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Based on interview and record review, the facility failed to ensure patient's or their responsible parties were given a copy of the conditions of admission after signatures were obtained as per the facility's own policy and procedure.

Findings:

A review of the facility's policy and procedure entitled, "Conditions of Services", dated, 9/09, indicated, "The patient/parent/patient representative must read and sign the Conditions of Services upon admission for each hospitalization, outpatient or emergency room visit or as soon thereafter as possible.".....A copy of the form should be given to the person who signs it, and the original placed in the patient's medical record. "

A review of the "Conditions of Services" form, dated 4/2015, states, "A Copy of This Document Should Be Given to the Patient and Any Other Person Who Signs This Document."

During an interview with the Director of Admissions (DOA), on 7/9/2015, at 9:30 a.m., the DOA stated, "No we don't give a copy of the Conditions of Services to the patient's. We have them sign it and it goes into their medical record." When asked about the form and the statement at the bottom of the form about "a copy of the form should be given to the patient or any one who signs it", the DOA stated, "We need to be giving them a copy of what they sign." When asked why the facility staff were not following the facility's policy and procedure regarding giving a copy to the person who signs the form, The DOA stated, "Sometimes the patient doesn't want a copy."




35399

During a tour of the emergency department (ED) and concurrent interview with the ED admitting receptionist (AR) on 7/6/15 at 3:37 p.m.,the AR was questioned regarding the facility's Conditions of Admission documents that are given to patients or patients responsible party. The AR stated "We don't give any documents to patients. I go over and explain the conditions of admission to patients. Patients sign the documents but we don't give them a copy. We only give them a copy if they ask for a copy otherwise we don't."
During a tour of the direct observation unit (DOU) on 7/7/15 at 2:45 p.m., patient N101 was interviewed and asked if she was given a copy of the Conditions of Admission documents when she was admitted into the hospital two days ago. Patient N101 stated "No, I was not given a copy of any documents, or at least not yet " .

Based on observation, staff interview, document review and record review, the facility failed to ensure:

1. PRN (as needed) medication orders covered specific instructions for use. Two orders for PRN pain medications had no pain scale to indicate when to administer the medication. There was no documentation to indicate the facility attempted to clarify a pain scale for administration with the physician.

2. A PRN pain medication was not administered as written by the physician.

3. Licensed nurse 10 (LN) failed to implement the hospital's policy and procedure (P&P) by observing Patient P 100 take and swallow medications during the medication administration process.

4. Ensure sedation level was checked prior to the administration of hydromorphone injection for Patient P 200 per physician order.

5. Patient P 300's insulin (used to control high blood sugar) infusion was titrated as ordered.

6. Medications administered are labeled and identified correctly.

Findings:

The facility policy and procedure entitled "Medication Ordering" dated 2/7/13, indicated"...Medication orders are clear and accurate...The use of as needed (PRN)... should be qualified so there is no question as to the prescriber's intent. Without the qualifier, the order is considered incomplete and the prescriber will be contacted by the pharmacist or the nurse before the medication will be dispensed..."

The facility policy and procedure entitled "Medication Administration and documentation" dated 2/6/14, indicated"...7.3.5 The following medications require the identified clinical parameters to be assessed prior to the administration of the medications: 7.3.5.1 Analgesic require pain scale..."

The facility policy and procedure entitled "Pain Management" dated 5/7/2015 indicated"...Role of the Pharmacy: 8.3.1 Appropriately trained and certified pharmacists will clarify with the ordering physician all pain orders not written in compliance with State and Federal regulations (e.g...incomplete...)."

The facility policy and procedure entitled, "Medication Orders Requiring Clarification", dated 2/7/14, indicated "... To establish and implement the processes and procedures to assure that incomplete, conflicting or incompatible orders are corrected and any required missing information is obtained prior to dispensing and administration of medication...A complete medication order shall include... Directions for use...The pharmacist shall intervene regarding any orders that require clarification or that are inconsistent with approved policies and procedures and standards of practice regarding medication use, including circumstances when additional information is needed to complete the required element of orders...".

1. During concurrent record review and interview with administrative staff 1 (AS) on 7/7/15 at 4:30 p.m., Patient N 304's record reflected physician's orders dated 7/6/15 at 3:05 a.m. for Norco 325 mg. (milligram)/5 mg. (a combination pain medication- hydrocodone-an opioid and acetaminophen) 1 tab every four hours as needed for pain and a second order for Norco 325 mg./5 mg. two tabs every six hours for pain. AS agreed that there were no parameters for the administration of the PRN pain medication.

During a concurrent interview and order review with LN 3 on 7/8/15 at 2:50 p.m., she said there was no pain scale indicated and that the order needed to be clarified.

During a concurrent interview and order review with LN 4 on 7/8/15 at 2:55 p.m. she said there were no parameters like mild or moderate for the level of pain and she would call the doctor because the order needed parameters.

2. During concurrent record review and interview with AS 1 on 7/8/15 at 10:45 a.m. Patient N 306's record reflected physician's orders dated 7/6/15 which indicated morphine (a narcotic pain reliever used to treat moderate to severe pain) 2 mg. IV (intravenously) push every 2 hours PRN for moderate pain 4-6 and a second order that indicated morphine 4 mg. IV push every 2 hours PRN for severe pain 7-10. Upon further record review a medication administration report dated 7/8/15 indicated that morphine 2 mg IV push was administered for a pain score level of 8. AS 1 agreed that the medication was not administered per physician orders. Patient N 307 should have received a dose of 4 mg for a pain scale of 8.






32097

Review of the hospital's P&P entitled "Medication Administration and documentation" dated 2/14, showed "...Administer the medication. Observe the patient take the medication. Remain with the patient until he/she has swallowed the drug ..."

3. LN 10 was observed administering medications to Patient P 100 on 7/8/15 at 9 a.m. LN 10 pulled the medications; the tablets were then put in a medication cup given to Patient P 100. LN 10 then proceeded to work on the computer on wheels. LN 10 did not observe the patient take the medications, contrary to the hospital's P&P.
During concurrent staff interview, LN 10 was unable to affirm that Patient P 100 took the medications and acknowledged she did not watch Patient P 100 take and swallow the medications.
Review of the hospital's P&P entitled "Medication Administration and documentation" dated 2/14, showed "...Monitor the patient periodically to identify presence or absence of therapeutic effect or adverse effects ...in 10 minutes for medication administered IV"
4. Patient P 200 medical record was reviewed on 7/7/15 at 2:15 p.m., in the presence of the ED Assistant Director.
Patient P 200 visited emergency department (ED) for right flank pain. Review of medication order written on 6/30/15 at 7:51 p.m., showed hydromorphone 1 mg intravenous injection every 15 minutes as needed for pain x 4 doses, hold for sedation.
Patient P 200 received hydromorphone 1 mg injection at 8:11 p.m., and at 8:35 p.m. Level of consciousness was documented at 6:15 p.m., but there was no other documentation of the sedation or level of consciousness prior to the administration of hydromorphone.
During concurrent staff interview, the ED Assistant Director acknowledged sedation level was not documented prior to hydromorphone administration.
5. On 7/7/15 at 3:50 p.m., review of Patient P 300's medical record was initiated in the presence of the Clinical Informatics Nurse (CIN) and the Pharmacist in Charge (PIC).
Review of the medication order showed insulin infusion ordered on 7/6/15 and discontinued on 7/7/15 at 12:55 p.m. Insulin determir (long lasting insulin) was ordered and administered subcutaneously on 7/7/15 at 10:08 a.m.
The insulin infusion was ordered to follow Algorithm A and titrate as follows:
Move up or down on the same algorithm each hour if glucose remains outside target range.
Change patient resistance algorithm up if glucose greater than 400 mg/dL for 2 consecutive hours.
Change patient resistance algorithm down if glucose 60 - 69 mg/dL x 2 blood glucose checks or decreases by more than 60 mg/dL in 1 hour.
Algorithm A:
60-109 mg/dL = stop insulin and notify MD
110-149 mg/dL = 1 unit/hour
150-199 mg/dL = 1.5 units/hour
200-249 mg/dL = 2 units/hour
250-299 mg/dL = 2.5 units/hour
300-349 mg/dL = 3 units/hour
350-399 mg/dL = 3.5 units/hour
400 and above = 4 units/hour and call MD
On 7/7/15 the glucose levels were as follows: 288 mg/dL at 10:05 a.m., 298 mg/dL at 10:59 a.m., and 357 mg/dL at 12:27 p.m. The documentation showed insulin infusion running at 2 units/hour at 9:59 a.m., 10:59 a.m. and 11:59 a.m.; it was not titrated as ordered above.
During staff interview on 7/10/15 at 10:10 a.m., the Clinical Nurse Specialist (CNS) reviewed Patient P 300's medical record and acknowledged there was no order to stop titrating insulin infusion. CNS also stated the protocol did not contain an order to stop titrating after administration of determir.




35399

6. During a tour of the Direct Observation Unit (DOU) on 7/7/15 at 2:30 p.m., antibiotic and intravenous fluids were observed being administered without proper patient labeling (no patient's name, medication name, date and time ...). The intravenous (IV) tubing was not labeled to indicate when it needed to be changed.
The DOU director (DOUD) was interviewed and questioned about facility practice related to the administration of IV antibiotics, fluids and labeling of IV tubing. The DOUD stated "Yes, antibiotics and IV fluid need to be labeled with the patient's information, date and time medication administered and IV tubing needs to be label with a change date sticker (96 hours)."
During a tour of the ED and concurrent interview with the CNO on 7/9/15 at 2:40 p.m., antibiotic and IV fluids were being administered without proper patient labeling (no patient's name, medication name, date or time ...). The intravenous (IV) tubing was not labeled to indicate when it needed to be changed. Three patients in the ED had intravenous fluids without proper patient labeling (no patient's name, medication name, date or time ...). The intravenous (IV) tubing was not labeled.
The CNO was asked regarding medications and tubing not being labeled. CNO agreed staff was not following facility policies and procedures when administering and labeling medications and IV tubing.
Facility policy and procedure entitled: Medication: Preparation of Sterile Admixtures Outside the Pharmacy, dated 2/7/13, Procedures 7.5.2, indicates " The Registered Nurse shell be responsible for assuring that: The containers are labeled with: 1. The name of the patient, 2. Name and amount of the additive, 3. Name & volume of the solution, 4. Rate of administration, 5. Date & time prepared. "
Facility policy and procedure entitled: IV Therapy and Infection Control Guidelines for IV Initiation, Dressing Changes and Tubing Changes, dated 2/03, Procedures D., indicates "All tubing will be changed every 96 hours ... e. All tubing will be labeled with the start date/time and change date."

