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PA Bulletin, Doc. No. 09-733

RULES AND REGULATIONS

Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS

STATE BOARD OF NURSING

[ 49 PA. CODE CH. 21 ]

Nursing Education Programs; Provisional Approval; Removal from Approved List; Examination Pass Rates

[39 Pa.B. 2103]
[Saturday, April 25, 2009]

   The State Board of Nursing (Board) adopts amendments to Chapter 21 (relating to State Board of Nursing) regarding approval of nursing education programs for professional nurses (RNs) and practical nurses (LPNs), to read as set forth in Annex A. These amendments will establish a new pass-fail rate for approved registered nursing and licensed practical nurse programs in this Commonwealth. Beginning 1 year after the amendments are promulgated, nursing education programs will remain on full approval status if at least 75% of the programs graduates pass the National licensure examination. Beginning 2 years after the amendments are promulgated, nursing education programs would remain on full approval status if at least 80% of the programs graduates pass the National licensure examination. These provide for oversight and assistance to those programs whose pass rates fall below acceptable standards.

   Notice of proposed rulemaking was published at 38 Pa.B. 344 (January 19, 2008). Publication was followed by a 30-day public comment period during which the Board received numerous comments from stakeholders. On February 13, 2008, the House Professional Licensure Committee (HPLC) submitted its comments. The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) made no comments. The Independent Regulatory Review Commission (IRRC) submitted comments to the proposed rulemaking on March 20, 2008.

Statutory Authority

   These final-form regulations are authorized under section 6.1 of the Professional Nursing Law (RN act) (63 P. S. § 216.1), which requires the Board to establish standards for the operation and approval of nursing education programs and for the preparation of RNs. Section 9 of the Practical Nurse Law (LPN act) (63 P. S. § 659) authorizes the Board to approve all schools and institutions that educate LPNs. The Board is further authorized to establish rules and regulations for the practice of professional nursing and the administration of the RN act under section 2.1(k) of the RN act (63 P. S. § 212.1(k)) and for the practice of LPNs and the administration of the LPN act under section 17.6 of the LPN act (63 P. S. § 667.6).

Summary of Comments and Responses to Proposed Rulemaking

Comments from Stakeholders

   The Board received comments from several nursing education programs. Butler County Community College (Butler) agreed with the proposal to increase the licensure passing rate requirements for nursing education programs. However, Butler suggested that the Board could support nursing education by identifying the appropriate faculty to student ratios for clinical courses. Butler suggested that this requirement would assist program administrators when requesting additional faculty positions. Second, Butler suggested that a program that admits students annually in the fall semester would be including students from two different cohorts in their annual report, which is based on an examination year October 1 through September 30.

   The Board has consistently declined to establish a minimum faculty to student ratio for clinical courses because it believes that each program is in the best position to make determinations regarding the effectiveness of its student to faculty ratio based on the program's instructors, the acuity of the patient population in a clinical program and the nature of the program's student body. While establishing the student to faculty ratio by regulation might assist some schools in successfully lobbying their administration for additional faculty positions, other schools might be placed in a position of justifying current faculty assignments and decrease faculty. The Board believes that the best way to ensure an effective student to faculty ratio is to allow each nursing education program to set its ratio consistent with meeting educational objectives.

   The Board cannot dictate when program graduates sit for the licensure examination. Therefore, no matter what dates the Board might set for the examination year, it is possible that individuals from more than one cohort from a particular nursing education program may sit for any given administration of the examination. The Board obtains examination results from the National Council of State Boards of Nursing, which are provided quarterly. The Board chose the October 1 through September 30, examination year to capture the majority of each program's cohorts.

   The Clearfield Campus of Lock Haven University (Lock Haven) wrote in support of the increase to 70%, but commented that the additional increase to 80% 2 years following the first increase would not provide nursing education programs ample time to implement and evaluate strategies and their effectiveness. For at least 10 years, the Board has written to all programs with pass rates between 60.1% and 80% and notified these programs that the Board has been planning to raise the minimum pass rate. Included with this notice, the Board provided suggestions for self-assessment and correction and offered assistance from its education advisors. The Board believes that it has given nursing education programs sufficient notice of its intention to increase the minimum pass rate and that the programs will be able to implement and evaluate strategies and their effectiveness.

   Lock Haven also commented that the proposal would force nursing programs to ''implement stringent admission criteria, decrease enrollment, increase GPA requirements, increase grading scales and utilize standardized exams as a means to weed out students prior to graduation'' and suggested that these changes ''could affect the numbers of potential registered nurses in the Commonwealth, and have a direct impact on the nursing shortage.'' The Board disagrees with Lock Haven's conclusion. There are many reasons why a nursing education program's graduates cannot pass the licensure examination. Rather than decreasing enrollment, a program could evaluate its status related to having an adequate number of qualified faculty, a well-defined faculty development plan, and a sound curriculum plan as evidenced through program outcomes in its systematic evaluation plan.

   The Board's proposal to increase the minimum pass rate will positively impact the number of potential registered nurses in this Commonwealth. If at least 70%, and, after 2 years, at least 80%, of the graduates of every nursing program in this Commonwealth pass the licensure examination, enabling them to become licensed nurses practicing in this Commonwealth, there will be more nurses than if only 60% of the graduates of the programs pass the licensure examination and become licensed nurses practicing in this Commonwealth.

   The Board received two comments from Thomas Jefferson University (TJU). The Dean of the School of Nursing expressed support for the increase in the minimum pass rates for program graduates as essential to ensuring the quality of nursing education programs in this Commonwealth and assuring the safety of the public and the integrity of the nursing profession. The Dean requested that the Board consider establishing regulations to require an individual who was unsuccessful after twice taking the licensure examination to meet additional educational requirements prior to repeating the examination and to require graduates to sit for the examination within 3 years of completing their nursing education. The Board will take up these recommendations at its meetings and consider regulations in these areas.

