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Based on interview and document review, the Critical Access Hospital (CAH) failed to maintain documentation of an agreement with a Quality Improvement Organization (QIO) and failed to assure that a QIO did an annual evaluation of the CAH's total program which included a representative sample of medical records. This failure could allow unrecognized deficient clinical practices to remain undetected without correction.

Findings:

On 9/8/14, the contract or other documentation of an agreement with their chosen QIO was requested for review. In an interview with the CAH's Executive Assistant (EA 1) on 9/11/14 at 2:15 p.m., EA 1 stated that the CAH did have an arrangement with a Quality Improvement Organization (QIO-1), however after a thorough search, she was unable to locate any documentation (e.g., contract, memorandum of understanding or any invoices) to demonstrate that QIO-1 had agreed to perform credentialing, utilization review or a full periodic review of the facility's total program as specified in CFR §485.641. (Refer to Q-330)

Based on observation, interview, and document review, the hospital failed to ensure patient care equipment and supplies were readily available when they were expired. This had the potential to put patients at risk for poor clinical outcomes including infections.

Findings:

On 9/8/14 at 2:15 pm, the hospital's emergency room was toured with the Chief Nursing Officer (CNO).

The following medical supplies were observed to be in dated sterile packaging, marked as expired (sterility not ensured):
a. Four povidone iodine swabs (used to clean wounds), dated 3/20/13;
b. Vaseline packets, dated 6/20/14; and
c. Six vials of sterile water (used for mixing intravenous medications), dated 9/1/14.

The CNO confirmed the above findings and stated that the supplies were expired and should not be available for patient use.

Based on observation and interview, the facility failed to ensure that all equipment and supplies located at one of two clinics (Clinic A) had not expired. This had the potential to put patients at risk for poor clinical outcomes including infection and inaccurate laborary test results.

Findings:

During a general tour of Clinic A on 9/10/14, starting at 2 pm, patient care supplies stored in each room was observed with Clinic Manager (CM) B.

a. Four bottles of potassium hydroxide 10% (a chemical solution used when preparing wet mounted slides for microscopic examination), with the expiration date of 5/28/13, was observed in the drawer of Clinic Room 1.

b. One bottle of hydrogen peroxide (an over the counter, solution used to clean wounds), with the printed expiration date of 11/2013, was observed in the cabinet of Clinic Room 7.

c. Two pairs of separately wrapped and sterile forceps (an instruments used to grasp or hold something) were determined to be expired, one with the expiration date of 11/3/13 and the other had no date present.

During an interview on 9/9/14 at 2:50 pm, CM B acknowledged the above findings and stated that the items should have been removed, thrown away or reprocessed.

Based on observation and interview, the facility failed to ensure all mechanical, electrical, and patient-care equipment was operating safely, when the internal temperature of the laboratory refrigerator was not monitored at one of two clinics (Clinic B). This failure could potentially place laboratory specimens and test reagents at risk for loss and/or degradation, which had the potential to result in inaccurate test results and poor clinical outcomes for patients.

Findings:

During a general tour of Clinic B on 9/10/14 starting at 9:30 am, the laboratory department was observed with Clinic Manager (CM) A. It was observed that the internal temperature of the small refrigerator in the laboratory department used for the storage of test reagents and laboratory specimens, was not being monitored. CM A confirmed this observation during an interview, on 9/10/14 at 10:30 am. CM A stated that no temperature log existed to document the monitoring of the refrigerator temperature and that the refrigerator was not hooked into the central monitoring system. CM A acknowledged that without monitoring, to ensure the refrigerator temperature remained within specified and acceptable parameters (below 41 Fahrenheit), the integrity of items stored in the refrigerator could not be ensured. CM A 1 confirmed that there was no specific clinic process, which would direct the staff to monitor the temperature of this refridgerator, but that there needed to be.

The Center for Disease Control and Prevention; Morbidity and Mortality Weekly Report, dated 11/11/05, indicated that temperature ranges for the storage of test components and controls, medications and vaccines (a biological preparation that improves immunity to a particular disease) needed to be monitored to ensure integrity. Extreme temperatures can degrade reagents and test components, impact reaction times, cause premature expiration of solutions, and affect results.

Based on food storage observations, dietary staff interview and dietary document review, the hospital failed to ensure the development of a mass disaster menu that had adequate amounts of food for 75 people that would be fed during a potential disaster. This failure may result in limited food supply for patients and staff during a mass disaster.

Findings:

On 9/8/14, beginning at 12 pm, food service for disaster preparedness was reviewed with the Dietary Manager (DM). Concurrent review of the hospital's disaster menu noted the plan included the provision to provide meals for 75 people (combined patients and staff) for three days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as peanut butter (2 pails/container out of 2 pails were short), three bean salad (1 out of 1 case short), and canned beets (2 cans short out of 6).

In a concurrent interview with the DM, she stated these items were on her next order with the food supplier. It was noted the cases of three bean salad were not written on the inventory list. The DM stated she would update the list.

Based on interview and document review, the Governing Body (GB) failed in their Organizational Structure obligates evidenced by the following:

1. The GB failed to assume and exercise full responsibility in determining, implementing and monitoring policies governing the Critical Access Hospital's (CAH) total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment. (Refer to Q-241)

2. The GB failed to ensure that the CAH had documented an agreement with and utilized the services of a recognized Quality Improvement Organization (QIO) to carry out an annual sampling of medical records to assess the quality and appropriateness of the diagnoses and treatments provided in the CAH. (Refer to Q-195 and Q-330)

3. The GB failed to ensure that the CAH had developed and implemented an operational Quality Improvement Program. (Refer to Q-330)

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: Organizational Structure, 42 CFR 485.627.

Based on interview and document review, the Governing Body (GB) failed to assume and exercise full responsibility in determining, implementing and monitoring policies governing the Critical Access Hospital's (CAH) total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment. The GB failed to ensure that the CAH had developed and implemented an operational Quality Improvement Program. The GB failed to ensure that the CAH had a documented agreement with and utilized the services of a recognized Quality Improvement Organization (QIO) to carry out an annual sampling of medical records, to assess the quality and appropriateness of the diagnoses and treatments provided in the CAH. These failures permitted the Medical Staff (MS) to fail in adhering to their MS Rules and left a lack of assurance that only quality and appropriate healthcare was being provided, with the possible outcome of patient harm.

Findings:

On 9/10/14 and 9/11/14, the minutes of the GB for the past 12 months were reviewed and it was noted that no documentation showed actions had been taken or directed by the GB on any items concerning quality improvement, credentialing processes, or quality assurance review of the CAH's total program. These items were searched for because of concern regarding compliance with Condition of Participation: Periodic Evaluation and Quality Assurance Review. (Refer to Q-330)

On 9/11/14 beginning at 10:40 a.m., the Executive Assistant (EA-1) assisted with concurrent review of the GB minutes for the past year. This review showed: there was no documented action taken to bring about a quality assurance review of the CAH's total program; there was no action taken to ensure the establishment of a functioning quality improvement program; and there was no recorded discussion of consideration or actions taken on recommendations from a QIO with regard to improvements needed in the credentialing/privileging processes. On 9/11/14 after concurrent review of the GB minutes, which began at 10:40 a.m., EA-1 confirmed the noted absence of documentation of actions taken or directed for the above items.

On 9/10/14 at 2:25 p.m., the Medical Staff Coordinator (and also Executive Assistant: EA-1) was questioned concerning the credentialing and privileging process. EA 1 stated that not all of the MS members had been cooperating and that one MS member (Physician C) had been delinquent in submitting his reappointment application and related documents. As a result, the Medical Executive Committee (MEC) had to recommend and the GB had to grant him temporary privileges, which was contrary to the MS Rules and Credentialing/Privileging policies.

Based on observation, interview and document review, the facility failed to ensure the provision of services were in accordance with appropriate written policy, procedures and standards of practice as evidenced by:

1. 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. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area (Refer to 278, item 1a.,1.b).

B. Staff persons were trained and competent to perform hand hygiene in accordance with nationally accepted infection control guidelines and facility policy (Refer to 278, item 2).

C. Endoscopes were cleaned and disinfected between each patient use in accordance with nationally accepted infection control guidelines and manufacturer's recommendations (Refer to 278, item 3).

D. Vaginal probes were high level disinfected between each patient use in accordance with nationally accepted infection control guidelines and manufacturer's recommendations (Refer to 278, item 4).

E. Participating physicians were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards (Refer to 278, item 5).

F. Clean and sterile patient supply items were stored in a manner to prevent contamination (Refer to 278, item 6.a.-6.c.).

G. Staff was trained and competent to practice isolation precautions in accordance with nationally accepted infection control guidelines (Refer to 278, item 7).



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2. Failure to provide respiratory assessments in the the emergency room (Refer to C 281);

3. Failure to provide and document patient pain assessments (Refer to C 295);

4. Failure to administer medications in accordance with accepted professional principles (Refer to C 276);

5. Failure to ensure that nutritional needs of inpatients were met in accordance with recognized dietary practices (Refer to C 279);

6. Failure to develop a disaster plan to ensure that they had enough food supplies on hand in the event of a disaster (Refer to C 230);

7. Failure to provide nursing care plans for patients (Refer to C 298); and

8. Failure to implement written policies for patient identification (Refer to C 271).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality care in a safe environment, and ensure provisions of services were in compliance with the statutorily-mandated Condition of Coverage: Provision of Services.

Based on observation, interview and record review, the facility failed to implement their policy in regards to patient identification when one of 10 inpatients, on the medical/surgical unit was observed without an identification armband (Patient 1). This failure had the potential in Patient 1 not being properly identified prior to medication administration, diagnostic testing or medical treatments.

Findings:

During an initial tour of the facility on 9/8/14 starting at 11:10 am, with the Chief Nursing Officer (CNO) all 10 patients in the medical/surgical unit were observed.

Patient 1 was observed in his room and was noted not to be wearing an identification armband. This observation was verified by the CNO at 12:05 pm, she stated that all patients need to have proper identification in order to make sure that they receive the correct medication and treatments.

Patient 1 was interviewed on 9/8/14 at 12:08 pm, he stated that he was admitted on 9/5/14 (4 days ago) and had never received an identification armband.

The facility's policy titled, "Patient Identification," dated 7/2013, indicated that all patients must have an armband placed when registering in admitting for any type of care, procedure or treatment.

Based on observation, interview, and document reviews, the hospital failed to administer medications that were in accordance to professional standards of practice and hospital policy for 10 of 10 patients as evidence by:

1. The hospital failed to accurately account for controlled medications when hydromorphone syringes (Narcotic, strong pain medication filled) were missing and could not be accounted for which could indicate the possibility of diversion (medications taken by someone for which they were not prescribed). The hospital staff did not take corrective action and the possible diversion was not reported as an incident as required by hospital policy;

2. The hospital failed to accurately list medications on the outside of the emergency crash cart. The emergency medication list indicated Magnesium Sulfate (Electrolyte correction) 4 grams (gm, weight measurement)/50 milliliter (ml, liquid measurement) would be inside the emergency crash cart. The emergency crash cart contained one Magnesium Sulfate 2 gm/50 ml instead of the 4 gm/50 ml;

3. Unlabeled medications were observed at the patient's bedside in the Medical/Surgical Unit (inpatients);

4. Expired medications were found available for patient's use in the Medical/Surgical Unit; and

5. Expired medications were found available for patient's use in the Emergency Department.

These failures have the potential to lead to poor clinical outcomes for all patients requiring medications for routine and emergency care.

Findings:

1. During an interview on 9/9/14 at 11 am, the Director of Pharmacy (DOP) stated that he had identified a discrepancy with hydromorphone (controlled substance that is a potent opioid) syringes that were not resolved. The DOP stated that there should have been two more syringes in stock and the syringes were missing without any documented explanation. The DOP said that he suspected diversion based on several different reports (discrepancy reports, medication administration record [MAR], drug storage [MDG] report).

A review on 9/9/14 of the Discrepancy Report indicated that there were two missing hydromorphone syringes without any documented explanation for the missing syringes. During an interview on 9/9/14 at 2:25 pm, the DOP stated that based on the Discrepancy Report, there were two missing syringes of hydromorphone.

During an interview, on 9/9/14 at 2:30 pm, the DOP, after reviewing the reports, he stated that RN H obtained five syringes and only administered three syringes. There were two syringes that were not accounted for and there was no record that the two syringes were wasted.

A review on 9/9/14 of the hospital policy entitled, "CONTROLLED SUBSTANCE: DISTRIBUTION AND ADMINISTRATION," indicated for controlled substances such as hydromorphone, "Inaccurate counts require that the charge nurse be immediately notified. The charge nurse shall determine the need for notification of the nursing supervisor and/or Pharmacy. If the inaccurate count cannot be properly corrected, an incident report form must be completed as soon as possible."

During an interview on 9/9/14 at 11 am, the DOP stated that he notified the CNO of the possible controlled substance diversion by RN H.

During an interview on 9/9/14 at 2:45 pm, the CNO stated that there was no charge nurse during the time of the suspected diversion, no documented incident report, and no follow up on the suspected diversion. "The hospital policy was not followed."

