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Medication Safety-Reliability of Preference Cards

Posted on: Sunday, 18 September 2005, 03:01 CDT

ABSTRACT

* A CLINICAL ANALYSIS of surgeons' preference cards was initiated in one hospital as part of a comprehensive analysis to reduce medication-error risks by standardizing and simplifying the intraoperative medication-use process specific to the sterile field.

* THE PREFERENCE CARD ANALYSIS involved two subanalyses: a review of the information as it appeared on the cards and a failure mode and effects analysis of the process involved in using and maintaining the cards.

* THE ANALYSIS FOUND that the preference card system in use at this hospital is outdated. Variations and inconsistencies within the preference card system indicate that the use of preference cards as guides for medication selection for surgical procedures presents an opportunity for medication errors to occur. AORN J 82 (September 2005) 399-414.

Medication use in perioperative settings involves a complex process that has the potential to result in serious errors. During a surgical procedure, different medications are added to the surgical field, and this can increase the risks of mishaps at any stage of the medication delivery process. Possible problems include

* misidentification of medications or solutions;

* inadvertent intravascular or organ infusion of a potentially toxic substance;

* infusion and infusion-device problems;

* timing of medication administration, specifically of preoperative antibiotics;

* miscommunication of verbal orders; and

* outdated preference cards.1

This article describes an analysis of preference cards that was conducted as part of an overall evaluation of the intraoperative medication-use process at a major metropolitan academic medical center. The objective of the analysis was to ascertain the medication-error potential associated with the use of the preference card system. A secondary subanalysis was performed to evaluate the process of using and maintaining the cards.

MEDICATION SAFETY DURING SURGERY

The American Society of Health-System Pharmacists defines a medication error as

any preventable event that may cause or lead to inappropriate medication use and patient harm while the medication is in the control of the health care professional, patient, or consumer.2(p165)

Such events may be related to professional practice; health care products; procedures; and systems, including prescribing, communicating orders, labeling products, packaging and nomenclature, compounding, dispensing, distributing, administering, educating, monitoring, and using.2

Preventing medication-related errors is a goal shared by many national professional organizations. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has incorporated medication safety goals into its standards3 and has revised its medication management standards for 2006 to

. . . increase safe practices surrounding the selection and procurement of medications; address safe medication management practices for medications that are brought into an organization by a licensed independent practitioner; and address risks associated with medications that are used as part of a procedure, regardless of whether there is a specific order for the medication.4

AORN has emphasized the importance of safe medication practices in the OR by recommending practices for health care providers to manage and administer medications on the surgical field.5 The Institute for Safe Medication Practices (ISMP) has presented case studies of mix-ups and misinterpretations on the surgical field, along with safe practice recommendations to prevent these types of mishaps from occurring.6

Opportunities exist for improving medication safety during surgery. An analysis of medication error reports submitted to the US Pharmacopeia's MEDMARX reporting system found that 731 of 150,000 medication events occurred in the OR. Ten percent of the reported OR medication errors resulted in temporary or permanent harm or death.7 Errors involving medications commonly administered on the sterile field accounted for 19% of all reports.7

Many of the OR error reports involved problems with preoperative antibiotics or medications given by anesthesia care providers.7 After undertaking an extensive self-study of medication errors encountered in the practice of anesthesiology, anesthesia care providers have built a body of work that demonstrates their accomplishments in improving medication safety.8-12 They succeeded in reducing anesthesia errors through better use of technology, standardized guidelines and protocols, and the adoption of an approach to patient safety that embraced human factors and improved systems. The use of patient simulation for research, training, and performance assessment has further contributed to this accomplishment.8

Very few studies have examined medication-error risk during surgery with respect to medications that are prepared and administered on the surgical field. Systems that support safe medication practices can reduce the incidence of medication errors,13-16 but many established medication safety practices have yet to be adopted in ORs. Although guidelines and recommendations have been published to address some of the issues regarding intraoperative medication use on the sterile field,5 a comprehensive systems analysis of this process has not appeared in the literature. Furthermore, no one has combined the various recommendations published by national professional organizations in an effort to build a safer system.