Based on observation, document review, and staff interview, the hospital failed to ensure:
a. Dinoprostone (used for the induction of labor) was stored at the appropriate freezer temperature.
b. Pharmacist inspected every month all areas where pharmaceuticals were available.
c. The IV (intravenous) hood/preparation room was cleaned in accordance with the hospital's P&P.
Findings:
a. Review of the hospital's P&P titled "Drug procurement, distribution and administration" dated 2/13, showed "... All medications shall be stored in a manner complying with any special storage requirements (under refrigeration, protected from light ...) ..."
Review of the manufacturer's product insert for dinoprostone dated 10/12, showed "...store in a freezer between - 4 degree Fahrenheit (F) and 14 degree F ..."
The Pharmacy department was inspected on 7/6/15 at 1:45 p.m., in the presence of the Pharmacist in Charge (PIC). Inspection of the Pharmacy freezer showed the temperature was -10 degree F. Dinoprostone 10 mg was stored in the freezer, outside of the manufacturer's temperature range above.
During concurrent staff interview, the PIC acknowledged dinoprostone was stored outside of the manufacturer's temperature range.
b. Review of the hospital's P&P titled "Unit inspections" dated 2/13, showed "...Medication stock areas outside the Pharmacy are inspected monthly by the pharmacist ..."
Unit inspection record for the year 2015 was reviewed on 7/9/15 at 10:40 a.m., in the presence of the PIC. The review showed unit inspection was not completed for radiology department in April, May and June 2015. The review also showed none was completed for the Ortho clinic in 2015.
Radiology department was inspected on 7/9/15 at 11:20 a.m., in the presence of the PIC and the Assistant Director of Imaging. During inspection of the CT (computerized tomography) room, medications including lidocaine and sodium bicarbonate injections were observed in the biopsy cart in the room.
During concurrent staff interview, the PIC acknowledged the biopsy cart in the CT room and the medications used in Ortho clinic had not been inspected by the Pharmacist in 2015.
c. Review of the hospital's P&P titled "Quality Assurance: IV Admixture preparation" dated 3/14, showed "...The IV room is cleaned daily ...The deep cleaning should occur weekly on Wednesday ..."
The IV room was inspected on 7/8/15 at 10:10 a.m., in the presence of the PIC.
Review of the pharmacy IV hood/Room cleaning log for June and July 2015, showed the daily, weekly and monthly (first Wednesday of the month) cleaning should be documented.
The review showed monthly cleaning was not documented for the month of June and July 2015. Only three weekly cleaning were documented for June and none for July 2015. No cleaning was documented for 6/27 and 6/28/15.
During concurrent staff interview, the PIC confirmed the IV hood/Room cleaning is expected to be documented on the log. The PIC acknowledged the above missing documentation.

Based on observation, interview, and record review, the facility failed to ensure medications and biologicals were stored in a safe and secure manner in several areas of the facility. These failures could have led to patient's removing medications or biologicals from the facility, or improper use of medications or biologicals by patients, visitors, and facility staff.

Findings:

A review of the facility's policy and procedure entitled, "Drug , procurement, distribution and administration", dated 2/7/2013, indicated, "The Pharmacy, upon advice and guidance of the Pharmacy and Therapeutics Committee, is responsible for procurement, storage, ordering, dispensing, monitoring, and administration of all pharmaceuticals."

During a tour to the Labor and Delivery unit, and a concurrent interview with the Director of Obstetrics (DOB), on 7/6/2015, at 1:45 p.m., a cupboard in Labor Room 1 with a lock on the door was found to be open and unlocked. The cupboard contained betadine prep solution bottles, aroma therapy oils, prefilled saline flush syringes, sutures, needles, and intravenous catheters. When asked about the cupboard and if it should be locked the DOB stated, "It should be locked unless the nurse is in the room and needs something." The DOB indicated the charge nurse had failed to follow the departments procedure for locking and securing the drugs and biologicals stored in the patient care area.





35399

During a tour of a patient care area in the nuclear medicine department on 7/8/15 at 10:00 a.m., a drawer containing intravenous catheters, normal saline pre-filled flush syringes, needles and alcohol prep-swabs was found unlocked.
During a concurrent interview with the director of radiology (DR) the DR agreed the drawer should be locked.
Policy and procedure titled: Security for Syringes and Sharps, dated 7/9/15, indicates "Syringes and sharps stored in areas accessible by patients or the public must be locked in a cupboard, drawer, cart or Pyxis."

Based on observation, interview, and record review, the facility failed to ensure drugs and biologicals designated, "For individual use" were discarded after use on patient's, leaving them already used/opened in multiple patient care areas. The facility also failed to ensure outdated, unusable drugs, biologicals and medical supplies were not availabe for patient's use

This failure could have led to contaminated medications being utilized on patient's, increasing patient's risk for infection and had the potential for patients receiving outdated unusable drugs,biologicals and medical supplies which may not meet their needs.

Findings:

A review of the facility's policy and procedure titled, "Drug , procurement, distribution and administration", dated 2/7/2013, indicates, The Pharmacy, upon advice and guidance of the Pharmacy and Therapeutics Committee, is responsible for procurement, storage, ordering, dispensing, monitoring, and administration of all pharmaceuticals." This policy also indicates, "If medication is not appropriate for redistribution (e.g. expired, contaminated, not stored per guidelines), the medication will be wasted....."

1. During a tour of the labor and delivery unit and concurrent interview with the Director of Obstetrics (DOB), on 7/6/15, at 1:45 p.m., an opened 4 ounce bottle of Betadine Prep solution 10% (a solution used to clean skin surfaces), was found opened with half of the solution gone in an unlocked cabinet in Labor Room 1. There was no date on the bottle and the bottle indicated, "For individual use". The DOB stated, "That is for one patient use. It should have been thrown out."





32097

Review of the hospital's P&P titled "Expiration dating of Medications" dated 3/14, showed "Outdated medications that have exceeded the stability established by the manufacturer or the pharmacist shall not be used ... Medications that are beyond the expiration date shall not be used ... Expired medications shall be segregated from the medications used for patients ..."
Review of the hospital's P&P titled "Multi-Dose Containers Drug Distribution" dated 2/13, showed "All multi-dose containers (containing preservative) may be used for up to 28 days or as specified by manufacturer...The multi-dose vial will be dated when it is initially opened and first entered and a beyond use date (BUD) of 28 days or less if indicated by the manufacturer will be indicated on the label ..."
2. The Pharmacy department was inspected on 7/6/15 at 1:45 p.m., in the presence of the Pharmacist in Charge (PIC). Inspection of the Pharmacy freezer showed 2 vials of varicella zoster vaccine (used to reduce the risk of getting shingles) expired 10/14.
Inspection of the Pharmacy refrigerator showed an opened vial of folic acid injection ( B vitamin) 5 mg/ml 10 ml had BUD of 6/11/15 and of Tuberculin purified protein derivatives injection 1 ml (skin test for tuberculosis) with a BUD of 6/29/15.
The Pharmacy refrigerator also showed 2 opened vials of gentamicin 40 mg/mL 20 mL injection (antibiotic) and an opened vial of Humulin R 100 units/mL 3 mL injection (regular insulin) had no beyond use date noted on the vials.
During concurrent staff interview, Pharm tech stated "it is the hospital policy to date multi-dose vial when opened with a BUD". The PIC also acknowledged the above findings.
3. On 7/6/15 at 3:15 p.m., the emergency department (ED) crash cart was inspected in the presence of the PIC. The inspection showed 3 filter needles expired 7/14.
Inspection of the rapid sequence intubation box in ED on 7/7/15 at 3:05 p.m., showed a vial of sterile water for injection 10 mL expired 5/1/15.
During concurrent staff interview on 7/6/15 and on 7/7/15, the PIC acknowledged the above findings.
4. On 7/7/15 at 9:50 a.m., the clean utility medication room in the medical surgical unit was inspected in the presence of the PIC. The inspection showed the following expired items:
ECG (electrocardiogram) conductive adhesive electrodes x 19, expired 11/13
Benzalkonium chloride antiseptic towelette x 5, expired 11/12
Lubrication jelly x 2, expired 3/13
ECG electrodes Ag/Agcl (silver/silver chloride) solid gel x 2, expired 12/13
Steri strip (wound care skin closure) ¼ inch x 4 inch, expired 5/15
Tegaderm film dressing (wound dressing) 4 inch x 41/2 inch, expired 3/15
Hydrogen peroxide 3% 16 oz (antiseptic), expired 5/15
During concurrent staff interview, the PIC acknowledged the expired items.
5. The operating room (OR) suite was inspected on 7/9/15 at 1:50 p.m., in the presence of the Director Perioperative, the Assistant Director Perioperative and the PIC.
Inspection of OR room 3 showed an opened lubricating jelly tube with a BUD of 7/2/15.
During concurrent interview, the Assistant Director Perioperative and the PIC acknowledged the finding.
The Assistant Director Perioperative stated the BUD was noted on the irrigation solution containers in the OR warmer.
Inspection of the OR warmer showed one bottle of 0.9% sodium chloride irrigation solution 2 Liters had a BUD of 7/7/15.
During concurrent staff interview, the Director Perioperative acknowledged the above finding.





35399

6. During a tour of the CT Scan Department and concurrent interview with the director of radiology (DR) department on 7/8/15 at 9:50 a.m., an opened "single use" bottle of Betadine Prep solution (solution to clean skin/wounds), and three open and used 16 ounce Hydrogen Peroxide (solution to disinfect skin surfaces) bottles were found inside a biopsy cart. None of the bottles had open or discard dates written on them.
During interview with the DR, the DR confirmed all teh bottles should be single use and they should be discarded.
7. During a tour of the orthopedic clinic on 7/8/15 at 3:35 p.m. an opened and used 16 once Hydrogen Peroxide bottle, two "single use" 500 ml (milliliter) Normal Saline irrigation bottles were found inside a supply cart. One bottle had only one date written on it, unclear if date was an open or discard date. The other bottles had no dates written on them.
A license nurse (LN) was interviewed concurrently; she was asked about the open and used items. LN stated "We use the Hydrogen Peroxide and the Saline irrigation for multiply patients here in the orthopedic clinic. We pour the solution onto gauze to clean wounds. We don't use the whole bottle on only one patient. I didn't know the bottle was for only one patient."
On 7/9/15 at 10:50 a.m., the pharmacy director (PD) was questioned regarding the Betadine Prep, Hydrogen Peroxide, and Normal Saline irrigation bottles being single use or multi-dose solutions. The PD stated "We have limited medications that are multi-dose, most of them are single use. Yes, the Betadine Prep, Hydrogen Peroxide and Saline irrigation bottles are single use."
The facility policy and procedure titled: "Multi-Dose Containers Drug Distribution", dated 2/7/13, 7.0, Procedures, indicates "The multi-dose medications will be dated when it is initially opened and a beyond use date of 28 days or less if indicated by the manufacturer will be indicated on the label."

Based on observation, staff interview, and document review, the hospital failed to ensure safe food handling practices as evidenced by not thawing frozen spinach product under running water. Failure to ensure standardized procedures are followed may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

Findings:

Food and Drug Administration (FDA) Food Code 2013 states, " improper thawing provides an opportunity for bacteria to grow to harmful numbers and/or produce toxins (poisons). Proper thawing when not under refrigeration requires product to be completely submerged under running water 70 degrees Fahrenheit (F) or below, and with sufficient velocity to agitate and float off loose particles in an overflow.

During an observation in the kitchen on 7/6/15 at 1:40 p.m., three packages of frozen spinach were observed in a food preparation sink. There was no running water. There was one soiled mixing bowl sitting on top of the packages of spinach. Cook 1 was asked how the spinach was to be thawed and he turned on the running water. The three packages of spinach blocked the sink drain and prevented draining of water.

During a concurrent interview the Food and Nutrition Manager (FNM) placed the spinach in container and started the water. The FNM stated the procedure was to thaw under running water. FNM stated the soiled mixing bowl should not be placed in the food preparation sink.
Review of in service training dated 4/22/15, and attended by Cook 1, stated " Thawing may only be done using one of the methods per FDA Food Code: 1. Refrigerated at 41 degrees F or below; 2. Submerged under cool running water (70 degrees or below out of faucet); ... "

Based on staff interview, and document review, the hospital failed to ensure patient weights were timely and accurate to meet nutritional and medical nutrition therapy (MNT) (therapeutic approach to treating medical conditions and monitored by a registered dietitian) needs of 3/6 patients (D 100,D 103, and D 104) that were reviewed for nutrition standards. These failures put patients at risk of compromised nutritional and medical status.


