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January 01, 2011 Mr. Robert Stacey Staff Inspector ASCLD/LAB 1730 E. Night Heron Court Green Valley, AZ 85614 Dear Mr. Stacey: On December 13, 2010, County Executive Edward P. Mangano authorized the transfer of the Nassau County Police Department‟s Forensic Evidence Bureau (FEB) operations to the Nassau County Medical Examiner, Dr. Tamara Bloom. As the director of the crime laboratory, I have been tasked to lead the current and future operations of the forensic science program as we transition into a consolidated civilianized laboratory. The new facility is slated to be located within the County‟s state of the art Public Safety Center by early 2012, under the jurisdiction of the Medical Examiner. The County Executive‟s support of the current initiative is outlined in the attached memo from Deputy County Executive Robert Walker, dated December 17, 2010. The collaborative effort between the County Executive, Medical Examiner, Police Commissioner, District Attorney and Commissioner of Information Technology is assurance that the current probationary status and reaccreditation of the laboratory is being handled as a critical issue and all organizations are committed to the restoration of the forensic science program. In order to determine the root cause of the laboratory‟s reoccurring inspection difficulties related to the October 22-26, 2007 inspection and November 07-11, 2010 mid-cycle inspection, I have appointed a “Transition” Committee to investigate the entire laboratory operation, encompassing the management system through the physical plant. In addition to myself, the Committee consists of the following members: Dr. Peter Pizzola. Dr. Pizzola was hired as a private consultant for his unquestionable expertise in laboratory operations and the ASCLD/LAB inspection and remediation process. His theoretical and practical knowledge of forensic science makes Dr. Pizzola integral to the success of this program.
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Karen E. Dooling, M.S. Ms. Dooling is the current Nassau County Medical Examiner Department of Forensic Genetics Assistant Director and QA Manager. I have assigned Ms. Dooling as the interim Quality Manager. Her main responsibility is to revitalize the laboratory‟s Quality Control system which will be modeled after the current QA/QC program of the Department of Forensic Genetics. Dr. Joseph Avella. Dr. Avella is the current Chief Toxicologist of the Nassau County Medical Examiner‟s Office Department of Toxicology. Dr. Avella has been tasked with the review and evaluation of the toxicology program, which is responsible for the analysis of blood alcohol. Dr. Avella is currently involved in the development of policies and procedures aimed toward the consolidation of the Police Department‟s toxicology testing into the current Medical Examiner Toxicology program. As part of the remediation process, the “Transition” Committee is tasked with an active review of the entire laboratory operation to determine the root cause of the laboratory‟s failure to operate within the scope of the ASCLD/LAB Legacy standards and criteria. Several contributing factors have been preliminarily identified through the interview of current staff members and review of laboratory documentation as potential root causes of the laboratory‟s history of non-compliance. These factors include, but are not limited to: Unclear paths of communication within the organizational structure Insufficient funding Lack of adequate staffing Poorly structured QA system Unclear and/or ambiguous standard operating procedures Lack of Automation LIMS which does not support electronic workflow for all disciplines Inadequate training and continuing education Lack of technical support from Information Technology unit Physical plant constraints The determination of the root cause of past and current laboratory issues and the prevention of recourrence is the long-term goal of this endeavor. The work of the committee has made significant progress to achieve this and to bring the laboratory back into ASCLD/LAB Legacy compliance. In addition to the immediate resolution of essential criteria, great importance is placed on all non-compliant important and desirable criteria. Therefore, the laboratory will make every effort to remediate these criteria in a timely manner. The corrective action plan‟s twenty-six (26) non-compliant criteria with the corresponding corrective action are as follows: (E) Does clearly written and well understood documentation or procedure exist for control of materials and supplies?

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Finding: Laboratory policy states the laboratory “will maintain the chemical inventory, verify the quality of chemicals, and utilize the appropriate controls and standards as required” and “The Chemical Inventory is dynamic, requiring continual maintenance as the chemicals and materials are utilized.” The policy is not a well understood in the controlled substances discipline concerning the control of drug standards. They do not keep track of the amounts of drug standards, such as cocaine, diacetylmorphine (heroin), ∆9-Tetrahydrocannabinol, and ketamine, which are used in the section. Corrective Action: Although procedures exist for the maintenance of chemical inventory, they are not clear for the inventory of “primary” drug standards. Quality Assurance (QA) procedure FEBQA2.21 states:
Custody of Chemicals, Reagents, and Reference Materials At a minimum, the history of custody shall indicate the FEB Laboratory storage location. Generally, chemicals or reagents in use by a member shall remain in the custody of the storage location (See Exception for Drug Chemistry Section); personal custody is not required for chemical usage. Exception for Drug Chemistry Section: Custodial transfers of the drug standards must be documented at the time of occurrence. The amount of the drug standard used for the analysis shall be documented. Representative samples of drug standards used in analyses are regarded as non-recoverable, to be properly disposed at the conclusion of the analysis.

