HospitalInspections.org

Based on medical record review and review of facility policies and procedures, it was determined that the facility failed to ensure that the policy and procedure "Allow Natural Death (AND)" was implemented.

Findings include:

Reference: Facility policy titled, "Allow Natural Death (AND)" states under Policy, "... The term "Allow Natural Death" order refers to the direction by the attending physician that if a patient suffers a cardiac or pulmonary arrest, defibrillation, cardiac massage and/or artificial ventilation will not be administered ..." stated under Process: "I. If the physician determines that no extraordinary measures should be taken: a. Date, time and identity of those persons (patient, family, etc.) with whom the physician has discussed the "AND" Order must be recorded in the patient record by the physician. If the patient is alert, the patient's informed choice must be honored. Check the medical record for an Advanced Directive ... b. The condition of the patient and circumstances (terminal illness, no prospect of beneficial therapy, etc) must be thoroughly documented by the physician. c. The order must be entered in the patient's record and the AND Order Sheet, and signed by the attending physician ... III. Telephone Order for "AND": ...The physician will verify the order and statement in writing and document in the Progress Notes within 24 hours ..."

1. Review of Medical Record #23 revealed the following:

a. The patient, a 67 year old male, was admitted to the facility on 10/6/12. The patient, a resident of a Long Term Care Facility, has a past medical history of dementia. An "AND" order was written by the physician on 10/7/12 at 08:02 that states, "RESUSCITATION STATUS ALLOW NATURAL DEATH Attending physician has provided to patient/surrogate information about his/her dx [diagnosis] & prognosis, the range of available resuscitation measures, reasonably foreseeable risks & benefits of emergency resuscitation for him/her and consequences of AND order."

i. There was no evidence in the medical record of the date, time and identity of the person with whom the physician discussed the AND order with, as required by the above referenced policy.

ii. There was no documentation in the medical record by the physician of the condition of the patient and the circumstances (i.e. terminal illness, no prospect of beneficial therapy), as required by the above referenced policy.

2. Review of Medical Record #24 revealed the following:

a. The patient, a 78 year old male, was admitted to the facility on 10/9/12. The patient, a resident of a Long Term Care Facility, has a past medical history of Parkinson's disease, bipolar, dementia, and COPD [Chronic Obstructive Pulmonary Disease]. There was evidence in the medical record that the patient has a court appointed guardian through the New Jersey Office of the Public Guardian for Elderly Adults.

i. An "Emergency Telephone Order" was obtained on 10/9/12 at 9:40 PM for the "AND."

ii. There was no evidence that the telephone order for the "AND" was signed by the physician within 24 hours.

iii. There was no evidence in the medical record of the date, time and identity of the person with whom the physician discussed the AND order with, as required by the above referenced policy.

iv. There was no documentation in the medical record by the physician of the condition of the patient and the circumstances (i.e. terminal illness, no prospect of beneficial therapy), as required by the above referenced policy.

Based on a review of policy and procedure and three medical records, it was determined that one patient was not provided care in a safe setting.

Findings include:

Reference: The section of Hospital policy titled "Special Observation - Procedure for" stated: "POLICY: Safety is the main concern with all patient care. Patients may need special levels of observation to maintain patient safety. Risks to patient safety may include: altered mental status, thoughts to harm self or others, or thoughts to leave treatment, [sic] the hospital or unit before being evaluated as safe. ..... PURPOSE: To provide optimum safety of all patients. ..... DEFINITIONS: ..... Restricted Activity - Patient is voluntarily restricted to a specific room or area (unlocked) with 1:1 monitoring by staff." The SPECIAL OBSERVATION section of the policy indicated that documentation of patients placed on 'Restricted Activity' will be done every 15 minutes and entered on a Special Observation Sheet.

1. Review of the SPECIAL OBSERVATIONS sheet, dated 10/7/12, in Medical Record #28 indicated that he/she was on restricted activity. There was no documentation on the form, between 6:15 PM and 7:15 PM. Additionally, another SPECIAL OBSERVATION form in the medical record did not indicate any documentation between 2:45 PM and 4:00 PM on 10/6/12. It could not be determined that the patient was being monitored in those time frames.

