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Based on observation, interview and record review the facility failed to meet the Condition of Participation for Physical Plant and Environment by failing to do the following:

1. The facility failed to ensure that the humidity of the operating room (OR) was monitored and maintained within professional standards, creating the risk of incorrect humidity and the increased risk of infection for patients having surgery at the facility. (Refer to C221).

2. The facility failed to: (A) Perform preventive maintenance on its x-ray machines in accordance with manufacturer's recommendations, resulting in the risk of substandard quality of service for patients receiving x-rays in the facility, and (B) ensure its operating room mattresses had no breaches in the cleanable surface, creating the increased risk of the spread of infection for patients using that mattress. (Refer to C222).

3. The facility failed to ensure the safe warming of intravenous fluid, creating the risk of burns in patients treated with hot intravenous solution. (Refer to C224).

The cumulative effect of these systemic problems resulted in the facility being unable to ensure that high quality healthcare was provided in a safe environment.

Based on observation and interview, the facility failed to ensure that the humidity of the operating room (OR) was monitored and maintained within professional standards, creating the risk of incorrect humidity and the increased risk of infection for all patients having surgery at the facility.

Findings:

During a tour of the OR on 5/9/11 at 10 AM with the ER/OR (Emergency room/ Operating Room) Manager, there was no humidity gauge found in the operating room. There was a dial for setting the desired humidity, which was set at 50.

During a concurrent interview with the ER/OR Manager, she stated that there was no humidity gauge for the operating room, and that she did not believe that the humidity selection dial was working. She stated that they did not collect information regarding humidity in the operating room.

The humidity of operating rooms is to be monitored and controlled in accordance with NFPA 99, Health Care Facilities 1999 edition.

Based on interview and record review, the facility failed to: (1) Perform preventive maintenance on its x-ray machines in accordance with manufacturer's recommendations, resulting in the risk of substandard quality x-rays and the risk of equipment malfunction for all patients receiving x-rays from those machines in the facility, and (2) ensure its operating room mattresses had no breaks in the cleanable surface, creating the increased risk of the spread of infection for all patients using that mattress.

Findings:

1. During a review of the maintenance records of the radiology department on 5/12/11, the records showed that the last preventive maintenance was performed on the X-Ray Room 2 Proteus XR machine was in February, 2006. The last preventive maintenance was performed on the AMX-4 portable x-ray machine in 2001, with a calibration performed in 2007.

During a interview with Radiology Technician 1 on 5/12/11 at 1:45 PM, she stated that there was no current maintenance contract for the radiology department. She stated that there were no additional maintenance records, and concurred that the last dates of preventive maintenance on the Proteus XR x-ray machine and the portable AMX-4 x-ray machine were in 2006 and 2001, respectively. Radiology Technician 1 confirmed that both machines were still in use.

During a review of the manufacturer's recommendations for preventive maintenance for the AMX-4 portable x-ray machine, on page 25 of the manual, read, "Periodic maintenance checks are required at the following intervals: one month and three months after installation, and every six months thereafter."

During a review of the manufacturer's recommendations for preventive maintenance for the Proteus XR x-ray machine, on page 11-4 of the operator's manual, multiple checks and preventive maintenance activities such as calibration and lubrication are to occur each 12 months.

2. During a tour of the operating room on 5/9/11 at 10 AM, the surgical table mattress was observed. The surface was covered with a black washable coating, but the coating was chipped or worn off in approximately 25 places, exposing absorbent material underneath.

During a concurrent interview with the ER/OR Manager, she concurred that the cleanable surface had multiple breaks with absorbent material showing through.

Based on observation, interview and record review, the facility failed to ensure the safe warming of intravenous (given through the patient's vein) fluid, creating the risk of burns in all patients treated with heated intravenous solution.

Findings:

During a tour of the operating room on 5/9/11 at 10:00 AM with the ER/OR (Emergency room/Operating room) Manager, the blanket warmer contained 3 pouches of lactated ringers (a type of fluid with electrolytes added) intravenous fluid labeled "5/3". There was no temperature log for the blanket warmer seen. The temperature gauge mounted outside of the blanket warmer with wires extending to the measuring device inside, registered a temperature of 109 degrees Fahrenheit inside the blanket warmer. During a subsequent observation on 5/10/11, a second thermometer had been placed outside the blanket warmer, and it registered 119 degrees Fahrenheit.

During a concurrent interview with the ER/OR Manager, she stated that there was no temperature log for the blanket warmer. She stated that the solutions were usually cooled before administering them to a patient. She concurred that the bags of solution felt very warm. She stated that she was not able to find a facility policy on solution warming.

Typical manufacturer recommendations for intravenous fluid warming indicate that intravenous fluid should be warmed to a temperature of maximum 104 degrees Fahrenheit.

The ERCI Institute recommended a maximum setting of 110 degrees F for blanket warmers (Health Devices Journal, May, 2005), and also recommends that IV fluids not be warmed in a blanket warmer without additional safeguards due to the risk of overheating the fluid.

Based on observation, interview and record review, the facility's governing body failed to take full responsibility for determining and implementing policies because it did not ensure that quality assurance (such as department quality rounds), performance review and grievance processes (such as investigation of grievances) were carried out per policy and stated practice, creating the risk of substandard quality of care for all patients and the risk of unaddressed grievances.

Findings:

1. During an interview on 5/9/11 at 10:00 AM, the CEO (Chief Executive Officer) stated that a new physician group was performing hospitalist (admission and care of inpatients) services in the facility.

During an interview with the COB (Chief of the Board), on 5/11/11 at noon, he concurred that the Governing Board had not required that quality assurance of the new hospitalist group be undertaken, and concurred that such quality assurance was needed to ensure high quality service and patient safety.

2. During an interview with the QA/IC (Quality Assurance/ Infection Control) Manager on 5/11/11 at 10 AM, she stated that as part of the QA (Quality Assurance) process, each hospital department selected criteria related to performance improvement and utilization management on which to report periodically, and that an annual summary report of the results was compiled. She stated that the facility departments performed QA rounds (a visual inspection) as part of their periodic QA process.

During a review of QA documentation for 2010 on 5/11/11, no QA rounds documentation for the year were seen from the pharmacy department, and for some time periods QA documentation was missing from other departments.

During an interview with the CNO (Chief Nursing Officer) on 5/11/11 at 12:20 PM, she stated that she was not sure that the hospital departments' failure to complete QA rounds were made clear to the Governing Board. She stated that QA did not report to the Governing Body, but instead to the MEC Medical Executive Committee).

3. During a review of the facility grievance process on 5/11/11, for Patient Y, there was no clear investigation of her allegation of unprofessional physician behavior, and no evidence of any response that was provided to the patient and no documentation of actions taken based on the outcome of an investigation of her allegation (see C285).

During an interview with the QA/IC Manager on 5/11/11 at 10 AM, she stated that there was no specific log for the complaints that she followed up on, that there was no specific timeframe for complaint resolution and that follow-up was only provided to the complainant if the grievance was not resolved. She stated that documentation of feedback to the complainant was only maintained if the Risk Manager was involved.

During a review on 5/11/11 of the facility grievance policy, the policy required that a response be sent to the complainant within a specific time frame.

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Provision of Services by failing to:

1. Have written policy and procedure in place for and adhere to all aspects of safe preparation of sterile compounding in the IV (intravenous-given through the patient's vein) Room consistent with state law. (Refer to C 271).

2. Perform and have written policy and procedure in place for monthly inspection of the medication storage area that included the outpatient rural health clinic in Running Springs according to state regulations (Refer to C 271).

3. Have committee approved written policy and procedure in place that addressed the content and procedure related to the use of the facility's Malignant Hyperthermia Cart in the Surgery Room and the Emergency Kit located in the outpatient rural health clinic in Running Springs according to the state regulations (Refer to C 271).

4. Have written policy and procedure in place for and perform, for patient safety, pharmacist review of new physician orders before first dose of medications were dispensed and administered to the patient (Refer to C 271).

5. Have policy and procedure in place and implement segregation of the non-expired controlled substances from the expired controlled and non-controlled substances (See C 276).

6. Have accountability for expired controlled substances (Refer to C 276).

7. Have the pharmacist responsible for distribution and dispensing of the controlled substances (Refer to C 276);

8. Have policy and procedure in place that addressed the security of controlled substances in the Pharmacy (Refer to C 276),

9. Remove expired and unusable medication from patient care area in the Emergency Department (ER) (Refer to C 276).

10. Implement policy and procedure that addressed multi-dose vials and follow manufacturer's recommendation on the open bottle of eye drops (Refer to C 276).

11. Establish policies for ensuring physicians and allied health practitioners had screening for communicable diseases prior to and routinely after beginning providing services at the facility, creating the risk of the spread of communicable diseases from physicians to the patients (Refer to C 278).

12. Ensure that the chemical cleaner used in the operating room was used according to manufacturer directions. This practice created the increased risk of the spread of infection to patients using the operating room (Refer to C 278).

