Women & Teens Healthcare Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 27, 2024 through September 3, 2024. Women & Teens Healthcare Inc clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record Quality Control (QC) when the frequency for testing was reduced since July of 2022 until July of 2024 for the ABO Group & Rh Group Antibody Detection. Findings included: 1- The laboratory did not record daily quality control (QC) in 2023. The laboratory did not provide External QC files referenced in the QC log for 10/30/2022 and 02/05/2024 in the QC files provided. 2- Review of the Quality Control procedure section 3 states that "Data is collected for monitoring quality control including control material evaluation, tolerance limits, linearity and calibration. Data is reviewed and maintained in the department as well as Levy-Jennings and statistical analysis. A minimum of two levels of quality control samples will be run prior to and each day of patient testing. The laboratory will follow the Westgard multiple rule procedure for Quality Control acceptability as defined in the Quality Control." 3- The Blood Grouping Reagent instructions for use (PN e631200466 EN) Anti-D Anti-Rh BioClone is a qualitative 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 -- test for recognition of the D(Rho) antigen on human red blood cells, states "Quality Control testing is required to confirm the reactivity of the product prior to use. Positive control-red blood cells known to possess the D antigen, preferably of phenotype R1. Negative control-red blood cells known to lack the D antigen." 4- Interview on 8/27/2024 at 1:50 PM with laboratory office manager stated that volume of testing had significantly decreased. Surveyor requested QC records. On 8/29/2024 the office manager sent incomplete QC logs and surveyor asked for follow-up documentation to be provided by 09/03/2024. 5-On 09/03/2024 the office manager emailed at 10:03 AM "We run a QC control and submit only failures to the laboratory for correction." The laboratory did not provide additional documentation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on October 23, 2020 for Women & Teens Healthcare Inc., is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of ABO/RH in the specialty of Immunohematology. Refer to D2163. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services 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 -- (CMS) 153 and 155 reports, on October 23, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, ABO and Rh, for two consecutive testing events in 2020. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of of ABO/Rh, under the specialty of immunohematology. Findings include: On October 23, 2020 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analytes ABO and Rh, as shown below. Event #1, 2020 ABO-60% Rh-60% Event #2, 2020 ABO-80% Rh- 80%. 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of ABO/Rh under the specialty of immunohematology. Findings include: On October 23, 2020, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analytes, ABO and Rh, in the sub-specialty of ABO/RH in the specialty of immunohematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2163 . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analytes, ABO and Rh, in the subspecialty of ABO/RH in the specialty of immunohematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on October 23, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2020 ABO-60% Rh-60% Event #2, 2020 ABO-80% Rh-80%. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/05/2020 found that the Women & Teens Healthcare Inc clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. Cited the following Condition: -D6063 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 record review and staff interview, the laboratory failed to document the initial competency assessment for 2 out of 2 new Testing Personnel (TP) who started on year 2020. Findings include: 1)Review of CMS 209 Laboratory Personnel Report, which was dated and signed by the Laboratory Director (LD) on 08/24/2020 revealed the following: -The laboratory had 5 TP (A, B, C, D, E) 2) Review of employee folders revealed that TP C started on 5/28/2020, TP E started on 3/20/2020. There was no documentation of the initial evaluation performed by the Technical Consultant before the TP started testing. During an interview on 10/05/2020 at 11:30 AM, with office manager, she confirmed that the laboratory failed to document the initial competency assessment for the TP listed above. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. 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 CONDITION is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to verify the education of 2 (A, C) out of 5 (A-E) Testing Personnel. See D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the education of 2 (A and C) out of 5 (A-E) testing personnel (TP). Findings include: - Review of CMS 209 Laboratory Personnel Report, which was dated and signed by the Laboratory Director on 08/24/2020 included 5 TP (TP A-E). -Review of employee files revealed that for TP A there was no High School Diploma, and for TP C a Nursing Assistant; the Certificate and a Foreign High School Diploma did not show a valid equivalence evaluation in the Unites States. During an interview on 10/05/2020 at 11:30 am with office manager, she confirmed that the laboratory failed to have documentation that meet the criteria of the education requirement for the TP listed above. -- 2 of 2 --

Summary Statement of Deficiencies D2159 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing records and interview with office manager, the laboratory failed 1 out of 3 events for ABO /RHO test during the year 2016. Findings include: Review of API proficiency records revealed that the laboratory failed the ABO/RHO second event of 2016 with a 0 % score due to late submit of results. During an interview on 9/11/2018 at 11:30 AM, the office manager confirmed that the laboratory failed to submit on time the event of reference. 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 record review and interview with the office manager, the laboratory failed to 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 -- document the room temperature for 2 out of 2 years Findings include: Review of the Blood Grouping Reagent Anti D (Anti Rh) user manual indicated a requirement for room temperature range 15 to 30 C, there was no documentation of the room temperature for the period of 2017 to 2018. During an interview on 09/12/18 at 11:30 a.m., the office manager confirmed that there was no record of room temperature for the years of reference. 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 review of quality control records and interview with the officer manager, the laboratory failed to run positive and negative control for Anti D testing from 2017 to 2018. Findings include: Review of Blood Grouping Reagent Anti D (Anti Rh) (BioClone) manufacturer instructions revealed that quality control testing is required to confirm reactivity of the product prior to use. Review of quality controls log, revealed that no positive and negative control ran from 2017 to 2018. During an interview on 9/11/2018 at 11:30 am the office manager confirmed that no positive and negative controls were currently being run. -- 2 of 2 --