The procedure will be modified to include, "The amount of the primary drug standard used for the preparation of analytical standards (e.g. quantitation drug standard, calibration standards, thin layer chromatography standards etc.,) shall be documented in the BEAST chemical inventory application." All members will be trained as such. Quality assurance procedures will be revised and implemented which direct sectional oriented random and periodic audit checklists to be completed and reviewed by appropriate personnel. In addition, the BEAST chemical inventory application will be evaluated for practicality and efficiency. The laboratory director or laboratory member(s) selected by the director will work with the Porter Lee Corporation to configure a barcoded chemical inventory system which will facilitate the electronic tracking of chemicals and supplies within the laboratory system. (D) Does clearly written and well understood documentation or procedure exist for personnel evaluations and objectives?

Finding: A policy exists for personnel evaluations and objectives, but due to an agreement between the agency and the police union, there is no procedure to perform evaluations and evaluations are not being performed.
Corrective Action: The Quality Section Preface, FEBQA1.0, references personnel evaluations: NCPD Manual POL3005 ADMIN Order 06-011, 3/16/06 Inspection and Control Performance Appraisal Program

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However, under the current system personnel evaluations are a violation of the union contract. Further clarification will be obtained from the relevant unions. If the possibility of personnel evaluations exists, this standard will be addressed. (I) Does a system exist to encourage each examiner to review appropriate new literature?

Finding: The laboratory has a policy that states, “The literature shall be circulated with the record being initialed or signed and dated by the reviewing members.” There is no record that literature has been reviewed by members of the controlled substance discipline for 2009 or 2010. Corrective Action: The laboratory will implement a quality system which will assure that the Literary Review procedure, FEBQA2.31, is adhered to by all sections. The policy currently states:
A record shall be prepared, including the literature title and the applicable FEB Laboratory section(s). Section Supervisors are responsible for ensuring the disseminating of the literature to members of their section(s). The literature shall be circulated with the record being initialed or signed and dated by the reviewing members. Literature review records shall be retained in the Quality Section.

FEBQA2.31 will be modified to include the use of a Quality Assurance Literary Review Form that will cite the literary reference and require a signature and date from each laboratory member confirming their review. (E) Is all evidence marked for identification?

Finding: In the controlled substances discipline, neither the actual evidence nor its proximal container is being marked for identification. In the review of approximately eight evidence packages, only the external container or package was marked. Interviews confirmed that it was the practice in the controlled substances discipline to mark only the external container. Corrective Action: The Evidence Control procedure FEBQA2.25 states:
Analyst Identification At the conclusion of analyses, examiners will apply their initials to the evidence and/ or containers. It is recognized that some materials do not lend themselves to labeling; marking their containers will suffice.

In this section the line reading “marking their containers…” will be changed to "regarding samples examined, the evidence itself will be uniquely marked when possible or its proximal container". All laboratory members will be trained as such. In the controlled substance section, when packaging size does not allow for labeling, all analyzed items (substances) will be placed into a new bag which will be identified. All unanalyzed items will be placed into a single container and properly identified.

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Is evidence stored under proper seal?

Finding: At least five submissions of latent print evidence were received into the laboratory that were not packaged or under any seal. The items were placed into the evidence storage facility and not placed under a proper seal. They remain in an unpackaged and unsealed condition until the time of examination which could be up to sixty (60) days. Examples of evidence which was not packaged and sealed were beverage containers and fire extinguishers. Corrective Action: Evidence will not be accepted into the laboratory without being properly sealed. Large evidence items and any other latent evidence involving fingerprints which may become compromised because of packaging will be processed in the field, (e.g., with superglue) to make the prints less fragile. This policy will preserve the integrity of crime scene evidence and allow it to be amenable for analysis across all disciplines without compromise. The FEBQA2.25 policy regarding Evidence Packaging will be revised to include procedures aimed for the prevention of deleterious change to packaged evidence items containing latent print evidence. The policy regarding Non-Packaged/ Non-Sealed Evidence will be revised to include handling and prioritization of “unsealable” evidence items. Prior approval by the laboratory director or assistant director will be required to accept “unsealable” evidence items. The director or assistant director will communicate the proper procedure to prevent the loss or deleterious change to potential forensic evidence. A definitive time-period will be specified between the time of receipt and examination of such items. (E) Is there a secure area for overnight and/or long-term storage of evidence?

