Raleigh Group, Pc

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer quality control (QC) package insert, and staff interview, the laboratory failed to label two of two Bilirubin control vials with a corrected expiration date. The findings include: 1. Observation of the laboratory on 04/11/2024 at 9:45 am revealed the Reichert Unistat bilirubinometer instrument used for neonatal total bilirubin patient testing. The two Quantimetrix Bilirubin control vials were not labeled with a corrected expiration date. During the observation, testing person four stated that controls were used until the vial is empty before a new container is opened. 2. A review of the manufacturer package insert revealed the controls were stable for 21 days once opened. 3. An interview with the technical consultant on 04/11/2024 at 1:00 pm confirmed the laboratory failed to label two of two bilirubin controls with corrected expiration dates. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 observation of the laboratory, review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS-155), the laboratory's proficiency testing (PT) records and the laboratory's PT program catalog, and interview with the technical consultant, the laboratory enrolled in the incorrect PT program for total (neonatal) bilirubin for 2022 and 2023, resulting in the laboratory failing to ensure the Centers for Medicare and Medicaid Services (CMS) was notified of the laboratory's PT results for total bilirubin in 2022 and 2023. The findings include: 1. Observation of the laboratory on 01/05/23 at 8:45 am revealed the Reichert Unistat Bilirubinometer in use for performing total bilirubin testing on neonates. 2. Review of the laboratory's CMS 155 revealed no bilirubin results were reported to CMS in 2022. 3. Review of the laboratory's proficiency testing enrollment records and the American Proficiency Institute (API) website revealed the following: Enrollment for 2022 and 2023 was in program #129-Neonatal Bilirubin-2 Samples The 2022 and 2023 catalog for API stated that "Catalog #129 is not scored for CMS" 4. Interview with the technical consultant on 01/05/23 at 12:30 pm confirmed the laboratory enrolled in the incorrect proficiency program for the total bilirubin analyte resulting in the laboratory failing to ensure the results were reported to CMS. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient SARS-CoV-2 test records and interview with the technical consultant, the laboratory failed to report positive SARS-CoV-2 test results as required for one of four days selected for review from 2021 and 2022. The findings include: 1. Observation of the laboratory on 01/05/23 at 9:00 am revealed patient testing being performed for SARS-COV-2 antigen on the BD Veritor waived test system. 2. SARS-CoV-2 patient logs and test reporting documentation was reviewed for the dates of 03/11/21, 09/22/21, 02/01/22 and 12/03 /22. 3. Documentation revealed that positive SARS-CoV results were not reported as required on 03/11/21 for one patient (#96447). 4. Interview with the technical consultant on 01/05/23 at 4:30 pm confirmed the laboratory was unable to provide documentation that positive SARS-CoV-2 results were reported as required for one of four dates selected from 2021 and 2022. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records for bilirubin and interview with the technical consultant, the laboratory failed to retain complete analytic QC records for the bilirubin analyte that include the time the QC was performed in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's QC records for bilirubin revealed no record of the time the QC was performed for five of five selected dates (03/03/21, 06/03/21, 12/13/21, 06/04/22, 12 /29/22). 2. Interview with the technical consultant on 01/05/23 at 4:30 pm confirmed the laboratory failed to retain QC analytic records that included the time the QC was performed for five of five dates selected in 2021 and 2022. She further confirmed the laboratory's forms did not include the time bilirubin QC was performed for the last two years through the date of the survey on 01/05/23. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of testing personnel competency assessment records, personnel records and interview with the technical consultant, competency assessment for testing person #4 was not performed by the technical consultant in 2021. The findings include: 1. Review of testing personnel competency assessment records revealed that competency assessments were performed by testing person #1 as follows: Testing person #3 on 07/05/21 for Complete Blood Count and Bilirubin. Testing person #4 on 01/20/21 and 07/01/21 for Complete Blood Count and Bilirubin. 2. Review of personnel records for testing person #1 revealed no delegation of duties for performing technical consultant duties and education that did not meet the regulatory requirements of a technical consultant. 3. Interview with the technical consultant on 01 /05/23 at 11 am confirmed testing personnel competencies were performed by testing person #1 for testing person #3 and #4 in 2021. She further confirmed that testing person #1 does not have the appropriate regulatory education for performing the duties of the technical consultant. The technical consultant failed to perform competency assessment for testing person #3 on 07/05/21 and #4 on 01/20/21 and 07 /01/21. -- 3 of 3 --

