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115 MALL DRIVE

HANFORD, CA 93230

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

22968

Based on staff interview and closed record review, the hospital failed to ensure two of two newborn (patients) records (Patient 2 and Patient 3) contained Conditions of Registration consent forms that were properly executed and complete. This failure had the potential to result in the hospital treating patients without documentation of the patient/responsible party's consent and to result in the lack of documentation of financial responsibility for payment of services rendered.

Findings:

On 5/22/12 at 2:00 p.m., closed record review indicated two of two newborn records (Patient 2 and Patient 3) contained Conditions of Registration consent forms that lacked date, time and signature at the bottom of the form. The Conditions of Registration consent forms contained a clause " ... 5. Maternity Consent for newborns ... If I deliver an infant(s) while a patient of the hospital, I agree that these same Conditions of Registration shall apply to the newborn infant(s)." Subsequent interview with Staff 10 (Assistant Director, Health Information Management Department) stated that the mother of the infant signs the consent and initials the clause and the form is contained within the mother's record. These two newborn records lacked a copy of the Conditions of Registration consent form that was signed by the mother of each newborn.

On 5/22/12 at 4:00 p.m., the policy and procedure that addressed documentation within the Conditions of Registration forms for both the Maternity Consents and newborn infant's records was requested from Staff 11 (Admitting Manager). Subsequent interview with Staff Member 11 stated that she checked with the Admitting Manager, Staff 10, and no policy or procedure was available for review.

DELIVERY OF DRUGS

Tag No.: A0500

28358

Based on staff interviews, clinical record and administrative document review, the hospital failed to ensure all newly ordered medications for patients in the Emergency Department (ED) and the Post Anesthesia Recovery Unit (PACU) received a pharmacists review before administration. Pharmacists reviewed new medication orders for safety and efficacy (effective drug for disease/disorder) reasons. The absence of a pharmacist's review before administration increased the potential for medication error and an adverse outcome.

Findings:

On 5/23/12 at 10:00 a.m., during an interview, Staff 12 (Director of Pharmacy) said the ADCs (automated drug dispensing cabinets) in the ED (Emergency Department) and in the PACU (Post Anesthesia Care Unit) were not profiled. Staff 12 stated nurses removed medications from ADCs when they were ready to administer them to patients. "Profiled" ADCs were those which required a pharmacist to review prescribers' new medication orders before a nurse could remove the ordered medication from the ADC. Prescribers' orders were delivered to the pharmacy where a pharmacist reviewed them. Medications obtained from ADCs which were not profiled did not require a pharmacist to review the new medication orders before removal. Pharmacists communicated their approval of the order with the pharmacy computer which had an electronic connection to the computer in the ADC. This electronic approval subsequently allowed the nurse to remove the medication. Pharmacists reviewed new medication orders for several safety and efficacy (effectiveness of the drug for the disease or disorder) reasons which included: ensuring the correct medication and dose was ordered and to avoid unwanted drug interactions, adverse drug effects (side effects), drug allergies, and medication errors. Medications removed for patients from ADCs which were not profiled did not benefit from these safety and efficacy checks. Nurses obtained medications from ADCs which were not profiled without having a pharmacist review the prescribers' order before removal from the ADC. On 5/23/12 at 10:30 a.m., Staff 12 agreed that the ADCs in the ED and PACU needed to be profiled to improve patient safety and efficacy. Hospital policy and procedures ("Automated Dispensing System: Medication Administration; Narcotic Policy; Medication Supply Pharmacy Access") read, "When a patient is admitted to the hospital, the orders for medications are faxed to pharmacy for review by a pharmacist. The pharmacist enters the order onto the patient medication profile ...".

On 5/23/12 at 10:35 a.m., Staff 12 stated the ADC's in the ED and PACU were "semi-profiled" cabinets and required pharmacist review for "high risk/high alert" medications such as, Alteplase (used to break down blood clots), and Heparin (anticoagulant). All other medications such as Alprazolam (antianxiety), and Insulin (used to regulate blood sugar level) are considered "dangerous medications" and were available with out pharmacist review in the ADCs located in the ED and PACU.

