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Based on observation, staff interview, and document review, the hospital failed to ensure an ongoing quality appraisal and performance improvement program for high risk, high volume NICU human milk and formula preparation. Hospital failed to develop infection control indicators for which there is evidence that it will improve health outcomes for a quality appraisal and performance improvement (QAPI) program with ongoing data based measurable indicators or show evidence of improving health outcomes for the program developed. The failure to measure, analyze, and track the infection control practices and develop a robust QAPI program in the NICU breast milk and formula preparation activities would allow the failures to continue and compromise patient care.
Findings:
Each health care facility should establish an ongoing performance improvement program as part of a hazard Analysis and Critical Control Point Program (HACCP) (systematic preventive program approach to food safety) process designed to ensure the following: 1) Monitor and evaluate the quality and appropriateness of the feedings prepared, handled, stored, transported, and administered, 2) Pursue and prioritize opportunities to improve or advance practical applications, 3) Resolve identified problems. Infant Feedings: guidelines for preparation of human milk and formula in health care facilities Second edition (2011). American Dietetic Association.
Nurse Epidemiologist stated on 4/9/14 at 9:30 a.m., there were no policies or procedures or staff training that implemented the standards of practice outlined in the Infant Feedings: guidelines for preparation of human milk and formula in health care facilities Second edition (2011). American Dietetic Association.
There was no documentation that the hospital had initiated a QAPI program to address the NICU formula preparation.

Based on observation, interview and record review the facility failed to ensure documentation regarding dissemination of Advanced Directive information for four sampled patients (Patient 301, Patient 302, Patient 303, and Patient 308) was accurately reflected in the medical record.

A review of the facilities Policy and procedure titled "Advanced Directives", dated, 4/13/13, " (the facility) shall provide each adult inpatient at the time of his/her admission, written information describing.......the right to make healthcare decisions and to formulate an Advance Directive." Admitting department responsibilities include asking patients if they have an Advanced Directive and then following up depending on the patient's answer. The policy also indicates, "Admitting department will provide patient and/or responsible party with a patient's rights brochure entitled, "Your Right to Make Decisions About Medical Treatment" (English or Spanish) and the Meditech screen updated accordingly." Nursing responsibilities include asking "the patient if he/she has an Advance Directive..." and, "If the patient does not have an Advance Directive but requests information, Social Service Department is available to assist."

During an interview with Patient 301 on 4/8/14 at 8:45 a.m., Patient 301 indicated that she was never asked or informed about an Advanced Directive. Patient 301 indicated she was admitted for induction of labor and had come through the admissions department on the first floor prior to being sent to the labor and delivery department. Patient 301 asked, "What is an Advanced Directive, what is it for?" after being questioned by surveyor.

A review of Patient 301's medical record indicated an answer of "No" to the question "Patient has Advanced Directives?" on the labor and delivery admissions paperwork. There is no documentation that supports the patient was ever offered or given written information regarding an Advanced Directive.

During an interview with Patient 302 on 4/8/14 at 9 a.m., Patient 302 indicated she had been admitted for a scheduled repeat cesarean section. Patient 302 indicated she had been admitted through the admissions department before being sent to the labor and delivery unit and that she had signed forms both in admitting and in the labor department area before she had her cesarean section done. Patient 302 stated, "What is that?" when asked if she had been questioned regarding and Advanced Directive upon admission to the facility.

A review of Patient 302's medical record indicated an answer of "No" to the question "Patient has Advanced Directives?" on the labor and delivery admissions paperwork. Documentation in the medical record inaccurately reflects the patient's understanding regarding an Advanced Directive.

During an interview with Patient 308 on 4/8/14 at 9:15 a.m., Patient 308 indicated she had been admitted through the admissions office on the first floor before being sent up to the labor and delivery department. Patient 308 did not know what an Advance Directive was when asked if the admitting department or the labor nurse had asked her about it. Patient 308 indicated she was not given any written information regarding Advanced Directives.

A review of patient 308's medical record revealed a blank box with no answer marked for the question, "Patient had Advanced Directives?" There is no documentation anywhere in the medical record showing the admitting nurse asked Patient 308 about Advanced Directives. Patient 308 was admitted with possible leaking of fluid.