A. Based on observation and staff interview conducted on 10/9/12, it was determined that the facility failed to implement policies and procedures addressing self-administration of drugs by patients.

Findings include:

Reference: Facility policy titled 'Medication, Self Administration' states, "Policy: Medication may be left at the bedside for self-administration by the patient only as ordered by the physician. ... Procedure: 1. Only the following medications may be left at the bedside: External local anesthetic preparation for perineum care."

1. During a medication pass observation on unit 3 North at 11:15AM, Staff #17 was observed administering medications to Patient #11. One 15 ml (milliliter) bottle of hypromellose 0.5% (Artificial Tears) ophthalmic solution and one 28 gram tube of topical bacitracin zinc ointment was noted on the patient's bedside tray table. Upon interview, Staff #17 stated that these medications were for self-administration by the patient.

a. An order for "Artificial Tears 1 gtt [drop] OD [right eye] Q2H [every 2 hours]" was noted in the medical record for Patient #11. A physician's order for the self-administration for Artificial Tears was not noted in the medical record.

b. An order for "Bacitracin ointment to open sores BID [twice daily]", written on 10/4/12, was noted in the medical record for Patient #11. On 10/8/12, an order to "Discontinue Bacitracin ointment" was written. Upon interview, Staff #17 confirmed that the order for topical bacitracin ointment was discontinued on 10/8/12 at 13:40PM and that the medication was not collected from the patient's bedside tray table.

B. Based on observation and staff interview conducted on 10/9/12, it was determined that the facility failed to implement policies and procedures addressing the administration of medications in accordance with facility policy.

Findings include:

Reference: Facility policy titled 'Medications: ...Administering' states "... Administration of Medications-Handling ... 6. All routine medications must be administered within one hour of stated administration times."

1. During a medication pass observation at 10:50AM, Staff #17 was observed administering medications to Patient #10.

a. At 10:56AM, Staff #17 administered OxyContin 10 mg (milligram) to Patient #10. The routine order for OxyContin 10 mg was scheduled for 9AM.

b. Patient #10 had a routine order for Lidoderm patch at 9AM. Lidoderm was documented on the administration record as administered at 10:11 AM. Upon interview at 11 AM, Staff #17 stated that he/she applies medication patches after the patient receives their bath. When asked if Patient #10 had received their bath, Staff #17 stated that the patient had not received their bath and the patch was not applied on the patient.

2. These findings were confirmed by Staff #17 and #7.

Based on staff interview, document review, observation and a tour of the kitchen, it was determined that the "Director Food Services" failed to provide daily supervision of the Food and Nutrition Services Department.

Findings include:

Reference #1: The Food Services Director's Job specific duties states: "Ensures the delivery of patient and employee meals are delivered utilizing current industry and regulatory standards.

1. On 10/16/12 during observation in the food services kitchen, in the presence of Staff #43 and Staff #44, it was determined that the Food Services Director failed to ensure compliance with the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24, as stated in the Food Service Director's job description.

2. The NJ State Sanitary Code NJAC 8:24 inspection report dated 10/16/12 contained the following observations and citations:

Reference #2: NJAC 8:24-2.1(c)iii states, "The person in charge shall ensure the following: Through daily oversight of the employees' routine monitoring of the cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated, that employees are properly cooking potentially hazardous food, being particularly careful in cooking those foods known to cause severe foodborne illness and death."

a. At the time of the inspection, critical risk factors were observed out of compliance as evidenced by: improperly cooled meat sauce located within the refrigeration unit, final cook temperature of hamburger was not observed to reach the appropriate temperature, and the hot holding of mashed potatoes was below the appropriate holding temperatures."

