HospitalInspections.org

Based on observation, document review, and staff interview, it was determined that the hospital 's governing body failed to ensure the hospital met all Federal regulations, assume full responsibility for determining, implementing, and monitoring policies governing the
hospital 's total operation. The governing body failed to require that contracted staff follow hospital policies and procedures as agreed in the provider contract (refer to A0084) which created non-compliance with the following regulations: right to make informed decisions (refer to A0131), right to receive care in a safe setting (refer to A0144), drugs must be kept in a secure area (refer to A0502), scheduled drugs must be locked in secure area (refer to A0503).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

The hospital data base worksheet completed on 1/6/14 indicated seven services were provided by arrangement, agreement/contract. Based on observation, document review, and staff interview, the hospital's governing body failed to require contracted staff follow hospital policies and procedures as agreed in the provider contract. The failure of anesthesia staff to follow hospital policies and procedures about drugs and drug storage created the potential for patients, families, and staff to have unauthorized access to controlled and prescription drugs.

Findings include:

- Review of the anesthesia provider contract on 1/13/14 at 2:30pm revealed " ...will follow all hospital policies and procedures ... "

- The hospital policy " Drug Room Policies " updated on 6/13 and reviewed on 1/6/14 at 4:10pm revealed " ...all medication storage areas should be kept locked at all times ...surgery and anesthesia medication supplies will be kept locked ... "

- Observation of two labor and delivery rooms joined by a workroom on 1/6/14 at 1:20pm revealed a laboring patient in one labor room with family members present including three minor children. The workroom was unlocked, unmonitored, and included an unlocked anesthesia drug cart.

- See A502 for medications found in the unlocked anesthesia drug cart.

- Director of nursing Staff A interviewed on 1/6/14 at 1:30pm in the workroom, observed the unlocked anesthesia drug cart in the workroom and acknowledged the potential for the family to gain access to the unlocked medication cart.

- Observation on 1/6/14 at 3:20pm in the surgical area revealed two anesthesia drug carts.

- See A502 for medications found in the unlocked anesthesia drug carts.

- Director of nursing staff A interviewed on 1/6/14 at 3:20pm in the procedure room of the surgical department observed and acknowledged the unlocked anesthesia drug cart in the procedure room of the surgical department.

- Director of nursing staff A interviewed on 1/6/14 at 3:30pm in the surgical room of the surgical department observed and acknowledged the unlocked anesthesia drug cart in the surgical room of the surgical department.

The hospital database worksheet indicated the hospital staffed for eight beds with an average daily census of two. The hospital reported a census of five patients. Based on observation, record review and staff interview the hospital failed to inform each patient the hospital lacked an onsite physician 24 hours a day seven days a week. The failure to inform each patient of physician coverage resulted in the patient ' s inability to make informed healthcare decisions.

Findings include;

- Sampled patients reviewed on 1/6/14 thru 1/14/14 revealed the hospital failed to provide a notice of physician availability to 30 of 31 ( patients # ' s 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, and 31) .

- Nursing Staff A interviewed on 1/9/14 at 11:17am in the hospital conference room indicated the hospital updated and changed the bill of rights form for patients several (about six) months ago but failed to identify the omission of physician availability.

- The emergency department observed on 1/9/2014 at 0930 failed to prominently display information of physician coverage.

- Nursing Staff B interviewed on 1/9/14 at 11:25am in the hospital conference room verified the emergency department lacked posted information about physician coverage.

The hospital database worksheet indicated the hospital staffed for eight beds with an average daily census of two. Based on observation, record review and staff interview the hospital failed to provide care in a safe setting when patients, visitors and unauthorized staff had access to unsecured medications. The hospital failed to protect surgical patients from healthcare associated infections (HAI ' s).

Findings include;

- Observation of the surgery department on 1/6/2014 at 2:55pm revealed one sterile package containing a size 7.5 endotracheal tube (used for intubation) open and exposed in the surgical room and two endotracheal tubes ( one size 7 and one size 7.5) open and exposed in the procedure room. Anesthesia provider ' s practice of preopening sterile endotracheal tubes created potential for contamination and HAI ' s.

- Hospital policy entitled Shelf Life of Sterile Supplies written 7/1987 and updated 3/2005 obtained and reviewed on 1/13/2014 at 2:00pm stated " The integrity of sterile wraps should be kept constant at all times. Any item should not be used if its sterility is in question. " and " All items or trays wrapped in paper or muslin, or single or double peel backs are sterile until the integrity of the package is compromised. " The packages containing endotracheal tubes were single peel back and opened.

- Nursing staff A interviewed on 1/6/2014 at 3:20pm in the procedure room verified the endotracheal tube sterile packages were open and potentially contaminated.

