefilled pen)," dated 12/2015, indicated, "Unopened Lantus Solostar Pens will be stored in the refrigerator. Open Lantus Solostar Pens labeled for patient use may be stored in the patient medication cart for up to 28 days."

Review of the facility policy, "Storage of Pharmaceuticals," dated 12/2015, indicated, "A beyond use date, in accordance with the manufacturer guidelines, will be placed on the medication when it is removed from the refrigerator."

28773

Based on interview and record review, the hospital failed to:

1) Ensure that the nutritional needs of two sampled patients (Patients 51 and 52) were met in accordance with recognized dietary practices. This failure had the potential to negatively impact the medical condition for these patients; and

2) Ensure that the patient menus met the nutrition needs of the patients. This failure had the potential to result in constipation and under nutrition in a medically vulnerable patient population.

Findings:

1. Review of the hospital policy and procedure, titled, "Nutrition Assessments," revised 5/2014, indicated a nutrition assessment was completed to determine the patient's current nutritional status, identify nutritional problems/diagnoses, determine appropriate nutrition interventions and goals and then monitor/evaluate the effectiveness of those interventions.

Review of the hospital's policy and procedure for nutrition assessment and prioritization guidelines, revised 5/14, indicated high nutrition risk (priority 1) will be assessed in one to three days for patients with primary diagnosis including renal failure - critically ill, NPO (nothing by mouth)/ clear liquids greater than or equal to five days, albumin less than 2.4 grams (g) per deciliter (dL) (normal is 3.4 to 5.4 g/dL). It stated for patients with moderate nutrition risk they will be assessed within three to five days and mild nutrition risk from five to seven days. It indicated the progress note for high nutrition risk will be one to three days after assessment, four to six days for moderate risk, and six to eight days for mild risk. It indicated the reassessment time frames for high risk is six to eight days from initial assessment for high risk or six to eight days from progress note for moderate and mild risk.

Review of the hospital's policy and procedure, titled, "Nutrition Reassessments," revised 3/2012, indicated the nutrition reassessment was completed to evaluate the patient's response to nutrition interventions.

a. Clinical record review was conducted for Patient 51. Patient 51 was admitted to the intensive care unit (ICU) in the hospital on 3/3/16 with diagnoses that included anascara (widespread swelling of the skin usually caused by renal failure/disease, liver failure, severe malnutrition/protein deficiency), end stage renal disease, Diabetes Mellitus, and hypertension. Patient 51 was in the intensive care unit (ICU) until 3/26/16, 23 days.

Review of the Nutrition Assessment, dated 3/10/16 (seven days after Patient 51 was admitted to the ICU), indicated Patient 51 had been on and off NPO since admission and has not received many trays of regular foods. Patient 51 had a poor appetite, tired and did not feel like eating. Patient 51 was requesting beverage type things to drink and was a little hesitant regarding supplements and would trial them. The Registered Dietitian (RD) indicated the diet order of consistent carbohydrate renal dialysis was restarted that day and the oral intake was 0-25% (percent) for three meals (only meals documented as patient had been +/- NPO since admission). The RD indicated the nutrition diagnosis was Nutrition Risk related to multiple procedures, decreased appetite as evidenced by decreased energy intake. Inadequate oral intake related to poor appetite as evidenced by documented oral intake of meals. The RD indicated the nutrition interventions/recommendations were a nutrition supplement (Nepro) three times a day, nephrovite (vitamin/mineral supplement) once a day, and obtained food/diet preferences and would provide accordingly. The RD indicated the goals/monitoring and evaluation was to meet Patient 51's nutrient needs via diet order and nutrition supplements and oral intake greater than 65% of meals and drinking 2-3 supplements.

Review of the Nutrition progress note dated 3/16/16 (six days after the Nutrition Assessment), indicated a renal dialysis, consistent carbohydrate (CCD), pureed diet and Nepro three times a day. The RD indicated the oral intake was 0-10% documented and the patient's wife stated about 25% a few meals as well. The RD indicated the patient does not drink the Nepro and discussed changing to health shakes. The RD indicated they will fortify the oatmeal and cream soups and that the wife planned to bring in some food from home and would pureed it. The RD indicated Patient 51 was with continued inadequate oral intake and will continue pureed texture. The RD indicated the nutrition interventions to change to sugar free health shakes (chocolate three times a day) and fortify meals.