   The Assistant Dean of the School of Nursing sent the second letter from TJU. This letter also expressed support for the Board's proposal to raise the minimum passing standard. The writer proposed that the Board amend its rulemaking to add anther type of approval. The writer suggested that a program that is on provisional approval status and is not improving after 2 years should be placed on probationary approval status for another period of time prior to the program being removed from the approved list. The Board does not agree that adding another step in the process would improve schools' compliance with the regulations.

Comments From Other Interested Parties

   The Executive Director of the Pennsylvania Association of County Affiliated Homes (PACAH) wrote in support of the regulation raising the pass rates to around the National average, noting that this Commonwealth had been behind most states in regards to this issue. PACAH suggested that the Board place additional restrictions on nursing education programs to ensure that the programs contain the essential elements/instructional processes to support their students. As part of the process of granting initial approval to nursing education programs, the Board performs a detailed review of the program's curriculum, faculty, resources and clinical sites. The Board's assessment of these areas is ongoing through the annual and triennial reports that programs are required to file with the Board.

   PACAH expressed concern about the impact on students if a program is removed from the approved list, and asked for more information about transitioning students to another program. The Board's educational advisors monitor all nursing education programs on provisional status. However, it is the responsibility of the controlling institution to provide for the completion of the program for students currently enrolled either by placing the students in an approved program or continuing the enrolled classes until completion.

   The Pennsylvania State Nurses Association (PSNA) wrote to support increasing the pass rates over the 2-year period and downgrading programs to provisional approval status if their pass rate falls below 80%. PSNA noted that the revision would align the Commonwealth with other states that mandate higher standards and will motivate programs that hover near marginal levels to improve. PSNA also wrote in support of the procedures developed by the Board for removal of a program from the approved list.

   PSNA asked that the Board further investigate whether individuals who successfully take the licensure examination on the first try are safer practitioners than those who pass on their second attempt. The Board has never collected data to correlate the efficacy of practitioners and the number of times practitioners took the licensure examination nor is the Board aware of any research that even suggests a correlation between safe practice and number of times an individual examined. Nevertheless, it is not clear to the Board that any relation that might be revealed would indicate the quality of particular nursing education programs. To the Board's knowledge, all states consider only first time test takers when evaluating the success of their nursing education programs.

   The Hospital and Healthsystem Association of Pennsylvania (HAP) wrote in support of increasing the accountability of nursing education programs for achieving increased pass rate standards, but expressed concern that the regulations might have the unintended effect of negatively impacting the supply of nurses in this Commonwealth. The Board believes that the increased pass rate standard will increase the number of nurses licensed in this Commonwealth. By way of illustration, the Board compared the number of nurses eligible for licensure from programs with pass rates below 80% during the October 1, 2006, through September 30, 2007, period to the number of nurses eligible for licensure if those programs met the 80% pass rate. During this period of time, 1,962 students from nursing programs with a pass rate below 80% took the examination and 1,422 passed the examination. If, during this same period of time, 1,962 students from nursing programs with a pass rate of 80% took the examination, 1,570 would have passed, resulting in an increase of 148 new nurses who could be licensed in this Commonwealth.

   HAP suggested that the Board amend its rulemaking to provide a 3-year phase in of the 80% standard to give programs more time to meet the upgraded standards. HAP opined that ''it generally takes considerable effort--often over several years time--to assess what . . . issues [have resulted in low pass rates], develop plans for correction, implement changes, and monitor those changes to evaluate effectiveness.'' As noted previously, the Board has, for at least 10 years, notified all programs with pass rates between 60.1% and 80% of the Board's intention to raise the minimum pass rate. Also, it has requested that the programs assess the factors contributing to the low pass rate and address those factors. The Board does not believe that programs need more time to implement changes; rather, by virtue of the new regulation, programs that do not assess shortcomings and implement changes will be faced with the consequence of being placed on provisional approval status. Once on provisional status, the programs will be subject to a timetable for assessing the programs' weaknesses and improving the program so that at least 80% of program graduates are prepared to pass the licensure examination and begin their careers as nurses.

   HAP also suggested that the Board determine a program's pass rate based on a 3-year average. The vast majority of states evaluate programs based on annual NCLEX performance. Several states consider NCLEX performance of program graduates over more than 1 year.

   Delaware Board of Nursing, which uses an 80% pass rate standard, places a program on provisional approval status if pass rates are below 80% for 2 consecutive years. Looking at examination results for this Commonwealth's programs for the examination year October 1, 2005, through September 30, 2006, 16 programs failed to achieve a minimum 80% pass rate and would be subject to provisional approval status. Using Delaware's standards, that is, schools below the 80% minimum in the 2005-2006 year and still below the 80% minimum in the October 1, 2006, through September 30, 2007, examination year, 15 programs would be subject to provisional approval status.

   Georgia Board of Nursing also uses 80% as the minimum pass rate standard. If a program fails to meet the 80% standard in any given year, the Board will consider a 4-year average of the program's pass rates. Applying Georgia's standard to this Commonwealth, 16 programs failed to achieve the minimum 80% standard in the 2005-2006 examination year. Seventeen programs failed to achieve the minimum 80% standard when all 4 years of examination score data, from 2003-2004 through 2006-2007, were considered.

