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Based on policy review and interview the Governing Body failed to ensure that the Hospital's dialysis services vendor complied with quality and performance standards and furnished services for the Hospital to comply with all applicable standards and Conditions of Participation.

Findings included:

On 4/26/18 at 7:55 A.M., during interview, the Unit Manager of the St. Camillus Unit said that there is a room on her unit that is used specifically for inpatient dialysis treatment. She said the Hospital has a contract with an outside vendor to supply these services and said that the outside vendor follows the policies and procedures of their company.

On 4/26/18 at 10:30 A.M., during observation of the dialysis suite, located on the St. Camillus Unit, indicated that contracted dialysis staff use the jug system for administering the dialysate to the patient during his/her dialysis treatment. Also revealed were packets of powdered calcium and potassium used to add to the jugs of dialysate if the physician orders indicated so.

Review of the contracted agency's policy, entitled, Use of Concentrate Additives for Inpatient Services, dated 7/11, indicated that the physician will only authorize the use of concentrate additive in unusual circumstances. All individually mixed dialysis concentrate will be documented on the mixing log that will be reviewed on a routine basis at a minimum of quarterly. The mixing log will include at a minimum:
* Signature of registered nurse mixing the dialysis concentrate.
* Date of mixing.
* Original acid concentration of electrolytes being altered.
* Electrolyte and gram weight of packet used to change concentration.
* Number of packets used to change final concentration and lot numbers.
* Intended final concentration.
* Signature of physician oversight on the log.

On 4/26/18 at 12:25 P.M., during interview, the contracted dialysis nurse said that he has never used a mixing log while providing dialysis care in this Hospital. He said he was not aware that there was a requirement for a mixing log and there is not one in use at this Hospital.

Based on observation and interview, the hospital failed to keep an updated list of all contracted services. Findings include:

During the entrance conference on 4/23/2018 at approximately 9:00 A.M., the hospital administration was requested to provide a list of all contracted services at the hospital which included the scope and nature of the services provided. The hospital complied and provided the list by 2:00 P.M. on 4/23/2018.

Review of the list indicated that four (4) contracted services of the hospital were not included on the list as required: the hospital dietary services; the water management company, the nursing contract agency and telemedicine services.

On 4/25/2018, at approximately 12:30 P.M., the Director of Quality said the four services had not been included on the list.

Based on records reviewed and interview, the Hospital failed to ensure that all staff involved in the application of restraint were certified in cardiopulmonary resuscitation (CPR) and first aid techniques.
Findings include:

The Emergency Department (ED) Policy titled, Restraint and Seclusion for Non-Behavioral Health Units-Provision of Care, dated 02/17/17, indicated that Hospital staff members who assist in applying restraint shall receive training in the use of first aid techniques and certification in the use of cardiopulmonary resuscitation.

The Surveyor interviewed the Security Supervisor at 1:00 P.M. on 04/25/18. The Security Supervisor said that the Security Guards assist with the application of restraint in the ED. The Security Supervisor said that the Security Guards were not trained in the use of first aid techniques nor were they certified in the use of cardiopulmonary resuscitation.

Based on observation, record review and staff interview, the Hospital failed to ensure that for one sampled patient (#31), in a total sample of 41, licensed staff stored, prepared and administered medications according to the orders of the practitioner responsible for patients' care and accepted standards of practice. Findings include:

1. For Patient #31, the Hospital failed to ensure that staff administered the intravenous (IV) medication Lasix (a diuretic) according to the physician's order.

Review of a preprinted, signed physician's order, dated 3/24/18, indicated that the patient was to receive a blood transfusion every week if his/her hematocrit was less than 24. The patient was to receive 2 units of packed red blood cells (PRBC) and Lasix 20 milligrams (mg) IV between each unit.

On 4/24/18 at 12:10 P.M., during review of the electronic clinical record with Nurse #10, indicated that nursing staff administered the first unit of PRBCs beginning at 8:07 A.M. and began the 2nd unit of PRBC's at 10:12 A.M. The surveyor asked Nurse #10 to show when the the IV Lasix 20 mg was administered. Nurse #10 said that it wasn't documented in the computer because the physician's order was sent down late to the pharmacy. Nurse #10 said that another nurse created an override in the Pyxis (automated medication dispensing system) in order to administer the Lasix. Nurse #10 and the surveyor reviewed the Pyxis electronic documentation which indicated that the Lasix was signed out by Nurse #8 at 11:56 A.M., which was after the 2nd unit of blood had been running for over an hour.

On 4/24/18 at 12:20 P.M., during interview, Nurse #8 said she forgot to notify the pharmacy of the Lasix order, and that's why the computerized order was not in the electronic record. She said she created an override in the Pyxis and took the Lasix out to give to the patient. Nurse #8 said she can't remember what time that was and she can't remember if she gave the Lasix before the start of the second unit of PRBCs.

2.) The Surveyor toured the Operating Room at 8:00 A.M. on 4/24/18 and interviewed the Nurse Manager. The Malignant Hyperthermia Cart (MH is a severe reaction that occurs to particular medications used during general anesthesia) was reviewed. According to the Nurse Manager the cart was checked by staff daily to ensure that the temperature of the refrigerated intravenous fluid and insulin was maintained. The Nurse Manager said the Operating Room (OR) Staff was often called in over the weekend and otherwise the temperature was remotely monitored by the Pharmacy.

