HospitalInspections.org

Based on observation and interview, the facility failed to ensure state regulations were observed.

* The California Department of Public Health (CDPH) was not contacted for written approval to use beds licensed for acute care for the care of patients of the distinct part skilled nursing unit;
* The facility license was not updated to include mobile CT (computerized tomography - a two dimensional x-ray) and MRI (magnetic resonance imaging - a three dimensional x-ray); and
* Written approval for offsite clinical record storage was not obtained from CDPH.

Findings:

1. On 7/9/12 at 9:30 am, during the initial tour of the facility, Administrative (Admin) Nurse K stated that the census of the hospital was three patients. More than three patients were noted in beds and Admin Nurse K was questioned about this. Admin Nurse K stated that the skilled nursing facility was in the process of remodeling and moved the patients out to the acute unit while their room was being refurbished.

California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70805 governing general acute care hospital indicated, "Spaces approved for specific uses at the time of licensure shall not be converted to other uses without written approval of the Department."

On 7/12/12 at 9:15, the Department confirmed that the facility had not requested a temporary change of use for the acute beds used to house the skilled nursing patients.

On 7/12/12 at 2 pm, Nurse Manager P acknowledged the above findings.

2. On 7/12/12, Admin Staff J stated the facility had added new services with a mobile CT unit and a mobile MRI unit.

The CDPH was not notified of the above mobile units nor did the facility license reflect the addition of the above mobile units.

The CDPH all facilities letter 08-48, dated 12/30/08, reported an amendment to the California Health and Safety regulation 1765.150 (e) which stated, "The licensee shall report to the department the location of the site (mobile health care units) at least 24 hours prior to operation of a mobile unit at any site for the first time."



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3. During an interview with Health Information Staff A beginning at 11:15 am on 7/9/12, she stated that inactive medical records were stored in a building off the facility premises. However, the facility had not requested and obtained prior approval from the Department of Public Health Licensing and Certification for this arrangement. In addition, the facility was unable to provide a written agreement with the owner of the building; and there were no approved policies and procedures to address how records were transported back and forth; retrieved after-hours if necessary; and safeguarded.

Admin Staff E confirmed this finding during an interview beginning at 12:05 pm on 7/10/12.

Based on observation, interview, and record review, the facility failed to ensure that guidelines for the treatment of malignant hyperthermia, a rare life-threatening condition that is usually triggered by exposure to general anesthetic drugs (used to lose the sensation of pain during surgery), were implemented. The facility also failed to ensure emergency room medications were not expired, and that single use medications and solutions were discarded after use.
* Sterile water stored for reconstituting Dantrolene (an antidote used to treat MH) contained preservatives, and was not in a glass vial as recommended;
* Lactated Ringers solution (fluid with electrolytes) was chilled for intravenous (IV) cooling instead of normal saline as recommended for MH, and had expired; and
* Expired medications and opened single use medications were available for use in the emergency room.
These failures had the potential to delay the treatment for a patient who would experience malignant hyperthermia (MH) and ineffectively treat patients in an emergency situation.

Findings:

1. On 7/12/12, the Malignant Hyperthermia Association of the United States (MHAUS) online reference indicated the following should be available in a designated area, "A supply of sterile water for injection USP (without a bacteriostatic agent) should be kept nearby to mix with dantrolene before injection (60 ml/vial). A video education was available online which indicated that sterile water in glass vials (without preservatives) was recommended to avoid accidental IV administration of this hypotonic solution (which can cause cells to swell, burst and die).

On 7/12/12 at 2:30 pm, during a tour of the operating room (OR), the OR Supervisor (ORS) was asked where supplies were kept for MH. The MH cart did not contain a supply of bacteriostatic water without bacteriostatic agents.

2. On 7/12/12, the MHAUS online reference indicated the following should be in supply for a MH emergency, "A minimum of 3,000 ml (milliliters) of refrigerated cold saline solution for IV cooling."

On 7/12/12 at 2:30 pm, the OR refrigerator was observed to have three 1000 ml bags of Lactated Ringers solution which were expired.

In a concurrent interview, ORS confirmed these bags were expired. ORS stated he was not fully aware of the recommendations made by MHAUS.



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3. During initial tour of the facility's emergency rooms with Nurse Manager D, at 10 am on 7/9/12, the following expired and single use biologicals and supplies were observed in emergency room one:

Undated bottle of sterile water;
- Opened single dose 30 milliliter (ml) vials of Bupivacaine 0.25% (local anesthetic injected under the skin for minor procedures);
- Two vials of expired 1% lidocaine with epinephrine (local anesthetic);
- Vial of expired amiodarone (medication that slows heart rate);
- Opened brown plastic bottle with handwritten, masking tape label that read, Zephiran solution (used to rapidly disinfect skin before treating intact skin, superficial injuries and infected wounds), 750 ml, dated 4/3/11 (opened date 15 months ago), there were no instructions, precautions, or dilution specifications on the label; and
- And a vial with typed label that read, Tetra 1:1:12 (anesthetic).

Nurse Manager (NM) D was concurrently interviewed and confirmed the bottle of sterile water and opened single vial medications should have been discarded after use. NM D stated the vial with the typed label of Tetra 1:1:12 had been compounded (customized medication made by mixing individual ingredients) by their pharmacist. NM D was not able to definitively state what medication was in the vial labeled Tetra 1:1:12.

On 7/9/12 at 2:55, the facility pharmacist (RPH) was interviewed about the date on the Zephiran solution. RPH stated the facility had obtained the solution from an outside pharmacy. RPH stated the solution should have been discarded 30 days after being opened.

On 7/10/12 at 1:45 pm RPH was interviewed about the Tetra 1:1:12 vial with the typed label. RPH stated she had typed the label and that the vial contained a Tetracaine solution she had compounded. RPH stated she was not able to fit the entire word onto the label. When RPH was told facility staff could not identity what "Tetra" meant or what medication was in the vial, she confirmed the incorrectly labeled vial created an unsafe situation in the emergency room.

Based on interview and record review, the facility failed to ensure the crash carts (a cart containing medications, supplies and equipment used in life threatening situations) in the medical-surgical (Med Surg) unit and the Emergency Department (ED), were regularly checked for readiness in the event of an emergency. This failure had the potential for patients to not receive immediate and effective medical care in the event of a life threatening situation.

Findings:

1. On 7/9/12, the facility policy, titled Crash Cart Policy, dated 8/10, indicated, "The RN Charge Nurse will assign a nurse to check the Crash Cart for readiness each shift in...Med/Surg."

On 7/9/12 at 10:15 am, during the initial tour of the facility, the medical-surgical unit crash cart records were reviewed. From 6/1/12 through 7/9/12, the above crash cart was not checked 48 of 77 shifts (62%) for readiness to respond to an emergency.

During a concurrent interview, Administrative Nurse K and RN L acknowledged the above finding.



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2. On 7/11/12, the facility's Crash Cart Policy, dated 8/10, was reviewed and read, "Purpose: To provide an effective means to ensure that adequate life support equipment is readily available in the Emergency Department..." The policy showed the emergency room crash carts were to be checked on each shift. Policy 3.a. read, "The nurse is responsible for checking the proper operations and readiness of the equipment used. After checking for completeness, sign in box for that date and shift on the Crash Cart Check Record." The policy showed that the nurse was to restock the cart if its contents did not match the list of contents, posted on the cart.

a. During the initial tour of the facility's emergency rooms with Nurse Manager (NM) D, at 10 am on 7/9/12, several pairs of expired Triflex sterile surgical gloves and expired sterile eye drapes were observed in emergency room one.

NM D concurrently confirmed the expired supplies were available for use and should have been discarded.

b. The emergency room crash cart was opened and several laryngoscopes (medical instrument with a light that is used to visualize the airway in order to intubate or insert a tube into the patient) were observed. There was an extra set of C size batteries in the drawer for use in the laryngoscopes. The batteries were labeled with an expiration date of 3/09. One of the laryngoscopes was observed to have a light that was only slightly lit (not working properly). NM D concurrently confirmed the laryngoscope's batteries were worn out and that the extra set of C batteries were expired. NM D confirmed the equipment was not being checked during the crash cart checks.

On 7/11/12, Registered Nurse (RN) S was interviewed about how she checked the crash cart that morning. She stated that if the crash cart was locked, she did not open it to check the contents, but put a checkmark on the Crash Cart Check Record to show it was locked. RN S confirmed she had signed the Crash Cart Check Record that morning and checked it to signify the lock was intact. RN S stated she had never checked to see if the laryngoscopes worked, if the light bulbs were functioning, or if the extra batteries were functional and not expired. RN S stated their was no inventory list with the crash cart to check the contents to.

On 7/12/12, NM D confirmed the facility was not following their Crash Cart Policy.

On 7/12/12, Infection Control Nurse C confirmed that the expired sterile gloves and drapes could malfunction or break and create the potential for patient infection.

Based on observation and interview, the facility failed to ensure the emergency room medication refrigerator was properly functioning, when it was found to be leaking condensation into containers of medication. This failure had the potential to affect the integrity of medications used for emergency room patients.

Findings:

During initial tour of the facility's emergency rooms with Nurse Manager D, at 10 am on 7/9/12, the locked medication refrigerator was opened and observed to have dripping condensation beneath the top freezer compartment. A tray located under the dripping condensation was observed to be full of water and contained suppository medications (small solid preparation of medication inserted into body orifice other than the oral cavity). Nurse Manager D concurrently confirmed the medications should not be stored in the standing water and that the moisture could affect the integrity of the medications.

On 7/17/12 at 10 am, Emergency Maintenance (EM) T stated that the emergency staff had never told him their medication refrigerator was not operating properly. EM T stated there was no regularly scheduled monitoring or maintenance of the emergency room refrigerators.

Based on staff interview, medical record review, and document review, the governing body (Board) of the hospital failed to ensure that the hospital's policies, procedures, and rules and bylaws were complied with in a manner that assured quality health care was provided in a safe manner and safe environment by qualified practitioners. This failure potentially could allow patients to receive poor quality of care.

Findings:

1. The Board failed to put in place and enforce mechanisms that ensured compliance with the requirement that for all surgical patients, before surgery the medical record must contain a complete medical history and physical (H&P) examination that was done and recorded no more than 30 days prior to surgery, with an update to the H&P within the 24 hours prior to surgery. (Refers to C320)

2. The Board failed to put in place, enforced and participated in a well-designed Quality Assessment and Performance Improvement (QAPI) program with a specific yearly plan that did look at verifiable data. (Refers to C330, C278, C279, C320, C302, and C336)

3. The Board failed to enforce the medical staff bylaws were followed:

The preamble to the medical staff bylaws notes the bylaw's importance in maintaining quality medical care when it states: "These Bylaws are adopted in order to provide for the organization of the Medical Staff of (hospital) and to provide a framework of self-government in order to permit the Medical Staff to discharge its responsibility in matters involving the quality of medical care, and to govern the orderly resolution of those purposes. These Bylaws provide the professional and legal structure for Medical Staff operations, organized Medical Staff relations with the Governing Board, and relations with applicants to and members of the Medical Staff."

Between 7/9/12 and 7/12/12 the medical staff bylaws, medical staff rules, medical staff meeting minutes, medical executive committee (MEC) minutes, physician peer review and credential committee (PPRCC) minutes, and selected practitioners credential files ( Physician O, Physician P, Podiatrist X, Physician Y, Physician Z, Physician CC, AHP BB, AHP DD and AHP EE) were reviewed. In these the following exceptions to the bylaws were noted to have occurred during the past year.

a) The medical staff bylaws specify at Article XIV the manner in which those bylaws are to be amended. On 12/3/11 the MEC voted to amend the bylaws without following Article XIV. The Board minutes do not document that an amendment was made or approved.

Also on 5/8/12 the MEC voted to change the medical staff bylaws without following Article XIV of the bylaws. The Board did not meet in 5/12.

b) The medical staff bylaws at Article III specify that there are seven categories of medical staff membership, Active, Courtesy, Consulting, Provisional, Locum Tenens, Honorary/Emeritus and Retired. Beginning in 6/11 and continuing on the the present the PPRCC and MEC made recommendations the physicians providing radiological interpretation from distant site location be appointed to a category named "Telemedicine" and the Board subsequently approved the appointments. In the medical staff bylaws there is not a category of "Telemedicine."

c) The medical staff bylaws specify at Article VIII that medical staff "officers must be members of the Active Medical Staff at the time of their nomination and election, and must remain members in good standing during their term of office." During the 4/17/12 MEC meeting Physician O, who was not an active staff member, but rather a provisional staff member, was appointed at Secretary/Treasurer of the Medical Staff. The minutes do not record that the exception to the bylaws was done for any specific reason. Physician O's appointment as Secretary/Treasurer was announced to the Board during their 4/24/12 meeting.

d) The medical staff bylaws at Article IV specifies what should happen if a medical staff "member files to submit a completed application for reappointment...". The 4/28/12 minutes of the PPRCC document that at that time five physicians had staff privileges that had expired: Physician P's and Physician Y's privileges had only just expired in 4/12; Physician CC's and Physician FF's privileges had expired three months previously in 1/12; and Physician Z's privileges had expired one month prior in 3/12. Specific dates of expiration were not recorded in the minutes and had not been recorded in their credential files. The minutes document that "letters of extension have been sent to all physicians with expired staff privileges", without noting a justification for an exception to the bylaws. There is no record in the PPRCC minutes that credential files or any physician performance data had been reviewed prior to the decision to extend privileges for those physicians. At the next MEC meeting, 5/8/12 the MEC approved the reappointment of these five physicians. There were not Board meeting minutes from 5/12.

