Raleigh Endocrine Associates

Summary Statement of Deficiencies 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 AAFP (American Academy of Family Physicians) proficiency testing records 5/12/20, the laboratory failed to successfully participate in proficiency testing for Chloride. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 AAFP (American Academy of Family Physicians) proficiency testing records 5/12/20, the laboratory failed to achieve satisfactory performance for Chloride on two consecutive proficiency testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS 155D and AAFP proficiency testing results revealed the laboratory provided incorrect responses for 2 of 5 samples and received a score of 60% for Chloride on the 2019-C test event. 2. Desk review of CMS 155D and AAFP proficiency testing results revealed the laboratory failed to participate and received a score of 0% for Chloride on the 2020-A test event. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 AAFP (American Academy of Family Physicians) proficiency testing records 5/12/20, the laboratory director failed to provide overall management and direction to ensure successful participation in proficiency testing. See the deficiency cited at D6016. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 AAFP (American Academy of Family Physicians) proficiency testing records 5/12/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS 155D and AAFP proficiency testing results revealed the laboratory provided incorrect responses for 2 of 5 samples and received a score of 60% for Chloride on the 2019-C test event. 2. Desk review of CMS 155D and AAFP proficiency testing results revealed the laboratory failed to participate and received a score of 0% for Chloride on the 2020-A test event. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of CMS (Centers for Medicare and Medicaid Services) Casper 155D report, review of 2018 and 2019 AAFP (American Academy of Family Physicians) proficiency testing records, and staff interview 3/10/20, the laboratory failed to retain all proficiency testing records for at least two years. The laboratory's "PROFICIENCY TESTING" policy states "... The completed result form should be reviewed and signed by the laboratory director and kept for two years. ... Have the laboratory director sign all documentation and keep records for two years. ..." Review of the CMS Casper 155D report revealed the laboratory participated in proficiency testing for the 2019 3rd test event (AAFP 2019- C). Review of 2018 and 2019 AAFP proficiency testing records revealed there were no records available for review for the AAFP 2019-C test event, including signed attestation statements, report forms, and graded results. During interview at approximately 10:50 a.m., the IT (information technology) Liaison stated she was unsure where the records might be if they were not in the notebook with the other proficiency testing records. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of 2019 Roche Cobas e411 calibration verification records and review of the manufacturer's product insert 3/10/20, the laboratory failed to discard calibration verification linearity material that had exceeded the expiration date. Findings: Review of the calibration verification linearity records revealed linearity was performed on 1/7/19 for the following analytes: T3 (Triiodothyronine), FT4 (free thyroxine), PSA (prostate specific antigen), and TSH (thyroid stimulating hormone). Review of the calibration verification linearity report and AUDIT MicroControls Linearity FD Immunoassay product insert revealed the Linearity FD Immunoassay material, lot #06605, expired on 10/24/18 and was used for the calibration verification on 1/7/19. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and review of 2018 and 2019 Roche Cobas e411 and Envoy 500+ QC (Quality Control) records 3/10/20, the laboratory failed to ensure QC was acceptable before reporting patient test results. Findings: 1. The laboratory's "IN-HOUSE QUALITY CONTROL PROTOCOL" states for the Roche Cobas e411, "1 High and 1 Low control ran every testing day or after any instrument malfunction. With every new lot number. After every calibration. ... **NEVER RELEASE PATIENT RESULTS WHEN QC IS NOT IN RANGE!!**" Review of the Roche Cobas e411 QC records revealed: a. Bio-Rad Liquichek Specialty Immunoassay Level 3 QC results for Vitamin D were out of acceptable range on 16 days: 8/10/18, 8/3/18, 8/14/18, 8/17/18, 5/7/19, 5/10/19, 5/15/19, 5/23/19,5/24/19, 6/4 /19, 6/5/19, 6/6/19, 6/7/19, 6/12/19, 6/13/19, and 6/14/19. Additional QC documentation received from the IT (information technology) Liaison by email on 3 /19/20 revealed level 2 and level 3 QC results were out of acceptable range for Vitamin D on 11/20/19. The laboratory was unable to determine the number of patients tested on the days when QC was outside the acceptable limits for Vitamin D. b. Bio-Rad Lyphochek Immunoassay Level 1 QC results for FT4 (free thyroxine) were out of acceptable range on 3 days: 11/14/18, 11/15/18, and 11/20/18. Additional QC documentation received by email from the IT Liaison on 3/19/20 revealed level 1 QC was out of acceptable range for FT4 on 11/14/19. The laboratory was unable to determine the number of patients tested on the days when QC was outside the acceptable limits for FT4. c. Bio-Rad Lyphochek Immunoassay Level 3 was out of acceptable range for TSH (thyroid stimulating hormone) on 1/29/19. The laboratory was unable to determine the number of patients tested on the day when QC was outside the acceptable limits for TSH. 2. The laboratory's "IN-HOUSE QUALITY CONTROL PROTOCOL" states for the Envoy 500+, "1 High and 1 Low control ran every testing day or with any new lot number. After every calibration. ISE is calibrated and qc'd every 4 hours. ... **NEVER RELEASE PATIENT RESULTS WHEN QC IS NOT IN RANGE!!**" Review of the Envoy 500+ QC records revealed Bio-Rad Liquichek Levels 1 and 2 were out of acceptable range on 7/2/19 for ALP (Alkaline Phosphatase). The laboratory was unable to determine the number of patients tested on the day when QC was outside the acceptable limits for ALP. -- 2 of 5 -- D5779

