Newstart Family & Obstetrical Care Llc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records, testing personnel records, patient test records, and a staff interview, the laboratory failed to ensure that two of four testing personnel (testing personnel three and four) participated in proficiency testing in 2025 and 2026. 1. A review of the FORM CMS-209 revealed four individuals who performed patient testing for Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff). 2. A review of the laboratory's WSLH proficiency testing records revealed that testing persons three and four (as listed on Form CMS-209) did not participate in proficiency testing in 2025 or 2026. 3. A review of testing personnel records revealed that testing person three was signed off for initial competency on 03/24/25, and testing person four was signed off for initial competency on 02/20/25. 4. A review of randomly selected patient records revealed patient CBC w/Diff testing performed by testing person three (patient number 75765 on 03/02/26; patient numbers 74545 and 81835 on 05/27/26) and by testing person four (patient number 83747 on 05/27/26). 5. The lead testing person confirmed the survey findings during an interview on 07/23/26 at 1:15 p.m. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's testing personnel policy, a review of testing personnel training and competency assessment records, and staff interview, the laboratory failed to establish procedures for training that was in compliance with Subpart M, failed to follow established procedures for competency assessment, and failed to ensure the procedure required competency assessment twice during the first year of patient testing. This was cited on the previous survey from 10 /18/24, and compliance was not maintained. The findings include: 1. Laboratory observation on 07/23/26 at 8:55 a.m. revealed the Medonic M instrument was used to perform CBC w/Diff patient testing. 2. A review of the laboratory's testing personnel policy revealed that the policy did not define elements required for training, or a requirement for competency assessment twice during the first year of patient testing. The policy titled "Competency Assessment Checklist" revealed the following: "Key to methods used for competency evaluation: 1. Direct observations of routine patient test performance, including patient preparation, specimen handling, processing, testing. 2. Monitor the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records, proficiency test results, and preventive maintenance logs. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples. 6. Assessment of problem solving skills." 3. A review of testing personnel training and competency assessment records revealed the following: The training documentation for two of two new testing persons (three and four) did not include troubleshooting, control procedures, factors that affect test results, review of background counts, and evaluation of quality control data. Testing person three: The initial competency on 03/24/25 did not include assessment of specimen collection and handling, record review, evaluation of problem-solving skills, or assessment of test performance using previously analyzed specimens, internal blind testing, or external proficiency testing samples. The 6-month competency assessment performed on 09/30 /25 did not include assessment of specimen collection and handling, record review, evaluation of problem-solving skills, or assessment of test performance using previously analyzed specimens, internal blind testing, or external proficiency testing samples. The annual competency assessment performed on 03/27/26, did not include assessment of specimen collection and handling, record review, or assessment of test performance using previously analyzed specimens, internal blind testing, or external proficiency testing samples. Testing person four: The initial competency assessment performed on 02/20/25 did not include assessment of specimen collection, record review, evaluation of problem-solving skill, or assessment of test performance using previously analyzed specimens, internal blind testing, or external proficiency testing samples. The six-month competency assessment performed on 08/15/25 did not include assessment of specimen collection, record review, evaluation of problem- solving skills, or the assessment of test performance using previously analyzed specimens, internal blind testing, or external proficiency testing samples. The annual competency assessment performed on 02/25/26 did not include assessment of specimen collection, record review, or assessment of test performance using previously analyzed specimens, internal blind testing, or external proficiency testing samples. 4. The lead testing person confirmed the survey findings during an interview on 07/23/26 at 1:15 p.m. -- 2 of 5 -- 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 laboratory observation, a review of the manufacturer's control package insert, and staff interviews, on the survey date, the laboratory failed to label three of three control vials with the corrected expiration after opening. The findings include: 1. Laboratory observation on 07/23/26 at 8:55 a.m. revealed the Medonic M instrument used to perform CBC w/Diff patient testing. Three levels of Boule Con-diff control lots were observed (22603-01-Low, 22603-02-Normal, 22603-03-High), with 07/07 /26 written on the vials. During the observation, the lead testing person stated that it was the date the controls were opened. The controls were not labeled with a corrected expiration date. 2. A review of the manufacturer's control package insert revealed that the controls were good for 14 days after opening. 