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Based on observation, interview and record review the Hospital failed to obtain a physician's order for controlled medications from the Pyxis (an automated dispensing system), Demerol (a pain medication), Versed (an anti-anxiety medication) and oxygen prior to a colonoscopy. This was for 1 Outpatient (#1) out of 10 Outpatients and 31 Inpatients, a total sample of 41 patients. Findings include:

Observation on 6/9/14 at 12:00 noon in Exam Room #1, (the pre-operative area for Endoscopy) RN #2 had 2 vials of medication stored in a plastic bag in her left pocket. She took the medication and held it up and said, "I pulled all (Outpatient #1's) medications from the Pyxis and put them in my pocket before. We know what she (referring to the physician) usually orders."

Review of the Physician order sheet in the Procedure Room on 6/9/14 at 12:03 P.M., indicated the Physician order sheet was blank. No orders were written, despite RN #2 obtaining controlled medication from the Pyxis without a physician's order.

On 6/9/14 at 12:03 P.M., RN #2 then proceed to put oxygen via a nasal cannula at 2.5 liters on Outpatient #1 (without a physician's order). At this time, Surveyor #1 said to RN #3, "Could you show me where the physician's orders are?" RN #3 opened the patient's record, the physician order sheet was blank, and she said, "There are none, she (referring to the physician) writes the orders for everything after the procedure."

During an interview on 6/9/14 at 12:35 P.M. with RN #2, Surveyor #1 said, "I did not see any physician orders for the oxygen you administered (to Outpatient #1), nor any written orders for the Demerol and Versed prior to obtaining them from the Pyxis." RN #2 said, "There weren't orders." Surveyor #1 said, "Do you have a standing protocol from the physician?" She said, "We have an informal protocol, but nothing is written up."

Based on observation and interview, the Hospital failed to properly maintain the medical records in a location that was protected from fire and water damage. Findings include:

Review of the Hospital's Protection of Hard Copy Records Through Disaster and Recovery Policy indicated the health record must be guarded against unexpected losses due to a disaster or theft.

A tour of the Health Information Management Department (medical records) conducted on 6/10/14 at 3:20 P.M. with the Director and Assistant Director of Health Information Management, indicated the following concern:

-In both storage areas (cage 1 and cage 2), the medical records were stored on open metal shelves that were not completely enclosed. Some records were stored in wooden racks awaiting further filing and others in cardboard boxes. Both the Director and Assistant Director said the medical records were not stored in an effective manner that would protect them from fire or water sprinkler damage in both storage areas.

Based on record review and staff interview, the Hospital failed to ensure that 6 of 31 sampled Inpatient medical records (#1, #2, #3, #5, #6, and #18)), 1 of 6 of sampled discharged records (#28), and 4 of 10 sampled Outpatient medical records (#2, #3, #4, and #5), were legible, completed, dated, timed and authenticated in written or electronic form by the person responsible for providing the service, consistent with hospital policies and procedures. Findings include:

According to the Hospital's Policy and Procedures for Medical Record Content & Charting Guidelines, "Basic Requirements," stated that "Entries must be timely and made by the individual who has knowledge of the act, event, or assessment...all medical record entries are dated, timed and signed (by written signature, electronic signature or identifiable initials) by the individual who made the entry."

1. For Inpatient #1, the Hospital failed to ensure that the physician completed, certified, signed and dated the patient's admission for inpatient psychiatric treatment.

Patient #1 was admitted to the Fowler Psychiatric Unit on 6/4/14.

Inpatient chart review on 6/9/14 indicated a blank "ADMISSION Certification for Inpatient Hospitalization" form. There was no date, estimation of the days/weeks of inpatient treatment necessary for the Patient, nor the attending physician's signature and date signed.

During interview on 6/9/14 at 2:00 P.M., the Fowler Unit's Director and Nurse Manager said that the Patient's attending physician failed to complete, sign and date the certification for the patient's admission to the inpatient psychiatric unit, within 48 hours of admission, as required by the Hospital's policy and procedures.

2. For Inpatient #2, the Hospital failed to ensure that the physician completed, certified, signed and dated the patient's admission for inpatient psychiatric treatment.

Patient #2 was admitted to the Fowler Psychiatric Unit on 5/13/14.

Patient chart review on 6/9/14 indicated a blank "ADMISSION Certification for Inpatient Hospitalization" form. There was no date, estimation of the days/weeks of inpatient treatment necessary for the Patient, nor the attending physician's signature and date signed.