ANALYSIS OF SURGEONS' PREFERENCE CARDS

Many ORs in hospitals throughout the United States use preference cards to communicate physician preferences for each surgical procedure. Traditionally, preference cards contain important information, such as specific supplies needed for the procedure, special equipment, the surgeon's preference for setup and positioning, and other detailed instructions. In addition, preference cards essentially serve as the physician's orders for medications that the surgeon typically uses for a given procedure. Systems for maintaining these cards include use of both electronic data files and handwritten changes.

As part of a comprehensive analysis to reduce medication-error risk by standardizing and simplifying the intraoperative medication- use process specific to the sterile field, a clinical analysis of surgeons' preference cards was undertaken at NewYork-Presbyterian Hospital, a 2,246-bed, not-for-profit, academic medical center in metropolitan New York. The analysis was conducted at the Weill Cornell Medical Center, one of five centers at NewYork- Presbyterian. The Weill Cornell Medical Center houses 38 ORs in which approximately 24,000 surgical procedures are performed each year, accounting for 27% of all surgeries performed in the hospital.

When a surgical procedure is scheduled at the hospital, it is logged in the OR calendar system, and the staff members in central sterile supply (CSS) pull the surgeon's preference card from a computer database. If there is an add-on or emergency case, the perioperative nurse calls in the request to CSS. The CSS staff members are responsible for assembling trays and soft goods but have no role in obtaining medications or items such as surgeon-specific implants. The preference card then is clipped to the case cart, and the circulating nurse or surgical technician retrieves it when the cart is sent to the OR. The circulating nurse is responsible for retrieving and preparing the medications for the procedure.

METHODOLOGY

The preference card analysis involved two steps: first, a review of the information as it appeared on the original cards, and second, a failure mode and effects analysis (FMEA) of the process involved in using and maintaining the cards. Medication errors can result from system failures in a process, so it is important to have a tool for analyzing system deficiencies. Failure mode and effects analysis is a proactive, systematic method for identifying and preventing product or process problems before they occur.17 The use of FMEA concedes that errors are inevitable and predictable.18 The steps that a hospital should follow in conducting an FMEA have been described by various organizations.19 The end result of an FMEA is an action plan that provides recommendations on potential ways to redesign processes to prevent patient harm.17

The hospital hired a research pharmacist to manage the project and perform the data collection and analysis. In part one, 392 preference cards (ie, 18% of the total) were randomly selected from a database of 2,175. To be included in the analysis, two or more medications had to be listed per card. A web site designed to help researchers perform random sampling20 was used to generate random numbers for each service with preference cards that met the inclusion criterion. The number of preference cards chosen for each service was equal to the proportion of preference cards with medications in the database for that service. Table 1 contains the data elements collected for review. A pilot study of 20 preference cards was conducted to evaluate and adjust the project plan. A computer database was created to hold the data.

Medications were defined as any medicinal substance, agent, product, or solution that is intended to be admin\istered to a patient during the course of an invasive or surgical procedure. These included such substances as sterile water or saline, irrigation solutions, dye, topical agents, and IV agents.

TABLE 1

Preference Card Analysis Data Elements

In the second part of the analysis, an interdisciplinary team was assembled to conduct an FMEA of the process involved in using preference cards. This team was composed of front-line staff members, including perioperative nurses, surgical technologists, pharmacists, and two members of the hospital's patient safety department. During an 11-week period, the FMEA team met weekly and created a series of flow charts that ultimately resulted in the construction of a highly detailed map of the processes involved in using preference cards. A modified version of the 10-step FMEA process as outlined by JCAHO was followed.19

This FMEA was a subanalysis of a comprehensive review of the entire sterile field medication-use process. It reviewed all the steps related to preference card use, including how the cards are updated or revised, and showed the role the cards play in the prescribing subprocess. Worksheets adapted from JCAHO's FMEA workbook18 were used at the end of the mapping process to allow the team members to assess and score the failure modes they identified for each step of the process, including the causes and effects. Failure modes for each step in the process were determined. Criticality scores were then calculated to identify and prioritize vulnerabilities in the process. At the conclusion, specific steps in the process where errors were likely to occur were identified and classified by category on six worksheets that represented the final results of the FMEA.

FINDINGS

The two independent subanalyses of the process-the analysis of the 392 preference cards and the FMEA-yielded similar results in that the top concerns identified in one subanalysis reflected those identified in the other subanalysis. The major concerns noted were as follows.

