The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

COMMUNITY HOSPITAL OF SAN BERNARDINO 1805 MEDICAL CENTER DRIVE SAN BERNARDINO, CA 92411 March 20, 2015
VIOLATION: CONTRACTED SERVICES Tag No: A0085
Based on observation, interview, and record review, the facility failed to provide an approved contract for the maintenance of the water treatment system in the hemodialysis unit which affected a universe of approximately 170 hemodialysis patients. This failure had the potential for the water treatment system to fail (inability to filter impurities from the water) due to not having a contract with a licensed vendor to provide maintenance and process checks of the soft water system.

Findings:

During an initial tour of the Hemodialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 3:15 PM, a small room was observed in the Dialysis Unit which had the water treatment system. The system was set up where plumbing came out from the wall with the main gauge, then the first filter (about 2 feet tall) with two (2) gauges, approximately 4 foot water softener tanks, then the second filter (about 2 feet tall) with two (2) gauges, then the pressure release/back flow tank (same size as the filters), and finally, the plumbing exits to the opposite wall. The water softener tanks were marked with [company name 2] stickers.

A review of the Facility Services Agreement signed by both parties on June 27, 2014 and July 29, 2014, indicated the contract was between the facility and [company name 1]. Under schedule 1 a description of services of the contract indicated, "Water treatment services for the city water."

A review of the letter from [company name 1] on October 2, 2014, indicated on page 3 of 4, "Site #045- 47 Dialysis Department: sold to [company name 2] SITE CANCELED..."

During an interview with the Director of Facilities (DOF) on March 16, 2015 at 4:05 PM, the DOF stated the water system was maintained formerly by [company name 1]. The DOF added [company name 1] sold the Dialysis Department to [company name 2]. The DOF stated the facility did not have any contract with [company name 2] because [company name 2] wanted to change parts of contract made by the facility with [company name 1]. The DOF added it had been 5 months that the facility did not have a new contract with [company name 2].
VIOLATION: PATIENT RIGHTS Tag No: A0115
The hospital failed to ensure the Condition of Participation: CFR 482.13 Patient's Rights was met by failing to:

1. Ensure a patient was not physically abused by a staff member. (Refer to A 0145)

The cumulative effect of this systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Patient's Rights.
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
Based on interview and record review, the hospital failed to ensure 1 of 30 sampled patients (Patient 25) was free from abuse. This failure occurred when Patient 25 presented to the Emergency Department being uncooperative with an altered mental status. During the assessment (examination) of the patient, the Emergency Department physician was observed to twist the patient's right nipple in an attempt to elicit an appropriate response from the patient. This type of neurological stimulation is not sanctioned (authorized) by the hospital's medical staff to perform.

Findings:

On March 12, 2015 an entity reported event was reported to the California Department of Public Health (CDPH) for the suspected abuse of Patient 25. It was alleged that the Emergency Department Physician (EDP) in an attempt to elicit an appropriate response from the patient, the EDP grabbed and twisted the patient's right nipple. The event was witnessed by three nurses.

On March 17, 2015 at approximately 10:15 AM, an interview was conducted with the Director of Risk Management, Patient Relations and Patient Safety Officer (DRMPRPSO). The DRMPRPSO stated on March 9, 2015, she was informed of an alleged abuse which occurred on March 7, 2015 in the Emergency Department. The DRMPRPSO further stated she "Immediately escalated the event."

As the interview continued on March 17, 2015 at 10:15 AM, the DRMPRPSO stated, "The patient was not cooperating and would not provide his last name," further stating that the patient kept yelling, "Lord help me, Jesus help me."

On March 7, 2015 at approximately 5:54 AM, Patient 25 arrived to the hospital's Emergency Department (ED) via ambulance in 4 point soft restraints (arms and legs tied down) due to being in an altered mental state, uncooperative, agitated and combative with a suspected drug overdose.

A review of the ED "Smart Chart," dated March 7, 2015 at 6 AM, documentation revealed the patient as being "Agitated."

Continued review of the patient's medical record revealed a form dated and signed by the EDP on March 7, 2015 at 6:15 AM, titled "Physician Orders and Assessment Sheet Restraint and or Seclusion," in the section "Non-Violent/Non Self Destructive Restraints," documentation under "Clinical Justification," revealed the following:

"Patient pulling at/removing essential equipment/dressing/lines" and "Patient climbing out of bed."

Further review of the "Physician Orders and Assessment Sheet Restraint and or Seclusion," sheet dated March 7, 2015 at 6:15 AM, revealed Patient 25 was to be placed in "Soft limb (R) (L), two (2) upper extremities."

A review of nursing notes from Registered Nurse 2 (RN 2), dated March 7, 2015 at 6:15 AM, documentation revealed the following:

"Pt (patient) appears anxious, constantly moving, awake, alert to name, unable to follow commands, uncooperative, attempting climbing out of bed, unable to reorient, pt. altered, unable to answer question appropriately..ED at bedside for evaluation."

On March 18, 2015 at 7:23 AM, an interview was conducted with RN 1. RN 1 stated on the morning of March 7, 2015 at approximately 5:55 AM, Patient 25 was brought to the ED by ambulance for altered level of consciousness, further stating the patient was awake and continuously saying "Father God, please Lord."

As the interview continued with RN 1, on March 18, 2015 at 7:23 AM, RN 1 stated the EDP was at the patient's bedside for examination. The EDP was heard asking the patient for his name and the patient continued to repeat "Father God, please Lord," at this point the EDP was observed "Twisting the front right side of the patient's shirt above his chest." While still holding onto the patient's front right side of the patient's shirt, the EDP again asked what the patient's name was, the patient responded with his name, at which point the EDP let go and left the bedside.

On March 17, 2015 at 7:30 AM, an interview was conducted with RN 2. RN 2 stated Patient 25 was brought into the ED on March 7, 2015. RN 2 further stated the patient was repeatedly stating "Lord help me." RN 2 described the patient as awake and alert to first name.

As the interview continued with RN 2 on March 17, 2015, at 7:30 AM, RN 2 stated multiple attempts by various staff members were asking the patient to state his full name or date of birth, however; the patient was still unable to answer appropriately. RN 2 further stated, "The patient remained verbally and physically uncooperative," unable to follow simple commands despite multiple attempts by staff to reorient the patient.

During the interview with RN 2 on March 17, 2015 at 7:30 AM, RN 2 stated the EDP was at the patient's bedside, with current approaches being ineffective the EDP used painful stimuli towards the patient by "twisting the right side of the patient's chest." RN 2 further stated, upon the patient answering the EDP's questions, the painful stimulation was no longer used.

On March 19, 2015 at 7:38 AM, an interview was conducted with RN 3. RN 3 stated that on the morning of March 7, 2015, Patient 25 was brought into the ED via ambulance, for a possible drug overdose. RN 3 further stated that the patient was restless, hyper-verbal, and did not follow instructions.

As the interview continued with RN 3 on March 19, 2015 at 7:38 AM. RN 3 stated Patient 25, was being asked by multiple people what his name was, but the patient was not being cooperative. RN 3 stated that as the EDP was at the patient's bedside the patient kept moving his head back and forth not allowing the EDP to check his pupils, RN 3 stated he had to hold the patient's head while the EDP manually opened the patient's eyes.

During the interview with RN 3 on March 19, 2015 at 7:38 AM, RN 3 stated, "We kept asking him his name, because the description of the name that he told us did not match, per the police officer at the bedside," that's when I saw the EDP reach over and grab the patient's right breast, while asking the patient what his name was. RN 3 further stated, "This was not a neuro assessment because she was only grabbing his nipple and twisting it attempting to make Patient 25 provide the correct name and information."

On March 19, 2015 at 3:50 PM, a telephone interview was conducted with the EDP. The EDP stated that when she arrived at the EDP she observed Patient 25 as being altered (a medical term used to describe a patient when they are confused or disoriented), combative and uncooperative.

The EDP further stated during the interview conducted on March 19, 2015 at 3:50 PM, that multiple attempts to gain information from the patient were unsuccessful, the patient "was not responding appropriately," the EDP further indicated that multiple verbal attempts were made, a supra-orbital (around the eye) examination and a sternal rub (a medical technique of putting pressure on the sternum of a patient to create a pain stimulus in order to assess the consciousness level of a person who is not responding to normal interaction, voice commands or gentle physical stimuli), prior to performing a nipple twist. The EDP stated,"At the time of the nipple twist the patient was able to tell me his full name."

As the telephone interview continued on March 19, 2015 at 3:50 PM, the EDP stated, "There was no malicious intent." The EDP continued to state the nipple twist was not used in an attempt of coercion.

On March 20, 2015, a review of the document that the EDP presented to the Medical Executive Committee was reviewed. The document titled, Chapter 57 Level of Consciousness-Clinical Methods-NCBI (National Center for Biotechnology Information-a website for free online access to books and documents in life science and healthcare) Bookshelf, from the book "Clinical Methods, 3rd edition: The History, Physical and Laboratory Examinations" dated 1990, revealed the following under the "Definition" section:

"The normal state of consciousness comprises either the state of wakefulness, awareness, or alertness in which most human beings function while not asleep or one of the recognized stages of normal sleep from which the person can be readily awakened."

Further review of the documentation provided by the EDP to the Medical Executive Committee revealed the following:

The Grady Coma Scale, "has been used for more than 10 years" to gauge the level of consciousness of patients...documentation revealed the following:

"Grade I patient is only slightly confused.

Grade II patient requires a light pain stimulus (such as a sharp pin tapped lightly over the chest wall) for appropriate arousal, or may be combative or belligerent.

Grade III patient is comatose but will ward off deeply painful stimuli such as sternal pressure or a nipple twist with an appropriate response...."

Subsequent review of the document provided by the EDP revealed the following:

"As the patient's name is called in a normal tone of voice or if, during an attempt at a simple conversation, it is noted that the person is confused, drowsy, or indifferent, an abnormal level of consciousness exists. Individuals who respond with recognition when their name is called and do not lapse into sleep when left undisturbed, can be said to be in a grade 1 coma. If the alteration in level of consciousness is more severe, so that the person lapses into sleep when not disturbed and is arousable only when a pin is tapped gently over the chest wall, the grade of coma in II."

Further review of the Chapter 57 Level of Consciousness-Clinical Methods-NCBI Bookshelf," revealed:

"If such efforts as calling the patient's name in a normal tone of voice or pricking the skin over the chest wall lightly with a pin result in no response, the examiner must choose a deeper pain stimulus," such as a pinch or slight twist of the nipple. "The patient's response to the deep pain stimulus is then noted. A patient who winces and/or attempts to ward off the deep pain stimulus appropriately can be said to be in a grade III coma."

A review of the interview conducted with RN 1, RN 1 stated Patient 25 was awake and continuously saying "Father God, please Lord." RN 2 described the patient as awake and alert to first name, stating "Lord help me."

A review of the interview conducted with RN 2, RN 2 stated, "The patient remained verbally and physically uncooperative," unable to follow simple commands despite multiple attempts by staff to reorient the patient. Nursing notes documented by RN 2 revealed "Pt (patient) appears anxious, constantly moving, awake, alert to name, unable to follow commands, uncooperative, attempting climbing out of bed, unable to reorient, pt. altered, unable to answer question appropriately

A review of the interview with RN 3 revealed the patient was restless, hyper-verbal, and did not follow instructions.

On March 20, 2015 at 12:50 PM, an interview was conducted with the Director of Quality and Risk Management (DQRM) and the Interim Vice President of Patient Care Services and Chief Nursing Officer (IVPPCSCNO), the DQRM and the IVPPCSCNO were asked if nipple twisting was an accepted procedure allowed by the hospital, the IVPPCSCNO replied, "No," as the DQRM shook her head in a side to side motion indicating "No."
VIOLATION: GOVERNING BODY Tag No: A0043
The hospital failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to ensure:

1. The President of the Medical Executive Committee and the entire committee were aware of the issues on the dedicated hemodialysis machine for HBsAg (Hepatitis B surface Antigen - a protein that is part of the Hepatitis B virus that is used to detect whether a person has an active infection or not) positive patients. The Committee was also not aware of the following: sodium bicarbonate (a chemical used in hemodialysis {removal of excess fluida and toxins in the blood through a specialized machine} to neutralize high acid levels) mixing procedure was not in accordance to the company's direction; using a sodium bicarbonate concentration not identified in the facility policy and procedure when the hemodialysis doctor failed to prescribe the sodium bicarbonate concentration; lack of oversight on the hemodialysis unit by the Medical Staff; and corrective actions on the death of a patient in the Behavioral Health Services. (Refer to A 0283, 0347, 0395, 0749)

2. Provide oversight to the Registered Nurse Hemodialysis Coordinator (RNHC) in the preparation and administration of sodium bicarbonate to use with the hemodialysis machine. (Refer to A 0405)

3. The Hemodialysis Unit water treatment system did not have a current contract with the new company. This had the potential for the water treatment system to fail due to having no contract with the new company to provide maintenance and process checks of the soft water system. (Refer to A 0085)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Governing Body.
VIOLATION: CARE OF PATIENTS - PRACTITIONERS Tag No: A0064
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the facility failed to provide oversight to the Registered Nurse Hemodialysis Coordinator (RNHC) in the preparation and administration of sodium bicarbonate to use with the dialysis machine for eight (8) of 30 sampled patients (Patients 21, 22, 23, 24, 26, 27, 28, and 29). This failure had the potential to cause under or over correction of the acidity in the blood which can affect the health condition of the patients receiving hemodialysis (a process where the patients blood passes through a machine which filters and removes toxins out from the blood) which could lead to harm of the patients including death .

Findings:

During an initial tour of the Dialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 2:34 PM, it was observed that there were two (2) transportable and one (1) fixed dialysis machine in the room. One dialysis machine was being used in one of the rooms in the hospital. There were five (5) containers labeled as "RO (reverse osmosis - water purification technology that uses a semipermeable membrane to remove particles including bacteria from the water) Water", three (3) filled with bicarbonate solution and 2 were empty near the Hemodialysis Unit sink.

