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Based on observation, record review, review of facility policies and procedures, review of admission information provided to patients, review of patient grievances, and staff interview, the hospital failed to protect and promote each patient's rights by failing to allow patients to make informed decisions regarding his or her care (code level status) (Refer to A131); failed to provide privacy and dignity for a patient while completing an assessment on the patient (Refer to A143); failed to establish a comprehensive procedure for abuse/neglect prohibition and failed to thoroughly investigate an allegation of sexual abuse (Refer to A145). These failures violated patient's rights and placed all patients at risk of experiencing abusive situations, being treated in an undignified manner, and not being allowed to make decisions regarding their own care.

Based on policy review, record review, and staff interview, the Hospital failed to follow the patient's wishes pertaining to code level status for 1 of 6 closed inpatient records (#16). Failure to follow Patient #16's wishes regarding preferred code level status is a violation of that patient's rights.

Findings include:

- Review of the policy, "Code Level Directives," occurred on 05/08/14. This policy, effective June 2012, stated, "Patients or their authorized decision-makers have the right to choose or refuse treatment, including cardiopulmonary resuscitation. Sanford Medical Center Fargo and Sanford South University uses two Code Levels to specify whether or not cardiopulmonary resuscitation should be administered in case of cardiac or respiratory arrest.
*Code Level 1 refers to full CPR [cardiopulmonary resuscitation] resuscitation (sic)
* Code Level 2 refers to no CPR . . .
DEFINITIONS: . . .
* Code Level 2: Equivalent to DNR [Do Not Resuscitate] . . .
PROCEDURE: A. Code Levels . . . 4. Code level status will be reviewed and changed . . . according to changes in patient's wishes. . . ."

- Review of Patient #16's closed records occurred on May 7-8, 2014. The Hospital admitted Patient #16 on 11/07/12 for right total knee arthroplasty and discharged the patient on 11/11/12 at 1:15 p.m. to a care facility for rehabilitation. Near midnight on 11/11/12, the care facility transferred Patient #16 to the Emergency Department (ED) because of fever and vomiting. The Transfer/Discharge Report sent with the patient to the ED identified her as a "Code Level 1," meaning full CPR.

Review of a Physician Progress Note, dated 11/13/12 at 11:18 a.m., identified Patient #16 with a code status of "DNR." The medical record contained no information to indicate the physician visited with the patient about the code level status or the patient requested a change in code level status from Code Level 1 to Code Level 2 (DNR).

During an interview on 05/08/14 at 10:00 a.m., an administrative risk management staff member (#29) did not provide additional information regarding the change in Code Level Status for Patient #16.

Based on observation, record review, review of admission information provided to patients, policy and procedure review, and staff interview, the Hospital failed to provide privacy and dignity for 1 of 1 sampled inpatient (Patient #14) observed during a National Institutes of Health Stroke Scale (NIHSS) assessment. Failure to close the door during the assessment, knock and wait for a response before entering the room, and speak in a dignified manner did not ensure Patient #14's privacy and respect.

Findings include:

On the afternoon of 05/05/14, the Hospital administrative staff provided a copy of the information given to patients at the time of admission to the Hospital. The information included a form titled, "SANFORD HEALTH PATIENT BILL OF RIGHTS AND RESPONSIBILITIES." This form, revised April 2012, stated on page 16, ". . . Respecting your privacy . . . We will give you private places for exams and talks with doctors and staff. . . ."

Review of the hospital policy titled "Patient Bill of Rights and Responsibilities" occurred on 05/08/14. This policy, dated April 2012, stated, ". . . Policy: It is the policy of Sanford to support and care for all patients in a manner and in an environment that promotes quality of life with emphasis placed on dignity . . . As a Patient, You have the Right To: * Receive kind and respectful care. . . ."

Review of Patient #14's active medical record occurred on 05/07/14 and identified the Hospital admitted the patient on 05/05/14 for an acute stroke.

Observation on 05/07/14 at 2:15 p.m. showed the door to Patient #14's room open and a nurse (#8) measuring the patient's blood pressure. The nurse stated to the patient, "[I'm] going to do a stroke scale, ok? We're looking for field cuts." The nurse asked Patient #14 to focus on her nose (nurse's nose) and tell her if she could see her finger. The patient became upset and stated she didn't understand field cuts. The nurse used other words to describe the test such as peripheral vision and neurological test. The nurse (#8) attempted to calm Patient #14 down and called her "honey." The patient stated, "Don't call me honey! My name is [full name]!" At 2:30 p.m., a physician entered Patient #14's room and the nurse (#8) exited. The physician sat down and visited with the patient and after a few minutes, stood and closed the door to the room to conduct an assessment. The nurse (#8) entered Patient #14's room twice without knocking during the time the physician conducted the assessment.

Review of a nursing progress noted, dated 05/07/14 at 3:34 p.m., stated, "Attempted to complete NIHSS with patient. She started off okay with the exam and as exam went along she became very verbal, mad stating 'you are trying to make it look like I can't see your fingers.' I explained the reason for the test and what we were looking for and that this is a base line test just in case her symptoms became worse. She wouldn't stop saying I was doing wrong to her. I told her we would stop the exam because she was very angry and upset. I told her we would continue at a later time."

During an interview on 05/08/14 at 9:45 a.m., a nurse manager (#9) stated she expected the nurse to shut the door during the assessment and knock before entering the room. She stated when Patient #14 became upset with the nurse (#8), the nurse should have left the room and gotten another nurse to complete the assessment.

Based on review of patient grievances, policy review, and staff interview, the Hospital failed to establish a comprehensive procedure for abuse/neglect prohibition and failed to thoroughly investigate 1 of 1 patient allegation of sexual abuse (Patient #17). Failure to investigate allegations of abuse placed all patients at risk of experiencing abusive situations.