* Changes made on preference cards by perioperative nurses were not double-checked by surgeons.

* Medications were listed on a preference card, but the card was outdated, contained wrong or missing information, or the card layout made the medications hard to find.

* The preference card was incorrect for the surgical procedure that was to be performed.

* The medications listed on the preference card were not what the surgeon wanted or intended to use.

The links between the findings of the two analytical processes became apparent as the results were analyzed.

SUBANALYSIS I: PREFERENCE CARDS

The preference card analysis revealed numerous potential sources of error. The key findings showed significant variation in the aspects and function of preference card use, including instructions, abbreviations, timely up-date of cards, and clarity in communicating numeric values (eg, zero to the left of decimals, nonmetric units). Similar (ie, sound-alike, look-alike) medication names, high-risk medications, and the use of brand versus generic medication names also were issues.

INSTRUCTIONS. Medication-specific instructions were scarce and often unclear. The average number of medications per card was 4.93. The average number of listed medications accompanied by specific instructions of any kind was 0.65 medications per card. Medication instructions were defined as the quantity of medication to be administered, how to mix the medication, and the calculations to mix it appropriately. The average number of medications per card was compared to the average number of medications with instructions per card by surgical service. The transplant surgical service had the highest percentage of listed medications with specific instructions (ie, 40%), and the cardiothoracic surgical service had the lowest percentage (ie, 0.9%).

The majority of instructions were incomplete or unclear. Examples include

* "hep-saline for flushes ready,"

* "soak in povidone iodine strength,"

* "diatrizoate meglumine or iohexol x 1 bottle-250 cc NS 0.9% IV,"

* "have epinephrine/saline irrigation ready,"

* "heparin solution age dependent-please ask MD," and

* "usually kanamycin sulfate irrig before closure."

MIXING INSTRUCTIONS. Of 73 medication mixes identified, 60.3% contained mixing instructions. One example was, "mix bupivicane 0.25% plus lidocaine 1% and mix in a one-to-one ratio."

ABBREVIATIONS. Abbreviations, a known source of medication errors,21,22 were used on 97% of the cards. The average number of abbreviations per card was eight with a range of one to 39. Examples included

* "1% Lido W/Epi & 1% Lido PL 25% bupivacaine hydrochloride,"

* "uses 1,000 cc L/R 50 cc 1% Lido & 1 mg," and

* "have Epi Sol."

The abbreviations that most frequently appeared were U for units and mcg for micrograms.

TIMELY UPDATES. The average time it took to update the preference cards was 427 days, or 1.17 years, with the overall range varying from two days to 2.4 years. When a preference card was updated, it was unclear whether the entire card was updated (eg, soft goods, supplies, medications).

CLARITY IN COMMUNICATING NUMERIC VALUES. On 2.1% of the cards, there was at least one number less than one with no zero to the left of a decimal point (eg, .05). Approximately 36% of the cards reviewed had at least one nonmetric unit associated with a medication, usually related to package size (eg, "one bottle" instead of "30-mL vial").

SIMILAR MEDICATION NAMES. At least two medications with names that looked or sounded similar appeared on 19.6% of the cards. Examples include

* epinephrine and ephedrine,

* glycine and saline,

* papaverine and phenylephrine,

* kanamycin and neomycin,

* lidocaine plain and lidocaine with epinephrine, and

* bupivacaine 0.25% and bupivacaine 0.5%.

HIGH-ALERT MEDICATIONS. High-alert medications are those that have been identified in the medication safety literature as medications that may cause significant patient harm if they are used incorrectly.23 On 52% of the preference cards, there were no high- risk medications listed. There was one high-risk medication on 27% of the cards, two high-risk medications on 7% of the cards, and up to three high-risk medications on 14% of the cards. High-risk medications identified include bupivacaine with epinephrine, calcium chloride, cardioplegic solution, epinephrine, heparin, lidocaine, lidocaine with epinephrine, and phenylephrine.

BRAND VERSUS GENERIC NAME. Although hospital policy requires that generic names be used for all medications, only 24% of the preference cards listed medications exclusively by generic names. Medication names typically appeared as a combination of brand and generic names. On 75.8% of the cards, brand and generic names were used interchangeably on the same card, and the brand and generic names did not always match (ie, the incorrect generic name was listed for a brand or vice versa).