The Surveyor interviewed the Director of Pharmacy Services at 4:00 P.M. on 4/25/18. The Director of Pharmacy Services said the refrigerator was not set up for remote temperature monitoring and the nurses were to record the temperature.

The Surveyor reviewed the Operating Room Malignant Hyperthermia Cart refrigerator temperature logs at 4:10 P.M. on 4/25/18. The log indicated that there was no temperature entry for 2/11/18, 4/8/18 or 4/15/18.

The facility failed to ensure safe and appropriate storage, tracking, control and disposal of medications in one medication room out of nine medication rooms surveyed. Findings include:

Review of the facilities "Medication Storage Version Two Chapter: Medication Management Policy Number:MM27 indicates that the Director of the Pharmacy oversees the storage of medications in the facility. The Director of each nursing service/clinical department is responsible for ensuring support and assistance in the execution of this policy. The Policy also indicates that medications stored in patient care areas are stored according to the manufacturers recommendations or in the absence of such recommendations, according to the pharmacist instructions, and all patient care personnel observe proper storage and labeling requirements for all medications and demonstrate safety in regard to the safe storage of medication.

The Surveyor toured the fourth floor telemetry unit with the Nurse Manager on 4/23/18, at 11:30 A.M. The Surveyor and Nurse Manager entered the medication room together. On the Pyxis machine (locked medication dispenser), was a 50 milliliter (ml) saline bag, labeled Cefazolin 1 gram premix. The medication had an expiration date of 4/26/18, and was labeled "Refrigerate". The Nurse Manager could not determine how long the medication was not refrigerated and could not determine why it was left out and not refrigerated. The Nurse Manager said that the medication should have been refrigerated. The Nurse Manager said that she would investigate. The Nurse Manager said the Medication would not be used and would be destroyed and then took possession of the medication.

The Surveyor interviewed the Nurse Manager on 11/25/18, at 12:30 P.M. The Nurse Manager said that they could not determine why the medication was left out and for how long. The Nurse Manager again stated that the medication should have been stored in the refrigerator.

Based on record review and interview, the hospital failed to review the medication orders of one patient (#9), in a total sample of 41, for correctly written orders that did not allow nurses to arbitrarily select as needed (PRN) pain medication doses without specific physician orders as to when to deliver a specific dose and when to administer an as needed dose of a supplemental drug to enhance pain medication. Finding include:

The hospital must have a process in place for medication orders dispensed in a safe and timely manner. Safe dispensing of medications
must be in accordance with accepted standards of practice and includes, but is not limited to, the following:
o Reviewing all medication orders (except in emergency situations) for appropriateness by a pharmacist before the first dose is dispensed. A process is established for resolving questions with the prescribing practitioner and the discussion and outcome are documented in the patient's medical record or pharmacy copy of the prescriber's order. This review should include:
o Therapeutic appropriateness of a patient's medication regimen;
o Therapeutic duplication in the patient's medication regimen;
o Appropriateness of the drug, dose, frequency, and route of administration.

Patient #9 was admitted on 4/22/2018 in labor. Medical record review for Patient #9 indicated there were physician orders as follows:

1. Stadol 1 milligram (mg) IM (intramuscularly) Q3H ( every 3 hours) PRN can be given in addition to the 1 mg IV dose, not to exceed maximum dose 16 mg/day for labor pain
2. Stadol 1 milligram (mg) IV (Intravenously) Q3H PRN can be given in addition to the 1 mg IM dose, not to exceed maximum dose 16 mg/day for labor pain;
3. Vistaril 50 mg IM Q4H for for pain

During an interview on 4/24/2018 at approximately 9:30 A.M., Registered Nurse (RN)#14 said she could give Patient #9 Stadol, for example, IV at 9:00 A.M. and if she thought it was necessary, she could then give Stadol IM with Vistaril IM at 10:00 A.M. When asked when the next dose of Stadol could be given, RN #14 said she could give Stadol IV at 12:00 Noon but said she could not give Stadol IM with the Vistaril until 3:00 P.M.

Review of the orders for Stadol with RN #14 and the Unit Manager at 10:00 A.M. on 4/24/2018, indicated the orders allowed the nurse to choose how much Stadol (either 1-2 mg) the nurse could give every 3 hours without parameters for choosing the dose. When asked if pain was a indication for the use of Vistaril (indication for use include anxiety, IM Pre- and postoperative adjunctive treatment with other pain medications in labor pain management), the Unit Manager said no and that the indications on the order and medication administration record were not correct.

During an interview on 4/25/2018 at 2:45 P.M., the Director of Pharmacy said the above orders were poorly written, lacked specificity with nurses picking doses of pain medications, and due to the confusing nature of the orders, could lead to medication errors in dosing.

The facility failed to assure that only authorized personnel may have access to locked areas where drugs and biologicals are stored.