13. Ensure that all movable patient medical equipment and patient examining room tables were regularly disinfected after each patient use according to the disinfectant's manufacturers' recommended instructions. This deficient practice had the potential for further transmission of infectious microorganisms to other patients and staff (Refer to C 278).

14. The services provided by the physician group acting as hospitalists was subject to quality assurance, creating the risk of a poor standard of care for inpatients in the hospital treated by hospitalists (Refer to C 285).

15. To assess a range of clinical services provided in the emergency room, creating the risk of substandard emergency room services (Refer to C 285).

16. To provide provider performance evaluations for services provided in the facility's rural clinics, creating the risk of substandard outpatient treatment for patients in those clinics (Refer to C 285).

17. To ensure that a registered nurse (RN) supervised and evaluated the care for each patient in accordance with accepted standards of practice for 2 of 21 sampled patients (Patients 1 and 2). This failure resulted in patient assessments being performed by licensed vocational nurses (LVN) without validation by an RN which had the potential to result in substandard care to be delivered without adequate RN supervision (Refer to C 296).

The cumulative effect of these systemic problems resulted in the facility being unable to provide safe and effective pharmaceutical services.

Based on observation, interview, and document review, the facility failed to provide pharmacy services with written policies and procedures that were consistent with state law in order to meet the needs of the patients by failing to:

1. Have written policy and procedure in place for and adhere to all aspects of safe preparation of sterile compounding in the IV (intravenous) Room consistent with state law.

2. Perform and have written policy and procedure in place for monthly inspection of the medication storage area that included the outpatient rural health clinic in Running Springs according to state regulations.

3. Have committee approved written policy and procedure in place that addressed state regulations for the procedure related to the use of the facility's Malignant Hyperthermia Cart in the Surgery Room and the Emergency Kit located in the outpatient rural health clinic at Running Springs.

4. Have written policy and procedure in place for and perform, for patient safety, pharmacist review of new physician orders before first dose of medications were dispensed and administered to the patient.

Findings:

1. The Hospital's pharmacy was toured on 5/9/11 starting at 1:30 PM. It was noted that the pharmacy had an area dedicated to preparing sterile compounding of intravenous (IV) drugs with a closed biological safety cabinet (IV hood) - an IV room. The following issues relating to sterile IV compounding in the Pharmacy were identified:


a. During concurrent interview on 5/9/11, at 1:30 PM, the DOP (director of the Pharmacy) was asked to provide documented evidence of training and competency evaluation of the staff on sterile compounding and written policy and procedure related to sterile compounding. The DOP was unable to provide documented evidence that training was provided and competency evaluated for staff given the privilege to prepare sterile IV compounds. The DOP was also unable to provide written policy and procedure on sterile compounding competency and training.

During an interview on 5/11/2011 at 2:30 PM, PT (Pharmacy technician) 500 stated s/he occasionally prepared sterile IV products in the IV Room and that most recently s/he used the IV Hood to prepare IV products about 2 weeks ago. PT 500 stated that s/he was not provided training or competency assessment on sterile compounding.

According to California Code of Regulations (CCR), Title 16, Section 1751.1,

"(b) In addition to the records required by section 1735.3 and subdivision (a), for sterile products compounded from one or more non-sterile ingredients, the following records must be made and kept by the pharmacy:

(1) The training and competency evaluation of employees in sterile products procedures ...
(4) Other facility quality control logs specific to the pharmacy's policies and procedures (e.g., cleaning logs for facilities and equipment)."

According to CCR, Title 16, Section 1751.3,

"(d) Pharmacies compounding sterile injectable products from one or more non-sterile ingredients must have written policies and procedures that comply with the following ...
(3) Policies and procedures must address at least the following:
(A) Competency evaluation."

b. During concurrent interview, on 5/9/11, at 1:30 PM, the DOP was asked to provide evidence of quality assurance on sterile IV product preparation in the IV Room. S/he was also asked for end-product testing records to assess process validation and determination of purity, accuracy, and sterility. The DOP acknowledged that the end-product testing was not consistently done.

The DOP was unable to specify how often the testing needed to be done and acknowledged that no written policy and procedure on end-product testing was available.

Review of the facility documents available indicated that the end-product testing was last done in January 2010 and previous to that in February 2007 and none in between.

According to CCR, Title 16, Section 1751.3,

"(d) Pharmacies compounding sterile injectable products from one or more non-sterile ingredients must have written policies and procedures that comply with the following ...
(3) Policies and procedures must address at least the following ...
(K) End-product evaluation and testing."

c. During concurrent interview on 5/9/11, at 1;30 PM,, the DOP was asked to provide evidence of cleaning and disinfecting of the controlled area in the IV Room. The DOP stated that the weekly disinfecting of the area was not consistently done and upon request of cleaning log, the DOP could not provide documented evidence the cleaning and disinfecting of the controlled area of the IV Room was done.

The DOP was asked to provide written policy and procedure on cleaning and disinfecting of the controlled area as required by the California Board of Pharmacy Regulations. The DOP was unable to do so.

According to California Code of Regulations (CCR), Title 16 Section 1751.4,

"(d) Exterior workbench surfaces and other hard surfaces in the designated area, such as walls, floors, ceilings, shelves, tables, and stools, must be disinfected weekly and after any unanticipated event that could increase the risk of contamination."

According to CCR Title 16 Section 1751.3,

"(d) Pharmacies compounding sterile injectable products from one or more non-sterile ingredients must have written policies and procedures that comply with the following ...
(3) Policies and procedures must address at least the following ...
(G) Regular cleaning schedule for the controlled area and any equipment in the controlled area and the alternation of disinfectants ..."

d. During concurrent interview on 5/9/11, at 1:30 PM, the DOP was asked to provide written policies and procedures that addressed the IV sterile compounding in the pharmacy. The DOP was unable to provide policies and procedures related to IV sterile compounding to meet the following California State Board of Pharmacy regulation requirements:

CCR Title, 16 Section, 1751.3,

"(a) Any pharmacy engaged in compounding sterile injectable drug products shall maintain a written policy and procedure manual for compounding that includes, in addition to the elements required by section 1735.5, written policies and procedures regarding the following:
(1) Compounding, filling, and labeling of sterile injectable compounds.
(2) Labeling of the sterile injectable product based on the intended route of administration and recommended rate of administration.
(3) Equipment and supplies.
(4) Training of staff in the preparation of sterile injectable products.
(5) Procedures for handling cytotoxic agents.
(6) Quality assurance program.
(7) Record keeping requirements."

CCR Title, 16 Section, 1751.3

"(d) Pharmacies compounding sterile injectable products from one or more non-sterile ingredients must have written policies and procedures that comply with the following ...
(3) Policies and procedures must address at least the following:
(A) Competency evaluation.
(B) Storage and handling of products and supplies.
(C) Storage and delivery of final products ...
(E) Personnel access and movement of materials into and near the controlled area ...
(G) Regular cleaning schedule for the controlled area and any equipment in the controlled area and the alternation of disinfectants ...
(H) Disposal of packaging materials, used syringes, containers, and needles to enhance sanitation and avoid accumulation in the controlled area ...
(K) End-product evaluation and testing."

2. The facility's Rural Health Clinic located in Running Springs was toured on 5/10/2011, at 11 AM, the following unusable medications were noted:

a. One opened 20-ml multi-dose vial of Lidocaine (local anesthetic) 1 percent with the open date of 2/11/2011 located in the medication cabinet in Examination Room 2.

b. One opened 20-ml multi-dose vial of Lidocaine/Epi (local anesthetic) 1:100000 with no open date located in the medication cabinet in Examination Room 2.

c. One opened 1-ml multi-dose vial of Tuberculin PPD diluted 5 TU/0.1 ml with the open date of 3/22/2011 located in the clinics refrigerated vaccine refrigerator.

d. One 5-ml ophthalmic solution bottle of Fluorescein Sodium/ Benoxinate HCl (anesthetic for eyes) 0.25/0.4 percent with the expiration date of 4/2011.

e. One opened 15-ml ophthalmic solution bottle of Tetracaine (anesthetic for eyes) 0.5 percent with open date of 3/25/2010.

During concurrent interview on 5/10/11, at 11:00 AM, the PA (physician assistant) stated that the multi-dose solution bottles and injectable vials once opened were good for 30 days and acknowledged that the above medications should not be used because they were expired.

On 5/10/11, at 11:30 AM, the PA further stated that medications were requested and brought from the hospital inpatient pharmacy and that the pharmacist did not visit the Rural Health Clinic for any inspection.

During concurrent interview on 5/10/11, at 11:30 AM , the MA (medical assistant) stated that vaccines and medications were inspected for expiration dates by her and also acknowledged that the pharmacist did not visit the Rural Health Clinic.

During an interview on 5/10/2011 at 2 PM, the DOP acknowledged that the medications were provided by the Hospital Inpatient Pharmacy and were not inspected by the pharmacist.

