NEW YORK STATE DEPARTMENT OF HEALTH CLINICAL LABORATORY EVALUATION PROGRAM
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- Beatrix Waters
- 7 years ago
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1 The Proposed General Systems Standards were circulated for comment on October 9, The announcement and copies of the proposed standards with a crosswalk were sent to NYS-permitted facilities that held or were in application for a permit (facilities). This distribution was by to the facility and laboratory contact person s address. The documents were also posted to the CLEP website. The comment period ended November 30, There were 14 commenters from regulated parties and coalitions with 25 comments. Modifications and clarifications to the General Systems Standards have been made based on the comments received. We appreciate your comments and recommendations. The standards with the changes described below will be adopted with an effective date of January 1, Director Sustaining Standard of Practice 3 (DIR S3): Director Responsibilities A determination as to whether the director has adequately fulfilled the responsibilities indicated in a-n of this standard will be based on an assessment of laboratory compliance with department requirements. While certain of these responsibilities may be delegated to qualified individuals, such delegation must be in writing. Notwithstanding such delegation, the director remains ultimately responsible for monitoring that these responsibilities have been met and for the oversight of all laboratory operations. The director shall: a) provide oversight of all aspects of the laboratory s quality management system to ensure conformance to requirements described in the Quality Management System chapter of these Clinical Laboratory Practice Standards; b) provide effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory; c) ensure that qualified personnel are employed including, where applicable that staff are not engaged in practices limited by license or beyond the scope of licensure; and by defining the qualifications and responsibilities of all laboratory technical staff and documenting training and/or competency; d) provide continuing educational to laboratory technical staff that is relevant to laboratory medicine; 1
2 e) ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills; f) specify in writing the technical and administrative responsibilities and duties of all laboratory personnel, including assistant directors designated in the permit application(s) materials submitted to the Clinical Laboratory Evaluation Program. The director is responsible for competency assessment of assistant directors and direct-report supervisors. Documentation of assessments must be performed annually and whenever new systems are introduced. Remedial steps must be documented when staff do not perform as expected; g) promote a safe laboratory environment for personnel and the public; h) ensure that an approved procedure manual is available to all personnel; i) monitor all work performed in the laboratory to ensure that medically reliable data are generated; j) assure that the laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed; k) provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient interpretation; l) ensure that the laboratory is enrolled in the Department s proficiency testing program, or a New York State defined equivalent, for the testing performed and that the laboratory adheres to the program s Department s administrative and technical requirements and for all tests with no available New York State proficiency test or equivalent, ensure that the laboratory adopts an alternate method to verify test accuracy and reliability; m) select all reference laboratories; 2
3 n) maintain an effective working relationship with applicable accrediting and regulatory agencies, administrative officials, and the medical community; and o) effectively implement a plan of correction to deficiencies identified. Comment 1: Indicate that equivalent programs are any CMS approved PT programs RESPONSE: Not all modules of a CMS-approved proficiency test provider have been deemed equivalent to the New York State proficiency testing program(s), therefore the suggestion to modify the revision would not be accurate. The proposed standard remains unchanged. A list of modules deemed to be equivalent to the New York State proficiency testing program is available on our website at 3
4 Human Resources Sustaining Standard of Practice 2 (HR S2): Personnel Records Laboratory management shall maintain records of the relevant licensure, educational and professional qualifications, training and experience, continuing education, dates of employment, and competence of all personnel for the duration of employment and six years thereafter. Duties and qualifications for laboratory supervisors and cytology supervisors are described 10NYCRR Part 58. Requirements for licensure through the New York State Education Department are available at Licensure is not required for individuals performing testing for non-medical purposes, such as parentage/identity testing or forensic toxicology, or for individuals employed as technicians, technologists or cytotechnologists in out-ofstate laboratories; however, these individuals must continue to meet the education and experience requirements in 10NYCRR Subpart Laboratories located in New York State must maintain copies of the registration license or limited permit license issued by the New York State Education Department for all technical personnel. Documentation required for