Reproductive Services

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of ABO Group and D (Rho) Typing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Compatbility Testing. Refer to D2160 and D2162. 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 -- 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, 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 a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for ABO Group and D (Rho) Typing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third event in 2017 and the first event in 2018. Refer to D2162. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The findings were reviewed with the clinic adminstrator at the conclusion of the survey. 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 a review of records, manufacturer's instructions, observation, and interview with the clinic administrator, the laboratory failed to ensure materials were being stored as required. Findings include: (1) At the beginning of the survey, the clinic administrator stated the following to the surveyors: (a) Rh slide typing was performed using the Baxter Rh Viewbox; (b) Patient blood specimens were collected in Becton Dickinson Vacutainer K2 EDTA 10.8 mg tubes. (2) Later during the survey, surveyor #1 observed the laboratory and reviewed the manufacturer's instructions for the room temperature requirements, which were as follows: (a) The Baxter Rh Viewbox required an ambient operating temperature of 18-26 degrees Centigrade (C); (b) The Becton Dickinson EDTA Vacutainer tubes required storage at 4-25 degrees C (26 tubes, lot #6342985, were observed in the laboratory). (3) Surveyor #1 then reviewed temperature records for 7 months (January, October, November, and December 2017; and January, February, and March 2016) and identified the following for 1 of 7 months: (a) January 2017 - There was no documentation the room temperature had been monitored 17 of 17 days of patient testing (days 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 -- 03,04,05,06,10,11,12,13,17,18,19,20,21,24,25,26,31). (4) The surveyors reviewed the findings with the clinic administrator who stated the room temperature had not been monitored as indicated above. -- 2 of 2 --