   North Carolina Board of Nursing uses 95% of the National pass rate as its minimum pass rate standard, but uses a 3-year average to determine a program's pass rate. Using North Carolina's system, 21 programs would fall below the minimum pass rate in the 2005-2006 examination year, as compared to 16 that would fall below the proposed Pennsylvania standard in the same year. In addition, using the 3-year average, over 16 programs would be subject to provisional approval status in the 2005-2006 examination year under the North Carolina Standard.

   Maryland Board of Nursing uses 90% as the minimum pass rate standard. Applying Maryland's rules in this Commonwealth during the 2005-2006 examination year, 47 programs would have been placed on ''warning status'' and given only 1 year to improve performance. Using the model proposed by the Board, only 16 programs would have been placed on provisional status and given 2 years to improve performance.

   In short, the Board is aware that there are different approaches by the states to calculate and evaluate pass standards as one method of evaluating the effectiveness of the state's nursing education programs. Remediation programs also vary from state to state. The Board considered other states' regulatory schemes. The Board is satisfied that its proposal, which emphasizes early intervention with programs experiencing difficulty and the emphasis on a plan to ensure improvement so that programs can be returned to full approval status, will be an effective method to improve the quality of nursing education programs in this Commonwealth.

   Regarding HAP's comments about the licensure examination and test plan, the Board is confident that the examination, which is used in by every Board of Nursing in the United States, has not placed graduates of Pennsylvania nursing programs in a negative position in comparison with their colleagues in other states. Changes to the test plan and passing standard occur through a rigorous scientific methodology in accordance with psychometric principles at most once every 3 years. The 2005 RN Practice Analysis conducted by the National Council of State Boards of Nursing demonstrated that the RNs surveyed ''worked an average of 3.64 months as RNs'' and not the 6 to 12 months asserted. In addition, approximately one-third of this Commonwealth's programs experienced an increase in their pass rate in the October 2006-September 2007 reporting period as compared to the prior reporting period. Of this Commonwealth's programs whose pass rates declined in the October 2006-September 2007 reporting period, approximately one-third experienced a decline in their pass rate of less than 2 percentage points.

   HAP next questioned whether the Board would have sufficient resources to monitor and assist programs on provisional approval status. The Board is committed to having appropriate resources available for monitoring all nursing education programs with the intent to assure regulatory compliance and overall program quality provided in the education of nurses in this Commonwealth.

   HAP next recommended that the Board use the pass rate only as a first-level screening tool to determine whether any nursing education program should be placed on provisional status, and that the Board ''fully consider other data'' before placing a program on provisional status. Specifically, HAP suggested that the Board consider the pass rate of program graduates who tested in another state. When a candidate applies for licensure by examination, the candidates must provide on the application the Program Code assigned by NCSBN to the nursing education program. This program code identifies the program the candidate graduate from and their results are reported to that respective program. The Board already considers the test results reported to each program, which includes program graduates who tested in another state.

   HAP also suggested the Board consider whether the examination year test results included a mixing of cohort groups. The Board is not clear why this is a concern, considering HAP's suggestion to average 3 years of pass rates, which would clearly involve mixing cohort groups. The Board does not have a method to track individual cohorts from programs, nor does the Board require individuals to test at any particular time. The Board does not believe that having examination year results include students from several cohorts decreases the validity of the pass rate data. HAP next suggested that the Board consider the diversity of the program's student population. The Board is not clear how HAP foresees a regulatory scheme to address any relationship that might exist between the diversity of a program's student population and NCLEX performance.

   Next, HAP suggested that the Board recalculate the pass rate of programs by considering second-time pass rate success due to generational differences and approaches to the examination. First, the Board has no way to correlate the age of the test takers with their scores. Second, the NCLEX has been a computer based examination for 14 years. The Board knows of no basis for HAP's suggestion that some students view the first time taking of the NCLEX as a practice examination. The cost of the examination is around $200; the Board has not received reports that students view it as a ''practice'' examination.

   HAP then suggested that the Board should consider the number of students that sat for the examination. The Board is aware that if only a small number of students sit for the examination, even a small number of failures will affect the pass rate. However, percentage-based assessment inherently treats large and small programs with equality. The Board's education advisors consider the size of the graduating class and the program's historic pass rate performance when working with a program to improve performance.

   Finally, HAP suggested that the Board consider the retention rates of the programs. HAP stated that some schools have implemented periodic testing throughout the program to ''weed out students before graduation to ensure that the school attains the NCLEX pass rate standards.'' Students pay tuition to the program with the intention of gaining an education that will permit them to successfully pass the NCLEX, obtain licensure and work in their chosen profession. The Board does not agree with HAP's implication that a program should continue to take tuition payments from students in a nursing education program when the program has every indication that the student will not be able to pass the licensure examination and practice the profession. In fact, the Board believes that a program that does so is doing a disservice to the student, who should either be given the tools to succeed in the program or encouraged to choose another course of study that will enable the student to find employment upon graduation. By increasing the minimum pass rate standard, the Board is requiring nursing education programs to be more responsible and accountable to their students by providing a high quality educational program that will ultimately lead graduates to the practice of the profession.

   Next, HAP suggested that there may be serious unintended consequences of the Board's proposal, including having nursing programs institute more stringent admission criteria resulting in the acceptance of fewer nursing students, particularly fewer minority students, into the programs; limiting the pool of applicants for admission by excluding those that don't perform as well on standardized tests such as the SAT; limiting the number of diverse students because demographically, certain populations of students don't perform well on standardized tests; and encouraging schools to ''weed out'' students before graduation. HAP suggested that these unintended consequences would exacerbate the current nursing shortage. The Board disagrees with HAP's predictions. It is the responsibility of the school to determine its admissions criteria. Programs should provide sound, ongoing evaluation for students' progression through the program to ensure that graduates will be prepared to enter the workforce.