Findings include:

The Surveyor toured the fourth floor telemetry unit (St Camillus) with the Nurse Manager on 4/23/18, at 11:30 A.M. The Surveyor and Nurse Manager entered the medication room together. Inside the medication room were two unlicensed personnel who were stocking. The surveyor asked the nurse manager about the employees. The Nurse Manager said that they were Nurses Aides and they were not supposed to be in the locked medication room without a nurse. The Nurse Manager said that one Nurse Aide was on orientation and the other was showing her how to stock items in the locked medication room. The Nurse Manager said that she would look into the reason the two Nurses Aides were left unaccompanied.

Review of the facilities "Medication Storage Version Two Chapter: Medication Management Policy Number:MM27 indicates that medication storage areas are accessible only to designated and authorized personnel. The policy also indicates that all medications are stored in a secured location or in an area where the medication storage area is under continuous surveillance by licensed personnel.


The surveyor interviewed the Nurse Manager on 11/25/18 at 12:30 P.M. The Nurse Manager said that she interviewed the nurse who was working that day. The Nurse Manager said that the nurse originally was in the locked medication room with the two Nurse Aides but was called away. The Nurse Manager said that the Nurses Aides should have left at that time. The Nurse Manager said that at no time should the Nurse Aides be in the locked medication room unsupervised. The Nurse Manager said that the nurse was reprimanded and the code for the locked medication room was changed that day.

Based on documentation, observation and interview, the Hospital did not maintain the Food Service Department at the Haverhill Campus in a manner to ensure an acceptable level of safety and quality. Findings include:

Review of the City of Haverhill Board of Health Inspection Report, dated 7/19/17, indicated that the wall coving on the wall outside the dishmachine room was missing. The report also indicated that floor tiles were missing under the hand wash sink in the dishmachine room.

On 4/24/18 at 10:00 A.M., during a tour of the kitchen at the Haverhill Campus, the Surveyor observed missing wall coving on the wall outside the dishmachine room and missing floor tiles at the handwash sink in the dishmachine room as noted on the 7/19/2017 Board of Health Report.

The Operations Manager present with the Surveyor acknowledged that repairs to the wall coving and the floor at the hand wash sink had not been done.

Based on observation and interview, the hospital staff failed to keep the return vents in the cesarean section (c-section) operating room clear from obstruction, which could affect the ability of the ventilation system to maintain the appropriate positive pressure in the operating room and reduces the risk of infectious organisms around the patient during surgery. Findings include:

On 4/23/2018 between 11:45 A.M. and 12:45 P.M., the Surveyor observed a c- section delivery in the c-section operating room (OR) on the labor and delivery unit of the hospital. The Surveyor observed that both of the return vents were obstructed by equipment left in front of them. The return vent located near the floor next to the anesthesia machine, was 90% blocked by equipment despite labeled with a strip of tape that read "do not block." The return vent located on the opposite wall next to the infant warming incubator was 50% blocked by a three tier stainless steel stand.

During an interview on 4/24/2018 at 3:00 P.M., the facility HVAC person said he had problems with staff constantly blocking the vents with equipment in the OR and the vents should not be blocked. The ventilation man showed the Surveyor the weekly pressure readings from the OR, taken at the door, that showed the room was able to remain so far in positive pressure.

Based on observations, records reviewed and interviews the Hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases and failed to provide an active program for the prevention and control of infections and communicable diseases. Findings include:

Observations, record review and interviews indicated that Hospital staff, (Respiratory Therapist (RT) #1, Certified Registered Nurse Anesthetist (CRNA #1) and Nurses #3, #5, #9, #15, #16 and #17), failed to adhere to infection prevention standards for 6 sampled patients (#8, #20, #29, #35 #40 and #41), in a total sample of 41. Breaches included but were not limited to hand hygiene practices, administration of IV (Intravenous) medications, care of indwelling catheters increasing the potential for urinary tract infections, cross contamination of medical equipment between patients, dressing changes and improper use of personal protective equipment and isolation precautions.

The Hospital failed to consistently adhere to the manufacturer's direction for use of a High-Level Disinfectant solution and the use of biohazard waste bags and failed to follow safe food handling guidelines related to hand hygiene and proper use of single service disposable gloves.

See A-749.

Based on observations, records review and interviews, Hospital staff Respiratory Therapist (RT) #1, Certified Registered Nurse Anesthetist (CRNA #1) and Nurses #3, #5, #9, #15, #16, #17 and #18) failed to adhere to infection prevention standards for 7 sampled patients (#8, #13, #20, #29, #35, #40 and #41) in a total sample of 41 Patients and the Hospital failed to ensure staff consistently adhered to the manufacturer's direction for use of a High-Level Disinfectant solution and the use of biohazard waste bags and failed to follow safe food handling guidelines related to hand hygiene and proper use of single service disposable gloves. Findings include:

1. In the Food and Nutrition Department, Hospital dietary staff did not follow safe food handling guidelines related to hand hygiene and proper use of single service disposable gloves.

