Newstart Family & Obstetrical Care Llc

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