Kids Clinic

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the laboratory tour, review of the Complete Blood Count (CBC) Quality Control (QC) package insert, and an interview with the Testing Personnel 1 (TP1), the laboratory failed to write the open expiration dates on the QC vials. The surveyor noted the three levels of QC currently in use had no dates written on the vials when they were opened. The findings include: 1. During the laboratory tour on 05-23-2025 at approximately 8:48 AM the surveyor observed the three levels of CBC QC in use had no dates written on the vials. The TP had not recorded the new expiration date upon opening, on the vials. 2. A review of the package insert revealed the QC materials should not be utilized more than 14 days after opening. 3. In an interview with TP1 on 05-23-2025 at 8:50 AM on, she stated they never write dates on the QC vials because they replaced them every 8 days and if anything was written on the QC label, it will get smeared when handled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 3 -- This STANDARD is not met as evidenced by: Based on a review of the Complete Blood Count (CBC) Quality Control (QC) records for the Sysmex XP-300 analyzer, Patient records, and an interview with the Testing Personnel 1 (TP1), the laboratory utilized expired QC materials prior to patient testing. The surveyor noted all three levels of expired CBC QC materials were used for 7 of the 31 days in August 2024. The findings include: 1. A review of the CBC QC records revealed the laboratory had utilized the three levels of CBC QC, Lot numbers 41350710, 41350711, 41350712, Expiration date of 08-21-2024 for the following days. There were 18 patients performed and reported during the seven-day period. A) 08-22-2024 and 08-23-2024 (Two days) B) 08-26-2024 through 08-30- 2024 (Five Days) 2. During an interview with the TP1 on 05-23-2025 at approximately 11:42 AM, TP1 stated she became aware the expired CBC QC were used prior to patient testing when the surveyor discovered them. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 a review of the Sysmex XP-300 Maintenance Log, and an interview with the Testing Personnel 1(TP1), the laboratory failed to completely document the weekly maintenance. The surveyor noted the missing weekly maintenance occurred 7 of the 12 months in 2024. The findings include: 1. A review of the Sysmex XP-300 Maintenance Logs revealed a place to document weekly maintenance for the analyzer. For the months of February, March, May, August, October, November and December, the weekly maintenance was only performed and documented during the first week of each month. The second, third and fourth weeks were not completed. 2. A further review of the Sysmex XP-300 Maintenance Log revealed the manufacturer's specification to clean the SRV tray weekly. 3. During the exit interview with TP1 on 05-23-2025 at 1:35 PM, the TP1 confirmed the above findings and agreed incomplete documentation of the required weekly maintenance. 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. This STANDARD is not met as evidenced by: Based on a review of the Hematology Quality Control (QC) records and an interview with the Testing Personnel 1 (TP1), the laboratory had missing documentation of the -- 2 of 3 -- mechanism to monitor for shifts and trends of test performance over time. This was noted for 8 of the 12 months in 2023. The findings include: 1. A review of the Sysmex XP 300 QC records revealed the following months in 2023 had no evidence of Levey- Jennings charts or peer group comparison data: a) March, May, June, July, August, October, November, and December. 2. During the exit conference on 05-23-2025 at 1: 35 PM, TP1 confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the environmental records and an interview with Testing Personnel #1, the Laboratory failed to ensure humidity in the room in which the Sysmex XP 300 Hematology analyzer was operated was within the manufacturer's acceptable limits. Humidity was noted below acceptable ranges for 55 days from 2021 to 2023. The findings include: 1. A review of the Sysmex XP 300 Hematology temperature records revealed Humidity was below the manufacturer's acceptable parameters (30-85%) for a total of 55 days as follows: A) November and December 2021; 8 days B) January through March and October through December 2022; 44 days C) January 2023; 3 days 2. During an interview on February 10, 2023, at 12:05 PM, Testing Personnel #1 confirmed the above findings. 