Review of the Nutrition Reassessment note, dated 3/22/16 (Six days after the Nutrition progress note), the RD indicated oral intake was improving, but still poor. The RD indicated the patient dislikes the health shakes but enjoys the hot cereal and cream soups, likes puddings and will eat a little yogurt. The RD indicated the patient was on a CCD standard, renal dialysis, dysphagia mechanical soft diet with sugar free health shakes three times a day and fortified. The RD indicated the oral intake was 23% meals and trending up. The RD indicated the patient had lost 74 pounds since admission, if weights were accurate. The RD indicated the nutrition diagnosis of inadequate oral intake was improving, but not resolved. The RD interventions indicated to continue fortified meals and to discontinue health shakes and will provide food preferences. The RD goals/monitoring & evaluation indicated to meet patient's nutrient needs via the diet order.

Review of the Nutrition Progress Note, dated 3/29/16 (seven days after the Nutrition Reassessment note), indicated oral intake had improved to 76% times five meals. The RD indicated they were planning on discharging the patient once they found a bed. The RD indicated the nutrition diagnosis of inadequate oral intake was improving, but not resolved.

On 3/30/16 at 10:20 am, an interview was conducted with the Registered Dietitian (RD). The RD stated once a patient was receiving an oral diet they were considered to be at moderate nutrition risk even if they were eating very poor. The RD acknowledged they should follow up to see if their nutrition inventions were working after they initiate them before six days. On 3/30/16 at 10:30 am, an interview was conducted with the Director of Nutrition and Environmental Services (DNEVS). The DNEVS acknowledged that this patient was high risk and should have been seen more frequently.

The RD provided a copy of a reference article in which their policy was based, however it only addressed the characteristics for malnutrition and not a professional standard of practice to indicate where the time frames come from to be seen by the RD. It was unclear why Patient 51 was not seen for a nutrition assessment in 1-3 days with a diagnosis of a new end stage renal disease in the ICU when the policy stated renal failure critically ill.

The Nutrition Department was monitoring a quality indicator to see if patients were being seen according to policy however there was no evaluation in relationship to see if the policy met the patient's nutritional needs.

b. A clinical record review of Patient 52 was conducted. Patient 52 was admitted to the hospital on 3/21/16, with diagnoses that included nausea, vomiting, end stage renal disease, diabetic ketoacidosis (DKA), protein calorie malnutrition.

The Nutrition Initial Assessment dated 3/24/16 indicated Patient 52 was NPO for three days with inadequate nutrition since admission. The RD indicated the nutrition diagnosis for nutritional status was severe inflammatory protein malnutrition related to acute disease state as evidenced by albumin less than 2.4. Problem #1 was inadequate intake for protein energy related to vomiting, dysphagia (difficulty swallowing) as evidenced by NPO status. Problem #2 was altered nutrition related laboratory values finger stick blood glucose related to DKA as evidenced by finger stick blood glucose results (92-300 milligrams per dL). The RD indicated to defer nutrition interventions due to NPO status. The RD indicated the goals were to monitor progression of diet past clear liquids by 3/28/16.

On 3/30/16 at 11:10 am, an interview was conducted with the RD and the DNEVS regarding Patient 52. The RD stated the patient should have been seen on 3/28/16 to see how the diet was being tolerated and she was not sure what happened since her papers said 3/28/16 then another paper on another floor said 3/30/16. The DNEVS acknowledged the RDs needed to document on the patients more frequently and ensure the nutrition needs of the patients were being met.

No professional standard of practice was provided to show where the policy time frames were based on during the survey.

2. A review of the hospital's nutrition analysis of the patient menus showed that for the regular diets, it met on average 56% of the Dietary Reference Intakes (DRIs) for dietary fiber. The DRIs are published by the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences and serve as the standard of practice in menu planning. For Potassium the menu met 66% of the DRIs. For Magnesium the menu met 63% of the DRIs. For Vitamin D the menu met 40% of the DRIs. Review of the hospital diet manual for the regular diet, dated reviewed on 4/11, indicated the diet was adequate in all nutrients according to the DRIs.