Based on observation, interview and record review, the facility failed to ensure that staff was sufficient to provide essential services.
* The pharmacy did not have sufficient staff to oversee operations and conduct preventative measures to ensure medication safety; and
* One registered nurse (RN) failed to have current basic life safety (BLS - cardiopulmonary resuscitation) certification as required by her job description.

These failures had the potential to result in adverse outcomes for patient health.

Findings:

1 (a). On 7/9/12, a list of pharmacy employees was reviewed. The pharmacy was staffed by one full time pharmacist and one per diem pharmacy technician (tech).

On 7/9/12, at 11:30 am, the pharmacist (RPH) stated that appropriate staffing should include a per diem pharmacist and two full time techs to complete the required functions of the pharmacy. RPH stated that the administration was aware of the need for additional pharmacy staffing and that positions were approved but had not yet been posted.

RPH stated that she is unable to do all the first dose review (a review of the medications for appropriateness, dose, frequency, route, and safety for each new medication ordered) prior to the medication being delivered. RPH also stated that she is on-call for first dose review every evening and weekends. When asked if there were concerns regarding this arrangement, RPH stated that she had concerns about whether she was providing proper oversight to pharmacy operations and employee supervision. RPH also expressed concerns that the fatigue from interrupted sleep may contribute to medication errors. RPH further stated that she had pharmacy coverage for times when she was off. RPH stated that for several months the administration of the facility had been working on an alternative plan for the first dose review but the plan had not yet been approved.

On 7/9/12 at 2:15 pm, Administrative (Admin) Staff J stated they were aware of the current challenges for the pharmacist and were working on a plan to provide first dose coverage. No alternative was arranged in the interim. Admin Staff J further stated additional pharmacy positions had not been requested.

During the survey, from 7/9 to 7/17/12, there were no pharmacy positions posted on the facility web site.

(b). On 7/9 through 7/17/12, the following areas of non-compliance were noted: (See 203, 222, 276, 277, 279, 297, and 337 for more information)
- First dose review not routinely done for all patients;
- Nursing staff accessed the night medication locker (Omnicell) during the the day shift;
- The facility did not have an effective method of ensuring that black box warnings (Federal Food and Drug Administration - FDA) strongest warning to prevent potential harm to patients) recommendations were readily available to nursing staff and implemented;
- Failed to have facility drug policies reflect FDA information such as black box warnings and reporting serious adverse drug reactions to FDA Med Watch;
- Biohazardous medication waste was unsecured in the trash and accessible to others;
- Expired medications available for use in the operating and emergency rooms;
- Failure to report serious medication adverse events to the FDA MedWatch program;
- Use of single dose medications for multiple patients;
- Failure to observe medication administration to evaluate for opportunities to prevent medication errors;
- Failure to secure the night locker from unauthorized access; and
- Failure to have a robust quality assurance plan to identify the above areas of non-compliance.

On 7/17/12 at 10:30 am, RPH acknowledged the above areas of non-compliance and stated that the pharmacy quality program did not include monitors of the above functions.

2. On 7/12/12, RN M's personnel record was reviewed. RN M's job description listed current BLS certification as a minimum requirement. RN M's record did not contain a current BLS certification.

On 7/17/12 at 10:15 am, Human Resource Staff B confirmed that RN M had not renewed her BLS certification and was allowed to work without a current certification.

Based on observation, interview, and medical record reviews, the facility failed to provide patient care services in accordance with facility policy and procedure and nationally recognized standards of practice as evidence by the following:

1. Failure to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:

A. Surgical instruments were sterilized in accordance with nationally accepted infection control standards when hinged instruments were not sterilized in the open position (Refer to C 278, finding 1);

B. Shared patient equipment potentially exposed to blood borne pathogens (Hepatitis B, C, and the virus that causes immunodeficiency), was safely and effectively cleaned and disinfected between each patient use (Refer to C 278, finding 2);

C. Monitoring of air temperature and humidity was performed in accordance with standards of practice in the perioperative decontamination and sterile processing areas (Refer to C 278, finding 3);

D. Endoscopes (used to visualize the gastrointestinal tract) were dried and stored according to nationally accepted infection control guidelines and manufacturer's recommendations (Refer to C 278, finding 4);

E. Medical staff were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards (Refer to C 278, finding 5);

F. Single use and single dose medications were not available for multiple patient use in accordance with hospital's policy and nationally accepted infection control guidelines.
(Refer to C 278, finding 6);

G. High touch areas in the hospital environment were effectively cleaned and disinfected in accordance with nationally accepted infection control guidelines (Refer to C 278, finding 7);

H. Clean and contaminated patient items were stored in a manner to prevent cross contamination (Refer to C 278, finding 8);

I. Dispose and store sharps (needles, scalpels) per policy in a safe manner. (Refer to C 278, finding 9);

J. Store linen in a manner that would prevent cross-contamination. (Refer to C 278, finding 10);

K. Provide appropriate personal protective equipment for hoppers in the utility rooms (Refer to C 278, finding 11);

2. Failure to follow facility policy and procedures for medication administration (Refer to C 271, finding 1, and C 297, findings 1, 2, and 3);

3. Failure to secure, administer, dispense, and dispose of drugs in a safe manner, in accordance with the facility policy (Refer to C 276 and C 297);

4. Failure to ensure food was within the use by dates, and stored at appropriate temperatures (Refer to C 279);

5. Failure to ensure expired lab supplies were not available for use (Refer to C 282);

6. Failure to provide discharge planning evaluation and care planning (Refer to C 294);

7. Failure to administer patient restraints according to facility policy (Refer to C 271, findings 2 and 3);

8. Failure to follow procedures that were developed to prevent, evaluate, and report adverse drug reactions and prevent medication errors. (Refer to C 277);

9. Failure to ensure that Radiology Services furnished at the hospital are provided by qualified personnel in a safe manner and that does not expose patients and staff to radiation hazards. (Refer to C 283);

10. Failure to maintain a list of all services furnished under contract. (Refer to C 291);

11. Failure to ensure that all contracted services are furnished in compliance with applicable conditions of participation and standards of quality. (Refer to C 293);

12. Failure to implement policies for pre-surgical histories and physicals (Refer to C 241, finding 1);

13. Failure to ensure that expired food is removed from the general stock available to patients (Refer to C 279);

14. Failure to ensure nursing care for patients with chemical restraints followed policy and standard of practice; (Refer to C 276, finding 3);

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.

Based on interview and record review, the facility failed to follow facility policies for medication administration and restraints for three of 34 sampled patients as evidence by:

1. Failed to obtain documentation that one of 34 sampled patients was informed of possible consequences, prior to the administration of medication for which he had a stated allergy; (Patient 11)
and

2. Failed to follow the facility policy on restraints for two of sampled patients. (Patient 16 and 17)

These failures had the potential for the patient to be unaware of signs and symptoms of an allergic reaction which could result in patient harm during the medication administration, and unnecessary patient restraint.

Findings:

1. On 7/12/12, the facility's "Administration of Medications When the Patient is Allergic" policy, dated 5/10, was reviewed. The policy read, "...If a provider request a medication be given when a patient has a stated allergy, documentation must be shown that the patient was made aware of possible consequences prior to administration."

Patient 11 was admitted to the facility on 7/9/12 with diagnoses that included abdominal pain and small bowel obstruction.

Patient 11's allergy profile showed that Patient 11 reported a moderately severe allergy to Ciprofloxacin (Cipro, antibiotic) on 7/9/12.

Patient 11's record included a physician's order, dated 7/9/12 at 8:26 pm, for Cipro to be administered intravenously, every 12 hours. The record included an alert message that showed the use of Cipro may result in an allergic reaction based on the reported history of a Cipro allergy. Special instructions show the physician was aware of the stated allergy, and after the physician review stated it was not a true allergy, and to give the Cipro and monitor for any allergic reactions. There was no documentation found in Patient 11's record, that he was made aware of the possible consequences to receiving the Cipro, prior to receiving it.

On 7/11/12 at 1:35 pm, Administrative (Admin) Nurse K was interviewed and confirmed the facility's policy to document that the patient was made aware of the possible consequences prior to administration of the drug. Admin Nurse K was not able to provide documentation that Patient 11 was made aware of the possible signs, symptoms, and consequences to receiving Cipro, after a stated allergy and prior to administration of the medication.



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2. On 7/10/12, Patient 16's record was reviewed. Patient 16 was admitted on 6/28/12 with diagnoses that included congestive heart failure (fluid build up in the lungs and heart), chronic kidney disease, and dementia. Patient 16's record contained a nursing note, dated 6/28/12 at 2330 (11:30 pm), which indicated, "Patient out of bed walking in hall confused looking for cane, patient not accepting reorientation, Called MD new order Haldol 1 milligram IV (intravenous) now."

The facility policy, titled, "Restraint and Seclusion," dated 4/28/10, indicated, "A chemical restraint is a medication used to control intentionally dangerous behavior or to restrict the patient's freedom of movement and is not a standard therapy or treatment for the patient's medical or psychiatric condition." The policy further indicated that restraints were used only when less restrictive measures have been found to be ineffective to protect the patient from harm...a physician was to see and evaluate the patient within one hour of the initiation of the behavioral use of restraints... and the patient was to be monitored every 15 minutes."

Patient 16's record did not contain any evidence that less restrictive measures were attempted, a physician saw and evaluated Patient 16 within one hour of initiation of restraints, and that Patient 16 was monitored by the nursing staff every 15 minutes.

On 7/12/12 at 4 pm, Administrative (Admin) Nurse K reviewed the restraint policy and acknowledged that the Haldol was a chemical restraint. Admin Nurse K reviewed Patient 16's record and acknowledged that it did not contain evidence of less restrictive measures were attempted, physician evaluation within one hour, and monitoring every 15 minutes.

3. On 7/10/12, Patient 17's record was reviewed. Patient 17 was admitted on 6/26/12, with diagnoses that included gastrointestinal bleeding and shock. Patient 17's record contained physician orders for protective wrist restraints on 7/5/12. Patient 17's record indicated that restraints continued until 7/10/12 at 1600 (4 pm). There was no evidence of physician orders for the restraints every 24 hours from 7/6 - 7/10/12.

The facility policy, titled, "Restraint and Seclusion," dated 4/28/10, indicated, "A written order should be obtained and authenticated by the physician within 24 hours... A renewal, or new order, for the use of restraints no less than each calendar day."

On 7/12/12 at 4 pm, Administrative (Admin) Nurse reviewed Patient 17's record and acknowledged that Patient 17's record did not contain a physician order for each day Patient 17 was in wrist restraints.

Based on observation, interview, and record review, the facility failed to ensure that medications were stored, administered, dispensed, and disposed of in accordance with accepted professional principles as evidence by:

1. Failure to have effective system in place to ensure an anesthesia medication, Propofol, was disposed of in a safe manner;
2. Failure to provide first dose review (pharmacist review of drug orders for appropriateness, dose, frequency, route, and valid condition) for all medications, except in emergency situations;
3. Administration of Haldol (a tranquilizing agent) to one of 34 sampled patients without a proper indication, using an unlabeled (not approved by Food and Drug Administration - FDA) route (Patient 16); and
4. Unauthorized access to night locker medications.

These failures had the potential for patients and members of the public to be harmed by medications in which safety precautions were not followed.

Findings:

1. On 7/9/12 at 2:55 pm, four (4) syringes with 10 to 15 milliliters of a milky white substance contained in syringes were observed in a large blue and white pharmaceutical waste container located in operating room 1. The waste container had a lid, approximately 24 x 12 inches wide that was flipped half-way back. The contents of the pharmaceutical container were readily accessible. The ICN C confirmed the presence of the syringes containing milky white substance in the open blue and white container.

On 7/9/12 at 2:20 pm, during an interview in operating room 1, with Operating Room Supervisor (ORS), he identified the syringes containing the milky white substances as Propofol (also known as Diprivan). ORS acknowledged the content of the syringes were accessible to hospital staff persons.

During an interview on 7/10/12 at 3:45 pm, with the Pharmacist (RPH), she indicated the syringes with Diprivan should not have been present in the blue and white pharmaceutical container(s). RPH stated the hospital's process was to waste the medication (referring to the Diprivan) in the blue and white pharmaceutical container before disposing of the syringe. RPH indicated there was absorbent cloth in the bottom of the blue and white pharmaceutical containers to absorb the wasted medications. RPH stated, "We have to address this (referring to the finding of syringes containing Diprivan in the OR pharmaceutical container) with the anesthesiologists and check our written policy."

Review of the hospital's policy, titled, "Medical Waste Management Plan," revised 4/12, and presented as current, did not contain information about the disposal process for non-narcotic anesthesia medications.



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2. On 7/12/12, the Pharmaceutical Waste Containers Assembly and Usage Instructions for the facility's medication waste containers was reviewed. Page 2 included instructions that showed the lid had a sealing gasket and that the container was not to be used for "sharps" (needles). The assembly instructions indicated the lid needed to be snapped down and to "listen for clicks." The instructions for final disposal read, "Lock door by pressing down securely on edges of lid. Listen for clicks...Attach tamper evident label to both sides of container."

On 7/12/12 at 9:30 am, the biohazard storage shed was concurrently observed with Environmental Services (EVS) U. There were several red bins marked "Biohazard" and one contained a white plastic storage container with a blue lid that was used to store medication waste. The medication waste container's blue lid was hinged which created a small lid on one side and a large lid on the other side. There was masking tape criss crossed across the lid and onto the base of the bin. The small lid was not closed. When EVS U removed the masking tape, the small end was not sealed shut and the container was half filled with several containers of medications. There were several large bottles filled with white fluid that were labeled Propofol (general anesthesia) and several large syringes filled with the white liquid. There were multiple large vials of fluid labeled midazolam (controlled substance, sedation medication used intravenously for preoperative and conscious sedation, and as an anesthetic during surgery). The large end of the container was also not sealed or snapped shut and easily opened by EVS U.