Summary Statement of Deficiencies 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2019 AAFP (American Academy of Family Physicians) proficiency testing records 11/5/19, the laboratory failed to successfully participate in proficiency testing for HDL cholesterol in two consecutive proficiency testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2019 AAFP (American Academy of Family Physicians) proficiency testing records 11/5/19, the laboratory failed to achieve satisfactory performance for HDL cholesterol in two consecutive proficiency testing events, resulting in unsuccessful performance. Desk review of CMS 155D and 2019 AAFP proficiency testing results revealed: 1. The laboratory provided incorrect responses for 5 of 5 samples and received a score of 0% for HDL cholesterol on the 2019-A test event. 2. The laboratory provided incorrect responses for 4 of 5 samples and received a score of 20% for HDL cholesterol on the 2019-B test event. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2019 AAFP (American Academy of Family Physicians) proficiency testing records 11/5/19, the laboratory director failed to provide overall management and direction to ensure successful participation in proficiency testing. See the deficiency cited at D6016. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153 and 155 on 9/5/19 and desk review of 2019 AAFP (American Academy of Family Physicians) proficiency testing records 11/5/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Desk review of CMS 155D and 2019 AAFP proficiency testing results revealed: 1. The laboratory provided incorrect responses for 5 of 5 samples and received a score of 0% for HDL cholesterol on the 2019-A test event. 2. The laboratory provided incorrect responses for 4 of 5 samples and received a score of 20% for HDL cholesterol on the 2019-B test event. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with TP (testing personnel) 7/24/18, the laboratory failed to establish a written policy for specimen labeling. The laboratory's "VENIPUNCTURE PROCEDURE" states "... PERFORMANCE OF A VENIPUNCTURE: ... Identify the patient correctly. ... Mix and label all appropriate tubes." The procedure does not indicate the information included on the label, and does not indicate whether labels are computer-generated or handwritten. During interview at approximately 3:20 p.m., TP #1 confirmed that the laboratory's venipuncture procedure did not indicate the information that should be included on specimen labels. 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 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of manufacturers' instructions and review of temperature logs 7/24 /18, the laboratory failed to establish acceptable ranges for room temperature and freezer temperature that were consistent with manufacturers' requirements. Findings: 1. Room Temperature The Cobas ProCell product insert states "... Storage and stability Store at 15-25 degrees C. ..." The Cobas ProCell M product insert states "... Storage and stability Store at 15-25 degrees C. ..." Review of the laboratory's temperature logs revealed the acceptable range for room temperature was listed as 18- 30 degrees C (Celsius). 2. Freezer Temperature The BIO-RAD Liquichek Specialty Immunoassay Control product insert states "... This product will be stable until the expiration date when stored unopened at -20 to -70 degrees C. ..." Review of the laboratory's temperature logs revealed the acceptable range for freezer temperature was listed as -25 +/- 6 degrees C. 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 surveyor observation and testing personnel (TP) interview 07/24/18, the laboratory failed to discard diluent that had exceeded the expiration date. At approximately 2:00 p.m. the surveyor observed 1 bottle of Roche-Cobas Diluent Universal, Lot #180-209-02, expiration date 6/18, on the shelf in the door of the laboratory's refrigerator, available for use. During interview at approximately 2:00 p. m., TP #1 verified the diluent had expired and immediately disposed of the diluent. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of chemistry analyzer maintenance records and testing personnel (TP) interview 07/24/18, the laboratory failed to perform and/or document maintenance for the Vital Diagnostics Envoy 500+ chemistry analyzer and the Siemens DCA Vantage analyzer at the frequency specified by the manufacturer. 1. Review of manufacturer's instructions for the Vital Diagnostics Envoy 500+ chemistry analyzer pages 7-5 and 7-6 revealed "Weekly... Wipe the sample needles....Perform a Shutdown.....Extra Wash Cuvettes....". Review of 2018 maintenance records for the Vital Diagnostics Envoy 500+ chemistry analyzer revealed the laboratory failed to document and/or perform weekly maintenance for 1 week in March, 3 weeks in April and 3 weeks in May of 2018. Interview with TP #1 at approximately 1:00 p.m. confirmed the laboratory had failed -- 2 of 4 -- to document and/or perform the weekly maintenance of the Vital Diagnostics Envoy 500+ chemistry analyzer as required by the manufacturer. He stated he was sure the maintenance had been performed, but it had not been documented on the maintenance records. 2. The laboratory performs microalbumin and creatinine testing on 1 Siemens DCA Vantage chemistry analyzer and glycated hemoglobin testing on 2 Siemens DCA Vantage chemistry analyzers. Review of manufacturer's instructions for the Siemnes DCA Vantage chemistry analyzer page 97 revealed "...Maintenance Schedule...Weekly...Cleaning the Onboard Barcode Reader Window...Cleaning the Exterior...Quarterly...Removing and Cleaning the Cartridge Spring and Cartridge Area...Changing the Air Filter...Optical Test..." Review of 2017 and 2018 maintenance records for the 3 Siemens DCA Vantage chemistry analyzers revealed the laboratory had documented maintenance for the 2 analyzers that performed glycated hemoglobin testing, but failed to document maintenance for the 1 analyzer that performs microalbumin and creatinine testing. Interview with TP #1 at approximately 1:00 p.m. confirmed the laboratory had failed to document and/or perform the required maintenance for the 1 Siemens DCA Vantage chemistry analyzer that performs microalbumin and creatinine testing. He stated he was sure the maintenance was being performed, but it had not been documented. D5785