2. A review on 9/9/14 of the emergency crash cart content list indicated that Magnesium Sulfate 4 gm/50 ml, medication used for cardiac arrest in emergency situations, would be inside the cart. It was observed on 9/9/14 at 8:30 am at the hospitals' nursing station that the content list was on the outside of the cart indicating that 4 gm/50 ml should be in the cart. The emergency crash cart was opened and Magnesium Sulfate 2 gm/50 ml was observed inside the cart not the 4 gm/50 ml (normal dosage in an emergency) as indicated by the content list.

During interview on 9/9/14 at 8:30 am the CNO stated that she was not aware that the Magnesium Sulfate 2 gm/50 ml was stocked in the emergency crash cart instead of the 4 gm/50 ml. She said that the hospital policy required that the 4 gm/50 ml be stocked inside the emergency crash carts.

A review on 9/9/14 of the hospital policy entitled, MAGNESIUM SULFATE, indicated, "Magnesium Sulfate will only be available outside the Pharmacy in the concentration of 4 GMs (gm) in 50 ml..."

During an interview on 9/9/14 at 8:45 am the DOP stated that the Magnesium Sulfate 4 gm/50 ml was not on the hospital formulary (list of approved medication used by the facility). A review on 9/9/14 of the hospital formulary indicated that Magnesium Sulfate 2 gm/50 ml was listed and not the 4 gm/50 ml. The DOP stated that the hospital formulary did not have the 4 gm/50 ml and the emergency crash carts were stocked instead with the 2 gm/50 ml.


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3. During initial tour of the medical surgical unit, two tubes of unlabeled home medications were observed on Patient 11's bedside table, available for his use.

On 9/10/14 at 3:30 pm, the DOP stated that patients' home medications were not allowed to be used or stored at their bedside unless they had been sent to the pharmacy for review and re-labeling.

4. During initial tour of the medical surgical central supply room (stock room with supplies for patient care) on 9/8/14 at 11:30 am with the CNO, four packets of psyllium (a soluble fiber used primarily as a gentle bulk forming laxative) were observed to have expiration dates of 3/2014. CNO confirmed they were expired. An opened (unwrapped) 250 milliliter bag of 5% dextrose (sugar in water solution used as intravenous [IV, in the vein]) fluid was observed and available for patient use. The outside packaging of the IV bag indicated the contents were sterile, but it had been torn open and removed. CNO confirmed the package was open.

A review of the hospital's Event-Related Shelf Life-Sterile Storage policy, dated 11/2013, included a standard that read, "1...The integrity of the package will be the determining factor in establishing sterility of the enclosed items."

5. During initial tour of the hospital's emergency department (ED) on 9/8/14 at 3:10 pm, with the CNO, one multi-dose vial of insulin (used for making an IV drip to treat extremely high blood sugar emergency) was observed in the medication refrigerator. The CNO confirmed the insulin had been opened on 8/1/14.

On 9/10/14 at 11:05 am, Pharmacy Technician A stated that opened vials of insulin were to be discarded after 28 days (they could not be assured to be free of bacteria and are considered contaminated).

A review of the hospital's Medication Regulations, dated 7/2013, showed that multi-dose vials expired within 30 days of being opened.

Based on observations, staff interviews, and document reviews, the infection control officer failed to develop effective systems 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. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area when:

a. Restricted areas and traffic patterns in the GI (gastrointestinal) procedure areas were identified and implemented in accordance with nationally accepted standards of practice and

b. Appropriate room air exchange rates and pressures were maintained in the operating room and decontamination room located in the perioperative suite;

2. Healthcare workers were trained and competent to perform hand-washing in accordance with nationally accepted infection control guidelines and the facility's policy;

3. Endoscopes were cleaned and disinfected between each patient use in accordance with nationally accepted infection control guidelines and manufacturer's recommendations;

4. Vaginal probes were high level disinfected between each patient use in accordance with nationally accepted infection control guidelines and manufacturer's recommendations;

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

6. Clean and sterile patient supplies were stored in a manner to prevent cross contamination when:
a. Corrugated cardboard boxes that potentially contained insects were stored in the same area as clean and sterile patient supplies.
b. A sink used for hand-washing was located immediately adjacent to where clean and sterile supplies were stored.
c. Clean and sterile supplies were stored on the bottom shelf of a cart that did not have a solid bottom;

7. Staff were trained and competent to practice isolation precautions in accordance with nationally accepted infection control guidelines (Refer to 278, item 7); and

8. Five of 10 inpatients did not have intravenous (IV, in the vein) tubing labeled and/or changed per policy. (Patients 7, 18, 23, 25, and 26)

This placed all patients at potential risk for transmission and serious infection from infectious microorganisms, and both staff and patients at risk from exposure to the disinfectant.



Findings:

1. a. On 9/10/14 at 6:35 a.m. an endoscopy procedure area (referred to as the GI area) was observed. The GI area contained one GI procedure room located in the unrestricted area of the perioperative suite.

An interview was conducted with Registered Nurse (RN) C on 9/10/14 at 6:40 a.m. When asked about the traffic patterns and surgical attire in the GI area, RN C indicated the GI area was not considered a sterile area only clean and therefore surgical traffic patterns and attire were not indicated. RN C indicated the types of procedures performed in the GI area included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument consists of a tube and a light), EGD (Esophagogastroduodenoscopy or upper endoscopy - a procedure that enables the examiner to examine the swallowing tube, stomach, and the first portion of small bowel using a thin flexible tube that can be looked through on a monitor), and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination).

A review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was conducted. The definition of surgery indicated, "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel."

Review of the Perioperative Standards and Recommended Practices published by the AORN (Association of perioperative Registered Nurses), 2014 edition indicated, "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area."

b. During an interview with Director of Plant Operations (DPO) on 9/10/14 at 9:15 a.m., he stated the operating room was tested in 2012 and had a little over 9 room air exchanges per hour. DPO stated the pressure of the operating room was unknown. DPO indicated the number of air exchanges and pressure of the decontamination room located in the perioperative suite was also unknown.

During an interview with the Chief Nursing Officer (CNO) on 9/10/14 at 2:15 p.m., she indicated AORN was the standard the facility used for perioperative /surgical standards.

Review of the Perioperative Standards and Recommended Practices published by the AORN 2014 edition under Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment" indicated, "The decontamination area heating, ventilation, and air conditioning (HVAC) system should be controlled and monitored according to local requirements...VII.c.1. At a minimum, the following HVAC settings should be maintained in the decontamination area: negative air pressure, at least six air exchanges per hour, temperature of 68° Fahrenheit (F) to 73° F, and 30% to 60% humidity. Doors to the decontamination area should be kept closed, except when personnel are moving equipment. Keeping the door closed exhausts aerosols out of the building, minimizing contamination of adjacent areas. Negative pressure within the decontamination room cannot be maintained if the door is held open."


2014 AORN standards section, "Recommended Practices for Traffic Patterns in the Perioperative Practice Setting" indicated, "The air in the Operating Room should be maintained under positive pressure with a minimum of 20 total room air exchanges per hour..."

2. On 9/10/14 at 7:35 a.m., Physician (Phys.) C was observed exiting the procedure room where he had just performed a colonoscopy procedure. He removed his gloves and gown before exiting the room and without washing his hand proceeded down the hall to room where he began documenting on a patient chart and holding a phone located on the desk. During a concurrent interview, when asked when he washed his hands after performing a procedure, Phys. C said, "I didn't wash my hands because I didn't touch anything dirty." Phys. C said that most physicians do not wash their hands after performing procedures.

On 9/10/14 at 9:30 a.m. RN D was observed putting on gloves without first washing his hands as he prepared to enter a room of a patient on contact isolation precautions. In a concurrent interview when questioned about not washing his hands before putting on the gloves, RN D stated, "I forgot."

On 9/10/14 at 9:35 a.m. RN D was observed wearing a gown and gloves in a patient room who was on contact isolation precautions. RN D was observed grabbing the patient's garbage can with his right one gloved hand and moving the can from near the room doorway to near the foot of the patient's bed. He then removed the glove from his right hand with his left gloved hand and placed a new glove on his right hand only. When questioned why he did not wash his hands and replace both gloves, RN D stated, "I changed my glove. Have you ever worked in a hospital?" When asked about handwashing training, RN D stated he had received training on hand-washing at orientation and on a regular basis.

Review of the Facility's undated policy titled, "Hand Hygiene was conducted. The policy stipulated, "Handwashing is the single most effective technique to prevent the spread of infection. Handwashing is required: after removing gloves...The policy did not address the need to perform handwashing prior to donning gloves or if the gloves became contaminated.

According to the World Health Organization, a nationally accepted infection control resource, Glove use and the need for hand hygiene: "When an indication for hand hygiene precedes a contact that also requires glove usage, hand washing should be performed before donning gloves. When an indication for hand hygiene follows a contact that has required gloves, hand rubbing or hand washing should occur after removing gloves. When an indication for hand hygiene applies while the health-careworker is wearing gloves, then gloves should be removed to perform handwashing."

The 2014 AORN Perioperative Standards and Recommended Practices Recommended Practices for hand hygiene in the perioperative setting provided the following information: "A hand wash should be performed: Upon arrival at the health care facility, before and after every patient contact, before putting gloves on and after removing gloves or other personal protective equipment, any time there is a possibility that there has been contact with blood or other potentially infectious materials or surfaces, before and after eating, before and after using the restroom, before leaving the health care facility, and when hands are visibly soiled. Hand washing remains one of the most important measures in maintaining patient and health care personnel safety. Following these hand washing practices will prevent transmission of infection and reduce health care-associated infections for the patient and health care personnel."

3. On 9/10/14 at 7:15 a.m., Operating Room Technician (OR Tech) B was observed cleaning an endoscope that had just been used in a colonoscopy procedure for high level disinfection in the decontamination room located in the perioperative suite. OR Tech B was observed cleaning and brushing the scope in an enzymatic cleaning solution. OR Tech B was not wearing any personal protective equipment to protect her eyes, such as a face shield. She then placed the scope in the high level disinfectant solution (Cidex OPA).

In a concurrent interview with OR Tech B, she stated she had pre-cleaned the endoscope in the operating room immediately after the procedure. OR Tech B stated the endoscope would soak in the Cidex OPA solution for 15 minutes. When asked if the temperature of the Cidex OPA solution was monitored, OR Tech B said, "No." OR Tech B acknowledged she was not aware the cidex solution had a temperature requirement. OR Tech B acknowledged she should be wearing a face shield. She stated, "I forgot it." When asked when or if she tested the endoscope for leakage, OR Tech B stated the endoscope was leak tested twice, before use on a patient and after cleaning the scope in enzymatic cleaning solution. OR Tech B acknowledged, she was not aware the endoscope should be leak tested before it was submerged in enzymatic solution for cleaning.

Review of the Olympus manufacturer's instructions for cleaning, disinfection, sterilization procedures for endoscopes was conducted. The instructions stipulated, "After pre-cleaning, perform leakage testing on the endoscope to ensure that it is waterproof...Soak the endoscope and suction cleaning adaptor for the amount of time and at the temperature recommended by the detergent (this facility used Cidex OPA solution) manufacturer." The instructions also indicated personal protective equipment was needed to protect personnel throughout the cleaning, and high level disinfection process.

Review of the Facility's policy titled, "Scopes" and dated approved 4/24/12 was reviewed. The policy was noted to be a copy of the Olympus manufacturer's instructions described, in part, in the paragraph above, but did not contain section 7.3 titled "Precleaning" or section 7.4. titled "Leakage Testing."

Review of the manufacturer's instruction for use of Cidex OPA (the solution used to high level disinfect the endoscopes) was reviewed. The instructions indicated that items should be high level disinfected in the OPA solution at 68 degrees Fahrenheit for a minimum of 12 minutes.

4. On 9/8/14 at 3:30 p.m., during an interview with Ultra Sound Technician (US Tech) A, she explained she was responsible for high level disinfecting the vaginal probes used for ultra-sound. US Tech A stated she placed the probes in a high level disinfectant called Cidex OPA for 20 minutes. When asked, US Tech A stated she did not check the temperature of the solution nor did she test the solution each day with a OPA testing strip to ensure it would effectively disinfect the probe. US Tech A also stated she did not perform a quality check when a new bottle of testing strips was opened to ensure the strips could accurately test the solution. US Tech A indicated the probe was processed in the ultrasound room where patients were seen in an open container. US Tech A also indicated the OPA solution was not neutralized before disposal.