Monthly inspection of the drug storage areas conducted by the Pharmacy was reviewed and it was noted that the inspection did not include the Rural Health Clinic in Running Springs.

According to California Code Regulations, Title 22, Section 70263,

"(q)(10) Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist ..."

The facility's policy and procedure titled, Monthly Unit Inspection, was reviewed and it stated,

"Purpose: The pharmacist will conduct monthly inspections of all nursing care units or other areas of the hospital where medications are stored ..."

3. The facility's Rural Health Clinic located in Running Springs was toured on 5/10/2011 starting at 11 AM and it was noted that the clinic maintained supplies of the following emergency medications in Zip-Lock plastic bags labeled with "Emergency Kit" on the bags:

a. Five 1-ml injectable vials of Epinephrine (emergency drug used for heart attack or serious allergic reactions) 1:1000 in a larger plastic bag.

b. Two injectable vials of Diphenhydramine (drug for allergic reaction) 50 mg in a smaller plastic bags.

c. One 118-ml oral solution bottle of Diphenhydramine 12.5 mg per 5 ml.

There were no visible seals to ensure the contents of the medication bags remained sealed or documentation of the pharmacist's monthly inspections to verify the contents of the medication bags.

During concurrent interview on 5/10/11, at 2:00 PM, the PA was unable to provide explanation of the determination of the contents of the emergency kit and could not provide the reason for storage of emergency medications in separate bags.

The PA acknowledged that the content list was missing and could not tell whether the kit had all the medications that should have been included in the kit. Further, the PA could not tell whether the emergency kit had been opened or not.

During an interview on 5/10/2011 at 3:30 PM, the DOP did not know where the emergency kit was located in the Rural Health Clinic in Running Springs. And was not able to provide written policy and procedure that had the contents of the emergency kit.

The DOP also confirmed the drug storage in the clinic was not inspected by a pharmacist.

According to California Code of Regulations, Title 22, Section 70263,

"(f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.

(1) Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed.

(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within.

(3) The supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years."

2. During inspection of the Malignant Hyperthermia (MH) Cart located in the facility's Surgery Department on 5/12/2011 at 4:00 PM, it was noted that the content list was inside the medication drawer of the cart. It was also noted that the content of the MH Cart list did not match the list that was included with the medications inside one of the drawers of the cart.

During concurrent interview on 5/12/11, at 4:00 PM, RN 501 acknowledged that the content list was not on the outside of the cart. She noted there were only two injectable syringes of Sodium Bicarbonate (drug used in emergency situations to treat blood acidity) 50 milliequivalent per 50 ml instead of five syringes per content list.

During concurrent interview on 5/12/11, at 4:00 PM, the DOP agreed the content list was on the inside of the cart instead of outside and the list did not match what was in the cart. The DOP also stated that the facility had no policy and procedure addressing the established content, use, restocking and sealing of the MH carts.

According to California Code of Regulations, Title 22, Section 70263,

"(f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.
(1) Written policies and procedures establishing the contents of the supply procedures for use, restocking and sealing of the emergency drug supply shall be developed.
(2) The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

4. During review of Patient 500's medical record on 5/11/2011 at 3:30 PM with the DOP, it was noted the patient had a physician order on 4/19/2011 at 8:18 PM for Levaquin (injectable antibiotic) 750 mg IV (intravenously) daily.

The printout of the scanned physician order for Levaquin from the eFax Secure indicated the order was entered on 4/19/2011 at 11:21 PM by RN 502 and approved and verified by the DOP on 4/25/2011 at 11:04 AM. It also indicated the scan was received by eFax Secure on 4/19/2011 at 11:47 PM.

On 5/11/11 ,at 3:30 PM, a review of electronic administration record of Levaquin for the patient (500) indicated it was administered daily from 4/20/2011, until 4/25/2011, when the order was reviewed and verified by the DOP.

During an interview on 5/11/11, at 3:30 PM,, the DOP stated the Pharmacy was open from 8 AM to 4:30 PM Monday through Friday, five days a week and that new physician orders outside the pharmacy hours were reviewed the next morning as soon as the Pharmacy was open.

The DOP stated on 5/11/11, at 3:30 PM, that the current hospital wide integrated health information computer system was called, Healthland, in which a new physician order could be entered by hospital staff by either LVNs (Licensed Vocational Nurses), RNs (Registered Nurses), and Pharmacists.

On 5/11/11, at 3:30 PM, the DOP stated that orders entered by RNs and Pharmacists would become active immediately and that any nursing staff authorized to administer medications would be able to do so and document medication administration in Healthland electronically. The DOP stated however, new physician orders entered by LVNs would remain inactive and need to be authenticated by either RNs or Pharmacists in order for the physician orders to become active.

On 5/11/11, at 3:30 PM, the DOP was not able to explain why physician orders, reviewed with the surveyor at the time of the interview, had not been reviewed and verified by the pharmacist until 5 days after the new orders had been written. The DOP agreed that new physician orders, under the facility's current practices, could be administered by staff nurses without the pharmacists having the chance to review and verify the orders bypassing pharmacist first dose review of new physician orders.

On 5/11/11, at 3:30 PM, the DOP further stated that pending new physician orders for review were not reviewed by the pharmacists due to several open windows on the screen shadowing the window with the pending order verification and the acoustic signal for pending new orders might not be heard.

On 5/11/11, at 3:30 PM, the DOP stated that written copies of new physician orders would be faxed to the remote website called, eFax Secure. Then a pharmacists must sign in to access the new physician orders that were scanned into the system by the nursing staff. The DOP stated that there were delays in when the new orders scanned into the system and their availability in eFax Secure. And a delay in when the pharmacist would review the new physician orders after they were available in eFax Secure.

American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacy organization, published a guideline called, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, which stated,

"Medication orders.
All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order. Information concerning changes must be communicated to the appropriate health professional."

Based on observation, interview, and document review, the facility failed to ensure rules for storage, handling, accountability of controlled substances, and expired drugs existed and were implemented in accordance with the facility's policies and procedures by failing to:

1. Have policy and procedure in place to implement segregation of the non-expired controlled substances from the expired controlled and non-controlled substances;
2. Have accountability for expired controlled substances;
3. Have the pharmacist be responsible for distribution and dispensing of the controlled substances;
4. Have policy and procedure in place that addressed the security of controlled substances in the Pharmacy;
5. Remove expired and unusable medication from patient care area in the Emergency Department (ED); and,
6. Implement policy and procedure that addressed multi-dose vials and manufacturer ' s recommendation on an open bottle of eye drops.


Findings:


1. The Hospital ' s Pharmacy was toured on 5/9/2011 starting at 2 PM. It was noted that there were two different locations in which controlled substances (Schedule II to V drugs) were kept: 1) A controlled substance locker located in the IV (intravenous) Room of the Pharmacy and 2) A cabinet with controlled substances stored on the shelves which was not lockable. It was observed that both the locker and the cabinet were not locked at the time of observation.

It was also observed that the following controlled substances were stored on the same shelf along with expired medications:

Eighteen individually sealed cups of morphine sulfate (narcotic pain medication) 10 mg per 5 ml oral solution in the opened original box;
Sixty-six individually sealed cups of APAP/Codeine (narcotic pain medication) 300mg/30mg per 12.5 ml oral solution in the original boxes; and,
Thirty-three individually sealed cups of Guaifenesin/Codeine 100mg/10mg per 5 ml oral solution in the original boxes.

During an interview conducted on 5/9/2011 at 2:30 PM, the DOP (Director of Pharmacy) stated the reason for storing these medications was that the boxes in which these medications were packaged were too large to fit on the shelves of the Controlled Substance Locker. The DOP also acknowledged that the usable and unusable medications were stored on the same shelf.

Review of the facility's controlled substance policy did not include the proper storage of controlled substances.


2. The Hospital ' s Pharmacy was toured on 5/9/2011 starting at 2 PM. It was noted that there were two different locations in which controlled substances (Schedule II to V drugs) were kept: 1) A controlled substance locker located in the IV (intravenous) Room of the Pharmacy and 2) A cabinet with controlled substances stored on the shelves which was not lockable.


It was observed in one of the drawers in the main Pharmacy area there were eleven tablets of alprazolam (controlled substance used for anxiety) 0.25 mg that were identified as past the expiration date.

During concurrent interview, the DOP stated the alprazolam tablets were expired and they were kept there for disposition (eventual relocation). The DOP acknowledged that there were no other expired alprazolam tablets kept in the pharmacy since the last disposition of the controlled substances.

The DOP after investigating the inventory log entries of the controlled substances in the computer stated that there should have been thirteen tablets of alprazolam that were logged as expired and could not explain the reason for discrepancy and was unable to reconcile the difference between the logged amount and the actual number of tablets kept in the drawer for disposition.