During an interview with Patient 303 on 4/8/14 at 9:45 a.m., Patient 303 indicated she did not know what an Advanced Directive was. Patient 303 indicated that she had been admitted and had signed some papers in the admissions department on the first floor before being sent to the labor and delivery department. Patient 303 stated, "I was not in labor but I thought my water broke so I came in. They had to induce my labor."

A review of Patient 303's medical record indicated an answer of "No" to the question "Patient has Advanced Directives?" on the labor and delivery admissions paperwork. There is no documentation that supports the patient was ever offered or given written information regarding an Advanced Directive.

During an interview with the labor and delivery department manager (LDM) on 4/8/14 at 10:00 a.m., the LDM stated, "Well I guess the nurses are just not asking about them (Advanced Directives) like they are supposed to when the patients are being admitted."

During an interview with a senior admissions staff member (SAS) on 4/8/14 at 3:30 p.m., the SAS indicated that there were problems on the weekends with staffing and that it was possible that the Advanced Directive questions were being missed.

During an interview with a licensed nurse (LN1), on 4/10/14 at 9 a.m., LN1 indicated that she would put a note in the drop down text box if the patient answered "No" to the Advanced Directive question on the labor and delivery admissions screen.

During an interview with a licensed nurse (LN2) on 4/10/14 at 9:15 a.m., LN2 indicated that that she would make a note if the patient answered yes or no to the Advanced Directive question on the labor and delivery admissions screen.

During an interview with a licensed nurse (LN3), on 4/10/14 at 9:30 a.m., LN3 indicated that she would make a notation in the long notes and that there were no prompts in the system to allow for any indication that Advanced Directive materials had been given to the patient.

Based on record review, the facility failed to ensure complete physicians orders were written for hemodialysis treatments for two patients (401 and 402). This failure had the potential to result in treatment errors during hemodialysis.

Findings:

The clinical record for Patient 401 was reviewed on 4/8/14. Doctor's Orders dated 4/7/14 indicated Patient 401 to be dialyzed. Doctor's orders did not include blood flow rate (BFR- speed of how blood is moved by dialysis machine) and dialysis flow rate (DFR- speed of how chemicals are moved by dialysis machine). Treatment sheets for dialysis indicate BFR 300 and DFR 500.

The clinical record for Patient 402 was reviewed on 4/8/14. Doctor's Orders dated 4/7/14 indicated that Patient 402 to be dialyzed. Doctor's orders did not include BFR and DFR but treatment sheets for dialysis indicate BFR 350 and DFR 600.
Patient 402 had additional orders to be dialyzed Tuesday, Thursday, and Saturday. The BFR and DFR were not included in the order.

The facility policy and procedure titled "General Rules and Regulations III. Medical Orders: A. Treatment Orders" indicated, "All orders of treatment must be recorded clearly, legibly and completely in the patient's medical record. Orders which are illegible or improperly written will not be carried out until clarified by the nurse and recorded legibly in the chart."

Based on inspection of the facility's Patient Own Medication storage area the facility failed to develop a system to ensure that controlled drugs could be accounted for at all times and the facility had failed to develop a system to prevent the removal of controlled drugs from the facility, without detection.

Findings:

Inspection of the hospital's, Patient Own Medication storage area in the basement Pharmacy on 4/8/14 revealed that several of the hospital's own controlled drugs had been stored inside of this storage area since 3/27/14 (for the past 11 days). Interview with the DOP and the facility's ADOP on 4/8/14 at 10:50 a.m. revealed that no controlled drugs, except for those belonging to patients who had been admitted to the facility should be present in this storage area. Two clear large plastic zip-lock bags were found on the top shelf of the Patient's Own Medication storage area. The following scheduled (narcotics) controlled drugs were found in this storage area on 4/8/14 at 10:50 a.m. and could not be accounted for by the facility (even though they were outside of the hospital's controlled drug system) and were techinically, "missing":