During an observation of the Hemodialysis unit with the RNHC on March 17, 2015 at 8:16 AM, there were 5 packs of 650 grams of dry pack of bicarbonate powder, which contains, Sodium = 37 mEq/L (milliequivalent per liter) and Bicarbonate = 37 mEq/L, stored in the cabinet above the dialysis unit sink. Posted on the cabinet door for the bicarbonate storage was "8.0 Litre [liter] x [for] 1 bicarb [bicarbonate] mix."

During an interview with the RNHC on March 17, 2015 at 8:25 AM, the RNHC stated that the dry pack of bicarbonate was dissolved in 8.0 liters of reverse osmosis (RO - water purification technology that uses a semipermeable membrane to remove particles including bacteria from the water) water.

During an observation of how the RNHC prepares the bicarbonate solution on March 18, 2015 at 9:02 AM, the RNHC demonstrated the following steps:

a. poured the entire package of bicarbonate powder to a container filled with eight (8) liters of RO water,

b. capped the container with the blue cap,

c. moved the container in a circular manner causing the solution to be agitated,

d. removed the blue cap to release the gas accumulation in the container,

e. recapped the container, then move the container in a circular manner again causing the solution to be agitated,

f. stopped then removed the blue cap to release the gas in the container.

The solution was now ready for use as the bicarbonate concentrate for hemodialysis.

During an interview with the RNHC on March 18, 2015 at 9:14 AM, the RNHC stated that she spoke with the company representative for the dry pack of bicarbonate powder on the phone on March 17, 2015 at 3:30 PM regarding the procedure of mixing the bicarbonate powder to the RO water. The RNHC further stated that the company representative said that the facility was "interpreting the directions wrong." The facility was mixing the bicarbonate powder in 8 liters of RO water instead of 7 liters initially, mixing the entire package of bicarbonate instead of gradually, and agitating the water instead of mixing it gently.

During an interview with the RNHC on March 18, 2015 at 9:25 AM, the RNHC stated the Director of ED (Emergency Department), ICU (Intensive Care Unit), and Hemodialysis (DEIH) was not involved in the interpretation of the direction for mixing the dry powder bicarbonate to the RO water. The RNHC also added that there were no in services organized by the DEIH for the mixing of the dry powder bicarbonate with the RO water.

During a review of Patient 21's medical record, Patient 21's face sheet (a general patient identifier information) indicated the patient was admitted on [DATE] at 6:53 PM. Patient 21's Hemodialysis Order Record on March 14, 2015 at 10:59 AM, and on March 16, 2015 at 9:16 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet (documentation of the nurse of the hemodialysis of the patient) for Patient 21 on March 14, 2015 at 4:45 PM, and on March 16, 2015 at 2:20 PM, indicated the hemodialysis nurse performing the dialysis procedure on the mentioned dates used 35 Gms (grams) of NaHCO3 (sodium bicarbonate).

During a review of Patient 22's clinical record, Patient 22's face sheet indicated the patient was admitted on [DATE] at 1:15 AM. Patient 22's Hemodialysis Order Record on March 13, 2015 at 10:55 AM, March 14, 2015 at 11:05 AM, and on March 15, 2015 at 11:08 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 22 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During a review of Patient 23's clinical record, Patient 23's face sheet indicated the patient was admitted on [DATE] at 11:15 PM. Patient 23's Hemodialysis Order Record on February 27, 2015 at 10:19, February 28, 2015 at 9:59 PM, March 2, 2015 at 11:51 AM, March 4, 2015 at 5:40 PM, March 5, 2015 at 1:11 PM, March 7, 2015 at 2:21 PM, March 8, 2015 at 8:44 AM, March 10, 2015 at 4:24 PM, March 11, 2015 at 10:34 AM, March 11, 2015 at 11:05 AM, March 13, 2015 at 10:29 AM, March 16, 2015 at 10:48 AM, March 19, 2015 at 10 AM, and on March 19, 2015 at 5:28 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 23 on February 27, 2015 at 12:30 AM, February 28, 2015 at 3:50 PM, March 1, 2015 at 3 PM, March 3, 2015 at 12:50 PM, March 5, 2015 at 12:15 PM, March 6, 2015 at 5:15 PM, March 8, 2015 at 3:10 PM, March 9, 2015 at 4:45 PM, March 11, 2015 at 8:15 PM, March 12, 2015 at 12:35 PM, March 14, 2015 at 12:20 PM, and on March 17, 2015 at 2:30 PM, indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During a review of Patient 24's clinical record, Patient 24's face sheet indicated the patient was admitted on [DATE] at 9:10 PM. Patient 24's Hemodialysis Order Record on March 9, 2015 at 3:27 PM, March 10, 2015 at 2:33 PM, March 12, 2015 at 3:38 PM, March 13, 2015 at 11:34 AM, March 14, 2015 at 8:39 PM, March 16, 2015 at 10:56 AM, and on March 17, 2015 at 10:44 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 24 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During a review of Patient 26's clinical record, Patient 26's face sheet indicated the patient was admitted on [DATE] at 11:30 PM. Patient 26's Hemodialysis Order Record on January 21, 2015 at 1:47 PM, and on January 22, 2015 at 2:52 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 26 on January 21, 2015 at 9:55 PM, and January 23, 2015 at 5:20 PM, indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During a review of Patient 27's clinical record, Patient 27's face sheet indicated the patient was admitted on [DATE] at 2 PM. Patient 27's Hemodialysis Order Record on February 26, 2015 at 1:35 PM, February 27, 2015 at 10:38 AM, March 1, 2015 at 9:07 PM, March 3, 2015 at 11:28 AM, March 5, 2015 at 1:32 PM, March 8, 2015 at 8:48 AM, and on March 11, 2015 at 12:26 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 27 on February 27, 2015 at 3:40 PM, February 28, 2015 at 11:30 AM, March 2, 2015 at 1:30 PM, March 4, 2015 at 12:40 PM, March 6, 2015 at 1 PM, March 10, 2015 at 8:40 PM, and on March 12, 2015 at 12:50 PM, indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During a review of Patient 28's clinical record, Patient 28's face sheet indicated the patient was admitted on [DATE] at 9:30 AM. Patient 28's Hemodialysis Order Record on February 12, 2015 at 4:46 PM, January 14, 2015 at 2:20 PM, January 16, 2015 at 11:49 AM, January 18, 2015 at 4:45 PM, and on January 19, 2015 10:12 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 28 on January 13, 2015 at 4 PM, January 15, 2015 at 4:30 PM, January 17, 2015 at 5:40 PM, January 19, 2015 at 1:00 PM, and on January 20, 2015 at 5:00 PM, indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During a review of Patient 29's clinical record, Patient 29's face sheet indicated the patient was admitted on [DATE] at 4 PM. Patient 29's Hemodialysis Order Record on February 18, 2015 at 8:53 AM, February 19, 2015 at 9:50 AM, February 22, 2015 at 10:23 AM, February 24, 2015 at 8:19 AM, February 24, 2015 at 4:21 PM, March 1, 2015 at 10:33 AM, March 2, 2015 at 10:04 AM, March 3, 2015 at 1:22 PM, March 5, 2015 at 10:05 AM, and on March 9, 2015 at 9:41 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 29 on February 18, 2015 at 1:50 PM, February 20, 2015 at 2 PM, February 23, 2015 at 1:25 PM, February 25, 2015 at 12:45 PM, March 2, 2015 at 12:40 PM, March 3, 2015 at 4:30 PM, March 4, 2015 at 1:30 PM, March 6, 2015 at 4:15 PM, March 9, 2015 at 1:10 PM, and on March 10, 2015 at 2:45 PM , indicated the hemodialysis nurse, performing the dialysis on the mentioned dates, used 35 Gms of bicarbonate.

During an interview with the RNHC on March 18, 2015 at 4:39 PM, the RNHC stated if some doctors did not specify in their orders the bicarbonate concentration to use during dialysis, the facility used 35 grams as a standard dose.

During an interview with the Medical Director of the Hemodialysis Unit (MDHU) on March 18, 2015 at 3:50 PM, the MDHU stated he relied on the hemodialysis nurse regarding what concentration of bicarbonate to use for dialysis when a doctor failed to prescribe the bicarbonate.

During a review of the First Amendment to Medical Director Agreement between the MDHU and the facility, effective on October 1, 2012, indicated under Director Services: "Physician shall: 1. Provide general administration of the day-to-day operations of the Department; 2. Advise and assist Hospital in implementing Hospital's policies and procedures regarding the Department; ...5. Be Responsible to the Hospital administration for the professional services and medical management of the Department and participate in the management development programs..."

During an interview with the RNHC on March 18, 2015 at 4:39 PM, the RNHC stated if some doctors did not specify in their orders the bicarbonate concentration to use during dialysis, the facility used 35 grams as a standard dose.

During an interview with the Director of ED, ICU and Hemodialysis (DEIH) on March 18, 2015 at 5 PM, the DEIH stated that the process and patient services oversight in the hemodialysis unit were the responsibility of the MDHU. The DEIH stated that she only functioned administratively in the hemodialysis unit. Examples she gave for her administrative oversight were payroll and materials and supply procurement.

The facility policy and procedure titled "Physician's Order for the Dialysis Patient," reviewed date March 2012, did not specify any concentration of bicarbonate to use during dialysis when the doctor failed to prescribed the appropriate concentration of bicarbonate. The facility did not provide any other policy and procedure to indicate 35 Gms as a standard to use when the doctor failed to prescribe the bicarbonate concentration for hemodialysis.
VIOLATION: QAPI Tag No: A0263
The hospital failed to ensure the Condition of Participation: CFR 482.21 Quality Assessment and Performance Improvement Program was met by failing to develop, implement and maintain an effective on-going hospital wide data quality assessment and performance improvement program as evidenced by:

1. Failing to ensure a hemodialysis (use of an artificial kidney to clear waste products and excess fluid from the blood) machine was designated specifically for Hepatitis B positive (infectious disease which affects the liver) patients. (Refer to A 0286 and A 0749)

2. Failing to ensure the current method of disinfection (application of a substance to materials and surfaces to kill bacteria and prevent infection)procedure for hemodialysis machines were approved by the Medical Executive Committee (a primary governance committee responsible for leadership decisions related to medical staff policies, procedures, and rules) and the Governing Body (a group of people who formulate policy and direct an institution along with its management). (Refer to A 0286 and A 0749)

3. Failing to ensure the current method of preparing bicarbonate (a chemical component used in hemodialysis machines) was being prepared per manufacturer guidelines. (Refer to A 0286)

4. The committees lack of knowledge of the Registered Nurse Hemodialysis Coordinator, choosing and setting the bicarbonate level on the hemodialysis machines, despite not having an approved hospital protocol or order from the prescribing physician. (Refer to A 0286)

5. Failing to ensure oversight was provided to the hemodialysis staff by the Director of Emergency Department/Intensive Care Unit/Hemodialysis or the hemodialysis Medical Director/Nephrologist (a medical doctor who specializes in kidney care and diseases of the kidney). (Refer to A 0286)

6. Failing to revise the hospital intake assessment procedure for patients requiring suicide risk/harm monitoring and receiving approval from appropriate committees, in addition failed to follow current hospital policy & procedure for a behavioral patient requiring monitoring. (Refer to A 0286)

7. The hospital failed to develop a policy and procedure for the care and management of a Hepatitis B positive patient receiving hemodialysis. (Refer to A 0286 and A 0749)

The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure the provision of quality health care in a safe environment, which created noncompliance with the Condition of Participation: Quality Assessment and Performance Improvement Program.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to implement preventive and corrective actions that could avoid an unexplained/unobserved patient death in the behavioral health unit for an adverse event for one (1) of 30 sampled patients (Patient 30). This failure had the potential for another patient to die without intervention.

On March 19, 2015 at 2:25 PM, Immediate Jeopardy #3 was called due to the facility's failure to physically monitor a behavioral patient requiring every 15 minutes monitoring as indicated in the Suicide/Self-Harm Assessment, and failure to revise the hospital's behavioral unit intake assessment procedure for patients identified as danger to self and/or others with cardiac issues, which contributed to Patient 30's death. On March 20, 2015 at 11:17 AM, Immediate Jeopardy #3 was abated after an acceptable corrective action plan was presented to the survey team.

Findings:

A review of medical record from the referring hospital for Patient 30 was conducted. The admitting face sheet (a document usually created during admission that contains basic patient information) indicated the patient was admitted on [DATE] at 8:31 AM on a 5150 (level of care for patient with psychological issues who is a danger to self and/or others). Lab results on October 2, 2014 at 8:30 AM, indicated Total CPK (Creatine PhosphoKinase - a protein found mostly in the heart, brain, and muscle that can reveal damage to these organs) = 382 (normal= 10-120 mcg/L (micrograms per liter). ECG (electrocardiogram - test done to check the electrical activity of the heart) results on October 2, 2014 at 9:45 AM, indicated: "Low voltage QRS. T wave abnormality (present in the ECG to signify damage to one part of the heart), consider anterior ischemia (lost of blood supply leading to tissue damage). Prolonged QT (seen in the ECG signifying another problem in the heart)."

A review of Patient 30's face sheet from the receiving hospital indicated the patient was admitted on [DATE] at 11:30 PM, with a diagnosis of schizophrenia (a chronic, severe, disabling brain disorder).

A review of the Adults Admission Nursing Assessment document for Patient 30 on October 2, 2014 at 11:40 PM, indicated the patient was referred from Hospital 1.

A review of the Intake Assessment Form for Patient 30 on October 2, 2014 at 6:30 PM, indicated the patient "met criteria for 5150. Admit to locked unit (east)..."