3. During the tour of the Pharmacy on 5/9/2011 starting at 2 PM the DOP was requested to examine the controlled substance inventory log for the stock count of MS Contin (narcotic pain medication) 15 mg. The Pharmacy had forty-six tablets of MS Contin 15 mg stocked in the Controlled Substance Locker located in the IV (intravenous) Room.

The DOP stated the inventory log showed there should have been eighty-six tablets of MS Contin 15 mg to date, a difference of 40 tablets.

During an interview on 5/11/2011 at 3:30 PM, PT 500, a pharmacy technician, stated the record of receipt and dispensing of controlled substances were kept in the computer using a spreadsheet and it was the pharmacy technician who logged the quantities received and dispensed, not the pharmacist.

PT 500 investigated the missing controlled substance entries in the log and stated that there were two entries of dispensing of 20 tablets of MS Contin 15 mg to the nursing unit that were not logged into the spreadsheet at the time they were dispensed.

During concurrent interview, the DOP acknowledged the controlled substance record was delegated to, and kept and maintained by the pharmacy technician rather than the pharmacist.

There was a lack of security of controlled substances as evidenced by: 1) the open Controlled Substance Locker and the cabinet; 2) the controlled substance count discrepancy; 3) a delay in data entry of controlled substance dispensing on the spreadsheet; and 4) the pharmacist not supervising the controlled substances.

The facility's policy and procedure titled, Medication Administration: Controlled Substances, was reviewed and it stated,

" Procedure ...
14. The pharmacist dispensing the order is responsible for the accountability of all controlled substances until a nurse signs for the medication(s) ... "


4. The facility's ED (Emergency Department) Medication Room was inspected on 5/9/2011 at 11 AM. Noted in the drawer was one 20-ml multi-dose vial of 2 percent lidocaine (local anesthetic) that was observed to be used. There was no date written on the vial indicating when the vial was opened.

During concurrent interview, RN 500 acknowledged that the vial was opened and stated that the vial should have been dated since open multi-dose vials were good for 28 days from the first day of use.

The facility's policy and procedure titled, Medication Administration Multi-Dose Vials (Use and Expiration Dates) indicated the following:

" Procedure ...
3. Multi-dose vials shall be dated when opened and properly stored ...
5. Multi-dose vials will be discarded after 30 days of date opened. The date of opening shall be marked on the vial by the staff member that opens it. "


5. The facility's Rural Health Clinic located in Running Springs was toured on 5/10/2011 at 11 AM.

The following several unusable medications were noted:

a. One opened 20-ml multi-dose vial of Lidocaine (local anesthetic) 1 percent with the open date of 2/11/2011 located in the medication cabinet in Examination Room 2;
b. One opened 20-ml multi-dose vial of Lidocaine/Epi (local anesthetic) 1:100000 with no open date located in the medication cabinet in Examination Room 2;
c. One opened 1-ml multi-dose vial of Tuberculin PPD diluted 5 TU/0.1ml with the open date of 3/22/2011 located in the clinics refrigerated vaccine refrigerator;
d. One 5-ml ophthalmic solution bottle of Fluorescein Sodium/ Benoxinate HCl (anesthetic for eyes) 0.25/0.4 percent with the expiration date of 4/2011;
e. One opened 15-ml ophthalmic solution bottle of Tetracaine (anesthetic for eyes) 0.5 percent with open date of 3/25/2010.

During an interview conducted on 5/10/2011 at 11:30 AM, the PA (Physician Assistant) stated that the multi-dose solution bottles and injectable vials once opened were good for 30 days and acknowledged that the above medications should not be used because they were expired.

The PA stated that medications were requested and brought from the hospital inpatient pharmacy and that the pharmacist did not visit the Rural Health Clinic for inspection of medication storage.

During concurrent interview, the MA (Medical Assistant) stated that vaccines and medications were inspected for expiration dates by her and also acknowledged that the pharmacist did not visit the Rural Health Clinic.

During an interview on 5/10/2011 at 2 PM, the DOP acknowledged that the medications were provided by the Hospital Inpatient Pharmacy and were not inspected by the pharmacist.

The facility's policy and procedure titled, Medication Administration Multi-Dose Vials (Use and Expiration Dates) indicated the following:

" Procedure ...
3. Multi-dose vials shall be dated when opened and properly stored ...
5. Multi-dose vials will be discarded after 30 days of date opened. The date of opening shall be marked on the vial by the staff member that opens it. "

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

1. Establish policies for ensuring physicians and allied health practitioners had screening for communicable diseases prior to and routinely after beginning the provision of services at the facility, creating the risk of the spread of communicable diseases from physicians to all facility patients.

2. Ensure that the chemical cleaner used in the operating room was used according to manufacturer directions, creating the increased risk of the spread of infection to all patients using the operating room.

3. Ensure that all movable patient medical equipment and patient examining room tables were regularly disinfected after each patient use according to the disinfectant's manufacturers' recommended instructions. This deficient practice had the potential for further transmission of infectious microorganisms to all other patients.

Findings:

1. During a review of the credential file of CRNA 2 (Certified Registered Nurse Anesthetist) on 5/10/11, there was no evidence of hepatitis B screening or hepatitis B screening declination found. During a review of the credential files of MD 1, MD 2, and MD 3, no evidence of tuberculosis or hepatitis B screening were found.

During an interview with the Medical Staff Services Manager on 5/10/11 at 10:00 AM, she stated that the medical staff had chosen not to undergo infectious disease screening, aside from a single question regarding their health on their medical staff applications.

A review of the national guidelines, "Immunization of Health Care Workers: Recommendation of the Advisory Committee on Immunization Practices and the Hospital Infection /control Practices Advisory Committee", 1997, and the Centers for Disease Control and Prevention, "Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities", 1994, indicated the need for screening health care workers for tuberculosis and hepatitis B as part of an overall infection prevention strategy.

2. Based on observation, interview and document review, the facility failed to ensure the sanitation of the operating room because: 1. The operating room mattress (the mattress on which a patient is placed during surgery) had breaks in its cleanable surface, and 2. The chemical used to clean the operating room was not used according to manufacturer's directions, creating an increased risk of infection and communicable diseases for patients using that area.

During an observation on 5/9/11, at 12:00 PM, of cleaning of the operating room after a surgical case, EVSS 1 (Environmental Services Staff) applied a cleaning chemical to a cloth, then applied it to furniture and equipment surfaces. The chemical was observed to dry in less than 2 minutes. Some surfaces were re-wetted by EVSS 1, while others were not.

During an interview with EVSS 1 on 5/9/11 at 12:00 PM, she stated that two minutes were enough time for the chemical to remain wet to provide disinfection. She displayed the container from which she acquired the chemical, and its label read, "Green Earth Daily Disinfectant".

During a review of the label of Green Earth Daily Disinfectant, the manufacturer directions for use included a 10 minute contact time (time the chemical needs to stay wet on the surface) for disinfection.

During an interview with the EVS Manager on 5/9/11 at approximately 3 PM, she concurred that the chemical had a 10 minute wet contact time and stated that she would discuss the contact time with EVSS 1.



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3. During the facility's outpatient rural health clinic inspection tour on 5/12/11, at approximately 10:15 AM, it was observed that the medical assistant, responsible for cleaning and disinfecting patient equipment and rooms, did not disinfect the patient's examination table and other movable patient medical equipment in rooms 1 and 2 after each patient's use. The medical assistant did not allow ample time for the disinfecting product solution to remain on the surface of the patients' examination table and all movable patient equipment according to the manufactures' recommended instructions for proper disinfection to take place.

On 5/12/11, at approximately 11:15 AM, a review of the manufactures' instruction sheet on the disinfecting product bottle used for disinfection was conducted. The manufacture's instruction sheet showed that "Steridol Wipes" as being a cleaner and disinfectant. The manufacturers' recommended instruction sheet documented that the disinfecting solution (towelettes) should make contact and be applied on non-porous surfaces and be allowed to "air dry" for at least 5 minutes to be effective (bactericidal and Virucidal).

On 5/12/11, at approximately 11:20 AM, an interview with the medical assistant was conducted. When asked how long the disinfecting product solution from the towelette should remain on the contact surface of all patients' movable equipment and examination tables for proper disinfection to take place, she stated, "10 to 15 seconds."

On 5/12/11, a review of the facility's policy and procedure manual was conducted. Under the title, "RURAL HEALTH CLINIC", dated 6/4/2007, it showed no documented evidence in the manual or in its table of contents that a policy or procedure was developed addressing disinfecting or sanitizing movable patient equipment in examining rooms 1 and 2 after each patient's use.

On 5/12/11, at the time of the observation, the Nurse Practitioner in charge of the facility's Rural Health Clinic confirmed the finding that the Steridol Wipes (disinfectant solution) should have remained on the surface of all patient's movable equipment and tables, and allowed to air dry for at least 5 minutes and not 10 to 15 seconds as stated by the medical assistant and that there was no specific procedure to follow regarding disinfecting all movable patient equipment in examination rooms 1 and 2 after each patients' use.