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 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 review of patient test reports and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure patient reports included all required parameters. The findings include: 1. On 5/25/2021 at 3:50 PM, the surveyor reviewed the post-analytical process in the facility. Upon the surveyor's request, TP #1 provided the instrument printout and an EMR (Electronic Medical Record) report from ReliMed Solutions with patient CBC (Complete Blood Count) results; TP #1 stated both can be used as patient reports. 2. A review of the ReliMed Solutions EMR report for revealed no units of measurement for CBC analyes, and a review of the instrument printout from the Sysmex XP-300 (in use since 9/22/2020) revealed no laboratory address. 3. In an interview on 5/25/2021 at approximately 3:53 PM, TP #1 confirmed the above noted findings. . D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on a review of personnel files, the installation records for the Sysmex XP-300 Hematology analyzer, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure training for Testing Personnel was performed and documented prior to analyzing patient specimens and reporting CBC (Complete Blood Counts) results. This affected 4 of 4 testing personnel, who perform moderate-complexity testing. The findings include: 1. A review of the Sysmex XP- 300 records revealed the analyzer was installed on 9/22/2020; The Laboratory Director approved the validation procedures on the same day, and the laboratory began using the instrument for patient CBC testing. 2. A review of the personnel files of Testing Personnel (TP) listed on the Form CMS-209 (Laboratory Personnel Report) revealed TP #1, #2, #3, and #4 had been employed since the previous survey on 4/18 /2019. However, there was no documentation of training on the new Sysmex XP-300 Hematology analyzer. 3. During an interview on 5/25/2021 at 1:20 PM, the surveyor asked TP #1 for testing personnel training documentation on the Sysmex XP-300. TP #1 explained she was trained by the Sysmex Technician during the installation, then she had trained the other TP, however the training was not documented. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on initial tour observations, a review of installation records, a review of the operators' guidelines for the Reichert Unistat Bilirubinometer, a lack of documentation of specification verifications for the Bilirubinometer (Chemistry testing) and Emerald Cell-Dyn (Hematology), and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the instruments performed, according to the manufacturers' claims for accuracy, precision and analytical measurable range, prior to beginning patient testing. The findings include: 1. During the initial tour of the laboratory, on April 18, 2019, TP #1 stated the laboratory performed CBCs (Complete Blood Counts) on the Emerald Cell-Dyn and Bilirubins on the Reichert Bilirubinometer. TP #1 also stated the laboratory began patient testing on February 1, 2019. 2. A review of the CLIA manual revealed the Emerald Cell-Dyn was installed in February 2019, with a calibration being performed on February 6, 2019. The Bilirubinometer was installed on January 7, 2019, with documented calibration (only one manufacturer's glass cuvette used) and one high control cuvette. 3. On April 18, 2019 at 10:40 AM, the surveyor inquired about the installation and validation studies for the Cell-Dyn. TP #1 stated she performed a calibration and ran quality controls (QC), which she was instructed to do by the individual who sold the laboratory the instrument. When asked about the purchase of 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 -- the instrument, TP #1 explained the Cell-Dyn had been purchased from on-line, and identified the company as "Beke Diagnostics." TP #1 further explained the company had not provided any validation studies to prove accuracy, precision or reportable range, other than a certificate (see paragraph 4). During the interview at 10:40 AM, when asked about the installation and validation of the Bilirubinometer, TP #1 stated she had performed the manufacturer recommended calibration only. At 11:03 AM, the surveyor asked for clarification of the initial studies performed on the Bilirubinometer. TP #1 explained she only used the calibration cuvette, supplied by the manufacturer and the high control cuvette supplied by the manufacturer, as well. No calibration verification had been performed. 