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UNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER
INFECTION CONTROL PROGRAM
Tag No.: A0749
Based on observation, interview and record review, the hospital failed to:
1. provide evidence physicians had assessed daily the need for the continuation of a central line (a central catheter inserted in the vein to give medications over a long period of time), and
2. ensure separation of clean and soiled supplies and equipment in an area used for cleaning instruments used for procedures in the eye clinic.
Findings:
1. In review of facility Policy ID: XIII-01 titled Access Catheter Master Policy with Links to Procedures, dated 09/21/2010, Page 6, there was stipulation to "assess the need for continued intravascular access on a daily basis".
In an interview with the Infection Control Manager (ICM) on 5/7/11 at 1:00 p.m., she stated the physician was responsible for the assessment of the need for a central line (as per state regulatory requirements) and acknowledged this was not clearly defined in the policy.
In a tour of the Trauma Intensive Care Unit (TICU) with the Surgical ICU Manager (SICUM) on 5/7/12 at 1:45 p.m., she defined her responsibilities for the oversight of the Trauma (ten beds) and Cardiac (ten beds) Surgical ICU's. The SICUM stated fourteen of the 20 patients in the two SICU's had central lines. The SICUM revealed that a new software program had been initiated this morning and would prompt the physician to document the assessment of the need for the central line at the time of daily rounds. Prior to this date, the physician was required to document this assessment in the daily progress notes.
In review of a current patient report presented by the SICUM, dated 5/7/12 at 2:30 p.m., only one (RP 41) of 15 patients (Patients 12, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41) with a central line in the SICU's had a documented assessment for that day. In review of the medical records these patients for the period of time in which there was a central line present, there was no evidence the physician had assessed the need on a daily basis.
In an interview with the Chief Medical Officer (CMO) on 5/7/12 at 3:30 p.m., he acknowledged the physicians had been inconsistent with the daily documentation of the need for a central line. The CMO stated he had sent the physicians an e mail on 5/4/12 describing the new MD Rounding Navigator which would alert the physician to document the central line assessment. The CMO also referenced a document titled Required Documentation of Central Line Necessity by Physicians, dated 5/7/12, that provided significant detail on the computer program and where and how to document the need for the central line. The CMO acknowledged the education of the physicians had been delayed due to the time it took to develop and implement the computer program. The CMO stated he would receive daily reports and would expect the compliance to be better.
In a review of the first monitoring report of the Central Line Necessity and Assessment, dated 5/8/12, there were 136 patients noted to have central lines. In a medical record review of patients in Pediatric Intensive Care Unit, TICU, CICU, Transplant Service and Medical Surgical Service, three of six patients did not have evidence the physician had assessed the need for a central line on 5/7/12. Of the 136 patients in the hospital with a central line, 64.7% were assessed for the need.
In a review of the second monitoring report of the Central Line Necessity and Assessment, dated 5/9/12, there were 156 patients noted to have central lines. Of the 156 patients with central lines, 59.6% had been assessed for the need for a central line in the 24 hour period from 7 a.m. to 7 a.m.
In a further interview with the CMO on 5/8/12 at 11 a.m., he stated he had been following up on specific units (Orthopedic/Trauma, Neuro, Burn Unit and Transplant/Special Care) where compliance with the documentation of the assessment of the central line in the previous day's report was minimal.
17065
17121
2. On 5/7/12 at 2:30 p.m., a general tour of the outpatient eye clinic was conducted with the Practice Manager (PM1) and the Nursing Manager (NM1) for the Eye Clinic. The managers identified various procedures performed in the clinic such as intraocular (within the eyeball), extraocular (outside of the eyeball) and cosmetic procedures for the skin around the eyes. During the tour a Certified Opthalmic Assistant (COA) was interviewed about the process of cleaning instruments after procedures. The COA showed the Department a sink and counter area in an alcove off a hallway where the cleaning occurred. The right 2/3's of the counter area contained a sink in which the COA said the instruments were cleaned prior to packaging to sending to Central Processing for sterilization. The left 1/3 of this area was marked by a line of red tape. There was a sign on the right side that identified the area as soiled and a sign on the left side that identified that area as clean. On the clean side were some biological waste bags that the COA said the instruments were placed in after cleaning and left on the soiled side for Central Processing to pick up.