Findings:


Morrison Clinical Nutrition Management Manual approved 1/21/15, states " Weight evaluation is part of the nutrition assessment. Weight should be routinely evaluated to determine the outcome of nutrition interventions. If possible, a patient should be weighed on admission to any clinical setting and monitored frequently throughout the length of stay. Body weight and changes in body weight are two of the most reliable indicators of declining or improving nutrition status. "

1. Patient D 103 was admitted 6/27/15 with small bowel obstruction and incarcerated hernia (entrapped intestine). Patient D 103 underwent an emergent laparotomy with lysis (destruction of cells) of adhesions. Other medical conditions include cirrhosis (chronic liver disease) and chronic obstructive pulmonary disease (lung disease) urinary tract infection (bladder infection).
Weight on hospital admission was 64.4 kilograms actual weight by bed scale. Height was 155 centimeters stated.
Review of weight flow sheet showed weight and weight scale type:
6/30/15 60.9 kilograms bed scale
7/05/15 80.2 kilograms bed scale
7/8/15 75.7 kilograms digital

Review of nursing and physician progress notes did not show any assessment of the significant weigh changes of up to 19.3 kilograms (42.46 pounds) during 12 days. Progress notes did not show any notification of the physician of the weight changes. Food and Nutrition Manager (FNM) was asked on 7/8/15 at 4:00 p.m., to provide any notifications or assessments of the weight changes from the electronic or paper medical record but none was provided.
Nutrition Services nutrition screening dated 6/29/15, verified Registered Dietitian (RD) received the RN consult regarding history of weight loss and decreased appetite.
Nutrition initial assessment dated 7/2/15, stated appetite poor, moderate nutrition risk. Weight was documented at 64.4 kilograms.
Nutrition brief note dated 7/3/15 stated patient to start on TPN and high nutrition status. No weight was documented in the nutrition assessment.
Nutrition follow-up dated 7/6/15 stated weight at 80.2 kilograms and change of plus 15.8 kilograms (34.76 pounds) with assessment of the TPN. There was not assessment of the weight gain of 15.8 kilograms.
Nutrition reassessment dated 7/7/15 listed weight at 80.2 kilograms and listed a weight change of 16 kilograms. There was no discussion of the 15.8 kilogram weight change. The plan was for weight checks.
Altered nutritional status Interdisciplinary Plan of Care started on 6/29/15 through 7/7/15 showed interventions to monitor weight. Goal was for stable weight or gradual weight gain/ loss toward ideal body weight. There was no care planning for the weight changes.

2. Patient D 100 was admitted 6/23/15 with diagnoses of left foot pain. Diagnoses include history of bilateral venous stasis dermatitis and ulcerations (lesion) and hospitalization for wound care. Admission weight 56.8 kilograms. Height was 160.2 centimeters.
Nutrition assessment dated 6/27/15, stated nutrition risk level was moderate with poor meal intake. Nutrition goal was for weight within 7 days.
Nutrition services note dated 7/3/15, stated admission weight 56.8 kilograms. There was not current weight. Patient assessed at moderate acute nutritional risk.
Interdisciplinary Plan of Care for altered nutritional status was dated 6/29/15 with monitor weight. The goal was for stable weight or gradual weight gain/loss toward ideal body weight.
Patient medical record was reviewed on 7/7/15 and there was no weight for 15 days.
During an interview on 7/7/15 at 11:30 a.m., the FNM stated she would expect the RD ' s weight recommendations to be followed and communicated to the nursing staff.
During an interview on 7/7/15 at 11:35 a.m., staff nurse LN 1, stated Patient D100 was receiving wound care and not eating much.
During an interview on 7/7/15 at 8:45 a.m., CNO stated that weight was obtained on admission. Further patient weights "would be obtained with a physician order." CNO confirmed there was not policy to weigh a patient on a regular basis especially if they were in the hospital for more than the average length of stay.

3. Patient D104 was admitted 5/25/15 and discharged 6/4/15. Patient D 104 ' s admission weight was 98.7 kilograms. Height is documented as 165 centimeters. Patient D 104 was admitted for fall. Diagnoses included urinary tract infection with sepsis (presence in tissues of harmful bacteria and their toxins), congestive heart failure, hypertension (high blood pressure), Diabetes Mellitus (high blood sugars), acute and chronic renal failure.
Nutrition assessment dated 5/29/15 showed appetite was poor and nutrition risk level was high. Nutrition goal was for weight maintenance while in the hospital. Plan was to monitor weight, lab results.
Nutrition follow up note dated 6/1/15, stated admission weight and no new weight. Patient continues to have very minimal oral intake of meals and is at high nutrition risk.
Review of the weight flowsheet showed no weights documented after the 5/25/15 admission weight. Patient D 104 had a length of stay of 10 days with no periodic weight to assess and reassess Patient D 104 ' s nutrition status or progress toward goal.
During an interview on 7/7/15 at 8:45 a.m., CNO stated that weight was obtained on admission. Further patient weights " would be obtained with a physician order." CNO confirmed there was not policy to weight a patient on a regular basis especially if they were in the hospital for more than the average length of stay. CNO stated the expectation was for the RD to call the hospitalist and request weight for the patient.

Based on observation, interviews and record review the facility failed to assure staff maintain continuous ECG monitor alarms on while monitoring patients.
1. National Patient Safety Goal (NPSG) NPSG.06.01.01 is to improve the safety of clinical alarm systems. Clinical alarm systems are intended to alert caregivers of potential patient problems, but if they are not properly managed, they can compromise patient safety. Standards of nursing care in continuous electrocardiogram (ECG) monitoring indicate alarms must be appropriately set and turned on at all times (The Joint Commission, 2014).
Findings:
1. During a tour of the Emergency Department and a concurrent interview with the assistant director of the emergency department (ADED) on 7/6/15 at 3:01 p.m., the central ECG monitor (device that monitors heart) was observed with the alarms turned OFF. The patients ECG rhythms and heart rate were flashing on the monitor due to abnormalities, however there were no audible alarms and the monitor was unattended.
The ADED was interviewed and stated "Yes, I agree this is not safe, the alarms need to be on. I don't know what's wrong with the monitor that the alarms are off."
Minutes later the charge nurse (CN) who was supposed to be observing the monitor was interviewed. the CN stated "Yes, the monitor should be alarming. I don 't know what 's wrong with them now. "
According to the facility's policy entitled: "Patient Clinical Alarms" dated 2/6/14," C. Telemetry alarms," policy indicates " Monitor alarms are never to be turned off or have alarm functions bypassed by clinical patient care staff ."
the following day on 7/7/15 at 8:45 a.m., the central monitor alarms were observed and while the alarms were on they were very soft, and unable to be heard from a short distance. The ADED was questioned regarding the low alarm sound. and she stated "We can't adjust the monitor alarm sound because it requires a code or password to make any changes. We don't know that code or password so I 'm calling Biomed."

Based on interview with facility staff and review of documents the facility failed to ensure that the infection control officer implemented policies and procedures, based as much as possible on national guidelines that required adherence to nationally recognized infection prevention and control precautions, such as current Centers for Disease Control and Prevention (CDC) guidelines and recommendations, for infections/communicable diseases when not all physicians were required to provide documentation of annual screening for tuberculosis (TB).
Findings:
During an interview on 7/7/15 at 10:15 a.m. the Infection Preventionist stated members of the medical staff were not subject to the same requirements for tuberculosis screening as other healthcare personnel. Review of the facility policy titled " Tuberculosis Screening Skin Testing Procedure " supplied by the Infection Preventionist revealed instead of the documentation required for tuberculosis screening of hospital employees, members of the medical staff were allowed to provide an attestation that they were free from infectious tuberculosis at the time of initial application to the medical staff and then every two years at the time of reappointment. The Infection Preventionist stated the hospital followed CDC guidelines for the screening of healthcare workers (HCWs). According to the CDC's Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, HCWs refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to Mycobacterium tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in annual TB screening programs. All HCWs who have duties that involve face-to-face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program.

Based on observation, staff interview, and document review, the hospital failed to develop a system for evaluating hospital wide infection control prevention as evidenced by:

1. One of one kitchen bin ice machine and two of two pantry ice machines (maternity unit and ICU) were not cleaned and sanitized per manufacturer 's directions.

2. One food service staff did not wash her hands per policy.

3. One food service staff did not wash her hands when changing gloves when doing food preparation activities.

4. Maintaining seperation of clean and dirty items.

5. Handwashing.

6. Proper cleaning and mainteance of sterilizer units.

7. Proper use use of single use patient care items.

8. Cleaning and disinfecting of patient care items.

9. proper disinfecting of medication vials for patient use.

Failure to follow specific manufacturer's directions for cleaning and sanitizing ice machines put all patients at risk of food borne illness (infection by food or ice that contain harmful bacteria, parasites, viruses, or chemicals) for hospital licensed for 122 patients. Failure to thoroughly wash hands puts all patients at risk of food borne illness for a hospital licensed for 122 patients. As well as increased opportunity for the spread of infection to patient's receiving care in multiple areas of the facility.

Findings:

Immune-compromised patients are those patients whose immune mechanisms are deficient because of immunologic disorders (e.g., human immunodeficiency virus [HIV] infection or congenital immune deficiency syndrome), chronic diseases (e.g., diabetes, cancer, emphysema, or cardiac failure), or immunosuppressive therapy (e.g., radiation, cytotoxic chemotherapy, anti-rejection medication, or steroids). Immunocompromised patients have the greatest risk of infection caused by airborne or waterborne microorganisms. Guidelines for environmental Infection Control in Healthcare Facilities Center for disease Control 2003.

Review of Center for Disease Control guidelines (CDC) stated mold and slime build up inside ice machines allows bacteria growth and slime buildup inside commercial ice-making machines which can contain pathogenic microorganism.

1. During an observation on 7/8/15 at 10:10 a.m., the kitchen bin ice machine interior was white scale and brown and black substance on the tube connected to the water trough. There were significant white mineral-like deposits on sides and front of ice making area. During concurrent interview Engineer 1 stated he had just cleaned the ice machine and changed the filters every three months with a nickel safe ice machine cleaner. Engineer 1 stated he scraped the white scale but the hospital had very hard water and the scale was hard to get off. Engineer 1 stated the cleaner was the only chemical he used in preventive maintenance of the ice machine. Engineer 1 stated when asked about the brown/black substance on the tubing, " I guess I should clean that. "
Review of the Preventative Maintenance Work Order dated 6/24/15 for the kitchen bin ice machine, showed instructions which included clean condenser coil and filter, descale and clean.
During concurrent interview with the food and nutrition manager (FNM), stated that there was detailed ice machine cleaning directions attached to the ice machine and was not aware that the engineers were not following the manufacturer ' s directions provided by the ice machine. FNM acknowledged the interior of the ice machine had significant white mineral-like scale and brown and black substance. FNM acknowledged the ice machine was not sanitized as required and would provide ice from a sanitary source until the bin ice machine was properly cleaned and sanitized.
Review of the manufacturer ' s directions specified the cleaning with the nickel safe ice machine cleaner for step one. Step two required an approved sodium hypochlorite food equipment sanitizer to form a solution of 100 to 200 parts per million concentration.
On 7/7/15 at 2:00 p.m., the shoot ice machine on ICU pantry was observed. There was significant white coating on the catch tray.
On 7/8/15 at 11:30 a.m., the maternity unit shoot ice machine was observed. The catch tray had significant buildup of with white scale substance. During concurrent interview maternity charge nurse stated the Environmental Services (EVS) staff wipes down the outside daily. Review of the Non Patient Rooms task sheet for EVS showed the nourishment rooms were checked and cleaned two times per day as needed.
There were no directions specific to maintaining the exterior of the pantry shoot ice machine in clean and sanitary condition.