Finding: In the latent print laboratory, the evidence room and the case record file storage which contains evidence is open during the day. The area was observed to be open when no one was present in the office area and the evidence room and case record file storage were open. The door to the latent print laboratory was often unlocked or unlatched, allowing anyone in the agency to enter the latent print laboratory. Corrective Action: The door in the latent print laboratory now requires keypad combination entry and the automatic door closer has been replaced. Securing the door is no longer a manual process. (Work Order #945). The laboratory will assure that the door leading into the evidence storage area and case record file storage area is locked when the area is unattended. Protocols regarding laboratory security will be revised to reflect this change in policy. (E) Did the accredited laboratory conduct and document an annual audit of its operations and submit an annual accreditation audit report to ASCLD/LAB by the required deadline?

Finding: The annual accreditation report for 2008 and 2009 were not submitted by the required deadline. The 2008 report was due February 7, 2009 and it was submitted on May 28, 2009. The 2009 report was due on February 7, 2010 and it was submitted on June 30, 2010. There is no record of a request to ASCLD/LAB for an extension for the submission of the reports.
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Corrective Action: Through an interview with the previous laboratory director, it was communicated that the lateness of both the 2008 and 2009 annual accreditation report was attributed to lack of resources required to conduct the internal audit required to complete the annual reports. In 2008 a sixty (60) day extension was requested and granted by ASCLD/LAB in order to complete the audit. In 2009 lateness of the audit and the submission of the application was lent to the current hardships in preparation of the most recent 2010 inspection. The Audits and Management Reviews (FEBQA2.40) and Quality Assurance General Statement (FEBQA1.01) policies will be revised to include advanced notification of the ASCLD/LAB Annual Audit process by the QA Manager and allow each discipline sufficient time conduct an audit of their section. As all other QA/QC related functions, this requirement will be placed on a QC calendar which will prevent lateness of the reports. The interim QA Manager, Karen Dooling, has worked with the NYS DCJS to arrange an ASCLD/LAB audit training course for the management staff of the laboratory (January 25-28, 2011). In addition, a Root Cause training course is in the process of being scheduled for the technical staff. This will give the management system the proper training required and accountability to the audit process. (E) Are appropriate controls and standards specified in the procedures and are they used and documented in the case record to ensure the validity of examination results?

Finding (A): In the latent prints section, controls are being used but they are not specified in the procedures. Corrective Action: Concerning Finding (A)- The FEBL4.01 procedure will be updated to specify "a known standard will be tested along with the evidence. The following known standards will be applied…..". The proper control will specified for the specific procedure in the FEBL SOPs. Finding (B): In the controlled substances section, procedures FEBN 1.17 (6) and FEBN 1.18 (4) require “the spectrum must be compared to an in-house standard. In the rare case that a standard is not available, an identification can be made using two literature searches.” In five of thirty-five cases reviewed, no standard was used and only one literature source was used for comparison. Corrective Action: Concerning Finding (B)- In the controlled substances discipline, new controls are validated and compared to the database to confirm their integrity. When a rare drug is encountered (e.g., rare steroid, etc.) a search of the database is conducted and compared to two literary citations. In addition to assuring the use of two sources through the technical and administrative review process, the Infrared Confirmation of Drugs and/ or Diluents procedure FEBN 1.17 (step 6) and the General Confirmation Procedure Using GC/MS FEBN 1.18 (step 4) will be modified to include the approved literary references. All of the reported cases in violation were processed by the same analyst. This analyst is no longer assigned to the laboratory. In addition to the five cases cited in the non-compliance all cases processed by the examiner will be investigated for the specific issue cited in Finding (B). Identified cases will be
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reanalyzed with a proper standard. To assure additional systemic problems concerning failure to follow SOP was not occurring, 10% of ALL cases analyzed between March 14, 2008 and April 19, 2010, the date the examiner transferred from the laboratory, will be reviewed.. This accounts for approximately 147 cases that were assigned to the examiner. The findings of this review will dictate the next step of this corrective action. Finding (C): Controlled substances procedure, FEBN 1.41 requires “where unknown samples are encountered and either no Thin-Layer Chromatography (TLC) results were obtained or the results were inconclusive, a blank solvent run is required when the confirmation procedure will be performed using GC/MS.” In five of thirty-five cases reviewed, GC/MS results without TLC data were noted without the use of a blank before the sample. Corrective Action: Concerning Finding (C)- Blanks will be run between unknowns when confirming samples with GC/MS. This policy has been reiterated to the controlled substance examiners. (E) Is the quality of the standard samples and reagents adequate for the procedure used?