4. Further review of the records revealed a "Certificate of Quality Assurance" from "BEKU DIAGNOSTICS, INC." for the Cell-Dyn Emerald, which indicated the following: "It is hereby certified that the following Cell-Dyn Emerald analyzer, with serial No. 033610-001360 has been assembled in compliance with the requirements and specifications listed by the Original Equipment Manufacturer. Inspections records, quality evidence and other objective information are on file at the point of assembly." This certificate was dated January 22, 2019, and was not signed by the Laboratory Director. An "INSTRUMENT VERIFICATION/PREVENTATIVE MAINTENANCE" record for the Cell Dyn Emerald, with the same serial number, from the same company, and dated 01/15/2019 included the following check-marked categories: "1. ANALYZER; a. Lubricate the Pistons. b. Replace all defective / worn parts. c. Check, clean and adjust sampler assembly. d. Check Pressure Levels. e. Clean backwash system. f. Bleach RBC / WBC apertures and electrodes. g. Replace O-rings. l. Verify syringes. 2. GAIN ADJUSTMENT VERIFICATION 3. QUALITY CONTROL..." 5. A review of the manufacturer's guidelines for the Reichert Unistat Bilirubinometer, page 14, revealed the following: "6.4 Calibration Verification Two assayed glass cuvettes are provided with the REICHERT UNISTAT Bilirubinometer: ...Calibration Cuvette ... High-Level Check Cuvette... glass cuvettes may be used to check the bilirubinometer at the mid and high points... A sample cuvette (Reichert cat. no. 13102140) filled with distilled water may be used to check zero. ...Low-Level Check Cuvette (assay value approximately 12 mg/dL (205 umol/L)) may be purchased separately." D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's CLIA manual (with policies and procedures), a review of Chemistry Quality Control (QC) records, a review of the manufacturer's guidelines for the Reichert UNISTAT Bilirubinometer, a review of the patient test logs, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to perform at least two levels of quality control each day of patient testing for Bilirubin, in the absence of an IQCP (Individualized Quality Control Plan). This affected at least twenty-seven patients, who had Bilirubin testing from February - April 15, 2019. The findings include: 1. A review of the CLIA manual revealed the Bilirubinometer was installed on January 7, 2019, with a documented calibration (only one manufacturer's glass cuvette used) and one high control cuvette. 2. A review -- 2 of 7 -- of QC records for Bilirubin testing revealed only one level (high) of quality control had been run on the instrument on the day of installation, January 7, 2019; although patient testing occurred on multiple days in February, March and April. 3. The patient test logs indicated five patients were tested in February; nine patients in March and thirteen patients in April (from the third to the fifteenth day). 4. In an interview on 4 /18/2019 at 11:20 AM, the surveyor discussed the requirement of quality control testing for Chemistry (at least two levels of external quality control each day of patient testing, unless an IQCP is developed to reduce the frequency of testing the QC). TP #1 stated the laboratory did not establish an IQCP. 5. A review of the manufacturer's guidelines for the Reichert Unistat Bilirubinometer, page 14, revealed the following: "7.1 Use of Commercial Serum Controls Analysis of at least a normal and abnormal level of a commercial serum control, assayed for total bilirubin, is recommended for checking performance of the Reichert Unistat Bilirubinometer. 7.2 Quality Control Frequency Quality control procedures should be performed before and after each sample run in response to questionable patient results and/or as mandated by local regulations." 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 initial tour observations, a review of installation records, a review of the operators' guidelines for the Reichert Unistat Bilirubinometer, a lack of documentation of specification verifications for the Bilirubinometer (Chemistry testing) and Emerald Cell-Dyn (Hematology), a review of quality control and personnel records, a review of patient test logs, and interviews with Testing Personnel (TP) #1, the surveyor determined the Laboratory Director failed to fulfill the director's responsibilities as noted in the following paragraphs: The findings include: 1. The Laboratory Director failed to ensure the position of Technical Consultant was filled with a qualified individual (must meet qualifications at 493.1411) to provide technical oversight in accordance with the CLIA (Clinical Laboratory Improvement Amendments) regulations at 493.1413. Refer to D6028, D6033 and D6034. 