Findings include:

Review of the policy "Complaints/Grievance Process" occurred on 05/06/14. This policy, created January 2014, stated, "Grievance Procedure Submission of Grievances: . . . 4. Staff should initiate abuse/neglect protocols respective to their regional site for grievances involving allegations of abuse or neglect. . . ."

Review of the policy/procedure "Adult Abuse and Neglect" occurred on 05/06/14. This policy, revised March 2014, failed to address suggested components necessary for a comprehensive abuse protection protocol. Among the missing components in this procedure was investigation into allegations of abuse or neglect.

Review of patient grievances for the past three months occurred on 05/05/14. A grievance, dated 04/29/14, stated, "Pt [patient] stated that this event involved a CNA [certified nurse aide] that works on the floor. . . . Pt stated that on 04/28/14 in the afternoon after the pastor had visited and told the aide to help the pt get dressed and washed up that this person had become 'aggressive with her hands and tried to masturbate me.' Pt stated he told her to 'back off' and she did for a couple minutes but then came back and proceeded again. Pt then stated that she [CNA] had later told his son that 'I don't think your father likes black women.' "

On 05/06/14, an interview occurred with risk management and patient representative staff members (#29, #31, and #32). When asked about the above grievance, the risk management staff member (#29) confirmed the Hospital did not interview Patient #17 until seven days after the incident and did not interview the patient's son (identified in the grievance) regarding the above allegation of sexual abuse. This staff member indicated she had not considered interviewing the son.

When asked about the interview that occurred with Patient #17 seven days after he alleged sexual abuse, the Patient Representative (Staff #31) said she did not ask the patient about the alleged abuse, but asked "in general terms" about his care. This staff member said the Patient did not bring up any concerns, and she did not mention the sexual abuse allegation.

When asked about an interview with the alleged nurse aide, a risk management staff member (#29) indicated she did not interview the alleged staff member, but the nurse manager for that unit talked with that staff member and removed the staff member from working with Patient #17. When asked what was learned from the alleged staff member, the risk management staff member (#29) did not know. She indicated the nurse manager had not documented the interview with the alleged staff member. When asked, this risk management staff member (#29) said she looked at this incident as a grievance, not an allegation of sexual abuse.

Based on record review, review of admission information provided to patients, review of professional reference, review of facility policy, and staff interview, the Hospital failed to ensure a Registered Nurse (RN) supervised and evaluated the effectiveness of medications given to patients on an as needed (prn) basis for 5 of 30 active patient records (Patient #6, #15, #18, #19, and #20) reviewed.

Failure to evaluate the effectiveness of prn pain medications in a timely manner and before administering another medication for pain control limited the RN's ability to assess whether the medication achieved the desired effect or if the patient experienced any side effects or adverse reaction from the medication.

Findings include:

On the afternoon of 05/05/14, the hospital administrative staff provided a copy of the information given to all patients at the time of admission to the hospital. This information included a booklet, dated October 2013, titled "Your Stay at Sanford." On page 9, "Making a Pain Control Plan," stated, ". . . Good pain control requires you and the health care team to work together. Here is what your health care team will do:
*We will ask about your pain. You will be asked to rate your pain on a scale of zero to ten, zero being no pain and ten being the worst pain you have had. [Other levels of pain listed in the margins on this page include mild pain level 1-3, moderate pain level 4-6, severe pain level 7-10.]
*We will offer a treatment plan to control your pain.
*We will check your pain after a treatment to see if you feel better.
*We will help you understand about pain and the pain control options that are are available to you. . . ."

Review of the hospital policy "Pain Management" occurred on 05/08/14. This policy, revised March 2013, stated,". . . PURPOSE: To guide Sanford Medical Center Fargo staff in managing pain in an interdisciplinary approach across all settings and patient populations. This policy is intended to provide basic guidelines of individualizing the plan of care for patients with pain; it is not inclusive and other resources should be explored when this policy is not effective in assessing and managing pain. POLICY: 1. Health care professionals are obligated to provide pain management and comfort to all patients within their scope of practice . . . 6. Reassessment of the effectiveness of a pain intervention occurs with a clinically appropriate time frame (dependent upon i.e. the type of pain, type of intervention, care setting); . . ."

Kozier & Erb's "Fundamentals of Nursing, Concepts, Process and Practice," 9th Edition, dated 2012, page 1229, stated, "CLIENT WITH PAIN . . . NURSING RESPONSIBILITIES: Assess pain prior to and 60 minutes after administration [of pain medication] . . ."

- Review of Patient #6's active medical record occurred on May 7-8, 2014. The hospital admitted Patient #6 on 05/02/14. Medical diagnoses included colitis and Clostridium difficile.

Review of Patient #6's pain assessments from May 3-4, 2014 showed the patient rated his pain at "4-5" (moderate pain).

PRN pain medication orders for Patient #6 included:
- Acetaminophen (Tylenol) 650 milligrams (mg) every six hours for mild pain intensity rating of 1-3 ordered on 05/02/14.
- Oxycodone (Oxy-IR) 5 mg tablet every four hours for moderate pain ordered on 05/02/14.

Patient #6's received prn Oxycodone on 05/03/14 at 7:09 p.m. and on 05/04/14 at 2:17 a.m., 9:00 a.m., 1:05 p.m., and 6:44 p.m. Patient #6 received prn Acetaminophen on 05/04/14 at 9:33 p.m.