- Observation on 1/7/14 at 10:25am in the surgical area revealed one surgical room and one procedure room. The procedure room is used for endoscopic (a flexible tube to look inside the body) procedures. Staff cleaned the endoscopes in the procedure room following the procedure.

- See A951 for additional information regarding Association of perioperative Registered Nurse (AORN) standards and recommended practices describing guidelines for endoscope cleaning.

- Staff C, scrub tech, interviewed on 1/7/14 at 10:25 in the procedure room, verified the endoscope cleaning takes place in the procedure room.

- Observation on 1/7/14 at 10:35am in the surgical area revealed two wall mounted surgical hand scrub sinks used for preoperative hand hygiene by the surgeons. Staff decontaminated the surgical instruments in the preoperative hand hygiene sinks used by the surgeons.

- See A951 for additional information regarding Association of perioperative Registered Nurse (AORN) standards and recommended practices describing guidelines for instrument decontamination.

- Staff C, scrub tech, interviewed on 1/7/14 at 10:35 in the procedure room, verified the surgical instrument decontamination takes place in the hand hygiene sink.

The hospital reported a census of five patients. Based on observation, document review, and staff interview, the hospital failed to keep drugs stored in a secure manner for three of three anesthesia drug carts located in two drug storage areas. The failure of the hospital to restrict drugs and drug storage created a potential for patients, families, and staff to have unauthorized access to controlled and prescription drugs.

Findings include:

- The hospital policy " Drug Room Policies " updated on 6/13 and reviewed on 1/6/14 at 4:10pm revealed " ...all medication storage areas should be kept locked at all times ...surgery and anesthesia medication supplies will be kept locked ... "

- Observation on 1/6/14 at 1:20pm revealed two labor and delivery rooms joined by a workroom. A pregnant, laboring patient occupied one of the labor rooms and had family members present, including three minor children. The workroom was unlocked, unmonitored, and included an unlocked anesthesia drug cart. The anesthesia cart contained the medications:

1. Povidone- Iodine solution ¾ ounce - I bottle, Povidone-iodine is a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds.
2. Betadine spray 3 ounces-2 bottles, Providone-iodine is a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds.
3. Glycopyrrolate 0.4mg/2 cubic centimeters (cc) - 3 vials, In anesthesia, glycopyrronium injection can be used as a preoperative medication in order to reduce salivary , tracheobronchial , and pharyngeal secretions, as well as decreasing the acidity of gastric secretion. It is also used in conjunction with neostigmine , a neuromuscular blocking reversal agent , to prevent neostigmine's muscarinic effects such as bradycardia .
4. Ephedrine Sulfate 50 milligrams/milliliter 2 cc- 3 vials, can be used to reduce constricted blood vessels.
5. Naloxone Hcl 0.4 -1 vial, a medication that reverses the effects of narcotic medications.
6. Lidocaine 1% 10milligrams/milliliter-4 vials, 1.5%- 4 vials, 2%- 4 vials, is used as a local anesthetic for minor surgery.
7. Metaclopramide injectable 2 cc 5 milligrams/cc- 3 vials, a medicine that increases the movements or contractions of the stomach and intestines.
8. Esmolol Hydrochloride 100 milligrams/10 cc - 1 vial, a medication used for control of perioperative tachycardia, fast heart rate and hypertension
9. Succinylcholine 200 milligrams 20 milligrams/cc- 1 10 cc vial, is used for rrelaxing muscles during surgery or when using a breathing machine (ventilator). It is also used to induce anesthesia or when a tube must be inserted in the windpipe.
10. Atropine sulfate 0.1 milligrams, 1 milligram/10 cc - 1 vial - is used when excessive (or sometime normal) muscarinic effects are judged to be life threatening or are producing symptoms sever enough to call of temporary, reversible muscarinic blockade.
11. Sodium Bicarbonate 8.4 84 milligrams/milliliter- 1 vial- is an antacid used to relieve heartburn and acid indigestion.
12. Naropin (ripirvacaine Hcl) 0.2%, 2 mg/cc-10 cc/vial- 8 vials- a local anesthetic used to inject into the body where it makes the nerves unable to pass messages to the brain. Depending on the amount used, NAROPIN will either totally stop pain or will cause a partial loss of feeling.
13. Bupivacaine Hcl (Sensorcaine) 0.25% 2milligrams/1cc -10 cc per vial- 28 vials -used for the production of local or regional anesthesia or analgesia for surgery , for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.