3. The lead testing person confirmed the survey findings during an interview on 07/23/26 at 1:15 p.m. 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. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the manufacturer's control package insert, the instrument data log, and a staff interview, the laboratory failed to ensure that three of three CBC w/Diff controls were not used beyond their open expiration date. Approximately 17 patients were reported on 07/22/26, during the period when the controls had expired. The findings include: 1. Laboratory observation on 07/23/26 at 8:55 a.m. revealed the Medonic M instrument used to perform CBC w/Diff patient testing. Three levels of Boule Con-diff control lots were observed (22603-01-Low, 22603-02-Normal, 22603-03-High), with 07/07/26 written on the vials. During the observation, the lead testing person stated that it was the date the controls were opened. 2. A review of the manufacturer's control package insert revealed that the controls were good for 14 days after opening. 3. A review of the instrument data log revealed that approximately 17 patient CBCs w/Diff were performed on 07/22/26 during the period when the controls had expired (patient medical record numbers 57992, 50986, 74135, 74134, 47248, 68746, 53467, 62723, 83703, 84600, 57576, 60242, 84458, 84397, 56128, 56128, 67060). 4. The lead testing person confirmed the survey findings during an interview on 07/23/26 at 1:15 p.m. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(g) (d)(7) Over time, rotate control material testing among all operators who perform the -- 3 of 5 -- test. This STANDARD is not met as evidenced by: Based on a review of the FORM CMS-209, a review of the laboratory's maintenance logs and quality control records, patient CBC w/Diff results, and staff interview, the laboratory failed to ensure quality control was performed by testing persons three and four (two of four testing personnel) in 2024, 2025, and 2026. 1. A review of the FORM CMS-209 revealed four testing personnel listed who performed patient testing for CBC w/Diff. 2. A review of the laboratory's maintenance and quality control records from November 2024 to the date of the survey on 07/23/26 revealed that testing persons (TP) three and four did not perform CBC w/Diff quality control. 3. A review of randomly selected patient records revealed patient CBC w/Diff testing performed by testing person three (patient number 75765 on 03/02/26; patient numbers 74545 and 81835 on 05/27/26) and by testing person four (patient number 83747 on 05/27/26). 4. The lead testing person confirmed the survey findings during an interview on 07/23/26 at 1:15 p.m. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records, testing personnel records, patient test records, and a staff interview, the laboratory director failed to ensure that two of four testing personnel (testing personnel three and four) participated in proficiency testing in 2025 and 2026. Refer to D2007. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's testing personnel policy, a review of testing personnel competency records, and staff interview, the laboratory director failed to ensure that policy and procedures for training and competency assessment were established and followed according to the requirements in Subpart M (Refer to D5209). D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) -- 4 of 5 -- (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of training documentation and staff interview, training documentation for testing persons three and four did not include instrument or sample troubleshooting, training on controls procedures, training on factors that affect patient test results, review of background counts, or evaluation of quality control data (two of two new testing personnel). The findings include: 1. A review of the training documentation for testing persons three and four revealed the training did not include instrument or sample troubleshooting, training on control procedures, factors that affect patient test results, review of background counts, or evaluation of quality control data. 2. The lead testing person confirmed the survey findings during an interview on 07/23/26 at 1:15 p.m. -- 5 of 5 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory personnel records, and staff interviews, the laboratory failed to follow its policy for testing personnel competency for three of three testing personnel (TP) that performed complete blood count (CBC) patient testing in 2023 and 2024. The findings include: 1. A review of the laboratory policy titled "Competency Assessment Checklist" revealed the following: "Key to methods used for competency evaluation: 1. Direct observations of routine patient test performance, including patient preparation specimen handling, processing, testing., 2. Monitor the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records, proficiency test results, and preventive maintenance logs. 4. Direct observations of performance of instrument maintenance and function checks., 5. Assessment of test performance through testing previously analyzed specimens internal blind testing samples, or external proficiency testing samples., 6. Assessment of problem solving skills". 2. A review of the Form CMS-209 revealed three TP who performed patient CBC testing. 