During interview on 6/9/14 at 2:00 P.M., the Fowler Unit's Director and Nurse Manager said that the Patient's attending physician failed to complete, sign and date the certification for the patient's admission to the inpatient psychiatric unit, within 48 hours of admission, as required by the Hospital's policy and procedures.

3. For Inpatient #3, the Hospital failed to ensure that the physician completed, certified, signed and dated the patient's admission for inpatient psychiatric treatment.

Patient #3 was admitted to the Fowler Psychiatric Unit on 5/21/14.

Patient chart review on 6/9/14 indicated a blank "ADMISSION Certification for Inpatient Hospitalization" form. There was no date, estimation of the days/weeks of inpatient treatment necessary for the Patient, nor the attending physician's signature and date signed.

During interview on 6/9/14 at 2:00 P.M., the Fowler Unit's Director and Nurse Manager said that the Patient's attending physician failed to complete, sign and date the certification for the patient's admission to the inpatient psychiatric unit, within 48 hours of admission, as required by the Hospital's policy and procedures.

4. For Discharged patient #28, the Hospital failed to ensure that the physician signed and dated the patient's History and Physical Examination, and the Admission Psychiatric Evaluation.

Discharged patient #28 was admitted to the Fowler Psychiatric Unit on 5/9/14 and discharged from the Hospital on 5/22/14.

Patient chart review on 6/10/14 indicated the Patient's History and Physical Examination of 5/9/14 and the Admission Psychiatric Evaluation of 5/9/14 were not signed by the physician.

During interview on 6/10/14 at 10:45 A.M., the Fowler Unit's Director and Nurse Manager said that the Patient's attending physician failed to sign the Patient's History and Physical Examination of 5/9/14 and the Admission Psychiatric Evaluation of 5/9/14, within 30 days of their completion, per the Hospital's policy and procedures.



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5. For Inpatient #18, the Hospital failed to ensure the physician timed and legibly signed the Consent for Surgery or Other Procedure Form.

Inpatient #1 was admitted to the Hospital on 6/4/14.

Review of the Consent for Surgery or Other Procedure Form indicated the physician signed and dated the form in the appropriate areas on 6/4/14. The signature was not legible and the form was not timed.

During an interview with Director of Health Information Management on 6/11/14 at 3:00 P.M., she said the physician must sign, dated and time their entries in the medical records and their signature needs to be legible.



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6. For Inpatient #6, the Hospital failed to have the informed consent for a blood transfusion dated and timed by the Nurse who was the witness (attesting to this being the correct patient or next of kin).

Inpatient #6 was admitted on 6/8/14 to 2 North with a diagnosis of anemia and received 2 units of packed red blood cells.

The Informed Consent for Blood and Blood Product Transfusion indicated the patient's next of kin signed for the consent for the blood transfusion on 6/8/14. The Nurse who signed as the witness did not date and time this form to indicated when she witnessed this patient's next of kin signing it (attesting to this being the right next of kin for this patient).

During an interview on 6/10/14 at 3:10 P.M., when Surveyor #1 asked the Director of Clinical Services where did the witness of the blood transfusion, date and time this consent, separate from the next of kin. She said that there is no date and time for when the witness signed the blood transfusion consent, it is the same date with no time.

7. For Inpatient #5, the Hospital failed to have the informed consent for an Upper Endoscopy with conscious sedation timed by the Nurse who was the witness (attesting to this being the correct patient).

Review of Inpatient #5's consent for an Upper Endoscopy with conscious sedation, the witness and the patient signed this form but there was not an area to indicate what time the patient signed the consent and what time the the witness signed the consent.


During an interview on 6/9/14 at 9:50 A.M. with the Director of Continuous Quality Improvement, she stated, "That is an old form that should not have been used. We have a space on the current consent form for the time the consent was signed."

8. For Outpatient #2, the Hospital failed to complete the anesthesia consent form with the type of surgery and to time the consent when it was executed.

Review of Outpatient #2's, consent for anesthesia indicated the patient and the Anesthesiologist signed the form on 6/10/14 and did not time it. The area for the type of surgery or procedure needing Anesthesia was left blank.

During an interview with the Director of the Operating Room (OR) on 6/10/14 at 4:00 P.M., she stated that the type of surgery should have been filled in with the time the consent was obtained.

9. For Outpatient #3, the hospital failed to complete the consent for anesthesia in regards to a witness signature and the time and date the Anesthesiologist signed the form.

Record review indicated Outpatient #3, had a cystoscopy with removal/replacement of bilateral stents on 6/10/14. This anesthesia consent was not signed by a witness to attest that it was the correct patient (this area was left blank). The Anesthesiologist did not date or time this form as to when this consent was obtained.