On 5/8/12 at 9:45 a.m., the Eye Clinic was revisited and the same COA was asked to walk the Department through a cleaning of instruments. The COA stated that dirty instruments were soaked in a solution and scrubbed with a brush. The instruments were then laid on a towel to dry for a few minutes then rolled up and placed in a biological bag on the soiled side. The COA was asked how she obtained the biological waste bags and she said she just reaches over the clean area to pick them up. The COA and the managers were asked if there were any measures to prevent splashed soap or water from the soiled to clean side and all acknowledged that there was nothing to prevent this from occurring. The managers also acknowledged that the staff would need to reach from a soiled area to a clean area to obtain supplies, i.e. the biological waste bags and possibly contaminate the clean area.
25738
OPERATING ROOM POLICIES
Tag No.: A0951
17334
Based on observation, staff interview, medical record and document review, the hospital failed to ensure that surgical services policies were consistently implemented and maintained to assure high standards of surgical care as evidenced by the lack of:
1. Physician oversight and supervision for the safe administration of procedural sedation medications by registered nurses (RNs) for 4 of 4 Gastroenterology Laboratory (GI Lab, procedure area where stomach and intestine surgeries were performed) patients (Patients 4, 5, 6, and 20); and
2. Nursing participation in bedside surgical procedures in all locations for 4 of 6 Emergency Department patients (Patient 16 and Random Patients 26, 27, and 28).
These failures placed patients at risk for preventable injuries or adverse events.
Findings:
1. Patient care related to the administration of procedural sedation in the GI Lab was not provided in accordance with the hospital's policies and procedures and with acceptable standards of medical practice and surgical patient care for moderate sedation ("procedural sedation" or "conscious sedation," a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures but enable the patient to respond to both verbal and light physical stimulation).
a. On 5/8/12 starting at 9:45 a.m. in the hospital's GI Lab, Patient 4's care was observed. The patient was checked in by GI RN 1 and then evaluated by GI RN 2 in the preoperative area. Patient 4 reported to GI RN2 having medical and psychiatric history including history of narcotic drug use. Patient 4 also reported he was told in the past that he had a heart murmur. The patient stated that he was currently taking Methadone. (Methadone is in a class of narcotic analgesics medications used to relieve moderate to severe pain that has not been relieved by non-narcotic pain relievers. It also is used to prevent withdrawal symptoms in patients who were addicted to opiate drugs and are enrolled in treatment programs in order to stop taking or continue not taking the drugs. Methadone carries a warning that it may cause slowed breathing and irregular heartbeat, which may be life-threatening.
On 5/8/12 at 10:15 a.m. Patient 4 was evaluated by GI MD1, (GI doctor) who was to perform the GI procedure. GI MD1 stated that she had not seen the patient before but had reviewed the patient's medications and history in the EMR (electronic medical record) prior to this evaluation. GI MD1 acknowledged that because of the patient's history of drug use it may be difficult to attain the desired level sedation, but proceeded with making the determination that the patient was appropriate for moderate sedation by a registered nurse.
On 5/8/12 at 10:25 a.m. the sedation RN (GI RN3) introduced herself to the patient in the preoperative area. GI RN3 also acknowledged the drug history and the possibility that the desired sedation may be difficult to attain but was going to try. GI RN3 proceeded to the automated medication dispensing machine and removed various sedation and pain drugs (Benadryl, Versed, Fentanyl) and other drugs (Atropine, Epinephrine and Narcan usually used as drugs to rescue a patient from the effects of the sedation and pain drugs). GI RN3 stated that the drugs she pulled to be used for sedation were routinely ordered as a part of preoperative set (standard set of orders) and appeared on the patient's specific preoperative orders once signed by the physician-surgeon.