During observation of the lunch tray line on 4/23/18 at the Methuen Campus and observation of the lunch tray line on 4/24/18 at the Haverhill Campus, the Surveyor observed that food servers did not consistently adhere to infection control protocols by failing to change gloves before handling Ready to Eat (RTE) food.

a. On 4/23/18 during observation of the lunch tray line at the Methuen Campus, the Surveyor observed the following:

From 11:05 A.M. to 11:17 A.M., the food servers failed to change gloves before handling RTE food (hamburg rolls, lettuce and tomato, grilled cheese and french fries). Food servers wore single use disposable gloves when serving from the trayline and used serving utensils (tongs, scoops, spoons) to serve most of the food items on the steamtable. However, food servers did not use serving utensils or change gloves before handling the french fries, the hamburg rolls, grilled cheese and lettuce and tomato. Food servers served these items with the same gloved hands that had touched other surfaces such as the steam table, refrigerator door handle, plate underliners and packages of hamburg rolls.

b. On 4/24/18 during observation of the lunch tray line at the Haverhill Campus, the Surveyor observed the following:

From 11:20 A.M. to 11:46 A.M., a food server was observed to fail to change gloves before handling Ready to Eat Food (chicken fingers and french fries). The food server wore single use disposable gloves when serving from the trayline and used serving utensils (tongs, scoops, spoons) to serve most of the food items on the steamtable. However, the food server did not use serving utensils or change gloves before handling the french fries and chicken fingers kept in the food warmer. Food servers served these items with the same gloved hands that had touched other surfaces such as the steam table and the door handle to the warmer.

Review of the Food and Nutrition Policy on Infection Prevention and Control, revised 2/2017, read that "Food shall be served with clean tongs, scoops, forks, spatulas or other suitable implements to avoid manual contact."

Review of the Food and Nutrition Inservice Meeting on Handwashing and PPE (personal protective equipment) presented to staff at the Haverhill Campus on 6/21/17 and to staff at the Methuen Campus on 6/22/17 included the following following guidelines when using gloves:

--Gloves must be changed or removed when they are torn, dirty or contaminated. Before starting another job.
--Hands must be washed each time when gloves are changed to start another job.

c. In addition, on 4/24/18 during observation of the meal tray pass at the Haverhill Campus, food servers did not always follow proper infection control guidelines related to hand hygiene and the use of personal protective equipment (disposable face mask).

From 11:49 A.M. to 12:01 P.M., the Surveyor observed the lunch tray pass on the 4 West Unit. As per the instructions on a patient room door, the food server donned a disposable mask and used hand hygiene prior to entering the room. When exiting the room, the food server performed hand hygiene first and then removed the mask, thus contaminating clean hands. Upon Surveyor inquiry about the food server performing hand hygiene prior to removing the mask, the Operations Manager instructed food server to wash their hands.

On 4/23/18 at 4:00 P.M., the Surveyor reviewed the above Methuen Campus observations with the Director of the Food and Nutrition Department and the District Manager.

On 4/24/18 at 2:00 P.M. the Surveyor reviewed the above Haverhill Campus observations with the Director of the Food and Nutrition Department and the Operations Manager.




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2. For Patient #20, the facility failed to ensure staff administered intravenous (IV) medication utilizing aseptic technique.

On 4/23/18 at 12:05 P.M., the Surveyor observed Nurse #9 as she proceeded to administer the IV medication Zosyn (antibiotic) to Patient #20. The Surveyor observed as Nurse #9 donned her gloves and began to type information into the computer (which is considered dirty). Without changing her gloves or performing hand hygiene, Nurse #9 disinfected the IV port with an alcohol swab (with the contaminated gloves on) and attached the IV tubing to the IV port. With the same contaminated gloves, she reached into her shirt pocket and searched for a pen. In her pocket was a normal saline syringe (which the Surveyor later learned had been dropped on the floor). Nurse #9 used the pen to date and time a label and attached the label to the IV tubing.

During interview on 4/23/18 at 12:10 P.M., Nurse #9 said that she should have changed her gloves prior to disinfecting the port of the IV tubing. Nurse #9 said that the normal saline syringe was in her shirt pocket because she dropped it on the floor earlier. She said she should have discarded the syringe and should not have put a gloved hand into her shirt pocket and then return to the patient's IV tubing.


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3. Nursing/Respiratory staff failed to consistently adhere to infection prevention standards for sampled patients (#20, #29, #35, #40 and #41) related to the following:

- (A) Indwelling Foley Urinary Catheters (F/C);
- (B) Hand hygiene practices;
- (C) Personal Protective Equipment (PPE), such as gloves;
- (D) Aseptic technique during administration of intravenous medication.

According to the Centers for Disease Control (CDC), health care workers are required to perform hand hygiene:

· Before eating
· Before and after having direct contact with a patient's intact skin (taking a pulse or blood pressure, performing physical examinations, lifting the patient in bed)
· After contact with blood, body fluids or excretions, mucous membranes, non-intact skin, or wound dressings
· After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient
· If hands will be moving from a contaminated-body site to a clean-body site during patient care
· After glove removal
· After using a restroom

a. For Patient #29, admitted to the Hospital 4/20/18 with shortness of breath, congestive heart failure (CHF), and dementia, Respiratory Therapist (RT) #1 failed to ensure appropriate infection control practices related to the provision of a nebulizer inhalant medication treatment and hand hygiene. In addition, Nursing staff failed to ensure the Foley catheter (F/C) was anchored to prevent trauma from pulling on the indwelling catheter, and ensure the F/C tubing was not on the floor and being stepped on, further pulling on the F/C.