A review of the Suicide/Self-Harm Assessment document for Patient 30, dated October 2 at 11:40 PM, indicated Patient 30 received a score of 7 which was "No Precaution" but needed "observation (q [every] 15 minutes)."

A review of the Q15-Minutes Observation Record - BHS for Patient 30 from October 2 2014 at 11:30 PM till October 4, 2014 at 4:45 AM, indicated the patient's every 15 minutes monitoring/observation was initialed by the nurses assigned (signifying it was done by the nurse).

A review of the Consultation Report for Patient 30, dictated on October 3, 2014 at 6:22 PM, indicated: "ADDENDUM REPORT: [Patient 30's] electrocardiogram (ECG) done at the previous facility revealed the patient had T-wave abnormality, consider anterior wall ischemia (lost of blood supply leading to tissue damage on the frontal side of the heart), prolonged QT..."

A review of the ECG results for Patient 30 on October 3, 2014 at 4:41 PM, indicated: "...Prolonged QT..."

A review of the laboratory results for Patient 30, the CK (substance produced by the heart when there is inflammation of the heart) level on October 3, 2014 at 7:20 PM was 337 (normal = 22 - 269), and the CKMB (a blood test to monitor heart attack if the CK is high) on October 3 2014 at 7:59 PM was 8.0 (normal = 0.6 - 6.3).

A review of the Medication Administration Summary document, dated October 3, 2014 at 12:45 AM, and October 3, 2014 at 11:56 PM, indicated Haldol (medication used for severe mental disorder like schizophrenia) 5 mg (milligrams), Ativan (medication used for agitation and anxious patients) 1 mg, and Benadryl (a medication used to induce drowsiness and combat the side effects of Haldol) 50 mg were given IM (intramuscular - injected into the muscle) to Patient 30.

A review of the ER Code Blue (an emergency procedure in the facility to revive a patient who is not breathing and does not have a pulse) Note on October 4, 2014 at 5:28 AM, documented: "...found at 4:50 AM per nurse with no pulse, last seen at midnight. CPR x 30 min with asystole for 30 min. [Cardiopulmonary Resuscitation for 30 minutes with asystole (heart not beating) for 30 minutes]. Intubated (breathing tube inserted through the mouth down to the lungs for breathing), central line placed (a large bore flexible tube placed on a large vein usually on the left or right upper arm)."

A review of the discharge summary sheet for Patient 30, dictated on October 9, 2014 at 11:05 AM, indicated: "Reason for Admission: The patient originally was admitted on 5150 for grave disability because [patient] was very disorganized and rambling in nonsense and incoherent things, and responding to internal stimuli..." Under Hospital Course: "...The patient was given Haldol 5 mg, Ativan 1 mg, and Benadryl 50 mg IM for increase agitation on October 3, 2014, which was ordered by MD 1 who was on-call doctor. The patient was exploring following symptoms. The patient was banging the feet on the wall and table in the room. The patient was not able to be redirected. The patient's on call doctor, MD 1, was called and the patient was given Haldol 5 mg, Ativan 1 mg, and Benadryl 50 mg on October 3, 2014. According to the reports, the patient was given the above medications on October 3, 2014 at 11:56 PM. The patient calmed down [after receiving the medications]. The patient was monitored by the nursing staff as per the protocol. At around 5 AM in the morning, Code Blue was called and the emergency cart was taken to the patient's room. The patient's respiratory therapist was present. A full code was done. The patient's emergency room doctor (MD 2) came for the CPR (Cardiopulmonary Resuscitation - cardiac compression with artificial means of breathing), also the patient was declared dead at around 5:30 AM..."

During an interview with the Director of Pharmacy (DOP) on March 18, 2015 at 1:35 PM, the DOP stated Haldol medication can cause a prolonged QT interval especially the IV (intravascular - administering medication through the vein) route. The DOP further added the drug warning is especially established for the reason of IV administration. The DOP stated the warning was not in place for other routes like IM, and via mouth.

During an interview with the Director of Risk Management, Patient Relations and Patient Safety Officer (DRMPRPSO) on March 18, 2014 at 1:51 PM, the DRMPRPSO stated the information regarding the low voltage QRS and the CKMB were not reported by the transferring facility nurse. The DRMPRPSO also added when the Internal Medicine Doctor (MD 3) received the report of the low voltage QRS and CKMB high, MD 3 instructed the transporting ambulance to turn around. During that time, the patient was already at the door of the unit, so Patient 30 was admitted .

The facility Medical Staff Rule and Regulations, approved October 24, 2012, indicated: "A. Admission and Discharge of Patient ...3. Prior to admitting a patient, the admitting physician must verify that the specific service needed is available at this facility. And, contact the consulting physician prior to admitting the patient if additional specialty care is indicated..."

During an interview with the DRMPRPSO on March 18, 2015 at 2:29 PM, when asked about the documentation of the ER (emergency room ) doctor during code blue, the DRMPRPSO stated the nursing staff told the ER Doctor (MD 2), Patient 30 was last seen by staff at midnight.

During an interview with the DRMPRPSO on March 18, 2015 at 2:32 PM, when asked about the Q 15-Minutes monitoring by the staff, the DRMPRPSO stated there were no registered nurse, licensed vocation nurse, and mental health worker who checked Patient 30 from midnight until found at 4:50 AM of October 4, 2014. The DRMPRPSO further stated the Director of Behavioral Health Services (DBHS), and the Vice President of Behavioral Health services (VPBHS) checked the surveillance video in the behavioral unit, and confirmed the staff members did not monitor Patient 30 for that entire time period of four (4) hours and 50 minutes..

During an interview with the DRMPRPSO on March 18, 2015 at 2:40 PM, when asked what was done by the facility to correct the situation, the DRMPRPSO stated the following:

"1. The facility educated the staff (Medical, intake nurse, psychiatrist, internist) of the revised Behavior Services Unit intake process. The admitting doctor should get medical report from the endorsing doctor. These involved the revision of the facility policy and procedure regarding the intake assessment and admission procedure.

2. The facility scheduled mock code blues.

3. The facility terminated staff involved with the falsification of the Q 15-Minutes Observation Forms.

4. The facility did random spot checks of the q 15-minute observation done by the Behavioral Unit staff and backed up by review of the surveillance videos. The facility expected a 100% compliance with the q 15 minute recording and observation by the Behavioral Unit staff."

During a review of the Performance Improvement Summary of Area: BHS - 15 Minute Observation Record Review from November 24, 2014 'til March 9, 2015, indicated:
a. January 12, 2015 - 93% compliance,

b. January 26, 2015 - 81% compliance,

c. February 2, 2015 - 82% compliance,

d. February 9, 2015 - 80% compliance,

e. February 23, 2015 - 79% compliance,

f. March 2, 2015 - 97% compliance, and

g. March 9, 2015 - 95 % compliance.

During a review of the Performance Improvement Summary of Area: BHS - 15 Minute Observation - Direct Observation from November 24, 2014 'til March 9, 2015, indicated:

a. November 24, 2014 - 80% compliance,

b. December 1, 2014 - 90% compliance,

c. December 8, 2014 - 97% compliance,

d. December 29, 2014 - 70% compliance,

e. February 23, 2015 - 70% compliance, and

f. March 2, 2015 - 80% compliance.

A review of the Clinical Service Policy Routing for the Intake Assessment and Admission Procedure dated February 26, 2015, indicated the policy was not reviewed and approved yet by psychiatry section. The Medical Staff and the Board of Directors had to review and approve the Intake Assessment and Admission Procedure before implementation of the policy.

During an interview with the Interim Vice President of Patient Care Services and Chief Nursing Officer (IVPPCSCNO) on March 19, 2015 at 10:45 AM, the IVPPCSCNO stated the policy on Intake Assessment and Admission Procedure was still with the Psychiatry Section for review and approval since March 9, 2015. The facility had started implementing changes on the intake assessment and admission procedure of the facility, without the prior approval by the facility leadership.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on observations and interview, the hospital's Quality Assessment and Performance Improvement (QAPI) program, failed to identify, measure and track medical errors and adverse patient events as evidenced by:

1. Failed to ensure a hemodialysis (use of an artificial kidney to remove waste products and excess fluid from the blood) machine was designated specifically for Hepatitis B (an infectious disease which affects the liver) positive patients.

2. Failed to ensure the current method of disinfection (application of a substance to materials or surfaces to kill bacteria and prevent disease) procedure for hemodialysis machines had yet to be approved by the Medical Executive Committee (a committee responsible for making key leadership decisions related to medical staff policies, procedures, and rules) and the Governing Body (a group of people who formulate policy and direct an institution along with its management).

3. Failed to ensure the current method of preparing bicarbonate (a chemical component used in hemodialysis machines) was being prepared per manufacturer guidelines.

4. The committees lack of knowledge of the Registered Nurse Hemodialysis Coordinator, choosing and and setting the bicarbonate level on the hemodialysis machines, despite not having an approved hospital protocol or order from the prescribing physician.

5. Failed to ensure oversight was provided to the hemodialysis staff by the Director of Emergency Department/Intensive Care Unit/Hemodialysis or the hemodialysis Medical Director/Nephrologist (a medical doctor who specializes in kidney care and diseases of the kidney).

6. Failed to revise the hospital intake assessment procedure for patients requiring suicide risk/harm monitoring and receiving approval from appropriate committees, in addition failed to follow current hospital policy & procedure for a behavioral patient requiring monitoring.

7. The hospital failed to develop a policy and procedure for the care and management of a Hepatitis B positive patient receiving hemodialysis.

These failures have the potential for patients to receive poor quality health care services, which may result in the transmission of disease and death, if not identified and investigated.

Findings:

1. On March 20, 2015, at 9 AM, an interview was conducted with members of the hospitals QAPI committee which included the Interim Vice President of Patient Care Services and Chief Nursing Officer, Senior Director of Nurses, Vice President of Medical Affairs and the spokesperson for the QAPI committee the Director of Quality and Risk Management (DQRM) and 15 other senior leadership persons for the hospital.

During the interview on March 20, 2015, at 9 AM, the QAPI members were asked if they were aware that the hemodialysis unit did not have a designated hemodialysis machine for patients with Hepatitis B, confirmed through observations of the hemodialysis unit and interviews with the Director of the Emergency Department/Intensive Care Unit/Hemodialysis Unit and the Registered Nurse Hemodialysis Coordinator. The DQRM stated they became aware of the hospital not having a designated hemodialysis machine for patients with Hepatitis B, only after the survey team identified the issue.

The members of the QAPI committee were asked if they had ever conducted Quality Assessment and Performance Improvement projects related to hemodialysis. The DQRM stated, "No."

2. On March 20, 2015, at 9 AM, an interview was conducted with members of the QAPI committee. The committee members were asked if they were aware that the current method of disinfection being used for the hemodialysis machines had not been approved by the Medical Executive Committee and the Governing Body. On March 17, 2015 at 8:10 AM, an interview was conducted with the Registered Nurse Hemodialysis Coordinator (RNHC), the RNHC stated the facility used 6% bleach to clean the machine as recommended by the manufacturer of the machine. On March 17, 2015 at 9:54 AM, an interview was conducted with the Senior Director of Nurses (SDN), the SDN stated the use of 6% bleach has not been approved by the Medical Executive Committee and the Board of Directors.

The spokesperson for the QAPI committee (the DQRM), stated the QAPI committee was not aware that the current method of disinfection of the hemodialysis machines had not yet been approved. Further stating the new method should not have been implemented until it was approved.

3. On March 20, 2015, at 9 AM, an interview was conducted with members of the QAPI committee. The committee members were asked if they were aware that the current method of preparing bicarbonate (a chemical component used in hemodialysis machines) was not being prepared per the manufacturer guidelines. This failure, confirmed with the RNHC through multiple interviews conducted on March 17, 2015 at 8:25 AM, stated the facility dissolves the dry pack of bicarbonate with 8.0 liters of reverse osmosis (RO-water purification system, that uses a semipermeable membrane to remove particles including bacteria from water) water, however; the RNHC stated on March 17, 2015 at 3:30 PM, she was informed by the company representative for the bicarbonate, that the facility had been "interpreting the directions wrong."

The DQRM, stated the QAPI committee was not aware the bicarbonate was not being prepared according to manufacturers recommendations.

4. On March 20, 2015, at 9 AM, a meeting was conducted with members of the hospitals QAPI committee. During the meeting the members were asked if they were aware that licensed staff from within the hemodialysis unit were choosing and setting the bicarbonate level on the hemodialysis machines, despite not having an approved hospital protocol or order from the prescribing physician. The finding was confirmed through an interview with the RNHC on March 18, 2015 at 4:39 PM, when the RNHC stated if doctors did not specify in their orders the bicarbonate concentration to use during hemodialysis, the facility used 35 grams as a standard dose.

The spokesperson, for the QAPI committee stated they were not aware that licensed staff were choosing and setting the bicarbonate level on the hemodialysis machine without a physician order or protocol.

5. On March 20, 2015, at 9 AM, the QAPI committee was asked if they were aware no oversight was provided to the hemodialysis staff by the Director of Emergency Department/Intensive Care Unit/Hemodialysis or the hemodialysis Medical Director/Nephrologist.

During an interview with the Director of ED, ICU and Hemodialysis (DEIH) on March 18, 2015 at 5:00PM, the DEIH stated that the process and patient services oversight in the hemodialysis unit were the responsibility of the MDHU. The DEIH stated that she only functioned administratively in the hemodialysis unit. Examples she gave for her administrative oversight were payroll and materials and supply procurement.

During an interview with the Medical Director of the Hemodialysis Unit (MDHU) on March 18, 2015 at 3:50 PM, the MDHU stated he relied on the hemodialysis nurse regarding what concentration of bicarbonate to use for dialysis when a doctor failed to prescribe the bicarbonate.

The spokesperson for the QAPI committee stated they were not aware of the issues in the hemodialysis unit until the survey team called an immediate jeopardy identifying the issues.