On 5/8/12 starting at 10:45 a.m. Patient 4 was transported on a mobile bed to a procedure room, where GI RN3 was observed preparing the room and the patient for the scheduled GI procedure (Esophago Gastro Duodenoscopy, scope of the digestive area) under sedation. GI RN3 drew-up sedation/pain medications (Versed, Benadryl and Fentanyl) into (separate) syringes and explained that standard orders were written for multiple drugs in ranges of doses. Therefore, GI RN3 would choose the appropriate drugs and dosage for the patient based on her experience and the patient's history. GI RN3 stated that although orders did not indicate specific starting doses, she usually administered medications in rounds, starting with injections into a plastic tube that was inserted in a patient's vein (intravenous, IV) via push (IVP) of Fentanyl (narcotic pain medication) 25 micrograms (mcg) followed by Versed (sedation agent) 1 milligram (mg). GI RN3 stated that RNs were trained in administration and monitoring of sedation; therefore, they were qualified to choose and adjust the sedation/procedural medications according to the patient's needs and the RN's own judgment. Prior to the procedure, GI RN3 again expressed a concern that for Patient 4 the usual rounds of medications may not work because of the patient's drug use history.
On 5/8/12 at 11:07 a.m. GI MD 1 was observed opening the door into the procedure room and without entering asked if the patient was ready, with a response from GI RN3 that she was just about to start sedation. GI RN 3 proceeded to administer sedation and pain medications without the MD giving a specific order or entering the room to direct and supervise the patient care. GI RN 3 was observed administering Fentanyl 25 mcg IVP at 11:08 a.m. following with Versed 1 mg IVP at 11:14 a.m. GI MD 1 entered the procedure room at 11:14 a.m. There was no discussion or verbalization of medications/doses administered as far. MD 1 did not verbally direct the drug selections or doses followed by "readback" verification by GI RN 3. At 11:16 a.m. GI RN 3 stated that she initiated 2nd round of medications (names and doses of medications were not stated). At 11:17 a.m. GI MD 1 made an attempt to begin the procedure (inserting the scope tube device into the patient's mouth) unsuccessfully (patient awakened fighting the tube and kicking). At 11:21 a.m. the sedation RN reported that she began 3rd round (of sedation medications, again no medications/doses were stated by either the RN or the MD). GI MD 1 was not observed directing the administration of sedation/analgesia. At 11:24 a.m., as GI RN 3 was observed administering a medication by IVP, GI MD 1 asked if it was Versed being administered; GI RN 3 responded, "no, it's Benadryl." At 11:24 a.m. a second RN present in the room attempted to suction Patient 4's mouth. The patient responded by jumping up from the bed. At 11:25 a.m. GI RN 3 announced administration of "round four." At 11:27 a.m. GI MD 1 made a second (final) attempt to insert the scope into the patient's mouth. The scope was inserted momentarily but was pulled out immediately (all within 1-2 seconds) because the patient was not cooperating (additional staff was summoned to the room to hold the patient's feet). At this point the physician decided that the procedure should be rescheduled with an anesthesia provider.
Review of Patient 4's EMR for documentation of the patient care showed a progress note on 5/8/12 at 11:32 a.m. by GI RN3 indicating: "After three rounds of versed 1 mg/cc (milliliters) and four rounds of Fentanyl 25 mcg patient could not tolerate placement of the EGD scope."
Review of the notes by GI MD1 indicated: "...endoscope was inserted into the mouth and advanced under direct vision to the stomach. A careful inspection was made as the gastroscope was withdrawn ...The patient tolerated the procedure poor...Sedation: Sedation was administered...Versed 4 mg IV and Fentanyl 100 mcg IV...Incomplete examination as the patient pulled the scope and difficult to scope...rest of the examination incomplete due to poor sedation...Will schedule EGD under GA (general anesthesia)."
The documentation by GI MD1 of Patient 4' EGD procedure and medication administered during the procedure were inconsistent with the observations and the documentation of medications administered by the sedation RN.
Review of the physician orders for Patient 4 dated 5/8/12 at 10:05 a.m. showed multiple pain, sedation and other medication orders labeled as pre-procedure order set and included the following medication orders:
-Versed 0.5-3 mg every 3 minutes if needed, 5 occurrences PRN (as needed for) sedation, titrate for GI procedure
-Benadryl 12.5-25 mg every 3 minutes if needed, 2 occurrences PRN sedation. Give one dose with Midazolam (Versed) and give 2nd dose PRN inadequate sedation after Midazolam administered; maximum dose 50 mg
-Phenergan 12.5-25 mg, 1 occurrence PRN sedation for inadequate sedation after 2nd dose of Benadryl
-Fentanyl 12.5-75 mcg every 3 minutes if needed, 5 occurrences PRN procedural discomfort, titrate for GI procedure
No medication quantity and directions for use were included in these orders for the sedation/pain medications:
-only ranges without specific doses were given for each medication, therefore no dose and no maximum doses were given; only maximum "occurrence" was given for each drug;
-no specific parameters of sedation or pain (such as intensity levels or numerical scale values) were ordered for PRN sedation/pain medications, or order sequence of selection for each medication.