Nursing documentation to evaluate Patient #6's response to the above PRN pain medications stated the following:
* 05/03/14 at 8:30 p.m. ". . . Pt [patient] denies pain at this time. . . ." Nursing staff documented the effectiveness/response of this medication one hour 21 minutes after medication administration.
*05/04/14 4:30 a.m. "Pt reporting pain in legs. PRN Oxycodone 5 mg administered. Pt sleeping on pain re-assessment . . . ." Nursing staff documented the effectiveness/response of this medication two hours and 13 minutes after medication administration.
* 05/04/14 at 9:00 p.m. ". . . Pt received Oxycodone 5 mg prn from previous nurse [at 6:44 p.m.]. Resting in bed with eyes closed . . . ." Nursing staff documented the effectiveness/response to this medication two hours and 16 minutes after medication administration.

Patient #6's record lacked evidence nursing staff reassessed the patient after administering the following prn medications: Oxycodone on 05/04/14 at 9:00 a.m. and 1:05 p.m. and Acetaminophen on 05/04/14 at 9:33 p.m.

During interview on 05/08/14 at 9:30 a.m., an administrative nurse (#13) stated she expects the nursing staff to reassess the effectiveness of a prn medication "within a reasonable timeframe" depending upon the route of administration and type of medication provided to the patient. When asked to be more specific as to what constitutes a "reasonable timeframe," this administrative nurse stated "within one hour."



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- Review of Patient #15's medical record occurred on 05/07/14. Diagnoses included an occipital wound infection. Pain medications included Lyrica (an anticonvulsant used to treat peripheral neuropathy) 100 mg three times a day, Tylenol 325-650 mg every four hours PRN, Percocet (a combination of oxycodone and acetaminophen for moderate to severe pain) 5/325 mg one to two tablets every four hours PRN, and Tramadol (for moderate to severe pain) 50 to 100 mg every 6 hours PRN.

Review of Patient #15's Medication Administration Record (MAR) and pain assessments identified the following:
*05/02/14 - Percocet administered at 11:00 a.m. - the nurse reassessed the patient's pain at 3:07 p.m. (four hours later) and administered Percocet again. At 5:24 p.m. (2 hours and 15 minutes later), the nurse reassessed the patient's pain and administered Tramadol.
*05/04/14 - Patient #15 received Percocet at 1:00 a.m. and Tramadol at 1:22 a.m. (22 minutes later); Tramadol at 2:10 p.m. and Percocet at 2:45 p.m. (35 minutes later). On both occasions the nurse failed to allow the first medication to take effect before administering the second medication.
*05/05/14 - Percocet administered at 4:38 p.m. - the nurse reassessed the patient's pain at 9:36 p.m. (five hours later) when the patient received Tramadol.
*05/06/14 - Percocet administered at 3:11 a.m. - the nurse reassessed the patient's pain at 5:26 a.m. (two hours and 15 minutes later) when the patient received Tramadol.
*05/07/14 - Percocet administered at 1:29 a.m. - the nurse reassessed the patient's pain at 6:06 a.m. (four and a half hours later) when the patient received Percocet again.

During an interview on 05/08/14 at 10:50 a.m., the charge nurse (#11) stated she would wait at least one hour after administering a pain medication to evaluate its effectiveness and then administer additional medication if necessary.



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- Review of Patient #18's active medical record occurred on 05/08/14 and identified the Hospital admitted the patient on 05/05/14 for labor. The record showed physician orders for hydrocodone/acetaminophen (used to treat moderate pain) 7.5/325 mg one to two tablets every four hours prn. Review of the patient's record showed nursing staff administered the medication on 05/06/14 at 9:36 p.m. with reassessment completed at 2:31 a.m. (five hours later); and on 05/07/14 at 8:49 a.m. with no reassessment completed.

- Review of Patient #19's active medical record occurred on 05/08/14 and identified the Hospital admitted the patient on 05/06/14 for labor. The record showed physician orders for hydrocodone/acetaminophen 5/325 mg one to two tablets every four hours prn. Review of the patient's record showed nursing staff administered the medication on 05/07/14 at 9:31 a.m. and reassessed Patient #19 at 2:04 p.m. (nearly five hours later).

- Review of Patient #20's active medical record occurred on 05/08/14 and identified the Hospital admitted the patient on 05/05/14 for severe pre-eclampsia. The record showed physician orders for Norco (used to treat moderate pain) 10/325 mg one tablet every four hours prn. Review of the patient's record showed nursing staff administered the medication on 05/06/14 at 12:19 a.m. and 9:24 p.m., and on 05/08/14 at 6:27 a.m. with no reassessment completed; and on 05/06/14 at 1:51 p.m. with reassessment completed at 4:00 p.m. (two hours later).

During an interview on 05/08/14 at 11:10 a.m., a nurse (#12) stated according to Hospital policy, reassessment of the patient after administration of a prn medication should occur within a reasonable amount of time, but did not specify "reasonable."

Based on observation and staff interview, the Hospital failed to ensure the safety of patients by failing to secure 1 of 1 therapeutic pool area (Main Campus Outpatient Physical Therapy) when unattended. Failure to ensure the security of the therapeutic pool area when unattended by staff placed patients and visitors at risk of entering the pool without supervision and experiencing injury.

Findings include:

Observation on 05/05/14 at 4:00 p.m., in the outpatient physical therapy area of the Hospital's Main Campus, identified a therapeutic pool area which included a swimming pool greater than four feet in depth, a whirlpool area, and a treatment area.

Upon approaching this enclosed area, a physical therapy management staff member (#17) reported the area was locked and he left to get the "key." During the staff member's (#17) absence, the surveyor opened the door without a key. A Hospital compliance staff member (#18) was present and observed the door opened without a key.

The therapeutic pool area is located at the end of a hall out of direct contact with the remainder of the physical therapy department. Patient locker rooms are located immediately outside the door entering the pool area. The physical therapy management staff member (#17) reported patients use the locker rooms to change clothes before and after treatment sessions.

During interview, on 05/08/14 at 10:00 a.m., the Hospital compliance staff member (#18) reported the Hospital did not have a policy or procedure for securing or monitoring the therapeutic pool area when not in use.