6. On March 20, 2015, at 9 AM, an interview was conducted with members of the QAPI committee. The members were asked if they were aware that the hospital failed to revise the hospital intake assessment procedure for patients requiring suicide risk/harm to self monitoring, failure to obtain approval from appropriate administrative committee's, and failure to follow current hospital policy & procedure for a behavioral patient requiring monitoring.

During an interview with the Interim Vice President of Patient Care Services and Chief Nursing Officer (IVPPCSCNO) on March 19, 2015 at 10:45 AM, the IVPPCSCNO stated the policy on Intake Assessment and Admission Procedure was still with the Psychiatry Section for review and approval since March 9, 2015. The facility had started implementing changes on the intake assessment and admission procedure of the facility, without the prior approval by the facility leadership.

The QAPI spokesperson stated the committee was not aware that the intake procedure had yet to be approved by the appropriate administrative committee and that the current hospital policies and procedures for behavior patients were not being followed.

7. During an interview conducted on March 20, 2015 at 9 AM, with the members of the QAPI committee, the committee members were informed a Hepatitis B positive patient was identified as having received dialysis during recent admissions to the hospital. The committee members were asked if they were aware the hospital did not have a policy and procedure for the care and management of a patient with Hepatitis B receiving hemodialysis.
On March 17, 2015 at 5:10 PM, an interview was conducted with the Manager of Infection Control (MIC). The MIC was asked if the hospital had a specific policy and procedure for the care and management of the patient with Hepatitis B, specifically those patients receiving hemodialysis services, the MIC stated, "Standard precautions are in place for everyone, we treat everyone as if they are infected, every patient is treated the same."

The spokesperson for the QAPI committee stated they were not aware until the survey team identified the issue.
VIOLATION: MEDICAL STAFF Tag No: A0338
The hospital failed to ensure the Condition of Participation: CFR 482.22 Medical Staff was met by failing to:

1. Identify and correct the issues regarding: the dedicated hemodialysis machine (artificial kidney used to remove waste products and excess fluid from the blood) for HBsAg (a hepatitis B surface antigen which indicates a current hepatitis B infection {an infectious disease which affects the liver}) positive patients; sodium bicarbonate mixing procedure was not in accordance to the company's direction; using a sodium bicarbonate concentration not identified in the facility policy and procedure when the hemodialysis doctor failed to prescribe the sodium bicarbonate concentration; lack of oversight on the hemodialysis unit by the Medical Staff; and corrective actions on the death of a patient in the Behavioral Health Services. The President of the Medical Executive Committee and the entire committee were not aware of these matters. (Refer to A 0283, A 0347, A 0395, A 0749)

2. Ensure the medical staff attempted to secure an autopsy for one patient with an unusual death and of medical-legal and educational interest. (Refer to A 0364)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver quality health care in safe environment which resulted in non-compliance with the Condition of Participation: Medical Staff.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to have the Medical Staff have oversight on the following situations in the hemodialysis unit:

1. Follow the manufacturer's instruction in mixing sodium bicarbonate (chemical compound usually used to counter acidity) dry powder pack for a universe of approximately 170 hemodialysis (a process where the patient's blood passes through a machine to filter the blood of toxins) patients for a period of six (6) months;

2. Provide oversight to the Registered Nurse Hemodialysis Coordinator (RNHC) in the preparation and administration of sodium bicarbonate to use with the dialysis machine for 8 of 30 sampled patients (Patients 21, 22, 23, 24, 26, 27, 28, and 29);

3. Identify in the facility policy and procedure the prescribed amount of sodium bicarbonate concentration to use when the dialysis doctor failed to write in the dialysis order, the amount of sodium bicarbonate for 8 of 30 sampled patients (Patients 21, 22, 23, 24, 26, 27, 28, and 29).

This failure had the potential to cause under or over correction of the acidity in the blood which can affect the health condition of the dialysis patients which could lead to death.

Findings:

1. During an initial tour of the Dialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 2:34 PM, there were two transportable and one fixed dialysis machines in the room. One dialysis machine was being used in one of the rooms in the hospital. There were five containers observed. Three of the containers were filled with bicarbonate solution, and two were empty.

During an observation of the Hemodialysis unit with the RNHC on March 17, 2015 at 8:16 AM, there were 5 packs of 650 grams of dry pack of bicarbonate powder, which contains, Sodium = 37 mEq/L (milliequivalent per liter) and Bicarbonate = 37 mEq/L, stored in the cabinet above the dialysis unit sink. Posted on the cabinet door for the bicarbonate storage was "8.0 Litre [liter] x [for] 1 bicarb [bicarbonate] mix."

During an interview with the RNHC on March 17, 2015 at 8:25 PM, the RNHC stated the dry pack of bicarbonate was dissolved in 8.0 liters of reverse osmosis (RO - water purification technology that uses a semipermeable membrane (a membrane which allows only water molecules and prevent water impurities and bacteria to pass through) to remove particles including bacteria from the water) water.

During an observation of how the RNHC prepared the bicarbonate solution on March 18, 2015 at 9:02 AM, the RNHC did the following steps:

a. poured the entire package of bicarbonate powder to a container filled with eight liters of RO water,

b. capped the container with the blue cap,

c. carried the container then moved the container in a circular manner causing the solution to be agitated,

d. stopped, then removed the blue cap to release the gas accumulation in the container,

e. recapped the container, then carried the container again, then moved the container in a circular manner again causing the solution to be agitated,

f. stopped, then removed the blue cap to release the gas in the container.

The solution was then ready for use as the bicarbonate concentrate for hemodialysis.

The manufacturer's direction for use of the 45X 650 grams [name of company] X1T Dry Pack for Bicarbonate Dialysis manufactured January 7, 2015, indicated: "1. To mix [name of company] dry pack, add 7 liters of purified water to the Mixer. Use purified water that meets AAMI (Association for the Advancement of Medical Instrumentation) water quality standards. Water temperature should be 24 degrees centigrade + 2 degrees centigrade. 2. Empty mix [name of company] dry pack into the water gradually while gently mixing the solution. Add water to 7.94 liters. Mix for 6 minutes after the powder has been added. Let it stand for 5 minutes until the solution will clear. Do not over mix. NOTE: Vigorous mixing and propeller style mixers can drive carbon dioxide from the solution and is therefore not recommended. If mixing is manual, it may be easier to dissolve one third of the bag at a time. Be sure to empty the bag completely..."

During an interview with the RNHC on March 18, 2015 at 9:14 AM, the RNHC stated she spoke with the company representative for the dry pack of bicarbonate powder on the phone on March 17, 2015 at 3:30 PM regarding the procedure of mixing the bicarbonate powder to the RO water. The RNHC stated the company representative stated the facility was "interpreting the directions wrong."

During an interview with the RNHC on March 18, 2015 at 9:24 AM, the RNHC stated there was no training provided on how to prepare the bicarbonate solution from the dry powder form.

During an interview with the President of the Medical Staff (PMS) on March 19, 2015 at 8:30 AM, the PMS stated the Hemodialysis Unit supervision belonged to the Medical Staff. The PMS added the Medical Staff was not aware of the issues in the Hemodialysis Unit.

2. During an initial tour of the Dialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 2:34 PM, it was observed there were five containers, three filled with bicarbonate solution and two were empty, placed near the hemodialysis sink.

During an observation of the Hemodialysis unit with the RNHC on March 17, 2015 at 8:16 AM, there were 5 packs of 650 grams of dry pack of bicarbonate powder, which contains, Sodium = 37 mEq/L (milliequivalent per liter) and Bicarbonate = 37 mEq/L, stored in the cabinet above the dialysis unit sink. Posted on the cabinet door for the bicarbonate storage was "8.0 Litre [liter] x [for] 1 bicarb [bicarbonate] mix."

During an interview with the RNHC on March 17, 2015 at 8:25 PM, the RNHC stated the dry pack of bicarbonate was dissolved in 8.0 liters of reverse osmosis (RO - water purification technology that uses a semipermeable membrane to remove particles including bacteria from the water) water.

During an observation of how the RNHC prepares the bicarbonate solution on March 18, 2015 at 9:02 AM, the RNHC did the following steps:

a. poured the entire package of bicarbonate powder to a container filled with eight (8) liters of RO water,

b. capped the container with the blue cap,

c. carried the container then moved the container in a circular manner causing the solution to be agitated,

d. stopped, then removed the blue cap to release the gas accumulation in the container,

e. recapped the container, then carried the container again, then move the container in a circular manner again causing the solution to be agitated,

f. stopped, then removed the blue cap to release the gas in the container.

The solution was now ready for use as the bicarbonate concentrate for hemodialysis.

During an interview with the RNHC on March 18, 2015 at 9:14 AM, the RNHC stated she spoke with the company representative for the dry pack of bicarbonate powder on the phone on March 17, 2015 at 3:30 PM, regarding the procedure of mixing the bicarbonate powder to the RO water. The RNHC stated the company representative said that the facility was "interpreting the directions wrong."

During an interview with the RNHC on March 18, 2015 at 9:25 AM, the RNHC stated the Director of ED (Emergency Department), ICU (Intensive Care Unit), and Hemodialysis (DEIH) was not involved in the interpretation of the direction for mixing the dry powder bicarbonate to the RO water. The RNHC added there were no in services organized by the DEIH for the mixing of the dry powder bicarbonate with the RO water.

During a review of Patient 21's medical record, Patient 21's face sheet (a general patient identifier information) indicated the patient was admitted on [DATE] at 6:53 PM. Patient 21's Hemodialysis Order Record on March 14, 2015 at 10:59 AM, and on March 16, 2015 at 9:16 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet (documentation of the nurse of the hemodialysis of the patient) for Patient 21 on March 14, 2015 at 4:45 PM, and on March 16, 2015 at 2:20 PM, indicated the hemodialysis nurse performing the dialysis procedure on the mentioned dates used 35 Gms (grams) of NaHCO3 (sodium bicarbonate).

During a review of Patient 22's medical record, Patient 22's face sheet indicated the patient was admitted on [DATE] at 1:15 AM. Patient 22's Hemodialysis Order Record on March 13, 2015 at 10:55 AM, March 14, 2015 at 11:05 AM, and on March 15, 2015 at 11:08 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 22 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the hemodialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 23's medical record, Patient 23's face sheet indicated the patient was admitted on [DATE] at 11:15 PM. Patient 23's Hemodialysis Order Record on February 27, 2015 at 10:19, February 28, 2015 at 9:59 PM, March 2, 2015 at 11:51 AM, March 4, 2015 at 5:40 PM, March 5, 2015 at 1:11 PM, March 7, 2015 at 2:21 PM, March 8, 2015 at 8:44 AM, March 10, 2015 at 4:24 PM, March 11, 2015 at 10:34 AM, March 11, 2015 at 11:05 AM, March 13, 2015 at 10:29 AM, March 16, 2015 at 10:48 AM, March 19, 2015 at 10 AM, and on March 19, 2015 at 5:28 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 23 on February 27, 2015 at 12:30 AM, February 28, 2015 at 3:50 PM, March 1, 2015 at 3 PM, March 3, 2015 at 12:50 PM, March 5, 2015 at 12:15 PM, March 6, 2015 at 5:15 PM, March 8, 2015 at 3:10 PM, March 9, 2015 at 4:45 PM, March 11, 2015 at 8:15 PM, March 12, 2015 at 12:35 PM, March 14, 2015 at 12:20 PM, and on March 17, 2015 at 2:30 PM, indicated the hemodialysis nurse performing the hemodialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 24's medical record, Patient 24's face sheet indicated the patient was admitted on [DATE] at 9:10 PM. Patient 24's Hemodialysis Order Record on March 9, 2015 at 3:27 PM, March 10, 2015 at 2:33 PM, March 12, 2015 at 3:38 PM, March 13, 2015 at 11:34 AM, March 14, 2015 at 8:39 PM, March 16, 2015 at 10:56 AM, and on March 17, 2015 at 10:44 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 24 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the hemodialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 26's medical record, Patient 26's face sheet indicated the patient was admitted on [DATE] at 11:30 PM. Patient 26's Hemodialysis Order Record on January 21, 2015 at 1:47 PM, and on January 22, 2015 at 2:52 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 26 on January 21, 2015 at 9:55 PM, and January 23, 2015 at 5:20 PM, indicated the hemodialysis nurse performing the hemodialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 27's medical record, Patient 27's face sheet indicated the patient was admitted on [DATE] at 2 PM. Patient 27's Hemodialysis Order Record on February 26, 2015 at 1:35 PM, February 27, 2015 at 10:38 AM, March 1, 2015 at 9:07 PM, March 3, 2015 at 11:28 AM, March 5, 2015 at 1:32 PM, March 8, 2015 at 8:48 AM, and on March 11, 2015 at 12:26 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 27 on February 27, 2015 at 3:40 PM, February 28, 2015 at 11:30 AM, March 2, 2015 at 1:30 PM, March 4, 2015 at 12:40 PM, March 6, 2015 at 1 PM, March 10, 2015 at 8:40 PM, and on March 12, 2015 at 12:50 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 28's medical record, Patient 28's face sheet indicated the patient was admitted on [DATE] at 9:30 AM. Patient 28's Hemodialysis Order Record on February 12, 2015 at 4:46 PM, January 14, 2015 at 2:20 PM, January 16, 2015 at 11:49 AM, January 18, 2015 at 4:45 PM, and on January 19, 2015 10:12 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 28 on January 13, 2015 at 4 PM, January 15, 2015 at 4:30 PM, January 17, 2015 at 5:40 PM, January 19, 2015 at 1 PM, and on January 20, 2015 at 5 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 29's medical record, Patient 29's face sheet indicated the patient was admitted on [DATE] at 4:00 PM. Patient 29's Hemodialysis Order Record on February 18, 2015 at 8:53 AM, February 19, 2015 at 9:50 AM, February 22, 2015 at 10:23 AM, February 24, 2015 at 8:19 AM, February 24, 2015 at 4:21 PM, March 1, 2015 at 10:33 AM, March 2, 2015 at 10:04 AM, March 3, 2015 at 1:22 PM, March 5, 2015 at 10:05 AM, and on March 9, 2015 at 9:41 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 29 on February 18, 2015 at 1:50 PM, February 20, 2015 at 2 PM, February 23, 2015 at 1:25 PM, February 25, 2015 at 12:45 PM, March 2, 2015 at 12:40 PM, March 3, 2015 at 4:30 PM, March 4, 2015 at 1:30 PM, March 6, 2015 at 4:15 PM, March 9, 2015 at 1:10 PM, and on March 10, 2015 at 2:45 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During an interview with the RNHC on March 18, 2015 at 4:39 PM, the RNHC stated if some doctors did not specify in their orders the bicarbonate concentration to use during dialysis, the facility used 35 grams as a standard dose.