directors and assistant directors is a copy of their New York State Certificate of Qualification. For out-of-state laboratories, diplomas, resumes, and transcripts, and/or official letters from an institution of higher education indicating board eligibility or attesting to the highest level of learning achieved; letters from former employers; or other records should be maintained to establish that education and experience requirements have been met. Individuals educated in a college or university outside the United States should refer to the CLEP Program Guide for a description of acceptable credentials evaluation policies. Comment 1: Regarding the proposed guidelines, I find this statement a bit confusing: For out-of-state laboratories, diplomas, resumes, and transcripts, and/or official letters from an institution of higher education indicating board eligibility or attesting to the highest level of learning achieved; letters from former employers; or other records should be maintained to establish that education and experience requirements have been met. I would like to offer the opinion that the need to have transcripts on file, in addition to a copy of the diploma, seems excessive. I graduated with a BS in Medical Technology in I do not see how my transcript would demonstrate my capabilities when I have 38 years of experience. I am sure there are others in the same situation. Thank you for considering the suggestion to make this requirement one that affects new graduates. Comment 2: Guidance now states that for out of state labs a diploma, resume and transcripts must be maintained. Recommend this be changed to "diploma and/or transcript if appropriate major is not indicated on diploma. Comment 3: [We require] clarification for the proposed guidance "For out-of-state laboratories, diplomas, resumes, and transcripts, andlor official letters from an institution of higher education indicating board eligibility or attesting to the highest level of learning achieved, letters from former 4
5 employers; or other records should be maintained to establish that education and experience requirements have been met." The current regulation allows any of the above listed documents to be maintained to establish that education and experience requirements have been met. The proposed regulation implies that all three documents (diplomas, resumes and transcripts) are required to support the level of education and experience. Please clarify the intent of the proposed regulation. RESPONSE: The proposed standard will be revised to state For out-of-state laboratories, diplomas, resumes, and/or transcripts; letters from former employers; or other records should be maintained to establish that education and experience requirements have been met. If the diploma does not state the specific academic major, then transcripts will be required. 5
6 Human Resources Sustaining Standard of Practice 3 (HR S3): Supervisor Responsibilities A qualified individual, under the general direction of the laboratory director, shall supervise technical personnel and the reporting of findings, perform tests requiring special scientific skills, and, in the absence of the director, be responsible for the proper performance of all laboratory procedures. An individual who qualifies as a cytology supervisor shall supervise technical personnel in the specialty of cytopathology. Responsibilities of a laboratory supervisor include: a) day-to-day supervision of test performance by testing personnel; b) monitoring laboratory processes to ensure that acceptable levels of analytic performance are maintained, to include review of quality control, instrument and equipment maintenance, and other quality assurance activities; c) assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications; d) in the event of non-conformances, ensuring that results of test examinations are not reported until all corrective actions have been taken and the test system is properly functioning; e) verifying that staff are trained and competent prior to performing testing on patient specimens independently; and, f) verifying that testing personnel are evaluated initially at six months semiannually during the first year of hire, and thereafter annually, as being competent for assigned tasks and that remedial action is performed when staff do not perform as expected. Qualifications for laboratory supervisors and cytology supervisors are described 10NYCRR Part 58. The requirement for the laboratory experience necessary to qualify as a supervisor must be gained subsequent to qualifying as a technologist or cytotechnologist. For individuals not previously qualified under 10 NYCRR Part 58 to serve as a technologist or cytotechnologist, the experience requirement must be met subsequent to obtaining a license issued by the New York State Education Department. Personnel assigned technical supervisory duties must meet the education and experience requirements of a supervisor regardless of the title (i.e., lead tech) the laboratory uses for the position. An individual functioning as a supervisor may delegate, in writing, responsibilities such as quality control review and quality assurance activities to other competent and trained supervisor qualified (as defined in section in Chapter 10 of NYCRR) technical staff, provided supervisory review of these activities is documented (e.g., periodic communications, summary reports, etc.) and non-conforming events are brought to the attention of the supervisor. f) Semiannual is used to describe an event that takes place two times during the calendar year, with the first event taking place in the first six months of the calendar year and the second event in the last six months of the calendar year, and where the interval between events is at least four months and not more than eight months. Comment 1: While the Standard and Guidance defines the requirement of semiannual evaluation during the calendar year, the practice is not obtainable for those employees hired in the later months of the year. RESPONSE: The proposed guidance will be revised to state f) Semiannual is used to describe an event that takes place two times during the first year of hire, with the first event taking place in the first six months of the year and the second event in the last six months of the year, and where the interval between events is at least four months and not more than eight months. 6