For the mechanical soft diets, it met on average 49% of the Dietary Reference Intakes (DRIs) for dietary fiber. For Potassium the menu met 50% of the DRIs. For Magnesium the menu met 53% of the DRIs. For Calcium the menu met 80% of the DRIs. For Vitamin B6 it met 76% of the DRIs. For Vitamin D the menu met 36% of the DRIs. Review of the hospital diet manual for the mechanical soft diet, dated reviewed on 4/11, indicated the diet was adequate in all nutrients according to the DRIs.

For the cardiac diets, it met on average 59% of the Dietary Reference Intakes (DRIs) for dietary fiber. For Magnesium the menu met 71% of the DRIs. For Vitamin D the menu met 37% of the DRIs. Review of the hospital diet manual for the cardiac diet, dated reviewed on 4/11, indicated the diet was designed to be heart healthy and therefore was high in fiber and adequate in all nutrients.

For the consistent carbohydrate diets, it met on average 57% of the Dietary Reference Intakes (DRIs) for dietary fiber. For Potassium the menu met 75% of the DRIs. For Magnesium the menu met 77% of the DRIs. For Vitamin D the menu met 55% of the DRIs. Review of the hospital diet manual for the consistent carbohydrate diet, dated reviewed on 4/11, indicated the diet was adequate in all nutrients according to the DRIs.

During an interview with the Director of Nutrition and Environmental Services (DNEVS) on 3/29/16 at 2 pm, DNEVS verified that the menus did not meet the above DRIs. DNEVS stated she was aware about the fiber, but not the potassium and magnesium. DNEVS was not sure why the potassium and magnesium were not being met with the variety in the menu and thought maybe it was an error in calculating the nutrients and they would need to look into it. DNEVS acknowledged the menus should be meeting the DRIs.

25755




26611

Based on observation, interview and record review, the hospital failed to ensure that two pieces of operating room (OR) equipment had preventative maintenance inspections annually. This failure had the potential to cause patient harm.

Findings:

On 3/21/16 at 9:15 am, a tour of the peri-operative unit was performed. A tourniquet system was present and had an inspection tag that indicated preventative maintenance was last performed on 7/2014. A solution warmer was present and had no evidence of an annual preventative maintenance inspection.

Records from the contracted service that performed the maintenance checks were reviewed and did not demonstrated checks were performed in 2015 or 2016.

In a concurrent interview, the OR Manager acknowledged that these two pieces of equipment required annual preventative maintenance checks.

28020

Based on observation, interview, and document review, the hospital failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases in a universe of 162 patients. The infection control program failed to meet the needs of all patients and staff as evidenced by failure to:

1. Provide a substantial infection Control Program to ensure effective systems were in place to provide an environment to avoid sources and transmission of infections communicable disease when the hospital failed to ensure all staff were offered all California State required immunizations. Refer to A 749, finding 1.

2. The hospital failed to provide a functional and sanitary environment for the provision of patient services who received services which required the use of a vaginal transducer (a probe used in the vagina to visualize organs within the pelvic cavity). The hospital failed to properly clean and disinfect vaginal probes according to the manufacturers guidelines and in a manner that protected the lives and assured the physical safety of patients who required these services. Refer to A 749, finding 2.

3. Cubicle curtains were not laundered according to nationally recognized standards. Refer to A 749, finding 3.

4. Surgical equipment and instruments were stored in the Interventional Radiology (surgeries done under x-ray guidance) unit without monitoring and maintaining the temperature and humidity to nationally accepted standards.

5. Expired alcohol based hand rub was found in the delivery room and available for use.

6. The soiled utility room was not equipped with personal protective equipment designed to protect staff from exposure to potentially infectious materials.

7. Laboratory staff did not follow contact precautions that resulted in contamination of a cart containing several laboratory supplies. Refer to A 749, finding 7.

8. Registered nurses failed to use proper infection prevention techniques during medication administration. Refer to A 749, findings 8 and 9.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the Condition of Participation for Infection Control Services.