Based on interview and document review, the facility failed to ensure that:

1. The services provided by the physician group acting as hospitalists (physicians who care for the patient while admitted to the hospital) was subject to quality assurance, creating the risk of a poor standard of care for all inpatients in the hospital treated by hospitalists.

2. Did not subject to quality assurance a range of clinical services provided in the emergency room, creating the risk of substandard service for all patients treated in the emergency room.

Findings:

1. During an interview with the CEO (Chief Executive Officer) 5/9/11 at 10 AM, he stated that the facility was using a group of emergency physicians to provide hospitalist services since January, 2011.

During a review of the credential file of MD 1 on 5/12/11, MD 1 was documented as part of the physician group providing emergency room services, which had also started performing hospitalist services in the facility during January, 2011.

During an interview with the QA/IC Manager on 5/11/11 at 10:20 AM, she stated that MD 1 was performing hospitalist duties and seeing inpatients in the facility.

During a review of the credential file of MD 1 on 5/12/11, the file contained evidence of only 3 emergency room patients. There was no evidence in his file of data being collected to assess his performance with inpatients.

During a review of grievances recorded by the facility, Patient Y, an inpatient, alleged that MD 1 became upset with her and called her "lazy". The facility was unable to produce documentation that an investigation or peer review of the incident occurred (see C382).

During an interview with the QA/IC (Quality Assurance/Infection Control) Manager on 5/11/11 at 10:20 AM, she stated that there had been no interviewing of staff or review of medical records to determine the safety and effectiveness of the hospitalist program.

2. During a review of the credential file of MD 1 on 5/12/11, MD 1 was documented as part of the physician group providing emergency room and hospitalist services in the facility. The file contained evidence of only 3 emergency room patients, all with a similar diagnoses, being sampled for review for the 8/09 through 6/10 time period, out of hundreds of patients with dozens of diagnoses treated by MD 1 during the same time interval. There was no evidence of data for MD 1's performance for the assessment period ending 12/10.

During a concurrent interview with the Medical Staff Services Manager, she stated that the medical staff recognized that the review criteria for emergency room cases were too narrow, and that they intended to select criteria that would better reflect the quality and range of clinical services provided in the emergency room. She concurred that the data for the assessment period ending 12/10 was missing from the file.

Based on interview and record review the facility failed to ensure that a registered nurse (RN) supervised and evaluated the care for each patient in accordance with accepted standards of practice for 2 of 21 sampled patients (Patients 1 and 2). This failure resulted in patient assessments being performed by licensed vocational nurses (LVN) without validation by an RN which had the potential to result in substandard care to be delivered without adequate RN supervision.

Findings:

The scope of practice for nurses in the State of California allows Licensed Vocational Nurses (LVN) to collect data for a patient assessment; however, the Registered Nurse (RN) must interpret the data and form a plan of care for the patient.

1. Record review revealed Patient 1 was an 86 year old female admitted to the facility on 4/21/11, with diagnoses that included weakness with endocarditis (inflammation of the inside lining of the heart chambers and heart valves) and congestive heart failure (a condition in which the heart can no longer pump enough blood to the rest of the body). Patient 1 was a swing bed patient.

"The swing bed concept allows a critical access hospital (CAH) to use their beds interchangeably for either acute-care or post-acute care. A "swing bed" is a change in reimbursement status. The patient swings from receiving acute-care services and reimbursement to receiving a skilled nursing (SNF) services and reimbursement... Swing-bed patients receive a SNF level of care, and the CAH is reimbursed for providing a SNF level of care, however swing-bed patients are not SNF patients. Swing-bed patients in CAH's are considered to be patients of the CAH." (State Operations Manual interpretive guidelines found at CFR 485.645

Record review revealed the following daily shift assessments (included AM and PM shifts) were performed by an LVN without documented evidence that the assessments were validated by an RN for accuracy: 5/4/11, 5/5/11, 5/6/11, 5/7/11, and 5/8/11.

2. Record review revealed Patient 2 was a 61 year old female admitted to the facility on 5/6/11, with diagnoses that included colitis (swelling of the large intestines) and bloody diarrhea.

Record review of the daily shift assessment revealed that Patient 2 was assessed by an LVN on 5/9/11 on the night shift. There was no documented evidence that an RN validated the shift assessment for the LVN who conducted the assessment.

During an interview on 5/12/11, at 10 AM, the above findings were confirmed by the facility's Clinical Informatics staff during review of the electronic medical records for Patients 1 and 2.

During an interview on 5/9/11, at 2:30 PM, LVN 501 stated that the RN does not validate her assessment but should do it.

During an interview on 5/10/11, at 11:08 AM, LVN 500 stated that she was assigned to care for 3 medical-surgical patients, 1 swing bed patient, and 1 outpatient surgery patient. When asked if she assessed patients on the medical surgical unit, LVN 500 replied yes that she usually conducts assessments on swing bed patients. LVN 500 stated that the RN usually gives her the swing bed patients to care for. LVN 500 further stated that some RN's like to do all the assessments on the patients on the unit and there are some RN's that allow her to complete the assessments.

During an interview on 5/10/11 at 1:15 PM, RN 504 stated that she assesses all patients on the unit and sometimes she will allow the LVN to assess the patients.

During an interview on 5/11/11 at 10:00 AM with the M/S (Medical Surgical) Unit Manager (MSUM) of the acute care unit, she stated that LVN's (Licensed Vocational Nurse) have more swing bed level of care and added that long term care units are usually run by LVN's. The MSUM added that the RN was responsible for the patients on the unit.

During an interview on 5/11/11 at 11:50 AM, the CNO stated that LVN's can do head to toe assessments and added that the LVN's assessments do not need to be validated or cosigned by an RN. When further questioned about LVN's being able to assess patients, the CNO confirmed that LVN's should be doing data collection only.

During further interview, the CNO stated that RN's were responsible for the care of more acute (brief and severe in regards to disease) patients and the LVN's cared for patients that were less acute. The CNO stated that she would expect to see that an RN documented that they (the RN) concur with the LVN's assessment however, she did not believe it was a requirement.

During an interview on 5/11/11 at 2:08 PM with RN 500, she stated that admission assessments were performed by RN's in the long term care unit and on the medical surgical unit. RN 500 further stated that follow up assessments (reassessments) could be performed by an LVN.

During an interview on 5/12/11 at 9:18 AM, the MSUM stated that LVN's can do an assessment on a swing bed patient, however an RN needs to validate the assessment. When asked how she verifies that an RN validated the patient assessments, the MSUM stated that the RN was to put a note in the progress notes. The MSUM further stated that she didn't have time to check to see if the RN's evaluated the care provided by the LVN's.

Record review of the facility's policy titled, "Nursing Service Standards: Initial Patient Assessment and Reassessment", revealed the following: "Procedure: 1. At the time of admission, each patient shall have an initial physical/psychological assessment completed by a registered nurse. A licensed practical/vocational nurse may conduct basic elements of the assessment under the direct supervision of a registered nurse and report these both on the nursing assessment and to the registered nurse. ...".

Record review of the facility's job description for the LVN, dated 3/9/02 revealed the following, "Summary: The LVN provides prescribed medical treatment and personal care to patients that are ill, injured, convalescent or disabled per State of California Nursing Practice Act under the supervision of the RN in the following settings at (facility named here): Medical surgical Unit, Emergency Services... ."

Based on medical records review and staff interviews, the facility failed to maintain a complete and comprehensive outpatient medical record for 2 of 2 sampled outpatients (Patients 11 and 12). Sampled Patient 11 was admitted as an outpatient for an exercise cardiac stress test procedure in the hospital, on 4/8/11 and for Sampled Patient 12, an exercise cardiac stress test was done as an outpatient procedure, on 2/23/11. These deficient practices resulted in incomplete documentation of information necessary to monitor the patients' condition during the procedures and had the potential for vital information not being documented for continuance of care and follow up for those patients.

Findings:

1. On 5/10/11, at approximately 10:30 AM, a review of Patient 11's outpatient medical record was conducted. Patient 11 was admitted to the facility as an outpatient, on 4/8/11, with a diagnosis of atypical chest pain and was scheduled for an "Exercise Cardiac Stress Test" to be performed at the hospital's Cardiopulmonary Department (Respiratory Department), on 4/8/11.

A review on 5/10/11, of Patient 11's outpatient medical record, dated 4/8/11, revealed the following contents in the folder:
a. Patient 11's admitting face sheet.
b. Admitting laboratory test results.
c. Exercise cardiac stress test rhythm strip results performed for the duration of the procedure. (Interpretation and Conclusion Sections not filled out and left blank by the physician).

There was no documented evidence that the facility maintained and included the following essential documents in Patient 11's outpatient medical record:
a. Admission and discharge orders by the physician.
b. Patient 11's medical history and physical examination report.
c. Assessment of the health status and health care needs of the patient.
d. Progress notes of the physician and staff member monitoring the patient during the procedure.
e. A summary of the episode, disposition, and educational instructions to the patient.
f. A discharge summary report and provisions for any follow-up care.