7 Reporting Sustaining Standard of Practice 1 (Reporting S1): Report Content Each clinical laboratory or blood bank shall produce a laboratory report and shall supply the original of said report to the physician or other authorized person submitting each specimen for analysis. Each report shall contain the following information: a) patient name or other identification and the name of the person or institution referring the specimen; b) the name under which the laboratory has been issued a permit and its address, except that a d/b/a may be used provided it has been reported to the Department; c) the date, and hour if required, when the specimen was originally collected by the physician or other authorized person; d) the date the specimen was received in the laboratory; e) the test report date; f) specimen source, when appropriate; g) test results, and if applicable, units of measure, reference intervals, or a similar method for identifying abnormal values; h) signature of the qualified person who reviewed, approved and/or diagnosed the case, where required in specialty areas of examination; i) information regarding the condition and disposition of specimens that do not meet criteria for acceptability; j) in the event a specimen is forwarded to another clinical laboratory for examination, the name and address of such laboratory, and the date the specimen was tested and or the date the result was reported; and k) any disclaimers or limitations to testing where required by laboratory validation or NYS approval of test method. e) the test report date should be indicated for each test included on the report, therefore, there may be multiple test report dates if some tests are completed and reported before others included on the requisition. The test report date is the date that the test result is available to the provider. Comment 1: Multiple test report dates for each test on the report creates a confusing and unclear report. In the current electronic environment, documentation of test results is trackable in the LIS as well as dates providers are sent reports. In some cases, providers only want final reports and not 7
8 multiple sends when each test is resulted. Recommend changing guidance to date on report or available in LIS. Comment 2: Date the specimen was tested by reference lab or date the result was reported should either be available on the report or trackable in LIS Comment 3: The inclusion of the test report date for each test is not the standard report format from most LIS systems generating paper laboratory reports. This Guidance seems only applicable to an electronic laboratory report where there is a separate HL7 field for each test result which provides the test report date. For paper laboratory reporting, if all the test results are not released at the same time, than the partial laboratory report(s) will provide the date the test result was available to the provider. In addition, the LIS system usually maintains the date each test was completed and reported; if that information is required at a subsequent period in time. We recommend deletion of the Guidance. RESPONSE: We have been advised by our regional office of the Center for Medicare and Medicaid Services that the test report date for each test must be present on the test report that is issued to the health care provider. Availability of test report date information in the laboratory information system (LIS) does not meet this requirement. 8
9 Records Retention Sustaining Standard of Practice 4 (Retention S4): Specimen Retention Specimens shall be retained so as to be accessible to the laboratory within 24 hours for at least the period set forth below. a) blood film - other than routine - 1 year; b) blood film or histogram - routine - 6 months; c) bacteriology slide on which a diagnosis depends - 1 year; d) cytology slide showing any abnormality - 10 years; e) cytology slide showing no abnormality - 5 years; f) tissue block - 20 years; g) histopathology block - 20 years; h) histopathology slide - 20 years; i) bone marrow biopsy - 20 years; j) cytogenetic slide - 6 years; k) photographic slide of cytogenetic karyotype - 25 years; and l) recipient blood specimens - 1 week stoppered at 1-6 degrees Celsius. (a)(b) A routine blood film is one where no abnormal cells or cell counts are observed or where a blood disorder is not indicated. (b) A routine histogram of an automated differential is one that results as normal or negative and does not imply the need for further analysis. Histograms are considered to be an instrument printout and must therefore be retained for two years as required in Retention S3. It is not required for a laboratory to create or maintain routine blood films if such films are not routinely generated in accordance