2. During an observation in cafeteria on 7/6/15 at 2:15 p.m., Food Service Worker 1 (FSW) changed disposable gloves and proceeded to make a sandwich.
During a concurrent interview FNM stated that in the cafeteria they allowed the food service workers to change gloves without washing their hands between glove changes because the handwashing sink was back in the kitchen. FNM stated there was no handwashing sink in the cafeteria for the food service workers to wash their hands.
Review of Department Meeting dated 4/22/15 review of policies stated " Wash your hands between EVERY (document emphasis) glove change. "
3. During an observation 7/7/15 at 10:10 a.m., FSW 2 was observed washing her hands. The hand washing consisted of wetting hands, applying soap and rinsing under running water.
FDA Food Code 2013 requires apply soap and scrub hands for 15- 20 seconds and then rinse with running water.

During concurrent interview the FNM stated acknowledged the FSW 2 had not followed the required washing for 20 seconds before she rinsed her hands.

During an interview with Infection Control Preventionist (ICP) on 7/7/15 at 3:45 p.m., regarding infection control involvement in food service operations. The ICP stated she was involved in observations of the food service area including ice machines. ICP starts she had not inspected the interior of the ice machine mechanical section. IPC stated engineering was responsible for the ice machine maintenance with a preventative maintenance schedule.




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A review of the facility's policy and procedure entitled, "Hand Hygiene Policy," dated 10/7/2010, indicates reasons, "for handwashing and hand antisepsis include:...Prior to donning gloves and after removing gloves...., to, "Decontaminate hands after removing gloves. NOTE: Gloves are not a substitute for hand hygiene....and, "The Infection Preventionist and designated A-Team member are responsible for implementing this policy."

A review of the manufacturer's booklet for the sterilizer units in the facility indicated, "The chamber drain strainer must be cleaned at least once a day...", and to "Wash the inside of the chamber and shelf assembly(plus any other loading equipment) with a mild detergent solution such as Steris Liqui-Jet or current Steris equivalent." The weekly recommended maintenance was to, "Flush the Chamber Drain".

A review of the facility's policy and procedure titled, "Cleaning and Disinfection of Noncritical Patient Care Items, dated 6/5/2014, indicates staff are to, "Follow manufacturer's guidelines regarding capability of items..."

A review of the facility's, "Surveillance, Prevention, and Control Program Plan", dated, 2/17/2015, indicated, "When reprocessing single-use devices, the hospital implements infection prevention and control activities that are consistent with regulatory and professional standards."

4. During a tour of the facility's Obstetrical floor and concurrent interview with the Director of Obstetrics (DOB) on 7/6/2015, at 2 p.m., a storage room designated as clean storage had two breast pumps and two IV poles with IV pumps on them along with various other clean supplies for use on patients. The two IV pumps had coverings over them and one breast pump had the same covering over it. One breast pump did not have any covering on it. When asked about the coverings the DOB stated, "The covers mean the items are clean." When asked about the breast pump which did not have a cover on it, the DOB stated, "I don't know if it (the breast pump) is clean or not. It should have a cover on it if it is clean."

5. During an observation of a surgical procedure on 7/8/2015, at 10:30 a.m., the surgical circulating nurse (SCN) put on gloves and handled a contaminated lap sponge to place it from the throw bucket into the sponge counter packaging. The SCN then removed her gloves and when to the computer and did some charting without washing her hands. This was repeated by the same SCN a second time during the final count of the items used during the surgical procedure.

6. During an tour of the surgical sterilization area on 7/8/2015 at 11:30 a.m., it was revealed the facility had no maintenance logs for the daily, or weekly cleanings for any of the sterilizer units.

During an interview with the Surgical Services Director (SSD) on 7/6/15 at 11:45 a.m., the SSD stated, "I know we do not have any logs like that." When asked why the facility was not cleaning and maintaining the sterilizer units according to the manufactures recommendations, the SSD indicated he was not aware there were daily, or weekly cleanings needing to be done. The SSD indicated there were no facility policy and procedures in place for the daily or weekly cleaning and maintenance of the sterilizer units.

During an interview with the SSD, on 7/8/2015 at 4:05 p.m., the SSD stated, "I called the Steris rep (Representative) and she told me the same thing about the cleaning an maintenance of the sterilizer units that they needed daily and weekly cleanings."






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Review of the hospital pharmacy newsletter used to train nurses on intravenous (IV) medication preparation titled " Tips on making safe IVs " showed " ...wipe vials tops with alcohol swap and allow to dry prior to puncturing ... "

Review of the American Journal of infection Control special article titled " APIC (Association for Professionals in infection Control and Epidemiology) position paper: Safe injection, infusion, and medical vial practices in healthcare " dated 4/10, showed " ...Cleanse the access diaphragm of vials using friction and a sterile 70 % isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab. Allow the diaphragm to dry before inserting any device into the vial ... "

9. On 7/8/15 at 9:45 am, LN 11 was observed administering medications to Patient P 400. Several medications including heparin 5000 units injection were administered. LN 11 removed the heparin vial cap and withdrew vial content with syringe and needle through the rubber stopper in the presence of the Charge RN. LN 11 did not disinfect the rubber stopper prior to piercing, contrary to the above training.
During concurrent staff interview, LN 11 and the Charge RN acknowledged heparin injection vial rubber stopper was not disinfected prior to piercing.
During the interview on 7/9/15 at 9:50 am, the infection preventionist indicated it was not necessary to clean the heparin vial rubber stopper with alcohol swab if cap was just removed. The hospital was unable to provide documentation to support this view.




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7. During a tour of the Emergency Department on 7/6/15 at 3:35 p.m., licensed nurse (LN) 5 was observed coming out of a patient's room with her gloves on, came to a clean supply cart, removed an item from the cart and continued with her work. Concurrently LN 5 was interviewed, and questioned regarding the use of dirty gloves to touch clean items. LN 5 stated LN 5 acknowledged she should have removed the dirty goves when she came out of the patients room.

During the same tour of the Emergency Department on 7/6/15 at 4:05 p.m., a urinal with approximately 400 mls. (milliliters) of urine was observed on top of a clean supply cart in a patient's room.

Concurrently , the quality coordinator (QC) and the infection preventionist (IP) were interviewed; they both agreed the (dirty) urinal should not be mixed with clean supplies.

During the same tour of the Emergency Department on 7/6/15 at 4:28 p.m., LN 6 was observed stripping down dirty linen from a gurney with gloves on. LN 6 removed her gloves, did not wash her hands after glove removal and continued her work. Concurrently LN 6 was interviewed, and questioned regarding handwashing after glove removal. LN 6 stated "I should have sanitized my hands after removing my gloves.

According to emergency department assistant director (EDAD), nurses clean ED rooms and gurneys after each patient use. During the same tour of the Emergency Department on 7/6/15 at 3:50 and 4:28 p.m. LN 6 and LN 7 were asked regarding wait time after cleaning a gurney with "Sani-cloth" wipes before the gurney is ready to be used again. LN 6 stated "no specific time." LN 7 stated "wait time is 10 seconds." Sani-cloth Q55172 Super wipes surface disinfectant germicidal cloths label was reviewed. According to manufacturer recommendations, the wait time is two minutes before the cleaned surface area can be used. Furthermore, the facility's policy titled "Cleaning and Disinfection of Noncritical Patient Care Items" dated 6/5/14, indicated " Manufacturer's guidelines regarding capability of items with specific disinfectants must be followed."

Based on interview and record review the facility failed to ensure a properly executed informed consent was on file in one of 30 sampled patients (Patient N 102). This failure could have led to the wrong procedure being performed on Patient N 102, and has the potential for wrong procedures to be performed on all patient's undergoing procedures within the facility.

Findings:

A review of the Facility's policy and procedure titled, "Informed Consent", dated 6/5/12, states, "Hospital staffs role in the informed consent process is limited to verifying that the physician obtained and properly documented the patient's informed consent before the physician is permitted to perform the medical procedure".....and, "The planned procedure should be written on the consent as ordered by the treating physician without any abbreviations of corrections. "

A review of the facility's policy and procedure titled, "Abbreviations Use/Unacceptable Abbreviations", dated 5/7/2015, indicates the letters DC stand for discontinue, or written as D/C stands for discharge." There are no other uses for the letters DC on the "Acceptable Abbreviations and Symbols list".

A review of Patient N 102's medical record revealed N 102 underwent a surgical procedure on 7/5/2015. The procedure documented by the licensed nurse was written as, "Suction D&C". The physician's order was written as, "Verify consent Urgent, T;N, Once scheduled, suction D&C".

During an interview with the Director of Quality Services (DQS), on 7/7/2015, at 10:00 a.m., the DQS stated, "The consent should have been clarified with the physician by the ER (Emergency Room) nurse prior to the patient signing it (informed surgical consent)."

During an interview with the Director of Surgical Services (DSS), on 7/10/2015, at 10:15 a.m., the DSS stated, "The OR (Operating Room) nurse who was reading the surgical consent should have stopped the line and the consent should have been clarified prior to the procedure being done." The DSS also stated, "We never use abbreviations on surgical consents. The OR nurses are responsible for making sure the surgical consents are correct. The first opportunity is in pre-op, the second chance in the OR during the time-out. The OR nurses should have caught this."

Based on interview with facility staff and review of documents the facility failed to ensure that the facility's policies allowed anesthesia to be administered only by a qualified anesthesiologist; a doctor of medicine or osteopathy; a qualified dentist, oral surgeon, or podiatrist; a certified registered nurse anesthetist; or an anesthetist ' s assistant under the immediate supervision of an anesthesiologist.
Findings:
Review of the facility's policy titled "Deep Sedation", as provided by the Director of Quality Services (DQS) during an interview on 7/7/15 at 3:30 p.m., revealed it stated deep sedation was only to be performed by staff anesthesiologists or emergency department physicians and intensive care unit (ICU) physicians who have privileges to perform deep sedation. However the policy also stated that in addition to the physician the only other required personnel was to be the registered nurse administering the medications for deep sedation and monitoring the patient. This policy may be more appropriate for conscious sedation than for deep sedation since deep sedation carries the risk of inadequacy of spontaneous respirations requiring airway management. If the proceduralist were occupied and unable to intervene in a case where the patient entered a deeper plane of sedation than intended there is no indication of who would perform any necessary intubation. The use of certain agents for deep sedation such as propofol in such a setting is not recommended by the manufacturer who states in its product labeling that the drug should be administered only by persons trained in the administration of general anesthesia and not involved in the surgical/diagnostic procedure. When used for sedation of intubated, mechanically ventilated adult patients in the ICU, the product labeling notes that the drug should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Deep sedation is not conscious sedation and should be administered only by persons who are trained in the administration of drugs that cause deep sedation and general anesthesia, are able to intubate the patient if necessary, and are not involved in the procedure.