A review on 5/10/11, of the facility's policy and procedure titled, "MEDICAL RECORD DEFINITION", dated 1/2009, stipulated, " ...The legal health record is the documentation of the healthcare services provided to an individual in any aspect of healthcare delivery by the organization. The term includes records of care in any health-related setting used by healthcare professional providing patient care services, for reviewing patient data or documenting observations, actions or instructions... "

A review on 5/10/11, of the facility's policy and procedure titled, "CARDIOPULMONARY SERVICES SCOPE OF SERVICES", dated 7/2008, stipulated, " ...The cardiopulmonary therapist conducting the procedure (exercise cardiac stress test) will conduct reassessments post treatment with documentation of results and evaluation noted on the patient's medical record ... "

There is no documented evidence that the cardiopulmonary therapist (respiratory therapist) conducting the test developed and maintained post treatment assessment notes of Patient 11's exercise cardiac stress test procedure, on 4/8/11, and there was no documented evidence that an evaluation of the procedure was entered in the medical record as per facility policy, dated 7/2008.

Therefore, the facility failed to maintain a complete and comprehensive outpatient medical record for Patient 11 by not including specific contents as part of the medical record such as:
a. Physicians' admitting and discharge orders
b. Medical history and physical examination reports
c. Assessment of the health status and health care needs of the patient
d. Progress notes of the physicain and staff member monitoring the patient during the procedure.
e. Summary, disposition and educational instructions to the patient and
f. Discharge summary report and provisions for any follow-up care required.

On 5/11/11, at approximately 10:55 AM, an interview with the Director of Cardio-Pulmonary Department was conducted, and confirmed, that Patient 11's outpatient medical record was not complete nor was it comprehensive and did not contain the physician's admission and discharge orders, medical history and physical examination report, assessments, progress notes and a discharge summary.

2. On 5/11/11, a review of Patient 12's outpatient medical record was conducted. Patient 12 was admitted to the facility as an outpatient on 2/23/11, with an admitting diagnosis of abnormal electroencephalogram (an abnormal heart rhythm) and was scheduled for an "Exercise Cardiac Stress Test" to be performed at the hospital's Cardiopulmonary Department (Respiratory Department), on 2/23/11.

A review on 5/10/11, of Patient 12's outpatient medical record, dated 2/23/11, revealed the following contents in the folder:
a. Patient 11's admitting face sheet.
b. Admitting laboratory test results.
c. Exercise cardiac stress test rhythm strip results performed for the duration of the procedure. (Interpretation and Conclusion Sections not filled out and left blank by the physician).

There was no documented evidence that the facility maintained and included the following essential documents in Patient 12's outpatient medical record:
a. Admission and discharge orders by the physician.
b. Patient 11's medical history and physical reports.
c. Assessment of the health status and health care needs of the patient.
d. Progress notes of the physician and staff member monitoring the patient during the procedure.
e. A summary of the episode, disposition, and instructions to the patient.
f. A discharge summary report and provisions for any follow-up care.

A review on 5/10/11, of the facility's policy and procedure titled, "MEDICAL RECORD DEFINITION " , dated 1/2009, stipulated, " ...The legal health record is the documentation of the healthcare services provided to an individual in any aspect of healthcare delivery by the organization. The term includes records of care in any health-related setting used by healthcare professional providing patient care services, for reviewing patient data or documenting observations, actions or instructions ... "

A review on 5/10/11, of the facility's policy and procedure titled, "CARDIOPULMONARY SERVICES SCOPE OF SERVICES ", dated 7/2008, stipulated, " ...The cardiopulmonary therapist conducting the procedure (exercise cardiac stress test) will conduct reassessments post treatment with documentation of results and evaluation noted on the patient's medical record ... "

There is no documented evidence that the cardiopulmonary therapist (respiratory therapist) conducting the test developed and maintained post treatment assessment notes of Patient 12's exercise cardiac stress test procedure, on 2/23/11, and there was no documented evidence that an evaluation of the procedure was entered in the medical record as per facility policy, dated 7/2008.

Therefore, the facility failed to maintain a complete and comprehensive outpatient medical record for Patient 12 by not including specific contents as part of the medical record. This includes the physicians' admitting and discharge orders, medical history and physical examination report, assessment of the health status and health care needs of the patient, progress notes of the physician and staff member monitoring the patient during the procedure, a summary of the episode, disposition, and educational instructions to the patient and a discharge summary report and provisions for any follow-up care.

On 5/11/11, at approximately 10:55 AM, an interview with the Director of Cardio-Pulmonary Department was conducted, and confirmed that Patient 12's outpatient medical record was not complete nor was it comprehensive and did not contain the physicians' admission and discharge orders, medical history and physical examination report, assessments, progress notes and discharge summary.

Based on medical records review and staff interviews, the facility failed to properly execute informed consent forms for 2 of 2 outpatient procedures performed on sampled Patients 11 and sampled Patient 12. This deficient practice resulted in Patient 11 and Patient 12 not receiving information, explanations, and options needed in order to consent to the procedure and exercise his or her right to make an informed decision.

Findings:

1. On 5/10/11, a review of Patient 11's outpatient medical record was conducted. Patient 11 was admitted to the facility with a diagnosis of atypical chest pain and was scheduled for an outpatient "Exercise Cardiac Stress Test" procedure to be performed at the hospital's Cardiopulmonary Department (Respiratory Department) on 4/8/11.

A review on 5/10/11, of Patient 11's Stress Test Consent Form, dated 4/8/11, revealed the following components were not included on the consent form:
a. No time that the consent form was obtained.
b. No name of the practitioner performing the procedure.
c. A statement in the medical record procedure was explained to the patient.
d. No name or signature of person explaining the procedure to the patient.

A review on 5/10/11, of the facility's policy and procedure titled, "CONSENT FOR TREATMENT: INFORMED CONSENT " , dated 2/2002, stipulated, " ...It is the treating physician's responsibility to obtain informed consents and provide information to the patient and allow the patient to ask questions about the procedure so that the patient is truly informed. The physician will document in the patient ' s medical record that a discussion was held with the patient, any alternatives to the procedure was disclosed and the informed consent was timed and dated when obtained ... "

On 5/11/11, at approximately 11:15 AM, an interview with the Director of the Cardio-Pulmonary Department was conducted, and confirmed that the Cardio-Pulmonary Department' s consent for Patient 11's exercise cardiac stress test was not timed, or had the name of the practitioner performing the procedure nor had the name of the person explaining the procedure to the patient. The Director of Cardio-Pulmonary Services also confirmed that there was no documentation in the medical record that a discussion had taken place between the practitioner and Patient 11 regarding the procedures risks, benefits, options, results, educational instructions and follow up care.

2. On 5/11/11, a review of Patient 12's outpatient medical record was conducted. Patient 12 was admitted to the facility with an admitting diagnosis of abnormal electroencephalogram (an abnormal heart rhythm) and was scheduled for an outpatient "Exercise Cardiac Stress Test" procedure at the hospital's Cardiopulmonary Department (Respiratory Department) on 2/23/11.

A review on 5/10/11, of Patient 12's Stress Test Consent Form, dated 2/23/11, revealed the following components were not included on the consent form:
a. No name of the practitioner performing the procedure.
b. A statement in the medical record noting the procedure was explained to the patient.
c. No name or signature of person explaining the procedure to the patient.

A review on 5/10/11, of the facility's policy and procedure titled, "CONSENT FOR TREATMENT: INFORMED CONSENT" , dated 2/2002, stipulated, " ...It is the treating physician's responsibility to obtain informed consents and provide information to the patient and allow the patient to ask questions about the procedure so that the patient is truly informed. The physician will document in the patient ' s medical record that a discussion was held with the patient, any alternatives to the procedure was disclosed and the informed consent was timed and dated when obtained ... "

On 5/10/11, at approximately 11:15 AM, an interview with the Director of Cardio-Pulmonary Department was conducted, and confirmed that the Cardio-Pulmonary Department's consent for Patient 12's exercise cardiac stress test did not have the name of the practitioner neither performing the procedure nor had the name of the person explaining the procedure to the patient. The Director of Cardio-Pulmonary Services also confirmed that there was no documentation in the medical record that a discussion had taken place between the practitioner and Patient 12 regarding the procedures risks, benefits, options, results, educational instructions and follow up care.

Based on interview and record review, the documentation of post-anesthesia (the period of time when the patient is recovering from anesthesia) assessments were incomplete and did not include specific information about the patient's status, such as cardio-pulmonary status and level of consciousness, creating the risk of a poor post-anesthesia outcome for all patients undergoing anesthesia.