2. The Laboratory Director failed to ensure testing personnel analyzed at least two levels of quality control each day of patient testing for Bilirubin, in the absence of an IQCP (Individualized Quality Control Plan). This affected at least twenty-seven patients, who had Bilirubin testing from February - April 15, 2019. Refer to D6020 and D5447. 3. The Laboratory Director failed to ensure the instruments (Cell-Dyn Emerald and Reichert Unistat Bilirubinometer) performed, according to the manufacturers' claims for accuracy, precision and analytical measurable range, prior to beginning patient testing in February 2019. Refer also to D6013 and D5421. 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 -- 3 of 7 -- 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 initial tour observations, a review of installation records, a review of the operators' guidelines for the Reichert Unistat Bilirubinometer, a lack of documentation of specification verifications for the Bilirubinometer (Chemistry testing) and Emerald Cell-Dyn (Hematology), and an interview with Testing Personnel (TP) #1, the surveyor determined the Laboratory Director failed to ensure the instruments performed, according to the manufacturers' claims for accuracy, precision and analytical measurable range, prior to beginning patient testing. The findings include: 1. During the initial tour of the laboratory, on April 18, 2019, TP #1 stated the laboratory performed CBCs (Complete Blood Counts) on the Emerald Cell- Dyn and Bilirubins on the Reichert Bilirubinometer. TP #1 also stated the laboratory began patient testing on February 1, 2019. 2. A review of the CLIA manual revealed the Emerald Cell-Dyn was installed in February 2019, with a calibration being performed on February 6, 2019. The Bilirubinometer was installed on January 7, 2019, with documented calibration (only one manufacturer's glass cuvette used) and one high control cuvette. 3. On April 18, 2019 at 10:40 AM, the surveyor inquired about the installation and validation studies for the Cell-Dyn. TP #1 stated she performed a calibration and ran quality controls (QC), which she was instructed to do by the individual who sold the laboratory the instrument. When asked about the purchase of the instrument, TP #1 explained the Cell-Dyn had been purchased from on-line, and identified the company as "Beke Diagnostics." TP #1 further explained the company had not provided any validation studies to prove accuracy, precision or reportable range, other than a certificate (see paragraph 4). During the interview at 10: 40 AM, when asked about the installation and validation of the Bilirubinometer, TP #1 stated she had performed the manufacturer recommended calibration only. At 11: 03 AM, the surveyor asked for clarification of the initial studies performed on the Bilirubinometer. TP #1 explained she only used the calibration cuvette, supplied by the manufacturer and the high control cuvette supplied by the manufacturer, as well. No calibration verification had been performed. 4. Further review of the records revealed a "Certificate of Quality Assurance" from "BEKU DIAGNOSTICS, INC." for the Cell-Dyn Emerald, which indicated the following: "It is hereby certified that the following Cell-Dyn Emerald analyzer, with serial No. 033610-001360 has been assembled in compliance with the requirements and specifications listed by the Original Equipment Manufacturer. Inspections records, quality evidence and other objective information are on file at the point of assembly." This certificate was dated January 22, 2019, and was not signed by the Laboratory Director. An "INSTRUMENT VERIFICATION/PREVENTATIVE MAINTENANCE" record for the Cell Dyn Emerald, with the same serial number, from the same company, and dated 01/15/2019 included the following check-marked categories: "1. ANALYZER; a. Lubricate the Pistons. b. Replace all defective / worn parts. c. Check, clean and adjust sampler assembly. d. Check Pressure Levels. e. Clean backwash system. f. Bleach RBC / WBC apertures and electrodes. g. Replace O-rings. l. Verify syringes. 2. GAIN ADJUSTMENT VERIFICATION 3. QUALITY CONTROL..." 5. A review of the manufacturer's guidelines for the Reichert Unistat Bilirubinometer, page 14, revealed the following: "6.4 Calibration Verification Two assayed glass cuvettes are provided with the REICHERT UNISTAT Bilirubinometer: ...Calibration Cuvette ... High-Level Check Cuvette... glass cuvettes may be used to check the bilirubinometer at the mid and high points... A sample cuvette (Reichert cat. no. 13102140) filled with -- 4 of 7 -- distilled water may be used to check zero. ...Low-Level Check Cuvette (assay value approximately 12 mg/dL (205 umol/L)) may be purchased separately." 