25755

4. On 3/28/16 at 3:50 pm, an observation of the interventional radiology (IR, surgeries done under x-ray guidance) department was conducted. In the observation room, several drawers containing sterile surgical instruments were observed. There was no thermometer observed in the room.

In a concurrent interview on 3/28/16 at 4:09 pm, the IR RN was asked if the temperature and humidity was monitored in the room containing the surgical instruments. The IR RN stated "No".

The AORN 2016 edition of Guidelines for Perioperative Practice was reviewed.

Recommendation III

Items to be sterilized should be cleaned, decontaminated, inspected, packaged, sterilized, and stored in a controlled environment and in accordance with the AORN Guideline for Cleaning and Care of Surgical Instruments and the device manufacturer's validated and written instructions for use.

A controlled environment is intended to facilitate effective decontamination, assembly, sterilization, and storage and to minimize environmental contamination and maintain sterility of sterilized items.

III.c. Room temperature, humidity, and ventilation must be controlled and monitored in accordance with local, state, and federal policy and regulation.

Monitoring and recording environmental controls in each area will assist in verification that minimum recommended parameters are met and maintained and will identify when corrective action needs to be taken.

Table 2, "Parameters for Controlled Environments During Sterilization" for Clean/sterile storage indicate the environment's airflow should be positive pressure, have a minimum of 4 air exchanges per hour, stored at 75 degrees Fahrenheit or less, and in 70% or less humidity.

On 10/29/16 at 10:45 am, an interview was conducted with the IP. (IPs specialize in recognizing, isolating, and preventing healthcare-associated infections that impact patient outcomes and the safety of healthcare professionals and adhere to nationally recognized infection prevention and control precautions).

During the interview, the IP was asked if she had any over site in regards to how the interventional radiology department was storing their sterile instruments. The IP stated that she had no involvement in the storage of the instruments.

5) On 3/28/16 at 10:50 am, two bottles of expired hand sanitizer were observed in a room marked "delivery room" in the obstetrics (OB) department. Obstetrics refers to the branch of medicine that specializes in care of women before, during and after childbirth.

One bottle had an expiration date of 5/15 and the second bottle had an expiration date of 6/15. Both bottles were mounted on the wall and available for use in a patient care area.

In a concurrent interview with the Nurse Manager of Critical Care Services, the Nurse Manager verified that the hand sanitizers had expired nine months ago and were currently available for use.

6) On 3/28/16 at 9:10 am, the soiled utility room on Unit 2 was observed with the Nurse Manager of Critical Care Services. (A soiled or dirty utility room is where contaminated patient care items, equipment, or bodily fluids are handled, disposed of, or stored). The soiled utility room contained trash cans with lids, a hopper (a clinical sink that is frequently located in a soiled utility room used for disposal of body fluids and liquids), a box of head covers, and gloves. No other PPE such as masks, gowns, or eye protection was observed.

On 3/28/16 at 9:13 am, in an interview with the Nurse Manager of Critical Care Services, she stated that cabinets were put up in every soiled utility room to store personal protective equipment (PPE). (PPE is designed to protect the wearer's skin, eyes, mucous membranes, airways, and clothing from coming into contact with infectious agents). When the NM of Critical Care Services opened the PPE cabinet it was empty.

The Nurse Manager was asked if there was any eye protection for the staff. She stated, "evidently not."

The OSHA regulations for personal protective equipment was reviewed. Occupational Safety and Health Administration (OSHA) is a federal organization (part of the Department of Labor) that ensures safe and healthy working conditions for Americans by enforcing standards and providing workplace safety training.

Application. Protective equipment, including personal protective equipment for eyes, face, head, and extremities, protective clothing, respirator devices, and protective shields and barriers, shall be provided, used, and maintained in a sanitary and reliable condition whenever is is necessary by reason of hazards of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation or physical contact.

7) On 3/28/16 at 10:23 am, during a concurrent observation with the Nurse Manager of Critical Care Services in the critical care unit, laboratory (Lab) staff A wheeled a small cart containing supplies such as test tubes, syringes, tape etc., used by laboratory personnel to draw blood specimens from patients, to a room of a patient in contact isolation. The Lab Staff A put on a gown and a pair of gloves. Lab Staff A gathered some supplies from the cart and entered the contact isolation room. (Contact Isolation Precautions are used for patients with infections, diseases, or germs that are spread by touching the patient or items in the room).