10. For Outpatient #4, the hospital failed to have the anesthesia consent form timed when this consent was obtained and to have a witness signature.

Record review indicated Outpatient #4, had a cataract extraction with an intraoccular implant on 6/10/14. The consent for anesthesia was not timed by the Physician or the patient (it was left blank). This consent was not signed by a witness (this area was left blank).

11. For Outpatient #5, the anesthesia consent was not timed by the patient, the witness or the physician.

Record review indicated Outpatient #5, had a cataract extraction with an intraoccular implant on 6/10/14. The anesthesia consent was signed and dated 6/10/14 and the time it was signed was blank. The witness did not date or time this consent and the physician did not time this form (it was left blank).

On 6/10/14 at 4:15 P.M., during review of the anesthesia consents for Outpatients #2, #3, #4, and #5 and interview with the Director of the OR, she stated that they needed to be complete.

Based on record review and observation, for 3 of 31 Inpatients (#5, #8, and 28) the Hospital failed to have all orders, including verbal orders, dated, timed and authenticated promptly by the ordering practitioner responsible for the patient's care. Findings include:

Review of the hospital's policy on Medical Record Content and Charting Guidelines, undated stated, under basic requirements, "All medical record entries are dated, timed and signed (by written signature, electronic signature or identifiable initials) by the individual who made the entry." Under provider orders it states, "Verbal/Telephone orders needed to be countersigned within 48 (referring to hours) of entree (sic)."

1. Review of Inpatient #5's record on 6/9/14 at 9:50 A.M., indicated the verbal/telephone orders were not countersigned (They lack a physician's signature, the approval/validation that the order taken off, and written by the nurse was accurate).

Inpatient #5 was admitted on 6/5/14 and diagnosed with acute kidney injury and dehydration.

The following verbal/telephone orders were not countersigned by the physician:

On 6/5/14 at 6:55 P.M. - Strict intake and output, Obtain a urine for sodium and creatinine and osmolality.
On 6/5/14 at 8:25 P.M. - Give a bolus of 500 milliters (ml) of Normal Saline once and then continue with Normal Saline 1000 ml with 40 milli-equivalents of Potassium at 125 ml/hour continuously.
Recheck the blood pressure in one hour. If the systolic blood pressure is 110 or greater give Coreg (an antihypertensive and congestive heart failure medication) as previously ordered.

During an interview with the Director of Patient Services on 6/9/14 at 3:30 P.M., she stated, "For verbal orders, it is 48 hours you have before it needs to be signed."

Record review and interview on 6/11/14 at 9:30 A.M., with the Director of Patient Services for 2 North, she stated that the 2 verbal orders from 6/5/14 at 6:55 P.M. and at 8:25 P.M. were still not countersigned by the physician (for greater than 5 days).


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2. For Inpatient #8's record indicated the verbal/telephone orders were not countersigned. They lack a physician's signature, time and date.

The Inpatient Registration Record, dated 5/21/14, indicated that the physician admitted Patient #8 to the Hospital for a fractured left hip and fractured right ankle after a fall at home. The Inpatient Registration Record indicated additional diagnoses included: fibromyalgia, migraine headaches, and depression.
The verbal/telephone Physician Orders, dated from 5/21/14 to 5/26/14, indicated that the nurses obtained and read back the following orders which, as of 6/12/14, the Physician did not cosign, date, or time:
-The Medication Reconciliation Form, at 9:27 P.M. on 5/21/14, which included medication orders for Carisoprodol (medication used to treat fibromyalgia), Diazepam (antianxiety), Fluoxetine Hydrochloride (antidepressant), Hydromorphone Hydrochloride (analgesic for migraine headaches), and Trazodone (antidepressant).
-The Physician Order, at 7:10 A.M. on 5/22/14, for compression stockings.
-The Physician Order, at 3:15 P.M. on 5/22/14, for Bacitracin (antibiotic) and Betadine (antiseptic).
- The Physician Order at 9:55 A.M. on 5/26/14, included: transfer Patient #8 to the rehabilitation Unit; weight bearing as tolerated to the left lower extremity; no weight bearing to the right lower extremity until the walking boot arrived, and follow-up with the Orthopedic Surgeon.


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3. For Inpatient #28, the Hospital failed to ensure the physician signed and dated Telephone Orders for antipsychotic, antianxiety and antidepressant medications, as required.

Patient #28 was admitted to the Fowler Psychiatric Unit on 5/9/14 with a diagnosis of Schizoaffective and Bipolar Disorder.