Based on interview and record review, the facility failed to ensure patient's or their responsible parties were given a copy of the conditions of admission after signatures were obtained as per the facility's own policy and procedure.

Findings:

A review of the facility's policy and procedure entitled, "Conditions of Services", dated, 9/09, indicated, "The patient/parent/patient representative must read and sign the Conditions of Services upon admission for each hospitalization, outpatient or emergency room visit or as soon thereafter as possible.".....A copy of the form should be given to the person who signs it, and the original placed in the patient's medical record. "

A review of the "Conditions of Services" form, dated 4/2015, states, "A Copy of This Document Should Be Given to the Patient and Any Other Person Who Signs This Document."

During an interview with the Director of Admissions (DOA), on 7/9/2015, at 9:30 a.m., the DOA stated, "No we don't give a copy of the Conditions of Services to the patient's. We have them sign it and it goes into their medical record." When asked about the form and the statement at the bottom of the form about "a copy of the form should be given to the patient or any one who signs it", the DOA stated, "We need to be giving them a copy of what they sign." When asked why the facility staff were not following the facility's policy and procedure regarding giving a copy to the person who signs the form, The DOA stated, "Sometimes the patient doesn't want a copy."




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During a tour of the emergency department (ED) and concurrent interview with the ED admitting receptionist (AR) on 7/6/15 at 3:37 p.m.,the AR was questioned regarding the facility's Conditions of Admission documents that are given to patients or patients responsible party. The AR stated "We don't give any documents to patients. I go over and explain the conditions of admission to patients. Patients sign the documents but we don't give them a copy. We only give them a copy if they ask for a copy otherwise we don't."
During a tour of the direct observation unit (DOU) on 7/7/15 at 2:45 p.m., patient N101 was interviewed and asked if she was given a copy of the Conditions of Admission documents when she was admitted into the hospital two days ago. Patient N101 stated "No, I was not given a copy of any documents, or at least not yet " .

Based on observation, staff interview, document review and record review, the facility failed to ensure:

1. PRN (as needed) medication orders covered specific instructions for use. Two orders for PRN pain medications had no pain scale to indicate when to administer the medication. There was no documentation to indicate the facility attempted to clarify a pain scale for administration with the physician.

2. A PRN pain medication was not administered as written by the physician.

3. Licensed nurse 10 (LN) failed to implement the hospital's policy and procedure (P&P) by observing Patient P 100 take and swallow medications during the medication administration process.

4. Ensure sedation level was checked prior to the administration of hydromorphone injection for Patient P 200 per physician order.

5. Patient P 300's insulin (used to control high blood sugar) infusion was titrated as ordered.

6. Medications administered are labeled and identified correctly.

Findings:

The facility policy and procedure entitled "Medication Ordering" dated 2/7/13, indicated"...Medication orders are clear and accurate...The use of as needed (PRN)... should be qualified so there is no question as to the prescriber's intent. Without the qualifier, the order is considered incomplete and the prescriber will be contacted by the pharmacist or the nurse before the medication will be dispensed..."

The facility policy and procedure entitled "Medication Administration and documentation" dated 2/6/14, indicated"...7.3.5 The following medications require the identified clinical parameters to be assessed prior to the administration of the medications: 7.3.5.1 Analgesic require pain scale..."

The facility policy and procedure entitled "Pain Management" dated 5/7/2015 indicated"...Role of the Pharmacy: 8.3.1 Appropriately trained and certified pharmacists will clarify with the ordering physician all pain orders not written in compliance with State and Federal regulations (e.g...incomplete...)."

The facility policy and procedure entitled, "Medication Orders Requiring Clarification", dated 2/7/14, indicated "... To establish and implement the processes and procedures to assure that incomplete, conflicting or incompatible orders are corrected and any required missing information is obtained prior to dispensing and administration of medication...A complete medication order shall include... Directions for use...The pharmacist shall intervene regarding any orders that require clarification or that are inconsistent with approved policies and procedures and standards of practice regarding medication use, including circumstances when additional information is needed to complete the required element of orders...".

1. During concurrent record review and interview with administrative staff 1 (AS) on 7/7/15 at 4:30 p.m., Patient N 304's record reflected physician's orders dated 7/6/15 at 3:05 a.m. for Norco 325 mg. (milligram)/5 mg. (a combination pain medication- hydrocodone-an opioid and acetaminophen) 1 tab every four hours as needed for pain and a second order for Norco 325 mg./5 mg. two tabs every six hours for pain. AS agreed that there were no parameters for the administration of the PRN pain medication.

During a concurrent interview and order review with LN 3 on 7/8/15 at 2:50 p.m., she said there was no pain scale indicated and that the order needed to be clarified.

During a concurrent interview and order review with LN 4 on 7/8/15 at 2:55 p.m. she said there were no parameters like mild or moderate for the level of pain and she would call the doctor because the order needed parameters.

2. During concurrent record review and interview with AS 1 on 7/8/15 at 10:45 a.m. Patient N 306's record reflected physician's orders dated 7/6/15 which indicated morphine (a narcotic pain reliever used to treat moderate to severe pain) 2 mg. IV (intravenously) push every 2 hours PRN for moderate pain 4-6 and a second order that indicated morphine 4 mg. IV push every 2 hours PRN for severe pain 7-10. Upon further record review a medication administration report dated 7/8/15 indicated that morphine 2 mg IV push was administered for a pain score level of 8. AS 1 agreed that the medication was not administered per physician orders. Patient N 307 should have received a dose of 4 mg for a pain scale of 8.






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Review of the hospital's P&P entitled "Medication Administration and documentation" dated 2/14, showed "...Administer the medication. Observe the patient take the medication. Remain with the patient until he/she has swallowed the drug ..."

3. LN 10 was observed administering medications to Patient P 100 on 7/8/15 at 9 a.m. LN 10 pulled the medications; the tablets were then put in a medication cup given to Patient P 100. LN 10 then proceeded to work on the computer on wheels. LN 10 did not observe the patient take the medications, contrary to the hospital's P&P.
During concurrent staff interview, LN 10 was unable to affirm that Patient P 100 took the medications and acknowledged she did not watch Patient P 100 take and swallow the medications.
Review of the hospital's P&P entitled "Medication Administration and documentation" dated 2/14, showed "...Monitor the patient periodically to identify presence or absence of therapeutic effect or adverse effects ...in 10 minutes for medication administered IV"
4. Patient P 200 medical record was reviewed on 7/7/15 at 2:15 p.m., in the presence of the ED Assistant Director.
Patient P 200 visited emergency department (ED) for right flank pain. Review of medication order written on 6/30/15 at 7:51 p.m., showed hydromorphone 1 mg intravenous injection every 15 minutes as needed for pain x 4 doses, hold for sedation.
Patient P 200 received hydromorphone 1 mg injection at 8:11 p.m., and at 8:35 p.m. Level of consciousness was documented at 6:15 p.m., but there was no other documentation of the sedation or level of consciousness prior to the administration of hydromorphone.
During concurrent staff interview, the ED Assistant Director acknowledged sedation level was not documented prior to hydromorphone administration.
5. On 7/7/15 at 3:50 p.m., review of Patient P 300's medical record was initiated in the presence of the Clinical Informatics Nurse (CIN) and the Pharmacist in Charge (PIC).
Review of the medication order showed insulin infusion ordered on 7/6/15 and discontinued on 7/7/15 at 12:55 p.m. Insulin determir (long lasting insulin) was ordered and administered subcutaneously on 7/7/15 at 10:08 a.m.
The insulin infusion was ordered to follow Algorithm A and titrate as follows:
Move up or down on the same algorithm each hour if glucose remains outside target range.
Change patient resistance algorithm up if glucose greater than 400 mg/dL for 2 consecutive hours.
Change patient resistance algorithm down if glucose 60 - 69 mg/dL x 2 blood glucose checks or decreases by more than 60 mg/dL in 1 hour.
Algorithm A:
60-109 mg/dL = stop insulin and notify MD
110-149 mg/dL = 1 unit/hour
150-199 mg/dL = 1.5 units/hour
200-249 mg/dL = 2 units/hour
250-299 mg/dL = 2.5 units/hour
300-349 mg/dL = 3 units/hour
350-399 mg/dL = 3.5 units/hour
400 and above = 4 units/hour and call MD
On 7/7/15 the glucose levels were as follows: 288 mg/dL at 10:05 a.m., 298 mg/dL at 10:59 a.m., and 357 mg/dL at 12:27 p.m. The documentation showed insulin infusion running at 2 units/hour at 9:59 a.m., 10:59 a.m. and 11:59 a.m.; it was not titrated as ordered above.
During staff interview on 7/10/15 at 10:10 a.m., the Clinical Nurse Specialist (CNS) reviewed Patient P 300's medical record and acknowledged there was no order to stop titrating insulin infusion. CNS also stated the protocol did not contain an order to stop titrating after administration of determir.




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6. During a tour of the Direct Observation Unit (DOU) on 7/7/15 at 2:30 p.m., antibiotic and intravenous fluids were observed being administered without proper patient labeling (no patient's name, medication name, date and time ...). The intravenous (IV) tubing was not labeled to indicate when it needed to be changed.
The DOU director (DOUD) was interviewed and questioned about facility practice related to the administration of IV antibiotics, fluids and labeling of IV tubing. The DOUD stated "Yes, antibiotics and IV fluid need to be labeled with the patient's information, date and time medication administered and IV tubing needs to be label with a change date sticker (96 hours)."
During a tour of the ED and concurrent interview with the CNO on 7/9/15 at 2:40 p.m., antibiotic and IV fluids were being administered without proper patient labeling (no patient's name, medication name, date or time ...). The intravenous (IV) tubing was not labeled to indicate when it needed to be changed. Three patients in the ED had intravenous fluids without proper patient labeling (no patient's name, medication name, date or time ...). The intravenous (IV) tubing was not labeled.
The CNO was asked regarding medications and tubing not being labeled. CNO agreed staff was not following facility policies and procedures when administering and labeling medications and IV tubing.
Facility policy and procedure entitled: Medication: Preparation of Sterile Admixtures Outside the Pharmacy, dated 2/7/13, Procedures 7.5.2, indicates " The Registered Nurse shell be responsible for assuring that: The containers are labeled with: 1. The name of the patient, 2. Name and amount of the additive, 3. Name & volume of the solution, 4. Rate of administration, 5. Date & time prepared. "
Facility policy and procedure entitled: IV Therapy and Infection Control Guidelines for IV Initiation, Dressing Changes and Tubing Changes, dated 2/03, Procedures D., indicates "All tubing will be changed every 96 hours ... e. All tubing will be labeled with the start date/time and change date."