The American Society of Health-Systems Pharmacists (ASHP) has established the standards of practice for ADCs ("ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices: Am J Health-Syst Pharm. 1998; 55:1403-07"). The ASHP guidelines indicated that the automated system or device should ... "Provide for prospective, timely review of medication orders by a pharmacist at all appropriate decision points in the medication-use process, especially before administration of the first dose and provide for the independent interpretation of the medication order by a pharmacist and a nurse." The ASHP standard also required that "Clearly stated organizational policies should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. " ASHP also had indicated "The pharmacist (except in emergency situations) must receive the physician's original order or a direct copy of the order before the drug is dispensed. This permits the pharmacist to resolve questions or problems with drug orders before the drug is dispensed and administered. (ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control. Am J Hosp Pharm. 1980;37:1097-103).

DIETS

Tag No.: A0630

Based on staff interviews and administrative document review, the hospital failed to ensure diet was provided in accordance with the orders of the practitioner for one of 11 sampled patients (Patient 1) reviewed for nutrition care. This failure resulted in the potential to not meet the nutritional needs of all patients.

Findings:

The clinical record for Patient 1 was reviewed. Patient 1 was admitted to the hospital on 5/17/12. Review of Patient 1's weight record dated 5/19/12 and 5/22/12 indicated 66 kilograms (kg) and 65.6 kg, respectively.

Review of the physician's orders dated 5/19/12 indicated Patient 1 was to have high oral protein, 2 grams (g) per kg per day and one can of Nepro (oral nutrition supplement) three times a day with meals.

Review of the electronic medical record indicated the diet order was entered on 05/22/12 as 80 g Protein, 2 g sodium and 2 g potassium diet and one can Nepro three times a day with meals. The diet ordered for the patient provided less protein than was ordered by the physician. The diet should have provided 132 g of protein based on the patient's weight on 5/19/12 (66 kg x 2 = 132 g).

On 5/22/12 at 9:00 a.m., during an interview, Staff 1 (RN Director of 3rd Floor, Campus 1) stated the order should have been clarified before being put into the computer. On 5/22/12 at 2:55 p.m. during an interview, Staff 2 (RN on the 3rd Floor, Campus 1) stated they (RNs) usually do not enter orders into the computer, but the Unit Secretaries do. Staff 2 stated the RNs go through the orders and sign off on them. Staff 2 stated the RNs compare what is written in the paper chart to what is entered in the electronic medical record.

On 5/22/12 at 3:20 p.m., during an interview, Staff 3 (unit secretary) stated the patient was a renal patient (a patient with kidney disease) and the renal diet consisted of 80 g Protein, 2 g sodium and 2 g potassium. Staff 3 explained the usual process for entering a renal diet was: she would ask the RN nurse if the patient was a renal patient; if yes, then the unit secretary would enter in the 80 g protein diet with the 2 g of sodium and potassium. Staff 3 confirmed that the input of the diet would be the same even if that was not what the physician's order indicated. Staff 3 stated she would enter the diet in the manner described even if the physician indicated differently.

Review of the physician's orders dated 5/22/12 at 10:30 a.m. indicated a new order for high oral protein intake 2 g per kg per day and two cans of Nepro three times a day with meals. Review of the electronic medical record dated 5/22/12 at 1:46 p.m. indicated the diet order entered was a high protein, 2 g sodium, and 2 g potassium diet. The previous order dated 5/19/12 for one can of Nepro three times a day was still active. There was no updated order for the two cans of Nepro three times a day with meals.

On 5/22/12 at 3:00 p.m. an interview was conducted with Staff 4 (unit secretary) regarding the diet order she entered into the computer. Staff 4 stated she entered into the computer high protein diet and also would enter other restrictions, if applicable. Staff 4 stated she thought the 2 g per kg was 2 g sodium was correct and was mistaken. She stated the nurse signed off on the orders at 12:30 p.m. on 5/22/12.