Reference #3: NJAC 8:24-2.3(f) states, "Food employees shall clean their hands and exposed portions of their arms immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, and unwrapped single-service and single-use articles, and...before donning gloves for working with foods."

b. Employee was observed to enter the food preparation area, don gloves and begin to sauté shrimp and veggies without first washing their hands. All employees should, upon entering and working with food, properly wash hands then don gloves.

Reference #4: NJAC 8:24-3.4(a)1 states, "Cooking temperature requirements for raw animal foods include the following"...raw animal foods such as eggs, fish, meat, poultry and foods containing these raw animal foods, shall be cooked to heat all parts of the food to a temperature and for a time that complies with one of the following methods based on the food that is being cooked: 145 degrees Fahrenheit or above for 15 seconds for fish, meat, pork..."

c. Final cook temperature of a burger on the line was observed to be at 123 °F.

Reference #5: NJAC 8:24-3.5(e)2 states, "When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be: i. arranged in the equipment to provide maximum heat transfer through the container walls; and ii. Loosely covered, or uncovered if protection from overhead contamination during the cooling period to facilitate heat transfer from the surface of the food."

d. Products observed within 5 gallon containers placed in the walk in refrigeration unit were tightly covered and exhibited temperatures above proper refrigeration temperatures.

Reference #6: NJAC 8:24-3.5(f)1 states, "Potentially hazardous food shall be cooked to safe cooking temperatures and received hot shall be at a temperature of 135°F or above."

e. Potentially hazardous foods were not observed to be hot held at temperatures above 135 °F as evidenced by: Mashed potatoes located at the steam table on the line had a temperature reading of 120°F.

Reference #7: NJAC 8:24-3.5(f)2 states, "Potentially hazardous food shall be maintained at refrigeration temperatures (at or below 41°F)."

f. The listed items were observed stored in 5 gallon plastic containers. The firm maintains a blast chiller which is used to cool products rapidly on site. Management indicated that the sauces had been prepared the day before, portioned into smaller containers to be cooled, placed into the blast chiller for cooling, poured into the 5 gallon containers and covered with saran wrap prior to being stored in the main walk in unit. Discussion with management uncovered that conversations concerning the discontinuation of use of the 5 gallon buckets for cooled items had been previously discussed within the department. However, the practice of cooling the products and transferring the cooled product to the 5 gallon bucket was still currently practiced.

Reference #8: NJAC 8:24-4.2(a) states, "Equipment and utensils shall be designed and constructed to be durable and to retain their characteristic qualities under normal use conditions."

g. On the meat slicer, the apparatus used to hold the meat in place while slicing, exhibits wear and cracking at the food contact surface. This apparatus due to the wear and cracking is not easily cleanable and no longer suitable for use. The cracked surface could potentially allow for an accumulation of minute food debris to lodge within the cracks and crevices potentially contaminating the food due to the state of the equipment surface.

h. The colander of the chopping food processor exhibited cracks and grooves within the food holding portion of the equipment. The cracks and grooves allow for the potential accumulation of bacteria within the crevices, thus rendering the equipment not easily cleanable.

Reference #9: NJAC 8:24-7.2(c) states, "Poisonous or toxic materials shall be used according to the following:...2. manufacturer's use directions..."

i. NJAC 8:24-7.2(c) Concentration of quaternary ammonia sanitizer within the 3 basin sink within the dish room was observed to be above the appropriate concentration levels. Although the facility was observed to have hand sanitizer strips, due to the concentration of the solution, the concentration had not been checked.

Reference #10: NJAC 8:24-4.11(f) states, "Single service and single use articles shall handled, displayed,and dispensed so that contamination of food- and lip-contact surfaces is prevented. Knives, forks, and spoons that are not prewrapped shall be presented so that only the handles are touched by employees and by consumers."

3. On 10/16/12, a tour of the 3N, 4E, and 5N pantries was conducted. Each pantry contained unprotected single serve utensils as per NJAC 8:24-4.11(f).