Based on observation, policy and procedure review, and staff interview, the Hospital failed to ensure secure storage of oxygen cylinders in 1 of 2 magnetic resonance imaging (MRI) areas observed (Open MRI unit). Oxygen cylinders may become a missile if the stem becomes dislodged during a fall. Failure to secure the oxygen cylinders placed patients, staff, and visitors at risk of injury.


Findings include:

Review of the Hospital policy and procedure "Medical Gas - High Pressure Cylinders" occurred on 05/08/14. This document, revised January 2012, stated, "PROCEDURE . . . 7. Cylinder Use . . . c. Cylinders will not be left free standing or lying on the floor . . . without a securing device. . . ."

Observation on 05/07/14 at 10:40 a.m., at the Open MRI unit, identified two "E" size oxygen cylinders stored upright in a storeroom. The facility failed to secure the cylinders to the wall or any other device. The storeroom was located adjacent to the MRI room and a patient waiting room.

During interview, on 05/07/14 at 10:40 a.m., a radiology management staff member (#15) and a MRI supervisory staff member (#16), confirmed the Hospital should secure oxygen cylinders.

1) Based on observation, policy and procedure review, and staff interview, the Hospital failed to follow professional standards of care regarding infection control practices during observations of patient care on 3 of 4 days of survey (May 5-7, 2014). Failure to follow established infection control practices may allow transmission of organisms and pathogens from patient to staff, to other patients, or to visitors; and from one environment to another.

Findings include:

Review of the policy titled "Hand Hygiene Policy" occurred on 05/08/14. This policy, revised August 2012, stated, ". . . PROCEDURE: . . . 1. Indications for handwashing and hand antisepsis.
A. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, wash hands with either a non-antimicrobial soap and water or an antimicrobial soap and water . . .
C. Decontaminate hands before having direct contact with patients . . .
F. Decontaminate hands after contact with a patient's intact skin . . .
G. Decontaminate hands after contact with body fluids or excretions, mucous membranes, nonintact skin, and wound dressings if hands are not visibly soiled.
H. Decontaminate hands if moving from a contaminated-body site to a clean-body site during patient care.
I. Decontaminate hands after contact with contaminated equipment.
J. Decontaminate hands after removing gloves. . . ."

Review of the policy titled "Isolation - Contact Precautions" occurred on 05/08/14. This policy, revised July 2013, stated, ". . . DISEASES: . . . Multi-drug Resistant Organism (infection or colonization) . . . 1. Methicillin resistant Staph aureus (MRSA) . . .
PROCEDURE: . . . Dedicate patient care equipment to the patient to avoid sharing between patients when possible. Disinfect prior to use with another patient . . . If precautions are due to infection or colonization with a DRO [drug resistant organism], equipment must be dedicated to the patient. . . ."

Review of the policy titled "Accucheck Inform Blood Glucose Monitor" occurred on 05/08/14. This policy, revised July 2013, stated, ". . . Patient Test: . . . 14. When the blood is applied correctly to the strip, an hourglass will appear on the display for 26 seconds while waiting for the result . . . 16. Remove the test strip from the meter and discard the test strip and lancet in a biohazard sharps container . . . 18. Remove and dispose gloves. 19. Wash hands . . . 21. Clean the meter with SaniCloth wipe per maintenance section below . . . MAINTENANCE: 1. The outside of the meter is to be cleaned/disinfected between all patient testing. . . ."

- Observation on 05/05/14 at 3:00 p.m. showed two nurses (#21 and #22) assisted a physician (#23) as he inserted Patient #27's central line under sterile procedure. One nurse (#21) stated the patient had MRSA and required contact precautions. After the procedure, the physician (#23) retrieved his pager from the patient's dresser and used his hands to wipe the pager with alcohol sanitizing foam.

During an interview on the afternoon of 05/05/14, a nurse (#21) stated staff should disinfect non-disposable equipment with SaniCloths stored in each patient's room.

- During observation on the morning of 05/06/14, a nurse (#5), upon completion of an infusion of platelets, disconnected the unit with tubing from Patient #1's main intravenous line. The nurse placed the bag and tubing inside a Ziploc plastic bag and sealed the bag. The nurse removed her gloves and failed to perform hand hygiene. The nurse laid the Ziploc bag on top of the cart with the computer, completed an entry in the medical record, picked up the bag, and exited the room. The nurse disposed of the bag in a red waste container in a utility room. The nurse proceeded to continue nursing tasks without completing hand hygiene.

- During an observation on 05/06/14 at 10:15 a.m., a certified nursing assistant (CNA) (#27) entered Patient #25's room, placed a glucometer carrying/supply case on the patient's bedside table, and tested Patient #25's blood glucose with a glucometer. After testing the patient's blood glucose, the CNA (#27) disposed of the lancet and test strip in the patient's garbage can, removed her gloves, disinfected the glucometer with a SaniCloth and placed it back in the carrying/supply case. The CNA (#27) failed to dispose of the lancet and test strip in a biohazard container and failed to disinfect the glucometer carrying/supply case prior to exiting the patient's room.

During an interview on the afternoon of 05/06/14, an administrative nurse (#19) stated staff should dispose of test strips and lancets in a biohazard container and avoid taking the glucometer carrying/supply case into each patient room.

- During an observation on 05/07/14 at 8:50 a.m., two nurses (#24 and #25) assisted a physician (#23) as he inserted Patient #26's dialysis catheter under sterile procedure. One nurse (#25) failed to position her face mask over her upper lip and nose.

- Observation on 05/07/14 at 10:00 a.m. identified two nurses (#24 and #25) repositioned Patient #26 to change his bottom sheet, wet with oral secretions. One nurse (#25) proceeded to date the dressing on his coccyx and without changing her gloves and performing hand hygiene, completed oral cares using moist gauze pads.