3. A review of the laboratory personnel records revealed the following completed competency assessments did not include documenation of direct observation of routine patient test performance (1), review of intermediate test results or worksheets (3), assessment of test performance through previous samples or blind testing (5), or assessment of problem solving skills (6). TP1 The initial competency assessment completed on 10/23/2023. The 6-month competency assessment completed on 04/24/2024. TP2 The initial competency assessment completed on 10/23 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 -- /2023. The 6-month competency assessment completed on 04/24/2024. TP3 The initial competency assessment completed on 10/23/2023. The 6-month competency assessment completed on 04/24/2024. 4. An interview on 10/18/2024 at 12:00 p.m. with testing person one confirmed the laboratory failed to follow its policy for testing personnel competency assessment for three of three personnel who performed CBC patient testing in 2023 and 2024. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of quality control records, lack of records, and staff interviews, the laboratory failed to have a procedure to monitor precision and accuracy over time for the quality control (QC) used for the Medonic M series instrument used for complete blood count (CBC) patient testing in 2023 and 2024. The findings include: 1. Observation of the laboratory on 10/18/2022 at 9:40 a. m. revealed the Medonic M series (serial #49877) instrument used for CBC patient testing. 2. A review of the laboratory's QC records for the Medonic M series revealed the following: Lots 2230901, 2230902, 2230903 used 12/20/2023 Lots 2240131, 2240132, 2240133 used 04/04/2024 Lots 2240631, 2240632, 2240633 used 09/10 /2024 3. A review of the laboratory QC records revealed that the laboratory did not include records that monitor precision and accuracy over time. 3. An interview on 10 /18/2024 at 12:00 p.m. with testing person one confirmed that the laboratory did not have a process in place to monitor the accuracy and precision of the QC used for the Medonic M series for patient testing in 2023 and 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 During a recertification survey on 09/27/2023, the laboratory was found out of compliance with the following conditions: 42 CFR 493.801 Condition: Enrollment and testing of samples 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: Based on review of the Centers for Medicare and Medicaid Services Casper Report 0155D (CMS 155), lack of records, patient rest review, and staff interview, the laboratory was not enrolled in proficiency testing (PT) for the regulated White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet (Plt), and automated WBC differential (WBC Diff) in 2023. The findings include: 1. Review of the CMS 155 revealed no proficiency testing scores for 2023 for the WBC, RBC, Hgb, Hct, Plt and WBC Diff analytes.. 2. Review of the laboratory's proficiency test records revealed none were available for 2023. 3. Review of patient test reports revealed patient reporting for CBC on 03/02/2023 (patient 2556) and 08/24/2023 (patient 79808). 4. Interview on 09/27/2023 at 11:00 am with testing person one confirmed the laboratory did not enroll in PT for the regulated CBC analytes in 2023 with patient testing being performed and reported. 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 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report CLIA (Form CMS-209), laboratory policy, personnel records, patient test record review, and staff interview the laboratory's testing personnel competency assessment policy failed to include the six required criteria for assessing competency, and failed to ensure the policy included a requirement to re-assess competency when test methodology changes as required in Subpart M. The findings include: 1. Observation of the laboratory on 09/27/2023 at 9:20 am revealed a Medonic M Series CBC instrument (Serial # 49877) in use for CBC patient testing (new since last survey). 2. Review of the Form CMS-209 revealed two testing personnel that performed moderately complex CBC patient testing. 3. Review of the laboratory policy titled "Quality Assurance Program" in section 5 "Personnel Assessment" revealed the policy did not include the six competency assessment criteria or a requirement to re-assess competency when test methodologies or instruments change as required in Subpart M. 4. Review of the laboratory personnel records revealed the following: Competency assessments performed for two of two testing personnel in 2021, 2022, and 2023 did not include direct observation of test performance, monitoring recording and reporting of test results, review of preliminary results, worksheets, quality control (QC), PT, and preventative maintenance, direct observation of instrument maintenance and function checks, assessment of test performance through blind testing or external PT samples, or problem solving skills. Competency assessments were not assessed for two of two testing personnel prior to patient testing for the Medonic CBC instrument in use beginning 06/14/2022. 5. Review of patient test reports revealed the fist date of patient testing on the Medonic M Series CBC instrument was on 06/14/2022. 6. Interview on 09/27/2023 at 11:15 am with testing person one confirmed the laboratory failed to ensure the personnel policy included the requirements in Subpart M for competency assessments in 2021, 2022, and 2023. She further confirmed that competency assessments performed for testing persons one and two during the period did not include the required six elements. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, laboratory procedure review, patient test report review, and staff interview, the laboratory director did not approve, sign, or date the new procedure for the Medonic M Series CBC instrument used for patient testing prior to use in 2022. The findings include: 1. Observation of the laboratory on 09/27/2023 at 9:20 am revealed a Medonic M Series (serial # 49877) CBC instrument in use for patient testing (new since the last survey). 