During an interview with the Medical Director Hemodialysis Unit (MDHU) on March 18, 2015 at 3:50 PM, the MDHU stated he relied on the hemodialysis nurse regarding what concentration of bicarbonate to use for dialysis when the doctor failed to prescribe the bicarbonate. The MDHU added: "I am not paranoid [referring to the hemodialysis nurses' judgment on the use of the bicarbonate concentration]."

During a review of the "First Amendment to Medical Director Agreement" between the MDHU and the facility, effective on October 1, 2012, indicated under Director Services: "Physician shall: 1. Provide general administration of the day-to-day operations of the Department; 2. Advise and assist Hospital in implementing Hospital's policies and procedures regarding the Department; ...5. Be Responsible to the Hospital administration for the professional services and medical management of the Department and participate in the management development programs..."

During an interview with the Director of ED, ICU and Hemodialysis (DEIH) on March 18, 2015 at 5 PM, the DEIH stated the process and patient services oversight in the hemodialysis unit were delegated to the MDHU. The DEIH only functioned administratively (policy process, payroll, materials and supply procurement) in the hemodialysis unit.

The facility policy and procedure titled, "Physician's Order for the Dialysis Patient," reviewed date March 2012, did not specify any concentration of bicarbonate to use during dialysis when the doctor failed to prescribed the appropriate concentration of bicarbonate.

During an interview with the President of the Medical Staff (PMS) on March 19, 2015 at 8:30 AM, the PMS stated the Hemodialysis Unit supervision belonged to the Medical Staff. The PMS added the Medical Staff was not aware of the issues in the Hemodialysis Unit.

3. During a review of Patient 21's medical record, Patient 21's face sheet (a general patient identifier information) indicated the patient was admitted on [DATE] at 6:53 PM. Patient 21's Hemodialysis Order Record on March 14, 2015 at 10:59 AM, and on March 16, 2015 at 9:16 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet (documentation of the nurse of the hemodialysis of the patient) for Patient 21 on March 14, 2015 at 4:45 PM, and on March 16, 2015 at 2:20 PM, indicated the hemodialysis nurse performing the dialysis procedure on the mentioned dates used 35 Gms (grams) of NaHCO3 (sodium bicarbonate).

During a review of Patient 22's medical record, Patient 22's face sheet indicated the patient was admitted on [DATE] at 1:15 AM. Patient 22's Hemodialysis Order Record on March 13, 2015 at 10:55 AM, March 14, 2015 at 11:05 AM, and on March 15, 2015 at 11:08 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 22 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 23's medical record, Patient 23's face sheet indicated the patient was admitted on [DATE] at 11:15 PM. Patient 23's Hemodialysis Order Record on February 27, 2015 at 10:19, February 28, 2015 at 9:59 PM, March 2, 2015 at 11:51 AM, March 4, 2015 at 5:40 PM, March 5, 2015 at 1:11 PM, March 7, 2015 at 2:21 PM, March 8, 2015 at 8:44 AM, March 10, 2015 at 4:24 PM, March 11, 2015 at 10:34 AM, March 11, 2015 at 11:05 AM, March 13, 2015 at 10:29 AM, March 16, 2015 at 10:48 AM, March 19, 2015 at 10 AM, and on March 19, 2015 at 5:28 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 23 on February 27, 2015 at 12:30 AM, February 28, 2015 at 3:50 PM, March 1, 2015 at 3 PM, March 3, 2015 at 12:50 PM, March 5, 2015 at 12:15 PM, March 6, 2015 at 5:15 PM, March 8, 2015 at 3:10 PM, March 9, 2015 at 4:45 PM, March 11, 2015 at 8:15 PM, March 12, 2015 at 12:35 PM, March 14, 2015 at 12:20 PM, and on March 17, 2015 at 2:30 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 24's medical record, Patient 24's face sheet indicated the patient was admitted on [DATE] at 9:10 PM. Patient 24's Hemodialysis Order Record on March 9, 2015 at 3:27 PM, March 10, 2015 at 2:33 PM, March 12, 2015 at 3:38 PM, March 13, 2015 at 11:34 AM, March 14, 2015 at 8:39 PM, March 16, 2015 at 10:56 AM, and on March 17, 2015 at 10:44 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 24 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 26's medical record, Patient 26's face sheet indicated the patient was admitted on [DATE] at 11:30 PM. Patient 26's Hemodialysis Order Record on January 21, 2015 at 1:47 PM, and on January 22, 2015 at 2:52 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 26 on January 21, 2015 at 9:55 PM, and January 23, 2015 at 5:20 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 27's medical record, Patient 27's face sheet indicated the patient was admitted on [DATE] at 2:00 PM. Patient 27's Hemodialysis Order Record on February 26, 2015 at 1:35 PM, February 27, 2015 at 10:38 AM, March 1, 2015 at 9:07 PM, March 3, 2015 at 11:28 AM, March 5, 2015 at 1:32 PM, March 8, 2015 at 8:48 AM, and on March 11, 2015 at 12:26 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 27 on February 27, 2015 at 3:40 PM, February 28, 2015 at 11:30 AM, March 2, 2015 at 1:30 PM, March 4, 2015 at 12:40 PM, March 6, 2015 at 1 PM, March 10, 2015 at 8:40 PM, and on March 12, 2015 at 12:50 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 28's medical record, Patient 28's face sheet indicated the patient was admitted on [DATE] at 9:30 AM. Patient 28's Hemodialysis Order Record on February 12, 2015 at 4:46 PM, January 14, 2015 at 2:20 PM, January 16, 2015 at 11:49 AM, January 18, 2015 at 4:45 PM, and on January 19, 2015 10:12 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 28 on January 13, 2015 at 4 PM, January 15, 2015 at 4:30 PM, January 17, 2015 at 5:40 PM, January 19, 2015 at 1 PM, and on January 20, 2015 at 5 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 29's medical record, Patient 29's face sheet indicated the patient was admitted on [DATE] at 4:00 PM. Patient 29's Hemodialysis Order Record on February 18, 2015 at 8:53 AM, February 19, 2015 at 9:50 AM, February 22, 2015 at 10:23 AM, February 24, 2015 at 8:19 AM, February 24, 2015 at 4:21 PM, March 1, 2015 at 10:33 AM, March 2, 2015 at 10:04 AM, March 3, 2015 at 1:22 PM, March 5, 2015 at 10:05 AM, and on March 9, 2015 at 9:41 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 29 on February 18, 2015 at 1:50 PM, February 20, 2015 at 2:00 PM, February 23, 2015 at 1:25 PM, February 25, 2015 at 12:45 PM, March 2, 2015 at 12:40 PM, March 3, 2015 at 4:30 PM, March 4, 2015 at 1:30 PM, March 6, 2015 at 4:15 PM, March 9, 2015 at 1:10 PM, and on March 10, 2015 at 2:45 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During an interview with the RNHC on March 18, 2015 at 4:39 PM, the RNHC stated if some doctors did not specify in their orders the bicarbonate concentration to use during dialysis, the facility used 35 grams as a standard dose.

During an interview with the Medical Director Hemodialysis Unit (MDHU) on March 18, 2015 at 3:50 PM, the MDHU stated he delegated on the hemodialysis nurse regarding what concentration of bicarbonate to use for dialysis when the doctor failed to prescribe the bicarbonate. The MDHU added: "I am not paranoid [referring to the hemodialysis nurses' judgment on the use of the bicarbonate concentration]."

The facility policy and procedure titled, "Physician's Order for the Dialysis Patient," reviewed date March 2012, did not specify any concentration of bicarbonate to use during dialysis when the doctor failed to prescribed the appropriate concentration of bicarbonate. There were no other facility policy and procedure provided to indicate 35 Gms as the standard to use if the doctor failed to prescribe the bicarbonate concentration for hemodialysis.

During an interview with the President of the Medical Staff (PMS) on March 19, 2015 at 8:30 AM, the PMS stated that the Hemodialysis Unit supervision belonged to the Medical Staff. The PMS further added the Medical Staff was not aware of the issues in the Hemodialysis Unit.
VIOLATION: AUTOPSIES Tag No: A0364
Based on interview and record review, the hospital failed to ensure the medical staff attempted to secure an autopsy for one patient with an unusual death and of medical-legal and educational interest. This failure led to the hospital not knowing how and why a patient died . This lack of knowledge could potentially lead to patient harm by not being able to institute a new hospital practice in similar situations.

Findings:

On October 4, 2014, Patient 30 was found not breathing in the hospital behavioral unit. Attempts to resuscitate failed and the patient was declared dead at 5:30 AM.

A review of the patient's clinical record indicated the patient had a history of cardiovascular concerns including QT prolongation (an elongation of the time between the start of a electrical event in the heart and another. A lengthened QT interval indicated the potential for fatal abnormal heart rhythm and a risk factor for sudden death). In addition, the patient was administered Haldol (haloperidol - a medication used for psychotic symptoms) at approximately 11:56 PM on October 3, 2014.

Lexicomp, a widely used and respected medication information resource, indicated in the medication profile for Haldol, "Warnings/Precautions; Altered cardiac conduction: May alter cardiac conduction and prolong QT interval. Monitor ECG closely for dose-related QT effects."

A record review for Patient 30 showed a "Death Notification/Mortuary Release" document was filled out partially. This document included the patient's name, date of birth, date/time of death, next of kin, etc. It also indicated the coroner was notified and a waiver for investigation was provided. Disposition of the patient's remains indicated they were being released to a mortuary. On the form, a section titled, "Consent for Autopsy" was not filled out with any information.

A review of the physician's notes in the clinical record does not indicate the next of kin or family was asked if an autopsy could be performed. Review of the physician's notes does not indicate the physician knew exactly how the patient expired.

On March 20, 2015 at 9:35 AM, an interview with the Director of Risk Management, Patient Relations and Patient Safety Officer (DRMPRPSO) was conducted. She provided a hospital policy and procedure on "Patient Death, Disposition, and Documentation" (Policy No. 8720.0120). The DRMPRPSO was asked if an autopsy was done and she stated, "No." When asked why one was not done, she stated, "I think that is a good question." When asked if she thought this was an unusual death and of medical-legal and education interested, she stated, "Yes."

The hospital policy and procedure regarding "Patient Death, Disposition, and Documentation" (Policy No. 8720.0120) mentions autopsy under the Procedure section, subsection 5.0, which showed, "If family, legal representative or physician is requesting an autopsy, contact the risk manager."

On March 20, 2015 at 10:15 AM, an interview with the patient's medical doctor (MD 1) was conducted. The case of Patient 30 was discussed and MD 1 stated he remembered it. He confirmed he was the physician responsible for medical care. When asked why an autopsy was not done, he stated, "Because Medicare doesn't pay for it." He stated, "Nobody gets reimbursed." He was asked whether he thought this patient's death was unusual or of medical-legal and educational interest, he stated, "Yes, but there are so many other cases that are more interesting." He stated, "It's so hard to get things done by a conservator."
VIOLATION: NURSING SERVICES Tag No: A0385
The hospital failed to ensure the Condition of Participation: CFR 482.23 Nursing Services was met by failing to:

1. Provide appropriate, adequate supervision, and evaluation of the type of care provided to one patient who died in the facility. The facility policy and procedure on Intake Assessment and Admission were not approved by the facility leadership for utilization. The compliance with the Q (every) 15-minute recording and observation is not 100%. The occurrence of Registered Nurse (RN) and Licensed Vocational Nurse (LVN) staff falsifying records. (Refer to A 0283, A 0395)

2. Appropriately prepare and administer sodium bicarbonate (a chemical component used in dialysate - a fluid mixture to help cleanse the blood and balance acidity in dialysis patients) used in hemodialysis. (Refer to A 0405)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Nursing Services.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to provide appropriate and adequate supervision and evaluation of the type of care provided to one (1) of 30 sampled patients (Patient 30). This failure led to Patient 30's death when the facility failed to monitor the patient every 15 minutes as falsely documented for 5 hours.

Findings:

A review of medical record from the referring hospital for Patient 30, the face sheet indicated the patient was admitted on [DATE] at 8:31 AM on a 5150 (level of care for patient with psychological issues who is a danger to self and others). Lab results on October 2, 2014 at 8:30 AM, indicated Total CPK (Total creatine phosphokinase - a substance produced by the heart, brain, and muscles as a result from injury) = 382 (normal = 10-120 mcg/L (micrograms per liter)); ECG (electrocardiogram - test done to check the electrical activity of the heart) results on October 2, 2014 at 9:45 AM, indicated: "Low voltage QRS. T wave abnormality (present in the ECG to signify damage at one part of the heart), consider anterior ischemia (a loss of blood supply, causing a shortage of oxygen and glucose leading to tissue damage). Prolonged QT (irregular heartbeat which originates from the ventricles {the lower two chambers of the heart} which can lead to ventricular fibrillation {where the muscle of the ventricles quiver instead of contract which can lead to fainting and sudden death})."