with the laboratory s approved procedures. (d)(e) includes gynecological, non-gynecological, and FNA (fine needle aspirate) for Cytology Comment 1: [We] addressed the issue of histogram retention to NYS CLEP in Please find below the guidance we have been following since that time. It is contrary to the proposed Guidance. Good afternoon XXXXX, We discussed the issue at our consensus conference this week and the group conclusion with section agreement was that since the laboratory never uses the actual histogram pictures, but can retrieve all raw data including any flags that would be printed on a hard copy, then there would not be any need to save actual histogram pictures either electronically or on paper for six months. We also agreed that since no slides were made on routine specimens with no instrument flags the laboratory would not need to make or save additional slides either. Obviously, SOP would include specific details on what instrument flags would require the preparation of a slide. Storage requirements for any slides actually prepared would be six months for routine and 1 year for other than routine. I hope this answers your question satisfactorily. Comment 2: [We], an ESRD reference laboratory, uses Siemens Advia 2120i instruments for hematology analysis. As a reference laboratory, our hematology samples routinely arrive at least 12 to 24 hours after the blood has been drawn. The age of the EDTA samples means that we do not perform or report any automated differential results on these samples, including samples from our NYS clinics. All of the raw data is archived for the 2120i instruments but not histograms, since we do not report automated differentials. Storing histograms would require a huge amount of additional electronic storage capabilities we do not have and would not be of any use because we do not report differentials. We are requesting that language be added that addresses situations like ours. 9
10 Specifically, adding an additional statement which states that laboratories that do not report automated differentials are not required to save histograms for 2 years. RESPONSE: We have been advised by the federal Center for Medicare and Medicaid Services that histograms are instrument printouts and therefore require a two year retention. Please note that the guidance indicates that It is not required for a laboratory to create or maintain routine blood films if such films are not routinely generated in accordance with the laboratory s approved procedures. Therefore, if a histogram is not routinely performed in the laboratory than there is no requirement for retention. 10
11 Records Retention Sustaining Standard of Practice 5 (Retention S5): Supplies Inventory There shall be an inventory control system for supplies. Appropriate quality records of external services, supplies, and purchased products shall be established and maintained for a period of time as defined in the quality management system. This system should include the recording of lot numbers of all relevant reagents, control materials, and calibrators; the date of receipt in the laboratory; and the date the material is placed in service. All of these quality records shall be available for laboratory management review and shall be retained for at least two years. Comment 1: Please clarify the requirement. The first part of the standard states that quality records..shall be established and maintained for a period of time as defined in the quality management system. However, toward the end of the standard, it reads quality records.shall be retained for at least two year. Please clarify which timeline laboratories must follow. RESPONSE: Guidance has been added to this standard to state The minimum retention period for the supplies inventory records is two years; the laboratory management may define any length of storage greater than two years. 11
12 Quality Assessment Sustaining Standard of Practice 3 (QA S3): Ongoing Verification of Examination Accuracy For all tests with no available New York State proficiency test (PT) or New York State defined equivalent the laboratory: a) shall have a system for verifying the reliability and accuracy of test results; b) shall perform this verification process at least every six months semiannually; c) shall evaluate all accuracy verification challenges: i. to ensure that results are consistent with the laboratory s specified performance criteria when an event is not graded by the external quality assurance program; ii. to identify shifts and trends regardless of the score received; and d) shall initiate and document a review of verification results within two weeks and perform and document corrective action when investigate results within two weeks when: i. the score received in an external proficiency testing program is less than 100 percent, the result(s) are unacceptable or indicate review is required; ii. results do not meet the laboratory s specified performance criteria; or iii. shifts and trends are identified. Preferably the laboratory will participate in an external quality assurance (proficiency testing) program. If a laboratory chooses to use PT samples from a CMS-approved PT program for the purpose of meeting this standard where there is no available NYSDOH PT material, and the laboratory intentionally refers those samples to another laboratory or engages in inter-laboratory communication, it will be subject to the same enforcement sanctions as described for the referral of NYSDOH PT specimens under Proficiency Testing Sustaining Standards of Practice S4 and S5. When no external program