On 5/22/12 at 3:14 p.m., an interview was conducted with Staff 5 (registered dietician) regarding the high protein diet. Staff 5 stated she thought the high protein diet consisted of around 100 g of Protein per day but she was not completely sure and would have to check. Review of the nutritional adequacy of the high protein diet indicated the diet would provide a minimum of 116 g Protein per day. This diet provided by the kitchen would have been inadequate by 15 g of Protein.

On 5/22/12 at 3:24 p.m., an interview was conducted with the Staff 6 (registered nurse). Staff 6 stated they (RNs) should have called the physician and clarified the order. On 5/22/12 at 3:40 p.m., during an interview, Staff 7 (registered nurse) stated she called to clarify the physician's order and he (physician) wanted a high protein, low sodium diet.

Review of the hospital's policy and procedures titled Nutritional Services: Diet Orders dated effective 3/14/12 indicated the diet orders and/or changes communicated to Nutritional Services were to reflect the written diet order in the patient's medical record.

Review of the hospital's consolidated medical staff rules and regulations dated 2011 indicated orders which were unclear, illegible or incomplete will not be carried out until rewritten or understood by the nursing or other caregivers.

On 5/23/12 at 7:55 a.m. an interview was conducted with MD 1 (chief medical officer), Staff 8 (Director of Food and Dietetics) and Staff 9 (Vice President of Patient Services). MD 1 stated the physician overseeing the care of Patient 1 was a newer physician on staff and he would need to be trained on the diets for this hospital.

In summary, the diet that was provided to Patient 1 by the kitchen was inadequate by 52 g of Protein due to the incorrect diet order being entered into the electronic medical record.

OPERATING ROOM POLICIES

Tag No.: A0951

29327

Based on observation, staff interview and administrative document review, the hospital failed to ensure surgical services achieved high standards of medical practice and patient care when:

1. The temperature and humidity for the surgical areas for Campus 2 were not maintained according to hospital policy and did not meet acceptable standards of practice according to the Association of periOperative Registered Nurses (AORN). The temperature log was out of range for 12 of 12 days reviewed. The humidity log was out of range for 7 of 12 days reviewed. The areas affected were for the Operating Room (OR) 1, OR 2, decontamination/dirty room in OR area, Central supply and OR storage area.

2. Three of five OR staff (Staff 15, 17, MD2) did not adhere to surgical attire requirements for restricted and semi-restricted areas of the surgical perioperative area (operating rooms, endoscopy rooms or suites [the room for procedures in which an instrument is passed into the body for the purpose of visual examining of the interior a bodily canal or a hollow organ such as the esophagus, bronchus, colon, bladder, stomach or intestine], and post anesthesia care unit).

3. Canisters filled with body fluids (biohazard waste) were not disposed of properly in the GI lab (Gastrointestinal laboratory area) as per hospital policy

4. The ceiling in the endoscopy/GI procedure room was not maintained in proper repair.

These failures had the potential of not achieving high standards of medical practice and patient care.

Findings:

1. On 5/22/12 at 1:30 p.m., during a tour of the surgical areas of Campus 2 the following temperatures were obtained via Laser gun in the surgical areas: OR 1 66.4 degrees Fahrenheit (F), OR 2 63.5 degrees, OR 3 67.5 degrees, OR hallway 67.8 degrees, Post Anesthesia Care Unit (PACU) 67.5 degrees, OR supply room 66.8 degrees.

On 5/22/12 at 1:35 p.m., during an interview, the Staff 14 (OR supervisor and registered nurse) stated the daily temperatures and humidities were checked by maintenance via an electronic computerized system. The Staff 14 confirmed no manual temperature or humidity gauges were in the OR's to validate temperatures daily. Staff 14 stated daily temperatures and humidity were available on the computer. Staff 14 was not able to access the documentation on the computer in the surgical area. Staff 14 stated she does not check temperature and humidify reports daily.