Summary Statement of Deficiencies 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 observation of the laboratory, review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS-155), the laboratory's proficiency testing (PT) records and the laboratory's PT program catalog, and interview with the technical consultant, the laboratory enrolled in the incorrect PT program for total (neonatal) bilirubin for 2022 and 2023, resulting in the laboratory failing to ensure the Centers for Medicare and Medicaid Services (CMS) was notified of the laboratory's PT results for total bilirubin in 2022 and 2023. The findings include: 1. Observation of the laboratory on 01/05/23 at 8:45 am revealed the Reichert Unistat Bilirubinometer in use for performing total bilirubin testing on neonates. 2. Review of the laboratory's CMS 155 revealed no bilirubin results were reported to CMS in 2022. 3. Review of the laboratory's proficiency testing enrollment records and the American Proficiency Institute (API) website revealed the following: Enrollment for 2022 and 2023 was in program #129-Neonatal Bilirubin-2 Samples The 2022 and 2023 catalog for API stated that "Catalog #129 is not scored for CMS" 4. Interview with the technical consultant on 01/05/23 at 12:30 pm confirmed the laboratory enrolled in the incorrect proficiency program for the total bilirubin analyte resulting in the laboratory failing to ensure the results were reported to CMS. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient SARS-CoV-2 test records and interview with the technical consultant, the laboratory failed to report positive SARS-CoV-2 test results as required for one of four days selected for review from 2021 and 2022. The findings include: 1. Observation of the laboratory on 01/05/23 at 9:00 am revealed patient testing being performed for SARS-COV-2 antigen on the BD Veritor waived test system. 2. SARS-CoV-2 patient logs and test reporting documentation was reviewed for the dates of 03/11/21, 09/22/21, 02/01/22 and 12/03 /22. 3. Documentation revealed that positive SARS-CoV results were not reported as required on 03/11/21 for one patient (#96447). 4. Interview with the technical consultant on 01/05/23 at 4:30 pm confirmed the laboratory was unable to provide documentation that positive SARS-CoV-2 results were reported as required for one of four dates selected from 2021 and 2022. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records for bilirubin and interview with the technical consultant, the laboratory failed to retain complete analytic QC records for the bilirubin analyte that include the time the QC was performed in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's QC records for bilirubin revealed no record of the time the QC was performed for five of five selected dates (03/03/21, 06/03/21, 12/13/21, 06/04/22, 12 /29/22). 2. Interview with the technical consultant on 01/05/23 at 4:30 pm confirmed the laboratory failed to retain QC analytic records that included the time the QC was performed for five of five dates selected in 2021 and 2022. She further confirmed the laboratory's forms did not include the time bilirubin QC was performed for the last two years through the date of the survey on 01/05/23. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of testing personnel competency assessment records, personnel records and interview with the technical consultant, competency assessment for testing person #4 was not performed by the technical consultant in 2021. The findings include: 1. Review of testing personnel competency assessment records revealed that competency assessments were performed by testing person #1 as follows: Testing person #3 on 07/05/21 for Complete Blood Count and Bilirubin. Testing person #4 on 01/20/21 and 07/01/21 for Complete Blood Count and Bilirubin. 2. Review of personnel records for testing person #1 revealed no delegation of duties for performing technical consultant duties and education that did not meet the regulatory requirements of a technical consultant. 3. Interview with the technical consultant on 01 /05/23 at 11 am confirmed testing personnel competencies were performed by testing person #1 for testing person #3 and #4 in 2021. She further confirmed that testing person #1 does not have the appropriate regulatory education for performing the duties of the technical consultant. The technical consultant failed to perform competency assessment for testing person #3 on 07/05/21 and #4 on 01/20/21 and 07 /01/21. -- 3 of 3 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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 review of the Aspen Web system, patient test reports, Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, and interview with the laboratory liaison, the laboratory director failed to ensure compliance with the CLIA regulations in 2019. The findings include: 1) Review of the Aspen Web system revealed the laboratory's previous CLIA certificate expired on February 22, 2019 due to nonpayment of fees and was reactivated as a certificate of registration on October 15, 2019. 