2. Review of the procedure in use -- 2 of 5 -- titled " Procedure Manual Boule Medonic M Series Hematology Analyzer" revealed the laboratory director had not approved, signed, or dated the procedure prior to patient testing that began 06/14/2022. 3. Review of patient test report revealed patient testing on the Medonic M Series began on 06/14/2022 (patient # 33413). 4. Interview on 09/27/2023 at 11:15 am with testing person one confirmed the laboratory director failed to approve, sign, and date the procedure prior to use for CBC patient testing in 2022 for the Medonic M Series instrument. 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 laboratory procedure, calibration records, and staff interview, the laboratory failed to follow the manufacturer instructions for calibration frequency for the Medonic M Series CBC instrument used for patient testing in 2022 and 2023. The findings include: 1. Observation of the laboratory on 09/27/2023 at 9:20 am revealed a Medonic M Series (serial # 49877) instrument in use for CBC patient testing. 2. Review of the laboratory procedure titled "Procedure Manual Boule Medonic M Series Hematology Analyzer" section "Calibration" revealed "Calibration must be performed upon setup of the instrument and then at a minimum of every six months". 3. Review of the laboratory calibration records revealed the following: Calibration performed 06/09/2022 (setup) No record of 6 month calibration due on 12/03/2022 4. Interview on 09/27/2023 at 11:15 am with testing person one confirmed the laboratory failed to perform calibrations according to the manufacturer requirements in 2022 for the Medonic M Series CBC instrument. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the CMS 155, lack of records, patient test review, and staff interview, the laboratory director failed to ensure the laboratory was enrolled in an -- 3 of 5 -- approved HHS PT program for 2023 for the CBC regulated analytes to include WBC, RBC, Hgb, Hct, Plt, and WBC Diff (See D2000). The findings include: 1. Review of the CMS 155 revealed no PT scores for the regulated CBC analytes for 2023. 2. There were no PT records available for review on the date of the survey (09/27/2023) for 2023. 3. Patient test report review revealed CBC results reported on 03/02/2023 (patient # 2556) and 08/24/2023 (patient # 79808). 4. Interview on 09/27/2023 at 11: 00 am with testing person one confirmed the laboratory director failed to ensure the laboratory was enrolled in PT for the regulated CBC analytes in 2023 with patient testing being performed and reported. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of personnel records, and staff interview, the laboratory director failed to ensure testing personnel (two of two) were trained prior to patient CBC results reported using the Medonic M series CBC instrument in 2022. The findings include: 1. Observation of the laboratory on 09/27 /2023 at 9:20 am revealed a Medonic M series (serial # 49877) instrument in use for CBC patient testing (new since the last survey). 2. Review of the laboratory personnel records reveled the following: The training documents for testing person one for use of the Medonic M Series CBC instrument did not include the laboratory director's signature. There was no documented training for use of the Medonic M Series CBC instrument for testing person two. 4. Interview on 09/27/2023 at 11:15 am with testing person one confirmed the laboratory director failed to review training documents for testing person one to ensure training was adequate, and failed to ensure testing person two received training for use of the Medonic M Series CBC instrument with patient testing that began on 06/14/2022. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on laboratory record review and staff interview, the laboratory director failed to specify in writing the responsibilities and duties of consultants and testing personnel that performed CBC patient testing in 2021, 2022, or 2023. The findings include: 1. Laboratory record review revealed responsibilities and duties of consultants and testing personnel was not available on the date of the survey (09/27/2023). 2. Interview on 09/27/2023 at 11:15 am with testing person one confirmed the laboratory director failed to ensure there were written responsibilities and duties for the testing personnel who perform patient testing for CBC on the date of the survey (09/27 /2023). -- 5 of 5 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to follow policy for investigation of unacceptable proficiency testing scores (Refer to D5291), failed to follow manufacturer instructions for calibration (Refer to D5437), and failed to use correct quality control ranges (Refer to D5469). D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, proficiency testing records and interview with the lead testing person, the laboratory failed to follow the policy for evaluation of unsatisfactory proficiency testing results in 2020. The findings include: 1. Review of the laboratory's policy titled "Quality Assurance Plan" revealed the following statement: "We will carefully evaluate any unacceptable, unsatisfactory, or unsuccessful proficiency testing result in an effort to identify the cause of failure." 2. Review of the laboratory's proficiency testing records revealed the following: 2020 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 -- event A for hematology was not submitted on time. Self grade of the proficiency testing scores revealed unacceptable results for White Blood Cell, Lymphocyte %, Monocyte %, Granulocyte %, Red Blood Cell, Hemoglobin, Hematocrit, MCV, Platelet Count and RDW. No