During an interview on the morning of 05/08/14, an administrative nurse (#20) confirmed staff should change gloves and perform hand hygiene prior to completing oral cares.

- Observation on 05/07/14 at 9:50 a.m. showed a nurse (#25) exited Patient #26's room without removing her gloves and performing hand hygiene.

- During observation of Patient #26's cares on the morning of 05/07/14, a CNA (#26) failed to perform hand hygiene upon entering and exiting the patient's room to restock linen and supplies.

During an interview on the afternoon of 05/07/14, an administrative nurse (#19) stated staff should perform hand hygiene when entering and exiting patient rooms.


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- On 05/07/14 at 8:20 a.m., observation showed a nurse (#14) wiped the buttock of a Patient (#7) five times with gloved hands. After wiping the patient's buttock for the second time, observation showed visible brown stool on the nurse's left gloved hand. The nurse failed to remove the soiled gloves upon the completion of perineal cares and proceeded to open a bed stand drawer, removed a lotion bottle, placed some lotion in her left gloved hand, and rubbed the patient's back.



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- On 05/07/14 at 10:45 a.m., observation showed a nurse (#6) entered Patient #11's room to perform dressing changes to a tracheostomy site and a percutaneous endoscopic gastrostomy (PEG) site. The nurse (#6) washed her hands, donned gloves, and changed the dressing to the PEG site. She removed her gloves and, without performing hand hygiene, donned new gloves and changed the tracheostomy dressing.

During an interview on 05/07/14 at 11:00 a.m., an administrative nurse (#7) agreed the nurse (#6) should have changed the tracheostomy dressing before the PEG dressing, and should have performed hand hygiene after completing the PEG dressing change and removing her gloves.


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2) Based on observation, record review, policy and procedure review, professional literature review, and staff interview, the facility failed to store, prepare, and serve foods in a safe and sanitary manner in 2 of 2 kitchens and 15 of 26 nourishment centers (North Campus - 3 South, 5 South, 6 South, 7 South, 5 East, 2 East, 3 East, 4 East, 1 West, Day Unit and South Campus - Psychiatry 3B, Orthopedics 4C Pod 1, Orthopedics Overflow, Palliative Care 5B, and Rehabilitation 5C), and failed to identify the lack of a monitoring system for proper sanitation of dishware and implement an alternative method of monitoring when facility staff documented dish machine gauge temperatures below the required temperature for sanitation of dishware using 1 of 2 dish machines (North Campus). These practices placed residents at risk for contamination of food during storage, preparation, and service which can lead to food borne illness. Failure to provide a method of monitoring final rinse temperatures of the dish machine has the potential for improper sanitization of equipment and utensils.

Findings include:

The 2009 Food Code, published by the Food and Drug Administration, Public Health Reasons, page 128, stated, "(A) . . . in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be . . . less than . . . (2) For all other machines, . . . (180 [degrees] F [Fahrenheit]). . . ." Page 462, stated, ". . . The surface temperature must reach at least . . . (160 [degrees] F as measured by an irreversible registering temperature measuring device to affect sanitation . . . (180 [degrees] F for other machines . . . are based on the sanitizing rinse contact time required to achieve . . . (160 [degrees] F) utensil surface temperature."

Review of the policy titled "Food Service Infection Control and Prevention" occurred on the afternoon of 05/06/14. The policy, dated May 2013, stated the following:
". . . Dish machine temperatures are maintained as follows: . . . IV. Final Rinse: 180-200 degrees F . . .
Clean service utensil . . . are used when necessary . . . to minimize manual contact with food . . .
Sanitizer solution will be changed at least every two hours. Manufactures [sic] suggest a range of 150 ppm [parts per million] - 400 ppm. 200 ppm - 300 ppm is the primary goal . . ."

- Observation of the North Campus kitchen occurred on 05/05/14 at 3:00 p.m. with two administrative dietary staff members (#1 and #2). Review of the "Dish Machine Temperature Record," posted in the dishwashing area, showed the ranges for the "Power Rinse" or final rinse temperature should be between 160 - 180 [degrees] F and 170 - 180 [degrees] F for each power rinse/final rinse cycle. These ranges are below the required temperature at the gauge of 180 degrees F.

A staff member (#2) passed a thermo chromatic color change strip (an irreversible registering temperature measuring device), provided by the surveyor, through the dish machine. This strip indicated the final rinse cycle temperature at the utensil/plate level to be at least 160 degrees F. This is an acceptable temperature for sanitization of equipment and utensils.

Reviewed on the afternoon of 05/05/14, the kitchen's dish machine temperature logs for March, April, and May 2014 identified the following recorded final rinse temperatures:
*March - 11 of 31 entries for the breakfast meal ranged from 160 - 170 degrees F, 5 of 31 entries for the lunch meal ranged from 155 - 170 degrees, and 4 of 31 entries for the dinner meal ranged from 170 - 174 degrees F.
*April - 4 of 30 entries for the breakfast meal ranged from 153 - 158 degrees F and 8 of 30 entries ranged from 167 - 176 degrees F, 2 of 31 entries for the lunch meal ranged from 152 - 158 degrees F and 2 of 30 entries ranged from 160 - 170 degrees F, and 1 entry of 158 degrees F for the dinner meal and 13 of 30 entries ranged from 160 - 172 degrees F.
*May - 2 of 5 entries for the breakfast meal ranged from 168 - 170 degrees F, 2 of 5 entries for the dinner meal ranged from 171 - 175 degrees F.
The temperature record stated, "If temperatures are unacceptable, the number is circled and the supervisor is notified immediately for follow-up action." Facility staff failed to circle any entries.