During observation on 4/23/18 at 4:26 P.M., the Surveyor observed as RT #1 was about to enter the Patient's room, stopped, used the hand sanitizing solution for hand hygiene, wheeled the computer cart into the room, typed information into the keyboard of the computer, then donned gloves. RT #1 picked up a small, digital pulse oximeter device (used to test the Oxygen saturation level in Patients' blood), applied it to the Patient's finger, and was unable to get a reading.

The RT failed to perform hand hygiene before patient contact after touching the computer.

RT #1 left the room, walked down the hallway to a linen cart, obtained a face cloth, walked back into Patient #29's room, then to the sink area, wet the cloth, and applied it to Patient #29's left hand and fingers (RT #1 should have performed hand hygiene after touching environmental surfaces and before touching Patient #29.)

Patient #29 was sitting up in a chair. The F/C tubing was coiled on the floor and co-mingled with Oxygen tubing around the Patient's feet. RT #1 periodically stepped on the coiled F/C tubing. The Patient was wearing a hospital gown. The Patient's legs were partially open. The indwelling catheter and connector tubing were observed to be pulled taught, and were exposed. The F/C was observed not to be anchored to the Patient's leg to prevent trauma from pulling on the tubing, and which increased the risk of pulling the F/C out and causing a trauma related urinary tract infection.

RT #1 then donned gloves, without performing hand hygiene after touching environmental surfaces and the Patient. After a few moments, RT #1 removed the wet face cloth, applied the pulse oximeter device and obtained the digital reading. RT #1 placed the device on the Patient's bedside table, then walked back to the computer keyboard, entered information, still wearing the same contaminated gloves, then removed the stethoscope from around her neck. RT #1 placed the diaphragm of the stethoscope on the Patient's bare back, listened for lung sounds, placed the stethoscope back around her neck without cleaning it first. RT #1 walked back to the keyboard, entered information wearing the contaminated gloves, picked up and opened a packet containing an inhalant medication (Albuterol), walked to a plastic bag that was suspended on the wall from a "Air" flow apparatus; obtained a nebulizer device, unscrewed the cap, and instilled the liquid medication.

RT #1 applied the nebulizer chamber to a face mask, then walked back to Patient #29, stepped on the F/C tubing that was coiled near the patient's feet on the floor, applied the mask to Patient #29's face, and began the inhalant treatment. RT #1 removed gloves and performed hand hygiene. RT #1 entered information using the contaminated keyboard to the computer.

After the nebulizer treatment ended, RT #1 donned gloves, without performing hand hygiene (after touching the keyboard), removed the nebulizer from Patient #29, turned off the air flow device at the wall, disconnected the nebulizer device from the tubing, opened, rinsed and dried the nebulizer apparatus at the sink, placed it inside the plastic bag suspended from the Air flow device on the wall, then donned gloves, without performing hand hygiene after rinsing the nebulizer apparatus, touching and reaching inside the plastic bag.

RT #1 checked the Patient's Oxygen saturation using the pulse oximeter, placed it on the computer cart table surface, removed the stethoscope from around her neck then checked the patient's lung sounds. RT #1 entered information into the computer using the keyboard, removed gloves and performed hand hygiene. RT #1 said she had to do another treatment for Patient #40 in Room 419 however did not clean and disinfect the stethoscope before moving to another patient.

b. For Patient #40, admitted to the Hospital on 4/18/18 with a Urinary Tract Infection (UTI), RT #1 and nursing staff failed to ensure appropriate infection control practices related to using a contaminated stethoscope and pulse oximeter device on Patient #40 that had not been disinfected after being used on Patient #29, previously. In addition, the RT and Nurses #5 and #15 stepped on coiled F/C tubing that rested on the floor.

On 4/23/18 at 4:46 P.M., RT #1 performed hand hygiene from the hand sanitizing solution outside the Patient's room, then wheeled in the computer cart which still held the contaminated pulse oximeter device. Patient #40's feet were hanging off the bed. The right thigh was exposed and revealed a white strap on the mid thigh where the F/C tubing was anchored. RT #1 summoned assist from Nurses #4 and #15, who came into the Patient's room, and assisted the patient out of bed. Nurse #4 held the F/C drainage bag up higher than the Patient's bladder (not appropriate infection control practice as this allows urine to drain back into the Patient's bladder which can cause infection) when the device was removed from the frame of the bed and transferred over to the chair where Patient #40 was transferred into.

RT #1 picked up the contaminated pulse oximeter, without disinfecting it, and placed it on Patient #40's finger. She then removed the contaminated stethoscope from around her neck, without disinfecting it, after it was used on Patient #29, prior to being used on this Patient and placed the diaphragm against the patient's bare back to listen to lung sounds, and placed the stethoscope back around her neck, and documented findings via the contaminated keyboard.

During interview, directly after what had been observed, RT #1 said that she should have disinfected the pulse oximeter, stethoscope, keyboard and table to the computer cart, before using the same contaminated equipment on Patient #40. RT #1 said that she should have performed hand hygiene prior to donning gloves, and after touching contaminated surfaces.