Review of the manufacturer's instruction for use of Cidex OPA was reviewed. The instructions indicated that items should be high level disinfected in the OPA solution at 68 degrees Fahrenheit for a minimum of 12 minutes. The instructions indicated the solution should be tested daily, before using the solution, with the manufactured recommended testing strip to ensure the solution would effectively disinfect the item placed in it. When new bottles of testing strips were opened the manufacturer recommended a quality check for the testing strips be done. Following removal from CIDEX OPA Solution, thoroughly rinse the medical device by immersing it completely in a large volume (e.g. 2 gallons) of water. Use sterile water unless potable water is acceptable. Keep the device totally immersed for a minimum of 1 minute in duration, unless a longer time is specified by the reusable device manufacturer. CIDEX OPA Solution should be used in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use of local exhaust hoods or ductless fume hoods/portable ventilation devices that contain filter media that absorb ortho-phthalaldehyde from the air. See package insert for detailed safety information. Check state and local disposal regulations. Glycine (free base) may be used as a neutralizer for CIDEX OPA Solution prior to disposal, if required. A minimum of 25 grams of glycine (free base) should be used to neutralize one gallon of CIDEX OPA Solution. The minimum recommended neutralization time is one hour. Discard residual solution into drain. Flush drain thoroughly with water. IED

The hospital's policy titled, "Cidex OPA Solution Disinfection of Ultrasound Probes, dated approved 4/24/12, was reviewed. The policy stipulated "Follow directions on bottle or in-service. Record date solution was poured into container. Solution cannot be used after 14 days or if the test strip (to be performed daily) is negative for minimum effective concentration (MEC). Quality control check for test strip ....Immerse instruments into Cidex OPA so they are completely submerged ...Instruments are to soak for 15 minutes for scopes and 45 minutes for laparoscopic instruments prior to use for high-level disinfection to be accomplished."

5. Review of three (3) hospital physician medical files (Phys. A, C, and D) were conducted on 9/9/14 at 3 p.m. Two of the three physician records did not have any evidence of tuberculosis screening (Phys. C and D). Three of the three physician records (Phys A, C, D) did not have any evidence of immunity or provision of immunizations for measles, mumps, rubella, varicella (chicken pox), hepatitis B, or acellular pertussis (whooping cough).

During an interview with the CNO on 9/10/14 at 2:15 p.m., she indicated the Centers for Disease Control and Prevention (CDC) was the standard the facility used for employee immunizations on, but hadn't tracked physician immunizations in the same manner as they were not facility employees.

According to the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Report (MMWR) MMWR. 2011;60 (RR07):1-45 "Healthcare workers (HCP) include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff. The guidelines recommend any facility or organization that provides direct patient care to formulate a comprehensive vaccination policy for all HCP ... To ensure that all HCP are up to date with respect to recommended vaccines, facilities should review HCP vaccination and immunity status at the time of hire and on a regular basis (i.e., at least annually) with consideration of offering needed vaccines, if necessary, in conjunction with routine annual disease-prevention measures (e.g., influenza vaccination or tuberculin testing).,, On the basis of documented nosocomial transmission, HCP are considered to be at substantial risk for acquiring or transmitting hepatitis B, influenza, measles, mumps, rubella, pertussis, and varicella." CDC provides detailed recommendations for these vaccinations in the MMWR document cited at the beginning of this paragraph.

According to the 2005 Centers for Disease Control (CDC) guidelines for the prevention of transmission of mycobacterium (M.) tuberculosis in healthcare settings "All HCWs are classified as medium risk and should receive baseline TB screening upon hire, using two-step TST or a single BAMT to test for infection with M. tuberculosis. After baseline testing for infection with M. tuberculosis, HCWs should receive TB screening annually (i.e., symptom screen for all HCWs and testing for infection with M. tuberculosis for HCWs with baseline negative test results). HCWs with a baseline positive or newly positive test result for M. tuberculosis infection or documentation of previous treatment for LTBI or TB disease should receive one chest radiograph result to exclude TB disease. Instead of participating in serial testing, HCWs should receive a symptom screen annually. This screen should be accomplished by educating the HCW about symptoms of TB disease and instructing the HCW to report any such symptoms immediately to the occupational health unit..."

6. a. On 9/8/14 at 1:30 p.m., two corrugated cardboard boxes were observed located on a shelf containing clean and sterile supplies located in the Medical Surgical utility room. In a concurrent interview with the Infection Control Practitioner (ICP), she acknowledged the cardboard boxes could harbor insects and should not be present in an area where clean and sterile patient supplies were stored.

b. On 9/8/14 at 1:25 pm, a sink was observed located next to shelves containing clean and sterile supplies in the Medical Surgical utility room. The sink had no shields to prevent splashing onto the supplies.

During a concurrent interview ICP acknowledged the sink was used by staff person for hand-washing and that it made sense that there was potential for contamination of the clean and sterile supplies with the sink in such close proximity to the supplies.

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."

c. On 9/8/14 at 1:20 p.m., a metal supply cart containing clean and sterile supplies was observed in the Medical Surgical utility room. The shelf of the cart held supplies and did not have a solid bottom. In a concurrent interview the ICP acknowledged the supplies could become contaminated when the floor under the cart was mopped and the cart should have a solid bottom if the bottom shelf held clean and sterile patient supplies.

7. On 9/9/14 at 12:00 p.m., Environment Staff (EVS) 1 was observed exiting a patient room, who was on contact isolation precautions, wearing an isolation gown and walking down the hall.

During an interview with EVS 1 at 12:05 p.m., he stated he did not know he was supposed to take off the isolation gown prior to exiting the patient's room.

According to the Centers for Disease Control and Prevention (CDC), Healthcare personnel caring for patients on Contact Precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient's environment. Donning personal protective equipment upon room entry and discarding before exiting the patient room is done to contain pathogens, especially those that have been implicated in transmission through environmental contamination (e.g., VRE [Vancomycin Resistant Enterococcus], C. [Clostridium] difficile, noroviruses and other intestinal tract pathogens; RSV [Rous sarcoma virus]).



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8. During the initial tour of the medical surgical unit on 9/8/14 at 11 am with the Chief Nursing Officer (CNO), 4 of 10 patients were observed to have IV tubing with no labels to show when they were initiated. One of the 10 patients had IV tubing that was labeled 9/4/14 (4 days/96 hours old).

Patients 18, 23, 25 and 26 had IV tubing had no labels or dates to show when they were initiated.

Patient 7's IV tubing had a label that showed it was initiated on 9/4/14 and was to be discarded on 9/5/14. It was attached to a bag of potassium (intermittent piggyback of electrolyte solution, hung alongside a continuous bag of IV fluid) that was labeled and showed it was initiated on 9/6/14, two days after the tubing was initiated.

A review of the hospital's IV Infusion Care policy, dated 9/2010, showed that all IV tubing will be labeled with start and expiration date/time and that all intermittent IV tubing will be changed every 24 hours to reduce the chance of infection.

The CNO confirmed that the IV tubing needed labels and was to be dated. The CNO confirmed that Patient 7's IV tubing was expired on 9/5/14 and should have been discarded before the potassium was administered on 9/6/14. The CNO confirmed the risk for infection to Patient 7 from the old (greater than 24 hours) IV tubing.

Based on observation, staff interview, medical record review, and document review, the hospital failed to ensure the implementation of effective systems to ensure the nutritional needs of inpatients were met in accordance with recognized dietary practices as evidenced by:

1. Registered Dietitian (RD) and licensed staff did not assess, reassess and screen for nutritional risk according to their policy patients who were high risk for compromised nutritional status for 4 of 5 sampled patients (Patients 11, 12, 13, and 14);
2. Ensure that performance improvement activities demonstrated opportunities for improvement and the development of an action plan for areas identified as requiring improvement;
3. Lack of a comprehensive diet manual that fully reflected the hospitals physician ordered diets;
4. The hospital did not develop a disaster preparedness plan to ensure that they had enough food supply on hand in the event of a disaster;
5. Lack of monitoring of the cool down of potentially hazardous foods (potato and pasta salads);
6. Bins containing loose bulk flour and sugar were lined with garbage bags;
7. The can opener was worn down and with metal shavings (fragments of metal); and
8. One ice machine was not maintained in a sanitary environment.

These failures resulted in the inability of the hospitals' food and nutrition services to direct and staff in a manner to ensure that the nutrition needs of the patients were met in accordance with practitioners' orders and current standards of practice.

Findings:

1. Review of the hospital's policy and procedure titled "Nutrition Screening Med Surg (Medical/Surgical)" dated 9/13, indicated a nurse will complete the nutrition risk screening form on each acute care patient within 24 hours of admission. It indicated to complete the nutritional risk screening form, it was noted whether the items or conditions listed were present or not. It indicated if information needed was not available that was noted on the form and the risk level was determined by the total number of conditions that exist (# of yes answers). It indicated the following lists items/conditions monitored and where to find that information needed: Tube Feeding/Total Parenteral Nutrition (TPN) (alternate nutrition support fed either by digestive system or vein), Diet of NPO (nothing by mouth)/clear liquid diet greater than three days; oral liquid nutrition supplement; diabetic or renal (diet when there was kidney disease) diet; skin breakdown/decubitus ulcer (Pressure ulcers or bedsores were localized injuries to the skin and/or underlying tissue that usually occur over a prominence as a result of pressure, or pressure in combination with shear and/or friction); weight less than ideal body weight; serum albumin, less than 3.0 grams per deciliter (serum albumin, the most abundant protein in human blood and produced by the liver); glucose (blood sugar) greater than 200 more than three times; chewing/swallowing problems; unintentional weight change; nausea/vomiting greater than three days; diarrhea/constipation greater than three days; and oral intake less than 50% less than three days. It indicated patients at no risk or low risk would be re-evaluated in one week and patients at moderate or high risk (level of three or more) will be referred to the Registered Dietitian (RD). It also indicated when a form had three or more items with information not available then the patient was re-screened in 2 days. The policy indicated the RD will complete the nutrition assessment on all patients referred and make recommendations. If the RD was not onsite then it would be faxed.

Review of the policy and procedure's attached Nutritional Risk Screening Form had different criteria than what was written in the policy. The form in the policy and procedure was different than what was in the medical record. The form indicated moderate risk was a two and to refer to the RD, not a three. The form indicated *** (three asterisks) next to the following items: Nutrition assessment ordered by physician; receiving tube feeding/TPN; and skin breakdown/decubitus ulcers. It indicated *** meant to refer to the RD however the asterisks were not on any items on the form that was in the medical record. The Form also indicated cultural/religious preferences; food allergies; and for pregnancy appropriate weight gain and positive for ketones (substances that are made when the body breaks down fat for energy).

Review of the hospital's policy and procedure titled, "Communication/Consultant Dietitian" dated approved 9/13, indicated a consulting RD was available seven days a week for nutrition assessments via phone and fax at Hospital B. It indicated patients were screened at admission and if found to be a nutritional risk, the screen was faxed to the consulting RD at Hospital B. It indicated within 48 hours the consultant RD will contact the nursing unit to gather additional information from the patient's chart and the assessment will be completed and returned via fax to the nursing floor and the dietary department. It indicated if an assessment was required on a weekend or holiday, the RD's on staff at Hospital B would complete the assessment. It indicated the Dietary Manager and RD will work together to follow up on all patients assessed and identified to have a nutritional risk via on-site visits, phone, and fax.

On 9/10/14 at 10 am, an interview was conducted with the RD. The RD stated she had not seen the policy regarding Communication/Consultant RD, therefore was not aware what it said.

a.) Patient 11 was admitted on 9/4/14 with diagnoses that included obtunded (decrease level of consciousness) and recurrent hypoglycemia (low blood glucose/sugar). The Nutrition Risk Screening Form, dated 9/4/14, indicated Patient 11 had an oral liquid nutrition supplement, skin breakdown/decubitus ulcer (stage II on the left heel), unintentional weight change, greater than 10% times six months, and diarrhea greater than three days. It indicated that anything over a risk level of a 2 will be referred to the Registered Dietitian (RD). It indicated it was faxed to the RD on 9/4/14 at 5 p.m.. There was no nutritional assessment by the RD in the medical record. Patient 11 was discharged on 9/8/14 at 5:13 p.m.

On 9/9/14 at 12 pm, a telephone interview was conducted with the RD. The RD stated she would receive a fax from the hospital and then would fax back her assessment within 48 hours. The RD stated she did not get it until today (5 days after fax sent). She stated she had found out Patient 11 had already been discharged.

b.) Patient 12 was admitted on 5/16/14 with diagnoses that included partial small bowel obstruction (blockage that keeps food or liquid from passing through the small intestine) and recent right oophorectomy (surgical removal of the right ovary). Review of the physician's orders, dated 5/17/14, indicated NPO (nothing by mouth). Review of the physician's orders, dated 5/28/14 at 12 pm, indicated clear liquids.

Review of the Nutrition Risk Screening Form, dated 5/16/14, indicated a nutrition assessment ordered by the physician and constipation greater than three days. There were two indicators on the form, however, the nurse indicated the risk level was one (No referral to RD was needed). The item of nutrition assessment ordered by the physician should have had asterisks next to it to indicate that would need a referral to the RD. This was not present on the form in the medical record. The form indicated risk level of a 1 then to re-evaluate in one week and a risk level of a 2 to refer to the RD. No referral was made to the RD when there should have been according to the hospital policy and procedure.

Review of the Nutrition Risk Screening Form dated 5/26/14, indicated Patient 12 had constipation greater than three days and oral intake less than 50%. The form was faxed to the RD dated 5/26/14 at 8:25 am. The re-evaluation was on day 10 not after one week as indicated on the hospital policy and procedure.