Lab Staff A entered the room and placed the supplies on the patient's bed. Lab Staff A was observed touching and positioning the patient's right arm. Lab Staff A walked over to the entrance of the room and without removing her PPE, she opened the drawer to the supply cart which was located outside of the room near the door and reached into the open drawer. Lab Staff A then reached up and touched supplies on the top of the cart as she was looking for supplies.

On 3/28/16 at 10:23 am, the Nurse Manager of Critical Care Services was interviewed. When asked if she observed Lab Staff A touching the supply cart wearing her contaminated PPE. The Nurse Manager of Critical Care Services stated, "I know, I saw the same thing. She touched everything in the tray at least four times now."

On 3/30/16 at 11:50 am, the Infection Preventionist (IP) was interviewed. The IP was asked if she had heard about the incident that was observed in which a staff member from the lab had handled her clean supplies with her contaminated PPE. The IP acknowledged she knew about the incident. The IP was asked what her expectation would be to prevent cross contamination of the cart in order to get the needed supplies. The IP stated, "They are supposed to bring in everything they need. If they need additional supplies, they need to ask for them."

The Centers for Disease Control and Prevention's (CDC) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings was reviewed.

I.B.3.a.ii. Indirect contact transmission: Hands of healthcare personnel may transmit pathogens (germs) after touching an infected or colonized body site on one patient or a contaminated inanimate object.

III.B.1. Contact Precautions: Healthcare personnel caring for patients on Contact Precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient's environment, donning (means to put on) PPE upon room entry and discarding before exiting the patient room is done to contain pathogens, especially those that have been implicated in transmission through environmental contamination.



29643





26611




28020

Based on observation, interview and record review, the hospital failed to develop and implement measures to govern the identification, prevention and control of infections and communicable diseases, when:

1. The hospital failed to provide a substantial Infection Control (IC) Program to ensure effective systems were in place to provide an environment to avoid sources and transmission of infections & communicable disease when the hospital failed to ensure that ten of ten sampled employees were offered all California State required immunizations.

2. The hospital failed to provide a functional and sanitary environment for the provision of patient services, which required the use of a vaginal transducer (a probe used in the vagina to visualize organs within the pelvic cavity). The hospital failed to properly clean and disinfect vaginal probes according to the manufacturers guidelines and in a manner that protected the lives and assured the physical safety of patients who required these services.

3. Decontamination of hospital textiles was not performed according to nationally recognized guidelines.

4. Sterile instruments were not being stored according to AORN guidelines. (Association of periOperative Registered Nurses guidelines provides nursing education, standards, and clinical practice resources to enable optimal outcomes for patients undergoing operative and other invasive procedures).

5. Expired alcohol based hand rub was found in the delivery room and available for use.

6. The soiled utility room was not equipped with personal protective equipment designed to protect staff from exposure to potentially infectious materials.

7. Lab staff did not follow contact precautions that resulted in contamination of a cart containing several laboratory supplies

8. Registered nurse (RN) 2 handled one of three patients' (Patient 2) tablets (2) with bare hands during medication administration.

9. RN 3 did not perform hand hygiene prior to reconstituting (mixing) a Protonix (to reduce stomach acid) IV (intravenous, injected through the vein) injection for one of three sampled patients (Patient 1).

These failures had the potential to result in the hospital's inability to protect, patients, families and workers from potentially harmful infectious exposures or outbreaks, in a universe of 162 patients.