   HAP also suggested exploring the implementation of a monitoring program that could be used to assist at-risk programs. For at least the past 10 years, the Board has been notifying programs that the Board has identified as at-risk and offering suggestions and assistance to these programs in identifying and correcting factors that might have led to substandard pass rates. A monitoring program has been in place for many years.

   HAP next suggested that the requirement that nursing programs apprise applicants and students whenever the program's approval status changes would place an operational burden on schools. The Board believes that programs must be responsible for and accountable to their students. Moreover, the Board believes that prospective students and current students should be aware of the approval status of programs they are intending to enroll in or in which they are currently enrolled. The Board purposefully left to the programs the means by which this notification would be made to give programs flexibility. At the request of IRRC, the Board will clarify the means of notification. The Board does not believe that the requirement places an undue burden on nursing education programs.

   Finally, HAP proposed that programs be given 3 years to correct deficiencies. The Board stands by its proposal that programs be required to correct deficiencies in 2 years, and has allowed that an extension of time may be granted if a program is showing progress toward correction.

HPLC Comments

   The HPLC submitted nine comments to the Board. HPLC asked if a program that had been removed from the approved list could reapply to be placed on the approved list and the procedure the program would follow. A program that has been removed from the approved list would be treated the same as any other program that does not have Board approval, that is, as if a new program were being established under § 21.51 (relating to establishment). If approved, the program would be placed on initial approval status, as set forth in § 21.33 (relating to types of approval).

   The HPLC noted that the Board used the numeral ''2'' in §§ 21.33a(g) and 21.162a(g) (relating to types of approval). The Board's usage appears to be consistent with § 4.11 of the Pennsylvania Code & Bulletin Style Manual. The Board is confident that if its usage is erroneous, the editors of the Pennsylvania Code will make an appropriate correction.

   The HPLC suggested that the informal process to correct deficiencies should be separated from the formal process for removal in §§ 21.33a and 21.162a. The Board has deleted the last part of subsections (a), (d) and (e) from these subsections, which seem to mingle the informal process and the process when a program is on provisional approval with the removal process. As the entire section relates to failure to comply with standards, the last part of subsections (a), (d) and (e) is more properly placed in its own subsection. The Board has created a new subsection (k) for the provision.

   The HPLC noted that Wilson College had commented on the proposal during the predraft comment period and requested that certain restrictions, such as only daytime programming, be placed on schools on provisional approval status. The Board noted in the preamble to proposed rulemaking that the Board already imposes restrictions as appropriate. The HPLC asked what other restrictions the Board might impose and how they might improve pass rates. The Board has imposed a variety of restrictions, such as requiring a program to institute a program of student testing to identify deficiencies in the curriculum, collecting data to correlate preadmission GPA and student performance, raising the GPA admission standard and instituting tutoring programs for at-risk students. Identifying deficiencies in the curriculum allows a program to make targeted improvements in teaching methodology or personnel, or both, correlating preadmission GPA to student performance allows a program to determine if remedial programs for students will improve NCLEX performance.

   The HPLC next asked for examples of the additional reports that may be required of a program on provisional approval status under §§ 21.33a(e) and 21.162a(e). Different reports may be required depending on the status of the program's self-assessment of the underlying causes for failing to meet the regulations and the educational advisor's identified deficiencies. Reports might include detail from the program's systematic evaluation plan, such as curriculum plans, admission and progression policies and competency determination tools.

   The HPLC noted that §§ 21.33a(g) and 21.162a(g) provide for a 2-year period for a program to become compliant with the Board's regulations. HPLC asked whether the Board had considered a period of time for correction of deficiencies. The Board has used the terms come into compliance or become compliant and correct deficiencies interchangeably. The same time period applies. The Board has rewritten these subsections for clarity.

   The HPLC's next comment related to a draft copy of the rulemaking that was corrected by the Pennsylvania Code and Bulletin editors prior to publication as proposed rulemaking.

   The HPLC asked at what specific points in time a program could appeal the Board's decision that a program has a deficiency. Specifically, the HPLC asked if there could be an appeal before formal action was taken and whether the restrictions in §§ 21.33a(g) and 21.162a(g) were appealable. Finally, the HPLC asked the Board to enumerate the appeals process in the regulation. Sections 21.33a(j) and 21.162a(j) provide that a program may appeal the decision to place the program on provisional status in accordance with 1 Pa. Code § 35.20 (relating to appeals from actions of the staff). This section of the General Rules of Administrative Practice and Procedure (GRAPP) applies to appeals from actions taken by administrative agency staff, such as actions of the Board's nursing education advisors. The section allows a party to appeal the action of staff within 10 days after service of notice of the action by the staff. The appeal would be filed with the Board. The GRAPP contemplate the appeal of all staff action; therefore, the Board believes that a program could appeal any restriction placed on the program by Board staff. These sections have been expanded to further explicate the appeal process provided by the GRAPP.

   Finally, the HPLC asked why the proposal did not require notice to current students of the changes in approval status or provide students the opportunity to transfer to another program with full approval status. Sections 21.33(b) and 21.162(b) require a program to notify applicants and students whenever the program's approval status changes. The provisions assume that the students know the status of the program upon enrollment. The Board does not have any authority to ''provide students the opportunity to transfer to another program.'' Students, as consumers of educational services, are free to apply to other programs and, if accepted, transfer, at any time.

IRRC Comments

   IRRC first addressed the clarity of §§ 21.31(d) and 21.162(c), noting that the word ''approval'' was confusing. The Board's nursing education advisors are authorized to move a program from initial approval status to full approval status. In addition, the Board's nursing education advisors conduct the compliance review and monitor the performance and improvement plan processes on behalf of the Board. Only the Board may grant initial approval status to a program or remove a program from the approved list. Based on comments received, the Board has amended this section to include, as a function solely of the Board, the authority to extend the 2-year maximum period for the correction of deficiencies. These sections have been rewritten for clarity. In addition, a typographical error was detected by IRRC and corrected.