Finding: A cocaine standard that does not have a certificate of analysis and has not been verified is used for quantitation purposes in casework. The verification data on cocaine is from a different lot number that could not be located in the section‟s controlled substance collection. Corrective Action: The Certificate of Analysis has been re-obtained from the manufacturer for the specific standard and is being maintained on file. All primary standards available for analysis have been re-inspected and all have met the requirement. The standards have been reanalyzed according to Chemical Control procedure FEBQA2.21 which states:
Reference Materials or Standards Reference materials shall, where possible, be traceable to the SI units of measurement. Internal reference materials shall be checked as far as technically and economically possible. Reference materials are distinguished as primary or secondary standards, depending upon their source. Primary standards Primary standards, or certified reference materials, are obtained from sources that can supply appropriate information, such as a Certificate of Analysis. When possible, the properties of the primary standard will be traceable to a national or international standard, such as NIST. They can be used for quantitative (if certificate is available) or qualitative analysis and added to an instrument library for confirmation tests. Verifications can include comparing literature of instrument library spectra, chromatographs or other reliable sources, or, in the case of tablets, identifications based on manufacturer markings along with any instrumental data from traceable sources that can be obtained. Secondary standards Secondary standards can be obtained from cases scheduled for destruction or other sources. They can be used for quantitative (after purity has been established) or qualitative analysis and compared directly to a known standard. Note: Literature sources (reference books, computer libraries, etc.) may be used to aid identification, but they should not be used exclusively. Identifications should be confirmed by comparison to a known reference material analyzed under the same conditions as the unknown sample. (E)

Does the laboratory routinely check the reliability of its reagents?
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Finding: After reagents (color test and TLC developing sprays) are made, the items are tested using drug standards. However, these tests are not documented or repeated at any defined interval to ensure that these reagents are still working as expected and there is no documentation in the case record to show the use of positive or negative controls. Corrective Action: A procedure shall be developed which specifies documented routine reagent reliability checks. The QA program and section supervisors will be required to assure routine reliability checks are performed. A negative control will be used which consists of the solvent used to dissolve the sample for spotting on the plate. The SOP will be revised to require the use of the negative control.

Are the instruments/equipment properly calibrated?

Finding (A): In blood alcohol, the pipettor has not been calibrated since 2007. Laboratory policy does not specify the frequency of calibration of pipettors. Corrective Action: Concerning Finding (A)-Because of the severity of the given finding and its implications on the integrity of the work product, an extensive review of this finding was conducted. The following actions were taken with the following conclusions:
Action The HamiltonMicrolab 500 Series pipettor/dilutor in question was outsourced to Novamed Inc. for a calibration check. Investigated the use of the same instrument for the preparation of known standards and unknowns. Reviewed proficiency test data specific to blood alcohol testing since 2004. Conclusion The instrument was found to be in calibration as received. It was confirmed that the same instrument was used to prepare known standards and unknown samples. In 28 blood alcohol proficiency tests 62 total samples were analyzed with BAC values within the acceptable limits. No failures were reported.