During interview on the morning of 05/06/14, an administrative dietary staff member (#1) confirmed the dish machine was a hot water sanitizing machine, and therefore, the final rinse cycle temperature should be 180 degrees F. This staff member identified an alternative method of monitoring final rinse temperatures, a holding thermometer, was available to determine the final rinse temperature at the utensil/plate level. The record lacked evidence of its use.

Observation on 05/05/14 at 3:00 p.m. and 05/06/14 at 10:00 a.m. showed the following:
*Four fans with dust buildup on their surfaces inside a vegetable produce walk-in cooler.
*One container of sanitizing solution in a food production area, used to clean surfaces in the kitchen, which measured 100 ppm with a test strip.
*One spray bottle of sanitizing solution in a coffee bar, which measured more than 400 ppm with a test strip. Sanitizing solutions with strength more than 400 ppm have the potential to leave a toxic residue on surfaces.

During an interview the afternoon of 05/05/14 a dietary staff member (#3) stated she used a full tablespoon of sanitizer in one gallon of water. Review of the manufacturer's instructions for the quaternary sanitizer stated, "Dishes . . . must be sanitized by immersion in a 0.75 to 2 ounces of product per 4 gallons of water use solution of this product." The conversion of this direction would be 1/2 tablespoon sanitizer per gallon of water.

- Observation of the South Campus kitchen occurred on 05/06/14 at 11:00 a.m. with two administrative dietary staff members (#2 and #4) and showed the following:
*Two cases of food product with a thick layer of ice buildup on their top surfaces in a walk-in freezer
*Nine rubber scrapers with rough, uncleanable surfaces
*Three cutting boards with rough, stained, uncleanable surfaces

- Observation of fifteen nourishment centers (North Campus - 3 South, 5 South, 6 South, 7 South, 5 East, 2 East, 3 East, 4 East, 1 West, Day Unit and South Campus - Psychiatry 3B, Orthopedics 4C Pod 1, Orthopedics Overflow, Palliative Care 5B, and Rehabilitation 5C) on 05/06/14 at 8:15 a.m. and 10:25 a.m. identified containers of powdered food products (Thick and Easy, Nutrisource, Benefiber, Beneprotein, Similac, Elecare) with a scoop, including its handle, stored within the product containers.

During an interview on 05/06/14 at 3:30 p.m., an administrative dietary staff member (#2) confirmed the Hospital should prepare sanitizing solutions according to manufacturer's instructions, maintain the cleanliness of equipment, and protect food from contamination.

Based on record review, review of admission information provided to patients, review of professional reference, review of facility policy, and staff interview, the Hospital failed to ensure a Registered Nurse (RN) supervised and evaluated the effectiveness of medications given to patients on an as needed (prn) basis for 5 of 30 active patient records (Patient #6, #15, #18, #19, and #20) reviewed.

Failure to evaluate the effectiveness of prn pain medications in a timely manner and before administering another medication for pain control limited the RN's ability to assess whether the medication achieved the desired effect or if the patient experienced any side effects or adverse reaction from the medication.

Findings include:

On the afternoon of 05/05/14, the hospital administrative staff provided a copy of the information given to all patients at the time of admission to the hospital. This information included a booklet, dated October 2013, titled "Your Stay at Sanford." On page 9, "Making a Pain Control Plan," stated, ". . . Good pain control requires you and the health care team to work together. Here is what your health care team will do:
*We will ask about your pain. You will be asked to rate your pain on a scale of zero to ten, zero being no pain and ten being the worst pain you have had. [Other levels of pain listed in the margins on this page include mild pain level 1-3, moderate pain level 4-6, severe pain level 7-10.]
*We will offer a treatment plan to control your pain.
*We will check your pain after a treatment to see if you feel better.
*We will help you understand about pain and the pain control options that are are available to you. . . ."

Review of the hospital policy "Pain Management" occurred on 05/08/14. This policy, revised March 2013, stated,". . . PURPOSE: To guide Sanford Medical Center Fargo staff in managing pain in an interdisciplinary approach across all settings and patient populations. This policy is intended to provide basic guidelines of individualizing the plan of care for patients with pain; it is not inclusive and other resources should be explored when this policy is not effective in assessing and managing pain. POLICY: 1. Health care professionals are obligated to provide pain management and comfort to all patients within their scope of practice . . . 6. Reassessment of the effectiveness of a pain intervention occurs with a clinically appropriate time frame (dependent upon i.e. the type of pain, type of intervention, care setting); . . ."

Kozier & Erb's "Fundamentals of Nursing, Concepts, Process and Practice," 9th Edition, dated 2012, page 1229, stated, "CLIENT WITH PAIN . . . NURSING RESPONSIBILITIES: Assess pain prior to and 60 minutes after administration [of pain medication] . . ."

- Review of Patient #6's active medical record occurred on May 7-8, 2014. The hospital admitted Patient #6 on 05/02/14. Medical diagnoses included colitis and Clostridium difficile.

Review of Patient #6's pain assessments from May 3-4, 2014 showed the patient rated his pain at "4-5" (moderate pain).

PRN pain medication orders for Patient #6 included:
- Acetaminophen (Tylenol) 650 milligrams (mg) every six hours for mild pain intensity rating of 1-3 ordered on 05/02/14.
- Oxycodone (Oxy-IR) 5 mg tablet every four hours for moderate pain ordered on 05/02/14.

Patient #6's received prn Oxycodone on 05/03/14 at 7:09 p.m. and on 05/04/14 at 2:17 a.m., 9:00 a.m., 1:05 p.m., and 6:44 p.m. Patient #6 received prn Acetaminophen on 05/04/14 at 9:33 p.m.