On 7/12/12 at 10 am, the medication waste container in the biohazard storage shed was observed concurrently with RPH and EVS U. RPH stated the container should not have tape on it and confirmed it was not sealed. She stated that the filled syringes should have been emptied and the needles removed and properly discarded into a separate "sharps" container. RPH stated the container was supposed to snap shut with an audible click to assure that it was properly sealed. RPH stated the labels affixed to the side were to be dated and used to tape up the two lids, and that tape was not to be used.

On 7/12/12 at 10:35 am, Surgical Tech V was interviewed about the medication waste container that was now in the biohazard storage shed. She stated that on 7/10/12, she taped the container shut with masking tape and wrote "Garbage" on it for removal. Surgical Tech V confirmed that she did not snap the lid openings shut and did not use the seals.

On 7/17/12 at 10:10 am, Infection Control Nurse (ICN) C, stated the medication waste containers were to be locked shut prior to disposal and that facility staff was in need of training on their use and disposal.


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3. On 7/17/12, the American Society of Hospital Pharmacists (ASHP) "Guidelines for Preventing Medication Errors in Hospitals," dated 1993, indicated, "All systems should provide for review and verification of the prescriber's original order (except in emergency situations) before a drug product is dispensed by a pharmacist (first dose review). Any necessary clarifications or changes in a medication order must be resolved with the prescriber before a medication is administered to the patient..."

On 7/10/12 at 1:53 pm, RPH stated that she conducted first dose review of medications except for the emergency room, and this was documented in the computer prior to the nurse being able to administer the drug. RPH indicated she worked Monday through Friday on the day shift and was on-call for first dose review on nights and weekends. RPH further stated she did not have a policy for the first dose review.

On 7/10/12, Patient 16's record was reviewed. Patient 16 was an 89 year old male admitted on 6/28/12 with diagnoses that included congestive heart failure (fluid build up in the lungs and heart), chronic kidney disease, and dementia. Patient 16's record contained a nursing note, dated 6/28/12 at 2330 (11:30 pm) which indicated, "Patient out of bed walking in hall confused looking for cane, patient not accepting reorientation, Called MD new order Haldol 1 milligram IV (intravenous) now." Patient 16's record revealed that the pharmacist did not perform a first dose review prior to administration of the Haldol.

On 7/10/12, the facility pharmacist (RPH) provided a computer printout from "UpToDate" for Haldol which indicated the following, "Elderly patients with dementia-related psychosis (loss of contact with reality) treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Haloperidol is not approved for the treatment of dementia-related psychosis." The UpToDate further indicated that the IV was an unlabeled (not FDA approved) route of administration.

On 7/12/12 at 9:15 am, RPH acknowledged that the first dose review was not done prior to the administration of the Haldol to Patient 16 and that Haldol was not an indicated drug for Patient 16. RPH further stated she was not sure how many of the first dose reviews were actually completed prior to medication administration

4. On 7/12/12 at 9:20 am, the Pharmacy door was unlocked and open. Registered Nurse (RN) Y was observed accessing the Omnicell night medication locker (inside of the Pharmacy). Simultaneously, RPH walked into the Pharmacy, through the unlocked door and ordered RN Y to stop because he was not authorized to access the night locker during the day while the Pharmacist was available.

RN Y was asked, in a concurrent interview, why he was accessing the night locker. RN Y stated he did not have all the medications he needed for his medication pass and just wanted to see if he could access them in the night locker.

RPH stated the Omnicell night locker was only to be accessed by one designated nurse each shift and only after the Pharmacist had left for the day. RPH further stated that at times RN Y was the designated nurse and would have access. RPH confirmed that the Pharmacy door does not close all the way and sometimes was left open, which allowed staff to gain access to the Omnicell night locker.

Based on interview and record review, the facility failed to ensure that procedures were developed to prevent, evaluate, and report adverse drug reactions (ADRs) as evidence by:

1. There was no analysis of ADRs to identify corrective actions that could be implemented to prevent further occurrences in the future;
2. ADRs were not monitored proactively, and incident reports were the only means of identification;
3. There was no proactive observation of medication administration to identify opportunities to prevent medication errors;
4. Policies and computer resources for nursing staff for high risk and high alert medications did not include information from FDA boxed warnings.

Failure to identify, report medication errors, and evaluate ADRs decreased the facility's ability to prevent and remedy medication errors.

Findings:

1. On 7/17/12 at 10:30 am, RPH was asked how ADRs were identified. RPH responded that they were identified by the floor staff using incident reports. RPH and Quality Manager C confirmed that there had been no ADRs reported since 8/11. Quality Manager C stated the nursing staff had a number of new members and had probably not been inserviced on ADR. Both RPH and Quality Manager C confirmed that there was not a proactive process to identify ADRs.

On 7/12/12, nursing personnel files were reviewed. Six of six files did not contain any evidence of education on the identification and reporting of ADRs.

2. On 7/17/12 at 10:30 am, RPH was asked if medication administration was observed as part of the oversight of the pharmacy services. RPH responded that observation of medication administration was not done.

3. On 7/12/12, the facility's pharmacological resource, "UpToDate," was reviewed for the drug haloperidol (Haldol). This reference indicated that Haldol had a boxed warning (the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening). The FDA boxed warning stated, "Elderly patients with dementia-related psychosis treated with antipsychotic are at increased risk of death compared to placebo." The reference also indicated that Haldol "may alter cardiac conduction and prolong the QT interval; life threatening arrhythmias have occurred with therapeutic doses with high doses or intravenous administration...Monitor ECG (electrocardiogram - monitors heart rhythm) closely for dose related effects."

On 7/12/12, the facility policy, titled, "Haloperidol Intravenous," dated 7/10, did not include information regarding the boxed warning or the need for patient monitoring with ECG.

On 7/17/12 at 10:30 am, RPH confirmed that the Haloperidol policy did not include the safety information from the boxed warning and monitoring recommendations. RPH was asked if nurses have access to this information when they administer the drug. RPH responded that the safety information from boxed warnings and other safety recommendations had not been added to the computer profile for the drugs. RPH further stated the nurses would have to look up the drug to find out if there was a boxed warning.

Based on observations, staff interviews, and document reviews, the infection control officer (ICN) failed to develop an effective system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with facility policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Hinged surgical instruments were sterilized in the open position;

2. Shared patient items were effectively cleaned and disinfected between each patient in accordance with nationally accepted infection control standards and manufacturer's recommendations when:

a. Shared patient glucometers were not cleaned and disinfected between each patient use and

b. Vaginal probes were not high level disinfected between each patient use;

3. Monitoring of air temperature and humidity was performed in accordance with standards of practice in the perioperative decontamination and sterile processing areas;

4. Endoscopes were dried and stored in accordance with nationally accepted infection control guidelines and manufacturer recommendations;

5. Medical staff persons were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards;

6. Single use and single dose medications were not available for multiple patient use in accordance with hospital's policy and nationally accepted infection control guidelines;

7. High touch areas in the hospital environment were effectively cleaned and disinfected in accordance with nationally accepted infection control guidelines; and

8. Clean and contaminated patient items were stored in a manner to prevent cross contamination.

9. Sharps were stored in a safe manner.

10. Linen was stored in a manner to prevent cross-contamination;

11. Personal protective equipment (PPE) such as face shields and splash -resistant aprons were provided for personnel using the facility hoppers (used to clean bedpans);

12. Expired feeding tubes were not available for use.

Failure to implement an effective system could place patients at risk for exposure to serious life-threatening infectious microorganisms, including blood borne pathogens (HBV, HCV, and HIV).

Findings:

1. During the initial tour of the perioperative sterile supply storage area on 7/9/12 at 11:25 am, multiple pairs of instruments of various types were observed in the closed and locked position in sealed peel pouches (Peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. Peel pouches are used primarily when visibility of the instrument is critical for its effective use).

During an interview with the ICN C on 7/9/12 at 11:30 am, he was shown the instruments with blades closed in the peel pouches and he acknowledged the hinged instruments were closed and in the locked position and should be processed in the open position. The ICN C acknowledged there was no way to ensure the instruments were sterilized if they were processed with the blades closed and in the locked position.

The hospital's policy, titled, "Steam sterilization/Use of the autoclave," dated/revised 9/1/11, and presented as current was reviewed. The policy stipulated, "All items are placed in the autoclave in an open position."

The 2012 Perioperative Standards and Recommended Practices published by AORN were reviewed. Direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

2a. During an interview with Licensed Vocational Nurse (LVN) U on 7/9/12 at 3:20 pm, in the medical specialty clinic, she indicated the shared patient glucometer (a machine that measures patient blood sugar levels) was cleaned daily by wiping it down with an alcohol swab. LVN U acknowledged the glucometer was not cleaned after each patient use.

During an interview with Medical Assistant (MA) T on 7/9/12 at 3:25 p.m. in the medical specialty clinic, she indicated the shared patient glucometer was cleaned once daily. MA T confirmed the glucometer was not cleaned after each patient use.

During an interview with LVN H on 7/10/12 at 3:40 p.m. in the hospital medical surgical department, she stated the shared ACU-CHEK (Name Brand) advantage glucometers was wiped down with alcohol between patient use and with a cloth disinfectant called "sani-wipe" at the end of the shift

The hospital's policy, titled, "Point of Care Equipment Cleaning," dated revised 1/31/11 and presented as current was reviewed. The policy stipulated, "The finger stick blood glucose machine will be cleaned daily and between patients with isolation precautions." The policy did not stipulate the glucometer should be cleaned between each patient use or stipulate what product(s) should be used to clean and disinfect the glucometer.

An ONLINE Centers for Disease Control and Prevention communication, titled, "Infection Prevention during Blood Glucose Monitoring and Insulin Administration" was accessed on 7/9/12. The article stated, "The Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration. CDC is alerting all persons who assist others with blood glucose monitoring and/or insulin administration of the following infection control requirements: Finger stick devices should never be used for more than one person. Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared."

An article published in volume 38, number 3 (April 2010), of the American Journal of Infection Control, by the Association for Professionals in Infection Control and Epidemiology (APIC), provided the following guidance: "Assign a glucometer to each patient if possible. Clean and disinfect glucometers if they must be shared between multiple patients. Thoroughly clean all visible soil or organic material (e.g., blood) from the glucometer before disinfection.
Disinfect the exterior surfaces of the glucometer after each use following the manufacturers
directions. Use an E.P.A. (Environmental Protection Agency) registered disinfectant
effective against HBV, HCV, and HIV (blood borne pathogens) or a 1:10 bleach solution (1 part bleach to 9 parts water)."

2b. A telephone interview was conducted with Clinic Tech F on 7/10/12 at 1:30 pm, Clinic Tech F stated she performed pelvic ultrasounds for an average of 4-6 patients per week at the hospital Medical Specialty clinic. Clinic Tech F stated she was primarily responsible for cleaning and disinfecting the vaginal probes after use. Clinic Tech F stated the vaginal probes were wiped down and then disinfected by covering the probe with a Super Sani-Cloth towelette for a minimum of 2 minutes. Clinic Tech F stated this provided an intermediate level disinfection. Clinic Tech F stated the vaginal probes did not have to be high level disinfected.

During an interview with the Radiology Supervisor on 7/11/12 at 9:50 a.m., he acknowledged he was unaware the vaginal probes had not received high level disinfection between patient use. The Radiology Supervisor indicated the probes should have received high level disinfection after each patient use.

The hospital's policy, titled, "Disinfection of Ultrasound Probes," dated/revised 7/2012,
was reviewed. The policy stipulated, "Ultrasound probes that pass through normally sterile tissue should be sterilized before each procedure. Ultrasound probes that come into contact with mucous membranes are considered semi-critical and should receive high level disinfection at a minimum."

3. An interview was conducted with the Operating Room Supervisor (ORS) on 7/11/12 at 11:55 am, in the perioperative area. When asked about monitoring the sterile processing and decontamination areas for temperature and humidity, the ORS indicated there was no system to monitor temperatures and humidity in the perioperative sterile processing area and no temperature monitoring system for the perioperative decontamination area. ORS confirmed the Association of Registered Perioperative Nurses (AORN) was the standard of care the hospital followed in the perioperative area.

The 2012 edition of Perioperative Standards and Recommended Practices, published by the AORN , made the following recommendations related to Safe Environment of Care: "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Temperature should be maintained between 68º F (Feirenheit) to 73º F (20º C, Centigrade, to 23º C) within the operating room suite and general work areas in sterile processing. The decontamination area temperature should be maintained between 60º F to 65º F (16º C to 18º C).

Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.

Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Free-standing humidifiers should not be used because they can harbor microorganisms in fluid reservoirs and aerosolize these microorganisms into the clean environment. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system."