Findings:

1. During review and a concurrent interview on 3/29/16 at 1:15 pm, with the hospital's Human Resource Director (HR Director), 11 of 11 employee files were reviewed (a Sterile Central Technician, an RN on Medical Unit 1, an Operating Room {OR} Charge RN, Director of Infection Control & Employee Health (IP), Endoscopy Licensed Vocational Nurse (LVN), Radiology Technician, Perioperative (OR) Charge Nurse, and three Environmental Services (EVS) Staff A, B, and C) The HR Director was unable to show written evidence to demonstrate the employees had complete vaccination records.

a. The Sterile Central Technician did not have records of the MMR immunization ([MMR - measles, mumps, rubella] {measles a viral infection of the respiratory system characterized by a rash; mumps an acute viral infection characterized by inflammation of the parotid gland; rubella a contagious viral infection that is characterized by a rash}).

b. The RN for Medical Unit 1 did not have records of the following immunizations: tDap ((Tetanus (a serious illness caused by bacteria that can enter the body through a deep cut) Diphtheria (a serious bacterial infection), and Pertussis (commonly known as Whooping Cough, an infectious bacterial disease that causes uncontrollable coughing and did not have MMR (measles, mumps, rubella) (measles a viral infection of the respiratory system characterized by a rash; mumps an acute viral infection characterized by inflammation of the parotid gland; and rubella a contagious viral infection that is characterized by a rash.

C. The OR Charge RN did not have records of the MMR immunization.

D. The IP's file did not complete records showing evidence that she received the mumps immunization or declined it.

E. The Endoscopy LVN's file did not have records of the MMR , tDap or Varicella (chicken pox) immunizations.

F. The Radiology Technician's employee health file did not contain records to show that she received or declined the influenza vaccine (flu shots).

G. EVS Staff B and C's files did not contain records to show that they received or declined the tDap or mumps immunizations.

H. EVS Staff A's file did not contain records to show she received or declined the tDap.

I. EVS staff C's file failed to have evidence of a complete hepatitis B vaccine series or a declination.

During an interview on 3/29/16, at approximately 3 pm, the IP verified the findings and stated that they did not require their employees to obtain the mumps immunization, and that the 11 employee files did not have complete record of their immunizations. IP also stated that the facility had adopted the Centers for Disease Prevention and Control (CDC) as one of the facility's nationally recognized infection control standards.

During a previous interview (on 3/28/16 at 11:25 am) with the IP, she indicated that she was not aware of the California's mandated healthcare worker law, which required employers to make available to all susceptible healthcare workers with occupational exposure all vaccine doses, including mumps.

During a review of the facility policy (provided by the IP on 3/30/16 at 10:35 am, titled, "Immunizations of Health Care Worker," revised on 11/15), referenced "CDC guideline for Infection Control in Healthcare Personnel, Sept. 1998". The policy stipulated, "Prior to beginning an assignment with {name of hospital}, a health screening/review will be required to determine the workers protection from or infection status of certain diseases. The health screening may include: Documentation of immune status for Rubella (German measles), Rubeola (Measles), Varicella, Hepatitis B, and Tetanus Toxoid, reduced Diphtheria Toxoid and Acellular Pertussis Vaccine {tDap} ..."

The CDC stated that those who work directly with patients or handle material that could spread infection should get appropriate vaccines to reduce the chance that they will get or spread vaccine-preventable diseases. The CDC further stated that healthcare workers include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff.

a. Employee health policies and procedures did not follow the facility adopted, nationally recognized CDC guidelines for immunizations of health care workers that state:

i. (recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace (i.e. hepatitis B, seasonal influenza, measles, mumps, rubella, pertussis, and varicella)

ii. Healthcare personnel should receive a single dose of Tdap (a vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, that prevents the diseases of Diphtheria, Tetanus and Whooping Cough) as soon as feasible upon hire if they have not been vaccinated previously.

Healthcare organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter.

For current California requirements, "Cal. Code Regulations, title 8, paragraph 5199, relating to 'aerosol transmissible diseases'. Cal. Code Regs. tit. 8, § 5199(h)(5) requires employers to make available to all susceptible healthcare workers with occupational exposure all vaccine doses listed in Appendix E. Doses listed in Appendix E include seasonal influenza vaccine, measles, mumps, and rubella vaccine, varicella vaccine, and tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Employers are required to ensure that employees who decline to accept a recommended and offered vaccination sign the declination statement in Appendix C1 for each declined vaccine. This regulation applies to hospitals, skilled nursing facilities, clinics, medical offices and other outpatient medical facilities, among others. Outpatient medical facilities whose policy is not to diagnose or treat aerosol transmissible diseases are not required to comply with this standard if they meet certain other conditions ..."