Patient chart review on 6/10/14 indicated the Patient's attending physician gave a Telephone Order on 5/11/14 at 1835 hours (6:35 P.M.): "Give 10 mg (milligrams) Haldol (an antipsychotic medication) PO (by mouth) x (times) 1 now" and "Give 2 mg Ativan (an antianxiety medication) PO x 1 now." There was no evidence that the physician signed, dated or timed this order. The physician gave another Telephone Order on 5/11/14 at 1840 hours (6:40 P.M.): "Give Trazadone (an antidepressant medication) 100 mg PO Q (at) HS (Hour of Sleep)." There was no evidence that the physician signed, dated or timed this order.

During interview on 6/10/14 at 10:45 A.M., the Fowler Unit's Director and Nurse Manager said that the Patient's attending physician failed to sign the Patient's Telephone Orders of 5/11/14, within 48 hours of their completion, per the Hospital's policy and procedures.

Based on record review and interview the Hospital failed to properly execute informed consents for blood transfusions for 2 Inpatients (#6 and #8) of 31 Inpatients. Findings include:

The Policy/Procedure titled Transfusions, Blood and Blood Components, dated 1/2012 indicated that prior to the transfusion, the Physician will explain to the patient the risks and benefits of the procedure. The Policy indicated informed consent for the transfusion will be obtained and verified by the patient's signature using the Informed Consent for Blood and Blood Products Transfusion form.
The Policy/Procedure titled Consent for Treatment, dated 5/2012, indicated the physician was responsible for obtaining the informed consent and providing sufficient information to enable the patient to decide whether to submit to treatment. The Policy/Procedure indicated assist in completing the documentation of informed consent, which must appear in the Surgical Consent Form, the Progress Notes, or the History and Physical. The Policy/Procedure indicated the nurse must review the chart for proper documentation, and if present, may ask the patient to sign the consent form. If the informed consent is not present, then the nurse must contact the physician to resolve the situation prior to the procedure.

1. For Inpatient #6, the Hospital failed to have the physician obtain and sign the Informed Consent for Blood and Blood Product Transfusion.

Inpatient #6 was admitted to 2 North with a diagnosis of anemia and received 2 units of packed red blood cells.

Record review on 6/10/14 at 3:10 P.M., indicated that Inpatient #6's Informed Consent for Blood and Blood Product Transfusion was signed by the patient's next of kin and a witness (a staff nurse). The consent was not signed by the physician, who is the person qualified to educate and discuss with the patient the risks and benefits of a blood transfusion.

During an interview on 6/10/14 at 3:10 P.M., Surveyor #1 asked the Director of Clinical Services, "Where is the area for the Physician to sign the Consent for a blood transfusion with the patient?" She said, "The Physicians do not sign the consent with the patient. A nurse signs as a witness."


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2. For Inpatient #8, the Hospital failed to have the physician obtain and sign the Informed Consent for Blood and Blood Product Transfusion.

The Inpatient Registration Record, dated 5/21/14, indicated that the physician admitted Patient #8 to the Hospital for a fractured left hip and fractured right ankle after a fall at home.

The Physician Order, dated 5/25/14, included a complete blood count.

The Pathology Inquiry Report, dated 5/25/14, indicated Patient #8 's hemoglobin level = 26.1% (normal range is 34.9 to 44.9%) and his/her hematocrit level = 8.3 grams per deciliter (G/dl) (normal range is 11.9 to 15.5 G/DL).

The Physician Order, dated 5/25/14, included transfuse one unit of packed red blood cells.

The Interdisciplinary Progress Notes, dated 5/25/13 and written by the physician, indicated that Patient #8 was to receive a unit of packed red blood cells and did not indicate the physician provided sufficient information to enable the patient to decide whether to submit to treatment.

The Patient Note, dated 5/25/14, indicated that the nurse educated Patient #8 on the signs/symptoms of hemolytic reactions.

The Informed Consent for Blood and Blood Products Transfusion form, dated 5/25/14, was signed by Patient #8 and the registered nurse and not the physician.

There was no evidence in the medical record that the physician indicated the physician obtained the informed consent and provided sufficient information to enable the patient to decide whether to submit to treatment.