1) Diazepam 5 mg- one oral tablet,
2) Hydromorphone 2 mg injectable syringes- four syringes
3) Hydromorphone 0.2 mg per ml Patient Analgesic Control (PCA) Syringe- two syringes
4) Lorazepam 0.5 mg- one oral tablet
5) Lorazepam 2 mg- two oral tablets
6) Morphine Sulfate 10 mg injectable syringe - one syringe
7) Morphine Sulfate 2 mg injectable syringes- three syringes
8) Morphine Sulfate 4 mg injectable syringes- eight syringes
9) Morphine Sulfate 1 mg per ml 30 mg syringe- one syringe
10) Phenobarbital 32.4 mg tablets- two oral tablets
11) Zolpidem 10 mg tablets- one oral tablet
12) Clonazepam 0.5 mg tablets- two oral tablets
13) Clonazepam 1 mg tablets- four oral tablets
14) Midazolam 5 mg injectable vial- one vial
15) Oxycodone with Tylenol 5 mg/325 mg tablets- four oral tablets
16) Oxycodone 5 mg tablet- two oral tablets

All of the controlled drugs above, had been removed from the facility's drug accountability system which meant that anyone who had access to the Patient's Own Drug storage area, could have walked out of the facility without anyone ever realizing that these controlled drugs were missing or that they had ever been removed from the hospital.

Based on inspection of the facility's Patient Own Medication storage area, medication administration observation, review of the facility's policy and procedures, and one patient interview, the facility failed to follow and implement its own policy and procedures for the safe storage of patient's own medications which had been brought into the hospital.

Findings:

Inspection of the facility's Patient Own Medication storage area on 4/8/14 at 9:45 a.m. revealed that multiple Patient's Own medications had not been secured and stored as outlined in the hospital's policy and procedures below:

The facility's policy and procedure entitled: "Medication Brought into the Hospital by Patients for use or Storage", dated 4/19/13, stated: "When a patient brings personal medications into the hospital,....The patient's family will then be encouraged to take the medications home.... 1. Patient medications not ordered by the physician and not taken home by the family are to be placed in a valuable's envelope by nursing personnel at the time of admission. 4. The number of medication containers placed in the valuable's envelope will be verified with the patient or family member and the envelope signed by both. 5.One copy of the receipt will be given to the patient or family member. 7. Nursing will place a copy of the receipt into the chart, stapling it to the discharge teaching form. For areas using electronic Meditech documentation, the nurse will enter that the medications were sent to pharmacy into the Meditech under the intervention called ADMISSION, Hx/AD/Belongings.... 3. Unclaimed medications will be processed as pharmaceutical waste after 14 days post discharge."

Inspection of the facility's Patient Own Medication storage area on 4/8/14 at 9:45 a.m. revealed several examples of Patient's Own Medications being stored inconsistent with the hospital's policy and procedure.

1) Patient 701 had a bag with various medications stored inside the Patient's Own Medication storage area located in the basement Pharmacy. This bag of medications had a handwritten list (of the medications on the outside of the bag written on a plain sheet of white paper). The facility's policy and procedure indicates in section 2 that "the valuable's envelope will be stamped with the patient's name and hospital identifiers. This bag had not been stamped with this information. Section 4 above states that the medication containers will be signed by the nurse (implied here), the patient, or the patient's family member. This bag had not been signed by the hospital's nurse, the patient, or the patient's family member as stated in the hospital's policy above. This patient had been discharged from the hospital on 4/2/14 (six days prior).

2) Patient 702 had one box of medications which was covered by a different type of Patient belongings bag, which had been stored inside the Patient's Own Medication storage area in the basement Pharmacy. This bag did not have any evidence that these medications had been verified by the hospital nurse, the patient, the patient's family member as outline in the hospital's policy and procedure (P&P). These bags also did not have any evidence that the patient or the patient's family member had received a copy of the inventory list of the content of drugs inside the bag, as outlined in the hospital's P&P above. This bag also did not have the Meditech label attached which is outlined in item # 7 of the hospital's P&P. Hospital records revealed that Patient 702 had expired at the facility on 3/15/14. The hospital's P&P reads: "3. Unclaimed medications will be processed as pharmaceutical waste after 14 days post discharge." These medications remained in the hospital for almost 28 days without being destroyed as outlined in the facility's P&P above.