exists the laboratory may evaluate the accuracy of testing through an internal proficiency testing program that may include performance of split-sample comparisons (patient and/or quality control samples) with another validated method; evaluation of clinical outcomes; blind testing of specimens with known results, or other equivalent system. For microscopic tests not included in a PT program, the laboratory supervisor may retest a random sample of specimens throughout the year while assessing all testing personnel. For tests such as KOH preparations and erythrocyte sedimentation rates, the laboratory may utilize duplicate testing performed by two different testing personnel. Laboratories unable to participate in a New York State proficiency test event as a graded participant are required to establish alternate means to verify the accuracy and precision of the test system for all un-graded analytes. b) Semiannual is used to describe an event that takes place two times during on calendar year, with the first event taking place in the first six months of the calendar year and the second event in the last six months of the calendar year, and where the interval between events is at least four months and not more than eight months. c) A laboratory s performance criteria should be based on established analytical specifications of the assay or clinical expectations. For example, the criteria used for evaluating quality control could be the criteria used for evaluating proficiency test results. Comment: [We require] clarification for the proposed regulation. Is it the intent of the proposed standard that an initial review of verification results be initiated within two weeks of receipt of the results? Or is it the intent that a final review of the verification results, including corrective actions performed be completed within two weeks? [We] would recommend providing clarification in the proposed standard. If the intent of the review is a final review of results and corrective actions, [we have] concerns regarding the two week review timeframe and would recommend an initial review within two weeks of receipt of the results and a final review by Quality Assurance and the Laboratory Director within 30 days. 12
13 RESPONSE: NEW YORK STATE DEPARTMENT OF HEALTH The proposed standard has been revised to state: shall initiate and document a review of verification results within two weeks and subsequently perform and document corrective action when: The proposed guidance has been revised to state: b) Semiannual is used to describe an event that takes place two times per year, with the first event taking place in the first six months of a year and the second event in the last six months of a year, and where the interval between events is at least four months and not more than eight months. 13
14 Proficiency Testing Sustaining Standard of Practice 2 (PT S2): Routine Analysis Unless instructed otherwise by the proficiency test provider, the laboratory shall handle, prepare, process, examine, test and report on the results obtained from the proficiency test samples it receives from the New York State proficiency testing program and other provider programs in the same manner as patient specimens and using the primary method of analysis. Participation in proficiency testing must be rotated amongst all operators who perform the test. The proficiency test specimens should be accessioned within the limitations of the laboratory system. The intent of the standard is that the proficiency test material will be handled as much like a patient sample as possible, with the exception of automatic reflex testing to another laboratory. Routine method is the analytical system, assay, test kit, examination or instrument used as the primary method for routine workload testing at the time of the proficiency test event. If the laboratory operates on multiple shifts, participation in proficiency testing shall be rotated through all shifts on a regular basis. Comment 1: If the PT survey includes labile/time sensitive samples then holding those samples over to the third shift is contraindicated by the appropriate specimen handling instructions. Not all PTs can be held over to 2nd and 3rd shifts. RESPONSE: The purpose of proficiency testing is to verify the accuracy and reliability of the laboratory s testing. In order to perform this task, all personnel performing the testing should participate in proficiency testing to fulfill the intent of the federal requirement. The comment is not applicable to known proficiency testing samples. The proposed standard will remain unchanged. 14
15 Proficiency Testing Sustaining Standard of Practice 8 (PT S8): Attestation For laboratories participating in a proficiency test offered by New York State, the attestation statement provided by the Department must be printed and signed by either the laboratory director or delegated, responsible assistant director, in addition to the delegated submitter and the analyst(s), prior to submission of the proficiency test results. For laboratories participating in a proficiency test offered by other providers, the laboratory director and analyst(s) must sign the proficiency test provider attestation statement indicating the routine integration of the samples in the patient workload using the laboratory s routine method. The signed document must be kept on file in the laboratory for review by the clinical laboratory consultant during future on-site surveys. a. In Cytogenetics the director and every designated assistant director must sign. For NYS Proficiency test electronic