Based on observations, and staff interview the Hospital Pharmacy failed to ensure that the production of sterile products followed accepted professional principles, including compliance with applicable Federal and State laws, regulations, and guidelines governing pharmaceutical services, as well as, standards or recommendations promoted by nationally recognized professional organizations such as the American Society of Health-System Pharmacists. Specifically, that sterile products should be prepared and labeled in a suitable environment by appropriately trained and qualified personnel. Findings include:

According to United States Pharmacopeia <797> Pharmaceutical Compounding Sterile Preparations (CSP), 2012:

Low-Risk Level CSPs with 12-Hour or Less beyond use date (BUD)- A laminar airflow workbench (LAFW) or a biological safety cabinet (BSC) that cannot be located within an ISO (International Organization for Standardization) Class 7 buffer area, then only low-risk level nonhazardous and radiopharmaceutical CSPs pursuant to a physician's order for a specific patient may be prepared, and administration of such CSPs shall commence within 12 hours of preparation or as recommended in the manufacturers' package insert, whichever is less. Low-risk level CSPs with a 12-hour or less BUD shall meet all of the following four criteria:
1. Maintain ISO Class 5 as described in Facility Design and Environmental Controls for exposure of critical sites and shall be in a segregated com¿pounding area restricted to sterile compounding activities that minimize the risk of CSP contamination.
2. The segregated compounding area shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to construction sites, warehouses, or food preparation. Note that this list is not intended to be all inclusive.
3. Personnel shall follow the procedures described in Personnel Cleansing and Garbing and Additional Personnel Requirements prior to compounding. Sinks should not be located adjacent to the ISO Class 5. Sinks should be separated from the immediate area of the ISO Class 5 Primary Engineer Control device.
A. Observations on 6/10/14 at 9:30 A.M. in an area of the pharmacy with limited traffic, this surveyor observed a horizontal laminar flow hood for the sterile compounding of sterile, non-hazardous parenterals. The area and environmental controls did conform to standards for the compounding of sterile products (CSPs) in the United States Pharmacopeia (USP) Chapter 797, as the hood was in a congested, relatively unclean area, that does not appear to minimize the risk of CSP contamination ". The pharmacy does follow USP <797> guidelines by assigning a beyond-use date (BUD) of <12 hours.
4. The specifications in Cleaning and Disinfecting Areas, Personnel training and Competency Evaluation of Garbing, Aseptic Work Practices and Cleaning/Disinfection Procedures, and Viable and Non-Viable Environmental Sampling (ES) Testing shall be followed as described in this chapter.

A. Observations on 6/10/14 at 9:35 A.M. in an area of the pharmacy with limited traffic, the surveyor observed a vented biologic safety cabinet for the sterile compounding of sterile, hazardous (chemotherapy) parenterals. The area and environmental controls did not conform to standards for the compounding of sterile products (CSPs) in the United States Pharmacopeia (USP) Chapter 797, as the hood was in a congested, relatively unclean area, that does not appear to minimize the risk of CSP contamination". USP <797> guidelines do not allow a beyond-use date (BUD) of up to 12 hours for hazardous (chemotherapy) products.

B. During an interview on 6/10/14 at 9:35 A.M., with the Director of Pharmacy, he said that he was aware of the congested area, but that there was no space in which the hoods could be relocated.

C. During an interview on 6/10/14 at 2:45 P.M., with the Chief Executive Officer (CEO) and Surveyor #1, the lack of compliance was discussed. The CEO indicated that an expanded, alternative location would be explored.

Based on observation, interview, and record review, the Hospital failed to ensure the Housekeeping staff maintained the physical environment to ensure the well being of patients on 1 of 4 Inpatient Units. The Rehabilitation Unit's physical environment had accumulation of dust in patient care areas . Findings include:
Review of the Environmental Services Department Duty List #103, dated 3/15/14 and signed by the housekeeper, indicated that cleaning duties included; high dust areas above eye level twice weekly; sanitize all horizontal surfaces, spot clean vertical surfaces, and inspect the room.

Surveyor #3 toured the Rehabilitation Unit at 8:30 A.M. on 6/10/14 and observed the following:
- Room 204, Beds #1 and #2: dust on tops of the televisions, on top of the heating/cooling unit, on top of the light over the sink in the room, and on top of the paper towel dispenser.
- Room 205, Beds #1 and #2: dust on tops of both televisions, tape residue on the handle of the television located at Bed #1, dust on top of the heating/cooling unit and in the vent on front of the unit, and dust on the windowsill.
- Room #206, Beds #1 and #2: dust on the heating/cooling unit, on the windowsill, and tops of both televisions and extender arms.

Surveyor #2 and Surveyor #3 toured the Rehabilitation Unit at 1:00 P.M. on 6/11/14 and observed the following:
- Room 202, Beds #1 and #2: dust on the heating/cooling units and on the vents of the units located in both windows, and dust on the windowsills.
- Room 204, Beds #1 and #2: dust on tops of the televisions, on top of the heating/cooling unit, and on top of the light over the sink in the room.