The RD Assessment, dated 5/28/14, indicated Patient 12 had been NPO for 12 days due to a bowel resection and gastrointestinal surgery. The RD indicated the current diet was not meeting estimated nutrition needs and placed Patient 12 at increased nutritional risk due to length of time that they were NPO without nutrition support. The RD recommended: 1) to advance diet as tolerated to a soft/low fiber diet; 2) would recommend peripheral parenteral nutrition (alternate nutrition support by vein) however the hospital does not have in stock; and 3) continue Intravenous (IV) for hydration and replaced electrolytes as needed.

c.) Patient 13 was admitted on 3/25/14 with diagnoses that included dehydration, renal (kidney) failure, cancer of the pancreas and diabetes (high blood sugar levels). Review of the history and physical dated 3/26/14 indicated Patient 13 had profound jaundice (yellow discoloration of the skin and other mucous membranes) four weeks ago and was found to have carcinoma of the head of the pancreas obstructing the common bile duct and underwent a procedure to surgically remove the tumor and part of the duodenum (first section of the small intestine), but pathology did show some small residual tumor in the uncinate process (the formed prolongation of the angle of junction of the lower and left lateral borders in the head of the pancreas, shaped like a hook). It indicated after being discharged home the patient went downhill with anorexia (lack of appetite) and dehydration. It indicated labs showed renal failure and new onset diabetes.

Review of physician orders dated:
3/25/14 indicated a full liquid diet;
3/26/14 indicated mightyshakes (oral nutrition supplement) three times a day;
3/29/14 indicated total parenteral nutrition (TPN) 5% amino acids (AA- protein) Dextrose (D - glucose) 15% at 42 milliliters (ml) per hour;
3/30/14 TPN AA5%D 15% at 42 ml per hour;
3/31/14 TPN AA5%D 15% at 63 ml per hour + intralipid (IL) 20% total volume 250 ml;
4/1/14 indicated clear liquids and IL 20% of 500 ml at 42 ml per hour every 48 hours;
4/2/14 AA5%D 15% at 84 ml per hour;
4/3/14 indicated clear liquids with whole milk and mightyshakes;
4/4/14 indicated full liquids low fat diet; and
4/9/14 indicated discontinue mightyshakes and add 1 can glucerna (diabetic nutrition supplement) twice a day.

Review of the Nutrition Risk Screening Form dated 3/25/14, indicated Patient 13 was at risk for the following items: diabetic diet; albumin less than 3 gm/dl; glucose greater than 200 more than three times; unintentional weight change; and oral intake less than 50%. It indicated a score of a five and was faxed to the RD dated 3/25/14. No time was filled out on the fax.

Review of the Nutrition Assessment, dated 3/26/14, indicated Patient 13 was 199.5 pounds and 69 inches, body mass index of 29.5 and ideal body weight (IBW) is 72 kilograms (kg) (~160 pounds). The RD estimated Patient 13's nutrition needs were 2100-2300 calories (30-32 calories per kg of IBW; 72-100 gm of protein (1-1.4 gm per kg IBW). The RD recommended to advance as tolerated to a low fat low cholesterol, consistent carbohydrate diet or a regular diet if needed to be liberalized due to poor intake; add mightyshakes four times a day as tolerated; and to monitor oral intake closely.

On 9/10/14 at 10 am, an interview was conducted with the RD. The RD stated she was not aware the patient was in the hospital for 16 days. She stated she relied on the nurse to send another nutrition risk screening form after they have been there for a week so when she did not get one she assumed he left. The RD stated she does not have any system in place to track or follow up on patients herself. The RD acknowledged this was not the standard of practice on how they follow up with patients at the other hospital she works at. The RD stated she was not aware that nursing was not following the policy and not re-screening after one week.

There was no reassessment done by the RD for Patient 13. The RD did not have any system in place to monitor patients that she had done assessments on. The standard of practice in hospitals was that there was a system in place to follow up and reassessed patients that were at nutritional risk. There was no re-screen on the Nutrition Risk Screening Form by the nurse according to the policy. Patient 13 was on TPN which should have had the nurse initiate a referral to the RD.

d). Patient 14 was admitted on 12/31/13 with diagnoses that included depression, acute pneumonia, and chronic obstructive pulmonary disease. Review of the nutrition risk screening form, dated 12/31/13, indicated the patient had chewing problems and he had left dentures at home. It indicated the form was faxed on 12/31/14 at 9 pm. There was no other nutrition risk screening done on the patient.

On 9/9/14 at 2:25 pm, an interview was conducted with RN B. RN B stated the nutrition risk screening form was completed within 24 hours of admission. If they mark 2 or more items then they fax over to the RD. The RN stated they only do this once while the patient was admitted unless they change their level of care, then everything will have to be done again.

2. On 9/10/14 beginning at 10:40 am, the departments' performance improvement plan was evaluated with DM and RD. Review of the foodservice departments' plan revealed all activities monitored reached near 100% compliance rates. The elements monitored included tray assessments/tray line checks (in relation to temperatures, palatability of food and if recipes were followed), food surveys, and emergency supplies with menu for the therapeutic diets. The hospital was monitoring nutrition assessment completed when the patient was at nutritional risk. For calendar year 2014, this element was below the hospital's performance benchmark of 100% and was at 97% for the second quarter. The results of the performance monitoring revealed for the first quarter the results were 90.4% respectively.

During a concurrent interview, RD stated she was not aware any quality assurance performance improvement activities were being done regarding clinical nutrition. RD stated this was not part of the contract with her or her employer.

Review of the Contract for the Dietary Consultant Services dated and signed 9/13, did not indicate under the responsibilities quality assurance performance improvement activities to be done by the RD.

During an interview on 9/10/14 at 12:05 pm, with Quality/Risk Manager, she stated she relied on the Dietary Manager to develop their own performance improvement indicators to be submitted not the RD.

3. During trayline observation on 9/8/14 at 12:20 pm, the following physician ordered diets were noted: 2 gram sodium (salt) restriction, 1800 calorie ADA (American Diabetic Association, a sodium restricted diet and a diet modified for diabetic problems) and a regular diet.

On 9/9/14 at 9:25 am, an interview was conducted with the DM regarding the hospital's diet manual. The DM stated they used the electronic Nutrition Care Manual by the Academy of Nutrition and Dietetics. When asked to see what the Manual stated regarding the 1800 calorie ADA diet and 2 gram sodium diet, the DM showed that it was a consistent carbohydrate diet and some information about that diet. However, the Manual did not give specifics about what the kitchen provided when given this diet. The dietary manager stated there was a consistent carbohydrate diet that could be ordered as well as the 1800 calorie ADA diet. There was nothing in the manual regarding an ADA diet. When asked to look up what the Manual stated regarding the 2 gram sodium diet. It discussed sodium restriction and also had information about heart healthy diet (low sodium, low fat and low cholesterol diet) and the therapeutic lifestyle change (low fat and low cholesterol) however it did not specifically address just a 2 gram sodium diet.

A diet manual would provide a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet and sample meal plans that were consistent with the hospitals' menu.

Review of the hospital's policy and procedure titled, "ADA Manual (on-line)," dated approved 9/13, indicated the ADA Dietary Manual was available on-line and how to access the manual. It indicated the purpose was to have all therapeutic diets readily available to all hospital staff. While the online document had some of the guidelines, not all the guidelines were present for each physician ordered hospital diet which would allow for hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare patient diets.

4. On 9/8/14, beginning at 12 pm, food service for disaster preparedness was reviewed with the Dietary Manager (DM). Concurrent review of the hospital's disaster menu noted the plan included the provision to provide meals for 75 people (combined patients and staff) for three days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as peanut butter (2 pails/container out of 2 pails were short), three bean salad (1 out of 1 case short), and canned beets (2 cans short out of 6 cans).

In a concurrent interview with the DM, she stated it was on her next order with the food supplier. It was noted the three bean salad was not written on the inventory list and the incorrect amount of baked beans was written. The DM stated she would update the list.

5. During the initial tour of the kitchen with the DM on 9/8/14 at 11:40 am, a large stainless steel bowl was observed with potato salad dated 9/7-9/10/14 in the refrigerator. The temperature of the potato salad was 39 degrees Fahrenheit (F). There was a container of ham pasta salad dated 9/5-9/8/14. The temperature of the ham pasta salad was 37.2 degrees F.

On 9/8/14 at 3:20 pm, an interview was conducted with Cook A regarding cool down (food cools down to appropriate temperature over time to decrease food borne illnesses). Cook A stated they cook the potatoes and usually pasta the day prior to making the salad. She stated they do not put this on their cool down log (documentation of time and temperature of the food), they just put it in the refrigerator.

On 9/9/14 at 9:20 am, an interview was conducted with the DM regarding the cool down procedure. The DM stated they do cool down for tuna and egg salad but have not done that for potato and pasta salad. The DM acknowledged they should be following the cool down procedure for those items.

Review of the cool down log did not show the potato or ham pasta salad.

Review of the hospital policy and procedure titled, "Food Preparation," dated 5/09, indicated instructions on cooling down meat and cooling of chicken and tuna salad. The policy did not address that all Potentially Hazardous Foods (Time/Temperature Control for Safety Food) need to be cooled down. According to the US Food and Drug Administration (FDA) Food Code Potentially Hazardous Food included a plant food that was heat treated. That would include cooked rice, pasta and potatoes.

The FDA refers to improper cooling and holding temperature activities that directly relate to food safety concerns a Food-borne illness risk factors.

To effectively reduce the occurrence of food-borne risk factors, food service operators develop and implement food safety management systems to prevent, eliminate or reduce the occurrence of food-borne illness risk factors. The FDA Food Code identified a preventative rather than a reactive approach to food safety through a continuous system of monitoring and verification. Control measures essential to food safety, such as proper cooking, cooling, and refrigeration, includes time/temperature control for foods. For example, within two hours of cooking, the internal food temperature shall reach 70 degrees Fahrenheit (F) or less and 41 degrees F or less after an additional four hours.

6. During a kitchen observation on 9/8/14, at 12:20 pm, loose flour, and sugar were stored in large stainless steel bins with black plastic liners.

On 9/8/14 at 3:30 pm, an interview was conducted with Cook A. When she was asked if they were food-grade liners, (liners that will not transfer noxious or toxic substances to food it is holding) Cook A stated that they were garbage bag liners.

On 9/9/14 at 9:20 am, an interview was conducted with the Dietary Manager (DM) regarding the liners. The DM stated they used garbage bags as liners and was not aware there were food grade liners.

According to the United States Department of Agriculture (USDA), the use of plastic trash bags was not recommended for food storage or cooking "...because they are not food grade plastic and chemicals from them may leach into the food." www.fsis.usda.gov/oa/pubs/meatpack.htm

7. During the initial tour of the kitchen with the DM on 9/8/14 at 11:35 am, the can opener was observed with a worn down blade, missing pieces of the blade with metal shavings. A concurrent interview was conducted with the DM. The DM stated the blade should be changed every three months and she was not sure when the last time it was changed. The DM acknowledged it needed to be changed.

Review of the hospital policy and procedure titled, "Equipment," review date 6/09, indicated the can opener should be ran through the dishwasher at least twice daily and to change the blade when needed.

According to the 2013 Federal Food and Drug Administration Food Code, Section 4-501.11 Good Repair and Proper Adjustment: "(C) cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened." The cutting or piercing parts of can openers may accumulate metal fragments that could lead to food containing foreign objects and, possibly result in consumer injury. (FDA Food Code Annex, 2013).

8. On 9/9/14 at 10 am, an observation was conducted with the DM of the ice and water machine on the medical/surgical unit. There was a blackish brown substance located in the nozzle where the water was dispensed. There was white substance located in the chute (where the ice was dispensed from the ice machine) and on the drain pan (at bottom of the dispenser to collect excess water and ice). The DM confirmed these blackish brown and white substances.

On 9/9/14 at 10:05 am, an observation and interview was conducted with the Plant Operations Lead (POL). He acknowledged the black and white substances in the ice machine. He stated he thought they were to be sanitized next month. The POL stated they had hard water so build up was common.

Review of the ice machine cleaning log indicated the ice machine had been cleaned in January and July and sanitized in April with check marks.

On 9/9/14 at 10:15 am, an interview was conducted with the POL. He stated that they clean twice a year and sanitize twice a year. The POL stated he was not sure if they cleaned and sanitized when it said sanitize on the log but they follow exactly what the manufacturer's directions say.

Review of the manufacturer's directions of the ice machine, indicated depending on local water conditions they recommend initiating preventative maintenance cleaning procedures between the six month cleanings. It indicated there was three separate cleaning procedures. It indicated the preventative maintenance cleaning procedure was to be performed as required for your water conditions and to do this monthly. The cleaning/sanitizing procedure must be performed a minimum of once every six months. The heavily scaled cleaning procedure was to be performed if you have some or all of the following systems including your water had a high concentration of minerals. It indicated to run a cleaning procedure after the heavily scaled cleaning procedure. It noted that a sanitizing procedure must be performed after all cleaning procedures had been completed.