During interview on 4/24/18 at 3:30 P.M., the Unit Manager said that infection control practices had not been adhered to related to RT #1's practices when administering inhalant medications and related to indwelling F/Cs, whereby, F/C tubing was coiled on the floor for both Patient's #29 and #40, and the F/C had not been anchored for Patient #29.



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4. On 4/23/2018 at 11:50 A.M., four operating room staff, including two surgeons and two circulating nurses, failed to wear face shields during a cesarean section (c-section) in accordance with hospital policy for personal protection equipment (PPE) and operating room standards.

AORN standards (Association of perioperative Registered Nurses) states that Health Care Workers (operating room staff) must wear protective eye wear when splatter is anticipated and must wear a face shield if a splash is anticipated. Personal eye glasses are not considered protective eyewear.

A c- section is surgical removal of a fetus from the uterus through an abdominal incision. The mother is under spinal anesthesia but is alert and oriented. The father is often present for the delivery of the baby. Blood and amniotic fluids spurt from the womb as the surgeon works quickly to remove the baby from the uterus.

During the c-section on 4/23/2018 at 11:50 A.M., the primary surgeon had no eyewear on, the assistant surgeon had regular eye glasses on and no protective eyewear, and the two circulating nurses had regular eye wear on and no protective eyewear on. Everyone else to include anesthesia, the scrub technician, the Surveyor and the nursery nurse had face shields on. When the surgeon cut into the uterus there was a spurt of amniotic fluid as well as blood from the incision.

During an interview on 4/23/2018 at approximately 2:00 P.M., the Unit Manager said that all staff, surgeons included must wear protective eye wear during a c-section per hospital policy.

5. On 4/23/2018 at 10:50 A.M., the Surveyor observed two Registered Nurses (RN #16 and #17) caring for newborn infants (NB) in the wellbaby nursery. RN #16 donned gloves without performing hand hygiene to weigh NB baby boy A. RN #16 the removed those gloves and donned new gloves without performing hand hygiene, to foot print NB baby boy A and check his blood pressure. RN #16 changed gloves again without performing hand hygiene and examined the baby's eyes put her pinkie in his mouth to check suck reflex and then removed her gloves without performing hand hygiene and went to retrieve medications out of the nursery.

RN #17, was then observed to put on gloves without performing hand hygiene and escorted a new father to the bassinet and checked the identification of baby and father together.

RN #16 returned to the nursery at 11:30 A.M. and entered without performing hand hygiene, with eye ointment, and two injections. RN #16 donned gloves without performing hand hygiene, applied E-mycin ointment to each of the NB baby boy A's eyes and then proceeded to inject each thigh with one of the injectable medications.

During an interview on 4/24/2018, at 10:00 A.M., the unit Nurse Clinical Leader said that hand washing was required after glove removal and before donning gloves.



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6. For Patient #35, the facility failed to ensure that appropriate infection control practices were in place in regard to the care of the patient's indwelling urinary catheter drainage bag.

On 4/23/18 at 9:45 A.M., observation on the 3rd floor behavioral unit revealed Patient #35 lying in a hospital bed with his/her indwelling urinary catheter drainage bag resting on the floor, increasing the risk of infection by cross contamination.


7. For Patient #41, the facility failed to ensure that appropriate infection control practices were in place in regard to the care of the patient's indwelling urinary catheter.

On 4/23/18 at 9:45 A.M., observation on the 3rd floor behavioral unit revealed Patient #41 being wheeled by staff in a recliner chair. As staff were transporting the patient, the tubing from the patient's indwelling urinary catheter was dragged along the hospital floor, increasing the risk of infection by cross contamination.

8.) According to the Guideline for Isolation Precautions; Preventing Transmission of Infectious Agents in Healthcare Settings (2007) published by the Center for Disease Control and Prevention (CDC) an ESBL is classified as a multi-drug resistant pathogen and Contact Precautions are used to prevent transmission of this organism.

The Surveyor observed Registered Nurse #3 administer medications to Patient #8 on at 4:20 P.M. 4/23/18. According to Patient #8's medical record's microbiology report indicated that Patient #8 grew an ESBL (stands for extended spectrum beta (ß) lactamase, a multi-drug resistant organism) from his/her sputum.

Registered Nurse #3 said that Patient #8 required "Droplet" Precautions because of the presence of an ESBL. This was not in accordance with the CDC recommendations.

The Surveyor observed the Precaution sign posted outside of Patient #8's doorway instructing those who were to enter Patient #8's room to use a mask upon entry. In fact Contact Precautions would instruct those who were to enter Patient #8's room to don a gown and gloves.

The Surveyor interviewed the Regional Infection Preventionist at 1:20 P.M. on 4/24/18. The Regional Infection Preventionist said that the presence of an ESBL would require Contact Precautions. With Patient #8 mistakenly placed on Droplet Precautions instead of Contact Precautions would have increased the likelihood of cross-contamination of an ESBL.