- Director of nursing Staff A interviewed on 1/6/14 at 1:30pm in the workroom, observed the unlocked anesthesia drug cart in the workroom and acknowledged the potential for the family to gain access to the unlocked medication cart.

- Observation on 1/6/14 at3:20pm in the surgical room of the surgical department area revealed one unlocked anesthesia drug carts containing:

Sevaflurane 250 milliliters- 1 container, a medication used to help you to become unconscious (fall asleep) before having surgery. This medicine is a type of anesthesia.

Compound Benzoin tincture 10% Scalslicd- 1 container- is used a skin protectant. It works by forming a barrier over the affected area.

- Director of nursing staff A interviewed on 1/6/14 at 3:30pm in the surgical room of the surgical department observed and acknowledged the unlocked anesthesia drug cart in the surgical room of the surgical department.

- Observation on 1/6/14 at3:20pm in the procedure room of the surgical department revealed one unlocked anesthesia drug cart containing:

Albuterol 90mcg (micrograms) ProAir HFC 1 inhaler- used for treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.

Ephedrine Sulfate 50 milligrams/milliliter- 2 milliliter vial- 2 vials- is indicated primarily to counteract the hypotensive effects of spinal or other types of anesthesia.

Lidocaine 20 milligrams/milliliter- 1- 8 milliliter vials - used as a local anesthetic for minor surgery.

Epinephrine 1:10,000 (0.1milligram/milliliter- 10 milliliters in prefilled syringes - used to treat severe allergic reactions (including anaphylaxis) in an emergency situation.
Atropine 1 milligram/10 milliliter- 1 vial- Helps keep your heart rate stable after a heart attack or during surgery.

Xylocaine 1% 10 milligrams/milliliter- 2 milliliter vial- 2 vials- causes numbness or loss of feeling in an area of your body. Given before and during surgery, childbirth, or dental work. Also treats emergency heart rhythm problems.

Glycopyrrolate 0.4 milligrams/2milliliter- 24 vials- used before and during surgery to dry up your mouth, throat, and stomach.

Metoclopramide 5 milligrams/milliliter in 10milliliter vial -6 vials- used to prevent nausea and vomiting caused by chemotherapy or that may occur after surgery.

Naloxone Hcl 0.4 milligrams/milliliter 1 vial- works by reversing the side effects of the narcotic, such as sedation and decreased breathing rate.

Diphenhydramine 50 milligrams/milliliter 2 vials used to treat severe allergic reactions, motion sickness.

Propofol1% 20 milliliter vials- 12 vials- This medicine causes a person to relax or sleep (be unconscious) before and during a surgery. Also given to people in an intensive care unit (ICU). This medicine is a type of anesthetic.

Depo-Medrol 80 milligrams/milliliter- one milliliter vials- 13 vials and 15 vials of 40 milligrams/milliliter. A steroid used to treat asthma, allergic reactions, inflammation, flare-ups of ongoing illnesses, and many other medical problems.

Succinylcholine 200 milligrams/milliliter 1 container - Relaxes your muscles during surgery or intubation (having a breathing tube put into your throat).

Neostigmine 10 milligrams/milliliter- 2 vials- a medication given after surgery to help reverse the effects of certain types of anesthesia on your muscles.

Flumazenil 0.5milligrams (mg)/5millileters (ml)-1 vial, in anesthesia, Flumazenil is used to cause sedation.

Ketamine 500mg/10ml-1 vial, in anesthesia, Ketamine is used to cause general anesthesia.

Rocuronium 50mg/5ml-1 vial, in anesthesia, Rocuronium is used to relax your muscles.

Dexamethosone 4mg/1ml-3 vials, in anesthesia, Dexamethosone may prevent nausea and vomiting.

Esmolol Hydrochloride 100mg/10ml-1 vial, in surgery, Esmolol Hydrochloride may be needed to help treat a heart problem.

Lidocaine Hydrochloride oral topical solution 2% 100ml-1 bottle in anesthesia, is used as a local anesthetic for minor surgery.

Lidocaine Jelly 2% 30ml-1 tube is used as a local anesthetic for minor surgery.

- Director of nursing staff A interviewed on 1/6/14 at 3:20pm in the procedure room of the surgical department observed and acknowledged the unlocked anesthesia drug cart in the procedure room of the surgical department.

Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be locked within a secure area.

There were five identified scheduled drug storage areas in the hospital. Based on observation, interview and policy review the hospital failed to keep one of four drug storage areas with Schedule II (high potential for abuse with use potentially leading to severe psychological or physical dependence) and schedule III (moderate to low potential for abuse and dependence) drugs locked within a secured area. The failure to keep these drugs locked in a secure area created the potential for access by unauthorized persons to the scheduled narcotics.