Surveyor #3 interviewed the Housekeeping Director at 10:00 A.M. on 6/11/14. The Housekeeping Director said he posted the housekeeping duties in the Housekeeping Closet on the Rehabilitation Unit. The Housekeeping Director said the housekeeper cleaned the high dust areas, located above eye level, when the patient was discharged. The Housekeeping Director said the housekeeper cleaned the eye level surfaces daily. The Housekeeping Director said the housekeeper worked 7:00 A.M. until 3:30 P.M. and was responsible for the Rehabilitation Unit as well as 2 other units in the Hospital. The Housekeeping Director said he inspected one room on the Rehabilitation Unit weekly for cleanliness.

Based on observation and interview, emergency equipment was not maintained to ensure an acceptable level of safety and quality for two areas of the hopsital. Findings include:

1. On tour of the Endoscopy Suite on 6/9/14 at 9:15 A.M., with the Director of Outpatient Services and RN #1, Surveyor #1 observed equipment on the code cart, the adult ambu mask was partially deflated (which could create an ineffective seal for ventilation).

During an interview on 6/9/14 at 9:15 A.M., with RN #1, she looked at it with Surveyor #1 and stated that it would be replaced.

2. On tour of Diagnostic Imaging and Ultra Sound on 6/12/14 at 10:50 A.M., Surveyor #1 observed the equipment on the code cart, the mask on the mouth to mask resuscitator was completely deflated (this would create an ineffective seal for ventilation).

During an interview on 6/12/14 at 10:50 A.M., with Ultrasound Technician #1, she stated, "There will be no seal with that (referring to this mask)."

Based on observations, interviews, and document review, the Hospital failed to consistently ensure an acceptable level of infection prevention practice. This was related to wearing personal protective equipment, documenting high level disinfectant solution changes and breeches of infection (with the initiation of intravenous starts and handwashing) control for 1 Inpatient (#5) out in a total sample of 31 Inpatients and for 2 Outpatients (#1, #2) out of a total of 10 Outpatients. In addition, for the lack of documented Hepatitis B immunity/vaccination and 1 Employee (#11) out of 32 employees sampled. Findings include:

1. For Outpatient #1, the Hospital failed to ensure an acceptable level of infection prevention practice related to the initiations of intravenous (IV) starts.

Review of the Hospital's policy on Intravenous Insertion and Maintenance, date 11/2010 it states, "Hand hygiene is the single most important means of preventing the spread of infection." under Procedure it states, "Prep arm with Chlorhexidine (a topical skin disinfectant) solution, and allow to dry."

According to the manufacturers guidelines for Chlorhexidine, it states, "Use for the preparation of the patient's skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection... Apply swab to skin using repeated back-and-forth strokes for 15 seconds. Allow the prepped area to dry for 30 seconds. Do not blot or wipe dry."

a. Outpatient #1 was in Endoscopy for a scheduled colonoscopy with conscious sedation. Surveyor #1 observed an intravenous insertion on 6/7/14 at 10:27 A.M., performed by Registered Nurse (RN) #1. RN #1 prepped this Patient's skin over the left lower arm twice with 2 Chlorhexidine pads, wiping the insertion site for less than 5 seconds. The Chlorhexidine was only in contact with this Patient's skin for 2 seconds and then RN #1 took a dry 2 by 2 gauze pad and wiped off the Chlorhexidine, inadequately disinfecting the skin. RN #1 then inserted a #20 angiocatheter.

b. Inpatient #5 was in Endoscopy for a scheduled upper endoscopy with conscious sedation. Surveyor observed an intravenous insertion on 6/7/14 at 11:30 A.M., performed by RN #2. This Nurse prepped this Patient's skin over the right anticubital area with 2 Chlorhexidine pads, wiping the insertion site for less 5 seconds. The Chlorhexidine was only in contract with this Patient's skin for 3 seconds and then RN #1 took a dry 2 by 2 gauze pad and wiped off the Chlorhexidine, inadequately disinfecting the skin. RN #1 then inserted a #22 angiocatheter.

2. For Outpatient #1, the Endoscopy Technician failed to wear protective eyewear/face shield during the enzymatic cleaning of the colonoscope.

According to the Hospital's policy on Cleaning of Flexible Endoscopes, dated 3/2014, it states, " Use appropriate personal equipment (eye protection...)."

a. The Surveyor observed on 6/9/14 at 12:28 P.M., the cleaning of a colonoscope by the Endoscopy Technician. She was wearing her own eye glasses during the cleaning procedure, but no protective goggles or face shield. The Surveyor asked, "You are not wearing protective goggles or a face shield to prevent a splash to the eyes, nose, or mouth from the dirty colonoscope." She said, "I have tried different goggles but none fit."