4. During an observation and concurrent interview with the ORS 7/10/12 at 11:50 am, two endoscopes were observed attached to a wall in operating room 1 (OR 1). The scopes were hung vertically on a wall less than a foot from where the operating stretcher was located. There was no enclosure around the scopes. Approximately 15 milliliters of clear fluid was observed on the floor immediately below the distal tip of one of the endoscopes and the tip of the other endoscope was observed resting on the top of a suction canister located on the floor nearby. The fluid under the one endoscope did not have a discernable odor. The ORS confirmed the presence of fluid under one endoscope and adjusted the other endoscope so that its proximal tip was not touching the suction canister located on the floor nearby. In a concurrent interview the ORS explained that during an endoscopy procedure in OR 1, in order to prevent contamination of the scope not in use, the scope was moved from the wall and stored laid flat on a table in the sterile reprocessing area. ORS indicated the scopes manufacturer was Olympus and provided the scope identification numbers as PCF Type H 180 Al and GIF type HI80 J. ORS indicated the endoscopes were processed, dried and stored according to the manufacturer (Olympus) and The Association of Registered Perioperative Nurses (AORN) standards.

During an interview on 7/11/12 with Clinic Tech X, she explained that she was primarily responsible for disinfecting and drying the scopes. Clinic Tech X explained that after the scopes were disinfected, she irrigated the scopes with water then dried them by hooking them up to wall suction at 200 mm of mercury of suction for 15 to 20 minutes. The scopes were then hung vertically in OR 1, or if there was a procedure going on in OR 1, the scope not in use was taken to the sterile processing area and laid flat on a regular laundry towel on a table. Clinic Tech X stated the scopes were never stored flat on table for more than 30-45 minutes.

The hospital policy for processing, drying, and disinfection of endoscopes was requested on 7/10/12 and the policy provided was titled, "Disinfection of Endoscopes," dated/revised 4/12 and presented as current. The policy stipulated, "Endoscopes will be rinsed thoroughly with water and dried before use." The policy did not contain information related to storage of the endoscopes.

A telephone interview was conducted with the Olympus Product technical support representative on 7/11/12 at 1 pm for information about drying and storage of endoscopes PCF Type H 180 Al and GIF type HI80 J. The Olympus representative indicated the manufacturer does not recommend storing scopes flat because if there is any retained fluid in the endoscopes microorganism growth can occur. The Olympus representative stated the manufacturer did not recommend applying suction to the endoscopes to dry them, because that process could draw water retained in the scope back into the scope channels.

The AORN Standards and Recommended Practices, 2012 edition, page 504 under recommendation VII stipulated, "After high-level disinfection, flexible endoscopes should be rinsed and the internal channel flushed with water followed by a 70% to 90% ethyl or isopropyl alcohol rinse and flush, unless contraindicated by the manufacturer's written instructions ..." "Rinsing with alcohol assists with removal of water because the alcohol binds with the water remaining in the channel and facilitating the drying process and killing any microorganisms contained in the water. After rinsing with 70% to 90% ethyl or isopropyl alcohol, the channels should be dried using low pressure forced air. Using forced air assists with removal of moisture remaining in the channels. Dry air does not support microbial growth."

The AORN Standards and Recommended Practices, 2012 edition, indicated on page 504-505 under recommendation IX, "Flexible endoscopes should be stored in a manner that protects the devise from damage and minimizes microbial contamination. Flexible endoscopes should be stored in a closed cabinet with internal surfaces composed of cleanable materials, adequate heights to allow flexible endoscopes to hang without touching the bottom of the cabinet and hanging in a vertical position ..."

5. Review of 6 hospital staff persons' medical files (Physicians 1, 2, 3, 4, 5, and 6) was conducted on 7/10/12 at 3 pm. Five of the five staff persons (Physicians 1, 2, 3, 4, and 5) where testing for tuberculosis upon hire was indicated, received a one-step tuberculin skin test. Physician 6's medical record contained no evidence of screening for varicella, measles, mumps, rubella, or hepatitis B. Physician 6's screening for tuberculosis was limited to performance of screening for symptoms and a risk assessment.

During an interview with the Medical Staff Consultant (MSC) on 7/11/12 at 10:30 pm, she indicated the hospital's policy required physicians to provide a current tuberculosis test (two-step) upon hire and then every two years at the time of their reappointment. The MSC confirmed participating physicians were not screened for varicella, measles, mumps, rubella, or hepatitis B. The MSC indicated she would look for a TB test for Physician 6, but it was not provided by the time of exit. The MSC stated she was unsure what standards the hospital's policies for screening the physician healthcare workers for immunizations was based on. The MSC stated, "I do not believe we have a policy or procedure, we just do what was done in the past." The MSC acknowledged all physicians were likely to have intimate contact with patients and also potential exposure to blood.

Review of the hospital's policy, titled, "Tuberculosis Exposure Control Plan" was performed. The policy stipulated, "Newly hired employees must provide documentation of a tuberculosis skin test within 90 days or receive a tuberculosis skin test ...At pre-employment, employees who have not had a PPD in the last (2) years will have a two-step tuberculosis skin test. Then, all employees will receive annual tuberculosis screening." Under the Purpose and Objective section of the policy it stipulated, "The Tuberculosis Control Plan is intended to meet The Centers for Disease Control Guidelines for Preventing the Transmission of Tuberculosis in Healthcare settings. Additionally, the policy defined employees at risk to include: Physicians, environmental service personnel, nursing students ..."

Review of the hospital's policy, titled, "Employee Illness Monitoring," revised 6/12 indicated all hospital employees will have evaluation that included but was not limited to screening for tuberculosis, rubella, mumps, rubeola, and varicella and hepatitis B.

The Centers for Disease Control Guidelines for Preventing the Transmission of Tuberculosis in a Health-Care Setting, 2005, page 10, indicated "The classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers (HCW) will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection, and after baseline testing for infection, HCWs should receive TB screening annually."

The Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: "Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all Healthcare Workers. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or nonstudent, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases on page 25, the MMWR documented: "All HCWs should ensure that they are immune to varicella."

The Occupational Safety and Health Administration (OSHA) requires hepatitis B vaccine be offered to healthcare workers (HCWs) who have a reasonable expectation of being exposed to blood on the job.

Review of the 7/30/09 Association for Professionals in Infection Control and Epidemiology (APIC) Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Healthcare indicated that healthcare workers whose activities involved contact with blood or body fluids be offered hepatitis B vaccination.

6a. On 7/10/12 two (2) opened single dose vials of 40 mg per 1 milliliter of solution Kenalog (a medication that reduces inflammation) was observed in the refrigerator in operating room (OR) 1 at 10:45 am. In a concurrent interview with Nurse Manager D, he acknowledged the presence of the opened Kenalog vials in the refrigerator and stated, "We need to throw these away."

6b. On 7/10/12 at 10:55 am, an inhaler labeled Ventolin, a medication used to treat breathing problems delivered via a portable devise that delivers medication that is inhaled, single use was observed. The inhaler was absent patient identification and date accessed and located in the upper drawer of the anesthesiologist's cart in Operating Room 2. The inhaler had originally contained 60 doses and the inhaler meter revealed 56 doses remained. In a concurrent interview, ORS indicated the anesthesiologist had the inhaler available to provide to the patient in the event a patient developed respiratory problems during a procedure. ORS indicated the anesthesiologist provided the medication orally or via an airway devise based on the level of consciousness of the patient. ORS acknowledged the inhaler had been used, could be contaminated, and should be thrown away.

Review of the hospital's policy, titled, "Dating of Sterile Supplies," revised 6/2012, and presented as current, stipulated, "Single dose vials: Discard after initial use."

On 7/2/12, The Centers for Disease Control and Prevention (CDC) reissued its position on use of single dose, single use medications. CDC called for medications labeled as "single dose" or "single use" to be used for only one patient. According to CDC, this practice protects patients from life-threatening infections that occur when medications get contaminated from unsafe use.

According to the USP (797), a regulation that governs a wide range of pharmacy policies and procedures the standards for single-dose vials opened in room air is the contents must be utilized within one hour. Additionally, single-use medications should never be used for more than one patient.

7. On 7/11/12 at 11:13 a.m. Environmental Services (EVS) V was observed cleaning a patient room located in the hospital medical surgical area. EVS V was using a cloth to wipe multiple surfaces. EVS V cleaned a bed, the bed frame, and a wall with one cloth moistened with Ramsey 64, a disinfectant (a solution that kills germs). The surfaces of the last surfaces she cleaned with this cloth began to dry one minute after they were wiped and were completely dry in three minutes. EVS V did not remoisten any of the surfaces. In a concurrent interview, LVN H was present during this observation and verified the dry times, described above, for the items EVS V cleaned.

During an interview with Housekeeping Staff (HSK) W on 7/11/12 at 11:20 am, she indicated she was taught to apply the disinfectant, Ramsey 64 and just let it dry. HSK W indicated the cleaner/disinfectant on the cloths was called Ramsey 64. When asked how long surfaces must remain wet with the disinfectant to kill microorganisms, HSK S stated, "I do not know." HSK W indicated she provided training to the environment services staff at meetings that were held monthly.

Review of the Ramsey 64 label was conducted and the instructions for use directed staff to apply use-solution to hard, nonporous surfaces, thoroughly wetting the surfaces, with a cloth, mop, sponge, sprayer or by immersion. Treated surfaces must remain wet for 10 minutes.

8. On 7/9/12 at 10:45 a.m. during a tour of a dirty utility room, with an unlocked door, located in patient room 4 in the emergency room the following were observed: A small room containing a hopper, a large toilet without a lid adjacent to a patient bedside commode that was available for patient use. Shelf and Carts, located 12 to 24 inches away from the hopper, housed the following items: Surgical hats and booties; patient specimen cups; and unwrapped cables used to attach patients to heart monitoring devises. Another entire shelf contained cleaning solutions, with labels that indicated the solution would be hazardous /dangerous if swallowed.

During an interview with the ICN C on 7/9/12 at 9:50 am in the dirty utility room, he acknowledged storing clean equipment in close location to a hopper, which was used to clean/decontaminate soiled patient equipment and to dispose of the bodily wastes of patients could result in contamination of the packaging of the patient and staff supplies and their contents when removed from the packaging. The ICN C acknowledged it was unsafe to store cleaning supplies in an unlocked room in close proximity to patients. The ICN C also acknowledged transmission of contaminants from the hopper into the immediately adjacent patient room could be a problem.

The hospital's policy, titled, "General Policy," revised 9/11 and presented as current was reviewed. The policy stipulated its objective was to provide a hygienic environment and to project an overall profile of cleanliness and safety to everyone.

The 6/03 Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) for Environmental Infection Control in Health-Care Facilities were reviewed and provided the following information, "The most common point-of-use fixtures for water in patient-care areas are sinks, faucets, aerators, showers, and toilets. The potential for these fixtures to serve as a reservoir for pathogenic microorganisms has long been recognized. Wet surfaces and the production of aerosols facilitate the multiplication and dispersion of microbes."



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9. During initial tour of the facility's emergency rooms with Nurse Manager (NM) D at 10 am on 7/9/12, Emergency Room One had a drawer filled with different sized empty syringes and needles. An uncapped needle was observed laying loose in the drawer. Upon further observation, a second uncapped needle was found and the broken top of a glass ampule (small sealed glass container of medication). The locked medication refrigerator was observed with NM D and contained an opened, visibly dirty, disposable scalpel. NM D confirmed the needles, broken glass ampule top, and used disposable scalpel were not safe.

On 7/17/12 at 10:10 am, ICN C stated the disposable scalpel, broken ampule top, and uncapped loose needles created an infection control issue and safety hazard. ICN C confirmed that no one was monitoring the emergency room supplies and equipment.



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10. On 7/9/12 at 8:30 am, during the initial tour of the facility, the linen carts in the intensive care unit and hallway 4-9's clean utility room contained linen that was not covered.

On 7/9/2 in a concurrent interview, Admin Nurse K acknowledged that the linen should be covered to prevent cross contamination.

11. On 7/9/12 at 8:30 am, during the initial tour of the facility, the dirty utility rooms throughout the facility failed to have PPE such as face shields and splash resistant aprons for use with the hoppers.

On 7/9/12, in a concurrent interview, Admin Nurse K was unaware that the above PPE was not available for personnel using hoppers.

On 7/18/11, the Centers for Disease Control and Prevention's (CDC's) Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007, indicated, "Standard precautions combine the major features of Universal Precautions and Body Substance Isolation and are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents. Standard Precautions include a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed infection status, in any setting in which healthcare is delivered... These include hand hygiene; use of gloves, gown, mask, eye protection, or face shield, depending on the anticipated exposure; and safe injection practices."

12. On 7/9/12 at 8:30 am, during the initial tour of the facility, the medical surgical unit was noted to have expired supplies such as feeding tubes available for use with patients.

On 7/9/12, in a concurrent interview, Admin Nurse K acknowledged the above finding.

Based on interview and record review, the facility failed to ensure that food available for patient consumption on the medical surgical unit was not expired and stored at temperatures that were appropriate to prevent food spoilage as evidence by: Food items that had expired were available for patient consumption; and Food was stored at temperatures that were out of range and no corrective action was taken. These failures had the potential for patients to incur food borne illnesses.

Findings:

1. On 7/9/12 at 8:30 am, during the initial tour of the facility, expired food items were noted in the medical surgical unit patient food refrigerator. In a concurrent interview, Administrative (Admin) Nurse K and Registered Nurse (RN) L acknowledged the expired food should not be available for patient consumption.

On 7/9/12, the facility policy, titled, "Food Preparation and Storage in the Patient Care Areas," dated 10/11, indicated, "Nutritional Services staff checks daily for outdated items and rotates stock according to expiration date."

2. On 7/9/12, the medical surgical unit refrigerator temperature logs were reviewed. The log indicated the temperature was 42 degrees Fahrenheit on 7/4 and 7/5/12. The log indicated that temperature should be between 32 and 40 degrees Fahrenheit. The log contained no record of corrective actions taken. In a concurrent interview, Admin Nurse K and RN L acknowledge the facility policy was not followed for food refrigerators temperatures that were out of range.