- Observation of the procedure room in the unattended surgery department on 1/6/2014 at 2:00pm revealed the anesthesia medication cart was unlocked with the locked narcotic box inside. The narcotic box contained the following schedule II and III narcotic medications:

1. Fentanyl 250 mcg (micrograms) in 5 ml (milliliters), 9 vials. Fentanyl is a schedule II narcotic pain medication.
2. Fentanyl 5 mg(milligram)/10 ml, 6 vials.
3. Fentanyl 50 mcg/2ml, 9 vials.
4. Duramorph 10 mg/10 ml, 10 vials. Duramorph is a schedule II narcotic pain medication.
5. Meperidine 50 mg/ml, 2 vials. Meperidine is a schedule II narcotic pain medication.
6. Midazolam 2mg/ml, 10 vials. Midazolam is a schedule III medication used to produce sedation and amnesia before surgical procedures.
7. Sufentanil 100 mcg/2ml, 10 vials. Sufentanil is a schedule II medication used for sedation.

- Director of Nursing staff A interviewed on 1/6/14 at 3:20pm in the procedure room of the surgical department observed and acknowledged the scheduled drugs to be locked but not in a secure attended area of the hospital.

Based on document review, staff interview, and observation, it was determined that the hospital failed to implement procedures and maintain standards of practice to ensure the provision of care in a safe and sanitary environment. The hospital failed to maintain a physical separation between the decontamination and clean areas in the surgical department (refer to A0951); failed to maintain the appropriate amount of dantrolene (a medication used for rescue of a patient who develops malignant hyperthermia, a life threatening reaction to anesthesia which can quickly result in death) (refer to A0951); failed to perform the appropriate count of surgical instruments, sponges and sharps during surgical cases (refer to A0951); and failed to update surgical history and physicals within 24 hours prior to surgery (refer to A0952).

The cumulative effect of the systemic problems of the hospital cleaning surgical instruments in the scrub sinks, failure to clean endoscopes in the appropriate decontamination area, and failure to keep the appropriate amount of dantrolene available for use, resulted in a finding by Centers for Medicaid and Medicare Services (CMS) of Immediate Jeopardy, a situation that is likely to cause serious injury, harm, impairment or death to a patient. Administrative staff advised on 1/8/14 at 4:30pm of the identification and implementation of Immediate Jeopardy by CMS.

The hospital abated the Immediate Jeopardy on 1/9/14 at 4:00pm. All endoscopies in the procedure room ceased, provided a room for decontamination of surgical instruments. An inventory of 36 vials of dantrolene 20 mg was obtained and onsite.

The hospital reported 37 surgeries and an average of two endoscopic (a flexible tube to look inside the body) procedures per week in the past year. Based on observation, document review, and staff interview, the hospital failed to provide adequate amounts of dantrolene (a medication used in a surgical emergency); failed to follow the Association of periOperative Registered Nurse (AORN) standards and recommended practices to maintain a physical separation between the decontamination and clean areas; failed to follow the Association of periOperative Registered Nurse (AORN) standards and recommended practices describing guidelines for endoscope cleaning in an area separate from patient care; and failed to follow their policy to perform three instrument, sponge, and sharps counts for six of six surgical patients sampled (patient # ' s 11, 22, 23, 24, 25 and 26). The practices of the hospital created the potential for failure to manage patient survival in a hyperthermia crisis, the potential for patient surgical contamination, the potential for health-care associated infections (HAI), and the potential for foreign body retention and injury.

Findings include:

- Malignant Hyperthermia Association of the United States " Proposed Protocol for Management " reviewed on 1/7/14 at 12:30pm revealed " ...To maintain an emergency cart stocked with all the drugs and supplies needed during a critical situation ...dantrolene sodium-36 ampules ... "

- Observation on 1/6/14 at 2:55pm revealed 18 vials of dantrolene available for surgical emergencies.

- Director of nursing staff A reviewed the Malignant Hyperthermia Association of the United States " Proposed Protocol for Management " on 1/7/14 at 12:30pm and acknowledged the hospital did not have 36 ampules available.

The Association of periOperative Registered Nurses (AORN) 2012 Perioperative Standards and Recommended Practices reviewed on 1/7/14 at 3:30pm directed at VII.b. "The decontamination area should be physically separate from clean areas and include a door...", " Cleaning and Care of Surgical Instruments ..." AORN 2012 at VII.a. " ...Instruments should not be decontaminated in scrub or hand sinks ... "


- Observation on 1/7/14 at 10:35am of the area adjacent to the surgery room revealed hospital staff decontaminated the soiled/contaminated surgical instruments in the surgical hand-washing sink.