ADDITIONAL FINDINGS. Among other findings, some preference cards specifically called for the use of restricted antibiotics, such as vancomycin. Other preference cards listed a particular medication package size (eg, epinephrine 1:1,000, 30 mL vial) that was not available to OR personnel.

The most significant additional finding appeared to be that the medication listed on the preference card did not match the medication being used in the procedure. For example, in one case, 1 mg epinephrine was mixed with 20,000 units of thrombin for topical administration, but epinephrine was not listed on the preference card for that type of procedure. Another procedure relied on a card that had no local anesthetics listed. Although bupivacaine did not appear on the card, bupivacaine 0.25% routinely was used by the surgeon. Examples of additional errors found in the sample include

* bupivacaine 0.25% with epinephrine 1:200,000 listed under supplies and bupivacaine 0.25% with no epinephrine listed in medication instructions;

* ferric subsulfate referred to on the card as ferrous sulfate; and

* gentamycin sulfate ointment 0.1% package size listed as 5 g- the smallest size available at that strength is 15 g.

SUBANALYSIS II: FMEA RESULTS

The detail of the map of the preference card process constructed by the FMEA team (Figure 1) reveals the presence of multiple steps with a number of potential system failure points throughout. A total of 22 decision points, or steps, were identified in the preference card process. Four of these steps were highlighted as targets for more in-depth analysis based on the actual experiences of the team members. Table 2 includes these four target steps along with 12 individual failure modes associated with the steps.

The FMEA team was asked to assign a criticality score for each of the 12 failure modes that were identified. Criticality scoring helps determine how harmful a failure mode may be if it is allowed to occur, and also helps to prioritize corrective action initiatives.18,19 The higher the score, the greater the chance of harm.

To determine criticality, team members were asked to score each of the failure modes using three variables (ie, severity, frequency, likelihood of detecting error). The scoring for each variable was on a 10-point scale, as follows:

FIGURE 1

Preference Card Failure Mode and Effects Analysis*

TABLE 2

Target Steps 1 Through 4 in Preference Card Process

* severity of effect (1 = no effect, 10 = death);

* frequency of failure (1 = never occurs, 10 = happens often); and

* chance of detecting error (1 = always detected, 10 = never detected).

Team members' scores for each variable were averaged, and the averages for each of the three values were multiplied to determine the criticality score. Criticality scores for the 12 identified failure modes are listed in Table 3.

Table 4 provides a breakdown of the scoring variables for the top five failure modes. Of all the failure modes identified, the two that were deemed most hazardous were outdated and incorrect medicationinformation on the preference cards. These results correspond with the findings of the card analysis.

DISCUSSION

National organizations, such as JCAHO, AORN, and the ISMP, have formulated recommendations that promote interdisciplinary collaboration in the administration of medications and emphasize the need for proper review of medication orders. These organizations also have recommended the development of systems for managing and administering medications on the surgical field. Such systems are not in widespread use in the OR with respect to medications on the sterile field (ie, no single, systematic approach to medication safety, standardization, and pharmacy and physician oversight exists to serve as a model). The preference card system review described in this article marked the beginning of a comprehensive evaluation of the intraoperative medication use process. The methods used to conduct the analysis were basic, fact-finding approaches aimed at breaking down and identifying the numerous steps in a complex process.

The findings of both subanalyses showed that the steps routinely followed in the OR in regard to preference card use are not as clear or straightforward as they are widely thought to be. The presence of outdated and incorrect information on the cards underscores the need for an overhaul of the preference card system as part of a proactive risk-reduction strategy.

Inconsistencies and variations in any complex process can increase the potential for error risk. This analysis did not attempt to quantify the error risk inherent in the preference card system; instead, its objective was to identify major areas of concern. One underlying concern that arose throughout the analysis was the variation in medication nomenclature. Unlike the routine, standardized terminology that was used for supplies and equipment on the preference cards, no standardization was found for the medications that were listed. On 24% of the analyzed cards, medications were listed by generic name only. A majority of the cards contained medications that were indicated by a combination of brand and generic names. Typically, the medication list at the top of a card showed a medication requested for the procedure by its generic name; however, if any instructions accompanied it, the reference to medications was given by brand name. The analysis showed that the brand name listed in the instructions was not always correct for the generic name written on the medication list.