On 5/22/12 at 1:40 p.m., during a concurrent observation and interview in the decontamination/dirty GI room, no device for monitoring temperature and humidity was observed. Staff 17 stated that the dirty GI room was not equipped with a supplier vent for cold or heat, and acknowledged there was no manual device in the GI room. Staff 17 stated "maintenance usually makes daily rounds in the(morning)." He provided a copy of "...Maintenance Daily Zone Parameters for May 3, 4, 10, 11, 13, 15, 16, 12 of 2012 which documented the humidity gauges for Operating Rooms 1, 2, Dirty Room in OR area, OR supply room were out of range. Temperature logged on May 2, 3, 4, 7, 9, 10, 11, 12, 13, 14, 15, 16 were out of range. Staff 17 could not determine if any corrective measures were taken.

On 5/22/12 at 1:45 p.m., during an interview, Staff 14 stated the hospital used the AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention) Professional guidelines as references for the OR infection control and surgical services.

The hospital policy and procedure titled, "AIR EXCHANGE, TEMPERATURE AND HUMIDITY - SURGICAL SERVICES" dated 3/14/2012 indicated "...an effective ventilation system is needed to minimize airborne microbial contamination...Temperature and humidity control is also needed to maintain integrity of sterile packaging...Temperature in each Operating Room, Endoscopy Suite, Soiled Decontamination...area is maintained at 68 - 73 degrees F... Temperature in Post-anesthesia Care Unit.. 70 degrees to 75 degrees...Humidity will be maintained between 30% to 60% in Operation Rooms...Endoscopy Suites...Soiled Decontamination areas...Temperature and humidity readings out of range will be reported to Surgical Services or appropriate area...Plant Operations will initiate corrective action...Surgical Services personnel will visually inspect monitors daily in each area...readings out of range are reported to Plant Operations for corrective actions".

The 2011 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms...instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas."

The 2011 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F to 73 degrees F within the operating room suite and general work areas in sterile processing."

2. On 5/22/12 at 9:15 a.m., during a concurrent observation and interview in the semi-restricted area of the GI suite, (the peripheral support areas of the surgical suite, work areas, and corridors leading to the restricted areas). Staff 15 (registered nurse), was oberserved in the restricted area with out a surgical mask. Staff 16 (licensed vocational nurse) was observed entering a restricted area with out a surgical mask. Staff 14 acknowledged staff not wearing surgical mask in a restricted area and stated that the requirement was to wear surgical mask in restricted areas. MD 2 was observed with a exposed full facial beard extending from one side of the face to the other side of the face in a semi-restricted area of the GI. Staff 14 acknowledged MD 2 having exposed facial hair and stated all hair is required to be covered in semi- restricted and restricted areas.

The facility policy and procedure titled, " Operating room aseptic technique practices", dated 2/16/11, indicated"...surgical attire and hair coverings are required...and cover all head and facial hair".

3. On 5/22/12 at 2:20 p.m., during a concurrent interview and observation of the GI procedure room, two (2) large suction canisters with greenish liquid were observed in the clean GI procedure room in a red garbage can. Staff 14 (OR supervisor), stated that one canister had about 300 cc's of liquid and the other canister had about 75 cc's of contaminated fluid from the last procedure done in the room. Staff 14 stated the canisters should have been removed before room was cleaned and taken out of the room and placed in the biohazard container in the dirty area.

The facility policy and procedure titled, "Operating Room Aseptic Technique Practices" dated 2/16/11, indicated, "suction canisters containing blood and other body fluids are sealed and placed in colored, contaminated labeled, impervious plastic bags and transported to the soiled utility room and placed in contaminated closed container".

4. On 5/22/12 at 2:20 p.m., during a concurrent observation and interview in the GI procedure room, an area of the ceiling measuring 48 inches wide and 30 inches long was observed to be bubbled, blistered, with a stained brown area. Staff 17, stated it looked like calcium build up from a water leak. Staff 14, acknowledged the damaged area and stated she had never noticed it before.