2. An observation was conducted of room 1 of the hospital's Ultrasound Department on 3/28/16 at 2:15 pm, with the IP. Radiology Technician (Rad Tech) A who was present in the department, was asked to demonstrate how the hospital provided high level disinfecting (a method used to kill vegetative bacteria, tubercle bacillus, fungi, lipid and nonlipid virus) of the vaginal probes, a semi-critical instrument (items that contact mucous membranes).

During the same observation, a concurrent interview was conducted with the Rad Tech A. She proceeded to open a cabinet door located under a sink, which housed a clear plastic container, (not dated or labeled) filled with 'Cidex OPA' solution (a high level disinfectant {HLD}, per Rad Tech A). The container had no lid, was uncontained and was exposed to the environment. The following demonstration was observed being performed by Rad Tech A:

1. Test strip was inserted in the Cidex OPA solution for 1 second and read immediately prior to the HLD.

2. The test strip container was not dated to show when it was originally opened.

3. According to Rad Tech A, after the probe was immersed for 20 minutes in the HLD, it was rinsed once with tap water and was then ready for use and wrapped in a towel. The solution was changed out every 14 days.

4. There was no timer or thermometer used for processing the vaginal probe.

5. According to Rad Tech A, they did not use Personal Protective Equipment (PPE) other than gloves and no logs were kept to record the cleaning process.

During the same observation, the IP was asked to produce a hospital policy for the HLD of vaginal probes and the use of the Cidex OPA solution. IP indicated that they did not have one specific to the probes or the Cidex solution.

According to the manufacturer, Cidex OPA was a high-level disinfectant (HLD) used in reprocessing heat sensitive medical devices such as vaginal probes. According to the manufactures guidelines, Cidex OPA provided HLD in 5 minutes at 25 degrees Celsius (77 degrees Fahrenheit) in a legally marked reprocessor or at room temperature (20 degrees Celsius/68 degrees Fahrenheit) for manual processing.

According to the manufacturer:

"DIRECTIONS FOR USE

Device Cleaning/decontamination

Blood, other body fluids, and lubricants must be thoroughly cleaned from the surfaces and lumens of medical devices before reprocessing in the disinfectant. Blood and other body fluids should be autoclaved and disposed of according to all applicable federal, state and local regulations for infectious waste disposal.

Refer to the reusable device manufacturer's labeling for instructions on disassembly, decontamination, cleaning and leak testing of their equipment.

Before immersion in CIDEX OPA solution, thoroughly clean devices, including lumens, as per SgnA guidelines. Thoroughly rinse and rough dry all surfaces and lumens of cleaned devices.

CIDEX OPA SOLUTION USAGE

No activation is required.

Record the date the container was opened on the container label, or in a log book. After opening, the solution remaining in the container can be used for up to 75 days does not extend past the expiration date listed on the container until used.

Record the date the solution was poured out of the original container into a secondary container in a log book (separate from the one mentioned above), or on a label affixed to the secondary container. The solution is the secondary container can be used for a period up to 14 days. The product must be discarded after 14 days even if the CIDEX OPA test strip indicates a concentration above the Minimum Effective Concentration (MEC).

High-Level Disinfection

1. Manual Processing:

* Immerse device completely, filling all lumens and eliminating air pockets, in CIDEX OPA Solution for a minimum of 12 minutes at 20degrees Celsius or higher to destroy all pathogenic microorganisms'... "

Other manufacturer guidelines included to thoroughly rinse the semi-critical medical device by immersing it completely in a large volume (e.g. two gallons) of water, keeping the device completely immersed for a minimum of one minute, manually flush all lumens with large volumes (not less than 100 ml) of rinse water, remove the water and discard the rinse water and always use fresh volumes of water for each rinse. The process was to be repeated two additional times for a total of three rinses, with large volumes of fresh water to remove CIDEX OPA solution residues.