   IRRC next suggested that the Board provide a time period for the notice programs are required to give to applicants and students under §§ 21.33(b) and 21.162(b). The Board will add a 30-day time period for the notice. In addition, the Board will add direction concerning the methods of acceptable notice, as requested by IRRC.

   IRRC suggested that §§ 21.33a(a) and 21.162a(a) specifically provide that the Board provide written notice to the program describing the reported deficiencies. The Board had anticipated that written notice would be provided and has added this provision. IRRC also asked, regarding the notice provision in subsections (b), whether this was a different notice than that in subsection (c). Depending on the circumstances, the education advisors may provide one notice or separate notices. In some cases, multiple notices may be provided. The process is intended to remain informal to permit the programs to address concerns without a formal, public proceeding. To this end, the Board seeks to encourage a collegial flow of information between the program director and the educational advisors.

   IRRC asked the Board what criteria or factors the Board would consider in making the determination to place a program on provisional approval status. Section 21.33(a)(3), and its counterpart for LPN programs, § 21.162(a)(3), provide that the Board may exercise its discretion to place a program on provisional approval status if the program does not meet the standards of the subchapter. The standards set forth in the subchapter are the criteria or factors that the Board considers. The Board also considers the steps a program takes to return to compliance.

   IRRC asked whether the provisions of subsections (c) and (g) were in conflict. The Board has amended subsection (g) to clarify that only the Board, and not the education advisors, may extend the correction period beyond 2 years.

   IRRC requested that the Board provide that its education advisors will provide written notice and requests in subsections (d) and (e). The Board anticipated that these requests would be in writing and has added the requested provisions.

   Many of the questions raised by IRRC under its question number 4 have been addressed in response to other commentators' concerns. IRRC also asked if the Board had any information on how many programs will be able to reach the 80% standard in 2 years, and what kind of changes would be required to meet the standard. As noted previously, programs with a pass rate between 60.1% and 80% have been receiving communication and assistance from the Board for the past 10 to 12 years. In answering IRRC's question, the Board considered the pass rates for the Commonwealth's nursing education programs for the examination years 2003-2004, 2004-2005, 2005-2006 and 2006-2007.

Exam Year PN programs below 75% PN programs 75.1-- 79.9% RN programs below 75% RN programs 75.1-- 79.9%
2003-2004 2 3 12 13
2004-2005 0 2 6 9
2005-2006 2 2 7 9
2006-2007 4 2 19 11

   Of the RN programs with pass rates below 80% for the 2003-2004 examination year, 15 programs increased their pass rate to over 80% in the 2004-2005 examination year, an additional five increased their pass rate to over 80% by the 2005-2006 examination year, and all but one of the programs was in compliance with the 80% pass rate by the 2006-2007 examination year. Based on this historic data, it appears that virtually all RN programs will be able to reach the 80% standard within 2 years.

   Of the LPN programs with pass rates below 80% over the 4 examination years considered, only one was unable to improve its pass rate to above 80% within 1 examination year; that program improved its pass rate to over 90% in the second year after initiating corrective measures. Based on this historic data, it appears that all LPN programs will be able to reach the 80% standard within 2 years.

   Only three programs have had pass rates below 80% for 4 consecutive examination years. These programs include two baccalaureate degree programs (with rates of 60%--74.42%--74.24%--74.58% for a total of 183 students sitting for examination over the 4 year period, and 50%--76.92%--47.37%--47.52% for a total of 61 students sitting for examination over the four year period), and one diploma program (with rates of 75%--64.29%--64%--63.16% for a total of 101 students sitting for examination over the 4 year period). The Board anticipates that the second BSN program and the diploma program will need to make significant improvements across their programs to meet the 80% standard. Because programs have never been subject to the 80% pass rate or a timetable for coming into compliance with the new pass rate, it is impossible to anticipate whether all three of these programs would be able to reach the goal.

   IRRC next noted that HAP recommended two additional approaches to meeting the 80% standard; first, phasing in the standard over a 3-year period and second, using a 3-year average to calculate the pass rate. As noted previously, the Board has notified programs for 10 years that a change would be coming to increase pass rates. The Board does not believe that programs need another year of notice that pass rate standards are increasing. The Board fully discussed the 3-year average suggestion in its response to HAP's comments. It is also interesting to note that two of the three programs identified previously would be placed on provisional approval status after 1 year under HAP's recommendation, and that all three of the programs would be placed on provisional approval status after 2 years under HAP's recommendation. The Board does not anticipate that its approach will be grossly over inclusive.

   IRRC commented that it agreed with other commentators who had suggested that the Board consider examining the success rate of second time test takers and, if there were a question about the nexus between the program and a second time test taker's success, the Board could require that applicants report and document additional course work. The Board's statutory authority is to approve, and disapprove, nursing education programs. Even if the Board reviewed and analyzed information about the study habits of applicants for reexamination, it is not clear that the Board could distinguish what made an applicant successful or unsuccessful on reexamination. Moreover, it is important to note that all states base the determination of an educational program's effectiveness on the pass rate of first time test takers.

   Regarding removal from the approved list, IRRC, following up on a question from HPLC, asked if in the past any programs had been removed from the approved list and later inquired about submitting an application for reinstatement. The Board has never removed a program from the approved list. Should a program be removed, it could reapply for initial approval by the Board.