A review of the Patient 30's face sheet from the facility indicated the patient was admitted on [DATE] at 11:30 PM with a diagnosis of schizophrenia (a mental disorder characterized by abnormal social behavior and failure to recognize what is real).

A review of the Adults Admission Nursing Assessment document for Patient 30 on October 2, 2014 at 11:40 PM indicated the patient was referred from [name of the hospital].

A review of the Intake Assessment Form for Patient 30 on October 2, 2014 at 6:30 PM, indicated the patient "met criteria for 5150. Admit to locked unit (east)..."

A review of the Suicide/Self-Harm Assessment document for Patient 30 on October 2 at 11:40 PM, indicated Patient 30 received a score of 7 which was "No Precaution" but needed "Observation (q [every] 15 minutes)."

A review of the Q15-Minutes Observation Record - BHS for Patient 30 from October 2 2014 at 11:30 PM till October 4, 2014 at 4:45 AM, indicated the patient's every 15 minutes (observation) was initialed [meant done] by the nurses assigned.

A review of the Consultation Report for Patient 30 dictated on October 3, 2014 at 6:22 PM, indicated: "ADDENDUM REPORT: [Patient 30's] electrocardiogram (ECG) done at the previous facility revealed the patient had T-wave abnormality, consider anterior wall ischemia (lost of blood supply leading to tissue death on the frontal side of the heart), prolonged QT..."

A review of the ECG results for Patient 30 on October 3, 2014 at 4:41 PM, indicated: "...Prolonged QT."

A review of the laboratory results for Patient 30, indicated the CK (substance produced by the heart when there is inflammation of the heart) level on October 3, 2014 at 7:20 PM was 337 (normal = 22-269), and the CKMB (a blood test to monitor heart attack if the CK is high) on October 3 2014 at 7:59 PM was 8.0 (normal = 0.6-6.3).

A review of the Medication Administration Summary on October 13, 2014 at 12:45 AM, and on October 13, 2014 at 11:56 PM, indicated Haldol (medication used for severe mental disorder like schizophrenia) 5 mg (milligrams), Ativan (medication used for agitation and anxious patients) 1 mg, and Benadryl (used for sleepiness effect and to counter the side effects of Haldol) 50 mg were given IM (injected to the muscles).

A review of the ER Code Blue (an emergency procedure to revive a patient who is not breathing and does not have a pulse) Note on October 4, 2014 at 5:28 AM, documented: "...found at 4:50 AM per nurse with no pulse, last seen at midnight. CPR (Cardiopulmonary resuscitation) x (for) 30 min with asystole (heart stopped with no rhythm). Intubated (breathing tube inserted through the mouth down to the lungs for breathing), central line placed (a large bore flexible tube placed on a large vein usually on the left or right upper arm)."

A review of the discharge summary sheet for Patient 30, dictated on October 9, 2014 at 11:05 AM, indicated: "Reason for Admission: The patient originally was admitted on 5150 for grave disability because [patient] was very disorganized and rambling in nonsense and incoherent things, and responding to internal stimuli (hearing voices, hallucination) ..." Under Hospital Course: "...The patient was given Haldol 5 mg, Ativan 1 mg, and Benadryl 50 mg IM for increase agitation on October 3, 2014, which was ordered by MD 1 who was on-call doctor. The patient was exploring following symptoms. The patient was banging the feet on the wall and table in the room. The patient was not able to be redirected. The patient's on call doctor, MD 1, was called and the patient was given Haldol 5 mg, Ativan 1 mg, and Benadryl 50 mg on October 3, 2014. According to the reports, the patient was given the above medications on October 3, 2014 at 11:56 PM. The patient calmed down [after receiving the medications]. The patient was monitored by the nursing staff as per the protocol. At around 5 AM in the morning, Code Blue was called and the emergency cart was taken to the patient's room. The patient's respiratory therapist was present. A full code was done. The patient's emergency room doctor (MD 2) came for the CPR (Cardiopulmonary Resuscitation - cardiac compression with artificial means of breathing), also the patient was declared dead at around 5:30 AM..."

During an interview with the DRMPRPSO on March 18, 2015 at 2:29 PM when asked about the documentation of the ER (emergency room ) doctor during code blue, the DRMPRPSO stated the nursing staff told the ER Doctor (MD 2) Patient 30 was last seen by staff at midnight.

During an interview with the DRMPRPSO on March 18, 2015 at 2:32 PM when asked about the Q 15-Minutes monitoring by the staff, the DRMPRPSO stated no registered nurse, licensed vocation nurse, or mental health worker checked Patient 30 from midnight of October 4, 2014. The DRMPRPSO stated the Director of Behavioral Health Services (DBHS), and the Vice President of Behavioral Health services (VPBHS) checked the surveillance video in the behavioral unit, and confirmed the staff members did not monitor Patient 30.

During an interview with the DRMPRPSO on March 18, 2015 at 2:35 PM, the DRMPRPSO stated the staff members, involved in the Q 15-Minute monitoring, were no longer working in the facility due to falsification of the Q 15-Minutes Observation Record for Patient 30.

During an interview with the Senior Human Resource Assistant (SHRA) on March 20, 2015 at 10:15 AM, the SHRA stated there were four (3) Registered Nurses and two (2) Licensed Vocational Nurses terminated related to the incident. The SHRA added the Senior Director of Nurses (SDN), who was the Interim CNO (Chief Nursing Officer) back in October 2014, informed the Board of Registered Nursing and Board of Vocational Nursing and Psychiatric Technician about the staffs termination due to falsification of medical records.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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

1) Follow the manufacturer's instruction for preparation of sodium bicarbonate (an ingredient used in dialysate - a fluid mixture used in hemodialysis [a process of removing of excess fluids and toxins in the blood through a specialized machine] to help cleanse the blood and balance the acid levels in the blood of patients with kidney failure) dry powder pack for a universe of approximately 170 hemodialysis patients for a period of six (6) months;

2) Provide oversight to the Registered Nurse Hemodialysis Coordinator (RNHC) in the preparation and administration of sodium bicarbonate to use with the hemodialysis machine for eight (8) of 30 sampled patients (Patients 21, 22, 23, 24, 26, 27, 28, and 29);

3) Identify in the facility policy and procedure, the prescribed amount of sodium bicarbonate concentration to use when the dialysis doctor failed to write in the dialysis order the amount of sodium bicarbonate for eight (8) of 30 sampled patients (Patients 21, 22, 23, 24, 26, 27, 28, and 29);

4) Administer a famotidine injection (medication used to prevent and treat ulcers of the stomach or intestines) as ordered by the physician for Patient 1;
5) Appropriately date emergency department medication orders for three (3) patients (Patients 5, 6 and 7);
6) Reassess pain for a patient (Patient 6) after pain medication was administered.
These failures had the potential to cause problems with dialysis patient's acid-base balance and patient's not receiving medications appropriately which can affect their health condition and lead to further complications.

On March 19, 2015 at 9:14 AM, Immediate Jeopardy #2 was called with the Interim Vice President of Patient Care Services, Chief Nursing Officer, Regional Vice President of Patient Care Services and the Vice President of Medical Affairs, due to the facility's failure to properly mix (gently mix) the bicarbonate (a chemical component used in dialysis machines) solution according to manufacturer guidelines, the dialysis coordinator Registered Nurse 4 (RN 4) choosing and setting the bicarbonate level on the dialysis machine despite no approved hospital protocol or order from the prescribing physician, and a lack of oversight of the dialysis unit by the Registered Nurse Director of Emergency Department/Intensive Care Unit/Hemodialysis and the Medical Director Nephrologist. On March 19, 2015 at 6:01 PM, Immediate Jeopardy #2 was abated in the presence of the Interim Vice President of Patient Care Services, Chief Nursing Officer, and the Regional Vice President of Patient Care Services after an acceptable corrective action plan was presented to the survey team.

Findings:

1. During an initial tour of the Dialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 2:34 PM, it was observed that there were five (5) plastic containers, three (3) filled with bicarbonate solution and 2 were empty, placed near the hemodialysis unit sink.

During an observation of the Hemodialysis unit with the RNHC on March 17, 2015 at 8:16 AM, there were 5 packs of 650 grams of dry pack of bicarbonate powder, which contains, Sodium = 37 mEq/L (milliequivalent per liter) and Bicarbonate = 37 mEq/L, stored in the cabinet above the dialysis unit sink. Posted on the cabinet door for the bicarbonate storage was "8.0 Litre [liter] x [for] 1 bicarb [bicarbonate] mix."

During an interview with the RNHC on March 17, 2015 at 8:25 PM, the RNHC stated the dry pack of bicarbonate was dissolved in 8.0 liters of reverse osmosis (RO - water purification technology that uses a semipermeable membrane [a membrane which allows only water molecules and prevent impurities and bacteria to pass through] to remove particles including bacteria from the water) water.

During an observation of how the RNHC prepares the bicarbonate solution on March 18, 2015 at 9:02 AM, the RNHC demonstrated the following steps:

a. poured the entire package of bicarbonate powder to a container filled with eight (8) liters of RO water,

b. capped the container with the blue cap,

c. moved the container in a circular manner (shaking) causing the solution to be agitated,

d. removed the blue cap to release the gas accumulation in the container,

e. recapped the container, then moved the container in a circular manner again causing the solution to be agitated,

f. stopped then removed the blue cap to release the gas in the container.

The solution was now ready for use as the bicarbonate concentrate for hemodialysis.

During an interview with the RNHC on March 18, 2015 at 9:14 AM, the RNHC stated that she spoke with the company representative for the dry pack of bicarbonate powder on the phone on March 17, 2015 at 3:30 PM regarding the procedure of mixing the bicarbonate powder to the RO water. The RNHC further stated the company representative said the facility was "interpreting the directions wrong."

The direction for use of the 45X 650 grams [name of company] X1T Dry Pack for Bicarbonate Dialysis manufactured January 7, 2015, indicated: "1. To mix [name of company] dry pack, add 7 liters of purified water to the Mixer. Use purified water that meets AAMI (Association for the Advancement of Medical Instrumentation) water quality standards. Water temperature should be 24 degrees centigrade + 2 degrees centigrade. 2. Empty mix [name of company] dry pack into the water gradually while gently mixing the solution. Add water to 7.94 liters. Mix for 6 minutes after the powder has been added. Let it stand for 5 minutes until the solution will clear. Do not over mix. NOTE: Vigorous mixing and propeller style mixers can drive carbon dioxide (a colorless, odorless gas) from the solution and is therefore not recommended. If mixing is manual, it may be easier to dissolve one third of the bag at a time. Be sure to empty the bag completely..."

During an interview with the RNHC on March 18, 2015 at 9:24 AM, the RNHC stated there was no in-service training done on how to prepare the bicarbonate solution from the dry powder form.

2. During an observation of the Hemodialysis unit with the RNHC on March 17, 2015 at 8:16 AM, there were 5 packs of 650 grams of dry pack of bicarbonate powder, which contains, Sodium = 37 mEq/L (milliequivalent per liter) and Bicarbonate = 37 mEq/L, stored in the cabinet above the dialysis unit sink. Posted on the cabinet door for the bicarbonate storage was "8.0 Litre [liter] x [for] 1 bicarb [bicarbonate] mix."

During an interview with the RNHC on March 17, 2015 at 8:25 PM, the RNHC stated the dry pack of bicarbonate was dissolved in 8.0 liters of reverse osmosis (RO - water purification technology that uses a semipermeable membrane [a membrane which allows only water molecules and prevent impurities and bacteria to pass through] to remove particles including bacteria from the water) water.

During an observation of how the RNHC prepares the bicarbonate solution on March 18, 2015 at 9:02 AM, the RNHC demonstrated the following steps:

a. poured the entire package of bicarbonate powder to a container filled with eight (8) liters of RO water,

b. capped the container with the blue cap,

c. moved the container in a circular manner causing the solution to be agitated,

d. removed the blue cap to release the gas accumulation in the container,

e. recapped the container, then move the container in a circular manner again causing the solution to be agitated,

f. stopped then removed the blue cap to release the gas in the container.

The solution was then ready for use as the bicarbonate concentrate for hemodialysis.

During an interview with the RNHC on March 18, 2015 at 9:14 AM, the RNHC stated that she spoke with the company representative for the dry pack of bicarbonate powder on the phone on March 17, 2015 at 3:30 PM regarding the procedure of mixing the bicarbonate powder to the RO water. The RNHC further stated the company representative said the facility was "interpreting the directions wrong."

During an interview with the RNHC on March 18, 2015 at 9:25 AM, the RNHC stated the Director of ED (Emergency Department), ICU (Intensive Care Unit), and Hemodialysis (DEIH) was not involved in the interpretation of the direction for mixing the dry powder bicarbonate to the RO water. The RNHC also added there were no in-service training organized by the DEIH for the mixing of the dry powder bicarbonate with the RO water.

During a review of Patient 21's medical record, Patient 21's face sheet (a general patient identifier information) indicated the patient was admitted on [DATE] at 6:53 PM. Patient 21's Hemodialysis Order Record on March 14, 2015 at 10:59 AM, and on March 16, 2015 at 9:16 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet (documentation of the nurse of the hemodialysis of the patient) for Patient 21 on March 14, 2015 at 4:45 PM, and on March 16, 2015 at 2:20 PM, indicated the hemodialysis nurse performing the dialysis procedure on the mentioned dates used 35 Gms (grams) of NaHCO3 (sodium bicarbonate).