TABLE 3

Criticality Scores

TABLE 4

Criticality Score Breakdown for Top 5 Failure Modes Identified

The visual appearance of the preference card also was a concern. The layout was not always clear or userfriendly. It was not easy to negotiate, and the print was small. Frequent lack of punctuation made the names of medications run together and confusing to read. Sterile field medications could be found under different subheadings, such as "supplies" or "other." On some cards, there was a question as to what constituted a medication; for instance, IV solutions and topical antiseptics were misplaced in a section labeled "sutures," while the medications section was left blank.

Another concern was that clear instruction for how medications should be mixed was not always provided. The data did not reveal any calculations, although mixing ratios were listed (eg, mix lidocaine, bupivacaine, and sodium bicarbonate 4:4:2). Within the analysis sample, 73 medication mixes were identified, but only 60.3% of them had mixing instructions. Additionally, there was no clear differentiation between calculations for adult and pediatric mixes.

The presence of high-alert medications on the preference cards also was identified as an area of concern. Many medications that appeared on a list of high-alert medications published by the ISMP also were listed on the preference cards.

Typically, the task of updating and editing the preference cards was left for nursing staff members to handle. A nurse often was the only member of the OR staff who would transcribe, review, and edit the preference cards without any oversight or double-checking on the part of a pharmacist or physician. Updates and edits to the preference cards generally became low-priority tasks amid the many responsibilities and duties facing a nurse or OR team leader during the course of a day.

Surgeons often were unaware of what was on the preference cards. Working with the same team members over a period of time, it is not unusual to develop a sense of complacency or false security. During observation in the OR in conjunction with this analysis, surgeons were heard referring to their "usual meds" as an order before the procedure, although they may not have known what was listed on the card.

IMPLICATIONS AND FUTURE GOALS

This analysis found that the preference card system in use at this hospital is outdated and that the risk of potential medication errors in the ORs is greater than expected. The striking similarity of the results of the independent subanalyses underscores the significance of the findings in regard to safe medication handling on the sterile field. Variation and inconsistencies within the preference card system indicate that although perioperative nurses use these cards on a daily basis, their usage may provide a false sense of security. Use of preference cards as guides to medication selection for surgical procedures offers an opportunity for medication errors to occur.

The findings presented here are part of an ongoing analysis that, when concluded, will enable the hospital to finalize and fully implement its risk reduction strategy. The three goals of this strategy are to

* standardize all sterile field medications to a set list of medications, medication mixtures, and medication concentrations;

* simplify ordering methods from three (ie, written, verbal, preference cards) to one method; and

* redesign the system to incorporate the creation of a best practices system for handling medications on the sterile field.

The implications of the analysis findings apply not just to this hospital, but to all hospitals that use preference cards in their ORs. The goal of proactively reducing the risk of medication errors in this area can be achieved through standardization of the preference card system; use of automation to reduce variation; and by regular, rigorous review of the medication orders on preference cards by OR pharmacists and surgeons.

Anesthesia care providers reduced anesthesia errors through better use of technology, standardized protocols, and an approach to patient safety that considered human factors.

The end result of a failure mode and effects analysis is an action plan that provides recommendations on potential ways to redesign processes to prevent patient harm.

Abbreviations, a known source of medication errors, appeared on 97% of the preference cards, and at least two medications that have similar names appeared on 19.6% of the cards.

Some preference cards called for the use of restricted antibiotics (eg, vancomycin), and others listed particular medication package sizes that were not available in the OR.

Inconsistencies within the preference card system indicate that although perioperative nurses use these cards daily, their usage may provide a false sense of security.

NOTES

1. S C Beyea, "Wake-up call-Standardization is crucial to eliminating medication errors," AORN Journal 75 (May 2002) 1010- 1013.

2. "Suggested definitions and relationships among medication misadventures, medication errors, adverse drug events, and adverse drug reactions," American Journal of Health-System Pharmacy 55 (January 1998) 165-166.

3. "Facts about the 2005 National Patient Safety Goals," Joint Commission on Accreditation of Healthcare Organizations, http:// www.jcaho.org/accredited+organizations /patient+safety/05+npsg/ npsg_facts.htm (accessed 12 July 2005).