Based on observation, interview, record review, the hospital failed to provide emergency room (ER) services that included on going respiratory assessment for one of 28 sampled patients, (Patient 6) when a complete set of vital signs (blood pressure, temperature, pulse, respiratory rate and oxygen saturation level) were not completed. This failure could potentially not identify patients in repiratory depression resulting in poor clinical outcomes related to lack of basic monitoring.

Findings:

Patient 6 was admitted to the ER, via ambulance, on 9/8/14 at 12:15 pm, with a chief complaint of unresponsiveness and ALOC (altered level of consciousness) following a new onset (first) seizure (abnormal overstimulation of nerve cells of the brain).

On 9/8/14 at 3:12 pm, Patient 6 was observed in ER Room 2C lying on a gurney. Patient 6's respiratory rate was observed to be very slow at 6 breaths per minute (bpm, a normal respiratory rate was 12 to 20 bpm). Patient 6's respiratory rate was observed for two-minutes.

On 9/8/14 at 3:15 pm, Patient 6's ER record, dated 9/8/14, documented her Respirations were at 14/minute on 3 liters of oxygen. Registered Nurse (RN) E concurrently stated that this rate was from the ambulance record when she arrived at the ER. When asked why Patient 6's respiratory rate was so slow, RN E stated the Narcan (narcotic reversing agent used with narcotic overdose patients) may have worn off and that her previous respiratory rate of 14 was likely the result that Narcan was administered in the ambulance. RN E was asked to show the record of Patient 6's vital signs and asked if she had noticed her slow respiratory rate. RN E had not noted or recorded Patient 6's vital signs but was able to print them out from the bedside monitor attached to Patient 6. RN E concurrently confirmed the vital signs record printed from the bedside monitor was blank in the column marked "Resp rpm (respirations rate per minute) between 12:14 pm and 3:16 pm (a 3 hours period). RN E stated that vital signs were to be done every 15 minutes on Patient 6 and that the respiratory rate was not recorded and should be included.

Lexicomp online medication information provided warning and precautions for opioid (narcotic) overdose. Recurrence of respiratory depression was possible if the opioid involved was long acting (greater than 4 hours). Observe patients until there was no reasonable risk of recurrent respiratory depression. Narcan was effective for 1 to 3 hours.

On 9/8/14 at 3:20 pm, Chief Nursing Officer (CNO) stated that Patient 6's bedside monitor could have been set to count respirations, but had not been set up correctly and had not recorded her respiratory rate. The CNO was observed setting the monitor to count respiratory rate, which displayed Patient 6's slow rate at 8 Resp rpm, as she was observed to momentarily arouse to our voices.

A review of Patient 6's bedside monitor vital sign record showed her slow respiratory rate was 7 at 3:26 pm, 8 at 3:36 pm, 12 at 3:46 pm and 6 at 3:56 pm.

On 9/8/14 at 3:22 pm, RN E stated that Patient 6's husband said he thought she may have secretly taken his narcotic pain medication. RN E confirmed that she had not documented or counted Patient 6's respirations and that her respiratory rate should have been 14 to be normal (slow respirations were a sign of drug overdose and/or ineffectiveness of reversal medication).

Patient 6's urine toxicology screening (used to detect drugs of abuse), dated 9/8/14 at 1:12 pm, showed positive for benzodiazepines (sedating medication with high potential for abuse; overdose can cause breathing to slow or stop) although she had not been prescribed it.

Lexicomp online medication information provided the reversal medication used for benzodiazepines was flumazenil, not Narcan.

The hospital's Assessment of the Emergency Department Patient policy, dated 1/2013, showed that vital signs shall be obtained as part of the patient assessment.

The hospital's policy, Management of a Patient Under the Influence of Drugs, dated 1/2013, also indicated vital signs were to be monitored.

Based on observation, interview, and record review, the hospital failed to provide nursing services that included ongoing patient assessments when four of 28 sampled patients (Patients 6, 7, 8 and 9) vital signs (blood pressure, temperature, pulse, respiratory rate and oxygen saturation level) and/or pain assessments were not done as ordered. This failure potentially placed patients at risk for poor clinical outcomes related to lack of respiratory monitoring.


Findings:

1. Patient 6 was admitted to the Emergency Room (ER), via ambulance, on 9/8/14 at 12:15 pm, with a chief complaint of unresponsiveness and ALOC (altered level of consciousness) following a new onset (first) seizure (abnormal overstimulation of nerve cells of the brain).

On 9/8/14 at 3:12 pm, Patient 6 was observed in ER Room 2C lying on a gurney. Patient 6's respiratory rate was observed to be very slow at 6 breaths per minute (bpm, a normal respiratory rate was 12 to 20 bpm). Patient 6's respiratory rate was observed for two-minutes.

On 9/8/14 at 3:15 pm, Patient 6's ER record, dated 9/8/14, documented her Respirations were at 14/minute on 3 liters of oxygen. Registered Nurse (RN) E concurrently stated that this rate was from the ambulance record when she arrived at the ER. When asked why Patient 6's respiratory rate was so slow, RN E stated the Narcan (narcotic reversing agent used with narcotic overdose patients) may have worn off and that her previous respiratory rate of 14 was likely due to the Narcan administered in the ambulance. RN E was asked to show the record of Patient 6's vital signs and asked if she had noticed her slow respiratory rate. RN E had not noted or recorded Patient 6's vital signs but was able to print them out from the bedside monitor attached to Patient 6. RN E concurrently confirmed the vital signs record printed from the bedside monitor was blank in the column marked "Resp rpm (respirations rate per minute) between 12:14 pm and 3:16 pm (a 3 hours period). RN E stated that vital signs were to be done every 15 minutes on Patient 6 and that respiratory rate should be included in those vital signs.

Lexicomp online medication information provided warning and precautions for opioid (narcotic) overdose. Recurrence of respiratory depression was possible if the opioid involved was long acting (greater than 4 hours). Observe patients until there was no reasonable risk of recurrent respiratory depression. Narcan was effective for 1 to 3 hours.

A review of Patient 6's bedside monitor vital sign record showed her slow respiratory rate was 7 at 3:26 pm, 8 at 3:36 pm, 12 at 3:46 pm and 6 at 3:56 pm.

On 9/8/14 at 3:22 pm, RN E stated that Patient 6's husband said he thought she may have secretly taken his narcotic pain medication. RN E confirmed that she had not documented or counted Patient 6's respirations and that her respiratory rate should have been 14 to be normal (slow respirations were a sign of drug overdose and/or ineffectiveness of reversal medication).

Patient 6's urine toxicology screening (used to detect drugs of abuse), dated 9/8/14 at 1:12 pm, showed positive for benzodiazepines (sedating medication with high potential for abuse; overdose can cause breathing to slow or stop) although she had not been prescribed it.

Lexicomp online medication information provided the reversal medication used for benzodiazepines was flumazenil, not Narcan.

The hospital's Assessment of the Emergency Department Patient policy, dated 1/2013, showed that on going vital signs shall be obtained as part of the patient assessment.

The hospital's policy, Management of a Patient Under the Influence of Drugs, dated 1/2013, also indicated on going vital signs were to be monitored.

2. Patient 7 was admitted to the hospital on 9/3/14 from the ER, where she was treated for abdominal pain and vomiting. Pain assessment was not documented every four hours.

On 9/9/14, Patient 7's Problem List included abdominal pain and nausea/vomiting/drug withdrawal symptoms (narcotics withdrawal), both dated 9/3/14, and epigastric (above the stomach) pain, dated 9/4/14.

Patient 7's History and Physical, dated 9/3/14, showed she had been recently taken off methadone (pain medication) to treat her chronic (condition over six months duration) lower back pain.

Patient 7's physicians orders, dated 9/5/14, included checking her vital signs every 4 hours.

Patient 7's Vitals Signs Flowsheet View Report, dated 9/4 to 9/9/14, showed her pain (considered a vital sign) was assessed:

9/4/14 at 10:53 pm at 9/10 (severe pain);
9/5/14 at 5:01 pm at 0/10 (no pain);
9/6/14 at 1:03 pm at 0/10;
9/6/14 at 7:13 pm at 5/10;
9/6/14 at 10:46 pm at 0/10;
9/7/14 at 7:30 am at 0/10;
9/7/14 at 2:10 pm at 0/10;
9/7/10 at 4:47 pm at 0/10;
9/8/14 at 12:12 pm at 6/10.

Patient 7's Nursing Assessment Flow Sheet included pain assessed:

9/3/14 at 11:15 am at 10/10;
9/3/14 at 3 pm at 0/10;
9/3/14 at 6:29 pm at 0/10;
9/4/12 at 7 am at 10/10;
9/4/14 at 1:42 pm at 0/10;
and not every 4 hours as ordered by her physician.

A review of the hospital's Pain Management policy, dated 7/2013, read, "The patient will be assessed for the presence/absence of pain upon admission, each time the vital signs are done or more often as indicated, and upon discharge...All patients will be reassessed for pain each time the vital signs are done or no less than each shift and recorded..."

On 9/10/14 at 2 pm, the Chief Nursing Officer (CNO) stated that pain was considered "the fifth vital sign" and should be assessed minimally, every 4 hours. The CNO confirmed Patient 7's record did not include pain assessments every four hours or every shift, per the hospital's policy.

3. Patient 8 was admitted to the hospital on 8/25/14, from the ER with diagnoses of febrile illness (fever). Vital signs were not documented every four hours.

Patient 8's physician admission orders, dated 8/25/14, showed his vital signs were to be done every four hours.

Patient 8's record included a nursing Admission ER Assessment, dated 8/25/14, with a section titled, "Vitals:" that was left blank.

Patient 8's record included a physician's History and Physical, dated 8/25/14, that included a "Physical Exam" section with no vital signs recorded.

Patient 8's ER Discharge Assessment, dated 8/25/14 at 8:25 pm, did not include any vital signs.

The hospital's Assessment of the Emergency Department Patient policy, dated 1/2013, showed that vital signs were to be done initially and upon discharge from the ER before admission to the hospital.

On 9/10/14 at 4 pm, RN F stated that vital signs should be part of the patient's ER assessment.

Patient 8's Vital Signs Flowsheet View Report, dated 8/25 to 8/29/14, showed the one pain assessments for 8/26/14 and three pain assessments for 8/27/14.

4. Patient 9 was admitted to the hospital on 8/24/14 at 6 pm from the ER, with a diagnosis of "Left Neck Cellulitis (severe skin infection)." Admission assessment was not competed timely and vital signs every 4 hours, including pain level was not documented.

On 9/11/14, a review of Patient 9's record included an Activity Occurrences for Admission Assessment, printed 9/11/14, that showed his admission assessment scheduled for 8/24/14 at 6 pm was "Past Due."

On 9/11/14 at 10:45 am, the CNO confirmed there was no Admission Assessment for Patient 9 done.

Patient 9's record included a physicians order, dated 8/24/14, for vital signs every 4 hours.

Patient 9's Vital Signs Flowsheet View Report, dated 8/24/14 at 7:34 pm to 8/30/14 at 4 am included vital signs that included daily pain at levels of up to 8/10 and 9/10 (severe pain) on 8/25, 8/26, 8/27, 8/28. and 8/29/14. The "Pain Intensity/Loc (level of consciousness)" section was left blank on:

8/25/14 at 3:11 pm;
8/26/14 at 6:36 am, 11:10 am, 4:10 pm;
8/28/14 at 4:21 am, 7:37 am, 8 pm;
8/29/14 at 4 pm;
8/30/14 at 12:05 am and 4 am.

Patient 9's Physician Notes Report showed he experienced continued acute pain as follows:
8/25/14 at 9:18 pm read, "He still has considerable pain at left jaw. The oxycodone (narcotic pain medication) 5 mg (milligram) was not effective..."
8/26/14 at 8:27 pm, read, "He says that the swelling is going down but that there is continued severe pain..."
8/27/14 at 8:57 pm, read, "he complains that the left jaw is enlarging and continues to be painful..."
8/28/14 at 9 pm read, "He feels that his left jaw is getting better but the swelling in the lateral neck it is still painful..."

The hospital's Pain Management policy, dated 7/2013, read, "The patient will be assessed for the presence/absence of pain upon admission, each time the vital signs are done or more often as indicated, and upon discharge."

Based on interview and record review, the hospital failed to develop care plans for four of 28 sampled patients. (Patients 6, 7, 8 and 9) This failure had the the potential to place patients at risk for poor clinical outcomes when there was no written plans of care available for continous patient care.

Findings:

On 9/10/14 at 2:30 pm, Registered Nurse (RN) D was interviewed about the lack of care plans in the patients' electronic medical records (EMRs). He stated, "We don't know how to create careplans. No one knows how to make one in this system...It's horrible. The company has not provided any training." When asked if hospital administration had provided any training on how to make patient care plans, RN D stated the nurses had not received that training.

On 9/10/14 at 2 pm, the Chief Nursing Officer (CNO) confirmed the above referenced patients had no care plans done for these identified problems.

1. Patient 6 was admitted to the emergency room (ER), via ambulance, on 9/8/14 at 12:15 pm, with a chief complaint unresponsiveness and ALOC (altered level of consciousness) following a new onset (first) seizure.