3) Patient 703 had two zip-lock quart size bags with various medications stored inside the Patient's Own Medication storage area located in the basement Pharmacy. Only one of these two bags of medications had a small Meditech label on the outside of the bag. The hospital's policy and procedure indicates in section 1 that "a valuable's envelope" would be used to store these medications. Section 4 above states that the medication containers will be signed by the nurse (implied here), the patient, or the patient's family member. These bags had not been signed by the hospital's nurse, the patient, or the patient's family member as stated in the hospital's policy above. Only one of the two bags had a Meditech label on it. The Meditech label indicated that the following items should have been present in both of these bags but the following drugs were missing from both bags: D-3, Doxazosin 1 mg (an unknown number of tablets or capsules), Carvediol 6.25 mg (an unknown number of tablets or capsules), Nifedipine 60 mg (an unknown number of tablets or capsules), Docusate Sodium Salt (DSS) 250 mg (an unknown number of tablets or capsules), and one cigarette lighter could not be found inside either of the zip-lock bags.

4) During a medication pass observation on 4/9/14 at 8:30 a.m. the hospital Medication Nurse and Patient 704 were discussing the patient's medications and the patient indicated to the Medication Nurse that his home medications were still sitting in the room on the window ledge in a brown paper bag. The patient pointed to the bag and I began to interview Patient 704 and ask him when he had been admitted to the hospital. The patient indicated that he had been admitted into the hospital on Friday 4/4/14. He also indicated that he had brought these medications with him for his admission into the hospital. The patient went on to say that he had notified his Admitting Nurse that he had these medications in his possession. The patient also indicated during the conversation that he had notified one of the other nurses who was taking care of him days after he had been admitted to the hospital. Apparently this nurse had taken his medications, inventoried them and brought them back to his room for storage. This brown paper bag contained a total of 19 medications which had not been placed into valuable's bags, and no envelopes had been signed by the nurse or the patient or his/her family, as outlined in the hospital's policy and procedures. The patient's bag of medications did not have a Meditech sticker on it as outlined under section 7 of the hospital's policy and procedure.

Based on observation, interview, and review of the facility policies and procedures the facility failed to ensure that their outsourced compounded intravenous (IV) medications, provided the same patient safety assurances (in terms of sterility and efficacy) which the hospital had established for its own compounded IV medications, under the facility's own policies and procedures. The facility also failed to ensure that stock Gentamycin solutions which had been compounded by the hospital had been given an expiration date which the facility was able to support with current clinical literature.

Findings:

1) Interview with the facility's Director of Pharmacy (DOP) and the facility's Assistant Director of Pharmacy (ADOP) on 4/7/14 at 11:40 a.m., revealed that the facility's Pharmacy was using an outside drug compounder to provide the facility with the following drugs:

1) Oxytocin 30 units in 500 milliliters (ml) of Normal Saline solution,
2) Bupivacaine 0.125% in 250 ml of Normal Saline,
3) Amiodarone 150 milligrams (mg) in 100 ml of Dextrose, and
4) Hydromorphone PCA 6 mg in 30 ml of Normal Saline.

Several boxes of the items above had been observed sitting on the Pharmacy's storage shelf inside the main Pharmacy on 4/7/14 at 11:40 a.m.

Review of the facility's policy and procedure entitled: "General Procedures Pertaining to the Preparation of Sterile Products", dated 5/6/13, stated: "....3. The preparation of all sterile products must be performed in such a manner as to minimize the possibility of contamination of the admixtures....10. The final product must always be checked for particulate matter, proper labeling, correct calculations, as well as the admixture components. 11. Whenever there is any doubt concerning the preparation of a parenteral product, discard it.....1. Random samples of IV admixtures will be sent to Microbiology for culturing, At least two samples will be sent each month....3. All Microbiology results will be reviewed by the Infection Control Committee and will be maintained on file in the Pharmacy. 4. Identified problems will be investigated, and reviews of technique will be performed. 5. Suspected problems will be investigated as necessary.... Air Sampling, (1. This procedure must be performed monthly.)...Surface Sampling, (1. This procedure must be performed monthly)...Replacement Filters: (1. Pre-Filters are replaced each month)....Every 6 months the hood is inspected, tested and certified according to Federal Standard. Records of certification will be maintained.....Once a month, the IV technician will culture randomly selected sterile products still within date. The cultures are sent to the lab for growth and identification...Measurement of aseptic technique is very important in order to provide quality sterile product to our patients at XXX (our hospital)."