On 7/9/12, the facility policy, titled, "Food Preparation and Storage in the patient Care Areas," dated 10/11, indicated that nursing was to "Report the non-compliance immediately to the Nursing Supervisor for corrective action... and to recheck the temperature in thirty minutes to ensure proper working temperature had been achieved."

Based on observation, interview, and record review, the facility failed to ensure the quality and integrity of their Wet Mount (test of vaginal discharge to diagnose cause of infection) solution tubes and stool culture medium. This had the potential for patient test results to be inaccurate.

Findings:

1. During initial tour of the facility's emergency rooms with Nurse Manager D, at 10 am on 7/9/12, Emergency Room Four was observed with a box of unlabeled, capped, glass tubes filled with saline. Nurse Manager D stated they were used for wet mounts. There were no dates to indicate when the tubes were filled.

On 7/9/12 at 2:27 pm, Lab Supervisor W stated the lab created the wet mount solution tubes and should have labeled them and dated them for expiration.

On 7/12/12, the facility's Wet Mount and KOH (potassium test) procedure, dated 7/10/12 was reviewed. It showed that the capped glass tubes of saline were to be labeled with the contents and expiration dates.

On 7/17/12 at 10:10 am, Infection Control Nurse (ICN) C stated that no one was monitoring or supervising the filling of the wet mount solution tubes. ICN C stated the facility had not had a policy and procedure for the wet mount solution tubes prior to 7/10/12.



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2. On 7/9/12 at 8:30 am, during the initial tour of the facility, three expired stool culture mediums were available for use in the medical surgical floor clean utility room. During a concurrent interview, Administrative Nurse K and RN L acknowledged the above finding.

Based on observation, staff interview and record review the hospital failed to develop a quality and safety program to ensure that radiology services were always provided by qualified staff members in a safe manner and that assured all patients and staff were protected from excess radiation. This failure left open the possibility that patients or staff could unknowingly be subjected to excess and harmful radiation.

Findings:

On 7/12/12 at 3:15 pm, the Radiology Supervisor was interviewed in the Radiology Department and asked to give a complete summary of the Radiology Services provided at the hospital. When asked for at written radiation safety program or plan, he acknowledged that one had not been developed for the department. He stated that all of the technicians by virtue of their training had good radiation safety practices, but he had no evidence that radiation safety monitoring or classes had been conducted in the past year. He stated that the department had not developed any means of testing for radiation safety practices in the department. The most current report of radiation exposure badge data for staff members (and operators) radiation exposure badges was reviewed, however no prior reports had been maintained for comparison. Neither the radiation exposure data nor any other quality indicators have been collected/reported to the hospital's QAPI program or to the Medical Executive Committee (MEC).

On 7/11/12 a random medical record (Patient 1) had been opened for review and it was noted to contain an operative report for a surgery done on 7/5/12 by Podiatrist X that prompted further investigation. That operative report dated 7/9/12 stated, "A C-arm (fluoroscopy) was used throughout the case to confirm appropriate alignment and positioning throughout the case." When the Radiology Supervisor was asked about fluoroscopy used in similar surgical cases, he acknowledged that the department had not been tracking the radiation exposure of patients during such cases. He also was unable to show the radiation operator permit for Podiatrist X. In fact, he told of being unaware that Podiatrist X had yet begun using the fluoroscope during his surgical cases.

During the tour of the Radiology Department and the Radiology Supervisor's supposed complete summary of the Radiology Services offered there was no information provided about two relatively new radiology service units that later were discovered to have been added. On 7/12/12, Administrative Staff J stated that the hospital had added services with a mobile computerized tomography (CT) scanner unit and a mobile magnetic residence imaging (MRI) scanner unit. The hospital's state license did not list either of these services. No evidence was provided to show that the hospital had sought permission from the CDPH to provide these services. No evidence was provided to show that these two new radiological services had been incorporated into a Radiology Department safety and/or quality maintenance/improvement plan or to an overall hospital QAPI program.
In a subsequent review of the minutes of meeting for the past year for the Board, MEC and Medical Staff, no entries were identified where authority or approval had been sought to provide mobile CT or MRI services and/or to do so without first seeking and documenting the approval of the required state agencies, CDPH & OSHPD.

Based on document review and staff interview, the hospital failed to compile a complete list of all services furnished by others under contract. The impartial list furnished by the hospital failed to describe the nature and scope of services provided. Without this list the hospital had no means to track the complete range of contracted services in order to perform analysis of the quality and safety delivered with those services.

Findings:

On 7/9/12 during the entrance conference at 9:30 am, the hospital was given several lists itemizing requested documentation. A list of all contracts and agreements was among those documents requested. On the morning of 7/10/12, review of the delivered documents revealed a two page document titled "Agreements and Contracted Services CAH 2012". This list contained 23 line items, many of which named a service or type of service and some listed the name of a hospital or clinic or other healthcare entity. Some of the listed services also contained the name of a service provider. But none contained a description of the nature and scope of the services provided.

During the course of the survey, from 7/12/12 through 7/17/12, the provided list of contracts was referred to whenever an outside service was noted to be utilized by the hospital. It was noted that a number of contracted services and/or service providers were not on the provided list of contracts. Those missing included at least the following:

a. The hospital's Clinical Pharmacy Consultant (RPH);
b. The firm that provides a relief pharmacist;
c. Another firm that provides a relief pharmacist when;
d. The firm that disposes of expired medications;
e. The medication wholesaler that provides medications to the hospital;
f. The firm that provides transcription services to the hospital;
g. The firm that provides secure off site records storage;
h. The firm that provides diagnostic and procedural coding for the health records; and
i. The firm that provides the new Electronic Medical Records (EMR) system.

On 7/12/12 during an interview at 9:45 am, the Quality Assurance/Infection Control Manager (INC C) stated that to his knowledge the hospital had not compiled a complete list of contracted services and currently the quality improvement program does not have a mechanism in place to assure that all contracted services are being assessed for quality and to assure that they are provided in a safe and effective manner.

Based on staff interview and document review, the hospital failed to develop a program to ensure that contractors of services furnish those services in a manner that enables the hospital to comply with all applicable conditions of participation and standards of care for those contracted services. This failure could permit a contractor to deliver poor quality services without being recognized and possibly harming patients.

Findings:

The hospital had not compiled a complete list of all contracted services with which to begin conducting assessment of those services, and had not put a mechanism in place to assure that all contracted services were being assessed for quality and to assure that they were provided in a safe and effective manner.

On 7/12/12 during an interview at 9:45 am, the Quality Assurance/Infection Control Manager (INC C) stated that to his knowledge the hospital had not compiled a complete list of contracted services and currently the quality improvement program does not have a mechanism in place to assure that all contracted services are being assessed for quality and to assure that they are provided in a safe and effective manner.

Based on interview and record review, the facility failed to ensure that one of 34 sampled patients had discharge planning needs evaluated and a plan of care developed for discharge. (Patient 16) This failure had the potential for the patient to be harmed or readmitted due to unmet needs at home.


Findings:

On 7/10/12, Patient 16's record was reviewed. Patient 16 was an 89 year old male admitted on 6/28/12 with diagnoses that included congestive heart failure (fluid build up in the lungs and heart), chronic kidney disease, and dementia. Patient 16's record indicated that his condition deteriorated and he had to be admitted to the intensive care unit. Patient 16's record did not contain any evidence of an evaluation of his needs at home or whether he was safe to be discharged home. On 7/1/12, Patient 16's record indicated he was discharged home with his wife. Patient 16's discharge summary indicated that he was having dementia-related psychosis at night while in the hospital.

On 7/10/12, the facility policy, titled, "Nursing Administration Policies and Procedures," dated 9/07, indicated that each patient shall have a care plan formulated based on their assessment and discharge planning would be reflected on the care plan.

On 7/10/12 at 2:30 pm, Administrative Nurse K reviewed Patient 16's record and acknowledged no discharge evaluation or planning was evident in the record.

Based on observation, interview, and record review, the facility failed to ensure that medications were administered in accordance with accepted standards of practice for three of 34 sampled patients as evidence by:

1. Patient identification procedures were not followed for two of four patients observed for medication pass; (Patients 33 and 34)

2. Procedures for wastage of narcotics were not followed; and

3. Haldol (an antipsychotic medication used to control behavior by tranquilizing) was given to a patient who did not meet the indications for use and was not monitored for adverse consequences. (Patient 16)

These failures had the potential for medication errors, drug diversion, and adverse consequences which could harm patients.

Findings:

1. On 7/11/12 at 9:10 and 9:20 am respectively, RN M was observed during the medication pass for Patients 32 and 33. RN M did not check Patients 32 and 33's arm band, ask the patient's name, or check the computer or medication administration record printout/physician's order to verify Patients 32 and 33's identity.

On 7/11/12, the facility policy, titled, "Medications, Oral - Tablet/Liquid," dated 9/11, indicated, "Identify patient by wrist identification, open unit dose medications, checking with Medication Administration Record (MAR) or physician's order."

On 7/11/12 at 12:05 pm, RN M acknowledged that she had not checked Patients 32 and 33's identity prior to the medication pass nor had the MAR or physician's order available.

On 7/11/12 at 4:15 pm, Administrative Nurse K acknowledged the facility policy was not followed for checking Patients 32 and 33's identity prior to administration of medications.

2. On 7/9/12 at 8:30 am, during the initial tour of the facility, the narcotic wastage sheets for the previous week were reviewed for the intensive care (ICU) and the emergency room (ER).

On the 7/6/12 ER Narcotic Log, Donnatal Elixir (for gastrointestinal distress) was administered at 2030 (8:30 pm) to a patient and 5 milliliters (ml) were wasted. The log did not contain a signature for who dispensed the medication or a signature that the wastage was witnessed.

On the 7/2/12 ICU Narcotic Log, Morphine (a pain reliever) was administered at 0700 (7 am) to a patient and one ml was wasted. The log did not contain a signature for witnessing the wastage.

On 7/9/12, the facility policy, titled, "Controlled Drugs in the Patient Care Area," dated 6/12, indicated, "Any controlled drug "wasted".... must be documented directly on the CSAR (narcotic log). The recording nurse will enter the date, time, patient name, and indicate the amount (or fraction) of the dose wasted. Another nurse must witness the destruction of all such partial doses and co-sign the entry."

On 7/10/12 at 9:50 am, the Pharmacist acknowledged the nursing staff had not properly recorded narcotic usage and wastage on the narcotic log.

3. On 7/10/12, Patient 16's record was reviewed. Patient 16 was an 89 year old male admitted on 6/28/12 with diagnoses that included congestive heart failure (fluid build up in the lungs and heart), chronic kidney disease, and dementia. Patient 16's record contained a nursing note, dated 6/28/12 at 2330 (11:30 pm) which indicated, "Patient out of bed walking in hall confused looking for cane, patient not accepting reorientation, Called MD new order Haldol 1 milligram IV (intravenous) now."

a. On 7/10/12, the facility pharmacist (RPH) provided a computer printout from "UpToDate" for Haldol which indicated the following, "Elderly patients with dementia-related psychosis (loss of contact with reality) treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Haloperidol is not approved for the treatment of dementia-related psychosis.

On 7/12/12 at 9:15 am, RPH acknowledged that Haldol was not an approved drug for Patient 16.

b. The UpToDate reference further included the following regarding adverse effects of Haldol, "May alter cardiac conduction and prolong QT interval (irregular heart beat); life-threatening arrhythmias have occurred with therapeutic doses of antipsychotics, but risk may be increased with doses exceeding recommendations and/or intravenous administration (unlabeled route)... Monitor ECG (electrocardiogram - heart rhythm monitor) closely for dose-related QT effects.

Patient 16's record contained no evidence that his ECG was monitored.

On 7/12/12 at 4 pm, Administrative (Admin) Nurse reviewed Patient 16's record and acknowledged that Patient 16 did not have ECG monitoring as indicated by the above UpToDate reference.

c. On 7/11/12, the facility policy, titled, "Restraint and Seclusion," dated 4/28/10, defined a chemical restraint as a medication used to control intentionally dangerous behavior or to restrict the patient's freedom of movement and is not a standard therapy or treatment for the patient's medical or psychiatric condition. The policy further indicated restraints were ordered, "When less restrictive measures have been found to be ineffective...A physician...must see and evaluate the patient within one hour of the initiation of behavioral restraints...The patient will be monitored every 15 minutes thereafter."

On 7/12/12 at 4 pm, Admin Nurse K reviewed Patient 16's record and acknowledged that Patient 16's Haldol met the definition of a chemical restraint used to control Patient 16's behaviors. Admin Nurse K acknowledged that Patient 16's record did not contain less restrictive measures that may have been attempted, physician evaluation within the first hour, and monitoring of Patient 16 every 15 minutes for adverse effects of Haldol and provision of personal care services.

Based on record review and staff interview, the facility failed to ensure that records were legible, complete, and accurately documented due, in part, to the lack of an approved abbreviation list in six of 34 sampled patient records. (Patients 10, 11, 20, 26, 27, and 28) This failure had the potential for miscommunication which could negatively impact patient's health status.

Findings:

The Medical Staff Rules and Regulations, last revised 4/12, were reviewed on 7/10/12. Section 13 states: "To avoid misinterpretation, only abbreviations approved by the Medical Staff may be used in the medical record...." In an earlier paragraph, this section also states: "....Each acute care patient shall be seen on a daily basis by the Attending Physician or designee, with pertinent progress notes recorded in the medical record at least daily." And Section 9 states: "All orders for treatment shall be written, timed and dated. Any verbal order shall be authenticated by the individual who gave it within 24 hours by the individual who gave it to the on-call physician."

