Desert Star Institute For Family Planning

Summary Statement of Deficiencies D0000 An onsite recertification survey was performed on April 26, 2023. It was determined that Immediate Jeopardy (IJ) existed for the following condition-level deficiencies: 42 C.F.R. 493.1217 Condition: Immunohematology 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 lack of Proficiency Testing (PT) records for 2023 and interview with the facility personnel, the laboratory failed to enroll in an HHS approved PT program for the regulated analyte, D(RHO), under the subspecialty of ABO Group and Rh Group, which is included in subpart I . Findings include: 1. No documentation was presented for review during the survey conducted on April 26, 2023 to indicate the laboratory was enrolled in a CMS-approved PT program for 2023 for the regulated analyte, D (RHO), for which the laboratory performed patient testing. 2. The facility personnel interviewed via email on July 3, 2023 at 3:25 PM confirmed that the laboratory was not enrolled in an HHS approved PT program for the regulated analyte, D(RHO), at the time of the survey conducted on April 26, 2023. 3. The laboratory's annual test volume reported on the CMS-116 form provided during the survey is 500. D2015 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records for review from 2022 and interview with the laboratory director, the laboratory failed to maintain a copy of all PT records for a minimum of 2 years from the date of the proficiency testing event. Findings include: 1. The laboratory performs D(RHO) testing in the specialty of Immunohematology, with an approximate annual test volume of 500. 2. During the survey conducted on April 26, 2023, the laboratory failed to produce evidence of the following PT documentation from the second testing event of 2022: - Attestation statements signed by the Laboratory Director and testing personnel - Copy of the PT program report form used by the laboratory to record PT results 3. The laboratory director interviewed on April 26, 2023 at 10:20 AM confirmed that the PT records indicated above could not be located during the survey. 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 Proficiency Testing (PT) reports for 2022 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the subspecialty of ABO/Rh Group and the regulated analyte, D (RHO), under the specialty of Immunohematology. Findings include: 1. The laboratory's PT -- 2 of 10 -- performance was unsatisfactory for the second event of 2022 for the subspecialty, ABO/Rh Group, with a score of 0%. 2. The laboratory's PT performance was unsatisfactory for the second event of 2022 for the regulated analyte, D (RHO), with a score of 0%. 3. The laboratory's PT performance was unsatisfactory for the third event of 2022 for the subspecialty, ABO/Rh Group, with a score of 80%. 4. The laboratory's PT performance was unsatisfactory for the third event of 2022 for the regulated analyte, D (RHO), with a score of 80%. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) reports for 2022 sent to the State Agency by the PT provider and interview with the laboratory director, the laboratory failed to attain a score of at least 100 percent of acceptable responses for each analyte/test in each testing event for testing performed under the specialty of Immunohematology. Findings include: 1. The laboratory's PT performance was unsatisfactory for the third event of 2022 for the regulated analyte, D (RHO), with a score of 80% . 2. The laboratory director interviewed on 4/26/2023 at 10:12 AM acknowledged the unsatisfactory PT score of 80% for D (RHO) for the third PT event of 2022. 3. The laboratory's reported annual test volume in the specialty of Immunohematology is 500. 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 Proficiency Testing (PT) reports for 2022 sent to the State Agency by the PT provider and interview with the laboratory director, the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program resulting in a score of 0 for the second testing event of 2022. Findings include: 1. Review of the laboratory's PT records from American Proficiency Institute (API) indicated the laboratory received a score of 0% for the second testing event of 2022 for the regulated analyte, D (RHO), resulting in unsatisfactory performance. 2. The laboratory director interviewed on 4/26/2023 at 10: 10 AM stated, "the laboratory failed to submit the PT results (for the second testing event of 2022) by the deadline" resulting in a score of 0 for the second testing event of 2022. D2160 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(e) (1) For any unsatisfactory testing event for reasons other than a failure to participate, -- 3 of 10 -- the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency for 2022, the laboratory failed to undertake appropriate training, technical assistance and remedial action necessary to correct problems associated with proficiency test failures for the regulated analyte, D (RHO), and for the subspecialty, ABO/Rh Group. See D2016 for findings. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in 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 review of Proficiency Testing (PT) reports for 2022 sent to the State Agency by the PT provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, D (RHO), in two consecutive testing events resulting in unsuccessful PT performance. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory performance for the subspecialty of ABO Group and Rh Group for the second and third events of 2022, resulting in unsuccessful PT performance. See D2016 for findings. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited for services provided in the -- 4 of 10 -- specialty of Immunohematology, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. See D5211, D5403, D5441, D5445 and D5791 for findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2022 and interview with the laboratory director, the laboratory failed to provide a documented review of PT results from the 3rd testing event of 2022. Findings include: 1. The laboratory participates in PT for the regulated analyte, D(RHO), in the specialty of Immunohematology. The laboratory's reported annual test volume of 500. 2. No evidence, either by written comment or signature, was presented during the survey conducted on April 26, 2023 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 3rd testing event of 2022. 3. Review of the laboratory's PT scores for the 3rd testing event of 2022 revealed the laboratory received a unsatisfactory score of 80% for the analyte, D(RHO), and 80% for the subspecialty, ABO Group and Rh Group. 4. The laboratory director interviewed on April 26, 2023 at 10:23 AM confirmed the PT results indicated above were not reviewed by laboratory personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records for review and interview with the laboratory director, the laboratory failed to maintain a copy of all PT records for a minimum of 2 years. Findings include: 1. The laboratory performs moderate complexity patient testing under the specialty of Immunohematology, with an approximate annual test volume of 1,000. It is the practice of the laboratory to participate in three PT events per year for the regulated analyte, Rh testing. 2. No documentation was presented for review for the 1st event of 2016 to indicate the laboratory maintained copies of all the PT records, including a copy of the PT program report form used by the laboratory to record results and the attestation statement signed by the analyst and laboratory director. 3. The laboratory director confirmed that the records indicated above could not be located during the survey. ** This is a repeat deficiency from the last survey conducted on 04/20/2016. 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 --