In an interview on 5/9/12 at 10:50 a.m., GI RN 3 confirmed that there were discrepancies in Patient 4's EMR in documentation of sedation medication administration, as to what was given and what was documented by her and by the physician. The RN again confirmed that standard PRN set of orders were written for each patient scheduled for a procedure under sedation by a RN, and it was for the RN to select drugs and doses based on the RN's judgment. The RN confirmed that the provider did not direct sedation care, i.e., did not specify each drug and dose to be used for Patient 4's procedural sedation.
The California Business and Profession Code, Division 2, Chapter 9, Article 2, Section 4040(a)1)(B) indicated that a written order (by an authorized prescriber) was required for all drugs administered to patients. The order must include the name, quantity, and directions for use.
In a position statement titled Conscious Sedation retrieved from the California Board of Registered Nursing at www.brn.ca.gov
Review on 5/10/12 of the American Association for Nurse Anesthetists (AANA) Practice Policy titled Considerations for Policy Guidelines for Registered Nurses Engaged in the Administration of Sedation and Analgesia, revised June 2003, indicated that sedation and analgesia was defined as a medically controlled state of depressed consciousness that allowed protective reflexes to be maintained. AANA listed various tasks that properly trained registered nurses could be authorized to perform under section "B" titled "Management and Monitoring." Item B.2 indicated that "A qualified anesthesia provider or attending physician selects and orders the agents to achieve sedation and analgesia... B.3. Registered nurses who are not qualified anesthesia providers should not administer agents classified as anesthetics, including but not limited to Ketamine, Propofol, Etomidate, Sodium Thiopental, Methohexital, Nitrous oxide and muscle relaxants..."
Review on 5/9/12 of the hospital policy titled "Sedation Policy" (revised 2/9/12) in part indicated, "...A non-physician, such as a RN or NP (Nurse Practitioner), who is certified to administer and monitor sedation must practice within the scope of practice as permitted by state law as well as adhere to {name of hospital} policy, Medical Staff Rules and Regulations and/or Bylaws..."
Review on 5/9/12 of the hospital policy titled "Physician Orders" (revised 5/11/11) in part indicated, "...Medication Orders (General) 1. Medication orders shall include the name of the drug, the dosage and the frequency of administration, the route of administration...4. Orders for PRN medications must contain a specific indication. 5. In the event that more than one medication is ordered PRN for the same indication (e.g. pain), each order must have unique instructions for use (e.g. for severe pain, moderate pain, pain not relieved by, etc.) to guide the nurse in selecting appropriate medication...H. Verbal Orders 1...a. Verbal orders may be used in the following situations...3) During a procedure, in which case the order will be entered by appropriate staff, and signed by the ordering provider immediately following the procedure...4. When verbal orders are issued, they must be read back to the prescriber (ordering provider). A. the person accepting the verbal order (communicator) enters the order into EMR and reads it back to the ordering provider..."
The hospital policy titled "Physician Orders" (revised 5/11/11) also indicated in section D.6 that "Orders may contain a range in dose but shall be written for an exact frequency of administration" and referred to policy PCS IV-42, Medication Orders Prescribed with a Dose Range. Review of the policy "PCS IV-42, Medication Orders Prescribed with a Dose Range" (revised 5/11/10) showed, it directed that "if more than one medication is ordered for a specific symptom...drug selection would be based on the physician medication order parameters for prioritization of use..." It also directed to "start by medicating the patient with the lowest dose in the ordered range..." The policy did not allow RNs to select and adjust the medication and doses based on their judgment and /or experience alone.
b. During an observation on 5/9/12 beginning at 10:43 a.m. of a surgical procedure involving the upper portion of the intestinal tract (EGD) on Patient 20 by MD 8 in the GI Lab, RN 10 was observed to administer and monitor moderate sedation.