Patients 26, 27, and 28 records were reviewed on 7/11/12, and the findings 1 through 6 were confirmed concurrently by IS Staff R.

1. During an interview with HIM Staff A on 7/9/12, she stated that the facility only had a "Do Not Use Abbreviation" policy and that there was no currently-approved list of acceptable abbreviations that may be used in the medical records. Patients 26, 27, and 28 records contained abbreviations in physicians' documentation.

2. Entries were not timed when documented (in physicians' orders and on the Emergency Department record, the Disposition time was left blank). There were no physician progress notes for two days of the patient's five day stay. (Patient 27)

3. The "Disposition and Condition," of the patient was incorrect on the Emergency Department record. The form was checked-off as the patient going "home" in "stable" condition; however, the patient actually was transferred to observation status, and later admitted. (Patient 27)

4. Patient 26's record contained seven telephone/verbal orders, given 6/27/12 through 7/1/12, that had not been signed by the physician.

5. The Conditions of Admission consent was not included in Patient 27's record and was unable to be located. The one that had been scanned into the record belonged to a different patient who was admitted on the same date.

6. On 7/10/12, Patient 27's record indicated he was discharged on 5/30/12. Patient 27 records lacked some of the documents from a procedure performed (consents, anesthesia report). They were later found in the backlog of documents waiting to be scanned into the electronic medical record, 41 days later.



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7. On 7/12/12, the facility's, "Administration of Medications When the Patient is Allergic," policy, dated 5/10, was reviewed. The policy read, "...If a provider request a medication be given when a patient has a stated allergy, documentation must be shown that the patient was made aware of possible consequences prior to administration."

Patient 11 was admitted to the facility on 7/9/12 with diagnoses that included abdominal pain and small bowel obstruction.

Patient 11's allergy profile showed that Patient 11 reported a moderately severe allergy to Ciprofloxacin(Cipro, antibiotic) that was discovered on 7/9/12.

Patient 11's record included a physician's order, dated 7/9/12 at 8:26 pm, for Cipro to be administered intravenously, every 12 hours. The record included an alert message that showed the use of Cipro may result in an allergic reaction based on the reported history of a Cipro allergy. Special instructions show the physician was aware of the stated allergy, and after review stated it was not a true allergy, and to give the Cipro and monitor for any allergic reactions. There was no documentation found in Patient 11's record, that he was made aware of the possible consequences to receiving the Cipro, prior to receiving it.

On 7/11/12 at 1:35 pm, Administrative (Admin) Nurse K was interviewed and confirmed the facility's policy to document that the patient was made aware of the possible consequences prior to administration of the drug. Admin Nurse K was not able to provide documentation that Patient 11 was made aware of the possible consequences to receiving Cipro, after a stated allergy and prior to administration of the medication.



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8. On 7/12/12, Patient 20's record was reviewed. Patient 20's record contained a verbal order for Vitamin K (used to block excessive bleeding caused by warfarin, a blood thinner), dated 6/3/12, which did not contain a physician's signature for verbal order verification, 46 days later.

On 7/12/12 at 3 pm, the Pharmacist acknowledged Patient 20's verbal order for Vitamin K did not contain a physician signature verifying the order.

9. On 7/12/12, Patient 10's record was reviewed. Patient 10's record contained a verbal order for naloxone (used to reverse the effects of narcotics when an overdose is suspected), dated 6/1/12, which did not contain a physician's signature for verbal order verification, 48 days later.

On 7/12/12 at 3:50 pm, Administrative Nurse K acknowledged Patient 10's verbal order for naloxone did not contain a physician's signature verifying the order.

Based on medical record and document review and staff interview, the facility failed to ensure that all records included a history and physical report, properly executed informed consents, and a complete discharge summary in four of 34 sampled patient records reviewed. (Patients 13, 15, 26, and 28) This failure had the potential for miscommunication which could negatively impact patient's health status.

Findings:

The facility's document, titled, "Medical Staff Rules and Regulations," last revised 4/12, was reviewed on 7/10/12. Section 6 reads: "A History and Physical examination shall be recorded on the medical record in writing, or dictated, within 24 hours of admission." "....Each hospitalization will have a Discharge Summary report including the condition of the patient on discharge, follow-up, medications, diet and activity."

1. Patient 26's record was reviewed on 7/11/12. Patient 26's record showed a hospital stay of five days; however, no History and Physical report was found in the medical record. IS Staff R confirmed this finding concurrently.

2. Patient 28's record was reviewed on 7/11/12. Patient 28's record indicated Patient 28 had a hospital stay of two days and was transferred to an outside skilled nursing facility. Patient 28's discharge summary had no information documented in the following sections: Condition on Discharge, History of Present Illness, and Hospital Course.

Health Information Staff A confirmed this finding on 7/11/12 at 4:40 pm, and stated that the report was insufficient/incomplete.


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3. On 7/17/12, the facility's "Condition of Admission" policy, dated 7/10, was reviewed. The policy showed that the patient's consent for Authorization for Test/Treatment (informed consent) was to be signed, prior to their admission to the hospital.

Patient 13 was admitted to the facility on 2/16/12 with diagnoses that included peripheral vertigo (sensation of rotation of one's self or surroundings) and functional decline.

Patient 13's record was reviewed on 7/11/12 and contained an Authorization for Tests/Treatment that was not completed or signed. There was no other consent for treatment found in Patient 13's record.

4. Patient 15 was admitted to the facility on 3/5/12 with diagnoses that included an ileus (bowel blockage).

Patient 15's record was reviewed on 7/12/12 and contained an Authorization for Tests/Treatment that was not completed or signed. There was no other consent for treatment found in Patient 15's record.

On 7/11/12 at 4:45 pm, Health Information Manager (HIM) A confirmed the Authorizations for Tests/Treatment were not signed.

Based on interview, medical record review and document review, the hospital failed to ensure that surgical procedures were only performed in a safe manner in accordance with the hospital's rules and policies and state regulations. This occurred when the hospital permitted 6 of 34 sampled patients (Patients 1, 5, 6, 7, 11, and 18), to undergo surgery without first ensuring that the patients had a complete history and physical report (H&P) completed, recorded and in the medical record prior to the surgery. This failure had the potential for those patients affected to permit them to not receive proper treatment due to unrecognized diagnoses, incomplete/incorrect medications lists or other missing or incorrect information leading to potential complications during or after surgery.

Findings:

On 7/10/12 and 7/11/12 the medical staff rules, the "Surgery Patient History and Physical" policy dated 9/2/11 and the "Completion of Medical Records" policy dated 9/09 were reviewed. Rule 6 "History and Physical Examination" states that "a medical H&P examination shall be recorded on the medical record in writing, or dictated, within 24 hours of admission." The Surgery Patient History and Physical policy states that "every surgical patient will have a medical H&P examination performed and recorded within 24 hours of surgery"; that "the H&P must include at least: past medical history... review of systems... current medications... physical examination including: temperature, pulse, blood pressure, weight, height, heart/lung sounds, ...procedure including risks and benefits of the procedure, anesthesia plan... and any medical problems pertaining to them". The Completion of Medical Records policy states that "the H&P must contain... a comprehensive physical examination to include rectal/genitalia." State regulations require that medical record contain a pre-surgical H&P which was done no more than 30 days prior to admission/surgery and an interval H&P done within the 24 hours prior to surgery.

1. The electronic medical record (EMR) documents that Patient 1 was admitted on 7/5/12 by Podiatrist X for fusion of the right great toe. The only medical H&P examination in the record was dictated by Podiatrist X at 4:04 pm on 7/5/12 and transcribed (appeared in the EMR) at 12:26 am the morning of 7/6/12. The H&P was incomplete with documentation only of an examination of the lower extremities and was not present in the medical record until after the surgery had been completed. There was not an examination of the heart, lungs or rectal/genitalia.

On 7/12/12 at 11:30 am, the medical records of Patient 1 was reviewed concurrently with the MSC and ICN C who agreed that each record did not contain the required per-surgical complete H&P.

2. Patient 5 was admitted on 10/24/11 by Podiatrist X for a total ankle arthroplasty. Podiatrist X dictated a podiatric H&P on 9/30/11 in which only an examination of the lower extremities was recorded. On the day of the surgery, 10/24/11 an "Interval History and Physical" stating the patient's condition was unchanged. There was no record of an examination of the heart, lungs or rectal/genitalia. Patient 5 had a more complicated hospital stay requiring medical treatment and on 10/28/11, she was transferred to a swing bed for continuation of her care.

On 7/12/12 at 11:30 am, the medical records of Patient 5 was reviewed concurrently with the MSC and ICN C who agreed that each record did not contain the required per-surgical complete H&P.

3. Patient 6 was admitted on 8/12/11 for same day surgery consisting of a total ankle arthroplasty by Podiatrist X. The admission H&P was done on 7/13/11 by Podiatrist X and contained only an examination of the lower extremities; there was no examination of the patients heart, lungs or rectal/genitalia. The H&P did not document all of the patient's medical history, medical conditions or medication list. The Interval History and Physical form indicated the patient's condition was unchanged. After surgery the patient was discharged that same day, 8/12/11. The patient was readmitted a week later on 8/19/11. The admission H&P by a physician documented a postoperative infection, a hematoma and acute blood loss anemia and nausea / vomiting complicating the management of her type 2 diabetes. She was discharged on 8/14/11.

On 7/12/12 at 11:30 am, the medical records of Patient 6 was reviewed concurrently with the MSC and ICN C who agreed that each record did not contain the required per-surgical complete H&P.

4. Patient 7 had an incomplete H&P documenting only an exam of the patient's lower extremities performed by Podiatrist X on 9/28/11. The surgery was done on 10/3/11 and was done without an update to the H&P.

On 7/12/12 at 11:30 am, the medical records of Patient 7 was reviewed concurrently with the MSC and ICN C who agreed that each record did not contain the required per-surgical complete H&P.



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5. On 7/11/12, the facility's "Surgery Patient History and Physical" policy, dated 9/2/11, was reviewed. The policy included a requirement that all surgical inpatients to have a full H & P and that the documentation "must include at least:"...past medical history...review of systems...current medications...physical exam including blood pressure...temperature...weight...age...procedure including risks and benefits of this procedure, anesthesia plan...

Patient 11 was admitted to the facility on 7/9/12 for total right hip replacement surgery. His H & P, dated 6/28/12 (11 days prior to surgery) did not include past medical history and only listed HBP (a non approved hospital abbreviation). The surgical history listed previous left shoulder surgery and bilateral total knee replacements, which indicated Patient 11 had a past medical history on his left shoulder and both knees. The current medication was listed as "BP med" and did not identify a specific medication or class of antihypertensive. The review of systems section was marked "Neg" (negative) and did not include any preoperative laboratory values or diagnostic testing done or identify problems with his musculoskeletal system (that was being operated on). The physical exam section did not include any objective data or findings for any areas of the body allegedly examined, indicating there was no exam done. The plan treatment section only listed the right hip replacement and did not list any medication or therapies following the planned surgery. The vital signs section did not include blood pressure with Patient 11's current problem of high blood pressure and blood pressure medication usage. The vital signs did not include Patient 11's temperature or weight. Weight is needed for dosing many medications both during and following surgery. There was no reference to anesthesia or the risks and benefits, as required by the facility's policy.

On 7/10/12 at 2:15 pm, Health Information Manager (HIM) A stated that Patient 11's preoperative H & P was not complete, contained an unapproved abbreviation of HBP (high blood pressure?) and no blood pressure, temperature, current medications or family history. HIM A confirmed Patient 11's preoperative H & P did not meet the requirements of the facility's Surgery Patient History and Physical policy.

On 7/12/12 Operating Nurse (OR) S confirmed that Patient 11's preoperative H & P was not a full or complete H & P.



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6. On 7/12/12, Patient 18's record was reviewed. Patient 18 was admitted on 2/14/12 for a laparoscopic cholecystectomy (removal of gall bladder). Patient 18's record contained a Short Form History and Physical Examination, dated 2/13/12, which contained no information related to Patient 18's age, past medical history, review of systems, and physical findings for abdomen, heart and lung functions. The Interval History and Physical, dated 2/14/12, indicated there was no changes to the above history and physical.

On 7/12/12 at 2:50 pm, the Operating Room Supervisor acknowledged that Patient 18's did not reflect required information to be a complete history and physical.

Based on staff interview and document review the hospital failed to ensure that requirements were met for the condition of participation: Periodic Evaluation and Quality Assurance Review as evidenced by:

* Failure to develop an effective, ongoing, data-driven, quality appraisal and performance program for the hospitals' total program and take appropriate remedial action (Refer to C 337 and C 342).

* Failure to ensure a system for identifying, reporting, investigating and controlling infections and communicable diseases and evaluate the quality and appropriateness of the diagnoses, treatment, and outcomes (Refer to C 278 and C 336).

* Failure to evaluate the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the hospital by an appropriate and qualified Quality Improvement Organization (QIO) or network hospital (Refer to C 340).

*Failure to develop an effective, ongoing, data-driven, quality appraisal and performance program for the hospital's total program (Refer to C279, C293, C302, and C342)

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Based on staff interview, medical record review and document review, the hospital does not have an effective quality assurance program to evaluate the quality and appropriateness of the diagnoses and treatments furnished in the hospital and of the treatment outcomes. This failure may permit poor quality practices to persist, potentially resulting in errant diagnoses and/or inappropriate treatments which may adversely affect the health of patients.