The following actions and conclusions verify the accuracy of the tests conducted with the HamiltonMicrolab 500 Series pipettor/dilutor and the results reported. In order to prevent this recurrence, the Maintenance, Calibration and Documentation of Laboratory Equipment, FEBQA2.26, procedure will be revised to include the proper calibration of ALL equipment within the laboratory. The procedures will be specific to each piece of equipment considered critical. The QA Manager will add critical dates of calibration to a QC calendar. Finding (B): The controlled substances procedure FEBN-A PP-B1 Gas Chromatograph- Mass Spectrometer requires “analysts to perform autotune daily prior to use on casework. Once the autotune is complete, examine the autotune display. If everything is working correctly, the following conditions will be satisfied: The peak widths (FW) of these three peaks should be 0.5 +/- 0.1 amu.” There are eighteen occurrences in the autotune records where peak widths were outside of the 0.1 amu recommended range and case work was performed on the instruments without investigating the cause. Corrective Action: Concerning Finding (B)-Upon interview with the controlled substances supervisor and examiners, it was communicated that the examiners were trained to review Auto Tune and Quick Tune calibration data with acceptable limits of 0.6 ± 0.2 amu. The limit of 0.5 ± 0.1 amu specified in the Gas Chromatograph- Mass Spectrometer procedure, FEBN-APP-B1, was never updated to reflect an error reported by Agilent Technologies. This was confirmed through a discussion between the controlled substances supervisor and an Agilent Technologies representative. In addition the
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information is available on the vender‟s website (http://www.chem.agilent.com/enUS/Support/FAQs/MS/Hardware/GC-MS/Pages/KB001300.aspx). FEBN-APP-B1 will be revised to reflect the acceptable peak with range (see below). The modification will be communicated through the QA manager and section supervisor. A review of all auto tune/quick tune reports was conducted since 1/1/2010. On July 12, 2010 it was determined that three mass spectrometers produced a quick tune report which indicated an overabundance of air/water. Examination of each of the three reports indicated that current conditions did not affect the ability to produce proper mass assignments and peak widths of the PFTBA calibration compound. Loss of high-end (502) sensitivity was evident in each of the reports causing relative abundance and isotopic ratios to be out of specification. Subsequent tune reports on the following workdays did not reveal any discrepancies. One of the instruments was not utilized for casework on that day (MSD#4). MSD #1 was used on lab cases L10-2782 and L10-2769. MSD #2 was used on cases L10-1789, L10-2679, and L10-2769. Re-examination of the mass spectral data as well as additional preliminary test data from the case notes of each case revealed positive findings for L10-2769, L102782, and 2679. Negative findings were revealed for L10-1789, a case submitted as an investigation (no charges) at the time. Reanalysis will be conducted on ALL cases cited to exclude false negative results or the potential loss of low level compounds in an analyte. Finding (C): FERN-APP-B1 Gas Chromatograph- Mass Spectrometer states, “The Isotope (Iso) Ratio figures, (indicating the relative abundance of the naturally occurring isotopes), should have values for masses 70, 220 and 503 that are close to those shown in the user‟s manual for „typical autotune results‟.” The autotune reports are not compared with the user‟s manual values for an acceptable autotune report. Finding (D): In the controlled substances discipline, a “Quick Tune” option for the autotune is utilized before casework is initiated for the day. The Quick Tune option does not provide a thorough autotune report. The controlled substance procedures, FERN-APP-B1, requires the use of the autotune function and not the “quick tune” function. Corrective Action: Concerning Finding (C&D)- FEBN-APP-B1 will be amended (see below) to include a required record of an auto tune verification report. This report will indicate if the auto tune results, including isotope ratios, are within acceptable ranges. In addition ALL autotunes run since 1/1/2010 were re-inspected as discussed above. Quality assurance procedures are to be revised and implemented which direct sectional oriented random and periodic audit checklists to be completed and reviewed by appropriate personnel. FEBN-APP-B1 will be revised to read:
An autotune must be performed once per week prior to use in casework. A quicktune must be performed on subsequent days of the week prior to use in casework. Once the autotune/ quicktune is complete, examine the autotune display. A reference of acceptable isotope rations will be readily available in the ‘Autotune Log binder’. If everything is working correctly, the following conditions will be satisfied: - The three tuning masses (shown in the upper part of the display) should be within +/- 0.2 amu of 69, 219 and 502. Any deviation larger than +/- 0.2 amu indicates that something is wrong. - The peak widths (PW) of these three peaks should be 0.6 +/- 0.2 amu. Page 9 of 16

- The relative abundances (lower part of the display) should show that the peak at 69 amu is referenced at 100%. Relative to that peak, the one at 219 amu should be at least 35%, and the one at 502 amu should be at least 1%. - The Isotope (Iso) Ratio figures, (indicating the relative abundance of the naturally occurring isotopes), should have values for masses 70, 220 and 503 that are close to those shown in the users manual for ‘typical autotune results’. If an autotune/quicktune fails to meet specifications, a full autotune must be repeated or performed (whichever applies). If new peaks are showing up (an increase in the number of peaks, without any change in the threshold, column flow rate, or GC oven temperature), the ion source may need cleaning. If there are peaks at 18, 28, and 32 amu that are greater than 1% relative abundance, then there may be an air leak somewhere in the system. Exceptions are when it is within 2 days of venting, or during the first tuning after refilling the PFTBA vial. Autotune report is printed, analyst will initial and date page and place it in the ‘Autotune Log’ binder, which is maintained in the instrumentation laboratory. In addition, a Tune Verification report will be performed, reviewed and included in the ‘Autotune Log’ binder.

Finding (E): In the controlled substance procedures, FEBN-APP-B2 Fourier Transform Infrared Spectrometer requires the following: “Prior to daily use, a polystyrene standard (NIST Traceable if available) will be run and the spectrum evaluated against the QC library maintained within the OMNIC software program. Using the QC compare function, within the OMNIC software, the spectrum of the polystyrene test film will be compared against the polystyrene standards in the specified QC libraries.” There are no records to support the comparison of the daily Polystyrene Test spectrum to a polystyrene standard in a specified QC library. According to analyst interviews, the daily polystyrene test spectrum is compared to the previous day‟s spectrum produced by the instrument. Corrective Action: Concerning Finding (E)- Revisions were made to the Fourier Transform Infrared Spectrometer procedure in March of 2008 to include the examination of a polystyrene standard. Technical procedure FEBN-APP-B2 that states, “Prior to daily use, a polystyrene standard (NIST Traceable if available) will be run and the spectrum evaluated against the QC library maintained within the OMNIC software program”, was not being followed by the examiners nor did the QC program, technical and administrative review processes detect the non-compliance. Analysts have been retrained on the usage of the QC compare function and have been directed to print and maintain a daily report. Quality assurance procedures are to be revised and implemented to prevent recourrence of the issue. In order to check past instrument calibration and efficiency, the vendor will be contracted to review saved calibration files that can attest to the performance of the instrumentation (FTIR). Members of the controlled substance division will review all polystyrene spectra over the period in question to determine the potential of calibration and efficiency problems. Finding (F): In the controlled substances procedure, “A minimum critical match value of 70.00 is required for a “passing” polystyrene film test. The “match value” is that percentage of matching data points between the sample spectrum and the QC library spectra. At a resolution of 4 cm -1 the data points are compared approximately every 2 cm-1. The data points must match exactly to be considered a match. If the match value falls below 70, check and/or adjust the parameters of the instrument and run the test film again. If the match value still falls below 70, call for service and record in the logbook.” There are
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no peaks picked on the daily Polystyrene test in order to allow for the comparison of data points every 2 cm-1 in order to generate a match value. There is also no documentation produced by the instrument that is placed in a logbook to document the instrument actually evaluates the daily spectra and the resulting critical match value associated with that test. Corrective Action: Concerning Finding (F)- See above (E). The daily QC compare report will document these values. (E) Does the laboratory’s unique case identifier appear on each page of examination documentation, and does the handwritten initials (or secure electronic equivalent) of the person generating the examination documentation appear on each page generated by that person?

Finding: In latent prints, double sided examination documentation does not display the unique case number and the examiner‟s Initials on both sides of the documentation. Examples are fingerprint cards and palm print cards. Interviews revealed the fingerprint cards and palm print cards are considered to be examination documentation. Corrective Action: All examiners have been retrained to initial and number both sides of these cards. Compliance with this policy will be monitored by the section supervisor and QA manager. (E) Are conclusions and opinions in reports supported by data available in the case record, and are the examination documents sufficiently detailed such that, in the absence of the examiner(s), another competent examiner or supervisor could evaluate what was done and interpret the data?

Finding (A): The latent print procedures require the use of the ACE-V procedure for examining latent prints, but the examination documentation does not show that the complete ACE-V process is being used. Only verifications are documented with a positive. Corrective Action: Concerning Finding (A)- In order to document the methodologies employed by the latent examiner during the examination process, a worksheet is currently in development which will consist of a stepwise checkbox system. This worksheet will replace handwritten bench notes and assure proper examination documentation. In addition, adequate methodologies are being investigated to document the specific characteristics that support a positive comparison. The laboratory is investigating a digital documentation system which will allow the examiners to annotate (mark) the comparisons between known and unknowns. The laboratory will be contracting the services of Jill Spriggs, Bureau Chief of the California Department of Justice, an independent auditor to verify a select number of cases from each latent examiner. Latent print SOPs have been exchanged for evaluation and reference. Finding (B): Latent prints case notes use only the words “Positive” or “Negative” or the abbreviations for positive and negative. These words are used to describe the results of latent print processing of an item of evidence or the evaluation of submitted latent print lifts and photos regarding their suitability. The reports issued based on these examination notes contain various statements indicating “identifiable
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latent impressions” to “Impossible to make a comparison.” The examination documentation in these instances does not provide sufficient information to support the conclusion expressed in the report. Corrective Action: Concerning Finding (B)- The worksheet described in Finding A will be developed with the specific information required to support ALL conclusions expressed in reports. Finding (C): In the controlled substances discipline, sample selection is occurring in the casework performed. Analysts routinely analyze cases which contain multiple bags of suspected controlled substances. The practice is to select ten (10) percent of the bags submitted and obtain a weight of each bag (gross and net), perform color tests on a sample removed from each bag, perform one TLC system on a sample removed from each bag, and then examine only one or two of the bags by GC/MS. The total weight of the bags selected for screening exams (color tests and TLC) is reported. A confirmatory test is not performed on all of the bags that are reported. Corrective Action: Concerning Finding (C)- The laboratory is in the process of implementing the ENFSI hypergeometric probability based sampling model. ENFSI documents and peer-reviewed literature will be distributed to examiners within the controlled substance discipline. A qualified expert (Bharat Lakhkar, QA Director of the Westchester County Department of Laboratories and Research) will be providing training on January 06, 2011, in the statistical significance of the model, its implementation in casework and proper reporting criteria. SOPs will be modified to reflect this procedural change. The current THIN-LAYER CHROMATOGRAPHY DRUG SCREENING procedure (FEBN1.05) combined with a single confirmation with GC/MS will be discontinued. The laboratory is currently implementing the use of presumptive color tests followed by confirmation by GC/MS on a statistically selected sample number. When statistical sampling is not applicable or cannot be used, a confirmation using GC/MS or FTIR will be required on every sample being used to achieve the weight threshold required for a respective charge in the Penal Law. This proposed method will require the use of GS/MS equipped with auto-samplers, which the laboratory is in the process of obtaining. The need for additional instruments will be assessed. (E) Is examination documentation of a permanent nature and is it free of obliterations and erasures?

Finding: In the firearms and toolmarks discipline, approximately 75% of the cases reviewed demonstrated cross-outs in the examination documentation that were not initialed by the examiner. Corrective Action: Examiners were routinely documenting “cartridge” vs. “gauge” by crossing-out the word that was not an indicator for the type of ammunition examined. The worksheet has been updated to require a circle of the correct selection. (E)

Does the laboratory generate written reports for all analytical work performed on evidence, and do the reports contain the conclusions and opinions that address the purpose for which the analytical work was undertaken?

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Finding (A): In the latent print discipline, written reports are not generated for all work that is performed. On Initial and subsequent AFIS entries, when no identifications are made, the results are not reported to the submitter. Annotations are made on the face of the case jacket to indicate that the work was performed. Corrective Action: Concerning Finding (A): Each Latent examiner will generate a supplementary report (PDCN 350) to document an AFIS search that did not result in an immediate identification. This report will be forwarded to the investigating detective. Finding (B): In the latent print discipline, comparisons are reported on a form to the detective who made the request. If comparisons are not requested, the latent print examiners will often take the initiative and make comparisons to known offenders. If no identifications are made, the work is not reported, but is annotated on the face of the case jacket. Corrective Action: Concerning Finding (A): In the event a Latent Examiner takes the initiative to compare a specific subject against an evolving crime pattern, the Latent Examiner will prepare a Latent Fingerprint Section Comparison Report FEBL-F-1.0 and file it in the LFS case jacket. It should be noted that no list of "known offenders" has ever existed. Protocols will be amended as such. The laboratory will adhere to the criteria as explained by ASCLD/LAB: http://www.ascld-lab.org/ interpretations/applicationslegacy.html (Posted 03/17/2009) which reads:
Reporting negative database searches: If a sample (e.g. latent print, test fire or DNA profile) is searched as a one-time event, then a report must be generated clearly stating the results of the search. A "one-time" event means that the sample will not be retained in the database and automatically searched against the database on some routine basis. If a sample is entered into a database(s) and is repeatedly searched with negative results, a report is not required for each search. However, the first time the sample is entered into the database a report (which may be in the form of a simplified notification) must be generated which clearly informs the customer that the sample was entered into the database. Anytime a positive association is made a report or follow-up report must be generated. (E)

Does the laboratory have, use and document a system of technical review of the reports to ensure that the conclusions of its examiners are reasonable and within the constraints of scientific knowledge?

Finding (A): Technical reviews on blood alcohol casework are conducted by the supervisor of toxicology. There is no documentation to show that the supervisor has expertise gained through training and experience in blood alcohol analysis. Corrective Action: Concerning Finding (A)- A formal agreement has been made with the Medical Examiner Toxicology Laboratory Director, Dr. Joseph Avella, to technically review 100% of future BAC related casework. Therefore, a policy of 100% technical review will be instituted in this discipline. In addition, Dr. Avella will be performing a 20% technical review of closed cases that were technically reviewed by supervisors that lack adequate training and experience in toxicology.

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Finding (B): Technical reviews in the controlled substances discipline do not routinely detect failure to follow the laboratory‟s technical procedures. Corrective Action: Concerning Finding (B)- All members will be retrained in the areas of technical and administrative reviews. A policy of 100% technical review will be instituted in this discipline. Finding (C): The lack of examination documentation in the latent print discipline precludes a thorough technical review of the reports. Corrective Action: Concerning Finding (C)- Examination documentation referenced in Corrective Actions (A) and (B) for standard will address the remediation for this finding. Proper examination and report documentation will allow for efficient technical reviews. A policy of 100% technical review will be instituted in this discipline. Note: A technical review and administrative review checklist will be developed and implemented to assure and document the proper review of casework in ALL disciplines. The QA SOP will be revised to reflect this change in policy. (I) Was each examiner proficiency tested annually in each sub-discipline in which casework was performed?

