Columbia Pediatric Clinic

Summary Statement of Deficiencies D0000 Intakes: TN00049973 Surveys were performed on December 5, 2019 and January 28, 2020 on the following two laboratories: On December 5, 2019, a recertification survey was performed on Columbia Pediatric Clinic, 44D2068197, located at 1003 Reserve Blvd., Suite 110, Spring Hill, TN 37174 (Laboratory A). On January 28, 2020, a complaint survey was performed on Columbia Pediatric Clinic, 44D0315886, located at 1600 Nashville Hwy., Columbia, TN 38401 (Laboratory B). Laboratory A performs complete blood count with differential on the Horiba ABX Micros 60 and neonatal bilirubin on the Unistat Bilirubinometer. Laboratory B performs complete blood count with differential on the Horiba ABX Micros 60, neonatal bilirubin on the Unistat Bilirubinometer, urine microscopy and wet prep. Both laboratories are enrolled and participate in proficiency testing with the same proficiency testing program, the College of American Pathologists (CAP). 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: Columbia Pediatric Clinic failed to ensure its laboratories did not participate in any communications or discussions across sites/locations concerning proficiency testing (PT) sample results until after the date the PT results were due (Refer to D2011). 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 -- D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of Laboratory A quality assurance and proficiency testing records, Laboratory B quality assurance and proficiency testing records, and interview with the director of Laboratory A, the Columbia Pediatric Clinic failed to ensure laboratories did not participate in inter-laboratory communications concerning proficiency testing sample results until after the date the PT results were due in 2018 and 2019. The findings include: 1) Review of Laboratory A quality assurance records and proficiency testing event cutoff dates provided by the laboratory's proficiency testing program revealed the following: Presence of complete blood count (CBC) instrument printouts for proficiency testing samples from Laboratory B for 2018 event two and 2019 event two. The printouts for both events were faxed to Laboratory A prior to the PT program's results due date. Instrument printouts for 2018 event two were faxed to Laboratory A on May 25, 2018 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2- 09, FH2-10). The PT results for 2018 event two had an assigned due date by the PT provider for May 29, 2018. Instrument printouts for 2019 event two were faxed to Laboratory A on May 28, 2019 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2- 09, FH2-10). The PT results for 2019 event two had an assigned due date by the PT provider for May 28, 2019. 2) Review of Laboratory B quality assurance and proficiency testing records revealed the presence of complete blood count (CBC) instrument printouts for proficiency testing sample numbers FH2-06, FH2-07, FH2- 08, FH2-09, and FH2-10 for 2019 event two that were performed at Laboratory A. The fax date on the printouts was May 28, 2019 (five of five proficiency testing CBC instrument printouts).The results due date for 2019 event two Hematology was May 28, 2019. 3) Interview with the director of Laboratory A on December 5, 2019 at 2 p. m. confirmed Columbia Pediatric Clinic failed to ensure Laboratory A did not participate in inter-laboratory communication with Laboratory B until after the date PT results were due to the PT provider for event two 2018 and 2019. The interview also confirmed that Laboratory A received faxed instrument printouts for proficiency testing results from Laboratory B for events 2018 event two and 2019 event two. Furthermore, during interviews conducted on January 28, 2020 at 2:45 pm at Laboratory B it was determined that Laboratory A faxed proficiency testing results to Laboratory B for 2019 event two. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. -- 2 of 6 -- This CONDITION is not met as evidenced by: The laboratory failed to perform calibration of the Bilirubinometer instrument (Refer to D5437), failed to perform calibration verification of the Bilirubinometer instrument (Refer to D5439), and failed to have an effective quality assessment process for the Bilirubinometer instrument (Refer to D5793). D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's instruction manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to follow manufacturer's instructions for calibration in 2018 and 2019. The findings include: 1. Observation of the laboratory on December 5, 2019 at 9:00 a.m. revealed the Reichert Unistat Bilirubinometer on the counter in use for pediatric patient testing for total bilirubin. (Serial number 09943-0817). 2. Review of the manufacturer's instruction manual revealed that the Bilirubinometer is to be calibrated at least every six months, or earlier if indicated by quality control data, using stable assayed glass calibration cuvette. 3. Review of laboratory records revealed no records were present for calibration of the Bilirubinometer in 2018 or 2019. 4. Interview with the laboratory liaison on December 5, 2019 at 12:20 p.m. confirmed the laboratory failed to follow the manufacturer's instructions for calibration of the Bilirubinometer every six months in 2018 and 2019. 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 -- 3 of 6 -- 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 Bilirubinometer manufacturer's instruction manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to perform calibration verification of the Reichert Bilirubinometer instrument in 2018 and 2019. The findings include: 1. Observation of the laboratory on December 5, 2019 at 9:00 a.m. revealed the Reichert Unistat Bilirubinometer on the counter in use for pediatric patient testing for total bilirubin. (Serial number 09943-0817). 2. Review of the manufacturer instructions for the Reichert Bilirubinometer revealed that the Bilirubinometer calibration can be verified using assayed glass cuvettes to check the mid and high points of the 0-40 mg /dL measuring range and that a sample cuvette filled with distilled water may be used to check zero. 3. Review of laboratory records revealed no records were present for verifying the calibration of the Bilirubinometer in 2018 or 2019. 4. Interview with the laboratory liaison on December 5, 2019 at 12:20 p.m. confirmed the laboratory uses the manufacturer's stated measuring range of 0-40 mg/dL and failed to perform calibration verification at least every six months using a low, mid and maximum value in 2018 and 2019. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 Intakes: TN00049973 Surveys were performed on December 5, 2019 and January 28, 2020 on the following two laboratories: On December 5, 2019, a recertification survey was performed on Columbia Pediatric Clinic, 44D2068197, located at 1003 Reserve Blvd., Suite 110, Spring Hill, TN 37174 (Laboratory A). On January 28, 2020, a complaint survey was performed on Columbia Pediatric Clinic, 44D0315886, located at 1600 Nashville Hwy., Columbia, TN 38401 (Laboratory B). Laboratory A performs complete blood count with differential on the Horiba ABX Micros 60 and neonatal bilirubin on the Unistat Bilirubinometer. Laboratory B performs complete blood count with differential on the Horiba ABX Micros 60, neonatal bilirubin on the Unistat Bilirubinometer, urine microscopy and wet prep. Both laboratories are enrolled and participate in proficiency testing with the same proficiency testing program, the College of American Pathologists (CAP). 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: Columbia Pediatric Clinic failed to ensure its laboratories did not participate in any communications or discussions across sites/locations concerning proficiency testing (PT) sample results until after the date the PT results were due (Refer to D2011). 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 -- D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of Laboratory A quality assurance and proficiency testing records, Laboratory B quality assurance and proficiency testing records, and interview with the director of Laboratory A, the Columbia Pediatric Clinic failed to ensure laboratories did not participate in inter-laboratory communications concerning proficiency testing sample results until after the date the PT results were due in 2018 and 2019. The findings include: 1) Review of Laboratory A quality assurance records and proficiency testing event cutoff dates provided by the laboratory's proficiency testing program revealed the following: Presence of complete blood count (CBC) instrument printouts for proficiency testing samples from Laboratory B for 2018 event two and 2019 event two. The printouts for both events were faxed to Laboratory A prior to the PT program's results due date. Instrument printouts for 2018 event two were faxed to Laboratory A on May 25, 2018 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2- 09, FH2-10). The PT results for 2018 event two had an assigned due date by the PT provider for May 29, 2018. Instrument printouts for 2019 event two were faxed to Laboratory A on May 28, 2019 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2- 09, FH2-10). The PT results for 2019 event two had an assigned due date by the PT provider for May 28, 2019. 2) Review of Laboratory B quality assurance and proficiency testing records revealed the presence of complete blood count (CBC) instrument printouts for proficiency testing sample numbers FH2-06, FH2-07, FH2- 08, FH2-09, and FH2-10 for 2019 event two that were performed at Laboratory A. The fax date on the printouts was May 28, 2019 (five of five proficiency testing CBC instrument printouts).The results due date for 2019 event two Hematology was May 28, 2019. 3) Interview with the director of Laboratory A on December 5, 2019 at 2 p. m. confirmed Columbia Pediatric Clinic failed to ensure Laboratory A did not participate in inter-laboratory communication with Laboratory B until after the date PT results were due to the PT provider for event two 2018 and 2019. The interview also confirmed that Laboratory A received faxed instrument printouts for proficiency testing results from Laboratory B for events 2018 event two and 2019 event two. Furthermore, during interviews conducted on January 28, 2020 at 2:45 pm at Laboratory B it was determined that Laboratory A faxed proficiency testing results to Laboratory B for 2019 event two. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. -- 2 of 6 -- This CONDITION is not met as evidenced by: The laboratory failed to perform calibration of the Bilirubinometer instrument (Refer to D5437), failed to perform calibration verification of the Bilirubinometer instrument (Refer to D5439), and failed to have an effective quality assessment process for the Bilirubinometer instrument (Refer to D5793). D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's instruction manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to follow manufacturer's instructions for calibration in 2018 and 2019. The findings include: 1. Observation of the laboratory on December 5, 2019 at 9:00 a.m. revealed the Reichert Unistat Bilirubinometer on the counter in use for pediatric patient testing for total bilirubin. (Serial number 09943-0817). 2. Review of the manufacturer's instruction manual revealed that the Bilirubinometer is to be calibrated at least every six months, or earlier if indicated by quality control data, using stable assayed glass calibration cuvette. 3. Review of laboratory records revealed no records were present for calibration of the Bilirubinometer in 2018 or 2019. 4. Interview with the laboratory liaison on December 5, 2019 at 12:20 p.m. confirmed the laboratory failed to follow the manufacturer's instructions for calibration of the Bilirubinometer every six months in 2018 and 2019. 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 -- 3 of 6 -- 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 Bilirubinometer manufacturer's instruction manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to perform calibration verification of the Reichert Bilirubinometer instrument in 2018 and 2019. The findings include: 1. Observation of the laboratory on December 5, 2019 at 9:00 a.m. revealed the Reichert Unistat Bilirubinometer on the counter in use for pediatric patient testing for total bilirubin. (Serial number 09943-0817). 2. Review of the manufacturer instructions for the Reichert Bilirubinometer revealed that the Bilirubinometer calibration can be verified using assayed glass cuvettes to check the mid and high points of the 0-40 mg /dL measuring range and that a sample cuvette filled with distilled water may be used to check zero. 3. Review of laboratory records revealed no records were present for verifying the calibration of the Bilirubinometer in 2018 or 2019. 4. Interview with the laboratory liaison on December 5, 2019 at 12:20 p.m. confirmed the laboratory uses the manufacturer's stated measuring range of 0-40 mg/dL and failed to perform calibration verification at least every six months using a low, mid and maximum value in 2018 and 2019. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of