   IRRC next questioned the responsibility of the controlling institution to students set forth in §§ 21.34(b) and 21.166(b). This provision requires the controlling institutions to maintain support from the program until currently enrolled students have graduated or been placed in other programs. The provisions that make the controlling institution responsible for students in the institution's program are found in § 21.41(c) (relating to notification; completion of program; records) for professional nursing education programs and in § 21.173(c) (relating to discontinuance or interruption of a program of a practical nursing education programs).

   Finally, IRRC suggested that the Board include in its regulation a reference to section 6.2(a) of the RN Law (63 P. S. § 216.2(a)). Section 6.2(a) of the RN Law provides that a students who obtained part of the nursing education from a program that was removed from the proposed list shall be granted credit for that course work by another program into which the student transfers. The Board has referenced this section of the RN Law in § 21.34(d). The LPN Act does not include a parallel provision for practical nursing students because practical nursing programs take less than a year to complete.

Fiscal Impact and Paperwork Requirements

   The final-form regulations will have no adverse fiscal impact on the Commonwealth or its political subdivisions. The final-form regulations will impose only minimal additional paperwork requirements upon the Board, and none upon any political subdivisions. Nursing education programs may incur additional costs in conforming to the regulations.

Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 9, 2008, the Board submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 344 to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.

   Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.

   Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on March 18, 2009, the final-form rulemaking was deemed approved by the HPLC. On March 18, 2009, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on March 19, 2009, and approved the final-form rulemaking.

Additional Information

   Additional information may be obtained by writing to Ann Steffanic, Board Administrator, State Board of Nursing, P. O. Box 2649, Harrisburg, PA 17105-2649.

Findings

   The Board finds that:

   (1)  Public notice of intention to adopt the administrative amendments adopted by this order was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder 1 Pa. Code §§ 7.1 and 7.2.

   (2)  A public comment period was provided as required by law and all comments were considered in drafting this final-form rulemaking.

   (3)  The amendments made to the final-form rulemaking do not enlarge the original purpose of the proposed rulemaking as published at 38 Pa.B. 344.

   (4)  These amendments to the regulations of the Board are necessary and appropriate for the regulation of the practice of RNs and LPNs in this Commonwealth.

Order

   The Board therefore orders that:

   (a)  The regulations of the Board, 49 Pa. Code Chapter 21, are amended by amending §§ 21.1, 21.31, 21.33, 21.34, 21.141, 21.162; by adding §§ 21.33a, 21.33b, 21.162a, 21.162b and 21.166; and by deleting § 21.26 to read as set forth in Annex A, with ellipses referring to the existing text of the regulation.

   (b)  The Board shall submit a copy of Annex A to the Office of the Attorney General and the Office of General Counsel for approval as required by law.

   (c)  The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

   (d)  The regulations shall take effect immediately upon publication in the Pennsylvania Bulletin.

ANN L. O'SULLIVAN, Ph.D., FAAN, CRNP,   
Chairperson

   (Editor's Note:  For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 1770 (April 4, 2009).)

   Fiscal Note:  Fiscal Note 16A-5123 remains valid for the final adoption of the subject regulations.

Annex A

TITLE 49.  PROFESSIONAL AND VOCATIONAL STANDARDS

PART I.  DEPARTMENT OF STATE

Subpart A.  PROFESSIONAL AND OCCUPATIONAL AFFAIRS

CHAPTER 21.  STATE BOARD OF NURSING

Subchapter A.  REGISTERED NURSES

GENERAL PROVISIONS

§ 21.1.  Definitions.

   The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

*      *      *      *      *

   Examination year--The period beginning on October 1st of a year through September 30th of the following year.

*      *      *      *      *

LICENSES

§ 21.26.  (Reserved).

APPROVAL OF NURSING EDUCATION PROGRAMS

§ 21.31.  Surveys; list of approved nursing education programs.

   (a)  Survey visits are made of basic nursing programs conducted in hospitals, colleges or universities of exchange visitor programs and of cooperating agencies. In this section, ''cooperating agency'' means an educational institution or health care delivery system which cooperates with the controlling institution. The survey report is presented to the Board and a written report of recommendations or requirements, or both, is sent to the school, college or university.

   (b)  Classified lists of approved schools of nursing and of exchange visitor programs are compiled and published annually and are made available for distribution.

   (c)  A list of approved cooperating agencies that provide educational programs for schools of nursing is compiled and published annually and is made available for distribution.

   (d)  For purposes of activities relating to the approval and status of nursing education programs, the term ''Board'' used in this subchapter may mean the Board's educational advisors appointed under section 2.1(i) of the act (63 P. S. § 212.2(i)). Only the Board may, by a majority vote, confer initial approval status on a proposed nursing education program, extend the maximum 2-year period for correction of deficiencies or remove a program from the approved list.

§ 21.33.  Types of approval.

   (a)  The Board grants the following types of approval to nursing education programs:

   (1)  Initial. The Board may grant initial approval to a new nursing education program, with evidence that the standards of this subchapter are being met, for a period of time necessary to evaluate the results of the licensing examination taken by the first cohort of graduates. A program will not be placed on full approval status until it has graduated its first class and the class has achieved an acceptable rate of passing the National licensure examination, as set forth in § 21.33b (relating to minimum rate for graduates of nursing education programs to pass the National licensure examination). A program on initial approval status that fails to achieve an acceptable rate of passing the National licensure examination upon graduation of its first class will be placed on provisional approval status.

   (2)  Full. The Board will place on full approval a nursing education program which attains and maintains the standards of this subchapter.

   (3)  Provisional. The Board may place on provisional approval a nursing education program not meeting the standards of this subchapter. A nursing education program on full approval status will be placed on provisional approval status if the program fails to meet the provisions of § 21.33b.