9.) The Surveyor observed Registered Nurse #3 administer medications to Patient #8 on at 4:20 P.M. 4/23/18. Registered Nurse #3 failed to perform hand hygiene prior to donning her gloves.

Also, Patient #8 was administered an intravenous (IV) medication by Registered Nurse #3, however the IV tubing was not labeled according to the Hospital policy. Registered Nurse #3 said IV tubing was required to be changed every 72 hours, however without a label Registered Nurse #3 would have no way of knowing if the tubing required changing prior to her administering medications.

10.) The Surveyor toured the Operating Room at 8:00 A.M. on 4/24/18 and interviewed the Nurse Manager. The Surveyor made two observations of improper use of biohazard bags (medical waste bags that are specially made to contain medical or bio-hazard waste and are clearly labeled with the universal bio-hazard sign).

At 8:00 A.M. on 4/24/18 the Surveyor observed multiple laboratory tubes and culture bottles being stored on top of the Malignant Hyperthermia Cart. The Nurse Manager said the tubes were stored for easy access by the staff but should not have been stored in a biohazard bag.

At 9:30 A.M. on 4/24/18 the Surveyor observed the Certified Registered Nurse Anesthetist (CRNA #1) in Operating Room #1 remove his pre-drawn medication syringes from a biohazard bag.

11.) High Level Disinfection (HLD) is a process for the complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. High Level Disinfection is used to reprocess certain medical devices that are to be re-used for another patient.

a.) The Surveyor interviewed the Sterile Processing Technician #3 at 10:30 A.M. in the Sterile Processing Department of Hospital #1 on 4/24/18. Sterile Processing Technician #3 reviewed the multiple steps involved to manually High Level Disinfect equipment in the Sterile Processing Department. Sterile Processing Technician #3 said the final rinse of the reprocessed item was done by running water over the instrument/scope or device.

According to the Manufacturer's directions for use, to ensure the complete removal of the chemical from the instrument/scope or device, it must be immersed in three separate clean water rinses. Manual High Level Disinfection was not done properly to ensure the removal of the disinfectant from the instrument/scope or device.

b.) The Surveyor interviewed Sterile Processing Technician #1 at Hospital Campus #2 at 7:30 A.M. on 4/25/18. Sterile Processing Technician #1 said she/he failed to describe the correct process to perform quality assurance on the test strips and did appreciate the temperature parameters for use of the High Level Disinfectant.

c.) The Surveyor interviewed Sterile Processing Technician #2 at the Outpatient Ambulatory Surgical Site at 11:20 A.M. on 4/25/18. Sterile Processing Technician #2 said that she rinsed the item that had been soaking in the High Level Disinfectant for three minutes in the clean sink. According to the Manufacturer's directions for use, to ensure the complete removal of the chemical from the instrument/scope or device, it must be immersed in three separate clean water rinses.




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12. The Hospital failed to ensure that a wound dressing for Patient #13 was cleansed and changed using proper infection control practices and in accordance with hospital procedure.

Findings include:

At approximately 2:30 P.M. on 4/24/18 the Surveyor observed Nurse #18 conduct a dressing change for a wound on Patient #13's right hip.

A Physician's order, dated 4/23/18, indicated to change dressing to right hip, gently cleanse with normal saline and gauze, pack with Aquacel Ag Strip (a moisture-retention dressing used for packing a wound), cover with Mepilex (self-adherent foam dressing) and large Tegaderm (a protective dressing).

The Surveyor entered Patient #13's room with Nurse #18 and observed a waste basket, bedside table draped with a clean Chux pad and unopened dressing supplies on top of the Chux pad. Nurse #13 explained the procedure to Patient #13 then proceeded to wash her hands, donned clean gloves and placed another Chux pad at the foot of the bed.

Nurse #18 then partially opened the new dressings and left them on the Chux pad on the bedside table, proceeded to remove the old dressing and wound packing which was visibly soaked in greenish/yellow drainage and blood and placed the old dressing and packing on the Chux pad at the foot of the bed.

Nurse #18 removed her gloves, used hand sanitizer, donned new clean gloves and obtained a measuring strip to measure the wound's periphery and used a Q-tip type probe to measure the wound's depth. After measuring the wound's depth, the Surveyor observed the Q-tip to be covered in greenish/yellow drainage and blood, Nurse #13 also placed the dirty Q-tip on top of the Chux pad at the foot of the bed.

Nurse #18 discarded her gloves, used hand sanitizer, donned clean gloves and with clean gloves proceeded to obtain an Aquacel Ag Strip, did not cleanse the wound with Normal Saline, picked up the visibly dirty Q-tip from the foot of the bed and used the dirty Q-tip it to pack the clean Aquacel Ag Strip into the wound. Using the same gloved hands, Nurse #13 then placed a clean Mepilex dressing on top of the wound and covered the wound with a Tegaderm dressing.

Nurse #18 removed her dirty gloves, placed them on top of the Chux pad at the foot of the bed, donned new gloves and proceeded to pick up this Chux pad with the dirty supplies wrapped inside it and discarded the items into the wastebasket

The Surveyor interviewed Nurse #18 on 4/24/18 immediately after the dressing change and Nurse #13 said she forgot to clean Patient #13's wound with Normal Saline and said she should not have used the dirty Q-tip to pack the wound. Nurse #18 said she would change Patient #13's dressing again.