Finding:

1. The written Policy & Procedure titled "Quality Assurance / Performance Improvement Program" was not followed as written as demonstrated by the following:
On 7/9/12, when asked for the hospital's current quality improvement plan, an eight page Policy & Procedure (P&P) titled "Quality Assurance / Performance Improvement Program" (QA/PI Program P&P) was provided. The QA/PI Program P&P documents that it was last reviewed in 11/11. On the morning of 7/10/12 the Quality Assurance Coordinator (ICN C) stated that the hospital did not have any other documents describing plans for the quality assessment activities planned for the current year or previous years. He said that the only written description of the hospital's quality improvement plan was the provided QA/PI Program P&P.

In this QA/PI Program P&P the section titled, "Program Composition" lists three key components to be used:
1. The QA/PI Program, which is described to be: "The QA/PI Program describes how the mission of (hospital) is to be carried out for the quality function and gives consistent structure and guidance for carrying out the process of evaluating, maintaining and improving the quality of care at (hospital)."
2. The QA/PI Plan, which is described to be: "The QA/PI Plan is part of the Program in which each department of function identifies the important criteria that will be measured each year. This allows the criteria to be better identified and evaluated on a year-to-year basis. Important indicators for Critical Access Hospital and Title XXII requirements are identified for measurement here. All departments and/or functions represented on the QA/PI Committee with create a QA/PI Plan for each year. All plans will be approved and forwarded to Medical Staff Peer Review Committee, and finally the Board of Directors. The exception is the Medical Staff QA/PI Plan will go only from the Peer Review Committee to the Medical Executive Committee and the Board of Directors."
3. The QA/PI Calendar, which is described to be: "The QA/PI Calendar for the identified year shows when reports are due to the QA/PI Committee, when the reports go to Medical Staff Peer Review Committee and which Board of Director meeting will receive them. Quarterly Reports are the minimum reporting frequency for all indicated departments and functions. The calendar is reviewed, revised if needed, and approved each year."

On 7/12/12 at 11:00 am, the ICN C was again interviewed concerning the hospital's QA/PI activities. When asked for the QA/PI Plan and QA/PI Calendar which were described in the QA/PI Program P&P, he reiterated that the only written "plan" was the QA/PI Program P&P itself. He did not provide a written QA/PI Calendar, but explained it by referring to the large three ring binder containing monthly QA/PI Committee minutes and data.

Review of the hospital's key committee minutes showed that there had been ten Peer Review/Credentialing Committee meetings from 6/22/11 to 5/31/12; twelve MEC meetings from 6/14/11 to 5/8/12; and ten Board meetings from 5/24/11 to 4/24/12. In the minutes of these twenty-three meetings, none documented action taken to approve, revise or take other action on a QA/PI Program, a QA/PI Plan or a QA/PI Calendar. Many of the meetings recorded the presentation of one or more quality report(s), some of which record the acceptance of one of those reports. However the minutes didn't documented the identification of any specific quality problems that had been found or any corrective action taken or the resolution of any previously addressed quality issue. The minutes of these three key hospital governance committees do not document the presence of or the encouragement for creation of any active quality assessment or performance improvement activities.

2. Identified weaknesses in the performance of care providers has not been systematically evaluated and reported up to the leading officials and the governing body so that corrections could be planned, performance improvement quantified and follow up actions taken, as demonstrated by the following:
According to committee minutes, a number of times quality or performance or compliance issues had been specified but there was either no record of action taken or no follow-up to show that the issue had been effectively resolution of the issue and the governing body apprised. These include:
1. In both the 10/5/11 and 11/3/11 minutes of the Physician Peer Review/Credential Committee (PPRCC) meetings are statements that "physicians are failing to write all the diagnoses on the H&Ps ... " this was followed by, "Recommendation/Action: (Physician P) recommended that (two physician members of the PPRCC) announce this in the next Medical Staff Meeting and then track changes."
2. In both the 10/5/11 and 11/3/11 minutes of the PPRCC meetings are statements that "(Physician P) said that there are many x-rays (reports that) are coming with different readings. He said it is almost like these are not the same films being read. He said it is getting very frustrating, (ICN C) said that they send us there (sic: their) QA report. (Physician P) asked that we send a specific patients chart to be reviewed. (ICN C) said that he will pull that pt. Chart and have (Radiology Supervisor) have it reviewed."

The 10/8/11 and 11/3/11 Medical Staff minutes do not record that the H&P issue had been announced and do not record that the problem with radiology reports had been addressed. In the 10/8/11 and 11/3/11 MEC minutes respectively are line items that read:
Committee Reports: The following reports were reviewed and discussed. QA/PI Committee: October 2011.
Committee Reports: The following reports were reviewed and discussed. QA/PI Committee: November 2011.

However these minutes and subsequent minutes of the MEC, Medical Staff and PPRCC do not record that these issues are specifically addressed. There is no record that any radiology QA reports (originating in the hospital or at the distant site radiology entity) had been received, reviewed or discussed. There is no record that improved performance in H&Ps or radiology reports were sought. There is no record that ongoing proficiency and performance in doing the H&Ps or reading the radiographs had been followed. In subsequent Board meetings the minutes do not document that either of these physician proficiency issues had been reported or acted upon.

In the 1/26/12 minutes of the PPRCC, there are two similar references to quality issues. One concerning dictated reports that were not done and incident reports generated in the pharmacy. The issue related to the missing dictated report was assigned to Admin Staff E to "follow up." The incident report problem was "forward(ed) to the Medical Staff/ Executive Committee for review only." There is a line item in the 2/14/12 MEC minutes stating that the January QA/PI Committee report was "submitted for information only to the medical staff". However there was no record that these two quality issues were reported or followed up by the MEC, Medical Staff, Board or PPRCC.

3. Practitioner (Physician and Allied Health Providers) Proficiency Review and Credentialing had not been conducted and recorded in a manner that follows the recognized standards, bylaws, rules and P&Ps as demonstrated by the following:

On the afternoon of 7/11/12 and the morning of 7/12/12, nine credential files of practitioners with current privileges were reviewed with the assistance of the Medical Staff Coordinator (MSC). Of the nine credential files reviewed, three were those of Allied Health Practitioners (AHP BB, AHP DD and AHP EE) and six were those of medical staff members (Physician O, Physician P, Podiatrist X, Physician Y, Physician Z and Physician CC).

a. Five of the nine credential files (Physician O, Podiatrist X, Physician Y, Physician Z and Physician CC).) did not have any form of primary verification of the practitioner's training, i.e. an AMA (American Medical Association) certifications or letters verifying the satisfactory completion from their training at schools, internship, residency and fellowship.

b. Nine of nine did not have any data showing the practitioner's current level of activity in the hospital and/or data capturing some aspect of their performance and proficiency in hospital during the recent past and/or the time period just before their most recent reappointment to the medical staff.

c. Nine of nine did not have a current recording of the exact beginning and ending dates of their most recent Medical Staff appointment or Allied Health Provider (AHP) privileges.

d. Four of the six medical staff members were not currently on provisional staff status. Three of those four (Physician Y, Physician Z and Physician CC) did not have any proctor reports, proctoring summaries or other documented data showing they had satisfied any proctoring requirements.

e. Two of the medical staff members (Physician O and Podiatrist X) had been at the hospital no more than a year and had no documentation in their credential file to show they were other than on provisional staff status. Neither of their files contained documentation to show that they had been assigned a "designated monitor" (i.e. proctor). Section 3.5-3 of the Medical Staff Bylaws states give to the MEC the duty of specifying the frequency and format of the proctoring observation or evaluations, but neither credential file contained this information. Their credential files did not contained any proctor reports, proctoring summaries or other documented/data showing where they were in the process of their progress toward graduation to active staff or another category of medical staff membership.

f. Review of Physician O's credential file showed that she had signed her application for membership on 9/2/11. There were no other files containing any data concerning Physician O's performance to date at the hospital such as proctoring reports or chart reviews, and the credential file contained no performance, proficiency or proctoring data. Her file contained an AMA certificate of training showing recent completion of her residency training. There was only one completed letter (form) of reference and two blank forms. With these blank forms were copies of two urgent appeals dated 10/22/11 which documented they had been sent by fax to physicians at her residency requesting that the forms be completed and "return(ed) ASAP (as soon as possible) (Physician O) would like to start 11/1/11." The MSC explained that three letters of reference were always requested and some applicants had more. Despite only one letter of reference in her credential file, documentation shows she had been given Temporary Privileges on 10/31/11. The PPRCC committee minutes of 11/3/11 show a recommendation for appointment to "Provisional/Active" staff status. Her privileges list show it had been signed as approved by a member of the Board on 11/8/11. The Board did not meet in November 2011 and minutes show that the Board had not approved her appointment until 12/6/11. Even with only one letter of reference and no data to show her competency with any one of the wide range of privileges she had requested, minutes of the Board, MEC, and PPRCC for when her appointment came before them state "Based on the applicant's training, professional experience, professional experience, validation of current licensure, references affirming the individual's competency, ethic character, and both physical and mental health status, the Medical Staff recommended the following appointments and reappointments to the Medical Staff as specifically delineated."

g. Review of Podiatrist X's credential file and professional proficiency (peer review) file and related committee minutes showed the following. Podiatrist X signed his application on 5/12/11. He was granted temporary privileges on 6/2/11 without specification of which specific privileges granted. His name appears in the 7/12/12 PPRCC minutes, the 7/12/11 MEC minutes, and the 7/26/11 Board minutes where he was appointed to Provisional staff membership. He was sent a letter from the then Medical Staff Coordinator dated 7/27/11 informing him of his appointment, but not specifying the category of his appointment, the beginning or ending dates of his appointment, information about which privileges that had been granted, or any proctoring assignments. His credential file did not contain a California certificate to be an operator of radiography and fluoroscopy equipment. His request for privileges does not include a request to do intraoperative fluoroscopy nor does it request privileges to do an admission history and physical (H&P). His credential file contained no proctor reports or other data pertaining to the level of his activity in the hospital or data concerning his performance at the hospital or in the operating room.

During the process of credential chart review, during the afternoon of 7/11/12 and the morning of 7/12/12 the MSC concurred with the above findings.

4. Scheduled Random Chart Reviews have not been conducted as planned, record keeping on the chart review forms had been lax and inaccurate chart analyses had been accepted without further evaluation to verify that the analyses were accurate. As a result the hospital has missed opportunities for improvement, as demonstrated by the following:

On 7/10/12, a randomly selected medical record of recent surgeries had been selected for review and one medical record (Patient 1) was noted to be incomplete. The electronic medical record (EMR) documented that the patient had been admitted, on 7/5/12, by Podiatrist X for fusion of the right great toe that was done at (time). The only medical history and physical examination (H&P) in the record was dictated by Podiatrist X at 4:04 pm on 7/5/12, and transcribed (appeared in the EMR) at 12:26 am, the morning of 7/6/12. The H&P was incomplete with documentation only of an examination of the lower extremities and was not present in the medical record until after the surgery had been completed.

In Podiatrist X's peer review file there were five "Quality Improvement Cart Review (Random Chart Review)" forms, each completed on 1/11/12, each noting that it was a "Random Quarterly Review" and each having only a hand written comment stating, "No problem." None of the eleven listed specific case review indicators on the form had been checked and none of the specified six review recommendations on the form were checked. Because of the incompleteness of these forms, the respective medical records were pulled for review. Three of these medical records also were missing complete H&P's prior to the surgery. One medical record should also have been reviewed because of surgical complication and readmission one week after surgery.

a. Patient 5 had an incomplete H&P documenting only an exam of the patient's lower extremities performed by Podiatrist X on 9/30/1. On 10/24/11 a total ankle arthroplasty was performed by Podiatrist X. The "Interval History and Physical" has a check mark indicating "I have examined the patient and the patient's condition is unchanged." This patient had a more complicated hospital stay requiring medical treatment and on 10/28/11, she was transferred to a swing bed for continuation of her care.

b. Patient 6 had an incomplete H&P documenting only an exam of the patient's lower extremities performed by Podiatrist X on 7/13/11. On 8/12/11 a total ankle arthroplasty was performed by Podiatrist X. The "Interval History and Physical" has a check mark indicating, "I have examined the patient and the patient's condition is unchanged." Patient 6 was discharged that same day, 8/12/11. The patient was readmitted by a week later on 8/19/11. The admission H&P by a physician documented a postoperative infection, a hematoma, acute blood loss, anemia, and nausea / vomiting complicating the management of her type 2 diabetes. She was discharged on 8/14/11.

c. Patient 7 had an incomplete H&P documenting only an exam of the patient's lower extremities performed by Podiatrist X on 9/28/11. The surgery was done on 10/3/11 and was done without an update to the H&P.

On 7/12/12 at 11:30 am, these findings were reviewed with the MSC and ICN C and there was general agreement that this small sample suggests that there may be a significant number of similar findings if they were to do a larger sample. They also agreed that perhaps medical records be reviewed a second time, if the Random Chart Review forms were noted to be incomplete or otherwise atypical.

Based on interview and record review, the facility failed to have an ongoing quality assurance program (QAP) to evaluate the nursing and pharmacy functions to to evaluate pharmacy functions as evidence by:

1. The QAP did not contain measures for the appropriate use of restraints;

2. The QAP did not contain measures for several key pharmacy processes;

3. The QAP did not contain analysis on reported ADRs to identify possible errors and corrective actions to prevent reoccurrences; and

4. The hospital failed to ensure that the quality assurance program did incorporate an evaluation of all patient care services and other services affecting patient health and safety.

These failures had the potential for process and system problems to persist and negatively impact patient care and permitted unsafe and poor quality services to possibly persist and potentially subjecting either patients or staff to harm.