- Scrub tech staff C interviewed on 1/7/14 at 10:35 in the procedure room, verified the surgical instrument decontamination takes place in the hand hygiene sink.


- Director of nursing staff A interviewed on 1/7/14 at 3:30pm in the meeting room, acknowledged the hospital used AORN guidelines and acknowledged the decontamination area and clean area has no physical separation including a door.


- The Association of periOperative Registered Nurse (AORN) 2010 standards and recommended practices for endoscope cleaning recommendation XI " ...Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed ... "


- Scrub tech staff C interviewed on 1/7/14 at 10:25 in the procedure room, verified the endoscope cleaning takes place in the procedure room where patient care activities are performed.


- Director of nursing staff A interviewed on 1/7/14 at 3:30pm in the meeting room, acknowledged the hospital used AORN guidelines and acknowledged the endoscope cleaning takes place in the procedure room.


- The hospital policy " Counting in the Operating Room " revised on 1/11 and reviewed on 1/9/14 at 11:15am revealed " ...sponge counts and sharp counts ...before procedure ...before closure of a cavity ...at skin closure ... "


- Patient #11 ' s closed medical record reviewed on 1/7/14 revealed an admission date of 4/11/13 with diagnosis of cesarean section (surgical removal of an infant from a pregnant patient). The medical record lacked documentation the hospital performed three sponge, sharps, and instrument counts.


- Patient #22 ' s closed medical record reviewed on 1/8/13 with a diagnosis of laparoscopic cholecystectomy (removal of gallbladder through small incisions) performed on 2/15/13. The medical record lacked documentation the hospital performed three sponge, sharps, and instrument counts.

- Patient # 23 ' s closed medical record reviewed on 1/8/2013 with a diagnosis of umbilical herniorrhaphy ( reduction of umbilical hernia) performed on 3/8/13. The medical record lacked documentation the hospital performed three sponge, sharps, and instrument counts.

- Patient #24 ' s closed medical record reviewed on 1/8/14 with a diagnosis of cesarean section (surgical removal of an infant from a pregnant patient). The medical record lacked documentation the hospital performed three sponge, sharps, and instrument counts.

- Patient #25 ' s closed medical record reviewed on 1/8/13 with a diagnosis of inguinal hernia repair (hernia reduction in groin area) performed on 5/10/13. The medical record lacked documentation the hospital performed three sponge, sharps, and instrument counts.

- Patient #26 ' s closed medical record reviewed on 1/8/2013 with a diagnosis of postpartum bilateral tubal ligation (severing fallopian tubes and cauterizing or tying off) performed on 6/27/2013. The medical record lacked documentation the hospital performed three sponge, sharps, and instrument counts.

- Director of nursing staff A interviewed on 1/9/14 at 11:15am in the meeting room, acknowledged the medical records lacked documentation the hospital performed three sponge, sharps, and instrument counts.

The hospital reported 37 surgeries in the past year with an average of two endoscopic (a flexible tube to look inside the body) procedures per week in the last year. Based on staff interview and record review the hospital failed to provide and update patient history and physicals within 24 hours prior to surgery for four of six surgical patient ' s sampled, patient # ' s 11, 22, 23 and 25. The physician ' s failure to update individual patient ' s history and physicals within 24 hours prior to surgery resulted in patients undergoing surgery without determination of continued eligibility.

- Patient #11 ' s closed medical record reviewed on 1/8/14 revealed a diagnosis of cesarean section (surgical removal of an infant from pregnant patient) performed on 4/11/13. The medical record lacked documentation the physician updated the history and physical examination within 24 hours prior to the surgery.

- Patient #22 ' s closed medical record reviewed on 1/8/13 revealed a diagnosis of laparoscopic cholecystectomy (removal of gallbladder through small incisions) performed on 2/15/13. The medical record lacked documentation the physician updated the history and physical examination within 24 hours prior to the surgery.

- Patient # 23 ' s closed medical record reviewed on 1/8/2013 revealed a diagnosis of umbilical herniorrhaphy ( reduction of umbilical hernia) performed on 3/8/13. The medical record lacked documentation the physician updated the history and physical examination within 24 hours prior to the surgery.

- Patient #25 ' s closed medical record reviewed on 1/8/13 revealed a diagnosis of inguinal hernia repair (hernia reduction in groin area) performed on 5/10/13. The medical record lacked documentation the physician updated the history and physical examination within 24 hours prior to the surgery.

-Director of Nursing Staff A interviewed on 1/8/13 at 11:30am in the hospital conference room verified the history and physicals were not updated within 24 hours prior to surgery on sampled patient # ' s 11, 22, 23 and 25.