Based on observation, document review, and staff interview, the hospital failed to ensure:
a. Dinoprostone (used for the induction of labor) was stored at the appropriate freezer temperature.
b. Pharmacist inspected every month all areas where pharmaceuticals were available.
c. The IV (intravenous) hood/preparation room was cleaned in accordance with the hospital's P&P.
Findings:
a. Review of the hospital's P&P titled "Drug procurement, distribution and administration" dated 2/13, showed "... All medications shall be stored in a manner complying with any special storage requirements (under refrigeration, protected from light ...) ..."
Review of the manufacturer's product insert for dinoprostone dated 10/12, showed "...store in a freezer between - 4 degree Fahrenheit (F) and 14 degree F ..."
The Pharmacy department was inspected on 7/6/15 at 1:45 p.m., in the presence of the Pharmacist in Charge (PIC). Inspection of the Pharmacy freezer showed the temperature was -10 degree F. Dinoprostone 10 mg was stored in the freezer, outside of the manufacturer's temperature range above.
During concurrent staff interview, the PIC acknowledged dinoprostone was stored outside of the manufacturer's temperature range.
b. Review of the hospital's P&P titled "Unit inspections" dated 2/13, showed "...Medication stock areas outside the Pharmacy are inspected monthly by the pharmacist ..."
Unit inspection record for the year 2015 was reviewed on 7/9/15 at 10:40 a.m., in the presence of the PIC. The review showed unit inspection was not completed for radiology department in April, May and June 2015. The review also showed none was completed for the Ortho clinic in 2015.
Radiology department was inspected on 7/9/15 at 11:20 a.m., in the presence of the PIC and the Assistant Director of Imaging. During inspection of the CT (computerized tomography) room, medications including lidocaine and sodium bicarbonate injections were observed in the biopsy cart in the room.
During concurrent staff interview, the PIC acknowledged the biopsy cart in the CT room and the medications used in Ortho clinic had not been inspected by the Pharmacist in 2015.
c. Review of the hospital's P&P titled "Quality Assurance: IV Admixture preparation" dated 3/14, showed "...The IV room is cleaned daily ...The deep cleaning should occur weekly on Wednesday ..."
The IV room was inspected on 7/8/15 at 10:10 a.m., in the presence of the PIC.
Review of the pharmacy IV hood/Room cleaning log for June and July 2015, showed the daily, weekly and monthly (first Wednesday of the month) cleaning should be documented.
The review showed monthly cleaning was not documented for the month of June and July 2015. Only three weekly cleaning were documented for June and none for July 2015. No cleaning was documented for 6/27 and 6/28/15.
During concurrent staff interview, the PIC confirmed the IV hood/Room cleaning is expected to be documented on the log. The PIC acknowledged the above missing documentation.

Based on observation, interview, and record review, the facility failed to ensure medications and biologicals were stored in a safe and secure manner in several areas of the facility. These failures could have led to patient's removing medications or biologicals from the facility, or improper use of medications or biologicals by patients, visitors, and facility staff.

Findings:

A review of the facility's policy and procedure entitled, "Drug , procurement, distribution and administration", dated 2/7/2013, indicated, "The Pharmacy, upon advice and guidance of the Pharmacy and Therapeutics Committee, is responsible for procurement, storage, ordering, dispensing, monitoring, and administration of all pharmaceuticals."

During a tour to the Labor and Delivery unit, and a concurrent interview with the Director of Obstetrics (DOB), on 7/6/2015, at 1:45 p.m., a cupboard in Labor Room 1 with a lock on the door was found to be open and unlocked. The cupboard contained betadine prep solution bottles, aroma therapy oils, prefilled saline flush syringes, sutures, needles, and intravenous catheters. When asked about the cupboard and if it should be locked the DOB stated, "It should be locked unless the nurse is in the room and needs something." The DOB indicated the charge nurse had failed to follow the departments procedure for locking and securing the drugs and biologicals stored in the patient care area.





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During a tour of a patient care area in the nuclear medicine department on 7/8/15 at 10:00 a.m., a drawer containing intravenous catheters, normal saline pre-filled flush syringes, needles and alcohol prep-swabs was found unlocked.
During a concurrent interview with the director of radiology (DR) the DR agreed the drawer should be locked.
Policy and procedure titled: Security for Syringes and Sharps, dated 7/9/15, indicates "Syringes and sharps stored in areas accessible by patients or the public must be locked in a cupboard, drawer, cart or Pyxis."

Based on observation, interview, and record review, the facility failed to ensure drugs and biologicals designated, "For individual use" were discarded after use on patient's, leaving them already used/opened in multiple patient care areas. The facility also failed to ensure outdated, unusable drugs, biologicals and medical supplies were not availabe for patient's use

This failure could have led to contaminated medications being utilized on patient's, increasing patient's risk for infection and had the potential for patients receiving outdated unusable drugs,biologicals and medical supplies which may not meet their needs.

Findings:

A review of the facility's policy and procedure titled, "Drug , procurement, distribution and administration", dated 2/7/2013, indicates, The Pharmacy, upon advice and guidance of the Pharmacy and Therapeutics Committee, is responsible for procurement, storage, ordering, dispensing, monitoring, and administration of all pharmaceuticals." This policy also indicates, "If medication is not appropriate for redistribution (e.g. expired, contaminated, not stored per guidelines), the medication will be wasted....."

1. During a tour of the labor and delivery unit and concurrent interview with the Director of Obstetrics (DOB), on 7/6/15, at 1:45 p.m., an opened 4 ounce bottle of Betadine Prep solution 10% (a solution used to clean skin surfaces), was found opened with half of the solution gone in an unlocked cabinet in Labor Room 1. There was no date on the bottle and the bottle indicated, "For individual use". The DOB stated, "That is for one patient use. It should have been thrown out."





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Review of the hospital's P&P titled "Expiration dating of Medications" dated 3/14, showed "Outdated medications that have exceeded the stability established by the manufacturer or the pharmacist shall not be used ... Medications that are beyond the expiration date shall not be used ... Expired medications shall be segregated from the medications used for patients ..."
Review of the hospital's P&P titled "Multi-Dose Containers Drug Distribution" dated 2/13, showed "All multi-dose containers (containing preservative) may be used for up to 28 days or as specified by manufacturer...The multi-dose vial will be dated when it is initially opened and first entered and a beyond use date (BUD) of 28 days or less if indicated by the manufacturer will be indicated on the label ..."
2. The Pharmacy department was inspected on 7/6/15 at 1:45 p.m., in the presence of the Pharmacist in Charge (PIC). Inspection of the Pharmacy freezer showed 2 vials of varicella zoster vaccine (used to reduce the risk of getting shingles) expired 10/14.
Inspection of the Pharmacy refrigerator showed an opened vial of folic acid injection ( B vitamin) 5 mg/ml 10 ml had BUD of 6/11/15 and of Tuberculin purified protein derivatives injection 1 ml (skin test for tuberculosis) with a BUD of 6/29/15.
The Pharmacy refrigerator also showed 2 opened vials of gentamicin 40 mg/mL 20 mL injection (antibiotic) and an opened vial of Humulin R 100 units/mL 3 mL injection (regular insulin) had no beyond use date noted on the vials.
During concurrent staff interview, Pharm tech stated "it is the hospital policy to date multi-dose vial when opened with a BUD". The PIC also acknowledged the above findings.
3. On 7/6/15 at 3:15 p.m., the emergency department (ED) crash cart was inspected in the presence of the PIC. The inspection showed 3 filter needles expired 7/14.
Inspection of the rapid sequence intubation box in ED on 7/7/15 at 3:05 p.m., showed a vial of sterile water for injection 10 mL expired 5/1/15.
During concurrent staff interview on 7/6/15 and on 7/7/15, the PIC acknowledged the above findings.
4. On 7/7/15 at 9:50 a.m., the clean utility medication room in the medical surgical unit was inspected in the presence of the PIC. The inspection showed the following expired items:
ECG (electrocardiogram) conductive adhesive electrodes x 19, expired 11/13
Benzalkonium chloride antiseptic towelette x 5, expired 11/12
Lubrication jelly x 2, expired 3/13
ECG electrodes Ag/Agcl (silver/silver chloride) solid gel x 2, expired 12/13
Steri strip (wound care skin closure) ¼ inch x 4 inch, expired 5/15
Tegaderm film dressing (wound dressing) 4 inch x 41/2 inch, expired 3/15
Hydrogen peroxide 3% 16 oz (antiseptic), expired 5/15
During concurrent staff interview, the PIC acknowledged the expired items.
5. The operating room (OR) suite was inspected on 7/9/15 at 1:50 p.m., in the presence of the Director Perioperative, the Assistant Director Perioperative and the PIC.
Inspection of OR room 3 showed an opened lubricating jelly tube with a BUD of 7/2/15.
During concurrent interview, the Assistant Director Perioperative and the PIC acknowledged the finding.
The Assistant Director Perioperative stated the BUD was noted on the irrigation solution containers in the OR warmer.
Inspection of the OR warmer showed one bottle of 0.9% sodium chloride irrigation solution 2 Liters had a BUD of 7/7/15.
During concurrent staff interview, the Director Perioperative acknowledged the above finding.





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6. During a tour of the CT Scan Department and concurrent interview with the director of radiology (DR) department on 7/8/15 at 9:50 a.m., an opened "single use" bottle of Betadine Prep solution (solution to clean skin/wounds), and three open and used 16 ounce Hydrogen Peroxide (solution to disinfect skin surfaces) bottles were found inside a biopsy cart. None of the bottles had open or discard dates written on them.
During interview with the DR, the DR confirmed all teh bottles should be single use and they should be discarded.
7. During a tour of the orthopedic clinic on 7/8/15 at 3:35 p.m. an opened and used 16 once Hydrogen Peroxide bottle, two "single use" 500 ml (milliliter) Normal Saline irrigation bottles were found inside a supply cart. One bottle had only one date written on it, unclear if date was an open or discard date. The other bottles had no dates written on them.
A license nurse (LN) was interviewed concurrently; she was asked about the open and used items. LN stated "We use the Hydrogen Peroxide and the Saline irrigation for multiply patients here in the orthopedic clinic. We pour the solution onto gauze to clean wounds. We don't use the whole bottle on only one patient. I didn't know the bottle was for only one patient."
On 7/9/15 at 10:50 a.m., the pharmacy director (PD) was questioned regarding the Betadine Prep, Hydrogen Peroxide, and Normal Saline irrigation bottles being single use or multi-dose solutions. The PD stated "We have limited medications that are multi-dose, most of them are single use. Yes, the Betadine Prep, Hydrogen Peroxide and Saline irrigation bottles are single use."
The facility policy and procedure titled: "Multi-Dose Containers Drug Distribution", dated 2/7/13, 7.0, Procedures, indicates "The multi-dose medications will be dated when it is initially opened and a beyond use date of 28 days or less if indicated by the manufacturer will be indicated on the label."

Based on observation, staff interview, and document review, the hospital failed to ensure safe food handling practices as evidenced by not thawing frozen spinach product under running water. Failure to ensure standardized procedures are followed may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

Findings:

Food and Drug Administration (FDA) Food Code 2013 states, " improper thawing provides an opportunity for bacteria to grow to harmful numbers and/or produce toxins (poisons). Proper thawing when not under refrigeration requires product to be completely submerged under running water 70 degrees Fahrenheit (F) or below, and with sufficient velocity to agitate and float off loose particles in an overflow.

During an observation in the kitchen on 7/6/15 at 1:40 p.m., three packages of frozen spinach were observed in a food preparation sink. There was no running water. There was one soiled mixing bowl sitting on top of the packages of spinach. Cook 1 was asked how the spinach was to be thawed and he turned on the running water. The three packages of spinach blocked the sink drain and prevented draining of water.

During a concurrent interview the Food and Nutrition Manager (FNM) placed the spinach in container and started the water. The FNM stated the procedure was to thaw under running water. FNM stated the soiled mixing bowl should not be placed in the food preparation sink.
Review of in service training dated 4/22/15, and attended by Cook 1, stated " Thawing may only be done using one of the methods per FDA Food Code: 1. Refrigerated at 41 degrees F or below; 2. Submerged under cool running water (70 degrees or below out of faucet); ... "

Based on staff interview, and document review, the hospital failed to ensure patient weights were timely and accurate to meet nutritional and medical nutrition therapy (MNT) (therapeutic approach to treating medical conditions and monitored by a registered dietitian) needs of 3/6 patients (D 100,D 103, and D 104) that were reviewed for nutrition standards. These failures put patients at risk of compromised nutritional and medical status.