Patient 6's record was reviewed on 9/10/14 and identified the problem "Disturbance of consciousness" needing a care plan. There was no care plan done for this identified problem.

2. Patient 7 was initially admitted to the hospital on 9/3/14 from the ER, where she was treated for abdominal pain and vomiting.
Patient 7's record was reviewed on 9/10/14 and identified the problems of anxiety, abdominal pain, nausea and vomiting, and N/V (nausea and vomiting) drug withdrawal symptoms all on 9/3/14; and epigastric pain (area above the abdomen) with nausea and vomiting on 9/4/14, all needing care plans. There were no care plans done for these identified problems.

3. Patient 8 was admitted to the hospital on 8/25/14, from the ER with diagnoses of febrile illness (fever).

Patient 8's Admission ER Assessment (nursing) identified the problems of anxiety and fever in need of a care plans. There were no care plans done for these identified problems.

4. Patient 9 was admitted to the hospital on 8/24/14 at 6 pm from the ER, with a diagnosis of "Left Neck Cellulitis (severe skin infection)."

Patient 9's record included a Problem List that identified the following problems in need of care plans: accidental fall, acute pain, anxiety, fever, smoker, dental pain, left jaw pain and right ankle pain. There were no care plans done for these identified problems.

Based on interview and record review, the hospital failed to ensure patient records were complete and accurately documented for five of 28 sampled patients. This failure could result in inaccurate record keeping or the incorrect treatment being received. (Patients 3, 6, 7, 8 and 9)

Findings:

The hospital's Guideline for Medical Record Entries policy, dated 1/2008, showed they would be factual, objective, accurate, timely (as close to the actual event as possible), late entries and addendum (added information to record at another time) would be noted as late or an addenda and authenticated.

1. No respiratory assessment was done and documented for Patient 6. Patient 6 was admitted to the ER, via ambulance, on 9/8/14 at 12:15 pm, with a chief complaint of unresponsiveness and ALOC (altered level of consciousness) following a new onset (first) seizure (abnormal overstimulation of nerve cells of the brain).

On 9/8/14 at 3:12 pm, Patient 6 was observed in ER Room 2C lying on a gurney. Patient 6's respiratory rate was observed to be very slow at 6 breaths per minute (bpm, a normal respiratory rate was 12 to 20 bpm). Patient 6's respiratory rate was observed for two-minutes.

On 9/8/14 at 3:15 pm, Patient 6's ER record, dated 9/8/14, documented her Respirations were at 14/minute on 3 liters of oxygen. Registered Nurse (RN) E concurrently stated that this rate was from the ambulance record when she arrived at the ER. When asked why Patient 6's respiratory rate was so slow, RN E stated the Narcan (narcotic reversing agent used with narcotic overdose patients) may have worn off and that her previous respiratory rate of 14 was likely the result that Narcan was administered in the ambulance. RN E was asked to show the record of Patient 6's vital signs and asked if she had noticed her slow respiratory rate. RN E had not noted or recorded Patient 6's vital signs but was able to print them out from the bedside monitor attached to Patient 6. RN E concurrently confirmed the vital signs record printed from the bedside monitor was blank in the column marked "Resp rpm (respirations rate per minute) between 12:14 pm and 3:16 pm (a 3 hours period). RN E stated that vital signs were to be done every 15 minutes on Patient 6 and that the respiratory rate was not recorded and should be included.

Lexicomp online medication information provided warning and precautions for opioid (narcotic) overdose. Recurrence of respiratory depression was possible if the opioid involved was long acting (greater than 4 hours). Observe patients until there was no reasonable risk of recurrent respiratory depression. Narcan was effective for 1 to 3 hours.

A review of Patient 6's bedside monitor vital sign record showed her slow respiratory rate was 7 at 3:26 pm, 8 at 3:36 pm, 12 at 3:46 pm and 6 at 3:56 pm.

Patient 6's urine toxicology screening (used to detect drugs of abuse), dated 9/8/14 at 1:12 pm, showed positive for benzodiazepines (sedating medication with high potential for abuse; overdose can cause breathing to slow or stop) although she had not been prescribed it.

Lexicomp online medication information provided the reversal medication used for benzodiazepines was flumazenil, not Narcan.

The hospital's Assessment of the Emergency Department Patient policy, dated 1/2013, showed that vital signs shall be obtained as part of the patient assessment.

The hospital's policy, Management of a Patient Under the Influence of Drugs, dated 1/2013, also indicated vital signs were to be monitored.

2. Patient 7 was initially admitted to the hospital on 9/3/14, from the ER, where she was treated for abdominal pain and vomiting.

a.) On 9/9/14 at 2 pm, Patient 7's History and Physical (H&P), dated 9/3/14, was reviewed concurrently with Health Information Management Director (HIMD). The H&P was used to communicate information about the patient to all providers and included concise information about the patient's history, exam findings and plans to address their medical issues, at the time of their hospital admission. The H&P included the patient's Chief Complaint (dominant reason for hospitalization). Patient 7's Chief Complaint was listed as: "all over." Her History of Present Illness read: "...She said at one 22 August Dr. A stopped her methadone and Xanax...She still diagnosed with bipolar disorder and schizophrenia forearm [sic] disorder (mental deterioration from a previous level of function) with hallucinations...She was taken off the medications 2 to [sic]alleged failed drug screen with one prescribed Percocet one half years ago and for murmurs of selling her medications.." HIMD confirmed that these made no sense. HIMD stated the physicians were using a voice recognition program because they did not like the hospital's EMR system. HIMD confirmed that the voice recognition program used for Patient 7's H&P was not effective and resulted Patient 7's medical record being inaccurate and incomplete.

b.) Patient 7's Vitals Signs Flowsheet View Report, dated 9/4 to 9/9/14, and Nursing Assessment Flow Sheets showed her pain was not assessed or documented every 4 hours as ordered by her physician.

A review of the hospital's Pain Management policy, dated 7/2013, read, "The patient will be assessed for the presence/absence of pain upon admission, each time the vital signs are done or more often as indicated, and upon discharge...All patients will be reassessed for pain each time the vital signs are done or no less than each shift and recorded..."

On 9/10/14 at 2 pm, CNO stated that pain should be assessed minimally, every 4 hours. CNO confirmed Patient 7's record was not complete and did not include the every 4 hour pain assessments, per the hospital's policy.

3. Patient 8 was admitted to the hospital on 8/25/14, from the ER with diagnoses of febrile illness (fever).

a.) On 9/9/10 at 2 pm, Patient 8's record was reviewed with HIMD and it was noted that amended items in the EMR were re-dated to the date they were amended and there was no identification that the record was an amended record. Patient 8's Face Sheet for her 8/25/14 admission included a "Diagnosis Date/Time: 9/9/2014 16:10 (4:10 pm)". HIMD stated that when the physicians amended their H&Ps or notes, the record was re-dated to the date of the amendment and was not identified as "amended." HIMD confirmed this situation caused the patients' records to be inaccurate.

b.) Patient 8's record included a nursing Admission ER Assessment, dated 8/25/14, with a section titled, "Vitals:" that was left blank.

Patient 8's record included a physicians History and Physical, dated 8/25/14, that included a "Physical Exam" section with no vital signs recorded.

Patient 8's ER Discharge Assessment, dated 8/25/14 at 8:25 pm, did not include any vital signs.

On 9/10/14 at 4 pm, RN F stated that vital signs should be part of Patient 8's ER assessment and that his record was incomplete.

4. On 9/10/14 at 2:30 pm, RN D was interviewed about the lack of care plans in the patients' EMRs. He stated, "We don't know how to do careplans. No one knows how to make one in this system...It's horrible. The company had not provided any training." When asked if hospital administration had provided any training on how to make patient care plans, RN D stated the nurses had not received that training.

On 9/10/14 at 2 pm, CNO confirmed Patients 6, 7, 8 and 9 were incomplete and had no care plans done.



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5. Patient 3's record was reviewed on 9/9/14. Patient 3's record contained a document titled, "Discharge Instructions," dated 8/30/14, this document did not contain an ordered diet upon discharge.

During a concurrent interview and record review, with the CNO on 9/11/14 at 8:30 am, she confirmed that Patient 3's discharge instructions were incomplete.

Based on interview and record review, the hospital failed to ensure that one of 28 sampled patients' records (Patient 9) included an admission assessment, to establish a baseline for staff to determine the patient's health care needs, response to treatments, medications, and interventions and to effectively determine their progress. This failure could place patients at risk for poor clinical outcomes.

Findings:

The hospital's policy, Guideline for Medical Record Entries, dated 1/2008, showed they would be factual, objective, accurate, timely (as close to the actual event as possible), late entries and addendum (added information to record at another time) would be noted as late or an addenda and authenticated.

Patient 9 was admitted to the hospital on 8/24/14 at 6 pm from the Emergency Room, with a diagnosis of "Left Neck Cellulitis (severe skin infection)."

a.) On 9/11/14, a review of Patient 9's record included an Activity Occurrences for Admission Assessment, printed 9/11/14, that showed the status of his admission assessment scheduled for 8/24/14 at 6 pm, was "Past Due."

On 9/11/14 at 10:45 am, Chief Nursing Officer (CNO) confirmed this meant there was no admission assessment in the electronic medical record for Patient 9. CNO was not able to provide evidence that nursing had assessed Patient 9 at the time of his admission into the hospital.

b.) Patient 9's record included a physicians order, dated 8/24/14, for vital signs every 4 hours.

Patient 9's Physician Notes Reports, dated 8/25, 8/26, 8/27 and 8/28/14 showed he experienced continued acute pain.

Patient 9's Vital Signs Flowsheet View Report, dated 8/24 to 8/30/14, had several blanks in the "Pain Intensity/Loc" column, that indicated his pain had not been assessed as required, when his vital signs were taken.

On 9/10/14 at 2 pm, CNO confirmed Patient 9's pain assessments were not documented and that his medical record was not complete.

Based on medical record review and staff interview, the facility failed to ensure that all entries were authenticated (signed and dated) by health care professionals in a timely manner for four of 28 sampled patients. (Patients 2, 3, 8 and 14) This failure may result in records not being properly authenticated in a timely manner.

Findings:

The following records were reviewed on 9/8 through 9/11/14;

1. Patient 2's record contained a document titled, "Operative Report," dated 8/20/14, this document was not signed or dated by the provider.

2 a). Patient 3's record contained a document titled, "Operative Report" dated 8/29/14, this document was not signed or dated by the provider.

b). Patient 3's record contained a document titled, "Discharge Instructions," dated 8/30/14, this document was not signed or dated by the provider and no diet was specified.

During a concurrent interview and record review, with the Chief Nursing Officer (CNO) on 9/11/14 at 8:30 am, she confirmed the above findings and confirmed that those records were delinquent per facility policy.

The facility's policy titled, "Medical Staff Delinquent Chart/Suspension," dated 12/16/09, indicated that providers must sign and date their discharge charts and operative reports within 14 days.



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3. Patient 14 was admitted on 12/31/13 with diagnoses that included depression, acute pneumonia, and chronic obstructive pulmonary disease. Patient 14 was discharged on 1/12/14. Review of the discharge summary dated dictated and transcribed on 2/1/14. It indicated the physician's signed on 2/22/14 at 2:30 pm.

On 9/10/14 at 8:35 am, an interview was conducted with the Health Information Management Director, she stated the discharge summary would be delinquent if not done by day seven after discharged. She acknowledged this was done after seven days.



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4. Patient 8 was admitted to the hospital on 8/25/14, with diagnoses of febrile illness (fever).

On 9/9/14, Patient 8's electronic medical record was concurrently reviewed with Health Information Management Director (HIMD). There were physicians orders that were flagged as "not signed," with a note indicated the physicians signature was not required. HIMD stated that the physicians were supposed to go in and fix the order and sign it, when it was flagged. When asked if the physicians were required to sign their orders, HIMD stated that they were but that the hospital was not enforcing the signature requirement.

Patient 8's record included a physicians telephone order, dated 8/26/14, that read, "Discharged to inpatient," to admit him from the emergency room to the hospital. The order had not been signed or dated by the physician.

Based on document review, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure all surgical procedures were performed in a safe manner by qualified practitioners, in accordance with the medical staff rules, for one of thirty one (1/31) medical records (Patient 26) reviewed. Permitting a patient to undergo surgery without a documented and qualified medical history and physical (H & P) examination, could permit surgery on a patient without recognized surgical risk factors.

Findings:

On 9/9/14, the Medical Staff Rules were requested. In these rules it is Rule 6.6, Patient Care, History and Physicals, which requires that for all surgical patients, a medical H & P examination of the patient must be completed and recorded in the medical record. Section 6.6 b) (3) specifically states, "Except in cases of life-threatening emergency, surgery shall not commence without the operating Staff Member's history and physical examination or a summary of the dictated history and physical written on the patient's chart." Rule 6.15, Surgery, goes on to state at 6.15-5 b) "The anesthetist (or the surgeon if a general anesthetic is not to be administered) shall verify the site and side of the body to be operated on, and shall ascertain that a record of the following appears in the patient's medical record: (1) An interval medical history and physical examination performed and recorded within the previous 24 hours."