In an interview at 11:20 a.m. with RN 10 following Patient 20's procedure on 5/9/12, RN 10 stated that the medication orders for moderate sedation were documented as ranges for the RN to select based on the RN's judgment of how the patient had tolerated treatments in the past, or how the RN expected the patient to respond for the current procedure. Although MD 8 did specify each drug and dose for Patient 20's procedure, RN 10 stated that most other physicians deferred to the RN to select the dose and choice of medications. The RN would tell the physician what drug and dose was selected, and the physician had the opportunity to agree or disagree. RN 10 indicated that the physicians relied on the RN's judgment for safety, which was based on the RN's sedation training and experience. RN 10 agreed that the written range order for a sedation drug (Versed, 0.5 to 3 milligrams [mg] every 3 minutes) for Patient 20 and most other unit patients would permit the RN to select the maximum dose of 3 mg every 3 minutes indefinitely, as no limit on frequency was included in the order. The order did not direct the RN to reduce the dose for elderly or debilitated patients. RN 10 acknowledged that many other medication orders for the unit patients (including Fentanyl) were similarly designed, as range orders with no limit on number of administrations.
Review of the manufacturer's insert (Roche) for Versed (midazolam HCL) injection carried a boxed warning: "Intravenous Versed has been associated with respiratory depression and respiratory arrest (cessation of breathing), especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy (brain injury) has resulted." The boxed warning further indicated, "The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and patients receiving concomitant narcotic or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect."
According to a U.S. Food and Drug Administration Black Box Warning and Lexi-Comp, an online drug reference retrieved at
It was further indicated, "Conscious sedation: Elderly I.V.: Initial 0.5 mg slow, give no more than 1.5 mg in a 2 minute period; if additional titration is needed, give no more than 1 mg over 2 minutes, waiting another 2 or more minutes to evaluate sedative effect; a total dose of >3.5 mg is rarely necessary."
The Lexi-Comp reference website,
The drug manufacturer's insert (Hospira) for Fentanyl Citrate Injections categorized the drug as a narcotic analgesic. "The onset of action of fentanyl is almost immediate when the drug is given intravenously; however, the maximal analgesic and respiratory depressant effect may not be noted for several minutes. The usual duration of action of the analgesic effect is 30 to 60 minutes after a single intravenous dose of up to 100 mcg ... The peak respiratory depressant effect of a single intravenous dose of fentanyl citrate is noted 5 to 15 minutes following injection." Under Precautions section it was noted, "The initial dose of fentanyl citrate should be appropriately reduced in elderly and debilitated patients. The effect of the initial dose should be considered in determining incremental doses." It was noted, "Cardiovascular Effects: Fentanyl may produce bradycardia (slowed heart rate), which may be treated with Atropine. Fentanyl should be used with caution in patients with cardiac bradyarrhythmias (slow heart rate rhythms)." The Adverse Reactions section noted that "As with other narcotic analgesics, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apnea, rigidity, and bradycardia; if these remain untreated, respiratory arrest, circulatory depression or cardiac arrest could occur."
In an interview on 5/9/12 at 11:20 a.m. with RN 10 about Patient 20's procedure, RN 10 indicated that she did not routinely document the administration of the intraoperative medications given as verbal orders, even though she considered each administration to have been a verbal directive from the physician. RN 10 acknowledged that for the other physicians who relied on the RN to select the drug and dose, the directive was opposite, with the RN directing and no "read-back" by the RN to the physician.
In an interview on 5/9/12 at 11:30 a.m. with the manager of the GI Lab (EM) where Patient 20 was treated, EM indicated that administration of Versed 3 mg every 3 minutes at any frequency would be inappropriate and unsafe for Patient 20 and for most patients.