Findings:


Morrison Clinical Nutrition Management Manual approved 1/21/15, states " Weight evaluation is part of the nutrition assessment. Weight should be routinely evaluated to determine the outcome of nutrition interventions. If possible, a patient should be weighed on admission to any clinical setting and monitored frequently throughout the length of stay. Body weight and changes in body weight are two of the most reliable indicators of declining or improving nutrition status. "

1. Patient D 103 was admitted 6/27/15 with small bowel obstruction and incarcerated hernia (entrapped intestine). Patient D 103 underwent an emergent laparotomy with lysis (destruction of cells) of adhesions. Other medical conditions include cirrhosis (chronic liver disease) and chronic obstructive pulmonary disease (lung disease) urinary tract infection (bladder infection).
Weight on hospital admission was 64.4 kilograms actual weight by bed scale. Height was 155 centimeters stated.
Review of weight flow sheet showed weight and weight scale type:
6/30/15 60.9 kilograms bed scale
7/05/15 80.2 kilograms bed scale
7/8/15 75.7 kilograms digital

Review of nursing and physician progress notes did not show any assessment of the significant weigh changes of up to 19.3 kilograms (42.46 pounds) during 12 days. Progress notes did not show any notification of the physician of the weight changes. Food and Nutrition Manager (FNM) was asked on 7/8/15 at 4:00 p.m., to provide any notifications or assessments of the weight changes from the electronic or paper medical record but none was provided.
Nutrition Services nutrition screening dated 6/29/15, verified Registered Dietitian (RD) received the RN consult regarding history of weight loss and decreased appetite.
Nutrition initial assessment dated 7/2/15, stated appetite poor, moderate nutrition risk. Weight was documented at 64.4 kilograms.
Nutrition brief note dated 7/3/15 stated patient to start on TPN and high nutrition status. No weight was documented in the nutrition assessment.
Nutrition follow-up dated 7/6/15 stated weight at 80.2 kilograms and change of plus 15.8 kilograms (34.76 pounds) with assessment of the TPN. There was not assessment of the weight gain of 15.8 kilograms.
Nutrition reassessment dated 7/7/15 listed weight at 80.2 kilograms and listed a weight change of 16 kilograms. There was no discussion of the 15.8 kilogram weight change. The plan was for weight checks.
Altered nutritional status Interdisciplinary Plan of Care started on 6/29/15 through 7/7/15 showed interventions to monitor weight. Goal was for stable weight or gradual weight gain/ loss toward ideal body weight. There was no care planning for the weight changes.

2. Patient D 100 was admitted 6/23/15 with diagnoses of left foot pain. Diagnoses include history of bilateral venous stasis dermatitis and ulcerations (lesion) and hospitalization for wound care. Admission weight 56.8 kilograms. Height was 160.2 centimeters.
Nutrition assessment dated 6/27/15, stated nutrition risk level was moderate with poor meal intake. Nutrition goal was for weight within 7 days.
Nutrition services note dated 7/3/15, stated admission weight 56.8 kilograms. There was not current weight. Patient assessed at moderate acute nutritional risk.
Interdisciplinary Plan of Care for altered nutritional status was dated 6/29/15 with monitor weight. The goal was for stable weight or gradual weight gain/loss toward ideal body weight.
Patient medical record was reviewed on 7/7/15 and there was no weight for 15 days.
During an interview on 7/7/15 at 11:30 a.m., the FNM stated she would expect the RD ' s weight recommendations to be followed and communicated to the nursing staff.
During an interview on 7/7/15 at 11:35 a.m., staff nurse LN 1, stated Patient D100 was receiving wound care and not eating much.
During an interview on 7/7/15 at 8:45 a.m., CNO stated that weight was obtained on admission. Further patient weights "would be obtained with a physician order." CNO confirmed there was not policy to weigh a patient on a regular basis especially if they were in the hospital for more than the average length of stay.

3. Patient D104 was admitted 5/25/15 and discharged 6/4/15. Patient D 104 ' s admission weight was 98.7 kilograms. Height is documented as 165 centimeters. Patient D 104 was admitted for fall. Diagnoses included urinary tract infection with sepsis (presence in tissues of harmful bacteria and their toxins), congestive heart failure, hypertension (high blood pressure), Diabetes Mellitus (high blood sugars), acute and chronic renal failure.
Nutrition assessment dated 5/29/15 showed appetite was poor and nutrition risk level was high. Nutrition goal was for weight maintenance while in the hospital. Plan was to monitor weight, lab results.
Nutrition follow up note dated 6/1/15, stated admission weight and no new weight. Patient continues to have very minimal oral intake of meals and is at high nutrition risk.
Review of the weight flowsheet showed no weights documented after the 5/25/15 admission weight. Patient D 104 had a length of stay of 10 days with no periodic weight to assess and reassess Patient D 104 ' s nutrition status or progress toward goal.
During an interview on 7/7/15 at 8:45 a.m., CNO stated that weight was obtained on admission. Further patient weights " would be obtained with a physician order." CNO confirmed there was not policy to weight a patient on a regular basis especially if they were in the hospital for more than the average length of stay. CNO stated the expectation was for the RD to call the hospitalist and request weight for the patient.

Based on observation, interviews and record review the facility failed to assure staff maintain continuous ECG monitor alarms on while monitoring patients.
1. National Patient Safety Goal (NPSG) NPSG.06.01.01 is to improve the safety of clinical alarm systems. Clinical alarm systems are intended to alert caregivers of potential patient problems, but if they are not properly managed, they can compromise patient safety. Standards of nursing care in continuous electrocardiogram (ECG) monitoring indicate alarms must be appropriately set and turned on at all times (The Joint Commission, 2014).
Findings:
1. During a tour of the Emergency Department and a concurrent interview with the assistant director of the emergency department (ADED) on 7/6/15 at 3:01 p.m., the central ECG monitor (device that monitors heart) was observed with the alarms turned OFF. The patients ECG rhythms and heart rate were flashing on the monitor due to abnormalities, however there were no audible alarms and the monitor was unattended.
The ADED was interviewed and stated "Yes, I agree this is not safe, the alarms need to be on. I don't know what's wrong with the monitor that the alarms are off."
Minutes later the charge nurse (CN) who was supposed to be observing the monitor was interviewed. the CN stated "Yes, the monitor should be alarming. I don 't know what 's wrong with them now. "
According to the facility's policy entitled: "Patient Clinical Alarms" dated 2/6/14," C. Telemetry alarms," policy indicates " Monitor alarms are never to be turned off or have alarm functions bypassed by clinical patient care staff ."
the following day on 7/7/15 at 8:45 a.m., the central monitor alarms were observed and while the alarms were on they were very soft, and unable to be heard from a short distance. The ADED was questioned regarding the low alarm sound. and she stated "We can't adjust the monitor alarm sound because it requires a code or password to make any changes. We don't know that code or password so I 'm calling Biomed."

Based on interview with facility staff and review of documents the facility failed to ensure that the infection control officer implemented policies and procedures, based as much as possible on national guidelines that required adherence to nationally recognized infection prevention and control precautions, such as current Centers for Disease Control and Prevention (CDC) guidelines and recommendations, for infections/communicable diseases when not all physicians were required to provide documentation of annual screening for tuberculosis (TB).
Findings:
During an interview on 7/7/15 at 10:15 a.m. the Infection Preventionist stated members of the medical staff were not subject to the same requirements for tuberculosis screening as other healthcare personnel. Review of the facility policy titled " Tuberculosis Screening Skin Testing Procedure " supplied by the Infection Preventionist revealed instead of the documentation required for tuberculosis screening of hospital employees, members of the medical staff were allowed to provide an attestation that they were free from infectious tuberculosis at the time of initial application to the medical staff and then every two years at the time of reappointment. The Infection Preventionist stated the hospital followed CDC guidelines for the screening of healthcare workers (HCWs). According to the CDC's Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, HCWs refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to Mycobacterium tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full-time HCWs should be included in annual TB screening programs. All HCWs who have duties that involve face-to-face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program.

Based on observation, staff interview, and document review, the hospital failed to develop a system for evaluating hospital wide infection control prevention as evidenced by:

1. One of one kitchen bin ice machine and two of two pantry ice machines (maternity unit and ICU) were not cleaned and sanitized per manufacturer 's directions.

2. One food service staff did not wash her hands per policy.

3. One food service staff did not wash her hands when changing gloves when doing food preparation activities.

4. Maintaining seperation of clean and dirty items.

5. Handwashing.

6. Proper cleaning and mainteance of sterilizer units.

7. Proper use use of single use patient care items.

8. Cleaning and disinfecting of patient care items.

9. proper disinfecting of medication vials for patient use.

Failure to follow specific manufacturer's directions for cleaning and sanitizing ice machines put all patients at risk of food borne illness (infection by food or ice that contain harmful bacteria, parasites, viruses, or chemicals) for hospital licensed for 122 patients. Failure to thoroughly wash hands puts all patients at risk of food borne illness for a hospital licensed for 122 patients. As well as increased opportunity for the spread of infection to patient's receiving care in multiple areas of the facility.

Findings:

Immune-compromised patients are those patients whose immune mechanisms are deficient because of immunologic disorders (e.g., human immunodeficiency virus [HIV] infection or congenital immune deficiency syndrome), chronic diseases (e.g., diabetes, cancer, emphysema, or cardiac failure), or immunosuppressive therapy (e.g., radiation, cytotoxic chemotherapy, anti-rejection medication, or steroids). Immunocompromised patients have the greatest risk of infection caused by airborne or waterborne microorganisms. Guidelines for environmental Infection Control in Healthcare Facilities Center for disease Control 2003.

Review of Center for Disease Control guidelines (CDC) stated mold and slime build up inside ice machines allows bacteria growth and slime buildup inside commercial ice-making machines which can contain pathogenic microorganism.

1. During an observation on 7/8/15 at 10:10 a.m., the kitchen bin ice machine interior was white scale and brown and black substance on the tube connected to the water trough. There were significant white mineral-like deposits on sides and front of ice making area. During concurrent interview Engineer 1 stated he had just cleaned the ice machine and changed the filters every three months with a nickel safe ice machine cleaner. Engineer 1 stated he scraped the white scale but the hospital had very hard water and the scale was hard to get off. Engineer 1 stated the cleaner was the only chemical he used in preventive maintenance of the ice machine. Engineer 1 stated when asked about the brown/black substance on the tubing, " I guess I should clean that. "
Review of the Preventative Maintenance Work Order dated 6/24/15 for the kitchen bin ice machine, showed instructions which included clean condenser coil and filter, descale and clean.
During concurrent interview with the food and nutrition manager (FNM), stated that there was detailed ice machine cleaning directions attached to the ice machine and was not aware that the engineers were not following the manufacturer ' s directions provided by the ice machine. FNM acknowledged the interior of the ice machine had significant white mineral-like scale and brown and black substance. FNM acknowledged the ice machine was not sanitized as required and would provide ice from a sanitary source until the bin ice machine was properly cleaned and sanitized.
Review of the manufacturer ' s directions specified the cleaning with the nickel safe ice machine cleaner for step one. Step two required an approved sodium hypochlorite food equipment sanitizer to form a solution of 100 to 200 parts per million concentration.
On 7/7/15 at 2:00 p.m., the shoot ice machine on ICU pantry was observed. There was significant white coating on the catch tray.
On 7/8/15 at 11:30 a.m., the maternity unit shoot ice machine was observed. The catch tray had significant buildup of with white scale substance. During concurrent interview maternity charge nurse stated the Environmental Services (EVS) staff wipes down the outside daily. Review of the Non Patient Rooms task sheet for EVS showed the nourishment rooms were checked and cleaned two times per day as needed.
There were no directions specific to maintaining the exterior of the pantry shoot ice machine in clean and sanitary condition.