4. The above was confirmed by Staff #43 on 10/16/12 at 2:30 PM.

Based on observation, it was determined that the facility failed to ensure that Alcohol Based Hand Rub dispensers (ABHR) are not installed above ignition sources.

Findings include:

1. On 10/16/12 at 11:25 AM, in the presence of Staff #39 in X-ray Room #4, an ABHR was installed above an electric outlet.

A. Based on a tour of one patient care unit, it was determined that facilities, supplies, and equipment were not maintained to ensure an acceptable level of safety and quality.

Findings include:

1. A tour of Unit 1 South, the psychiatric unit, on October 10, 2012 evidenced:

a. Recreational Therapist Office:

The patient food refrigerator had a thick, crusty, yellow stain beneath the right lower drawer. Red, tacky spillage was observed at the bottom of the right lower drawer. The thermometer in the refrigerator indicated a reading of 28 degrees Fahrenheit. There were four bags of sandwiches in the refrigerator, two of which did not indicate the last date of freshness. The interior of the freezer in the refrigerator contained bits of paper and stains. Dust and hair were observed on top of the exterior of the refrigerator.

b. Hallway:

i. Two stained ceiling tiles at the entrance to the Unit.

ii. A framed picture of a forest had a heavy accumulation of dust atop the frame.

c. Conference Room:

i. Heavy dust was observed behind a metal cabinet.

ii. Spider webs were near the window and heater.

iii. A wall was cracked.

d. Patient/Family Room:

i. Candy pieces, candy wrappers, scraps of paper, hair, grit, food particles, and a $10.00 bill were found between seat cushions and the sides of chairs.

ii. A cabinet in the corner of the room had paper scraps, dust, and pieces of gum behind it.

e. Medication Room:

i. A wall cabinet contained:

* One MedTronic Defib/ECG Electrode pack with an expiration date of '2009-02-28' and one with an expiration date of '2006-12-24.'

* One Tegaderm with an expiration date of '2006-05'.

* One Yankauer suction instrument in a partially opened sterile package.

ii. A drawer next to the refrigerator contained:

* One Paradigm Quick Set with an expiration date of '2011-02'.

iii. A cabinet beneath the countertop contained:

* One purple capped Vacutainer with an expiration date of '2012-08'.

* One purple capped Vacutainer with an expiration date of '2012-06'.

* Two pink capped Vacutainer with an expiration date of '2012-07.'

* One red capped Vacutainer with an expiration date of '2012-08.'

* One blue capped Vacutainer with an expiration date of '2012-04.'

* One light green capped Vacutainer with an expiration date of '2012-07.'

* One prefilled Mono-ject Sodium Chloride syringe with an expiration date of '04/2010.'

iv. A drawer beneath the fax machine contained broken Goldfish Crackers.

v. The fax machine had a heavy accumulation of dust, hair, paper scraps, and sunflower seeds beneath and behind it.

f. Patient Bedrooms:

i. P.S.-03 (Patient Room #) had a cracked wall with a hole in one section and a section of the wall plaster was buckled.

ii. P.S.-05 had heavy dust, used paper towels, and a dead flower behind and beneath the bed closest to the window.

iii. P.S.-06 had a heavy dust accumulation in and on the ceiling vent in the bathroom. Dust was beneath and behind both beds in the room.

iv. P.S.-07 had water damage on the wall near the window, stains on the ceiling, and paint peeling from the ceiling. The bathroom in the room had a heavy accumulation of dust in and on the ceiling vent.

v. P.S.-09 had dust and toilet tissue in a wall vent. The wall in the room had cracks and buckled sections of plaster.

vi. P.S.-10 had a heavy accumulation of dust atop the clothes closet and on the floor. A shower curtain in the bathroom had a black mold-like substance on the side facing the shower.

g. The Housekeeping Closet contained a spray bottle with a light yellow liquid inside of it. There was no indication on the bottle of its contents.


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B. Based on observation, staff interview, review of facility documents, and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure all equipment are maintained to an acceptable level of safety and quality.