4. "Joint Commission seeks input on proposed revisions to medication management standards," Joint Commission on Accreditation of Healthcare Organizations, http://www.jcaho.org/news+room/ news+release+ar chives/nr _122104.htm (accessed 22 March 2005).

5. "Safe medication practices in perioperative settings," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2005) 196-198.

6. Institute for Safe Medication Practices, "Cutting errors out of the operating room," Medication Safety Alert! 7 (March 6, 2002).

7. S C Beyea, R W Hicks, S C Decker, "Medication errors in the OR- A secondary analysis of Medmarx," AORN Journal 77 (January 2003) 122- 134.

8. D M Gaba, "Anaesthesiology as a model for patient safety in health care," BMJ (Clinical Research Ed) 320 (March 2000) 785-788.

9. E C Pierce, Jr, "The 34th Rovenstine Lecture. 40 years behind the mask: Safety revisited," Anesthesiology 84 (April 1996) 965- 975.

10. A D Auerbach, H J Murff, S D Islam, "Pre-anesthesia checklists to improve patient safety," in Making Health Care Safer: A Critical Analysis of Patient Safety Practices (Rockville, Md: Agency for Healthcare Research and Quality, US Department of Health and Human Services, 2001) Also available at http://imvw.ahcpr.gov/ dinic/ptsafe ty/chap23.htm (accessed 12 July 2005).

11. R H James, "1,000 anaesthetic incidents: Experience to date," Anaesthesia 58 (September 2003) 856-863.

12. F K Orkin, "Patient monitoring during anesthesia as an exercise in technology assessment," in Monitoring in Anesthesia, third ed, L J Saidman, N T Smith, eds (London: Butterworth- Heinemann Publishers, Inc, 1993).

13. D W Bates, "Frequency, consequences, and prevention of adverse drug events," Journal of Quality in Clinical Practice 19 (May 1999) 13-17.

14. M M Donnells, B J McDonald, J M Trimble, "Improving care through a medication administration process action team," Journal of Nursing Care Quality 9 (April 1995) 38-44.

15. J A Thomas, V Martin, S Frank, "Improving pharmacy supply- chain management in the operating room," Healthcare Finan\cial Management 54 (December 2000) 58-61.

16. J C Garrelts et al, "Automated medication distribution systems and compliance with Joint Commission standards," American Journal of Health-System Pharmacy 58 (December 2001) 2267-2272.

17. "System analysis: To RCA or FMEA? That is the question!" Joint Commission Perspectives on Patient Safety 3 (March 2003) 7-8.

18. "Using failure mode and effects analysis in healthcare," FMEA Info Centre, http://www.fmeainfocentre.com/download/using _failure_mode_and_effects_analysis_in_health care.doc (accessed 12 July 2005).

19. "System analysis: Helpful tools for effective FMEAs," Joint Commission Perspectives on Patient Safety 3 (August 2003) 5-6.

20. Research Randomizer, http://www.ran domizer.org (Accessed 12 July 2005).

21. J P Santell, "Beware of abbreviations: A 'do not use list' can help avoid problems," US Pharmacist 29 (November 2004) 58-63.

22. "Abbreviations can lead to medication errors!" USP Quality Review 80 (July 2004).

23. "ISMP's list of high-alert medications," Institute for Safe Medication Practices, http://www.ismp.org/MSAarticles/highalert.htm (accessed 12 July 2005).

Anthony Dawson, RN; Michael J. Orsini, RPh; Mary R. Cooper, MD; Karol Wollenburg, RPh

Anthony Dawson, RN, MSN, is a black belt-performance excellence at New York-Presbyterian Hospital, New York.

Michael J. Orsini, RPh, BS, is a research pharmacist, New YorkPresbyterian Hospital, Weill Cornell Medical Center, New York.

Mary R. Cooper, MD, JD, is chief quality officer, New York- Presbyterian Hospital, New York.

Karol Wollenburg, RPh, MS, is vice president and apothecary-in- chief at New York-Presbyterian Hospital, New York.

Editor's note: The authors thank the members of the perioperative staff at New York-Presbyterian Hospital for their contributions to this article.

MEDMARX is a registered service mark of the United States Pharmacopeia, Rockville, Md.

Copyright Association of Operating Room Nurses, Inc. Sep 2005

Source: Association of Operating Room Nurses. AORN Journal

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