Wc Health

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site initial CLIA certification survey conducted at your facility on July 2, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a random patient audit between the dates of April 16, 2024 and June 28, 2024, a review of the FDA test complexity classifications for the tests performed, the laboratory verification studies, a review of the manufacturer's instructions for the tests performed, and an interview with the laboratory supervisor, the laboratory failed to ensure the interpretive guidance was available on the report, or that the interpretive guidance available was appropriate to the testing performed by the laboratory. Findings include: 1. A random patient audit between the dates of April 16, 2024 and June 28, 2024 revealed that three of five final reports generated from the Horiba Pentra C400 analyzer print out included the following interpretive guidance: "Qualitative results are "Presumptive" performed by laboratory developed enzyme 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 -- Immunoassay, Clinical considerations and professional judgement should be exercised and further testing by GC/MS or LC/MC/MC (sic) may be required. The performance characteristics of these tests were determined by W-C Health Services. They have not been approved by the U.S. Drug Administration (499.1291(c)(4))" 2. A random patient audit between the dates of April 16, 2024 and June 28, 2024 revealed that two of five final reports generated from the LIS did not include the following interpretive guidance stated in the Thermofisher package inserts: "This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used." 3. A review of the FDA test complexity classifications revealed that the Thermofisher assays in use on the Horiba Pentra C400 analyzer for the following analytes were classifed as moderate complexity when performed according to the manufacturer's instructions: Amphetamines, THC (Cannabinoids), Barbiturates, Benzodiazapine, Buprenorphine, Ethanol, and Opiates. 4. A review of the laboratory verfication studies revealed that the laboratory did not establish and validate performance characteristics for the analytes as laboratory developed tests. The laboratory verified the manufacturer's performance characteristics for the drugs of abuse panel. 5. The findings were confirmed during an interview with the laboratory supervisor on July 2, 2024 at approximately 1:15 PM. The laboratory performs approximately 4000 routine chemistry, urinalysis and toxicology tests annually. D5811 TEST REPORT CFR(s): 493.1291(f) (f) Except as provided in 493.1291(l),test results must be released only to authorized persons and, if applicable, the persons responsible for using the test results and the laboratory that initially requested the test. This STANDARD is not met as evidenced by: Based on a random patient audit between the dates of April 16, 2024 and June 28, 2024, and an interview with the laboratory supervisor, the laboratory failed to ensure that name of the ordering provider was on the test reports. Findings include: 1. A random audit of five patients tested for urine drug screens between the dates of April 16, 2024 and June 28, 2024 revealed that two of five final patient reports did not include the name of the ordering provider on the report. The laboratory supervisor stated that the reports were instrument print outs that were issued because the Laboratory Information System (LIS) was not working on the dates of 4/16/24, 5/10 /24 and 5/23/24. 2. The laboratory supervisor confirmed the finding during an interview conducted on July 2, 2024 at approximately 1:15 PM. The laboratory performs approximately 4000 routine chemistry, urinalysis and toxicology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This statement of deficiencies was generated as a result of the on-site CLIA recertification survey conducted at your facility on March 14 and 16, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state or local laws. D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing results for the laboratory, a review of the API 2017 Order Confirmation for the 2017 proficiency testing events that the laboratory enrolled, a review of the CASPER Report 0096D which is designed to report laboratory proficiency testing scores for the laboratory and an interview with the program manager, the laboratory failed to authorize the release of proficiency testing information from the proficiency testing program to Health and Human Services (HHS) to determine compliance. Findings include: 1. There were no proficiency testing scores for any events for testing year 2017 from API that was indicated on the CASPER 0096D Proficiency Testing Scores report generated on 12/13/17 due to the laboratory not properly identifying the State Agency to receive the proficiency testing reports.. 2. The laboratory was enrolled in two different immunoassay events that were sent by API on 10/16/17, enrolled in one Chemistry 3 event sent by API on 8/28/17 and enrolled in one Hematology 3 event sent by API on 11/13/17. This was confirmed by the program manager on March 16, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 2018 at approximately 2:00 PM. The laboratory performs approximately 53,600 patient tests annually in the areas of Chemistry and Hematology. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the API proficiency testing reports for testing years 2017 and 2018 in the testing categories of Chemistry and Hematology and an interview with the laboratory program manager, the laboratory failed to achieve satisfactory performance for Total Bilirubin testing in two consecutive events (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the API proficiency testing reports for testing years 2017 and 2018 in the testing categories of Chemistry and Hematology and an interview with the laboratory program manager, the laboratory failed to achieve satisfactory performance for Total Bilirubin testing in two consecutive events. Findings include: The laboratory failed to achieve a satisfactory score of at least 80% in the Total Bilirubin laboratory testing for the third event 2017 (60%) and the first event 2018 (40%). This was confirmed by the laboratory program manager on March 16, 2018 at approximately 2: 00 PM. The laboratory performs approximately 50,000 Chemistry tests 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 -- 2 of 7 -- 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 review of the validation documents of new laboratory tests that the laboratory began performing on patients starting 10/19/17, a review of the director approved policy and procedure manual for test method validation and an interview with the laboratory program manager, the laboratory failed to demonstrate the accuracy performance according to the established laboratory policy. Findings include: 1. The laboratory failed to meet the criteria of acceptability for accuracy of 10% of the comparable reference laboratory values for 8 of 23 non-toxicology chemistry analytes. 2. The following analytes failed to meet the director approved policy criteria for acceptability for accuracy of 10% of the value given by the reference laboratory: PSA, Free T4, TSH3, Total T3, Vitamin B12, Total Bilirubin, Glucose, and CO2. This was confirmed by the laboratory program manager on March 16, 2018 at approximately 3:00 PM. The laboratory performs approximately 50,000 chemistry patient tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random audit of patient test reports and quality control reports for Hematology and Chemistry from November 2016 through March 2018 and an interview with the laboratory program manager, the laboratory failed to perform at least two levels of quality control that would meet the director approved policy for quality control acceptability before reporting patient test results. Findings include: 1. The laboratory failed to meet the established criteria for quality control acceptability by having no controls have results outside of the 3 Standard Deviation (SD) range and /or having no more than two consecutive results outside of the +/- 2SD range on the same side of the mean. 2. A random audit of patient test reports and quality controls performed between November 2016 and March 2018 found on 11/01/17, the level one quality control for chemistry was performed and revealed that the Total Protein and ALT were outside of the 2SD limit. There was no documentation found of a level two quality control for chemistry performed on this date. 3. The laboratory failed to retrieve evidence that a second level of control was performed on 11/01/17 for 18 different chemistry tests performed on patients. 4. There were four patient tests for -- 3 of 7 -- Total Protein and ALT that were reported on 11/01/17 with no acceptable chemistry quality control performed according to the director approved policy.. This was confirmed by the laboratory program manager on March 16, 2018 at approximately 3: 00 PM. The laboratory performs approximately 50,000 patient chemistry tests annually. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of API proficiency testing reports for testing years 2017 and 2018, a review of the director approved policy and procedure manual which includes instrument and methodology validation and the criteria for quality control acceptability, a review of the validation documents for Hematology and Chemistry for new instrumentation and methodologies, a random audit of patient test results and quality control results from November 2016 through March 2018 and an interview with the laboratory program manager, the laboratory director failed to verify that the procedures used are adequate to determine the accuracy of the tests performed (refer to D6013), failed to ensure that the proficiency testing samples are tested as required under subpart H of this part (refer to D6016), failed to ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided (refer to D6020), failed to establish and maintain a quality assessment system that would assure the quality of the laboratory services provided (refer to D6021) and failed to ensure that patient test results are reported only when the system is functioning properly (refer to D6025). D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the validation documents of new laboratory tests that the laboratory began performing on patients starting 10/19/17, a review of the director approved policy and procedure manual for test method validation and an interview with the laboratory program manager, the laboratory director failed to ensure that the criteria of acceptability for accuracy validation was met according to the established laboratory policy. Findings include: 1. The laboratory failed to meet the criteria of acceptability for accuracy of 10% of the comparable reference laboratory values for 8 of 23 non-toxicology chemistry analytes. 2. The following analytes failed to meet the director approved policy criteria for acceptability for accuracy of 10% of the value -- 4 of 7 -- given by the reference laboratory: PSA, Free T4, TSH3, Total T3, Vitamin B12, Total Bilirubin, Glucose, and CO2. This was confirmed by the laboratory program manager on March 16, 2018 at approximately 3:00 PM. The laboratory performs approximately 50,000 chemistry patient tests annually. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the API proficiency testing reports for testing years 2017 and 2018 in the testing categories of Chemistry and Hematology and an interview with the laboratory program manager, the laboratory director failed to ensure satisfactory performance for Total Bilirubin testing in two consecutive events. Findings include: The laboratory failed to achieve a satisfactory score of at least 80% in the Total Bilirubin laboratory testing for the third event 2017 (60%) and the first event 2018 (40%). This was confirmed by the laboratory program manager on March 16, 2018 at approximately 2:00 PM. The laboratory performs approximately 50,000 Chemistry tests annually. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a random audit of patient test reports and quality control reports for Hematology and Chemistry from November 2016 through March 2018 and an interview with the laboratory program manager, the laboratory director failed to ensure at least two levels of quality control materials performed whicht would meet the director approved policy for quality control acceptability before reporting patient test results. Findings include: 1. The laboratory director failed to ensure that the established criteria for quality control acceptability was met by having no controls have results outside of the 3SD range and/or having no more than two consecutive results outside of the +/- 2SD range on the same side of the mean. 2. A random audit of patient test reports and quality controls performed between November 2016 and March 2018 found on 11/01/17, the level one quality control for chemistry was performed and revealed that the Total Protein and ALT were outside of the 2SD limit. There was no documentation found of a level two quality control for chemistry performed on this date. 3. There were four patient tests for Total Protein and ALT that -- 5 of 7 -- were reported on 11/01/17. This was confirmed by the laboratory program manager on March 16, 2018 at approximately 3:00 PM. The laboratory performs approximately 50,000 patient chemistry tests annually. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the director approved policy and procedure manual for quality assessment, a review of the monthly quality assessment documents, a random audit of patient testing and quality control performed in the testing categories of Hematology and Chemistry from November 2016 to March 2018 and an interview with the laboratory program manager, the director failed to establish and maintain a system for quality assessment that would assure the quality of the laboratory services provided. Findings include: 1. The established laboratory quality assessment procedure failed to capture on 11/01/17 that there were two analytes, Total Protein and ALT, that were outside the 2 Standard Deviation (SD) range, that there was no evidence that the quality control was rerun for these analytes and that there was no evidence that a second level of control was performed. 2. The quality assessment procedure failed to capture that 18 chemistry analytes had no evidence that a level two chemistry quality control was performed on 11/01/17. 3. The quality assessment procedure did not capture that there were four patient tests for Total Protein and ALT that were reported on 11/01/17 with no acceptable quality control results for chemistry according to the director approved policy for quality control.. This was confirmed by the laboratory program manager on March 16, 2018 at approximately 3:00 PM. The laboratory performs approximately 50,000 patient chemistry tests annually. D6025 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(7) Ensure that patient test results are reported only when the system is functioning properly. This STANDARD is not met as evidenced by: Based on a review of the instrument and methodology validation documents for Chemistry and Hematology, a random audit of patient test reports and quality control performed between November 2016 and March 2018 and an interview with the laboratory program manager, the laboratory director failed to ensure that the patient test results are reported only when the laboratory test systems are functioning properly. Findings include: 1. The laboratory failed to meet the criteria of -- 6 of 7 -- acceptability for accuracy of 10% of the comparable reference laboratory values for 8 of 23 non-toxicology chemistry analytes. 2. The following analytes failed to meet the director approved policy criteria for acceptability for accuracy of 10% of the value given by the reference laboratory: PSA, Free T4, TSH3, Total T3, Vitamin B12, Total Bilirubin, Glucose, and CO2. 3. The laboratory director failed to ensure that the established criteria for quality control acceptability was met by having no controls have results outside of the 3SD range and/or having no more than two consecutive results outside of the +/- 2SD range on the same side of the mean. 4. A random audit of patient test reports and quality controls performed between November 2016 and March 2018 found on 11/01/17, the level one quality control for chemistry was performed and revealed that the Total Protein and ALT were outside of the 2SD limit. There was no documentation found of a level two quality control for chemistry performed on this date. 5. The laboratory failed to achieve a satisfactory score of at least 80% in the Total Bilirubin laboratory testing for the third event 2017 (60%) and the first event 2018 (40%). This was confirmed by the laboratory program manager on March 16, 2018 at approximately 4:00 PM. The laboratory performs approximately 50,000 Chemistry tests annually. -- 7 of 7 --