Findings include:

Reference #1: AAMI RD52:2004 section 5.2.7 on 'Reverse Osmosis' states "Depending on membrane configuration and materials of construction, RO systems are sensitive to various feed water conditions that may lead to diminished performance or premature failure. To avoid such problems, users should carefully follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters."

1. On 10/9/12, the manufacturer's operation manual for the solo GE Osmonics reverse osmosis system was requested from Staff #22. Staff #22 stated that the facility currently does not have the manual and therefore was not available onsite for review.

Reference #2: AAMI RD52:2004 section 6.2.5 on 'Carbon adsorption' states, Carbon adsorption performance is monitored by measuring free chlorine and/or chloramines concentrations in the water exiting the first carbon bed of a series connected pair. It should be noted that sampling for total chlorine (the sum of free chlorine and chloramines), allowing a maximum level of .1 mg/L of total chlorine is often simpler than analyzing for free chlorine and chloramines separately. Testing for free chlorine, chloramines, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine(DPD) based test kits or dip-and-read test strips. Whichever test system is used, it should have sufficient sensitivity and specificity."

Reference #3: Manufacturer's directions on 'HACH Aquachek Water Quality Test strips for Total Chlorine and Free Chlorine' states "1. Dip the strip into water and move back and forth for 30 seconds or hold pads under water stream for 10 seconds. 2. Compare the TOTAL CHLORINE and FREE CHLORINE pads to the color chart above. Estimate results if the color on the test pad falls between two color blocks."

1. On 10/9/12 at 11:30 AM, Staff #23 was observed testing for total chlorine with 'HACH AquaChek Water Quality Test strips for Total Chlorine and Free Chlorine' which were found with insufficient sensitivity. Total Chlorine and Free chlorine color chart comparator on these strips were noted with following 6 color blocks: 0 ppm, 0.5 ppm, 1.0 ppm, 2.0 ppm, 4.0 ppm, 10.0 ppm with intervals of .5 ppm. Total chlorine level of <.1 ppm could not be determined with these test strips.

When Staff #22 was questioned about the use of these specific dip-and read test strips, he/she stated that he/she was not aware these test strips were being utilized by patient care staff. Immediately, the total chlorine was rechecked two times using an approved DPD test kit and the result came out at an acceptable level of .02 ppm and .04 ppm of total chlorine.

Reference #4: AAMI RD52:2004 section 8 on 'Environment' states "Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range."

1. A Schematic diagram was not available for the water treatment system located in the small room within the patient treatment area. The sample ports and major components are not clearly labeled and identified.

Reference #5: AAMI RD52:2004 section Annex E on 'Special considerations for acute hemodialysis' states "E.3.4 Carbon adsorption media: Where practical, portable water treatment systems should include two carbon adsorption beds in series, which together provide a minimum of 10 minute Empty Bed Contact Time. Initially, the requirements for two carbon beds in series was waived for portable dialysis systems because of the impracticality of providing these features while retaining the portability of the system. However, alternative technologies are now available that allow portability while retaining the redundancy associated with two carbon beds in series."

1. On 10/9/12, Staff # 22 stated that the firm has a total of 4 portable reverse osmosis water treatment systems all equipped with only one carbon adsorption tank.


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C. Based on observation and review of facility policy and procedure, it was determined that the facility failed to implement its policy and procedure for maintaining and monitoring the temperature of the breast milk refrigerator.

Findings include:

Reference: Facility policy # 668, titled 'Storage and Handling of Expressed Breast Milk", states "... PROCEDURE: ... 7. Expressed breast milk may also be stored in the coldest section of the freezer. Use within one month (freezer must be maintained at 0 [degrees Fahrenheit] or lower).

1. On 10/9/12 at 11:40 AM, the Pediatric Unit was toured in the presence of Staff #1. The Breast Milk Refrigerator logs were reviewed and indicated on the log form that the freezer temperature must be within 0-10 degrees Fahrenheit. The temperature logs for the months of August, September, and October (thru this date, 10/9/12) indicate temperature readings for the freezer ranging from 18-24 degrees Fahrenheit. This is above the 0-10 degrees Fahrenheit range as per the directive on the log, or as per policy for freezer maintenance of 0 degrees Fahrenheit or lower.

a. The temperature of the freezer was checked at this time and was 20 degrees Fahrenheit.