In an interview on 5/9/12 at 3:30 p.m. with the Assistant Chair of the Department of Anesthesia (MD 9), MD 9 indicated that the hospital-wide sedation policies were based on the American Society of Anesthesiology and the Association of peri-Operative Registered Nurses standards. MD 9 stated that he expected the supervising physician of an RN who was administering and monitoring moderate sedation patients to be immediately available to the patient (not to leave the room) for safety should the patient need emergent rescue or medical interventions directed by the physician. MD 9 interpreted the sedation order for Versed (described above for Patient 20) differently than RN 10 in her interview. MD 9 confirmed that sedation care was to be directed by the supervising physician, not by the RN.
c. Review on 5/9/12 starting at 10:40 a.m. of Electronic Medical Records (EMR) for patients having endoscopic procedures performed under sedation by a RN showed that Patients 5 and 6 (similarly to Patients 4 and 20) had endoscopic procedures performed under sedation by a RN on 5/9/12 using standard order sets for procedural sedation with multiple sedation/pain drugs and dose ranges and no specific direction for use ordered.
In a concurrent interview with the GI Nurse Manager (EM) the Manager confirmed that standard PRN order sets were used for sedation by RNs for patients undergoing procedures in the GI Lab under sedation by a RN. The Manager confirmed that it was general practice that sedation RNs, based on their sedation training and experience selected drugs from the PRN menu ordered by a provider and chose doses within ranges ordered, based on their judgment and experience. The Manager acknowledged that the practice allowed the sedation RN, and not the provider, to direct the sedation care.
29821
2. Nursing participation in bedside surgical procedures was not documented.
The Association of Perioperative (time period before, during and after a surgical procedure) Registered Nurses' (AORN) "Perioperative Standards and Recommended Practices," 2012 edition, Recommended Practice for Managing the Patient Receiving Local Anesthesia (medication given near the procedure site to temporarily block pain) stated, "Minimum patient monitoring throughout the procedure should include the patient's heart rate and regularity, respiratory rate, level of consciousness, amount of local anesthetic administered, pain level, and response to medications...The perioperative registered nurse should reassess the patient postprocedure and before discharge to identify any potential latent [late-occurring] reactions that may put the patient at risk...."
A "Preventing Wrong-Patient, Wrong-Site, Wrong Procedure Events" Position Statement posted on the AORN website stated, "Multidisciplinary teams that include perioperative RNs, surgeons, anesthesia providers...and other health care professionals should collaboratively develop policies and procedures to prevent wrong-patient, wrong-site, wrong-procedure events. Multidisciplinary team members should implement and monitor standard processes for the prevention of wrong-patient, wrong-site, wrong-procedure events...."
Review of the hospital's "Universal Protocol" (process for preventing surgical procedures at the wrong site and on the wrong patient) policy, revised 5/4/12, revealed the following:
"V.G. All patients undergoing a surgical procedure are considered at risk for a wrong site surgery/procedure...
V.H. There is a team effort to ensure compliance with the procedure outlined...
V.H. [sic] All Other Areas within the Medical Center [outside the Operating Room] Where Invasive Procedures are Performed
In all areas, for all types of procedures requiring informed consent...the Universal Protocol will be followed...
6b. Verbal verification will be done with the patient and physician (and assistive personnel, if present)...."
Review of the following medical records revealed a lack of documentation of each patient's response to surgery and medication treatments (monitoring) and a lack of documentation to show nursing participation in surgical site verification procedures (universal protocol) performed in the Emergency Department (ED):
a. Patient 16 presented to the ED at 9:21 a.m., 5/6/12 with abdominal distention (swelling), chills, pain and constipation. He described his abdominal pain as "7" on a scale of 0 - 10, with 10 being the worst pain imaginable. A procedural note written at 1:27 p.m., 5/6/12 indicated P 16 underwent a paracentesis (fluid removal from the abdominal cavity) using a local anesthetic agent. 10 milliliters (two teaspoons) of Lidocaine (a local anesthetic) was injected into the surgical site through which a plastic tube was inserted to remove two quarts of excess belly fluid. A nursing note at 10:02 a.m., 5/6/12 stated, "Dr ...at bedside preparing for paracentesis." A "head-to-toe" nursing assessment was done between 9:31 a.m. - 10:04 a.m., 5/6/12 and vital signs and pain assessment documented at 10:14 a.m. A nursing note at 11:57 a.m. stated, "Dr ...at bedside to perform paracentesis" and the following note at 12:12 p.m. read, "Patient tolerating paracentesis." Vital signs and pain assessment were repeated at 12:41 p.m. Nursing notes written between 12:43 p.m. - 2:48 p.m. read, "Ambulatory to bathroom to give himself an enema ...Patient states no results from enema. Only 'cramping' in lower abdomen ...Wife at bedside. Patient ambulating." A comprehensive nursing assessment was not repeated until 4:45 p.m. No notes described P 16's wound, the presence or absence of fluid leakage, bleeding, or other monitoring for the specific complications of paracentesis. Nurse participation in surgical site verification was not documented prior to the procedure.