On 9/10/14 at 9:00 a.m., Physician C acknowledged that the H&P was dictated just prior to surgery and could not have been in the patient's medical record before surgery. He stated that he thought that was an acceptable practice.

On 9/9/14 at 10:50 a.m., Patient 26 was interviewed in her room in the CAH and her chart was reviewed. Her chart was comprised of paper documents and a portion was recorded in the Electronic Medical Record (EMR). Neither the paper portion nor the EMR portion of her record contained an admission medical history or an interval medical H & P examination. Paper copies of Patient 26's medical record were requested at that time. In an interview on 9/10/14 at 9:45 a.m., the Health Information Management Director (HIMD) acknowledged that the admission H&P should have been on the chart, prior to the patient being taken to surgery. HIMD then contacted the transcriptionist (individual the listens a dictated recording and types medical documents) and returned with a completed paper H&P documents. She noted that the H&P had been dictated a very short time prior to the surgery.

On 9/10/14, while looking for evidence of Patient 26's H&P and other pre-surgical evaluations, the surgical log was requested and reviewed. During this review it was noted that a surgical procedure that was performed on Patient 26, on 7/30/14, was not recorded in the surgical log. During the 9/10/14 interview at 9:45 a.m. with HIMD, assistance was requested to help locate the missing surgical procedure information. HIMD was able to locate the complete out-patient endoscopic procedure record for the date of 7/30/14. The only missing information was the absence of an entry in the Surgical Log Book.

Based on staff interview and document review, the Critical Access Hospital (CAH) failed to establish and maintain a functional Periodic Evaluation and Quality Assurance Review Program to annually assess the CAH's total program evidenced by the following:

1. The CAH failed to establish an agreement with a qualified Quality Improvement Organization (QIO) and failed to have a QIO conduct an annual comprehensive sample of records and total evaluation of the CAH's total program. (Refer to Q-195 and Q-340)

2. The CAH failed to develop an effective quality assurance, quality assessment or performance improvement program designed to evaluate the quality and appropriateness of the diagnoses and treatments furnished in the CAH, and of the treatment outcomes. (Refer to Q-340)

3. The CAH failed to provide sufficient staff and properly trained staff to accomplish essential quality improvement and credentialing functions. (Refer to Q-342)

4. The CAH's Governing Body (GB) and Medical Staff (MS) failed to consider, and failed to promptly take appropriate action, when a qualified QIO made recommendations concerning need for improvement. (Refer to Q-342)

5. The CAH failed to ensure that the medical staff bylaws, rules, and credentialing/privileging policies were followed so as to assure healthcare practitioners were properly qualified, competent, and providing appropriate diagnoses and treatments. (Refer to Q-342)

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: Periodic Evaluation and Quality Assurance Review, 42 CFR 485.641.

Based on staff interview and document review, the Critical Access Hospital (CAH) failed to ensure that a comprehensive review of all provided services and treatments had been done at least annually by a qualified outside Quality Improvement Organization and failed to develop an internal Continuous Quality Improvement Program or other evaluation and review processes that were capable of such a review. The lack of such a comprehensive review of services and treatments permitted the continuance of unrecognized poor quality services.

Findings:

On 9/8/14, the CAH was asked to provide documentation of their quality review and performance improvement programs with all relevant protocols, documents of their processes, and the outcomes. The CAH's agreement with their chosen Quality Improvement Organization (QIO) and the report provided by the QIO were specifically requested.

The CAH provided two similar documents titled, "(CAH) Continuous Quality Improvement Plan (CQIP)." On each respectively, the first page had handwritten lettering which read, "Approved 2010" and "Currently in process of approval." On review, neither of these documents contained specifications for a process that would review the CAH's total program. Each contained statement of an overall general approach, but both specified very limited details:

1) The documents do not specify a starting reference point with the current state of quality, available resources, current status of treatments or outcomes, etc.;
2) The documents do not describe specific objective(s) that the CQIP aimed to achieve;
3) The only time-line information stated there will be an "Annual Evaluation;"
4) There was very limited information regarding the processes or protocols to be used;
5) On the last page was an "Improving Performance - Performance Model" that stated, "(CAH) has adopted a performance improvement model - FOCUS PDCA."

Neither of these documents indicated the plan(s) have been used in the past, with any specified outcomes. The CAH did not provide annual reports showing that they had been utilized at any time since 2010.

In an interview beginning at 10:00 a.m. on 9/10/14 with the Quality/Risk Manager (QRM), QRM was unable to provide a general overview of the CQI Program at the CAH. QRM did not have a prepared presentation and did not have available periodic reports or charts to demonstrate the program's effectiveness. QRM did not have available any data table, reports or other documentation to show that there was an "Annual Evaluation" of the overall programs in the CAH.

The CAH was unable to provide documentation that there was an agreement with a qualified outside QIO to conduct an annual comprehensive review of all the CAH's provided services and treatments. The CAH was unable to provide documentation to show that the Governing Body (GB) had been participating in overviewing or directing an effort to produce a functional CQI (Continuous Quality Improvement) Program or an annual comprehensive review of the CAH's total program.

On 9/11/14 at 10:40 a.m., the hospital's Executive Administrator (EA-1) acknowledged that the CAH did not have documentation to demonstrate that a through annual comprehensive review of all provided services and treatments had been conducted within the last year.

Based on staff interview and document review, the Critical Access Hospital (CAH) failed to develop an effective quality assurance program designed to evaluate the quality and appropriateness of the diagnoses and treatments furnished in the CAH, and of the treatment outcomes. The CAH failed to maintain a contract or other documentation of an agreement with a Quality Improvement Organization (QIO) or other appropriate and qualified entities, to provide review and evaluation of a representative sample of active and closed clinical records, or to review for and recommend quality improvements needs found. The CAH failed to participate with their contracted telemedicine services providers in collecting or reviewing practitioner performance data. The Governing Body (GB) and Medical Staff (MS) failed to conduct an internal review and evaluation to determine the quality and appropriateness of the diagnoses, treatments or outcomes in the CAH. This lack of a periodic performance review and evaluation permitted the potential for continuation of unrecognized poor quality healthcare services in the CAH.

Findings:

On 9/8/14, the CAH was asked to provide: 1) the current quality improvement or quality assurance plan, 2) documentation of an agreement(s) with qualified QIO entities and 3) documented evidence that the quality and appropriateness of diagnoses and treatments furnished at the CAH by practitioners had been evaluated.

Documents provided in response to this request included the following:

1) Two versions of the "(CAH) Continuous Quality Improvement Plan"; one version (CQIP-2010) indicated it had been "approved (in) 2010"; the other version (CQIP-2014) indicated it was "Currently in process of approval."
2) Three documents from a recognized QIO (QIO-1) titled:
a) "(CAH) Quality and Credentialing Review, May 13, 2014-Survey Agenda;"
b) a memorandum from (QIO-1) to the CAH Administrator (CEO), dated May 16, 2014, which referenced "Re: Consulting Report;" and
c) a memorandum from (QIO-1) to (CEO), dated May 20, 2014, which referenced "Re: Credentialing Review" and included "Executive Summary."
3) The CAH did not provide documented evidence that the quality and appropriateness of diagnoses and/or treatments furnished at the CAH by practitioners had been evaluated.

In an interview on 9/10/14 and again on 9/11/14 at 10:30 am with the CAH's Executive Assistant (EA-1), she stated that the CAH did not have a written contract or any other documented evidence of an agreement between the CAH and QIO-1, which stipulated the nature or specifics of services that QIO-1 would provide. EA-1 stated that she was unable to locate any invoices or any other related documentation beyond the three documents (5/13/14 survey agenda, 5/16/14 consulting report, and 5/20/14 credentialing review - executive summary) referenced above.

On 9/10/14 and 9/11/14, the three documents listed above from QIO-1 were reviewed and the following was noted:

First: In the agenda titled, "(CAH) Quality and Credentialing Review May 13, 2014," there was no time set aside for the QIO-1 representative to conduct a full review of a representative sample of clinical records to evaluate the quality and appropriateness of the diagnoses and treatments furnished in the CAH and of the treatment outcomes. The agenda only requests 33 closed medical records to be pulled for the "record review" to be conducted from 12:00 - 4:30 p.m. 33 medical records would not be a representative sample of all open and closed records, and the request does not specify a time period or interval.

Second: In the memorandum, dated 5/16/14, concerning "Consulting Report," the representative of OIO-1 did not indicate a review had been done of the quality and appropriateness of diagnoses or treatments furnished by doctors or other providers in the CAH or in out-patient clinics of the CAH.
This report specifies that the QIO-1 did not review all 33 of the clinical records that were detailed in the agenda, but did state, "I reviewed a total of twenty (20) records including emergency, inpatient, outpatient surgery and endoscopy, and swing bed records." This report did not address the "quality or appropriateness of diagnoses or treatments." The report then detailed the following (numbered here as found in the report): "1) Quality Program - External reporting": - quality indicators had been inconsistent, was incomplete and data had not been maintained; "2) Annual Report" - the 2013/2014 annual report of quality had not been completed. This report contains multiple other observed opportunities for improvement with recommendations for consideration.

Third: The memorandum, dated 5/20/14, concerning "Credentialing Review" contained an "Executive Summary" that does not indicate a review had been done of the quality and appropriateness of diagnoses or treatments furnished by doctors or other providers in the CAH or in out-patient clinics of the CAH.
Among the multiple findings listed, the Executive Summary contained at least three significant opportunities for improvement in the credentialing and privileging procedures which follow:
1. There were inconsistencies within the credentialing process and other governance processes specified in the medical staff bylaws and rules.
2. There was considerable variability and lack of consistent documentation of chart review, with some departments or clinics reviewing up to 10% of charts and others with no specified number or percentage of charts to be reviewed.
3. The report called attention to a contracted tele-medicine entity that provides tele-radiologists to provide services in the CAH without exchange of ongoing professional proficiency review (peer) data information between the CAH and the entity. It then called attention to the requirements and interpretive guidelines at CFR 485.616 (c) (3) and 485.641 (b) (4).
The Executive Summary concluded most sections with specific "Recommendations for Consideration" such as the following examples:
* "Review job responsibilities and revise if necessary to ensure sufficient time is allocated to medical staff credentialing and privileging."
* "Develop expanded bylaws section for telemedicine."
* "Review all (medical staff credential) files to ensure all information is current."
* "Develop process for review of at least 10% of Hospital records for each provider."
* "Develop process to ensure external review for (a named specialist without a local peer)."
* "Review potential of contracting for external peer review."
* "Implement requirements (for specific privileges) as soon as possible."

In an interview on 9/10/14 at 4:30 p.m. the Medical Staff Coordinator (EA-1) acknowledged that the CAH had not yet put in place corrections similar to those recommended by QIO-1.

The CAH provided for review all of the key committee meetings occurring in 2013 and 2014. These minutes for the Governing Body (GB), the Medical Executive Committee (MEC), and the Continuous Quality Improvement, Risk Management and Compliance Committee (CQI) were reviewed on 9/9/14, 9/10/14 and 9/11/14. During the late morning and afternoon of 9/11/14, this ongoing review was conducted concurrently with the assistance of the CAH's Executive Assistant (EA-1). EA-1 was also the Medical Staff Coordinator and had transcribed many of these minutes. During this document review and interview with EA-1 on 9/11/14 beginning at 10:40 a.m., the following was noted: None of the MEC or GB minutes contained statements that action was taken relative to CQI, review of the two (2) reports, referenced above, from QIO-1, or any other actions which appeared relevant to performance review or quality improvement. EA-1 acknowledged that the minutes did not have clear statements that action on these topics had been taken. EA-1 stated that she was sure the reports for QIO-1 had been presented to both the MEC and the GB, but was unable to locate where that was documented in the minutes. When asked if the MEC or GB had considered or taken action with regard to the recommendations listed in these documents, she stated that some actions had been started, but this was not well documented and none had yet been completed.

On 9/10/14 and 9/11/14, the CAH's two documents titled, "Continuous Quality Improvement Plan," versions approved in 2010 (CQIP-2010) and to be approved in 2014 (CQIP-2014), were reviewed. There were no specified plans or any details to indicate that a representative sample and review of either active or closed clinical records was to be done to determine the quality and/or appropriateness of diagnoses and/or treatments furnished by doctors and other practitioners in the CAH or in out-patient clinics of the CAH. There was no reference to any QIO or other qualified external entities to be involved in any aspect of quality assessment, credentialing review, record review or any specification of the planned processes detailed in the plans. It was noted that the only changes found in CQIP-2014 compared to CQIP-2010 was that the names used for the CAH, related departments, individuals and its governing body had been updated.