Nursing documentation to evaluate Patient #6's response to the above PRN pain medications stated the following:
* 05/03/14 at 8:30 p.m. ". . . Pt [patient] denies pain at this time. . . ." Nursing staff documented the effectiveness/response of this medication one hour 21 minutes after medication administration.
*05/04/14 4:30 a.m. "Pt reporting pain in legs. PRN Oxycodone 5 mg administered. Pt sleeping on pain re-assessment . . . ." Nursing staff documented the effectiveness/response of this medication two hours and 13 minutes after medication administration.
* 05/04/14 at 9:00 p.m. ". . . Pt received Oxycodone 5 mg prn from previous nurse [at 6:44 p.m.]. Resting in bed with eyes closed . . . ." Nursing staff documented the effectiveness/response to this medication two hours and 16 minutes after medication administration.

Patient #6's record lacked evidence nursing staff reassessed the patient after administering the following prn medications: Oxycodone on 05/04/14 at 9:00 a.m. and 1:05 p.m. and Acetaminophen on 05/04/14 at 9:33 p.m.

During interview on 05/08/14 at 9:30 a.m., an administrative nurse (#13) stated she expects the nursing staff to reassess the effectiveness of a prn medication "within a reasonable timeframe" depending upon the route of administration and type of medication provided to the patient. When asked to be more specific as to what constitutes a "reasonable timeframe," this administrative nurse stated "within one hour."



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- Review of Patient #15's medical record occurred on 05/07/14. Diagnoses included an occipital wound infection. Pain medications included Lyrica (an anticonvulsant used to treat peripheral neuropathy) 100 mg three times a day, Tylenol 325-650 mg every four hours PRN, Percocet (a combination of oxycodone and acetaminophen for moderate to severe pain) 5/325 mg one to two tablets every four hours PRN, and Tramadol (for moderate to severe pain) 50 to 100 mg every 6 hours PRN.

Review of Patient #15's Medication Administration Record (MAR) and pain assessments identified the following:
*05/02/14 - Percocet administered at 11:00 a.m. - the nurse reassessed the patient's pain at 3:07 p.m. (four hours later) and administered Percocet again. At 5:24 p.m. (2 hours and 15 minutes later), the nurse reassessed the patient's pain and administered Tramadol.
*05/04/14 - Patient #15 received Percocet at 1:00 a.m. and Tramadol at 1:22 a.m. (22 minutes later); Tramadol at 2:10 p.m. and Percocet at 2:45 p.m. (35 minutes later). On both occasions the nurse failed to allow the first medication to take effect before administering the second medication.
*05/05/14 - Percocet administered at 4:38 p.m. - the nurse reassessed the patient's pain at 9:36 p.m. (five hours later) when the patient received Tramadol.
*05/06/14 - Percocet administered at 3:11 a.m. - the nurse reassessed the patient's pain at 5:26 a.m. (two hours and 15 minutes later) when the patient received Tramadol.
*05/07/14 - Percocet administered at 1:29 a.m. - the nurse reassessed the patient's pain at 6:06 a.m. (four and a half hours later) when the patient received Percocet again.

During an interview on 05/08/14 at 10:50 a.m., the charge nurse (#11) stated she would wait at least one hour after administering a pain medication to evaluate its effectiveness and then administer additional medication if necessary.



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- Review of Patient #18's active medical record occurred on 05/08/14 and identified the Hospital admitted the patient on 05/05/14 for labor. The record showed physician orders for hydrocodone/acetaminophen (used to treat moderate pain) 7.5/325 mg one to two tablets every four hours prn. Review of the patient's record showed nursing staff administered the medication on 05/06/14 at 9:36 p.m. with reassessment completed at 2:31 a.m. (five hours later); and on 05/07/14 at 8:49 a.m. with no reassessment completed.

- Review of Patient #19's active medical record occurred on 05/08/14 and identified the Hospital admitted the patient on 05/06/14 for labor. The record showed physician orders for hydrocodone/acetaminophen 5/325 mg one to two tablets every four hours prn. Review of the patient's record showed nursing staff administered the medication on 05/07/14 at 9:31 a.m. and reassessed Patient #19 at 2:04 p.m. (nearly five hours later).

- Review of Patient #20's active medical record occurred on 05/08/14 and identified the Hospital admitted the patient on 05/05/14 for severe pre-eclampsia. The record showed physician orders for Norco (used to treat moderate pain) 10/325 mg one tablet every four hours prn. Review of the patient's record showed nursing staff adm

1) Based on observation, policy and procedure review, and staff interview, the Hospital failed to follow professional standards of care regarding infection control practices during observations of patient care on 3 of 4 days of survey (May 5-7, 2014). Failure to follow established infection control practices may allow transmission of organisms and pathogens from patient to staff, to other patients, or to visitors; and from one environment to another.

Findings include:

Review of the policy titled "Hand Hygiene Policy" occurred on 05/08/14. This policy, revised August 2012, stated, ". . . PROCEDURE: . . . 1. Indications for handwashing and hand antisepsis.
A. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, wash hands with either a non-antimicrobial soap and water or an antimicrobial soap and water . . .
C. Decontaminate hands before having direct contact with patients . . .
F. Decontaminate hands after contact with a patient's intact skin . . .
G. Decontaminate hands after contact with body fluids or excretions, mucous membranes, nonintact skin, and wound dressings if hands are not visibly soiled.
H. Decontaminate hands if moving from a contaminated-body site to a clean-body site during patient care.
I. Decontaminate hands after contact with contaminated equipment.
J. Decontaminate hands after removing gloves. . . ."

Review of the policy titled "Isolation - Contact Precautions" occurred on 05/08/14. This policy, revised July 2013, stated, ". . . DISEASES: . . . Multi-drug Resistant Organism (infection or colonization) . . . 1. Methicillin resistant Staph aureus (MRSA) . . .
PROCEDURE: . . . Dedicate patient care equipment to the patient to avoid sharing between patients when possible. Disinfect prior to use with another patient . . . If precautions are due to infection or colonization with a DRO [drug resistant organism], equipment must be dedicated to the patient. . . ."