   (b)  A nursing education program shall notify applicants for admission of the program's approval status and, within 30 days of a change of status, shall notify applicants and students by electronic mail or first class mail that the program's approval status has changed. The program shall provide the Board with a copy of the notice sent to applicants and students. A program shall provide additional notice to applicants and students at the direction of the Board.

§ 21.33a.  Failure to comply with standards.

   (a)  If the Board receives information suggesting that a nursing education program has not maintained the standards of this subchapter, the Board will validate the information and will notify the program, in writing, of the alleged deficiency. The Board may request information from the program or conduct an announced or unannounced site visit before notifying the program of the alleged deficiency. The Board may informally resolve any deficiency.

   (b)  The Board will notify a program, in writing, that the program will be placed on provisional approval status.

   (c)  The Board will notify a program on provisional approval status, in writing, of the deficiencies and the amount of time that will be allowed for correction of the deficiencies that resulted in the program's placement on provisional approval status. The Board may extend the time period for correction of deficiencies at its discretion if the program is making demonstrable progress toward the correction of deficiencies. If additional deficiencies are identified, the existing provisional period may be extended at the discretion of the Board.

   (d)  The Board may place restrictions on a nursing education program on provisional approval status as deemed necessary by the Board to bring the program into compliance with this subchapter and will notify the program, in writing, of the restrictions.

   (e)  The Board may require that a nursing education program on provisional approval status prepare and submit additional reports and will notify the program, in writing, of the reports required.

   (f)  The Board may make announced or unannounced site visits to a nursing education program on provisional approval status.

   (g)  A period of 2 years will be the maximum time period allowed for the correction of deficiencies that returns the program to compliance with the regulations. A program may petition the Board for extension of the maximum period and the Board may, by majority vote, extend the period for good cause demonstrated by the program.

   (h)  If the standards of this subchapter are met within the designated time, the nursing education program will be removed from provisional approval status. The Board will notify the program in writing of this action.

   (i)  If the standards of this subchapter are not met within the designated time, the nursing education program will be removed from the approved list as provided in § 21.34 (relating to removal from approved list).

   (j)  Within 10 days of service of a request under subsection (a) or (e) or notice of the imposition of a restriction under subsection (d), a nursing education program may appeal the action of the staff as provided in 1 Pa. Code § 35.20 (relating to appeals from actions of the staff).

   (k)  The failure of a program to cooperate with the Board by failing to provide requested information or reports, by refusing or limiting a site visit, or by refusing to adhere to restrictions mandated by the Board will be considered a violation of the standards for nursing education programs and may result in immediate referral of the program to the prosecution division to consider formal action to remove the program from the approved list as provided in § 21.34.

§ 21.33b.  Minimum rate for graduates of nursing education programs to pass the National licensure examination.

   A nursing education program shall prepare its graduates to pass the National licensure examination at a rate at least equal to the minimum rate set by the Board. The minimum rate for graduates to pass the National licensure examination are as follows:

   (1)  A nursing education program shall achieve and maintain a minimum pass rate of 60% or more of its first-time examinees during an examination year.

   (2)  Beginning on October 1, 2009, a nursing education program shall achieve and maintain a minimum pass rate of 70% or more of its first-time examinees during an examination year.

   (3)  Beginning on October 1, 2010, a nursing education program shall achieve and maintain a minimum pass rate of 80% or more of its first-time examinees during an examination year.

§ 21.34.  Removal from approved list.

   (a)  The Board may remove a nursing education program from the approved list in accordance with the following procedures if the program fails to meet and maintain minimum standards, including the minimum passing rates on the National licensure examination, as established by this subchapter.

   (1)  The Board will give a nursing education program notice of its intent to remove the program from the approved list.

   (2)  The notice of intent to remove a program from the approved list will set forth the alleged violations of the standards for nursing education programs.

   (3)  A program served with notice of intent to remove will be given 45 days in which to file a written answer to the notice.

   (4)  The nursing education program will be provided an opportunity to appear at a hearing to demonstrate why approval should not be withdrawn.

   (5)  The nursing education program and the Commonwealth will be provided an opportunity to file post-hearing briefs.

   (6)  The Board will issue a written decision which will set forth findings of fact and conclusions of law.

   (7)  The Board's written decision is a final decision of a governmental agency subject to review under 2 Pa.C.S. § 702 (relating to appeals).

   (b)  If a nursing education program is removed from the approved list, the controlling institution shall provide for the completion of the program for students currently enrolled by placing the students in an approved program.

   (c)  If a nursing education program is removed from the approved list, the controlling institution shall make provision for permanent retention of student and graduate records in conformance with §§ 21.123 and 21.125 (relating to access and use of records; and custody of records).

   (d)  If a nursing education program is removed from the approved list, the program shall give students notice of the protection granted under section 6.2(a) of the act (63 P. S. § 216.2(a)).

Subchapter B.  PRACTICAL NURSES

GENERAL PROVISIONS

§ 21.141.  Definitions.

   The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

*      *      *      *      *

   Examination year--The period beginning on October 1st of a year through September 30th of the following year.

*      *      *      *      *

APPROVAL OF PRACTICAL NURSING PROGRAMS

§ 21.162.  Types of approval.

   (a)  The Board grants the following types of approval to nursing education programs:

   (1)  Initial. The Board may grant initial approval to a new nursing education program, with evidence that the standards of this subchapter are being met, for a period of time necessary to evaluate the results of the licensing examination by the first cohort of graduates. A program will not be placed on full approval status until it has graduated its first class and the class has achieved an acceptable rate of passing the National licensure examination, as set forth in § 21.162b (relating to minimum rate for graduates of nursing education programs to pass the national licensure examination). A program on initial approval status that fails to achieve an acceptable rate of passing the National licensure examination upon graduation of its first class will be placed on provisional approval status.