Findings:

1. During a review on 5/11/11 of the medical record of Patient X, the pre-printed small box containing the "Post-Anesthesia" part of the record did not contain a record of the patient's status with regard to pain, post-operative hydration, or specifics that would describe the patients cardio-pulmonary status such as pulse, blood pressure, respiratory rate and oxygen saturation. Additional details of the patient ' s post anesthesia condition had been documented by the nurses caring for the patient, but there was no evidence, such as a notation or signature, that the anesthesia provider had reviewed those details when completing the post-anesthesia documentation.

During an interview with CRNA (Certified Register Nurse Anesthetist) 1 on 5/11/11 at 2 PM, he stated that he did review the vital signs collected by the nurse at the time of the post-anesthesia check, but that he had not been documenting this. He stated that he was not aware of any specific facility policy regarding the required content of the post-anesthesia assessment, and that he was not aware of any specific national standard that the facility was following.

Pain level, hydration status, and details of cardiopulmonary and mental status assessment are items recommended for inclusion in the post-anesthesia assessment according to national guidelines such as the American Society of Anesthesiologists ' Practice Guidelines for Post-anesthetic Care, Anesthesiology , vol 96, no 3.


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2. A review on 5/10/11, of Patient 12's medical record was conducted. Patient 12 was admitted to the facility on 9/17/07 with admitting diagnoses of gallbladder disease and was scheduled for a "Laparoscopic Cholecystectomy" (surgical procedure to remove the gallbladder) procedure on 9/17/07.

A review on 5/10/11, of Patient 12's "Post-Anesthesia Note", dated 9/17/07 and timed at 10:50 AM, revealed a stamped entry with the following notation: "PATIENT INTERVIEWED, NO VOICED OR OBVIOUS ANESTHESIA COMPLICATIONS".

Further review of the facility's Post-Anesthesia Note section in Patient 12's medical record revealed that the following assessments were mandatory and all were checked as being "NO".
a. Sore throat, hoarseness.
b. Eye or oral trauma.
c. Nausea and/or vomiting.
d. Phlebitis (inflammation of the veins).
e. Urinary retention.
f. Syncope (fainting spells), headache, back pain.
g. General comments.
h. Operative recall.
i. Prolonged sedation (prolonged effects of the anesthesia agent).
j. Sensory block
k. Cough, fever, dyspnea
l. Muscle pain or weakness.
m. Complications in PACU (Post Acute Care Unit).

According to the following practice guidelines from the American Society of Anesthesiology (ASA-Professional group of physicians specializing in anesthesiology) dated 12/2009, recommended post- anesthesia care assessment and monitoring must include the following components:
a. Respiratory function, including respiratory rate, airway patency (unobstructive breathing process) and oxygen saturation.
b. Cardiovascular (heart and lung) function, including pulse and blood pressure.
c. Mental Status.
d. Temperature
e. Pain.
f. Nausea and vomiting.
g. Postoperative hydration (fluid status after surgery).

The facility failed to address specifically Patient 12's respiratory function, including the respiratory rate, airway patency and oxygen saturation; cardiovascular function including his pulse and blood pressure; mental status; temperature and postoperative hydration status prior to discharge from the recovery room on 9/17/07.

Based on observation, interview and record review, the facility failed to ensure the design and implementation of a quality assurance program to promote high quality health care provided in a safe environment because:

1 The facility was not able to provide documentation of ongoing chart review for quality assurance purposes (See 332 and 333)

2 The facility did not enforce the quality assurance practice of periodic walk rounds, and allowed departmental manager to specify their own quality criteria, and failed to proactively identify risks, resulting in environmental and equipment deficiencies such as no operating room humidity monitoring, a defective operating room mattress, lapses in radiology equipment maintenance, a surveillance system that risked violating patient privacy and excessive warming of intravenous solutions, creating the risk of an unsafe environment and substandard healthcare for all patients using the facility (See 336 and 221, 222, and 224).

3. The facility did not ensure the quality of the contracted physician group working in the emergency room and as hospitalists (physicians who care for hospital inpatients), creating the risk of a poor standard of care for inpatients in the hospital treated by hospitalists, and 2. did not assess a range of clinical services provided in the emergency room, creating the risk of substandard emergency room services and 3. failed to provide provider performance evaluations for services provided in the facility ' s rural clinics, creating the risk of substandard outpatient treatment for all patients in those clinics (See 337)

4. The facility did not oversee quality assurance for outpatient services, creating the risk of substandard outpatient services for all outpatients treated at those clinics. (See 337)

The cumulative effect of these failures meant the facility did not implement a comprehensive quality assurance program and was unable to ensure a high quality healthcare provided in a safe environment.

Based on interview and record review, the documentation of post-anesthesia (recovering from the effects of anesthesia) assessment was incomplete because it did not include specific information about the patient's status, such as cardio-pulmonary (heart and lung) status and level of consciousness (alertness and awareness), creating the risk of a poor post-anesthesia outcome for patients undergoing anesthesia.

Findings:

During a review on 5/11/11 of the medical record of Patient X, the pre-printed small box containing the "Post-Anesthesia" part of the record did not contain a record of the patient's status with regard to pain, post-operative hydration (the amount of fluid in the tissues), or specifics that would describe the patients cardio-pulmonary status such as pulse, blood pressure, respiratory rate and oxygen saturation (the amount of oxygen in the blood). Additional details of the patient's post anesthesia condition had been documented by the nurses caring for the patient, but there was no evidence, such as a notation or signature, that the anesthesia provider had reviewed those details when completing the post-anesthesia documentation.

During an interview with CRNA 1(certified registered nurse anesthetist) on 5/11/11 at 2 PM, he stated that he did review the vital signs collected by the nurse at the time of the post-anesthesia check, but that he had not been documenting this. He stated that he was not aware of any specific facility policy regarding the required content of the post-anesthesia assessment, and that he was not aware of any specific national standard that the facility was following.

Pain level, hydration status, and details of cardiopulmonary and mental status assessment are items recommended for inclusion in the post-anesthesia assessment according to national guidelines such as the American Society of Anesthesiologists' Practice Guidelines for Post-Anesthetic Care, Anesthesiology, vol 96, no 3.

Based on interview and record review, the facility failed to perform an ongoing assessment of its programs that included medical record review, creating the risk of unrecognized quality of care issues that could affect all patients using the facility.

Findings:

During an interview with the QA/IC (Quality Assurance/ Infection Control) Manager on 5/11/11 at 10:20 AM, she stated that as part of her quality assurance activities, she reviewed 30 facility medical records per month. However, she stated that she kept no documentation of the medical records reviewed, so she was unable to provide evidence that chart reviews for quality assurance purposes were being done.

During a review on 5/12/11 of the Quality Assurance Committee minutes from July 2010 through March, 2011, no documentation of systematic medical record reviews was seen.

Based on observation, interview and record review, the facility failed to maintain a quality assurance (QA) program that reflected the scope and complexity of services rendered because it failed to:

1. Ensure quality assurance was done on the new hospitalist (physicians who care for inpatients) group providing services in the facility, creating the risk of substandard healthcare for all patients cared for by hospitalists.

2. Failed to ensure that department managers performed quality assurance walk rounds per facility directives, creating the risk of a substandard services and an unsafe environment in all departments of the facility.

3. Did not participate in the selection or review of a patient surveillance (remote monitoring via camera) system, creating the risk of lost security and privacy for all patients subject to surveillance.

4. Did not oversee quality assurance for outpatient services, creating the risk of substandard outpatient services for all patients using the outpatient services.

Findings:

1. During an interview with the CEO (Chief Executive Officer) on 5/9/11, he stated that the facility had contracted with an emergency medicine physician group in January, 2011, to provide hospitalist (physicians who admit and care for the patient in the hospital) services in the facility.

During an interview with the QA/IC (Quality Assurance/Infection Control) Manager on 5/11/11 at 10:20 AM, she stated she had not, as part of her quality assurance activities, performed quality assurance on the new hospitalist group that had begun providing care in the facility in January, 2011. She stated that she had not reviewed records or interviewed staff to determine the safety and efficacy of the new hospitalist program.

2. During an interview with the QA/IC Manager on 5/11/11 at 10:20 AM, she was asked about the components of the Quality Assurance program at the facility. She stated that department managers were given the responsibility of selecting their own criteria for departmental quality assurance, and for performing "walk rounds" and completing documentation, which was to be reported monthly.

A review of QA's monthly documentation on 5/10/11, found not all of the documentation of monthly "walking rounds" were completed and included in the QA monthly reports.

3. During observations in the facility from 5/9/11 through 5/12/11, cameras were noted to be operating in patient care areas, with patient room images transmitted to the nursing station and visible to passersby, resulting in a loss of privacy for the patients.

During an interview with the QA/IC Manager on 5/11/11 at 10 AM, she stated QA was not involved in selecting the equipment or determining the use of the cameras for patient surveillance. She stated, "we have to come up with a policy for that " .

4. During an interview with the QA/IC Manager on 5/11/11 at 10:10 AM, she stated that there was no QA data regarding the cardiac stress testing outpatient service performed at the facility.