In a second interview with the DOP and the ADOP on 4/7/14 at 3:20 p.m., they were asked to provide quality assurance data which the facility would have received from the compounding Pharmacy. The facility would have matched this data with the criteria which the hospital had established from its own policy and procedures above. The outside compounding Pharmacy vendor had supplied the hospital Pharmacy, with something called: "Quality Trend Record Review". These "Quality Trend Record Reviews", which came from the Pharmacy compounder, were generic compilations of data which appeared to have been distributed to other drug purchasers (who used the same drug compounder) nationwide. No information on these reports indicated that any of the testing which had been completed, was directly linked to this particular drugs which the hospital had been purchasing from this particular drug compounder. The data also contained various codes and abbreviations which the hospital was unable to explain what these meant and they were unable to translate what the data meant. During the interview (on 4/7/14 at 3:20 p.m. above) with the hospital's DOP and the ADOP, the hospital acknowledged that any drugs, which are purchased and dispensed by the hospital, must meet the same standards as those set by the hospital, for it's own Sterile drug compounding, as identified above in the hospital's policy and procedures. The facility was unable to show that these outside compounded drugs meet the hospital's same standards.

2) Inspection of the hospital's Bulk compounding area on 4/17/14 at 4:30 p.m. revealed that the Pharmacy had been compounding a stock solution of Gentamycin (an antibiotic) 5 mg per 1 ml solution for quite some time. This antibiotic solution is used as a base solution to make multiple intravenous syringes of the the same drug. The DOP and the ADOP were interviewed while reviewing the facility's stock solution compounding log on 4/17/14 at 4:35 p.m. and they were asked how long the facility keeps the stock solution until it is considered expired. The DOP and the ADOP indicated that the Gentamycin stock solutions are kept for 7 days after they are made, before they are considered expired. The hospital's compounding log also reflected that the Gentamycin stock solution could be kept for 7 days. The facility's policy and procedure entitled: "General Procedures Pertaining to the Preparation of Sterile Products", dated 5/6/13, stated: "Once drugs are mixed they are time sensitive and are stable only for a period of time at room temperature or in the refrigerator." The DOP and the ADOP were asked if they could provide clinical literature to support the expiration date of 7 days which had been assigned to the stock Gentamycin solution. The Pharmacy was unable to provide current clinical literature at the time to support the drugs compounded stability beyond 4 days after the product had been made and kept under refrigeration. The facility had previously been providing an expiration date for this drug, which was three days beyond the current literature that the facility was able to provide at the time of our conversation on 4/17/14 at 4:30 p.m.