2. During an observation in cafeteria on 7/6/15 at 2:15 p.m., Food Service Worker 1 (FSW) changed disposable gloves and proceeded to make a sandwich.
During a concurrent interview FNM stated that in the cafeteria they allowed the food service workers to change gloves without washing their hands between glove changes because the handwashing sink was back in the kitchen. FNM stated there was no handwashing sink in the cafeteria for the food service workers to wash their hands.
Review of Department Meeting dated 4/22/15 review of policies stated " Wash your hands between EVERY (document emphasis) glove change. "
3. During an observation 7/7/15 at 10:10 a.m., FSW 2 was observed washing her hands. The hand washing consisted of wetting hands, applying soap and rinsing under running water.
FDA Food Code 2013 requires apply soap and scrub hands for 15- 20 seconds and then rinse with running water.

During concurrent interview the FNM stated acknowledged the FSW 2 had not followed the required washing for 20 seconds before she rinsed her hands.

During an interview with Infection Control Preventionist (ICP) on 7/7/15 at 3:45 p.m., regarding infection control involvement in food service operations. The ICP stated she was involved in observations of the food service area including ice machines. ICP starts she had not inspected the interior of the ice machine mechanical section. IPC stated engineering was responsible for the ice machine maintenance with a preventative maintenance schedule.




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A review of the facility's policy and procedure entitled, "Hand Hygiene Policy," dated 10/7/2010, indicates reasons, "for handwashing and hand antisepsis include:...Prior to donning gloves and after removing gloves...., to, "Decontaminate hands after removing gloves. NOTE: Gloves are not a substitute for hand hygiene....and, "The Infection Preventionist and designated A-Team member are responsible for implementing this policy."

A review of the manufacturer's booklet for the sterilizer units in the facility indicated, "The chamber drain strainer must be cleaned at least once a day...", and to "Wash the inside of the chamber and shelf assembly(plus any other loading equipment) with a mild detergent solution such as Steris Liqui-Jet or current Steris equivalent." The weekly recommended maintenance was to, "Flush the Chamber Drain".

A review of the facility's policy and procedure titled, "Cleaning and Disinfection of Noncritical Patient Care Items, dated 6/5/2014, indicates staff are to, "Follow manufacturer's guidelines regarding capability of items..."

A review of the facility's, "Surveillance, Prevention, and Control Program Plan", dated, 2/17/2015, indicated, "When reprocessing single-use devices, the hospital implements infection prevention and control activities that are consistent with regulatory and professional standards."

4. During a tour of the facility's Obstetrical floor and concurrent interview with the Director of Obstetrics (DOB) on 7/6/2015, at 2 p.m., a storage room designated as clean storage had two breast pumps and two IV poles with IV pumps on them along with various other clean supplies for use on patients. The two IV pumps had coverings over them and one breast pump had the same covering over it. One breast pump did not have any covering on it. When asked about the coverings the DOB stated, "The covers mean the items are clean." When asked about the breast pump which did not have a cover on it, the DOB stated, "I don't know if it (the breast pump) is clean or not. It should have a cover on it if it is clean."

5. During an observation of a surgical procedure on 7/8/2015, at 10:30 a.m., the surgical circulating nurse (SCN) put on gloves and handled a contaminated lap sponge to place it from the throw bucket into the sponge counter packaging. The SCN then removed her gloves and when to the computer and did some charting without washing her hands. This was repeated by the same SCN a second time during the final count of the items used during the surgical procedure.

6. During an tour of the surgical sterilization area on 7/8/2015 at 11:30 a.m., it was revealed the facility had no maintenance logs for the daily, or weekly cleanings for any of the sterilizer units.

During an interview with the Surgical Services Director (SSD) on 7/6/15 at 11:45 a.m., the SSD stated, "I know we do not have any logs like that." When asked why the facility was not cleaning and maintaining the sterilizer units according to the manufactures recommendations, the SSD indicated he was not aware there were daily, or weekly cleanings needing to be done. The SSD indicated there were no facility policy and procedures in place for the daily or weekly cleaning and maintenance of the sterilizer units.

During an interview with the SSD, on 7/8/2015 at 4:05 p.m., the SSD stated, "I called the Steris rep (Representative) and she told me the same thing about the cleaning an maintenance of the sterilizer units that they needed daily and weekly cleanings."






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Review of the hospital pharmacy newsletter used to train nurses on intravenous (IV) medication preparation titled " Tips on making safe IVs " showed " ...wipe vials tops with alcohol swap and allow to dry prior to puncturing ... "

Review of the American Journal of infection Control special article titled " APIC (Association for Professionals in infection Control and Epidemiology) position paper: Safe injection, infusion, and medical vial practices in healthcare " dated 4/10, showed " ...Cleanse the access diaphragm of vials using friction and a sterile 70 % isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab. Allow the diaphragm to dry before inserting any device into the vial ... "

9. On 7/8/15 at 9:45 am, LN 11 was observed administering medications to Patient P 400. Several medications including heparin 5000 units injection were administered. LN 11 removed the heparin vial cap and withdrew vial content with syringe and needle through the rubber stopper in the presence of the Charge RN. LN 11 did not disinfect the rubber stopper prior to piercing, contrary to the above training.
During concurrent staff interview, LN 11 and the Charge RN acknowledged heparin injection vial rubber stopper was not disinfected prior to piercing.
During the interview on 7/9/15 at 9:50 am, the infection preventionist indicated it was not necessary to clean the heparin vial rubber stopper with alcohol swab if cap was just removed. The hospital was unable to provide documentation to support this view.




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7. During a tour of the Emergency Department on 7/6/15 at 3:35 p.m., licensed nurse (LN) 5 was observed coming out of a patient's room with her gloves on, came to a clean supply cart, removed an item from the cart and continued with her work. Concurrently LN 5 was interviewed, and questioned regarding the use of dirty gloves to touch clean items. LN 5 stated LN 5 acknowledged she should have removed the dirty goves when she came out of the patients room.

During the same tour of the Emergency Department on 7/6/15 at 4:05 p.m., a urinal with approximately 400 mls. (milliliters) of urine was observed on top of a clean supply cart in a patient's room.

Concurrently , the quality coordinator (QC) and the infection preventionist (IP) were interviewed; they both agreed the (dirty) urinal should not be mixed with clean supplies.

During the same tour of the Emergency Department on 7/6/15 at 4:28 p.m., LN 6 was observed stripping down dirty linen from a gurney with gloves on. LN 6 removed her gloves, did not wash her hands after glove removal and continued her work. Concurrently LN 6 was interviewed, and questioned regarding handwashing after glove removal. LN 6 stated "I should have sanitized my hands after removing my gloves.

According to emergency department assistant director (EDAD), nurses clean ED rooms and gurneys after each patient use. During the same tour of the Emergency Department on 7/6/15 at 3:50 and 4:28 p.m. LN 6 and LN 7 were asked regarding wait time after cleaning a gurney with "Sani-cloth" wipes before the gurney is ready to be used again. LN 6 stated "no specific time." LN 7 stated "wait time is 10 seconds." Sani-cloth Q55172 Super wipes surface disinfectant germicidal cloths label was reviewed. According to manufacturer recommendations, the wait time is two minutes before the cleaned surface area can be used. Furthermore, the facility's policy titled "Cleaning and Disinfection of Noncritical Patient Care Items" dated 6/5/14, indicated " Manufacturer's guidelines regarding capability of items with specific disinfectants must be followed."

Based on interview and record review the facility failed to ensure a properly executed informed consent was on file in one of 30 sampled patients (Patient N 102). This failure could have led to the wrong procedure being performed on Patient N 102, and has the potential for wrong procedures to be performed on all patient's undergoing procedures within the facility.

Findings:

A review of the Facility's policy and procedure titled, "Informed Consent", dated 6/5/12, states, "Hospital staffs role in the informed consent process is limited to verifying that the physician obtained and properly documented the patient's informed consent before the physician is permitted to perform the medical procedure".....and, "The planned procedure should be written on the consent as ordered by the treating physician without any abbreviations of corrections. "

A review of the facility's policy and procedure titled, "Abbreviations Use/Unacceptable Abbreviations", dated 5/7/2015, indicates the letters DC stand for discontinue, or written as D/C stands for discharge." There are no other uses for the letters DC on the "Acceptable Abbreviations and Symbols list".

A review of Patient N 102's medical record revealed N 102 underwent a surgical procedure on 7/5/2015. The procedure documented by the licensed nurse was written as, "Suction D&C". The physician's order was written as, "Verify consent Urgent, T;N, Once scheduled, suction D&C".

During an interview with the Director of Quality Services (DQS), on 7/7/2015, at 10:00 a.m., the DQS stated, "The consent should have been clarified with the physician by the ER (Emergency Room) nurse prior to the patient signing it (informed surgical consent)."

During an interview with the Director of Surgical Services (DSS), on 7/10/2015, at 10:15 a.m., the DSS stated, "The OR (Operating Room) nurse who was reading the surgical consent should have stopped the line and the consent should have been clarified prior to the procedure being done." The DSS also stated, "We never use abbreviations on surgical consents. The OR nurses are responsible for making sure the surgical consents are correct. The first opportunity is in pre-op, the second chance in the OR during the time-out. The OR nurses should have caught this."

Based on interview with facility staff and review of documents the facility failed to ensure that the facility's policies allowed anesthesia to be administered only by a qualified anesthesiologist; a doctor of medicine or osteopathy; a qualified dentist, oral surgeon, or podiatrist; a certified registered nurse anesthetist; or an anesthetist ' s assistant under the immediate supervision of an anesthesiologist.
Findings:
Review of the facility's policy titled "Deep Sedation", as provided by the Director of Quality Services (DQS) during an interview on 7/7/15 at 3:30 p.m., revealed it stated deep sedation was only to be performed by staff anesthesiologists or emergency department physicians and intensive care unit (ICU) physicians who have privileges to perform deep sedation. However the policy also stated that in addition to the physician the only other required personnel was to be the registered nurse administering the medications for deep sedation and monitoring the patient. This policy may be more appropriate for conscious sedation than for deep sedation since deep sedation carries the risk of inadequacy of spontaneous respirations requiring airway management. If the proceduralist were occupied and unable to intervene in a case where the patient entered a deeper plane of sedation than intended there is no indication of who would perform any necessary intubation. The use of certain agents for deep sedation such as propofol in such a setting is not recommended by the manufacturer who states in its product labeling that the drug should be administered only by persons trained in the administration of general anesthesia and not involved in the surgical/diagnostic procedure. When used for sedation of intubated, mechanically ventilated adult patients in the ICU, the product labeling notes that the drug should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Deep sedation is not conscious sedation and should be administered only by persons who are trained in the administration of drugs that cause deep sedation and general anesthesia, are able to intubate the patient if necessary, and are not involved in the procedure.