West Hills Health Care Clinic

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records and discussion with testing personnel (TP), the laboratory failed to ensure that the testing personnel and the Laboratory Director (LD) signed the attestation form for each proficiency testing event from Medical Laboratory Evaluation (MLE/ACP). Findings include: 1. For Event #1, 2020, the LD did not sign or date the attestation form. 2. For Event #2, 2020, neither the TP or the LD signed or dated the attestation form. 3. For Event #3, 2020, neither the TP or the LD signed or dated the attestation form. 4. For Event #2, 2021, neither the TP or the LD signed or dated the attestation form. 5. For Event #2, 2021, there was no

Summary Statement of Deficiencies 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: Review of proficiency testing results from the Medical Laboratory Evaluation (MLE) showed that the laboratory failed two consecutive events for the analyte Sodium (Na). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) showed the laboratory had unsuccessful participation for the 1st and 2nd event of 2021 for the analyte Sodium (Na). Findings include: 1. 1st event 2021 Sodium (Na) = 60% 2. 2nd event 2021 Sodium (Na) = 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 records and discussion with the Technical Consultant (TC), the laboratory failed to perform Quality Control (QC) testing each day of patient testing. Findings include: 1. The instrument used to detect bacterial, fungal and protozoan vaginal infection known as the AFFIRM was not being QC'd each day of patient testing using a positive and a negative control for each of the three analytes. 2. The TC verified this during interview 8/19/2019 at approximately 1100. 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 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: Review of proficiency testing results from the Medical Laboratory Evaluation (MLE) revealed that the laboratory had subsequent failure in proficiency testing for Cell Identification or WBC Differential in the specialty Hematology . Refer to D2130.. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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: Review of the Medical Laboratory Evaluation Proficiency Testing reports revealed that the laboratory had subsequent failure in Cell Identification or WBC Differential. Findings include: 1. 1st event of 2018 - 0765 - Cell Identification or WBC Differential = 0% 2. 3rd event of 2018 - 0765 - Cell Identification or WBC Differential = 66% 3. 1st event of 2019 - 0765 - Cell Identification or WBC Differential = 20% 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: Review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) records revealed that the laboratory director (LD) failed to fulfill the laboratory director's responsibilities to make sure the laboratory achieved satisfactory performance of PT in each test events. Refer to D6018 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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: Review of proficiency testing results from the Medical Laboratory Evaluation (MLE) reveals that the laboratory director failed to ensure that the laboratory successfully participated in the proficiency testing for Cell Identification or WBC Differential in Hematology . Refer to D2122 and D2130.. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Review of the Medical Laboratory Evaluation Proficiency Testing reports reveals the laboratory failed to attain an overall passing score of 80% in Hematology. Findings include: 1. 1st event of 2018 - 0760 -Hematology = 76% 2. 3rd event of 2018 - 0760- Hematology = 71% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Review of the Medical Laboratory Evaluation Proficiency Testing reports reveals the laboratory failed to achieve satisfactory performance for 2 out of 3 testing events in Cell Identification or WBC Differential. Findings include: 1. 1st event of 2018 - 0765 - Cell Identification or WBC Differential = 0% 2. 3rd event of 2018 - 0765- Cell Identification or WBC Differential = 66% -- 2 of 2 --