Based on observation, interview, and document review, the hospital failed to have a director of food and dietetic services ensure food safety practices for food handling as evidenced by food service staff not following cool down practices and allowing dishware to air dry. The potential of not following cool down and air drying requirements puts medical compromised patient at high risk of food borne illness.
Findings:
1. Food borne bacteria in large numbers can cause food poisoning. Food borne illness becomes more dangerous in patient with immune compromise, young children, elderly and pregnant women. Time temperature control is critical in food safety systems. To prevent time temperature abuse and the growth of pathogenic microorganisms, the amount of time food spends in the danger zone must be minimized and documented to ensure food is properly cooled after preparation. Foods made at room temperature like tuna salad and egg salad require cooling from 70 degrees F to 41 degrees F in 4 hours of less. Food Code 2014.
On 4/7/14 starting at 8:30 a.m., one tall 20 quart container of tuna salad was in the walk in refrigerator. Food Service Worker 1 (FSW 1) stated at 9:20 a.m. she prepared the tuna salad this morning at 6:30 a.m. and place in the walk in refrigerator. FSW 1 stated that the tuna salad would be used on Tuesday (4/8/14). Temperature of the tuna salad at 9:35 a.m., with the facility digital thermometer was 60 degrees Fahrenheit (F).
Review of the cool down log (Hazard analysis and critical control point procedure) showed documentation of cooling hot foods through the danger zone (temperature range in which food borne bacteria grow) from 135 degree F to 70 degrees in 2 hours and from 70 degrees F to 41 degrees F in 4 hours. Executive Chef stated concurrently, he was not aware of the food code requirement for cooling the tuna salad through the danger zone from 70 degrees F to 41 degrees F in 4 hours to prevent the growth of pathogenic microorganisms.
Review of the policy titled Food Handling Guidelines dated 3/1/13, stated the Director of Food and Nutrition Services and the Executive Chef are responsible for the execution and monitoring of CCP ' s (Critical Control Points) and records associated with Good Food handling procedures. The policy stated " Potentially hazardous food shall be cooled within 4 hours to 41 degrees F if prepared from ingredients at room temperature. " This policy was reviewed by Facility Chief Administrative Office. There was no review by the Infection Control Committee.
2. Dishes stored away wet can become contaminated with bacteria. Holding wet dishes can re-contaminated because warm moist environment provides good conditions for bacterial growth. Journal American Dietetic Association. FDA Food Code 2013 specifies that all dishes should be air-dried before being stacked and stored. Use of a drying cloth will re-contaminate the surface of the dishware.
On 4/7/14 at 9:40 a.m., FSW 2 was drying plates with a paper towel. She stated the plates from the dishwashing were wet she dried them off before using. Assistant Director for Catering and RDs concurrently acknowledged that the plated were to be air dried and not wiped off.
Review of the policy titled Sanitation ware Washing dated 3/1/13 stated " 8. dishes are allowed to air dry before they are stacked in the service area or clean dish storage area. Dishes are not to be stored wet and are NEVER (facility emphasis) towel dried.

Based on observation, interview and document review the hospital failed to ensure therapeutic menus were served as planned as evidenced by cook not serving established meat portions. This failure has the potential of compromising patient nutrition and medical status.
Findings:
Therapeutic diets refer to diets prescribed by the physician indicated for the treatment of various medical and surgical conditions e.g. renal, cardiac, and diabetic carbohydrate (starch) controlled. Renal diets are modified for patient with kidney function impairment, restriction include protein (meat), salt, and other minerals. Diabetic diets may control calories and portions such at meat and starch. Failure to follow the therapeutic planned meal pattern can compromise the patients ' medical condition, American dietetic Association.
On 4/8/14 starting at 11:30 a.m., therapeutic diet assembly was observed. Cook 1 served 2 slices of roast pork loin on renal diet and consistent carbohydrate diet. Cook 1 the weight of 2 slices of pork loin was 3 ounces. .
Review of the Patient menu Tuesday lunch stated pork loin 2 ounces for renal diet and 4 ounces for consistent carbohydrate diet.
Assistant Director of Catering concurrently stated that then menus were posted for the cooks ' reference and verified the cook was not serving the correct portion as specified on the menu.

Based on observation, interview, and document review the hospital;

1. Failed to ensure the infection control officer developed systems for identifying potential infection control risks in the NICU (neonatal intensive care unit) as evidenced by potential for cross contamination when infant formula preparation does not adhere to standard of practice and policies and training have not been established. The lack of infection control oversight and practices resulting in cross contamination present the high risk of food borne illness (food poisoning) to medically compromised infants.

2. Failed to ensure the infection control officer developed a system for the control of infections which included active surveillance of methods for monitoring and evaluating practices of asepsis.

3. Failed to identify, report and follow the infection control measures as per the hospital policy on three sampled patients (patient 101,102 and 103) as evidenced by staff not following contact precautions with patients, and undated IV (intravenous) dressings.