During an interview on 6/7/14 at with the Director of Patient Care Services, she said, "She should be wearing protective face wear. That is our policy."

3. For Outpatient #2 the Circulating Nurse failed to perform hand hygiene after picking up a label on the Operating Room Floor.

Patient #2 had a cataract extraction with an intraoccular implant.

The Surveyor observed in the Operating Room (OR) on 6/10/14 at 1:06 P.M. Circulating Nurse #1, performed a time out for Outpatient #2's surgery. At 1:14 P.M. Circulating Nurse #1 dropped a label on to the floor, she picked it up from the contaminated OR floor and she did not wash her hands. With contaminated hands, she applied labels to this Residents' chart, wrote in the intra-operative section of the chart, moved a swivel stool with her contaminated hands and then removed a mayo table. After the cataract surgery was finished, with contaminated hands she removed the paper tape on this patient's head postoperatively, with a potential of cross contamination to this Patient's face.

4. During tour of an Ultrasound (US) Room on 6/12/14 at 10:50 A.M., Surveyor #1 asked Ultrasound (US) Technician #1, "What are the patient needs requiring the use of vaginal probes for?" She stated, "Anytime we do internal pelvic exams for staging pregnancies and when there is pelvic pain or bleeding." Surveyor #1 asked, "What are you doing between patients with the vaginal probes?" She said, "We follow an extensive cleaning and rinsing with Cidex (a high level disinfectant)."

According to the Cidex manufacturers guidelines, it states. "Always use personal protective equipment (PPE) when handling Cidex. Cidex stains are permanent and and can occur on clothing, skin, nails, transducers, or any contact surfaces. This is one of the things PPE protects against."

Review of the high level disinfection procedure for the vaginal probes with US Technician #1 and #2 indicated they did not have a formal system in place for documenting when the 14 day Cidex soaking solution needed to be changed (to ensure it is not out of date). Both US Technicians were changing the solution from April 2013 to April 2014 based on a date the Technicians wrote on a sticker on the soaking containers.

Review of US Technician #2's system for changing the soaking solution indicated in April 2014 to current, she put dots on a calendar for the 14 day Cidex solution changes. She said, "I will add the 14 day change schedule to our documentation tool and ensure others know this in the event others cover leave time."

During an interview and review of the PPE for cleaning the probes with Cidex on 6/12/14 at 10:50 A.M., with US Technician #1 and #2, they said that they did not have nor wear waterproof aprons over the protective gowns.



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5. For Employee #11, The Hospital failed to ensure evidence of a Hepatitis B vaccine and immunization record.

According to the Employee Health Policy for infection control, dated 1/2005, it states, "Employees whose job category will place them at risk for exposure to blood borne pathogens will be offered the Hepatitis vaccine series. The employee may refuse the series by signing the Hepatitis B Declination Form. Employees whose job category will place then at risk for exposure to blood borne pathogens will be offered the Hepatitis B vaccine series."

Employee #11 was hired by the Hospital in 6/2012 as a Surgical Technician for the operating room. A Surgical Technician would be considered at risk for exposure to blood borne pathogens.

Review of the Technician's Health File on 6/12/14 indicated there was no evidence of a Hepatitis B vaccine and immunization record.

During an interview on 6/12/14 at 12:20 P.M. with the Infection Control Officer, she said there was no documentation of whether the employee had previously received the Hepatitis B vaccine or was offered it after being employed.

Based on record review and interview, the Hospital failed to obtain a properly executed consent prior to a scheduled procedure/surgery for 2 Inpatients (#5 and #18 ) in a total sample of 31 Inpatients and for 6 Outpatients (#1, #2, #3, #4, #5, and #7) in a total sample of 10 Outpatients. Findings include:

1. For Outpatient #1, the Hospital failed to obtain written informed consent for a colonoscopy.

According to the Hospital Policy on Consent for Surgical Treatment, dated 12/2009, it states, "Patients undergoing any surgical or diagnostic procedure (at name of Hospital) must have a signed consent in their chart prior to the administration of any preoperative medication or initiation of the procedure."

Observation on 6/9/14 at 10:20 A.M. in Endoscopy indicated that this Resident signed the consent for a colonoscopy with conscious sedation and then the Nurse signed as a witness at the same time, 10:20 A.M. Surveyor #1 observed that the consent was not signed, timed and dated by the physician performing the procedure, the person competent to adequately explain the risks, benefits and alternatives of the procedure.