Review of the policy titled "Accucheck Inform Blood Glucose Monitor" occurred on 05/08/14. This policy, revised July 2013, stated, ". . . Patient Test: . . . 14. When the blood is applied correctly to the strip, an hourglass will appear on the display for 26 seconds while waiting for the result . . . 16. Remove the test strip from the meter and discard the test strip and lancet in a biohazard sharps container . . . 18. Remove and dispose gloves. 19. Wash hands . . . 21. Clean the meter with SaniCloth wipe per maintenance section below . . . MAINTENANCE: 1. The outside of the meter is to be cleaned/disinfected between all patient testing. . . ."

- Observation on 05/05/14 at 3:00 p.m. showed two nurses (#21 and #22) assisted a physician (#23) as he inserted Patient #27's central line under sterile procedure. One nurse (#21) stated the patient had MRSA and required contact precautions. After the procedure, the physician (#23) retrieved his pager from the patient's dresser and used his hands to wipe the pager with alcohol sanitizing foam.

During an interview on the afternoon of 05/05/14, a nurse (#21) stated staff should disinfect non-disposable equipment with SaniCloths stored in each patient's room.

- During observation on the morning of 05/06/14, a nurse (#5), upon completion of an infusion of platelets, disconnected the unit with tubing from Patient #1's main intravenous line. The nurse placed the bag and tubing inside a Ziploc plastic bag and sealed the bag. The nurse removed her gloves and failed to perform hand hygiene. The nurse laid the Ziploc bag on top of the cart with the computer, completed an entry in the medical record, picked up the bag, and exited the room. The nurse disposed of the bag in a red waste container in a utility room. The nurse proceeded to continue nursing tasks without completing hand hygiene.

- During an observation on 05/06/14 at 10:15 a.m., a certified nursing assistant (CNA) (#27) entered Patient #25's room, placed a glucometer carrying/supply case on the patient's bedside table, and tested Patient #25's blood glucose with a glucometer. After testing the patient's blood glucose, the CNA (#27) disposed of the lancet and test strip in the patient's garbage can, removed her gloves, disinfected the glucometer with a SaniCloth and placed it back in the carrying/supply case. The CNA (#27) failed to dispose of the lancet and test strip in a biohazard container and failed to disinfect the glucometer carrying/supply case prior to exiting the patient's room.

During an interview on the afternoon of 05/06/14, an administrative nurse (#19) stated staff should dispose of test strips and lancets in a biohazard container and avoid taking the glucometer carrying/supply case into each patient room.

- During an observation on 05/07/14 at 8:50 a.m., two nurses (#24 and #25) assisted a physician (#23) as he inserted Patient #26's dialysis catheter under sterile procedure. One nurse (#25) failed to position her face mask over her upper lip and nose.

- Observation on 05/07/14 at 10:00 a.m. identified two nurses (#24 and #25) repositioned Patient #26 to change his bottom sheet, wet with oral secretions. One nurse (#25) proceeded to date the dressing on his coccyx and without changing her gloves and performing hand hygiene, completed oral cares using moist gauze pads.

During an interview on the morning of 05/08/14, an administrative nurse (#20) confirmed staff should change gloves and perform hand hygiene prior to completing oral cares.

- Observation on 05/07/14 at 9:50 a.m. showed a nurse (#25) exited Patient #26's room without removing her gloves and performing hand hygiene.

- During observation of Patient #26's cares on the morning of 05/07/14, a CNA (#26) failed to perform hand hygiene upon entering and exiting the patient's room to restock linen and supplies.

During an interview on the afternoon of 05/07/14, an administrative nurse (#19) stated staff should perform hand hygiene when entering and exiting patient rooms.


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- On 05/07/14 at 8:20 a.m., observation showed a nurse (#14) wiped the buttock of a Patient (#7) five times with gloved hands. After wiping the patient's buttock for the second time, observation showed visible brown stool on the nurse's left gloved hand. The nurse failed to remove the soiled gloves upon the completion of perineal cares and proceeded to open a bed stand drawer, removed a lotion bottle, placed some lotion in her left gloved hand, and rubbed the patient's back.



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- On 05/07/14 at 10:45 a.m., observation showed a nurse (#6) entered Patient #11's room to perform dressing changes to a tracheostomy site and a percutaneous endoscopic gastrostomy (PEG) site. The nurse (#6) washed her hands, donned gloves, and changed the dressing to the PEG site. She removed her gloves and, without performing hand hygiene, donned new gloves and changed the tracheostomy dressing.

During an interview on 05/07/14 at 11:00 a.m., an administrative nurse (#7) agreed the nurse (#6) should have changed the tracheostomy dressing before the PEG dressing, and should have performed hand hygiene after completing the PEG dressing change and removing her gloves.


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2) Based on observation, record review, policy and procedure review, professional literature review, and staff interview, the facility failed to store, prepare, and serve foods in a safe and sanitary manner in 2 of 2 kitchens and 15 of 26 nourishment centers (North Campus - 3 South, 5 South, 6 South, 7 South, 5 East, 2 East, 3 East, 4 East, 1 West, Day Unit and South Campus - Psychiatry 3B, Orthopedics 4C Pod 1, Orthopedics Overflow, Palliative Care 5B, and Rehabilitation 5C), and failed to identify the lack of a monitoring system for proper sanitation of dishware and implement an alternative method of monitoring when facility staff documented dish machine gauge temperatures below the required temperature for sanitation of dishware using 1 of 2 dish machines (North Campus). These practices placed residents at risk for contamination of food during storage, preparation, and service which can lead to food borne illness. Failure to provide a m