reporting: The summary page(s) generated by the electronic proficiency testing system, signed by the required personnel, fulfills this requirement. These documents will be reviewed during the on-site survey. It is acceptable to print a blank summary page and provide the attestation statement to the analysts in order to obtain the necessary signatures once testing is completed, but prior to result submission. Once results are entered into the electronic proficiency testing system, the completed summary page must be printed and any signatures obtained previously may be attached to the final summary page signed by the laboratory director and/or responsible assistant director. The attestation statement must be signed by all required parties within two working days of that individual s return to the office. For NYS Proficiency test paper reporting (when pre-approved by NYS): If the laboratory director or responsible assistant director is unavailable to review the test results and sign the report prior to the postmark deadline, the laboratory should retain a copy of the results report form and transmit the unsigned original, with a note of explanation., to the proficiency test section prior to the deadline. The copy of the document, complete with signatures, should be forwarded to the Department within two working days of their return. Required signatures should be obtained within two working days of the director s or assistant director s return to the laboratory and kept on file for review during the on-site survey. Comment 1: We understand that if we are performing NYS proficiencies, the attestation sheet must be signed by the analyst and laboratory director/responsible assistant director prior to result submission. This was not mentioned in the section for proficiencies offered by other providers. Does that mean that if we are using another provider, that we would follow the requirements of the PT provider and this would not apply? For example, CAP specifically states in their COM standards on PT Attestation that The signature of the laboratory director or designee need not be obtained prior to reporting results to the proficiency testing provider. Also this section does not mention that delegated assistant directors can sign the attestation for other PT providers? If the PT providers allows for delegation to an assistant director, that would be acceptable? RESPONSE 1: New York State (NYS) has not established the timeframe for completion of the proficiency test (PT) attestation form for PT providers other than NYS, nor the appropriate signatories. Please follow the instructions and requirements of your respective proficiency test provider. 15
16 Comment 2: I am writing in regards to Proficiency Testing Sustaining Standard of Practice 8 (PT S8). The confusion is when to have the attestation form signed by the various parties. Information from the CNY - CLMA annual meeting, inspector and proposed standard and guidance vary. At the annual meeting: the response from the Q & A at the annual meeting was the attestation cannot be signed prior to submission, that is signed at the time the PT samples are distributed to staff. Inspector: our inspector suggested that we could design a form similar to the NYS attestation form and have it signed prior to submission.(at the time PT samples are distributed to staff). Example: microbiology - at the time samples are given to technical staff the form is signed and standards PT-S2 to PT-S5 reiterated. The director also signs the form at this time. After the results are submitted the delegated submitter signs the form. Proposed standard: The proposed standard states, the attestation statement provided by NYS must be printed and signed by either the laboratory director or delegated, responsible assistant director, in addition to the delegated submitter and the analysts, prior to submission of the proficiency test results. Proposed guidance: It is acceptable to print a blank summary page and provide the attestation statement to the analysts in order to obtain the necessary signatures once testing is completed, but prior to result submission and must be signed within 2 working days of that individual s return to the office. Proposed guidance: The completed summary page must be printed and any signatures obtained previously may be attached to the final summary page signed by the lab director and must be signed within 2 working days of that individual s return to the office. RESPONSE 2: For New York State (NYS) proficiency tests (PT), it is not acceptable for staff to sign the PT attestation form at the time of PT sample distribution. Since this attestation is related to the appropriate handling of PT samples, this form must be signed after testing and prior to results submission to NYS. Comment 3: I am [a] laboratory medical director at 2 small rural hospitals (not on site every day). I am writing regarding the proficiency testing sustaining standard of practice 8 (PT S8): attestation. It is difficult to sign the attestation statement prior to submission due to limited time on site at these hospitals. It is routine that I sign the attestation statements after submission because I am not on site the day the testing is due and more often than not due to staffing and competency requirements (rotating among all staff etc) we have to send the results out on the day they are due. The way I read the proposed guidance as long as we note that I am not on site and I sign the next time I am there we are okay? Also we can make that an official part of our PT policy if that is the case. Otherwise, it will be very difficult for many smaller, rural hospitals who do not have a medical director on site daily to meet this requirement. I appreciate any feedback. RESPONSE 3: Correct, it is acceptable for the PT attestation form to be signed within two working days of your scheduled return to a secondary location if it cannot be signed prior to PT results submission. 16