2. There was no evidence on the temperature logs of a temperature recheck within 30 minutes of a temperature out of range, as directed on the form, or notification to building services for any of the above dates.

Based on observation, staff interview, and review of documentation on October 9, 2012, it was determined that the facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. The facility's program for prevention, control, and investigation of infections and communicable diseases should be conducted in accordance with nationally recognized infection control practices and guidelines as well as applicable regulations of federal and state agencies. The facility failed to implement the adopted guidelines of; the Association for the Advancement of Medical Instrumentation, (AAMI) and the Society of Gastroenterology Nurses and Associates (SGNA).

Findings include:

Reference # 1: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79:2005. (ST 79 replaces and super cedes ST 46 by consolidating ST 46 with 4 other AAMI standards [ST 33, ST 37, ST 42, ST 35] approved 7/10/09.

The AAMI standard 3.4 Decontamination area housekeeping procedures indicate that all areas used in decontamination, preparation, or sterilization should ensure a high level of cleanliness at all times.

1. Upon observation on October 9, 2012 at 11:30 AM, the metal storage cabinets, metal storage table used for the staff radio, and the corner pump area adjacent to the ultrasonic equipment is soiled and not maintained clean in the decontamination area.

Reference #2: The Association for the Advancement of Medical Instrumentation (AAMI) ST 58, Chemical sterilization and high level disinfection in health care facilities, section 9.5.1 Physical monitors indicates that the operator should examine, interpret, and initial the printout to verify that the cycle parameters were met.

1. The digital tapes for the ASP endoscope reprocessing equipment in the Endoscopy department are not initialed to verify the cycle parameters have been met. Operator initials were not observed from June 2012 to the current date.

Reference # 3: The Society of Gastroenterology Nurses and Associates, Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, section entitled, " Procedure Rooms " indicates that to prevent cross contamination in an endoscopic procedure room, all contaminated areas must be cleaned and decontaminated between patients.
The hospital policy entitled, Basic Procedure; Endoscopy, 3844, page 3, #13 states that the Endoscopy suite will be cleaned & reorganized in between each case following universal precautions.

1. On October 11, 2012 at 11 AM, Staff #41 was observed to provide a potential source of cross contamination into Endo procedure Room #3. Staff #41 transported a tray of soiled equipment and a fluid filled suction canister from Endo Room #3 to the soiled utility where he/she emptied the fluid filled canister into the hopper sink. He/she then transported the tray of soiled instruments into the decontamination work room and placed soiled items into the sink. He/she returned to Endo Room #3 with the same personal protective gown, mask, and gloves while the patient was still in the room. This is contrary to the hospital policy and good universal precautions.

Reference #4: AAMI ST79:2010 states in 7.2.2 Manufacturers ' instructions, states "The written instructions of the device manufacturer should be followed."

Reference #5: Symetry Medical instructions for use states under daily instructions, "1. The container should be washed with a surgical instrument detergent, rinsed with tap water and dried with a soft absorbent towel. 2. Check the valves. The valves located in the top and bottom of the container should be vented at least once a day, when the container is cool. "

Reference #6: Facility Policy and Procedure titled Cleaning of Steam Autoclave and Flash Packs in O.R. states under Procedure #3 " Flash packs will sent to sterile processing on a weekly basis to be sent through the washer / sterilizer. "

1. On October 9, 2012 Staff #42 stated that the flash packs were cleaned and serviced on a quarterly basis.

2. On October 11, 2012 Staff #15 and #42 stated that flash packs were sent down to sterile processing for cleaning on a weekly basis. However, neither knew when the valves were vented or what cleaning process occurred on a daily basis as per manufacturer instructions.