6. See also D5421. 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 review of the laboratory's CLIA manual (with policies and procedures), a review of Chemistry Quality Control (QC) records, a review of the manufacturer's guidelines for the Reichert UNISTAT Bilirubinometer, a review of the patient test logs, and an interview with Testing Personnel (TP) #1, the surveyor determined the Laboratory Director failed to ensure testing personnel analyzed at least two levels of quality control each day of patient testing for Bilirubin, in the absence of an IQCP (Individualized Quality Control Plan). This affected at least twenty-seven patients, who had Bilirubin testing from February - April 15, 2019. The findings include: 1. A review of the CLIA manual revealed the Bilirubinometer was installed on January 7, 2019, with a documented calibration (only one manufacturer's glass cuvette used) and one high control cuvette. 2. A review of QC records for Bilirubin testing revealed only one level (high) of quality control had been run on the instrument on the day of installation, January 7, 2019; although patient testing occurred on multiple days in February, March and April. 3. The patient test logs indicated five patients were tested in February; nine patients in March and thirteen patients in April (from the third to the fifteenth day). 4. In an interview on 4/18/2019 at 11:20 AM, the surveyor discussed the requirement of quality control testing for Chemistry (at least two levels of external quality control each day of patient testing, unless an IQCP is developed to reduce the frequency of testing the QC). TP #1 stated the laboratory did not establish an IQCP. 5. A review of the manufacturer's guidelines for the Reichert Unistat Bilirubinometer, page 14, revealed the following: "7.1 Use of Commercial Serum Controls Analysis of at least a normal and abnormal level of a commercial serum control, assayed for total bilirubin, is recommended for checking performance of the Reichert Unistat Bilirubinometer. 7.2 Quality Control Frequency Quality control procedures should be performed before and after each sample run in response to questionable patient results and/or as mandated by local regulations." 6. See also D5447. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in -- 5 of 7 -- accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CMS form #209), a review of the personnel records, and an interview with Testing Personnel (TP) #1, the surveyor determined the Laboratory Director failed to ensure the position of Technical Consultant was filled with a qualified individual (must meet qualifications at 493.1411) to provide technical oversight in accordance with the CLIA (Clinical Laboratory Improvement Amendments) regulations at 493.1413. The findings include: 1. Refer to D6033 and D6034. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CMS form #209), a review of the personnel records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the position of Technical Consultant was filled with a qualified individual (must meet qualifications at 493.1411) to provide technical oversight in accordance with the CLIA (Clinical Laboratory Improvement Amendments) regulations at 493.1413. The findings include: 1. A review of the CMS form #209 revealed the laboratory staff had listed the Laboratory Director as the Technical Consultant. 2. The personnel file of the Laboratory Director failed to include supporting documentation of qualifications as a technical consultant, which is required for a laboratory, performing moderate complexity testing. 3. At 11:15 AM on 4/18/2019, the surveyor discussed the credentials and qualifications of the technical consultant with TP #1. TP #1 confirmed the qualifications were not on file at the laboratory; but may be possible to obtain. The surveyor asked the testing personnel to fax or email the qualifications by 12:00 Noon on Friday, April 19. Nothing was received by the State Agency from the laboratory by 3:00 PM on April 29, 2019. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CMS form #209), a review of the personnel records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to ensure the position of Technical Consultant was filled with a qualified individual (must meet qualifications at 493.1411) to provide -- 6 of 7 -- technical oversight in accordance with the CLIA (Clinical Laboratory Improvement Amendments) regulations at 493.1413. The findings include: 1. Refer to citation D6033, 493.1409. -- 7 of 7 --