b. A 5:46 p.m., 5/7/12 "Orthopedic Trauma Procedure Note" indicated 6 year-old RP 26 had undergone a closed reduction of a radial fracture (realignment of a broken forearm bone). Nursing documentation within the hour prior to the procedural note stated, "Ortho [orthopedics physician] at bedside." Nursing documentation within the hour following the procedural note stated, "Ortho at bedside. Placing cast on left arm. Bi-valved [splitting a cast to allow for swelling]. Post reduction films [after-the-realignment x-rays] done...." No specific nursing documentation of RP 26's response to the procedure, neurovascular checks (circulation, sensation, movement assessments) or pain treatments (e.g. anxious, restless, calm, relaxed) was noted. Nurse participation in surgical site verification was not documented prior to the procedure.
c. RP 27 presented to the ED at 5:35 p.m., 5/7/12 with problems related to the healing of a toe injury. He had visited an orthopedic surgeon who advised RP 27 to go to an ED for further care. RP 27's signs and symptoms included toe pain, discoloration and increased temperature and a recent onset of weakness, fever and increased foot swelling. A diabetic, RP 27 rated his pain level as "9" on a scale of 0 -10. By 10:56 p.m., his pain had increased to 10 out of 10, a level which was sustained until 9:56 a.m. the next morning; no evidence of pain medication administration was found in the record. A 12:55 p.m., 5/8/12 physician procedural note documented the incision and drainage of RP 27's toe wound. Documentation of nursing care in the two hours before and after the procedure included vital signs and pain assessments at 9:56 a.m., 11:33 a.m., 11:56 a.m. and 12:56 p.m. and the following notes: "OK to take home meds per MD. Patient ambulatory [walking] to restroom with steady gait. Awaiting ortho admit orders ...Assume one-hour lunch relief care - patient ambulate to restroom with steady gait ...Doctor ...from ortho at bedside to talk with family and patient ...Discharge instructions provided by Doctor. Patient and family members verbalize understanding ...IV discontinued, tip intact. Patient discharged to home, ambulates with steady gait." No nursing documentation of skin preparation to help prevent post-procedure infection was found in the patient's record. Toe wound assessment, foot circulation or sensation or other monitoring in the two hours before or after the procedure was not documented. Nurse participation in surgical site verification was not documented prior to the procedure. In addition, no physician or nursing notes documented the use of a local anesthetic (medication to prevent pain) even though the procedural note indicated, "Toe callous...was debrided with a...scalpel as well as blunt dissection.." Local anesthetic administration would be expected for this type of surgery.
d. RP 28 presented to the ED at 12:23 a.m., 5/7/12 complaining of a headache he described as "10" on a 0 - 10 scale, nausea, weakness and intermittent confusion. RP 28 underwent a lumbar puncture (LP - removal of fluid from around the spinal cord for diagnostic purposes) at 7:13 a.m.. From that time until 10:06 a.m., the only nursing notes referencing the procedure were "MD at bedside performing LP. Patient lying flat." Post-procedure vital signs and pain reassessment were not documented until 8:46 a.m. No pain medication administration was documented until 3:28 p.m. Specific post-procedure nursing assessment components including patient response and wound site inspection were not found in the medical record. Nurse participation in surgical site verification was not documented prior to the procedure.
Document review of the Emergency Department Structure Standards, revised 9/16/09, revealed the following:
"Documentation Guidelines
1. The purpose of nursing documentation in the Emergency Department is to establish a record for the overall care received in the ED. This includes ...
b. All care/treatment/medications ordered and implemented
c. Patient response to treatments/care/medications
d. Progress of the patient throughout his Emergency Department stay ....
D. Pain Management
Pain will be documented...Pain scores will be documented every two hours...If the patient's pain is not controlled by routine measures, a plan of care will be established and progress toward resolution of the problem will be documented in the nurse's notes...