17 Proficiency Testing Sustaining Standard of Practice 15 (PT S15): Data Entry and Delegation of Submission The laboratory shall not assign data entry privileges or delegated submitter privileges in the New York State Electronic Proficiency Test Reporting System (EPTRS) to any individual who has those privileges at another laboratory. Comment 1: Due to staffing limitations and the evolution of hospital systems, recommend that this be changed to indicate "if a staff member has data entry and/or delegated submitter status, they should not engage in entering or submitting more than 1 location's survey for each event. RESPONSE 1: While the department has the ability to track the identities of delegated submitters at each facility, due to an increase in occurrence of proficiency testing interlaboratory communication, this standard has become necessary. Comment 2: Proficiency Testing SSP 15 (PT S15): Data Entry and Delegation of Submission. I believe the intent of this is to avoid having two institutions share the same PT results prior to submission to the agency. What this new section does not take into account, nor is there an exception for, delegated submitters who support two different NYS licensed facilities that are part of the same parent company, but report PT results that are not similar. For instance, at [our laboratory] we have a [toxicology laboratory] that tests for clinical toxicology, trace elements, TDM and some clinical chemistry results. [We also have] a crime laboratory at a separate location that is obtaining NYS permit for Forensic Identity. Both facilities may have PT results that are submitted by the same administrative staff, but both facilities will never have the opportunity to test for the same PT analytes nor share similar data prior to reporting. The way the proposed standard is written it prohibits the administrative staff from reporting for both facilities. I recommend that clarification be added to except cases where the PT data are dissimilar, therefore there being no opportunity to collaborate prior to reporting. RESPONSE 2: Delegated submitters are able to view all proficiency testing events/results and due to the increase in occurrence of proficiency testing interlaboratory communication, this standard has become necessary. Comment 3: Regarding the proposed standards, two specific proposals are not logistically feasible for all laboratories. Specifically, PT S15 and PT S16 are problematic. While I completely understand the desire for eliminating any ability to "share" PT test results, this proposal put onerous difficulties on extremely small laboratories with only a few staff members and shared resources 17
18 among laboratories. My laboratories are an example. Our main laboratory is small, and also staffs and operates the tiny on site laboratories at two clinics. The three techs that we employ rotate between the main lab and the clinics. The administrative people (e.g. Lab Director and Manager) oversee all laboratories. It is just not possible for this very small number of people, some of whom may be on vacation or illness leave at any given time, to be limited from having EPTRS priviledges at all three sites. Quite simply, we do not have enough people employed in our laboratories to avoid overlapping of submitter privileges. S15 is therefore not a tenable proposal for our laboratories and I respectfully request that this proposal be withdrawn. In fact, although my lab manager and/or I typically submit all PT results, she and I take great pains to avoid any comparison of results between sites and only input directly from the techs worksheets or reports with no changes. RESPONSE 3: Our data to date has identified that small facilities such as you describe are the most at risk for engaging in proficiency testing interlaboratory communication, whether intentional or unintentional. Unfortunately, due to an increase in occurrence of proficiency testing interlaboratory communication, this standard has become a necessity. It is possible for administrators and other staff to be designated as delegated submitters to engage additional staff in the process. Comment 4: Many laboratories have supervisors/managers/techs who work multiple jobs at different facilities. In their various roles in these facilities, they may be designated to perform data entry into the EPTRS as part of their responsibilities. Limiting the ability of an individual to perform data entry into the EPTRS to only one facility can cause a hardship to facilities with limited resources. Given the reality of the profession, a large percentage of Lab Professionals work two jobs out of financial necessity. Implementing the proposed standard would cause potential conflicts between facilities and their employees competing for the necessity to perform data entry into EPTRS. In reality, result entry should be no different than the standards for Proficiency Testing. There is currently no prohibition for a performing proficiencies in different labs you may work in. RESPONSE 4: Please note that data entry and submission of proficiency testing results in the NYS EPTRS can be performed by both technical and administrative/clerical staff. Non-technical staff only need enter results as they are presented on the proficiency testing worksheet. Comment 5: The practice of submitting PT results using EPTRS is specific to the NYS PT program, recommend that this be clarified. RESPONSE 5: The standard indicates that it is specific to the New York State Electronic Proficiency Testing Reporting System. 18