Findings:

1. Special care must be taken to reduce the risk of microbiological (small forms of life) contamination (presence of unwanted matter) of infant feeding prepared in health care facilities. The primary goal for infant feeding preparation is to prevent any infant from ingesting microorganism (organism causing illness). The objectives to limit the entry of undesirable bacteria or other microorganisms in sterile formals during the preparation and delivery of enteral (by way of intestine) feedings. Feedings can become contaminated during any step of the process, from formula preparation, pumping of breast milk, to feeding delivery and administration. Risk of microbial growth increases as manipulation of feeding increases including addition of modular (unit) additives or medications. Factors that influence and discourage microbial growth and cross contamination include infection control procedures in place throughout the enteral feeding process from formula storage, preparation and handling with aseptic techniques (procedure aimed at protecting patients from infection by minimizing the presence of pathogenic (harmful) microorganisms), written training policies, preparation of human milk separate from commercial products.
To minimize these risks facility must develop a patient safety plan for infant feeding preparation and administration that includes infection control procedures. Policies and procedures developed under guidance and approval of a multidisciplinary committee. The facility infection control process should include in oversight of infant feeding practices on an ongoing basis. Infant Feedings: guidelines for preparation of human milk and formula in health care facilities Second edition (2011). American Dietetic Association.
On 4/8/14 starting at 8:30 a.m., the NICU consisted of east and west sides.
A. The NICU east formula preparation had a room consisting of a hand washing sink, breast milk freezer and refrigerator units and counter next to the sink. There was storage of sterile equipment on the counter and directly adjacent to the hand washing sink (within approximately 8 inches). NICU nurse manager stated concurrently the infant formula and additives to the breast milk were prepared on the counted adjacent to the hand washing sink. Nurse Manager acknowledged that there was a potential of the hand washing to overspray (contamination from hands landing on adjacent surfaces) the sterile packages stored next to the hand washing sink. Nurse Manager stated that the infection control practitioner was aware of the formula preparation area. Nurse Manager stated there were no specific policies or procedures for infant formula preparation and training of nursing staff.
B. The formula preparation area for West NICU was in the NICU room and next to a hand washing sink. RN Rachel stated she would place a paper towel on the counter and prepare the formula or the breast milk with fortifier additive. RN stated after preparation she would wipe the area with a sani wipe.
On 4/9/14 at 9:30 a.m., Nurse Epidemiologist Infection Prevention and Control stated that there was no infection control oversight of the formula preparation in the NICU. Nurse Epidemiologist acknowledged the infant preparation areas presented a risk for cross contamination and potential for infant illness when aseptic practices and facilities were not in line with infection control standards.
Nurse Epidemiologist stated that there were no policies or procedures or staff training that implemented the standards of practice outlined in the Infant Feedings: guidelines for preparation of human milk and formula in health care facilities Second edition (2011). American Dietetic Association.
Review of policies titled formula preparation and storage dated 2/24/2014, approval did not include the infection control committee. The breast milk collection, storage and handling dated 3/6/12 referenced the American Dietetic Association: Guidelines for Preparation of Formula and Breast Milk in Health Facilities. The policy review did not include the Infection Control Committee.



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2. The medical assistant responsible for the disinfection of cystoscopes in an outpatient clinic stated in an interview at 10 a.m. on 4/9/14 there was no thermometer used to measure the temperature of the disinfecting solution prior to use. Review of the manufacturer's instructions for use of the product revealed there was a temperature range recommended for the use of the solution. The medical assistant stated the temperature of the solution was not measured before it was used to disinfect the cystoscopes.


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3. Review of the facility's policy titled "Standard Precautions and Infection Prevention and Control Strategies" dated 1/28/2014 indicated "Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. Remove gloves promptly after use, before touching non-contaminated items and environmental surfaces and before going to another patient..."

During an observation with a cath lab manager on 4/8/14 at 10.15 a.m., a Phlebotomist Assistant (PA) wore personal protective equipment (gown, mask and gloves) before entering inside sampled Patient 103's room who was on contact precautions. The PA checked the name band of the patient and assessed the patient for good IV site for the blood draw. She then came out towards the door and to the sink, and with the same gloves on, took some tubes out from the uncontaminated container that had supplies to be used for other patients. PA acknowledged that she did not change gloves after assessing the patient and used the same gloves to take the tubes out of the uncontaminated supplies container. The cath lab manager confirmed that the PA should change gloves after caring a patient with contact precautions and before touching the uncontaminated sites.