2) Review of patient test reports revealed the laboratory continued patient testing from February 23, 2019 to October 14, 2019 when the laboratory did not possess a current CLIA certificate. 3) Review of CLIA regulation at 493.1 revealed the following: "This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)." 4) Review of CLIA regulations at 493.3 revealed the following: "Applicability: (a) Basic rule. Except as specified in paragraph (b) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it--(1) Has a current, unrevoked or unsuspended certificate of waiver, a registration certificate, certificate of compliance, certificate for 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 -- PPM procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory;" 5) Interview with the laboratory liaison on February 6, 2020 at 1:15 p.m. confirmed the laboratory director failed to ensure compliance with the CLIA regulations in 2019 when the laboratory continued to test patients without a valid CLIA certificate. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the lead testing personnel, the laboratory failed to label saline reagent with expiration date in 2018. The findings include: 1. Observation of the laboratory on December 5, 2018 at 9:30 am revealed a bottle labeled "Saline" in use for patient testing for wet prep. There was no expiration date on the vial. 2. Interview with the lead testing personnel on December 5, 2018 at 4: 00 pm confirmed the laboratory failed to ensure reagents were labeled with expiration date when it did not label the saline reagent with expiration date in 2018. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the complete blood count (CBC) control package insert, the laboratory's quality control data, and interview with the lead testing personnel, the laboratory failed to ensure complete blood count (CBC) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- controls were not used past their expiration date in 2018. The findings include: 1. Observation of the laboratory on December 5, 2018 at 9:30 am revealed CBC controls in use labeled with an open date of 11-02-2018 and no corrected expiration date (lot #s 068200, 078200, 088200). 2. Review of the CBC control package insert revealed the following: 35 day open vial stability if the maximum number of times performed is 20 times within 35 days. 3. Review of the laboratory's quality control data revealed that the quality controls had been used past the maximum allowable number of 20 times for all three lot numbers. 4. Interview with the lead testing personnel on December 5, 2018 at 4:00 pm confirmed that control lot numbers 068200, 078200, and 088200 were used past the maximum number of allowed runs in 2018. The laboratory failed to ensure the CBC controls were not used past their expiration date in 2018. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Reichert Unistat Bilirubinometer user guide, the laboratory's calibration and calibration verifcation records for the Unistat Bilirubinometer, and interview with the lead testing personnel, the laboratory failed to verify the low measuring range of the Unistat bilirubinometer in 2017 and 2018 with patient testing performed. The findings include: 1. Observation of the laboratory on December 5, 2018 at 9:30 am revealed the Unistat Bilirubinometer in use for patient testing. 2. Review of the Reichert Unistat Bilirubinometer user guide revealed the following: The instrument has a measuring range of 0-40 mg/dL. Calibration verification may be performed using manufacturer's glass cuvettes that cover the mid and high range. A sample cuvette filled with distilled water may be used to check zero. 3. Review of the 2017 and 2018 calibration and calibration verification records for the Reichert Unistat Biliruminometer revealed there was no check of the lower measuring range of zero. 4. Interview with the -- 2 of 3 -- technical consultant on December 5, 2018 at 4:00 pm confirmed the laboratory failed to verify the lower measuring range of the Unistat Bilirubinometer when it did not use distilled water to check zero in 2017 and 2018. 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 review of patient test reports for bilirubin, patient test reports for red blood cell count and interview with the technical consultant, the final patient test report failed to include units of measure for the bilirubin and red blood cell count in 2017 and 2018. The findings include: 1. Review of the final patient test reports for patient numbers 2,4,6,8,10, and 11 revealed patient testing reported for bilirubin in 2017 and 2018 with no unit of measure. 2. Review of final patient test reports and instrument printouts for patient numbers 1, 3, 5, 7, and 9 revealed patient testing reported for red blood cell count in 2017 and 2018 with incorrect units of measure on the patient reports. Unit of measure used = X10^3/uL, correct unit of measure from instrument printout = X10^6/uL. 3. Interview with the technical consultant on December 5, 2018 at 4:00 pm confirmed there were no units of measure included on the final patient reports for bilirubin and incorrect units of meaure for the red blood cell count in 2017 and 2018. -- 3 of 3 --