The QA/IC Manager also stated that the outpatient clinics had been asked, beginning in January, 2010, to provide quality data such as data on diabetic testing, breast exams and vaccinations, but that no such data had yet been provided, and therefore those identified quality measures had not been assessed.

Based on record review and interviews, the facility failed to ensure that all patient care services and other services affecting patient health and safety were evaluated. This failure had the potential to adversely effect the quality of patient care, as well as the health and safety of the patients.

Findings:

1. On 5/10/11, at approximately 10:30 AM, a review of Patient 11's outpatient medical record was conducted. Patient 11 was admitted to the facility as an outpatient, on 4/8/11, with a diagnosis of atypical chest pain and was scheduled for an "Exercise Cardiac Stress Test" on 4/8/11, to be performed at the hospital's Cardiopulmonary Department (Respiratory Department).


2. On 5/11/11, at approximately 11:00 AM, a review of Patient 12's outpatient medical record was conducted. Patient 12 was admitted to the facility as an outpatient on 2/23/11, with an admitting diagnosis of abnormal electroencephalogram (a test of electrical activity of the brain) and was scheduled for an "Exercise Cardiac Stress Test" on 2/23/11.

A review on 5/10/11, of the hospital's organizational chart, dated 2/2/10, revealed no documented evidence that a clear, well defined, line of authority (responsibility and accountability) was established for all outpatient services provided by the hospital.

During an interview with the Quality Assurance Director, on 5/11/11, at approximately 11:30 AM, when asked if the hospital had a Director for Outpatient Services, she stated, "No".

During an interview with the Director of Cardiopulmonary Services, on 5/10/11, at approximately 11:45 AM, when asked if any quality assurance data or evaluations of patient care services were being performed on all patients undergoing exercise cardiac stress testing procedures in the department, he stated, "No".

During an interview with the Quality Assurance Director, on 5/11/11, at approximately 11:35 AM, when asked if she monitored, analyzed, tracked quality indicators or collecting data to assess hospital performance when conducting exercise cardiac stress testing procedures, she stated, "No".

During an interview with the Chairman of the hospital's Governing Body, on 5/12/11, at approximately 1:15 PM, when asked if the Governing Body routinely received quality measurement indicators or any data collection to assess hospital performance in providing services such as exercise cardiac stress testing procedures, he stated, "No".

Based on observation, interview and record review, the facility failed to ensure the right to privacy for 1 of 3 sampled patients (Patient 2). This failure resulted in Patient 2 expressing feelings of disappointment regarding the facility's practice of continuous video monitoring on their acute care unit without informed consent.

Findings:

During an interview on 5/9/11 at 3:43 PM, the Medical Surgical Unit Manager (MSUM) stated that the registered nurses (RN) inform the patients on admission about the facility's video cameras. When asked to provide evidence that the patients were informed on admission about the video cameras, the MSUM pointed out preprinted documentation on the admission form that read the following, "Orientation to facility room, Patient oriented to call light, camera if applicable, lights, phone, ...". The MSUM stated that was the documentation that indicated the patient was informed about the continuous video monitoring.

During an interview on 5/10/11 at 9:27 AM, the CNO stated that patients were being monitored for safety reasons and that confused patients were also monitored. The CNO added, "we don't monitor all patients". When asked if patients were informed about being monitored by video cameras, she stated there was a sign posted informing the patients about the video monitoring and added that she was not sure if the patients signed an informed consent regarding the video monitoring, the CNO replied that she was not sure but would find out.

An observation was made of the nursing station on the medical surgical unit, on 5/10/11 at 10:15 AM. A surveillance monitor was observed showing all 4 patients who were admitted to the medical surgical unit, in their rooms. The following was noted:
Camera 01: Showed the patient in room 201.
Camera 02: Showed the patient in room 202.
Camera 03: Showed the patient in room 203.
Camera 04: Showed the patient in room 204.

During an interview on 5/10/11 at 10:17 AM, the Unit Secretary (US) stated the facility had the cameras for two months.

During an interview on 5/10/11 at 10:25 AM, RN 505 stated the cameras had been at the facility as long as she could remember. RN 505 stated she had been employed at the facility for 18 years and that the facility used to have a monitor that flipped through the patient rooms, one at a time. She indicated that's why the facility switched to the type of monitor where all patients can be viewed at once. RN 505 added that the new monitor allowed patients to be seen continuously on one screen.

Record review revealed Patient 2 was a 61 year old female admitted to the facility on 5/6/11 with diagnoses that included colitis (swelling of the large intestines) and bloody diarrhea.

During an interview on 5/10/11 at 10:40 AM, Patient 2 stated she was admitted to the facility for an intestinal problem. When asked if the facility informed her that she was being monitored by surveillance cameras, Patient 2 stated, "I wish they had of told me because I've been going back and forth to the bathroom because of the intestinal problem I have, this is not good". Patient 2 further stated that it bothered her that she was being monitored by a camera for her medical problem and that no one informed her.

Patient 2 was observed to look worried as she stated again, "I've been getting up going to the bathroom, thanks for telling me". Resident 2 further stated, "I wish they had of told me, that's not good, especially for what I am here for".

During an interview on 5/10/11 at 11:08 AM, LVN 500 stated that she normally informs the patients on admission that they are being monitored by a video camera.

An observation was made on 5/10/11 at 11:35 AM of the medical surgical nursing station. The surveillance monitors revealed a patient observed in camera 02, that was in her room with curtains drawn around her bed. There was netting noted at the top of the draw curtains that allowed you to see two staff performing cares on the patient.

During further observation of the medical surgical nursing station, while standing at the counter, facing the nursing station, the surveillance monitor was noted to be visible to patients, visitors, and staff who approached the nursing station.

During an interview on 5/10/11 at 11:50 AM, RN 504 stated that patients admitted to the medical surgical unit were not given a consent to have video monitoring upon admission and added that this would be added to the Conditions of Admission. RN 504 further stated that the facility would add this information to their policy (to obtain consent for video monitoring). When informed that the information was already in the facility policy, RN 504 confirmed the facility was not obtaining consent for video monitoring, and stated, "it fell through the cracks but we will take care of it".

During an interview with RN 500, the facility's QA (quality assurance) specialist on 5/11/11 at 10 AM, she stated that the facility had video cameras only if there was a need, example for confused patients. RN 500 confirmed that the 4 patients currently admitted to the medical surgical unit were not confused. RN 500 also stated that the facility informs the patients verbally and added that the facility had to come up with a policy for that. She added that the facility had a brand new system and the QA committee had not had any discussion regarding the camera once they received the new one (camera). RN 500 further stated that the QA committee had not had any discussion regarding the continuous video monitoring and stated the old camera broke and the facility had purchased a new one.

Review of the facility's policy titled, "Consent to Photograph" dated 7/2010, revealed the following, "Policy: 1. Consent to Photograph, A. The Consent to Photograph and Publish form will be completed whenever (facility named here), an authorized member of the medical staff (or representative), or any person not requested to do so by the patient, desire to take a photograph of a patient or any part of the patient's body for purposes not directly related to the medical treatment of the patient. 2. This also includes videotaping and filming as well as still photography".

Review of the facility's policy titled, "Surveillance Cameras" dated 3/17/11, revealed the following, "Policy: (facility named here) has strategically installed surveillance cameras throughout the facility to daily monitor and record staff, patients and visitors of the hospital for their protection."

Further review of this same policy revealed 18 camera locations within the facility. Two of the locations included in the list were of the medical surgical nurses station and medical surgical hallway. The patient rooms on the medical surgical unit were not included on the list of camera locations within the facility.

Record review of the facility's "Resident's Rights" document given to the patients on admission revealed the following: "The facility shall protect and promote the rights as identified below. Each resident, and his/her legal representative as appropriate, has the right... 10. To be treated with consideration, respect and dignity and assured complete privacy during treatment and when receiving personal care."

Based on interview and record review, for one of 21 patients reviewed (Patient Y), the facility failed to investigate the patient's allegation of inappropriate physician behavior, creating the risk of violation of patient's right to be free from all forms of abuse and harassment for that patient.

Findings:

During a review of facility complaints on 5/11/11, the complaint record contained the allegation of Patient Y on 1/31/11. Patient Y had been observed by the staff as being visibly distressed, and she stated that MD 1 became upset with her and called her lazy. During a review of the complaint record, the only action taken based on the complaint was the Chief of Staff was "to discuss bedside manner at the next Medical Executive Meeting". There was no evidence of an investigation of the alleged incident of the physician becoming upset with the patient and calling her lazy, nor that it had been submitted to a process of peer review.

During an interview on 5/11/11 at 2:43 with the QA/IC (Quality Assurance/Infection Control) Manager, she stated that she had not conducted an investigation, but that she believed the Risk Manager had done so. She stated that the Risk Manager was away, and the records were not available. She stated that she could forward the record of the investigation when he returned. However, no such records were received by the Department.