Care-Clinics For Abortion & Reproductive Excellenc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of the proficiency testing (PT) procedure, review of patient testing logs, and interview with the testing person (TP), the laboratory failed to document the PT sample results in the same manner as patient results. Findings: 1. The laboratory performed Rh typing. Patient results were recorded in a daily log. 2. The "Proficiency Testing" procedure stated that "The staff member and samples run will also be documented on a laboratory log day sheet in the same manner as patient samples." 3. The daily patient logs were reviewed for 2023. 4. The laboratory submitted PT results for three events in 2023. None of the PT results were documented on the daily patient logs as patient results were. 5. During the survey on 02/05/2024 at 12:15 PM, the TP confirmed that the PT results were not documented on the daily patient logs in 2023. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: 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 -- Based on review of the manufacturer's product insert (PI) and interview with the testing person (TP), the laboratory failed to follow manufacturer's instructions for using a timer for the incubation step when performing patient Rh typing. Findings: 1. The laboratory used the ALBAclone Anti-D blend slide technique for patient Rh typing. 2. The "General Information" section of the PI stated "When a test is required to be incubated for a specific time period, a timer should be used" and the "Slide Technique" section of the PI stated to "incubate the test at 18-24 C for 5 minutes with occasional mixing." 3. During the survey on 02/05/2024 at 12:15 PM, the TP confirmed that the laboratory does not use a timer to time the 5 minute incubation step. 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 review of the manufacturer's product insert (PI), review of the daily testing logs, and interview with the testing person (TP), the laboratory failed to document the room temperature on days when patient Rh typing was performed. Findings: 1. The laboratory used the ALBAclone Anti-D blend slide technique for patient Rh typing. 2. The "Slide Technique" section of the PI stated to "incubate the test at 18-24 C for 5 minutes with occasional mixing." 3. The laboratory recorded all Rh testing information on a daily patient testing log. Logs were reviewed for 2023 and 2024. The log form template changed after 07/29/2023. 4. The logs from 07/29/2023 and before captured the daily room temperature. After 07/29/2023, the daily room temperature was no longer recorded. 5. During the survey on 02/05/2024 at 12:15 PM, the TP confirmed that the daily room temperature was no longer recorded after 07/29/2023. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 review of the procedure, review of the daily patient testing logs, and interview with the testing person (TP), the laboratory failed to document the lot number and expiration date of the patient control used for Rh typing. Findings: 1. The laboratory tested ALBAcheck BGS Monoclonal Control with every patient as a control for spontaneous agglutination. 2. The laboratory recorded all Rh testing information on a daily patient testing log. Logs were reviewed for 2023 and 2024. The log form template changed after 07/29/2023. 3. The logs from 07/29/2023 and before included a section to document the lot number and expiration date of the BGS -- 2 of 5 -- Monoclonal Control. After 07/29/2023, the logs did not include this section so the lot number and expiration date were no longer recorded. 4. During the survey on 02/05 /2024 at 12:15 PM, the TP confirmed that the lot number and expiration date of the ALBAcheck BGS Monclonal Control were no longer being recorded after 07/29 /2023. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's product insert (PI), review of the daily patient testing logs, and interview with the testing person (TP), the laboratory failed to record the results for the patient control used for Rh typing. Findings: 1. The laboratory used the ALBAclone Anti-D blend slide technique for patient Rh typing. 2. The laboratory tested ALBAcheck BGS Monoclonal Control with every patient as a control for spontaneous agglutination. 3. The PI for the Anti-D blend stated "If a control test for spontaneous agglutination is desired, ALBAcheck - BGS Monoclonal Control ...may be substituted for the blood grouping reagent in the testing procedure. A negative result would serve as an appropriate control. If the monoclonal control test gives a positive reaction, a valid interpretation of the results obtained in red blood cell testing cannot be made without further investigation." 4. The laboratory recorded all Rh testing information on a daily patient testing log. Logs were reviewed for 2023 and 2024. The log form template changed after 07/29/2023. 5. The logs from 07/29/2023 and before included a section to document the patient results for the BGS Monoclonal Control. After 07/29/2023, the logs did not include this section so the patient control results were no longer recorded. 6. During the survey on 02/05/2024 at 12:15 PM, the TP confirmed that the patient results for the ALBAcheck BGS Monclonal Control were no longer being recorded after 07/29/2023. 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: Based on review of the federal report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory failed to successfully participate in the API PT program for immunohematology testing, in which the laboratory is certified under CLIA (D2162). D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) 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 -- 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 the federal report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the same analyte in two out of three consecutive testing events. 1. Failure to attain a score of at least 100% of acceptable responses for D (Rh) typing is unsatisfactory performance. 2. The laboratory received the following scores from API for D (Rh) typing: a. 80% in the 2022 3rd PT event b. 60% in the 2022 1st PT event 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 review of the federal report for unsuccessful proficiency testing (PT) results and review of the comparative evaluation report from American Proficiency Institute (API), the laboratory director failed to ensure an approved

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with Testing Person One, the afternoon of the day of survey, the laboratory did not have procedures to ensure testing of Rh proficiency test samples was performed by additional staff only after the results were reported to the proficiency test provider. Findings: 1. Proficiency test records show that Rh testing was performed by two testing persons April 13, 2022 (first test event 2022) and December 8, 2021 (third test event of 2021), the samples were tested by two different people and there was no documentation and no policy to show that the testing performed by the second person was performed after the results were already submitted to the proficiency test provider; and 2. This was confirmed with Testing Person One during the survey exit. 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 records and interview with Testing Person One on the afternoon of the day of survey, the laboratory did not maintain a record of each specimen tested by the laboratory and did not have records of the director review of 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 -- the proficiency test providers evaluation and the test providers scores for each sample tested for Rh testing. Findings: 1. The laboratory director did not document review for individual test scores of events 1, 2 and 3 of 2021 and event 3 of 2020 ( the lab failed to participate with this event); 2. The laboratory did not maintain a record showing each test score for each sample tested for events 1, 2 and 3 of 2021; and 3. This was confirmed with Testing Person One at the survey exit. 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 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory (lab) did not monitor and evaluate quality control testing for Rh testing. The lab failed to ensure that quality control test results met the laboratory's criteria for acceptability prior to reporting patient test results for Rh testing (refer to D5481 for findings); the lab failed to ensure that

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --