Ada West Dermatology

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of laboratory records and an interview with the Mohs lead on 10/24 /2024, the laboratory failed to enroll in proficiency testing (PT) for dermatophyte fungi cultures in 2024. The findings include: 1. A lack of laboratory PT records identified that the laboratory failed to enroll and participate in PT for dermatophyte fungi cultures performed by the laboratory since March of 2024. 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that the laboratory failed to enroll and participate in PT for dermatophyte fungi cultures since March of 2024. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessment records and an interview with the Mohs lead on 10/24/2024, the laboratory failed to follow written policies and procedures to assess testing personnel performing dermatophyte fungi cultures in 2024. The findings include: 1. A review of the CMS 209 form identified four (4) testing personnel performing dermatophyte fungi cultures. 2. A review of competency assessment records identified the laboratory failed to have documentation of six month competency assessments for four (4) of four (4) testing personnel in 2024. 3. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed the above findings. 4. The laboratory reports performing 73 dermatophyte fungi cultures annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual and an interview with the Mohs lead on 10/24/2024, the Laboratory Director failed to approve, sign and date the dermatophyte fungi culture policy prior to patient testing beginning in March 2024. The findings include: 1. A record review of the laboratory policy and procedure manual identified that the Laboratory Director failed to approve, sign and date the "DTM Policy- Ten Mile Clinic" used for dermatophyte fungi cultures prior to patient testing beginning in March 2024. 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that the Laboratory Director had not approved the "DTM Policy- Ten Mile Clinic" policy prior to patient testing. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure for dermatophyte fungi culture, the manufacturer's instructions for use (IFU), laboratory records and an interview with the Laboratory Director on 10/24/2024, the laboratory failed to follow the manufacturer's IFU for interpretation of results for dermatophyte fungi cultures. The findings include: 1. A review of the laboratory procedure for dermatophyte fungi culture,"DTM Policy- Ten Mile Clinic," identified that the laboratory was interpreting and resulting dermatophytes and yeast from the Dermatophyte Testing Medium (DTM). 2. A review of the Hardy Diagnostics IFU for DTM used in dermatophyte cultures identified interpretation of results to be positive or negative for dermatophytes. 3. A review of the laboratory's internal proficiency testing quiz identified that the laboratory failed to follow the manufacturer's IFU and result only positive or negative -- 2 of 6 -- for dermatophytes from cultures using the Hardy Diagnostics DTM. 4. An interview with the Laboratory Director on 10/24/2024 at 10:33 am confirmed the above findings. 5. The laboratory reports performing 73 dermatophyte fungi cultures annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instructions for use (IFU), laboratory records and an interview with the Mohs lead on 10/24/2024, the laboratory failed to document testing temperatures as required by the manufacturer for dermatophyte fungi cultures. The findings include: 1. A review of the IFU for Hardy Diagnostics Dermatophyte Test Medium (DTM) identified that the inoculated medium is to be incubated at room temperature (15-30 C) for up to 14 days. 2. A review of the laboratory's temperature log identified that the laboratory failed to document room temperature in the locations that dermatophyte fungi cultures were incubating. 3. An interview with the Mohs lead on 10/24/2024 at 10:35 confirmed that the laboratory fail to document incubation temperatures for dermatophyte fungi cultures. 4. The laboratory reports performing 73 dermatophyte fungi cultures annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a lack of documentation for verification of performance specifications for dermatophyte fungi cultures and an interview with the Mohs lead on 10/24/2024, the laboratory failed to ensure test performance specifications were established and verified before patient testing began in March 2024. The findings include: 1. A lack of documentation for the verification of performance specifications for dermatophyte fungi cultures identified that the laboratory failed to establish accuracy of the testing method prior to performing patient testing in March 2024. 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that the laboratory failed to verify manufacturer's performance specifications prior to beginning patient testing. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. -- 3 of 6 -- D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the Mohs lead on 10/23/2024, the laboratory failed to check each lot of prepared medium for its ability to support and inhibit growth for dermatophyte fungi cultures since March 2024. The findings include: 1. A lack of microbiology quality control (QC) records identified that the laboratory failed to perform and document quality control (QC) to show the ability of the prepared Hardy Dermatophyte testing medium (DTM) to support growth since beginning testing in March 2024. 2. A lack of microbiology quality control (QC) records identified that the laboratory failed to perform and document QC to show the ability of the prepared Hardy DTM to inhibit growth of selected organisms since beginning testing in March 2024. 3. A lack of microbiology quality control (QC) records identified that the laboratory failed to perform and document QC to show the ability of the prepared Hardy DTM to differentiate organisms since beginning testing in March 2024. 4. An interview with the Mohs lead on 10/23/2024 at 10:35 am confirmed that the laboratory failed to to perform QC on the DTM. 5. The laboratory reports performing 73 dermatophyte fungi cultures annually. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) personnel form 209, the manufacturer's instructions for use, a lack documents and an interview with the Mohs lead on 10/24/2024, the Laboratory Director failed to ensure that new test verifications were performed, that testing personnel had training and were competent to provide accurate and reliable patient results, that PT was ordered and performed that the laboratory was following the manufacturer's testing instructions and that the laboratory had a quality control plan for dermatophyte fungi culture. See D6086, D6087, D6088, D6093 and D6102. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. -- 4 of 6 -- This STANDARD is not met as evidenced by: Based on a lack of documentation for verification of performance specifications for dermatophyte fungi cultures and an interview with the Mohs lead on 10/24/2024, the Laboratory Director failed to ensure test performance specifications were established and verified before patient testing began in March 2024. The findings include: 1. A lack of documentation for the verification of manufacturer performance specifications for dermatophyte fungi cultures identified that the Laboratory Director failed to ensure test method accuracy was adequate prior to performing patient test in March 2024. 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that the laboratory failed to verify manufacturer's performance specifications prior to beginning patient testing. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure for dermatophyte fungi culture, the manufacturer's instructions for use (IFU), laboratory records and an interview with the Mohs lead on 10/24/2024, the Laboratory Director failed to ensure that the laboratory was following the manufacturer's IFU for accurate interpretation of results for dermatophyte fungi cultures. The findings include: 1. A review of the laboratory procedure for Dermatophyte fungi Culture, the Hardy Diagnostics IFU for DTM used in dermatophyte cultures and the laboratory's internal proficiency testing quiz identified the laboratory failed to follow the manufacturer's IFU for interpretation of results to result only positive or negative for dermatophytes. See D5411 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed the above finding. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the Mohs lead on 10/24 /2024, the Laboratory Director failed to ensure that the laboratory was enrolled in proficiency testing (PT) for dermatophyte fungi cultures in 2024. The findings include: 1. A review of laboratory records identified that the laboratory failed to enroll and participate in PT for dermatophyte fungi cultures performed by the laboratory since March 2024. 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that the Laboratory Director failed to ensure that the laboratory was enrolled and participated in PT for dermatophyte fungi cultures since March 2024. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. -- 5 of 6 -- D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a lack of quality control (QC) documentation and an interview with the Mohs lead on 10/24/2024, the Laboratory Director failed to ensure that the laboratory had an acceptable QC plan for dermatophyte fungi cultures that was followed by testing personnel. The findings include: 1. A lack of a QC policy and QC documentation for dermatophyte fungi cultures identified that the laboratory failed to perform and document acceptable QC since beginning testing in March 2024. See D5447 2. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that the Laboratory Director failed to ensure QC was performed. 3. The laboratory reports performing 73 dermatophyte fungi cultures annually. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, a lack of documentation, an interview with the Mohs lead on 10/24 /2024, the Laboratory Director failed to ensure that testing personnel performing dermatophyte fungi cultures had the training to accurately perform and report patient testing. The findings include: 1. A review of the CMS 209 identified four (4) testing personnel performing dermatophyte fungi cultures. 2. A lack of training documentation identified that the laboratory failed to have documentation of initial training for four (4) of four (4) testing personnel performing dermatophyte fungi cultures before beginning patient testing in March 2024. 3. An interview with the Mohs lead on 10/24/2024 at 10:35 am confirmed that there was no documentation of training. 4. The laboratory reports performing 73 dermatophyte fungi cultures annually. -- 6 of 6 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a lack of documents and an interview with the laboratory lead on 9/22/2022, the laboratory failed to ensure that testing personnel performing potassium hydroxide (KOH) examinations had initial training and competency assessments (see D5209); failed to perform bi-annual verification of KOH examinations (see D5217). Both D5209 and D5217 are repeat deficient practices from the previous inspection on 3/4 /2021 and there is no documentation of initial training, competency assessments or bi- annual verification for KOH examinations since the facility began testing in October 2019. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures, the Centers for Medicare and Medicaid Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Services (CMS) 209 personnel form, an interview with the laboratory lead on 9/22 /2022 and a lack of documentation, the laboratory failed to follow written procedures to assess testing personnel's training and competency for potassium hydroxide (KOH) examinations in 2021. The findings include: 1. A review of the laboratories KOH procedure identified that the laboratory performs initial training within two weeks of hire then six month and annual competency assessments. 2. A lack of training records identified two testing personnel listed on the CMS 209 hired since the last inspection on 3/4/2021 that failed to have documentation of initial training for KOH examinations. 3. A lack of competency assessment records identified two testing personnel listed on the CMS 209 hired since the last inspection on 3/4/2021 that failed to have documentation of a six month competency assessment for KOH examinations. 4. A lack of competency assessment records identified three testing personnel listed on the CMS 209 that failed to have an annual competency assessment for 2021 for KOH examinations. 5. An interview with the laboratory lead on 9/22/2022 at 2:11 pm confirmed the above findings. 6. The laboratory reports performing 67 KOH examinations annually. 7. This deficient practice was identified during the previous inspection on 3/4/21; failed to document initial training, six month and annual competency for testing personnel performing KOH examinations and was confirmed by interview with the laboratory lead on 03/04/21 at 2:00 PM. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the laboratory lead on 9/22 /2022, the laboratory failed to document, at least twice annually, the verification of accuracy for potassium hydroxide (KOH) examinations since the last inspection . The findings include: 1. A lack of documentation for bi-annual verification identified that the laboratory failed to document verification of accuracy for KOH examinations at least twice annually since the last inspection on 3/4/2021. 2. An interview with the laboratory lead on 9/22/2022 at 2:11 PM confirmed that the laboratory has not performed bi-annual verification of KOH examinations. 3. The laboratory reports performing 67 KOH examinations annually 4. This deficient practice was identified during the previous inspection on 3/4/2021; failed to document bi-annual verification of KOH examinations from the time the laboratory opened in October of 2019 and was confirmed by interview with the laboratory lead on 03/04/2021 at 2:00 PM. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a lack of documents and an interview with the laboratory lead on 9/22/2022, the laboratory failed to fulfill their responsibilities as a laboratory director. The laboratory director failed to ensure that testing personnel performing potassium -- 2 of 4 -- hydroxide (KOH) examinations had initial training and competency assessments (see D6079); that the laboratory perform bi-annual verification of KOH examinations (see D6088). Both are repeat deficient practices from the previous inspection on 3/4/2021 and there is no documentation of initial training, competency assessments or bi-annual verification for KOH examinations since the facility began testing in October 2019 D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, an interview with the laboratory lead on 9/22/2022 and a lack of documentation, the laboratory director failed to ensure testing personnel were trained and competent for potassium hydroxide (KOH) examinations before patent testing in 2021. The findings include: 1. A lack of training records identified two testing personnel listed on the CMS 209 hired since the last inspection on 3/4/2021 that failed to have documentation of initial training for KOH examinations. 2. A lack of competency assessment records identified two testing personnel listed on the CMS 209 hired since the last inspection on 3/4/2021 that failed to have documentation of a six month competency assessment for KOH examinations. 3. A lack of competency assessment records identified three testing personnel listed on the CMS 209 that failed to have an annual competency assessment for 2021 for KOH examinations. 4. An interview with the laboratory lead on 9/22/2022 at 2:11 pm confirmed the above findings. 5. The laboratory reports performing 67 KOH examinations annually. 6. This deficient practice was identified during the previous inspection on 3/4/21; failed to document initial training, six month and annual competency for testing personnel performing KOH examinations and was confirmed by interview with the laboratory lead on 03/04/21 at 2:00 PM. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the laboratory lead on 9/22 /2022, the laboratory director failed to ensure that bi-annual verification of accuracy for potassium hydroxide (KOH) examinations was performed since the last inspection . The findings include: 1. A lack of documentation for bi-annual verification identified -- 3 of 4 -- that the laboratory failed to document verification of accuracy for KOH examinations at least twice annually since the last inspection on 3/4/2021. 2. An interview with the laboratory lead on 9/22/2022 at 2:11 PM confirmed that the laboratory has not performed bi-annual verification of KOH examinations. 3. The laboratory reports performing 67 KOH examinations annually 4. This deficient practice was identified during the previous inspection on 3/4/2021; failed to document bi-annual verification of KOH examinations from the time the laboratory opened in October of 2019 and was confirmed by interview with the laboratory lead on 03/04/2021 at 2:00 PM. -- 4 of 4 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review of competency assessments, the CMS-209 personnel form, and an interview with the laboratory technician on 03/04/21, the laboratory failed to document the 6-month and annual competency assessments for the testing personnel listed on the CMS-209 personnel form. The findings include: 1. A record review of competency assessments revealed that six of six of the testing personnel listed on the CMS-209 personnel form did not have documented 6-month competency assessments performed for KOH examinations and Moh's gross examinations. 2. A record review of competency assessments revealed that four of four testing personnel listed on the CMS-209 personnel form did not have documented annual competency for KOH examinations. 3. An interview with the laboratory technician on 03/04/21 2:00 PM confirmed the above findings. 4. The laboratory reports performing 50 KOH examinations and 1,200 Moh's gross and slide examinations annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review of bi-annual verification and an interview with the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- technician on 03/04/21, the laboratory failed to document, at least twice annually, the verification accuracy of Potassium Hydroxide (KOH) examinations. The findings include: 1. A record review of bi-annual verification identified that the laboratory failed to document bi-annual verification of KOH examinations from the time the laboratory opened in October of 2019 to the time of the current survey on 03/04/2021. 2. An interview with the laboratory technician on 03/04/21 at 2:00 PM confirmed the above findings. 3. The laboratory report performing 50 KOH examinations annually D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on record review of training documentation, the CMS-209 personnel form, and an interview with the laboratory technician on 03/04/21, the laboratory failed to document initial training for Potassium Hydroxide (KOH) examinations prior to testing patient specimens. The findings include: 1. A record review of testing personnel training documentation revealed that four of four testing personnel listed on the CMS-209 had no initial training documented for KOH examinations prior to testing patient specimens. 2. An interview with the laboratory technician on 03/04/21 at 2:00 PM confirmed the laboratory had no documentation of initial training for KOH examinations. 3. The laboratory report performing 50 KOH examinations annually. -- 2 of 2 --