31580

8. On 3/29/16 at 8:30 a.m. RN 2 was observed administering 10 medications to Patient 2 including docusate (stool softener) and aspirin (blood thinner). RN 2 was observed opening the packaging of docusate and aspirin into her bare hands and then transferring them into a plastic cup. RN 2 then handed the plastic cup to Patient 2 who then swallowed the medications with water.

During an interview on 3/29/16 at 8:40 am, RN 2 stated that the docusate was slippery and she touched it to avoid losing it.

In an interview on 3/29/16 at 8:45 am, RN Manager (Mgr) C stated that it was not an acceptable practice to touch patient medications with bare hands and if the nurse was to touch the medications she should have worn gloves.

9. On 3/29/16 at 8:54 a.m. RN 3 was observed preparing and administering medications to Patient 1.

RN 3 was observed removing medications from the facility automated dispensing cabinet including a vial of Protonix injection. RN 3 then went into the medication storage room and reconstituted the Protonix injection with saline solution. RN 3 did not sanitize or wash hands before reconstituting the injection.

During an interview on 3/29/16 at 3:35 pm, RN Mgr C stated that hand hygiene should be performed before mixing drugs.

Review of the facility policy, "IV Mixing," dated 9/2015, indicated, "Procedure: Mixing by Nursing Personnel ...If possible, scrub hands and 4 inches above wrists using hospital hand washing techniques. Dry hands using a clean, dry disposable towel."


33399


3. On March 28, 2016 at 8:30 am, IP stated that the facility adopted the AORN, Association for the Advancement of Medical Instrumentation (AAMI), CDC, Association for Professionals in Infection Prevention and Epidemiology (APIC) and the Society for Healthcare Epidemiology of America (SHEA) standards as their nationally accepted infection control guidelines.

On 3/29/16 at 3:15 pm, on a tour of the laundry room, EVS Supervisor stated that the cubicle curtains were washed in cold water in a residential washer with "Tough Guy Detergent" and hung to dry. When the IP was asked if the detergent worked for cold water washes, she stated that the agitation process would be effective to remove spores. No directions were on the Tough Guy Detergent that related to use in hot or cold water. The IP was asked to produce documentation of the instructions for use for the Tough Guy detergent product. By the end of the survey, no definitive documentation was presented.

According to APIC (2016), the wash process shall ensure that healthcare textiles become hygienically clean. The three types of washing equipment used in the processing of healthcare textiles: washers, washer/extractors, and continuous batch washers. Each classification shall have established standards for: Cycle time: pre-wash, wash, rinse and final rinse times; water levels/usage; temperature (wash cycle, bleach cycle and rinse cycle temperatures); and chemical usage (chemical types and usage levels for each step in the wash process).

11389




20307

Based on interview and document review, the hospital failed to ensure that a medical history and physical examination (H&P) were completed and documented no more than 30 days prior to surgery in three of 27 medical records reviewed. This failure had the potential for surgical complications.

Findings:

On 3/29/16, review of the hospital's medical staff rules and regulations, Section II F (i), approved 10/27/15, demonstrated the requirement that an H&P shall be completed and documented "(dictated or entered into the hospital's electronic health record system)" for each patient no more than 30 days before surgery or a procedure requiring anesthesia services.

On 3/29/16, review of hospital policy: History and Physical Documentation Requirements (10/2015) demonstrated that it included the statement, under Procedure, Section 1.d., that an H&P that has been documented over 30 days prior to an admission, invasive procedure or surgery does not meet the requirement for a current H&P and cannot be updated with an interval note. A new H&P is required.

Review of Patient 30's record, on 3/30/16 at 10:30 am, demonstrated that the preoperative H&P was completed and documented on 2/22/16, 37 days before surgery on 3/30/16.

Review of Patient 31's record, on 3/30/16 at 10:30 am, demonstrated that the preoperative H&P was completed and documented on 2/22/16, 37 days before surgery on 3/30/16.

Review of Patient 35's record, on 3/30/16 at 11 am, demonstrated that the preoperative H&P was completed and documented on 2/23/16, 36 days before surgery on 3/30/16.

In interview on 3/30/16 at 12:45 pm, Administrative Nurse A acknowledged that the three patients under discussion had been admitted to the procedure room despite the H&P requirements not having been met.