The Surveyor observed on 6/7/14 at 12:02 P.M., Outpatient #1 receiving a colonoscopy without an adequately executed informed consent.

The Surveyor observed on 6/7/14 at 12:26 P.M., after Outpatient #1's colonoscopy with conscious sedation, the consent still lacked a physician's signature (it was left blank), and evidence of a properly executed consent.

During an interview on 6/7/14 at 12:27 P.M. with the Director of Outpatient Services, the Surveyor stated, "On the procedure consent form, the section for the physician's signature, date and time for the colonoscopy with conscious sedation consent was left blank." The Director of Outpatient Services said, "It should have been there."

2. For Inpatient #5, the Hospital failed to adequately execute an informed consent for an upper Endoscopy with conscious sedation.

The Surveyor reviewed Inpatient #5's medical record on 2 North Unit on 6/9/14 at 9:50 A.M., which indicated this patient's consent for an Upper Endoscopy with conscious sedation was signed by this patient and a nurse (as the designated witness) on 6/6/14. It was not timed when the witness signed the consent.

During an interview with the Nursing Director of 2 North, she said, "The nurses obtain the consent and sign this with the patient." The Director of Continuous Quality Improvement stated, "That is an old form that should not have been used. We have a space on the current consent form for the time the consent was signed."

3. For Outpatients #2 #3 #4, #5 and #7, the informed consents for surgery were not properly executed. The Physician is the only person qualified to obtain the surgical content, explaining the surgery, the risks, benefits and alternatives.

a. For Outpatient #2, record review indicated this patient had a cataract extraction with an intraocular lens implant on 6/10/14. The Surgical consent was signed and dated by the patient and the witness (a nurse) on 6/10/14 at 12:40 P.M.. This Patient's Surgical consent was not obtained by the physician. The physician signed and dated it on 6/10/14 at 12:45 P.M., five minutes after the patient consent was obtained by the nurse.

b. For Outpatient #3, record review indicated this patient had a cystoscopy with removal/replacement of bilateral stents on 6/10/14. The surgical consent was signed by the patient, the witness (a nurse) and the physician on 6/10/14. It was not timed when this consent was executed. (The area for the time was not on this form.)

c. For Outpatient #4, record review indicated this patient had a cataract extraction with an intraocular implant on 6/10/14. The surgical consent was signed by the patient, the witness and the Physician on 6/10/14. It was not timed. (The area for the time was not on this form.)

d. For Outpatient #5, record review indicated this patient, had a cataract extraction with an intraocular implant on 6/10/14. The surgical consent was signed but not timed by the patient. The witness (a nurse) dated and signed on 6/10/14 at 11:55 A.M. and the physician dated and signed dated on 6/10/14 at 12:00 P.M.

e. For Outpatient #7, record review indicated this patient had a breast lumpectomy with the placement of a catheter. The surgical consent was not timed by the patient, the witness or the physician. (The area for the time was not on this form.)

During an interview and review of Outpatients #2, #3, #4, #5, and #7, surgical consents with the Director of the Operating Room (OR) on 6/10/14 at 4:00 P.M., she stated that these forms need to be timed and dated with the patient and the physician.


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4. For Inpatient #18, the Hospital failed to ensure the physician timed the Consent for Surgery or Other Procedure Form.

Patient #1 was admitted to the Hospital on 6/4/14.

Review of the Consent for Surgery or Other Procedure Form indicated the physician signed and dated the form in the appropriate areas on 6/4/14, however it was not timed when it was signed. (The area for time was not on this form).

During an interview with Director of Health Information Management on 6/11/14 at 3:00 P.M., she said the physician must sign, date and time their entries in the medical records and their signature needs to be legible.

Based on record review and interview, the Hospital failed to complete a post-anesthesia evaluation within 48 hours after a surgery or procedure requiring anesthesia services for 1 Inpatient (#14) in a sample of 31 Inpatients. Findings include:

Review of the Hospital Policy on Post Anesthesia Care indicated that a patient should be observed to reduce post-operative adverse events.

Patient #14 was admitted to the Hospital on 6/4/14, and had a surgical procedure on 6/6/14.

Review of the medical record indicated the patient had a Pre-Anesthesia Evaluation on 6/6/14 at 10:30 A.M. for a surgical procedure. The form indicated that the patient would receive general anesthesia. Review of the reverse side of this form indicated that Post-Anesthesia Evaluation was not completed as evidenced by a blank, unsigned form.

During an interview on 6/12/14 at 3:00 P.M., the Director of Health Information Management said the blank form indicated an incomplete follow-up by the medical staff.