On 5/23/12 at 8:12 a.m., Staff 13 (Risk Manager) stated the ceiling damage in the GI restricted endoscopy room at campus 2 had been repaired the night before (5/22/12).

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on observation, staff interviews, and administrative document review, the hospital failed to adhere to professional standards of practice for Emergency Departments (ED) when two of two patients (Patient 4 and Patient 5) were treated and dispositioned in the hallway of the ED. Patient confidentiality and privacy were not protected in this area of the ED. These failures resulted in the potential loss of confidentiality and privacy and could negatively affect the quality of care for all patients seen in the ED.

Findings:

On 5/22/12 at 10 a.m., during an observation, the ED at Campus 2 was toured. The ED treatment area was separated from the patient lobby/registration area by a door controlled for limited access. The ED treatment area consisted of a nurse's station, triage examination room and ten treatment bays. Seven ED treatment bays (ED Bay 1, ED Bay 2 ... ED Bay 7) were configured on one side of the treatment area and separated by a hallway from the remaining three ED bays (ED Bay 8 ... ED Bay 10) on the other side of the hall. ED Bay 1 through ED Bay 10 were appropriately equipped to assess and treat patients (for example, patient examination bed, medical devices to obtain blood pressure, otoscopes/ophthalmoscope [device to examine ears/eyes], oxygen) and a privacy curtain .

The following numbers were observed placed on the hallway wall closest to ED Bay 1: 11, 12, 13, and 14 and were called Station 11, Station 12, Station 13, Station 14 according to the ED Director. Plastic chairs were placed under each corresponding number (11, 12, 13, 14) along the wall in the hallway. There was no other medical equipment or devices or privacy curtain in the hallway for Stations 11, 12, 13, 14. During the tour, two patients (Patients 4 and 5) were located in Stations 11 and 12. One patient was sitting hunched over with his head in his lap in Station 11 and the other patient was lying on a gurney (specialized patient bed with wheels) located at Station 12.

On 5/22/12 at 10:15 a.m., during an interview with the Registered Nurse, Staff 18, explained the process of patient flow in the ED treatment area and the use of Stations 11 through 14. Staff 18 confirmed he was the assigned registered nurse for Patient 4 in Station 11. Staff 18 explained that for patients presenting with uncomplicated symptoms (for example, upper respiratory illness, slight fever, minor sprains and abrasions), the patient would be seen in the triage room and assigned a low emergency severity index. Staff 18 stated that Patient 4 was placed at Station 11 because he was a re-check from an ED visit the day before (5/21/12).

Staff 18 stated that if all rooms (ED bays 1 through 10) were occupied, low acuity patients would be placed in the chairs associated with Stations 11, 12, 13, 14. In general these types of patients would be given discharge instructions from Stations 11, 12, 13, 14. Staff 18 explained that occasionally physical examination and treatment of the patient would occur in Station 11, 12, 13, 14, but that would be rare. In other words, Staff 18 explained, a patient would be asked to move to Stations 11 through 14 in order to receive final discharge instructions and treatment plan. Staff 18 confirmed that no accommodations were made in order to safeguard confidentiality, privacy and dignity while patients were placed at Stations 11, 12, 13, 14. Staff 18 confirmed that medical equipment occasionally would be carried to Stations 11 through 14 in order to complete the ED treatment process. (For example, blood pressure cuffs or devices, glucometer and/or otoscopes).