   (2)  Full. The Board will place those nursing education programs on full approval status which attain and maintain the standards of this subchapter.

   (3)  Provisional. The Board may place on provisional approval a nursing education program not meeting the standards of this subchapter. A nursing education program on full approval status will be placed on provisional approval status if the program fails to meet the provisions of § 21.162b.

   (b)  A nursing education program shall notify applicants for admission of the program's approval status and, within 30 days of a change of status, shall notify applicants and students by electronic mail or first class mail that the program's approval status has changed. The program shall provide the Board a copy of the notice sent to applicants and students. A program shall provide additional notice to applicants and students at the direction of the Board.

   (c)  For purposes of activities relating to the approval and status of nursing education programs, the term ''Board'' as used in this subchapter may mean the Board's educational advisors appointed under section 2.1(i) of the act (63 P. S. § 212.2(i)). Only the Board may, by a majority vote of a quorum, confer initial approval status on a proposed nursing education program, extend the maximum 2-year period for correction of deficiencies or remove a program from the approved list.

§ 21.162a.  Failure to comply with standards.

   (a)  If the Board receives information suggesting that a nursing education program has not maintained the standards of this subchapter, the Board will validate the information and notify the program, in writing, of the alleged deficiency. The Board may request information from the program or conduct an announced or unannounced site visit before notifying the program of the alleged deficiency. The Board may informally resolve any deficiency.

   (b)  The Board will notify a program, in writing, that the program will be placed on provisional approval status.

   (c)  If the Board places a nursing education program on provisional approval status, the Board will notify the program, in writing, of the deficiencies and the amount of time that will be allowed for correction of the deficiencies that resulted in the program's placement on provisional approval status. The Board may extend the time period for correction of deficiencies at its discretion if the program is making demonstrable progress toward the correction of deficiencies. If additional deficiencies are identified, the existing provisional period may be extended at the discretion of the Board.

   (d)  The Board may place restrictions on a nursing education program on provisional approval status as deemed necessary by the Board to bring the program into compliance with this subchapter and will notify the program, in writing, of the restrictions.

   (e)  The Board may require that a nursing education program on provisional approval status prepare and submit additional reports and will notify the program, in writing, of the reports required.

   (f)  The Board may make announced or unannounced site visits to a nursing education program on provisional approval status.

   (g)  A period of 2 years will be the maximum time period allowed for the correction of deficiencies that returns the program to compliance with the Board's regulations. A program may petition the Board for extension of the maximum period and the Board may, by majority vote, extend the period for good cause demonstrated by the program.

   (h)  If the standards of this subchapter are met within the designated time, the nursing education program will be removed from provisional approval status. The Board will notify the program in writing of this action.

   (i)  If the standards of this subchapter are not met within the designated time, the nursing education program will be removed from the approved list as provided in § 21.166 (relating to removal from approved list).

   (j)  Within 10 days of service of a request under subsection (a) or (e) or notice of the imposition of a restriction under subsection (d), a nursing education program may appeal the action of the staff as provided in 1 Pa. Code § 35.20 (relating to appeals from actions of the staff).

   (k)  The failure of a program to cooperate with the Board by failing to provide requested information or reports, by refusing or limiting a site visit, or by refusing to adhere to restrictions mandated by the Board will be considered a violation of the standards for nursing education programs and may result in immediate referral of the program to the prosecution division to consider formal action to remove the program from the approved list as provided in § 21.166 (relating to removal from approved list).

§ 21.162b.  Minimum rate for graduates of nursing education programs to pass the National licensure examination.

   A nursing education program shall prepare its graduates to pass the National licensure examination at a rate at least equal to the minimum rate set by the Board. The minimum rate for graduates to pass the National licensure examination are as follows:

   (1)  A nursing education program shall achieve and maintain a minimum pass rate of 60% or more of its first-time examinees during an examination year.

   (2)  Beginning on October 1, 2009, a nursing education program shall achieve and maintain a minimum pass rate of 70% or more of its first-time examinees during an examination year.

   (3)  Beginning on October 1, 2010, a nursing education program shall achieve and maintain a minimum pass rate of 80% or more of its first-time examinees during an examination year.

§ 21.166.  Removal from approved list.

   (a)  The Board may remove a nursing education program from the approved list in accordance with the following procedures if the program fails to meet and maintain minimum standards, including the minimum passing rates on the National licensure examination, as established by this subchapter.

   (1)  The Board will give a nursing education program notice of its intent to remove the program from the approved list.

   (2)  The notice of intent to remove a program from the approved list will set forth the alleged violations of the standards for nursing education programs.

   (3)  A program served with notice of intent to remove will be given 45 days in which to file a written answer to the notice.

   (4)  The nursing education program will be provided an opportunity to appear at a hearing to demonstrate why approval should not be withdrawn.

   (5)  The nursing education program and the Commonwealth will be provided an opportunity to file posthearing briefs.

   (6)  The Board will issue a written decision which will set forth findings of fact and conclusions of law.

   (7)  The Board's written decision will be a final decision of a governmental agency subject to review under 2 Pa.C.S. § 702 (relating to appeals).

   (b)  If a nursing education program is removed from the approved list, the controlling institution shall provide for the completion of the program for students currently enrolled by placing the students in an approved program.

   (c)  If a nursing education program is removed from the approved list, the controlling institution shall make provision for permanent retention of student and graduate records in conformity with §§ 21.233 and 21.234 (relating to custody of records; and access and use of records).

[Pa.B. Doc. No. 09-733. Filed for public inspection April 24, 2009, 9:00 a.m.]

   



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