On 9/10/14, the CAH provided statistics about the number of hospital admissions, emergency visits, surgical procedures, and clinical visits that had occurred in 2013 and earlier in 2014. This data was again provided after the survey on 9/16/14. There were 351 acute care hospital admissions in 2013 and 192 from January through August in 2014. There had been 4,320 emergency room visits in 2013 and 3,011 in the first 8 months of 2014. There had been 149 surgical or endoscopic procedures done (both in-patient and out-patient) in 2013 and 74 cases in the first 8 months of 2014. In 2014, there had been 4,439 clinic visits in the distant out-patient clinic located in a neighboring community, and 3,276 visits there in the first 8 months of 2014. In the out-patient clinic adjacent to the CAH, in 2013, there had been 9,644 visits and 7,295 visits in the first 8 months of 2014. The sum total of in-patient and out-patient visits, ER visits, admissions or surgeries in 2013 was 18,903, and in the first 8 months of 2014, was 13,848. The review of 20 clinical medical records on 5/13/14 by the QIO-1 representative did not constitute a representative sample and was not reported to have been a review for the quality and appropriateness of diagnoses, treatments or outcomes.

On 9/10/14, the CAH was asked to provide documentation to demonstrate that a representative sampling of clinical records had been evaluated to determine if the diagnoses and treatments provided by practitioners had been appropriate and justified. The CAH was unable to provide documentation to demonstrate that such a quality review had been conducted, reviewed by the governing body, or had been utilized in an effort to continuously improve quality. On 9/11/14, in an interview with the Medical Staff Coordinator (EA-1) at 10:30 a.m., she acknowledged that the CAH was unable to provide documentation of a comprehensive review of a representative sample of clinical records which did an evaluation to see if the diagnoses and treatments of all providers were both appropriate and justified. She went on to comment that 5 to 10 % of the clinical charts were reviewed by two selected physicians (Physician A and Physician D) to evaluate the performance of the allied health practitioners in the CAH's out-patient clinics. She stated that a percentage of emergency room records were reviewed by the Emergency Room Medical Director (Physician B), but she was not certain those evaluations always included the quality and appropriateness of diagnoses and treatments. She stated that the medical staff was not current on their peer review. She acknowledged that the medical staff had no system to evaluate the performance of tele-radiologists or other practitioners providing services via telephonic communications; and that the CAH had not received any performance data from these contracted services providers. EA-1 had no metrics (performance data) of the Allied Health Practitioners, the Emergency Room Physicians, tele-medicine providers or other Medical Staff members to demonstrate that their diagnostic and therapeutic performances had been monitored, evaluated, and tracked over time.

Based on interview and document review, the Critical Access Hospital (CAH) failed to maintain documentation of a functional Continuous Quality Improvement (CQI) program which had evaluated the quality of services being provided; failed to consider any results and any available evaluations, including any findings or recommendations by qualified Quality Improvement Organization(s) (QIO), and failed to have data available to show that improvements had been achieved and maintained. The lack of a functional CQI program permitted the potential for patient harm, due to unrecognized inadequate healthcare.

Findings:

On 9/10/14 at 10:00 a.m., the Manager of Quality and Risk Management (QRM) was interviewed in her office. QRM explained that she had worked in the CAH as a Registered Nurse for many years, but only 9 months ago had been put in charge of Quality and Risk Management. QRM stated that she had not had prior training or experience in Quality Improvement or Risk Management. QRM stated she was to have had some training, but because of the CAH's nurse staffing needs she had not yet been able to attend any training, and she expressed frustration with the fact that she had many other duties, which prevented her from accomplishing all of her quality and risk management duties. QRM's only training to date consisted of a former CAH employee that had provided on the job training, one day per week for 6 months. QRM acknowledged that she has been unable to keep up with all of her Quality and Risk Management assignments because she had daily nursing assignments on the adjacent acute care nursing unit.

During this interview, QRM was asked to present and explain the facility's Continuous Quality Improvement program, and to demonstrate examples of how it had been effective. QRM was asked to provide data on the quality or performance indicators that the CAH had been tracking and the reports or other documentation that was being provided to the Medical Executive Committee (MEC) and the Governing Body (GB). QRM stated she had not previously been asked for similar information and had not prepared an overview presentation for the CQI Program. QRM did not have quality data tables, dashboards or other graphics to show the CAH's quality trends. QRM did not have a prepared list of the indicators being tracked.

Later on 9/10/14, at 1:45 p.m., QRM provided 2 type-written pages of 26 short phrases titled, "List of quality indicators." QRM stated that this list was newly prepared and that she did not have a complete list of data for the listed Quality Indicators (QIs). QRM stated that she regularly "has asked for info (data) from all the departments, but hasn't gotten responses from all." QRM acknowledged that she was in charge of collecting and organizing the QI data, however, she had not previously put together a complete list of all the QIs, from all of the departments. QRM acknowledged she had a lot of work yet to do in collecting and compiling the QI data. She did not have detailed information about how the 26 QIs had been selected, how the various QIs were to be evaluated, or what improvements were being targeted. QRM had never previously written a report or presented data on the QIs or the CQI Program. When asked again for an example of how the QIs or the CQI program in general had been effective in bringing about improvements, QRM stated that she was unaware of any such examples.

The CAH provided two reports, dated 5/16/14 and 5/20/14, from a qualified QIO (QIO-1) that had conducted, on 5/13/14, a brief review of 20 medical records and the available documentation concerning the credentialing and privileging processes for Medical Staff (MS) members and Allied Health Practitioners (AHP). In the 5/20/14 report, titled, "Executive Report," there were seven (7) different sets of "Recommendations for Consideration" for improving the processes of credentialing or privileging or to improve compliance.

On 9/10/14 at 2:25 p.m., the Medical Staff Coordinator, also the Executive Assistant (EA-1) was asked, in general, about the credentialing and privileging processes. She stated that not all of the MS members had been cooperating and that one member (Physician C) had been delinquent in submitting his reappointment application and related documents. As a result, the MEC had to recommend and the GB had to grant him temporary privileges, which was contrary to the MS Rules and Credentialing/Privileging Policies.

On 9/10/14 at 2:25 p.m., EA-1 was asked if the MEC or GB had considered the recommendations for improving the credentialing/privileging processes that were in the 5/20/14 "Executive Report" by QIO-1. EA-1 stated that she and other administrative staff members had begun working on some of the recommendations, "such as amending the MS Bylaws." However, much of that had preceded the report. On 9/11/14 beginning at 10:40 a.m., during an interview and concurrent review of MEC and GB minutes, EA-1 acknowledged that neither sets of minutes, MEC nor GB, contained documentation that the recommendations from QIO-1 had been a topic of discussion or that action had been taken regarding improvements in the credentialing/privileging processes. EA-1 acknowledged that neither set of minutes had action items concerning any aspect of the CQI Program or CQI Plan.

Based on staff interview and document review, the Critical Access Hospital (CAH) failed to write and implement written protocols with respect to organ, tissue and eye donation, as evidenced by the following:

1. The CAH had no written protocols or evidence that CAH staff members had been properly trained in cooperation with the Organ Procurement Organizations (OPO) (Refer to C 347 and C 349);

2. The CAH had no written protocols or evidence that all patients and families had been properly informed of the option to donate or not donate organs or tissues (Refer to C 347 and C 349);

3. The CAH had no written protocols or evidence that on-site trained requestors were designated to initiate requests or facilitate communication with the families (Refer to C 347 and C 349);

4. The CAH had no evidence that staff members had been trained and had always exercised discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors (Refer to C 347 and C 349); and

5. The CAH had no written protocols or evidence that death records and results of referral statistics had been reviewed to evaluate if improvement was needed (Refer to C 347 and C 349).

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: Organ, Tissue, Eye Procurement.

Based on interview and document review, the Critical Access Hospital (CAH) failed to develop written protocols and enact a means to ensure that: 1) CAH staff members were trained, 2) that the family of each potential donor were informed of the option to either donate or not donate organs, tissues, or eyes and 3) the first person to initiate the request with the family be a trained designated requestor. This deviancy could potentially cause such patients or families to be approach in an improper manner or to receive incomplete or inaccurate information.

Findings:

On 9/9/14 at 8:55 am, during an interview with the Chief Nursing Officer (CNO) she stated that the CAH had not trained or designated a "Designated Requestor," and the task of requesting donations was always done by the Organ Procurement Organization's (OPO) coordinator; that individual was employed by the OPO and was not present in the CAH. The CNO also acknowledged that the OPO had not trained the CAH's nursing staff and the only related information provided to nursing staff members' was the policies which were given to them during their orientation at the time they were first hired. She acknowledged that the CAH had not trained the staff about the information they were to share with the families of potential donors and that no hospital staff members had been trained to be on-site facilitators or trained and assigned to be "Designated Requestors." (The term "Designated Requestor" refers to an individual who had completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation.)

On 9/10/14, review of the two policies and procedures documents pertaining to Organ, Tissue, Eye Procurement: Titled respectively, "Tissue Donations for Transplants" and "Organ and Tissue Donation," showed that: 1) there was no specifications instructing that the families of potential donors were to be informed of the option to either donate or not donate organs, tissues, or eyes, and 2) there was no specifications instructing any evaluation to assure that all families had received such information.

On 9/10/14 at 3:40 pm, Registered Nurse (RN) A was interviewed at the nursing station concerning how to care for patients and families when the patient was approaching death. She explained that she had been employed at the CAH for 3 months; that she had not received any formal training concerning how to approach patients or families concerning organ donation; and that she had seen a policy about the topic when she was first orientated. She explained that she would provide as much information as she could to the family and patient, and then would consult the policy for more information about who to contact and which forms to complete. She stated she was not certain where to find the relevant policy; if that situation occurred she would ask a co-worker were to find the policy and any needed documents.

On 9/11/14 at 10:40 am, RN G was interviewed concerning end of life care for patients and their families. She stated she had been employed at the CAH for many years. She also stated that she had never had any formal training concerning how to approach patients or families regarding organ donation. She also would provide the initial information to either a patient and/or family and then would locate the paperwork to follow any instructions on the form. She stated that the form did have the proper phone number to contact the OPO who would give more detailed instructions.

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure that it worked cooperatively with the designated Organ Procurement Organization (OPO), tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes took place. The result was that staff members did not have sufficient knowledge to perform related tasks and the CAH had not tacked performance data to ascertain if performance improvement was needed.

Findings:

On 9/8/14, the CAH was asked to provide the policies, contracts and performance data related to organ procurement. Two (2) contracts and two (2) policy and procedure documents were provided. Review of each contract, one with California Donor Network (CTDN)
and the other with California Transplant Bank (NCTB) specified that the OPO and CAH would exchange information and cooperate in training the CAH staff. The CAH was to provide timely information about pertinent patients at or near the time of death and the OPO would provide to the CAH quarterly and annual referral/donation statistics reports.

The two policy and procedure (P/P) documents were titled, "Tissue Donations for Transplants" and "Organ and Tissue Donation." Each document covered the same topics, had similar heading, but gave slightly varying instructions for the processes to be followed. Each indicated it had been written some (unspecified) time before 3/2000 and last reviewed and approved by the Governing Body (GB) on 9/3/2013.

Review of these two documents revealed the following:
a. Each of the two P/P documents was written in a manner that would facilitate that paperwork be properly filled out, however neither appeared to assure that the families of potential donors would be provided with necessary information;

b. In only one of the two documents, ("Tissue Donations for Transplants" at "Procedure 1.A.2") was one short statement cautioning that "discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors." The P/P did not provide guidance designed to assist the staff in understanding how to provide this discretion and sensitivity;

c. Neither P/P document specified that hospital staff members were to be trained in any aspect related to tissue and organ procurement;

d. Neither specified that an OPO would assist in the training of staff members;

e. Neither specified that on-site staff member(s) should be trained to be "designated requestor(s)" or specified that hospital staff members would be trained in the methodology for first approaching potential donor families and requesting organ or tissue donation;

f. Neither specified how the off-side OPO coordinator would be able to provide the families with the needed care and information in the absence of an on-site, trained, hospital staff member to facilitate communications with the families;

g. Neither specified anything about reviewing death records or statistical report provided by the OPOs; and

h. Neither document contained specifications about maintaining potential donors (or bodies) while necessary testing and placement of potential donated organs, tissues, and eyes took place.

In an interview with the Chief Nursing Officer (CNO) on 9/9/14 at 8:55 am, she stated that the nursing staff had not received any training in conjunction with the OPOs. She stated that the nurses received a copy of the relevant policies at the time of their initial orientation, but no other formal training. She stated that during the "past several years (~24 months) the nursing staff had not had any related training and that she had not contacted either CTDN or NCTB to request assistance for training. During this interview she stated that she did not know of any reporting/referral statistic that the CAH had kept or that had been received from either CTDN or NCTB.

In another interview concerning organ procurement requirements, on 9/10/14 at 11:30 am, the CNO stated that she had just learned that the Health Information Management Department had been receiving quarterly or monthly reports from one of the OPOs. She acknowledged that: 1) this information had not previously been conveyed to her; 2) that the data had not been incorporated into the Quality Assessment and Performance Improvement (QAPI) program (also referred to as Continuous Quality Improvement [CQI] program); and 3) that to her knowledge the information had not been reviewed or otherwise used to track or improve the CAH's reporting/referring performance. During this interview, copies of these reports were requested for review; however the reports were not provided during the survey.