Findings:

1. On 7/12/12, the facility QAP was reviewed. The QAP program did not contain measures for the appropriate use of chemical restraints. (Refer to C 271)

On 7/16/12 at 11 am, Quality Manager C confirmed that the QAP did not contain measures for restraints.

2. On 7/12/12, the facility QAP was reviewed. The program did not contain measures for the following pharmacy functions: (Refer to C 253 and C 297)
- Oversight of night locker (medications) access during the day;
- Staff education and oversight of monitoring required for drugs with FDA (Federal Food and Drug Administration) boxed warnings (for significant risk for serious or life-threatening adverse effects);
- First drug dose review;
- Availability of expired medications for use;
- Use of single dose medications for multiple patients;
- Proper disposal of medication; and
- Identification, evaluation, and reporting of adverse drug reactions.

On 7/17/12 at 10:30 am, the Pharmacist confirmed the Pharmacy QAP did not contain appropriate measures to evaluate the above functions of the Pharmacy.

3. On 7/16/12, the facility's Adverse Drug Event Logs were reviewed. The 8/11 log listed two events, dated 8/8 and 8/12/11, in which severe ADRs were identified. The log indicated the physicians were notified and the patients had responded to treatment. The log did not contain a notation of an analysis of the ADRs to identify possible errors or corrective actions that could prevent further occurrences.

On 7/16/12 at 9:50 am, the Pharmacist (RPH) confirmed that no evaluation was done on reported ADRs to identify possible errors and corrective actions which could prevent further occurrences.


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4. The radiology services department does not have an established quality and safety program to ensure that radiology services are always provided by qualified staff members in a safe manner and that patients and staff are protected from excess radiation or other safety risks. The radiology services department does not collect quality assessment and performance improvement data to send forward to the hospital's quality assurance program. (Refer to C 283)

Based on interview and document reviews, the facility failed to ensure an effective quality assurance activities to identify and resolve infection control problems. This failure placed hospital patients, staff persons, and participating physicians at increased risk for transmission of and infection from serious infectious diseases.

Findings:

During an interview with Infection Control Nurse (ICN) C on 7/11/12 at 10:30 am, when asked why the many infection controls identified during the survey, described under section C 278 of the survey findings report, had not been identified by ICN C or hospital managers and evaluated by quality assurance, the ICN C stated, "It's a small hospital and people have multiple hats." On 7/11/12 at 1:30 p.m., ICN C indicated that regular environmental rounding to assess infection control practices had not been done due to competing work priorities.

During a discussion with Administrative (Admin) Staff E on 7/11/12 at 5 pm, he indicated
hospital employees and managers staff did not have clear direction, and defined roles and responsibilities for identifying and resolving infection control problems.

Based on document review and staff interview, the hospital failed to ensure that the quality and appropriateness of the diagnoses and treatments furnished by physicians at the hospital were evaluated by either another hospital, a Quality Improvement Organization (QIO), or another appropriate and qualified entity. This failure may have provided for the continuance of any possible poor quality or inappropriate diagnoses and treatments rendered by physicians to the hospital's patients.

Findings:

On 7/10/12 through 7/12/12 the past 12 months of minutes of the Medical Executive Committee (MEC), the Board of Directors (Board), the Physician Peer Review/Credentialing Committee (PPR/CC) and the Quality Assurance/Performance Improvement Committee (QAPIC) were reviewed and no evidence could be found to document that a qualified outside entity had conducted an analysis of the diagnoses and treatments being rendered at the hospital. The minutes of the 3/27/12 Board meeting does reference the "Annual Critical Access Hospital Evaluation 2011 report." Review this 2011 report did not provide evidence of the required analysis of diagnoses and treatments.

On 7/12/12 during an interview at 9:45 pm, INC C stated that the hospital did not contract with a qualified hospital, QIO or other entity to perform quality analysis of the physicians' diagnoses and treatments. He also acknowledged that over the last years the hospital's QAPI program had not incorporated an explicit, internal and reported audit of the physicians' diagnoses and treatments.

On 7/16/12 at 12:10 pm, INC C stated that further search by hospital staff had found that a contract with the California Critical Access Hospital Network (CCAHN) was in place. The contract does provide for CCAHN, a qualified entity, to do the required quality reviews of practitioners' diagnoses and treatments. However the hospital had never in the past utilized this service.

Based on document review and staff interviews, the facility failed to ensure that appropriate remedial action was taken on deficiencies found through the performance improvement monitoring done by the Health Information Management (HIM) department. This failure had the potential for miscommunication which could negatively impact patient's health status.

Findings:

The Physician Documentation Quality Assurance/Performance Improvement (QA/PI) First Quarter, 2012 report was reviewed and discussed with HIM Staff A and Medical Staff Coordinator (MSC) beginning at 2:35 pm on 7/11/12. The results showed that two indicators fell below the threshold: operative reports and discharge summaries continued to be completed outside of acceptable time frames. These reports were presented to the QA/PI Committee in April. A summary was reported to the Peer Review Committee in April and then to the Medical Executive Committee in May. The committee minutes were reviewed on 7/11/12 and there was no documentation that any action was taken--only that the committee summary report was approved.

This finding was confirmed concurrently with MSC.

Based on document review and staff interview the hospital failed to write and implement a protocol that detailed how the collaboration between the nursing staff and the organ procurement organization representatives would ensure that each family of potential donors were informed of the option to either donate or not donate organs, tissues or eyes as specified in this regulation. This failure could potentially permit families to miss their opportunity to make this decision in a timely manner.

Finding:

On 7/9/12, the hospital was asked to provide all of their policies and procedures concerning procurement of organs, tissues or eyes. The single document provided was a 9 page Policy and Procedure (P&P) titled "Organ & Tissue Donation" which indicated it was last reviewed in 2/12. This P&P does contains a lot of information for procedures needed after the family had already decided that organs, tissues or eyes shall be donated. However, it did not detail how the the nursing staff and the organ procurement organization representatives should properly cooperate to ensure that the grieving family receives the needed information in a timely manner and yet understands that it is totally the family's choice if they donate or do not donate. The P&P does not make it clear who will first discuss organ donation with the family (i.e. the designated requestor) or how that individual will be trained.

On 7/11/12 at 11:30 am, ICN C, who is responsible for training nursing staff relative to organ procurement, acknowledged that the hospital had not written and implemented P&Ps that covered all of the points needed in this section of the regulation.

Based on document review and staff interview the hospital failed to write and implement a protocol that encouraged the nursing staff to show discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors. This failure could potentially result in families suffering unnecessary emotional discomfort.

Findings:

On request the hospital furnished the policy and procedure (P&P) titled "Organ & Tissue Donation," (refers to C 347). This P&P does not contain any information concerning the need for staff to be sensitive and discreet with respect to the circumstances, view and beliefs of the families.

On 7/11/12 at 11:30 am, ICN C acknowledged that the hospital had not written and implemented P&Ps that trained and encouraged the nursing staff to show discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors.

Based on interview and record review, the facility failed to ensure one of 34 patients was informed of her resident rights, when she was discharged from the acute care services and subsequently admitted to a swing bed status (bed in an acute licensed rural hospital bed which had been approved to provide short term post-acute skilled level of care). This failure had the potential for patients to be uniformed of their care, treatment, and choices. (Patient 13)

Findings:

Patient 13 was admitted to the facility's swing bed on 2/16/12, with diagnoses that included peripheral vertigo (sensation of rotation of one's self or surroundings) and functional decline.

On 7/11/12, Patient 13's record did not contain documentation that she was informed of her patient rights. There was no acknowledgement of patient rights in Patient 13's record and the "Authorization for Tests/Treatment" form that was not completed or signed.

On 7/11/12 at 4:45 pm, Health Information Manager (HIM) A confirmed Patient 13's Authorization for Tests/Treatment was not signed. She also stated that there was no documentation Patient 13 was informed of her rights upon admission to swing bed status.

Based on interview and record review, the facility failed to serve a notice of discharge to one of 34 patients, when she was discharged from the facility's swing bed (bed in an acute licensed rural hospital bed which has been approved to provide short term post-acute skilled level of care). This failure had the potential for patients to not be aware of their rights and choices upon transfer or discharge from the facility. (Patient 13)

Findings:

Patient 13 was admitted to the facility's swing bed on 2/16/12 with diagnoses that included peripheral vertigo (sensation of rotation of one's self or surroundings) and functional decline. Patient 13 was discharged from the facility on 2/24/12.

On 7/11/12, Patient 13's record did not contain documentation that she was given a notice of discharge.

On 7/12/12 at 2:30 pm, Nurse Manager P confirmed there was no notice of discharge in Patient 13's record.

Based on interview and record review, the facility failed to develop care plans for one of 34 sampled patients, when she was admitted to the facility's swing bed (bed in an acute licensed rural hospital bed which has been approved to provide short term post-acute skilled level of care) status. This failure had the potential for patients to not receive appropriate healthcare and had the right to refuse treatment. (Patient 13)

Findings:

Patient 13 was admitted to the facility's swing bed on 2/16/12 with diagnoses that included peripheral vertigo (sensation of rotation of one's self or surroundings) and functional decline. She was discharged from the facility to an outside skilled nursing facility (SNF) on 2/24/12.

1. On 7/11/12, the facility's Swing Bed Plan of Care policy, dated 10/11, was reviewed and showed that a, "Plan of Care must be initiated upon admission..."

On 7/11/12, Patient 13's record did not contain an care plans following her admission to the swing bed.

On 7/12/12 at 11:05 am, Nurse Manager P confirmed there were no care plans developed following her admission to the swing bed.

2. On 7/11/12, the facility's Swing Bed Discharge Summary policy, dated 10/11, was reviewed. It showed the facility was to develop a post discharge plan of care that identified specific resident needs after discharge and was designed to "ensure" the individual's needs would be met after discharge from the facility.

On 7/12/12 Patient 13's Swing Bed admission orders, dated 2/16/12, and discharge orders, dated 2/24/12, included an order for daily K-Dur (potassium supplement).

Patient 13's laboratory report, dated 2/24/12, showed her blood level of potassium (electrolyte that is critical to proper functioning of nerve and muscles cells, particularly heart muscle cells) was 3.3 millimoles/liter and flagged as "LOW".

Patient 13's record was concurrently reviewed with Nurse Manager P, on 7/12/12 at 11:05 am. It included a signed, handwritten physician's discharge order, dated 2/24/12 at 12:30 pm, that read, "D/C (discharge) to nursing home, repeat BMP (basic metabolic panel that measures blood potassium levels) in 3 days for hypokalemia (low blood potassium that can be life threatening).

Patient 13's record included a Swing Bed admission order form, dated 2/24/12 and signed by her physician, that was completed as a full set of discharge orders to an outside SNF. The form included a section that read, "Labs on admission: ...BMP..." that was not "checked" completed and did not include the physician's hypokalemia diagnosis or previous order to get the BMP in 3 days (to check the potassium level).

Nurse Manager P stated that Patient 13's discharge orders to the SNF, dated 2/24/12, should have included the omitted physician's order to repeat the BMP in 3 days for hypokalemia. Nurse Manager P confirmed Patient 13's post discharge plan of care did not ensure her need to have the BMP done 3 days after discharge would be met, per the facility's Swing Bed Discharge policy.

Based on interview and record review, the facility failed to develop a discharge care plan for one of 34 patients, when she was discharged from the facility's swing bed (bed in an acute licensed rural hospital bed which has been approved to provide short term post-acute skilled level of care). This failure caused the patient to be discharged without an order for a significant lab test, that was requested by her physician. (Patient 13)

Findings:

Patient 13 was admitted to the facility's swing bed on 2/16/12 with diagnoses that included peripheral vertigo (sensation of rotation of one's self or surroundings) and functional decline. She was discharged from the facility to an outside skilled nursing facility (SNF) on 2/24/12.

On 7/11/12, the facility's "Swing Bed Discharge Summary" policy, dated 10/11, was reviewed. It showed the facility was to develop a post discharge plan of care that identified specific resident needs after discharge and was designed to "ensure" the individual's needs would be met after discharge from the facility.

On 7/12/12 Patient 13's Swing Bed admission orders, dated 2/16/12, and discharge orders, dated 2/24/12, included an order for daily K-Dur (potassium supplement).

Patient 13's laboratory report, dated 2/24/12, showed her blood level of potassium (electrolyte critical to proper functioning of nerve and muscles cells, particularly heart muscle cells) was 3.3 millimoles/liter and flagged as "LOW".

Patient 13's record was concurrently reviewed with Nurse Manager P, on 7/12/12 at 11:05 am. It included a signed, handwritten physician's discharge order, dated 2/24/12 at 12:30 pm, that read, "D/C (discharge) to nursing home, repeat BMP (basic metabolic panel that measures blood potassium levels) in 3 days for hypokalemia (low blood potassium that can be life threatening).

Patient 13's record included a Swing Bed admission order form, dated 2/24/12, that was completed as a full set of discharge orders to an outside SNF and signed by her physician. The form included a section that read, "Labs on admission: ...BMP..." that was not "checked" completed and did not include the physician's hypokalemia diagnosis or previous order to get the BMP in 3 days (to check the potassium level).

Nurse Manager P stated that Patient 13's discharge orders to the SNF, dated 2/24/12, should have included the omitted physician's order to repeat the BMP in 3 days for hypokalemia. Nurse Manager P confirmed Patient 13's post discharge plan of care did not ensure her need to have the BMP done 3 days after discharge would be met, per the facility's Swing Bed Discharge policy.