On 5/22/12 at 11 a.m., during an interview, the ED Director (Staff 19) discussed the patient flow in the ED of Campus 2. The ED Director described a Rapid Medical Screening (RMS) patient flow process that had been in effect for approximately three or more years. The ED Director explained the RMS process was geared to "treat and street" patients with uncomplicated symptoms (for example, mild upper respiratory illnesses, minor skin cuts and bruises, minor fevers). These types of patients would be triaged and then placed in ED bays 1 through 10 and when ready for discharge would be placed in the chairs in the hallways designated Stations 11 through 14. The ED Director confirmed no accommodations were made in order to protect patient confidentiality, privacy and dignity while awaiting disposition in Stations 11 through 14. The ED Director explained that staff were trained to request permission from the patient to be placed in Stations 11 through 14. The ED Director acknowledged that on occasion, when the ED was very busy, patients would be placed in Stations 11 through 14 and have part of their physical assessment and treatment in the hallway. When asked whether the hallway and Stations 11 through 14 were designed for the assessment, treatment and discharge of patients, the ED Director did not comment. The ED Director stated there was no hospital policy and procedure providing guidance on "treat and street" or the use of Stations 11 through 14. The ED Director confirmed Stations 11 through 14 were not used for "parking" patients brought in by ambulance.

On 5/22/12 at 1:20 p.m., during an interview, Staff 20 (RN) stated he was the assigned Charge Nurse for the ED on 5/22/12. Staff 20 stated Patient 5 was placed at Station 12 after an order to place another patient in the assigned ED Bay. Staff 20 confirmed that Stations 11 through 14 were used for patients ready to be discharged and were stable and with uncomplicated symptoms. Staff 20 acknowledged that occasionally Stations 11 through 14 were used for patient assessment and treatment as well as discharge. Staff 20 confirmed no complicated patients were placed in Stations 11 through 14. Staff 20 confirmed patients brought in by ambulance were never placed in Stations 11 through 14.

The clinical record for Patient 4 who was in Station 11 was reviewed. The patient was seen in the ED Campus 2 on 5/21/12 with pain, redness and selling of the top of right foot. The diagnosis was cellulite (infection of the skin), treated with antibiotics and asked to return on 5/22/12. On 5/22/12 Patient 4 was placed in Station 11 on a chair in the ED hallway to be seen by the ED physician. The ED physician determined the patient required further assessment and treatment and placed in ED Bay 9. After receiving additional treatment, Patient 4 was discharged home from ED Bay 2.

The clinical record for Patient 5 was reviewed. Patient 5 was admitted to ED Bay 1 with symptoms of alcohol abuse "and not feeling well" at approximately 5:30 a.m. on 5/22/12. At approximately 9:45 a.m. on 5/22/12, Patient 5 was placed in Station 12 on a gurney to make room for another patient with symptoms of seizures. The physician had documented that Patient 5 was stable for discharge to home.

On 5/24/12 the hospital's Patient Rights policy (Number 1000.16.09) was reviewed. On page three under Privacy the policy stated "... The hospital respects the rights of patients to: ... b. Receive healthcare services in surroundings designed to provide reasonable visual and auditory privacy ... c. Expect that any discussion or consultation involving the patient's case will be conducted discreetly."

On 5/24/12 the Office of Civil Rights (OCR) HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule under 45 CFR 165.502(a)(1)(iii) was reviewed. Under " How the Rule Works: Reasonable Safeguards " the rule indicated " A covered entity must have in place appropriate administrative, technical, and physical safeguards that protect against uses and disclosures not permitted by the Privacy Rule, as well as that limit incidental uses or disclosures ... Covered entities should also take into account the potential effects on patient care ... " Under " Minimum Necessary " the Rule indicated " Covered entities also must implement reasonable minimum necessary policies and procedures that limit how much protected health information is used, disclosed, and requested for certain purposes. These minimum necessary policies and procedures also reasonably must limit who within the entity has access to protected health information, and under what conditions, based on job responsibilities and the nature of the business ... " As an example of reasonable safeguards under FAQ (Frequently Asked Questions) the rule indicated " ... In an area where multiple patient-staff communications routinely occur, use of cubicles, dividers, shields, curtains or similar barriers may constitute a reasonable safeguard. For example, a large common intake area may reasonably use cubicles or shield-type dividers, rather than separate rooms, or providers could add curtains or screens to areas where discussions often occur between doctors and patients or among professionals treating the patient ... "