During a review of Patient 22's medical record, Patient 22's face sheet indicated the patient was admitted on [DATE] at 1:15 AM. Patient 22's Hemodialysis Order Record on March 13, 2015 at 10:55 AM, March 14, 2015 at 11:05 AM, and on March 15, 2015 at 11:08 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 22 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 23's medical record, Patient 23's face sheet indicated the patient was admitted on [DATE] at 11:15 PM. Patient 23's Hemodialysis Order Record on February 27, 2015 at 10:19, February 28, 2015 at 9:59 PM, March 2, 2015 at 11:51 AM, March 4, 2015 at 5:40 PM, March 5, 2015 at 1:11 PM, March 7, 2015 at 2:21 PM, March 8, 2015 at 8:44 AM, March 10, 2015 at 4:24 PM, March 11, 2015 at 10:34 AM, March 11, 2015 at 11:05 AM, March 13, 2015 at 10:29 AM, March 16, 2015 at 10:48 AM, March 19, 2015 at 10 AM, and on March 19, 2015 at 5:28 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 23 on February 27, 2015 at 12:30 AM, February 28, 2015 at 3:50 PM, March 1, 2015 at 3 PM, March 3, 2015 at 12:50 PM, March 5, 2015 at 12:15 PM, March 6, 2015 at 5:15 PM, March 8, 2015 at 3:10 PM, March 9, 2015 at 4:45 PM, March 11, 2015 at 8:15 PM, March 12, 2015 at 12:35 PM, March 14, 2015 at 12:20 PM, and on March 17, 2015 at 2:30 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 24's medical record, Patient 24's face sheet indicated the patient was admitted on [DATE] at 9:10 PM. Patient 24's Hemodialysis Order Record on March 9, 2015 at 3:27 PM, March 10, 2015 at 2:33 PM, March 12, 2015 at 3:38 PM, March 13, 2015 at 11:34 AM, March 14, 2015 at 8:39 PM, March 16, 2015 at 10:56 AM, and on March 17, 2015 at 10:44 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 24 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 26's medical record, Patient 26's face sheet indicated the patient was admitted on [DATE] at 11:30 PM. Patient 26's Hemodialysis Order Record on January 21, 2015 at 1:47 PM, and on January 22, 2015 at 2:52 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 26 on January 21, 2015 at 9:55 PM, and January 23, 2015 at 5:20 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 27's medical record, Patient 27's face sheet indicated the patient was admitted on [DATE] at 2 PM. Patient 27's Hemodialysis Order Record on February 26, 2015 at 1:35 PM, February 27, 2015 at 10:38 AM, March 1, 2015 at 9:07 PM, March 3, 2015 at 11:28 AM, March 5, 2015 at 1:32 PM, March 8, 2015 at 8:48 AM, and on March 11, 2015 at 12:26 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 27 on February 27, 2015 at 3:40 PM, February 28, 2015 at 11:30 AM, March 2, 2015 at 1:30 PM, March 4, 2015 at 12:40 PM, March 6, 2015 at 1 PM, March 10, 2015 at 8:40 PM, and on March 12, 2015 at 12:50 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 28's medical record, Patient 28's face sheet indicated the patient was admitted on [DATE] at 9:30 AM. Patient 28's Hemodialysis Order Record on February 12, 2015 at 4:46 PM, January 14, 2015 at 2:20 PM, January 16, 2015 at 11:49 AM, January 18, 2015 at 4:45 PM, and on January 19, 2015 10:12 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 28 on January 13, 2015 at 4 PM, January 15, 2015 at 4:30 PM, January 17, 2015 at 5:40 PM, January 19, 2015 at 1 PM, and on January 20, 2015 at 5:00 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 29's medical record, Patient 29's face sheet indicated the patient was admitted on [DATE] at 4:00 PM. Patient 29's Hemodialysis Order Record on February 18, 2015 at 8:53 AM, February 19, 2015 at 9:50 AM, February 22, 2015 at 10:23 AM, February 24, 2015 at 8:19 AM, February 24, 2015 at 4:21 PM, March 1, 2015 at 10:33 AM, March 2, 2015 at 10:04 AM, March 3, 2015 at 1:22 PM, March 5, 2015 at 10:05 AM, and on March 9, 2015 at 9:41 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 29 on February 18, 2015 at 1:50 PM, February 20, 2015 at 2 PM, February 23, 2015 at 1:25 PM, February 25, 2015 at 12:45 PM, March 2, 2015 at 12:40 PM, March 3, 2015 at 4:30 PM, March 4, 2015 at 1:30 PM, March 6, 2015 at 4:15 PM, March 9, 2015 at 1:10 PM, and on March 10, 2015 at 2:45 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3 (sodium bicarbonate).

During an interview with the RNHC on March 18, 2015 at 4:39 PM, the RNHC stated if some doctors did not specify in their orders the bicarbonate concentration to use during dialysis, the facility used 35 grams as a standard dose.

During an interview with the Medical Director Hemodialysis Unit (MDHU) on March 18, 2015 at 3:50 PM, the MDHU stated he relied on the hemodialysis nurse regarding what concentration of bicarbonate to use for dialysis when the doctor failed to prescribe the bicarbonate.

During a review of the "First Amendment to Medical Director Agreement" between the MDHU and the facility, effective on October 1, 2012, indicated under Director Services: "Physician shall: 1. Provide general administration of the day-to-day operations of the Department; 2. Advise and assist Hospital in implementing Hospital's policies and procedures regarding the Department; ...5. Be Responsible to the Hospital administration for the professional services and medical management of the Department and participate in the management development programs..."

During an interview with the Director of ED, ICU and Hemodialysis (DEIH) on March 18, 2015 at 5 PM, the DEIH stated the process and patient services oversight in the hemodialysis unit were relied to the MDHU. The DEIH only functioned administratively (policy process, payroll, materials and supply procurement) in the hemodialysis unit.

The facility policy and procedure titled, "Physician's Order for the Dialysis Patient," reviewed date March 2012, did not specify any concentration of bicarbonate to use during dialysis when the doctor failed to prescribed the appropriate concentration of bicarbonate.

3. During a review of Patient 21's medical record, Patient 21's face sheet (a general patient identifier information) indicated the patient was admitted on [DATE] at 6:53 PM. Patient 21's Hemodialysis Order Record on March 14, 2015 at 10:59 AM, and on March 16, 2015 at 9:16 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet (documentation of the nurse of the hemodialysis of the patient) for Patient 21 on March 14, 2015 at 4:45 PM, and on March 16, 2015 at 2:20 PM, indicated the hemodialysis nurse performing the dialysis procedure on the mentioned dates used 35 Gms (grams) of NaHCO3 (sodium bicarbonate).

During a review of Patient 22's medical record, Patient 22's face sheet indicated the patient was admitted on [DATE] at 1:15 AM. Patient 22's Hemodialysis Order Record on March 13, 2015 at 10:55 AM, March 14, 2015 at 11:05 AM, and on March 15, 2015 at 11:08 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 22 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 23's medical record, Patient 23's face sheet indicated the patient was admitted on [DATE] at 11:15 PM. Patient 23's Hemodialysis Order Record on February 27, 2015 at 10:19, February 28, 2015 at 9:59 PM, March 2, 2015 at 11:51 AM, March 4, 2015 at 5:40 PM, March 5, 2015 at 1:11 PM, March 7, 2015 at 2:21 PM, March 8, 2015 at 8:44 AM, March 10, 2015 at 4:24 PM, March 11, 2015 at 10:34 AM, March 11, 2015 at 11:05 AM, March 13, 2015 at 10:29 AM, March 16, 2015 at 10:48 AM, March 19, 2015 at 10 AM, and on March 19, 2015 at 5:28 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 23 on February 27, 2015 at 12:30 AM, February 28, 2015 at 3:50 PM, March 1, 2015 at 3 PM, March 3, 2015 at 12:50 PM, March 5, 2015 at 12:15 PM, March 6, 2015 at 5:15 PM, March 8, 2015 at 3:10 PM, March 9, 2015 at 4:45 PM, March 11, 2015 at 8:15 PM, March 12, 2015 at 12:35 PM, March 14, 2015 at 12:20 PM, and on March 17, 2015 at 2:30 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 24's medical record, Patient 24's face sheet indicated the patient was admitted on [DATE] at 9:10 PM. Patient 24's Hemodialysis Order Record on March 9, 2015 at 3:27 PM, March 10, 2015 at 2:33 PM, March 12, 2015 at 3:38 PM, March 13, 2015 at 11:34 AM, March 14, 2015 at 8:39 PM, March 16, 2015 at 10:56 AM, and on March 17, 2015 at 10:44 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 24 on March 13, 2015 at 5:15 PM, March 14, 2015 at 3:45 PM, and on March 16, 2015 at 12:55 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 26's medical record, Patient 26's face sheet indicated the patient was admitted on [DATE] at 11:30 PM. Patient 26's Hemodialysis Order Record on January 21, 2015 at 1:47 PM, and on January 22, 2015 at 2:52 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 26 on January 21, 2015 at 9:55 PM, and January 23, 2015 at 5:20 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 27's medical record, Patient 27's face sheet indicated the patient was admitted on [DATE] at 2 PM. Patient 27's Hemodialysis Order Record on February 26, 2015 at 1:35 PM, February 27, 2015 at 10:38 AM, March 1, 2015 at 9:07 PM, March 3, 2015 at 11:28 AM, March 5, 2015 at 1:32 PM, March 8, 2015 at 8:48 AM, and on March 11, 2015 at 12:26 PM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 27 on February 27, 2015 at 3:40 PM, February 28, 2015 at 11:30 AM, March 2, 2015 at 1:30 PM, March 4, 2015 at 12:40 PM, March 6, 2015 at 1 PM, March 10, 2015 at 8:40 PM, and on March 12, 2015 at 12:50 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 28's medical record, Patient 28's face sheet indicated the patient was admitted on [DATE] at 9:30 AM. Patient 28's Hemodialysis Order Record on February 12, 2015 at 4:46 PM, January 14, 2015 at 2:20 PM, January 16, 2015 at 11:49 AM, January 18, 2015 at 4:45 PM, and on January 19, 2015 10:12 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 28 on January 13, 2015 at 4 PM, January 15, 2015 at 4:30 PM, January 17, 2015 at 5:40 PM, January 19, 2015 at 1 PM, and on January 20, 2015 at 5 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During a review of Patient 29's medical record, Patient 29's face sheet indicated the patient was admitted on [DATE] at 4 PM. Patient 29's Hemodialysis Order Record on February 18, 2015 at 8:53 AM, February 19, 2015 at 9:50 AM, February 22, 2015 at 10:23 AM, February 24, 2015 at 8:19 AM, February 24, 2015 at 4:21 PM, March 1, 2015 at 10:33 AM, March 2, 2015 at 10:04 AM, March 3, 2015 at 1:22 PM, March 5, 2015 at 10:05 AM, and on March 9, 2015 at 9:41 AM, did not indicate how much bicarbonate to use during dialysis. The Acute Hemodialysis Flowsheet for Patient 29 on February 18, 2015 at 1:50 PM, February 20, 2015 at 2:00 PM, February 23, 2015 at 1:25 PM, February 25, 2015 at 12:45 PM, March 2, 2015 at 12:40 PM, March 3, 2015 at 4:30 PM, March 4, 2015 at 1:30 PM, March 6, 2015 at 4:15 PM, March 9, 2015 at 1:10 PM, and on March 10, 2015 at 2:45 PM, indicated the hemodialysis nurse performing the dialysis on the mentioned dates used 35 Gms of NaHCO3.

During an interview with the RNHC on March 18, 2015 at 4:39 PM, the RNHC stated if some doctors did not specify in their orders the bicarbonate concentration to use during dialysis, the facility used 35 grams as standard.

During an interview with the Medical Director Hemodialysis Unit (MDHU) on March 18, 2015 at 3:50 PM, the MDHU stated he relied on the hemodialysis nurse regarding what concentration of bicarbonate to use for dialysis when the doctor failed to prescribe the bicarbonate. The MDHU further added: "I am not paranoid [referring to the hemodialysis nurses' judgement on the use of the bicarbonate concentration]."

The facility policy and procedure titled "Physician's Order for the Dialysis Patient, "reviewed date March 2012, did not specify any concentration of bicarbonate to use during dialysis when the doctor failed to prescribed the appropriate concentration of bicarbonate.