3d. Medication Administration...
The following will be documented in the EMR [Electronic Medical Record] via the Medication Administration Record (MAR):
1) The name of the medication
2) The dose
3) The time of administration
4) The route
5) The site, if applicable
6) The response to the medication...."
In a 2:40 p.m., 5/9/12 interview, the EDM stated the Emergency Department (ED) used the online "Mosby's Nursing Skills" software as a clinical nursing reference. The "Lumbar Puncture" reference included the following steps:
"2. Monitor the patient's neurologic, respiratory, and cardiovascular status during the procedure ...
4. Verify correct patient using two identifiers.
5. Comply with Universal Protocol.
6. Ensure that the patient is in the proper...position...
21. Observe the puncture site, dressing, and linen for cerebrospinal fluid leakage or bleeding ...."
The "Paracentesis" reference stated:
"6. ...Verify correct patient using two identifiers.
7. Before the paracentesis, comply with Universal Protocol requirements:
...c. Participate in a 'time out' to verify correct patient, procedure, and site...."
The reference did not provide direction on patient monitoring before, during or after the procedure and contained no documentation guidelines.
The EDM stated there were no specific Mosby's online references for nursing care of the adult patient undergoing wound incision and drainage or closed reduction of a fracture. The EDM stated there were no additional reference sources commonly used by the ED nursing staff.
Active nursing participation in surgical procedures, including involvement in the universal protocol, adds an additional layer of patient safety to the healthcare experience.
HISTORY AND PHYSICAL
Tag No.: A0952
Based on observation, staff interview, medical record and document review, the hospital failed to ensure that each patient have complete and updated pre-surgical assessment by a physician or other qualified practitioner to ensure it was safe to proceed with the planned surgery in accordance with the hospital Medical Staff Rules and Regulations for 1 of 1 surgical patients reviewed in the Same Day Surgery Center (Patient 2). This failure resulted in the potential to not recognize the need for additional intraoperative support or consultation, or the need to delay or reschedule surgery, in order to ensure safe surgery and to minimize the risk for adverse outcomes for all surgical patients.
Findings:
Review of the EMR (electronic medical record) for Patient 2 showed the elderly patient was having eyelid surgery on both eyes in the Same Day Surgery Center on 5/7/12. The record showed a 5/1/12 preoperative History and Physical Examination (H&P) documented by the surgeon. Patient 2 was noted to have a history of stroke, diabetes and high blood pressure. A section for physical examination contained no documentation of findings relevant to the planned procedure (such as exam of organ systems affected by diabetes and stroke, vitals signs, exam of heart, lungs, skin, mental status).
On the day of surgery on 5/7/12 the surgeon documented an update to the H&P, indicating no changes to the medical history or examination since the preoperative H&P dated 5/1/12. No relevant physical examination findings by the surgeon were documented as performed prior to the surgery on 5/7/12.
In an interview with the Chief Medical Officer (CMO) on 5/7/12 at 4:15 p.m., the CMO acknowledged that the H&P for Patient 2 did not have documentation of an appropriate physical assessment prior to the surgery on 5/7/12.
Review of the Medical Staff Rules and Regulations, last approved April 2012, documented under I-I-2 that the minimum information to be documented in an inpatient history and physical examination (H&P) included: chief complaint, history of present illness, review of systems, past medical history, family history, social history, physical examination, assessment, and treatment plan. Item I-I-3-a read, "Prior to surgery or a procedure requiring anesthesia services and except in the case of emergency, a medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission," and prior to surgery. Item I-I-3-b required that an update to the H&P be documented by a member of the surgical team performing the procedure. The update consisted of a reassessment of the patient's current condition and may be documented as an interval note. The interval note must state that the previous H&P was reviewed; the patient was examined, and indicates either no relevant changes have occurred or details the changes to the patient's medical status since the prior H&P.
Item I-I-5 required for outpatient procedures requiring sedation, a brief H&P recorded within 24 hours prior to the procedure must include at a minimum: relevant medical/surgical history, relevant physical exam, assessment or diagnostic impression, and treatment plan.
Review of a chapter from the online Merck Manual for Professionals (a nationally recognized reference for medical practice) titled Preoperative Evaluation retrieved at <
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