The Surveyor interviewed the Nurse Manager at approximately 3:10 P.M. on 4/24/18. The Nurse Manager said Nurse #18 should have cleansed Patient #13's wound with normal saline as ordered by the Physician and should not have used the dirty Q-tip to pack the wound with a clean dressing. The Nurse Manager said the dressing change would be redone. The Nurse Manager said the hospital followed Lippincott's Manual of Nursing Practice as their policy and procedure for conducting a wound dressing change and said she would provide the Surveyors with a copy.

On 4/25/18, the Nurse Manager provided the Surveyors with Lippincott's Manual of Nursing Practice 10th Edition, dated 2014, entitled Procedure Guidelines 7-1 Changing Surgical Dressings which indicated the dressing change procedure included: wash hands thoroughly, place dressing supplies on a clean, flat surface (overbed table), if linen protection is needed place a clean towel or plastic bag under the part of the body where the wound is located, put on gloves, remove old dressings and place them in a disposable bag, cleanse the wound, pat dry with sterile dressing sponge, dress the wound with sterile gloves and apply the appropriate dressing.

Based on observation, review of manufacturer's directions for use (MDFU) and interview, the hospital failed to provide surgical services regarding aseptic technique in the use of Chloroprep for spinal anesthesia skin preparation that was consistent with the manufacturer's direction for use (MDFU) and placed patients at potential risk. Findings include:

Review of the MDFU for Chloroprep One-Step with Tint indicated not to use the product for lumbar puncture or in contact with the meninges. (Meninges are three membranous envelopes-pia mater, arachnoid, and dura mater-that surround the brain and spinal cord. At least the first two layers of meninges may be are entered when a spinal anesthetic is administered.)

During observation of a spinal anesthetic block via a lumbar puncture, prior to a c-section on 4/23/2018 at 11:45 A.M., the anesthesiologist was observed to prepare the area of the lower lumbar spine of Patient #5 using a Chloroprep One step with tint sponge (an antiseptic solution). As the patient sat on the edge of the operating room table, the anesthesiologist exposed the patient's lower back and with the Chloroprep sponge performed a scrub from the center of the lumbar spine out to the edges of the patient's back in a large square. After allowing the prep solution to dry, the anesthesiologist performed the lumbar puncture and a successful spinal anesthetic block.

Spinal anesthesia, also called spinal block, subarachnoid block, intradural block and intrathecal block, is a form of regional anesthesia involving the injection of a local anesthetic into the subarachnoid space, generally through a fine needle, introduced through a lumbar puncture (medical procedure in which a needle is inserted into the spinal canal, through access in the lumbar region of the spine.)

Observation of the package of Chloroprep sponges used in the c-section room indicated that the sponges were 2% chlorhexidene and 70% isopropyl alcohol. The unit manager said they used these sponges for all their spinal anesthesia preps in the c-section room.

Review of the nurse competency skills exam for 2 of 2 Obstetrical nursing staff (RN #14 and Clinical Nurse Leader), last given in 2016, indicated that nurses in the operating room were asked the question about not using Chloroprep for lumbar punctures and were aware at that time.

During an interview on 4/25/2018 at 10:00 A.M., the Executive Director of Quality produced documents from the manufacturer of the Chloroprep sponge that indicated that only 0.5% Chlorhexidine (an active ingredient in Chloroprep) should be used in lumbar punctures and the anesthetist must take extreme caution to prevent contact with neural tissue. The manufacturer's study noted a very low risk of CAA (chronic adhesive arachnoiditis) associated with neural tissue exposure to Chlorhexidine in amounts greater than 0.5%.

The Director of Quality confirmed that the hospital only had 2% Chlorhexidine Chloroprep sponges.

Based on record review and interview, the Hospital anesthesia service failed to ensure that the intra-operative anesthesia record for one (#38) of 4 surgical records reviewed, included the time of administration of anesthesia agents consistent with anesthesia department policy and procedures. Findings include:


Review of the policy, entitled, Basic Standards of Anesthesia Care, Version 2, dated 11/15, indicated that evaluation and documentation is the responsibility of an anesthesiologist or qualified anesthesia provider under the supervision of an anesthesiologist. Intraoperative/procedural anesthesia(time-based records of events), at a minimum include: Name, dosage, route, and time of administration of drugs and anesthesia agents.


For Patient #38, the Intra-operative anesthesia record did not contain when the doses of Propofol(an anesthetic medication used to induce or maintain anesthesia during certain surgeries) were administered, only the total dose administered.

Review of the intraoperative anesthesia record, dated 4/24/18, indicated that Patient #38, received a total dose of 650 milligrams (mg) of Propofol. The start of surgery at 10:30 A.M., indicated that the patient received 100 mg of Propofol, followed by two entries of squiggled(curly) lines (which did not indicate the amount of Propofol received).

On 4/26/18 at 1:30 P.M., the acting Chief of Anesthesiology said that although the squiggled line has been used by anesthesia staff, it is not in line with the policy and procedure for Basic Standards of Anesthesia Care and will be corrected.