Director of Lab Services on 4/9/14 at 10.00 a.m. stated that all employees need to follow the proper isolation precautions as per the policy of the hospital. He further stated that the PA needed to remove or change gloves after caring a patient with contact precautions and before touching any non-contaminated items.

Review of the facility's policy titled "Intravenous Therapy Management" dated 4/22/13 indicated "Apply transparent occlusive dressing over the site...label dressing with date and initials."

During an observation and concurrent interview on 4/8/14 at 9.00 a.m., a licensed nurse (LN 4) confirmed that there were no dates on HL dressing for Patient 102.

During an observation and concurrent interview on 4/8/14 at 9.45 a.m., a licensed nurse (LN 5) confirmed that there were no dates on two HL dressings located on right wrist and left arm of Patient 101.

During a combined interview with the clinical manager of telemetry unit and a cath lab manager on 4/8/14 at 10.15 a.m., both acknowledged that there were no dates on IV dressings of two sampled patients (101 and 102).

Nurse Epidemiologist Infection Prevention and Control on 4/8/14 at 9.30 a.m. stated that the IV dressing needs to be dated according to the hospital policy.

Based on interview and facility document review the facility failed to ensure their policies and procedures were consistently implemented to ensure surgical services were provided in a safe and sanitary manner and in accordance with professional standards of practice. The facility failed to ensure staff wore laundered surgical attire that followed recommended professional standards of practice.


Findings:

Review of policy and procedure titled "Attire for Surgical Services" dated 2/12/12, reflected in part, the body and surfaces inherent to the surgical environment are major sources of microbial contamination and transmission. Surgical attire and appropriate personal protective equipment (PPE-masks, gowns, scrubs, gloves, eye protection, hair covers, shoe covers) are worn for worker safety and a high level of cleanliness within the setting. It is the hospital's policy that all personnel entering the surgical area wear appropriate apparel. Hospital laundered scrub clothes are available to personnel entering the area. However, if personnel choose to launder scrub clothing at home these criteria should be followed:
" a. Use of automatic washer and hot air dryer.
b. Water temperature of 110 degrees F. (Fahrenheit) - 125 degrees F. to facilitate microbial kill.
c. Using detergent according to manufactures instructions.
d. Laundering surgical attire in a separate load with no other items.
e. Using the highest dryer setting possible that is safe for the material of the clothing's construction.
f. Promptly removing attire when dry to avoid desiccation ( a state of extreme dryness)of materials.
g. Home laundered surgical attire should be protected during transfer and storage. This should include placing soiled scrubs in plastic bags for storage and transport to home laundry facility and then placing laundered scrub attire into a clean plastic bag for transport and storage to the hospital. Home laundered scrubs are not to be worn to the hospital."

According to the Perioperative Standards and Recommended Practices by the Association of Perioperative Nurses (AORN), 2013 edition, Recommended Practices for Surgical Attire reflected in part, "...Recommendation III All individuals who enter the semirestricted and restricted areas should wear freshly laundered surgical attire that is laundered at a health-care accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting...Worn reusable surgical attire should be left at the health care facility for laundering." Additionally the standard indicated, "Recommendation V... Surgical attire should be laundered in a health care-accredited laundry...Health care-accredited laundry facilities are preferred because they follow industry standards. The Healthcare Laundry Accreditation Council (HLAC) offers voluntary accreditation for those laundry facilities that process reusable health care textiles and which incorporate OSHA and the Centers for Disease Control and Prevention (CDC) guidelines and professional association recommended practices...Home laundering is not monitored for quality, consistency, or safety...Home laundering may not meet the specified measures necessary to achieve a reduction in microbial levels in soiled surgical attire."


During an interview with the Surgical Administrative Staff, who supplied a copy of the 2013 AORN Standards and Recommended Practices, on 4/10/14 at 9:40 a.m. agreed they could not state who was responsible for monitoring scrubs that were laundered at home to ensure the criteria enumerated in their policy was followed.