Finding: In the trace evidence discipline, none of the examiners were proficiency tested annually in any of the sub-disciplines in which they performed casework. Corrective Action: A database will be created by the QC Manager listing the subdisciplines that each examiner is performing casework in. The database will track the frequency at which examiners have taken proficiency tests to assure adequate quality of work is being performed in the subdisciplines. Policies and procedures will be adopted to support the initiative. (I) Does the laboratory conduct proficiency testing using re-examination or blind techniques?

Finding: While the laboratory does employ re-examination techniques to conduct proficiency testing, they did not conduct a case re-examination in one-half of the disciplines in which they perform casework. In 2008, re-examination was conducted in one of six disciplines. In 2009, re-examination was conducted in two of six disciplines, and to date in 2010, re-examination has been conducted on two of six disciplines. Corrective Action: At the time of the inspection, the Firearms section had not completed their reexamination. The re-examination will be completed by the close of 2010. 2.8.1 (I) Does each examiner possess a baccalaureate degree with science courses?

Finding: Not all of the latent print examiners have a baccalaureate degree. Corrective Action: This criteria cannot be amended with the current examiners.
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3.2.1 (I)

Does the physical design permit the efficient flow of evidence from the time of its acceptance until its proper disposal?

Finding: The laboratory is located in non-contiguous, individual office suites and laboratories on different floors within the Nassau County Police Department headquarters. This physical arrangement does not permit the efficient flow of evidence from the lime of its acceptance until its proper disposal. Corrective Action: The laboratory will be relocated in a state of the art forensic laboratory within the Nassau County Public Safety Center. Refer to the attached memo from Deputy County Executive Robert Walker, dated December 17, 2010. 3.2.6 (I) Is the heating, cooling and humidity control in the laboratory adequate?

Finding: Due to the high level of humidity in the controlled substances instrument room (water dripping from the ceiling), the logbooks for the GCIMSD #1 and the gas and liquid chromatographs have suffered water damage that has rendered pages to be illegible and entries are no longer visible. Corrective Action: The leak was due to a backup in the air handler. This problem has been rectified. Documentation pertaining to the work order can be produced. 3.3.3 (E) Do all internal areas requiring limited controlled access have a lock system?

Finding: Laboratory policy states, “The Latent Fingerprint Section will be secured with a deadbolt on the Records Bureau side when no member is present in that area.” The door from the Records Bureau does have a lock, but was often unlocked or malfunctioning during the period of the inspection when no laboratory member was present in the area. Corrective Action: Refer to the Corrective Action for criteria for the latent fingerprint noncompliance. To remediate the Records Bureau non-compliance, the door will be locked when no member is present in the area. 3.3.6 (I) Does the laboratory have a fire detection system?

Finding: The latent prints, the AFIS room and the processing laboratory do not have a fire detection system. Corrective Action: Work orders will be submitted to add systems to these areas. 3.4.3 (I) Is the health and safety program monitored regularly and reviewed annually to ensure that its requirements are being met?

Findings: The Chemical Hygiene Plan has not been updated to reflect current practices. The safety committee list has not been updated and contains the names of individuals who no longer work in the laboratory. Employees are required by policy to wash their hands each time they leave the laboratory area and the policy is not being followed by the employees.
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Corrective Action: A new Health and Safety Manager will be named who will have the responsibility of updating procedures and will have the authority to assure the procedures are being followed through an annual audit and periodic spot-checks. 3.4.9 (I) Does the laboratory have an adequate number of personnel holding current certification in first-aid?

Finding: The laboratory does not have any personnel holding a current certification in first-aid. Corrective Action: First-aid training in AED, CPR and Bloodborn Pathogens has been scheduled for 9 examiners on the 13th and 20th of January 2011. In the interim, other departmental personnel are being identified on each floor who can administer first aid when required.


Are the emergency exits from the laboratory adequate for safe exit in an emergency?

Finding: The second floor laboratory has one exit. The laboratory has purchased a steel escape ladder support device in order to allow a second escape route out of the laboratory. The ladder has not yet been installed. Corrective Action: Because of the safety implications of this non-compliance, prompt installation of a fire escape will be discussed with Police Department administration.

All revisions required to remediate the non-compliant criteria will not only be reflected in the pertinent SOP or QA procedure but will be the subject of persistent oversight by supervision and management to ensure that these changes are implemented and maintained. If there are any questions pertaining to the proposed corrective action plans, please contact me at the Department of Forensic Genetics, by telephone at (516) 572-5193 or email at pbuffolino@nassaucountyny.gov. I would like to take this opportunity to thank you and the members of your inspection team for the dedicated work towards the reaccreditation of the Nassau County Forensic Evidence Bureau.


Pasquale Buffolino, Ph.D. Director of Forensic Genetics Acting Director of Forensic Evidence Bureau

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