19 Proficiency Testing Sustaining Standard of Practice 16 (PT S16): Submission of Proficiency Test Results Proficiency test results must be electronically entered and submitted into the Electronic Proficiency Test Reporting System (EPTRS) from the physical location of the laboratory. Laboratories should ensure that multiple individuals have active Health Commerce System accounts and permission to submit results on behalf of the laboratory director. Comment 1: In this electronic age, this is an archaic requirement. Recommend this be changed to "cannot be submitted from another CLIA or NYS licensed location". In the past, even mailed in surveys could have been taken to the post office or home address to be mailed. Comment 2: the proposed requirement that states that PT results must be electronically entered and submitted into the EPTRS from the physical location of the laboratory. In the current paperless electronic age where data can be accessed remotely it is not necessary or feasible to require that electronic data entry be done from a specified physical location. Again, as in the first response, administrative staff that support two NYS permitted facilities will be unable to comply. What is the rationale for this proposed standard and how will it be enforced? For PT S16 I recommend that this requirement be dropped from the proposed changes. Comment 3: The proposal contained in S16 is also a logistical difficulty in the setting of my laboratories for somewhat similar reasons. In fact, in some cases it is more reassuring for PT integrity for myself or the manager to be able to enter and/or submit results from my second office which is across the street from the main lab or from some other physical location. Again, I respectfully request consideration for withdrawal of the above two proposals as written. I would be happy to discuss more specifics of my concerns if you wish to speak with me. Thank you for your time and consideration. Comment 4: Suppose that I am the director of two labs in Illinois that are licensed by NY DOH to process samples from patients in New York. How should I deal with the data entry of these two labs? Regarding the following guideline: Laboratories should ensure that multiple individuals have active Health Commerce System accounts and permission to submit results on behalf of the laboratory director. Can an experienced medical technologist who, because of her expertise, has a part-time job in two separate labs both licensed in New York, have data entry privileges at both labs considering the paragraph above from PT S15? 19
20 RESPONSE to comments 1, 2, 3, and 4: This is exactly the practice we are prohibiting by proposing and adopting this standard. Submission of PT results from another laboratory poses concerns of PT cheating. Please note that sufficient electronic traces exist to determine when and from where PT results are submitted. Comment 5: The practice of submitting PT results using EPTRS is specific to the NYS PT program, recommend that this be clarified. RESPONSE 5: The standard indicates that it is specific to the New York State Electronic Proficiency Testing Reporting System. 20
21 Control of Non-conformities Sustaining Standard of Practice 2 (Control of Non-Conformities S2): Actionable events The laboratory shall define a non-conformity to include, at a minimum, the following: a. when the test system does not meet the laboratory s verified or established performance specifications, as evidenced by: i. equipment or methodologies that perform outside of established operating parameters or performance specifications; or ii. iii. patient test values that are outside of the laboratory s reportable range of test results for the test system; or reference range for a test procedure that is inappropriate for the laboratory s patient population; or b. when results of control or calibration materials, or both, fail to meet the laboratory s established criteria for acceptability; c. when the criteria for proper storage of reagents and specimens are not met. Comment 1: The text for this Standard seems more appropriate as the Guidance for Control of Nonconformities Sustaining Standard of Practice 1 (Control of Non-Conformities S1): Procedures as it is providing the definition of actionable events, not a procedure. Comment 2: [We do] not agree with section (a)(ii) of the proposed changes to Control of Non-conformities Sustaining Standard of Practice 2 (Control of Non-Conformities S2): Action events. Please see below for wording of the proposed section. Laboratories establish reportable ranges for their tests based upon test method validation and the population served. It is possible for a sample to fall outside of the reportable range in the context of a pathologic process. Therefore, a patient result outside of the lab s reportable range does not necessarily indicate that a non-conformity occurred. A nonconformity is a failure to follow policy/process/procedure or a test system s controls/calibrators not performing appropriately, and not a unique patient sample that falls outside of the lab s reportable range. If an abnormal result is defined as a non-conformity, the definition of non-conformity is broadened 21
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