4. Review of the hospital's P&P titled, "Administration of Medications" dated "6/12", indicated to verify physician's order for medication prior to administration.
Registered Nurse 5 (RN 5) was observed during medication administration for Patient 1, on March 17, 2015 at 8:30 AM, in the presence of the Director of Pharmacy (DOP). RN 5 mixed famotidine (a medication used to prevent ulcers in the stomach) injection 20 mg (milligrams)/2 ml(milliliter) with 1 ml sodium chloride (a solution made of salt and water commonly used to mix with other medications) 0.9 % injection and administered to Patient 1.
Review of Patient 1's medication orders and the Medication Administration Record (MAR), indicated to mix famotidine 20 mg/2 ml injection with 5 to 10 ml sodium chloride 0.9 % injection prior to administration.
During the concurrent staff interview, RN 5 acknowledged administering famotidine 20 mg/2ml injection mixed with 1 ml sodium chloride 0.9 % injection to Patient 1.
The DOP also acknowledged the administration of famotidine 20 mg/2ml injection mixed with 1 ml of sodium chloride 0.9 % injection.
5. Review of the hospital 's P&P (policy and procedure) titled, "Medication Order Requirement" dated "1/15", indicated all orders must include an electronic or identifiable signature, date and time.
Patient 5, Patient 6, and Patient 7's medical records were reviewed in the presence of the Senior Director of Clinical Operations (SDCO) on March 18, 2015 at 3:45 PM.
Patient 5's medical record of March 15, 2015 service was reviewed. Review of Patient 5's medication orders showed hydromorphone (a medication used for pain) injection and ketorolac (a medication used for pain and inflammation) injection orders of March 15, 2015 were not dated.
Patient 6's medical record of March 16, 2015 service was reviewed. Review of Patient 6's medication orders of March 16, 2015 showed hydromorphone injection and ondansetron (a medication used for nausea and vomiting) tablet orders were not dated.
Patient 7's medical record of March 15, 2015 service was reviewed. Review of Patient 7's medication orders of March 15, 2015 showed ondansetron, pantoprazole (a medication used to prevent ulcers in the stomach), hydromorphone, metronidazole (a medication used for infections), and levofloxacin (a medication used for infections) intravenous (in the vein) administration orders were not dated.
The SDCO acknowledged the above orders should be dated.
6. Review of the hospital's policy and procedure (P&P) titled, "Pain Management" dated "6/12", indicated to perform and document a pain reassessment 30 minutes after IV (intravenous) or 1 hour after oral or intramuscular (in the muscle) medication administration.
Patient 6's ED medical record was reviewed in the presence of the SDCO on March 18, 2015 at 3:45 PM.
Patient 6 visited ED on March 16, 2015. Review of the medication orders showed hydromorphone 1 mg injection was ordered at 4:10 AM. Review of nursing documentation showed hydromorphone injection was administered at 5:05 AM, when Patient 6's pain level was 10 out of ten on a pain scale of 0 to 10, where zero was no pain reported.
There was no pain reassessment documented for Patient 6 after hydromorphone injection administration contrary to hospital's P&P.
During the concurrent staff interview, the SDCO stated pain reassessment should be done after pain medication administration, and acknowledged no pain reassessment was documented after Patient 6 received hydromorphone injection at 5:05 AM on March 16, 2015.
VIOLATION: INFECTION CONTROL Tag No: A0747
The hospital failed to ensure the Condition of Participation: CFR 482.42 Infection Control was met by failing to ensure a sanitary environment to avoid sources and transmission of infections and communicable disease as evidenced by:

1. Failing to have a designated hemodialysis machine for Hepatitis B positive patients. (Refer to A 0749)

2. Failing to decontaminate the hemodialysis machine according to the facility's approved policy and procedure. (Refer to A 0749)

3. Failing to develop a policy and procedure for the care and management of a Hepatitis B positive patient receiving hemodialysis. (Refer to A 0749)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Infection Control.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on interview and record review, the facility failed to:

1. Dialyze Hepatitis B positive patients (an infectious disease of the liver transmitted by having contact with the blood) using a separate hemodialysis machine per Centers for Disease Control and Prevention (CDC) guidelines, for a universe of approximately 170 hemodialysis patients, for a period of six (6) months;

2. Decontaminate the hemodialysis machine according to the facility's approved policy and procedure.

3. Develop, implement and evaluate facility policy and procedure regarding care of Hepatitis B patients receiving hemodialysis in the facility for eight (8) of 30 sampled patients (Patients 21, 22, 23, 24, 26, 27, 28, and 29).

This failure had the potential for blood transmission of hepatitis B to patients receiving dialysis in the facility.

On March 18, 2015 at 8:32 AM, Immediate Jeopardy #1 was called due to the facility's failure to use a dedicated dialysis (a process for removing toxic impurities from the blood) machine exclusively for Hepatitis B (a viral infection that affects the liver) positive patients and not following hospital policy & procedure regarding cleaning of the machines. On March 19, 2015 at 6:01 PM, Immediate Jeopardy #1 was abated after an acceptable corrective action plan was presented to the survey team.

Findings:

1. During an initial tour of the Dialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 2:34 PM, it was observed that there were two (2) transportable and one (1) fixed dialysis machine in the room. One dialysis machine was being used in one of the rooms in the hospital.

During an interview with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 17, 2015 at 8:10 AM, the RNHC stated the facility used any hemodialysis machine available which can be unplugged from the wall for use in hemodialysis of patients positive with Hepatitis B.

During an interview with the Medical Director Hemodialysis Unit (MDHU) on March 17, 2015 at 9:30 AM, the MDHU stated the facility used any hemodialysis machine to dialyze positive with Hepatitis B patients. The MDHU further added the use of a separate hemodialysis machine for Hepatitis B positive patients had not been discussed with the infectious control committee.

During an interview with the Manager Infection Control (MIC) on March 17, 2015 at 10:02 AM, the MIC stated, "we don't have a single machine [hemodialysis machine] used to the patients with blood borne pathogens infection [which includes Hepatitis b positive patients]."

According to Centers for Disease Control and Prevention Guidelines and Recommendations titled "Recommendations for Preventing Transmission of Infections Among Chronic Dialysis Patients, MMWR 2001; 50 (RR-5), page 21," indicated: "Management if HBsAg (hepatitis B surface Antigen-lab test of the blood done to detect hepatitis B) - Positive Patients: ...Dialyze HBsAg-positive patients in a separate room using separate machines, equipment, instruments, and supplies."

2. During an initial tour of the Dialysis Unit with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 16, 2015 at 2:34 PM, it was observed that there were two (2) transportable and one (1) fixed dialysis machine in the room. One dialysis machine was being used in one of the rooms in the hospital.

During an interview with the Registered Nurse Hemodialysis Coordinator (RNHC) on March 17, 2015 at 8:10 AM, when asked how the machines were decontaminated or cleaned, the RNHC stated the facility runs bleach into the system for the hemodialysis machine. The RNHC further added the facility used 6% of bleach to clean the machine as recommended by the manufacturer of the machine.

The hemodialysis machine manufacturer issued a field advisory, dated May 28, 2014, indicated on the attachment for "All Hemodialysis Machines:" "...2. Scope: Bleach Disinfection Clarification: ...The Centers for Disease Control and Prevention (CDC) refers to a concentration level between 5.25% - 6.15% for disinfection of the hemodialysis equipment. Our recommendation is to use the minimum bleach concentration referred to by CDC guidelines for disinfection (5.25% - 6.15% sodium chloride). Use of bleach concentrations above 6.15% level may potentially damage the machine components and/or reduce the longevity of the [brand names] filters."

During an interview with the Senior Director of Nurses (SDN) on March 17, 2014 at 9:54 AM, the SDN stated the use of 6% bleach has not been approved by the Medical Executive Committee and the Board of Directors.

During a review of the Clinical Service Policy Routing Sheet for Control of Hepatitis B on January 28, 2015, indicated it was signed by the CNO and Medical Director. The form was blank and was not approved by the Medical Executive Committee and Board of Directors.

During an interview with the RNHC on March 17, 2015 at 9:55 AM, the RNHC stated the 6% bleach use was changed in the policy and was already implemented.

During an interview with the RNHC on March 17, 2015 at 10:01 AM, the RNHC stated the RNHC was the only one who decided to implement the use of 6% in cleaning the hemodialysis machine.

During an interview with the Manager Infection Control (MIC) on March 17, 2015 at 10:02 AM, the MIC stated the facility followed the AAMI (Association for the Advancement of Medical Instrumentation) in cleaning the hemodialysis machine.

During an interview with the MIC on March 17, 2015 at 5:30 PM, when presented with the facility policy and procedure titled "Delivery System: Cleaning and Disinfecting," in which the facility referenced on the AAMI standards, the MIC is not familiar with the policy because the MIC was not involved with the drafting of the policy.

During an interview with Interim Vice President of Patient Care Services and Chief Nursing Officer (IVPPCSCNO) on March 18, 2015 at 5:30 PM, the IVPPCSCNO stated she did not have the AAMI referenced in the decontamination process of the hemodialysis machine. The IVPPCSCNO further stated what the policy referenced as AAMI is nonexistent.






3a. On March 17, 2015 at 7:30 AM, an interview was conducted with the Director of Quality and Risk Management (DQRM). The DQRM was asked to provide the survey team with a list of patients who had received hemodialysis for the past 6 months along with a list of patients with blood borne infections.

A comparison of the blood borne infections and hemodialysis patients lists, revealed on January 7, 2015, Patient 26 was "Confirmed Positive," to have Hepatitis B and received hemodialysis while at the hospital.

A review of Patient 26's medical record revealed the patient presented to the emergency department (ED) on January 6, 2015 and was subsequently admitted to the hospital on January 7, 2015 with diagnoses which include end stage renal disease (ESRD-the loss of renal function) and congestive heart failure (CHF-not enough oxygenated blood, caused by the reduced pumping action of the heart).

Further review of Patient 26's medical record from January 6, 2015 to January 15, 2015 (date of discharge), the patient received hemodialysis on the following days:

a. January 8, 2015: dialyzed with hemodialysis machine 8881.
b. January 10, 2015: dialyzed with hemodialysis machine X481.
c. January 12, 2015: dialyzed with hemodialysis machine 563T.

On January 20, 2015, Patient 26 was readmitted to the hospital with a diagnosis of colitis (an infection of the colon). From January 20, 2015 to January 24, 2015, Patient 26 received hemodialysis on the following days:

a. January 21, 2015: no documented evidence could be located on the "Acute Hemodialysis Flowsheet," to indicate which hemodialysis machine was used.
b. January 23, 2015: dialyzed with hemodialysis machine 8881.

Prior to Patient 26's Hepatitis B diagnosis, Patient 26 presented on December 5, 2014 for chest pain, and ultimately discharged the same day.

A record review, revealed Patient 26, presented on December 29, 2014 and was subsequently admitted to the hospital with diagnoses which included pulmonary edema (excess fluid in the lungs). During the patient's hospitalization Patient 26 received hemodialysis on the following days:

a. December 29, 2014: dialyzed with hemodialysis machine 8881.
b. December 31, 2014: dialyzed with hemodialysis machine 8881.
c. January 2, 2015: dialyzed with hemodialysis machine X481.

Prior to January 7, 2015, it is unknown if Patient 26 had been tested for Hepatitis B.

3b. Record review conducted on March 18, 2015, revealed Patient 21, was admitted to the hospital on March 13, 2015 with a diagnoses of colitis. During the patient's hospitalization , Patient 21 received hemodialysis on the following days:

a. March 14, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. March 16, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

3c. A medical record review was conducted on March 18, 2015, revealed Patient 22, was admitted to the hospital on March 13, 2015 with diagnoses which included cellulitis (a skin infection caused by a bacteria) at fistula (a surgical passageway used for hemodialysis). During the patient's hospitalization , Patient 22 received hemodialysis on:

a. March 14, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

3d. A record review conducted on March 18, 2015, revealed Patient 23, was admitted to the hospital on February 25, 2015 with diagnoses which included hypertension (high blood pressure) and chest pain. During the patient's hospitalization , Patient 23 received hemodialysis on:

a. February 27, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. February 28, 2015: dialyzed with hemodialysi machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
c. March 1, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
d. March 3, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
e. March 5, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
f. March 6, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
g. March 8, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
h. March 9, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
i. March 11, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
j. March 12, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
k. March 17, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

3e. Record review conducted on March 18, 2015, revealed Patient 24, was admitted to the hospital on March 8, 2015, with diagnoses which included CHF. During the patient's hospitalization , Patient 24 received hemodialysis on:

a. March 11, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. March 15, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
c. March 16, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

3f. Record review conducted on March 18, 2015, revealed Patient 27, was admitted to the hospital on February 25, 2015, with diagnosis which included pneumonia (infection of the lungs). During the patient's hospitalization , Patient 27 received hemodialysis on:

a. February 27, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. February 28, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
c. March 4, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
d. March 10, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
e. March 12, 2015: dialzyed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

3g. Record review conducted on March 18, 2015, revealed Patient 28, was admitted to the hospital on January 10, 2015, with diagnoses which included severe hypoglycemia (abnormal low blood sugar). During the patient's hospitalization , Patient 28 received hemodialysis on the following dates:

a. January 11, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. January 12, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
c. January 13, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
d. January 15, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
e. January 17, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
f. January 19, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
g. January 20, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

Patient 28 was readmitted to the hospital on January 26, 2015, with diagnoses which included generalized anasarca (a build up of serous fluid within the subcutaneous connective tissue), diabetes mellitus (abnormal blood sugars), and chronic renal failure (kidneys not working properly). During the patient's hospitalization , Patient 28 received hemodialysis on the following dates:

a. January 31, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. February 2, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

Patient 28 was readmitted to the hospital on February 11, 2015, with diagnoses which included hyperkalemia (abnormal elevated potassium level in blood) and anasarca. During the patient's hospitalization , Patient 28, received hemodialysis on the following dates:

a. February 13, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. February 16, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

3h. Record review conducted on March 18, 2015, revealed Patient 29, was admitted to the hospital on January 12, 2015, with diagnoses which included fistula infection. During the patient's hospitalization , Patient 29 received hemodialysis on the following dates:

a. January 15, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. January 16, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
c. January 17, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
d. January 18, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
e. January 20, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
f. January 21, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
g. January 22, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
h. January 24, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
i. January 26, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

Patient 29 was readmitted to the hospital on February 14, 2015, with diagnoses which included right groin cellulitis. During the patient's hospitalization , Patient 29, received hemodialysis on the following dates:

a. February 17, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
b. February 18, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
c. February 20, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
d. February 23, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
e. February 24, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
f. February, 27, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
g. March 2, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
h. March 3, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
i. March 4, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
j. March 6, 2015: dialyzed with hemodialysis machine 563T, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
k. March 9, 2015: dialyzed with hemodialysis machine 8881, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.
l. March 10, 2015: dialyzed with hemodialysis machine X481, the same hemodialysis machine used on a confirmed Hepatitis B positive patient.

At approximately 3:50 PM, on March 17, 2015, a policy and procedure (P & P) for the care and management of a Hepatitis B patient was requested from the Senior Director of Clinical Operations (SDCO). On March 17, 2015 at 4:50 PM the SDCO was asked if the Hepatitis B P&P had been located for review, the SDCO stated he "Couldn't find one," but was checking with Infection Control Manager. At 4:55 PM, on March 17, 2015 the SDCO stated the hospital had "No specific P & P regarding hepatitis."

On March 17, 2015 at 5:10 PM, an interview was conducted with the Manager of Infection Control (MIC). The MIC was asked if the hospital had a specific P & P for the care and management of the patient with Hepatitis B, specifically those patients receiving hemodialysis services, the MIC stated, "Standard precautions are in place for everyone, we treat everyone as if they are infected, every patient is treated the same."