Scotsdale Women's Center

Summary Statement of Deficiencies 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 interview with the Laboratory Director (LD), the laboratory failed to establish and implement a policy to assess testing personnel competency for 16 (February 24, 2021 to June 23, 2022) of 16 months reviewed. Findings include: 1. A review of the laboratory's policies and procedures revealed a lack of a policy regarding competency assessments for testing personnel. 2. A review of the laboratory's competency assessment documentation revealed a lack of competency assessment for 16 (February 24, 2021 to June 23, 2022) of 16 months as follows: 6 month assessment a. Testing Personnel #3 (TP3) - lack of documentation for the 6 month assessment which was due in 1/ 2021. Annual assessments due in 2021 a. TP4 - lack of documentation for 9/2021 b. TP5 - lack of documentation for 9 /2021 c. TP6 - lack of documentation for 7/2021 d. TP7 - lack of documentation for 9 /2021 3. When queried on 6/23/2022 at 10:50 am the LD was unable to provide the surveyor the documentation requested. 4. An interview on 6/23/2022 at approximately 10:50 am, the LD confirmed the laboratory failed to establish and properly implement TP competency assessments. ***Repeat Deficiency from the 4/14/2016 survey*** 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 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 -- 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 failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to ensure the immunohematology Rh quality control was performed and documented before patient testing. Refer to D5445. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to perform and document the function checks as required for the room temperature and refrigerator for 2 (2/25/2021 and 6/11/2021) of 16 days of patient testing reviewed. Findings include: 1. A record review revealed lack of documentation of the room temperature and refrigerator for 2 of 16 days reviewed as follows: a. 2/25/2021 - lack of documentation b. 6/11/2021 - lack of documentation 2. A record review of the "Quality Assurance Program Specifics" policy, the laboratory failed to follow procedures for completing the daily checklist by "Record (Fahrenheit) temperature reading from the refrigerator and Record (Fahrenheit) room temperature of the lab area. Ambient temperature." 3. An interview on 6/23/2022 at 9:40 am, the LD confirmed the laboratory failed to follow procedure for recording the room temperature and refrigerator daily. 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 with the Laboratory Director (LD), the laboratory failed to ensure the immunohematology Rh quality control was performed and documented before patient testing for 2 (2/25/2021 and 6/11/2021) of 16 days reviewed. Findings include: 1. A record review of the "Daily Laboratory Checklist" revealed for 2 (2/25/2021 and 6/11/2021) of 16 days reviewed, the laboratory did not -- 2 of 3 -- perform and document the positive and negative immunohematology Rh quality control before patient testing as follows: a. 2/25/2021 - 16 patients tested b. 6/11/2021 - 15 patients tested 2. A record review of the "Quality Assurance Program Specifics" policy, the laboratory failed to follow procedures for completing the daily checklist by "Run a positive and negative control for Rh Typing as per Rh Testing Protocol." 3. A interview on 6/23/2022 at 9:40 am, the LD confirmed the Rh positive and negative control was not performed and documented each day of testing. ***Repeat Deficiency from the 5/22/2018 and 2/24/2021 surveys*** -- 3 of 3 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on record review and interview with the new Laboratory Director (LD), the LD failed to approve, sign, and date for 4 (10/17/2020 to 2/17/2021) of 4 months since taking the director position the "Laboratory Manual" that included the immunohematology Rh group procedures. Findings include: 1. A record review revealed for 4 (10/17/2020 to 2/17/2021) of 4 months in the LD position, the "Laboratory Manual" with the immunohematology Rh group procedures were not approved, signed, and dated. 2. A interview on 2/17/2021 at approximately 10:31 am, the LD confirmed he did not approve, sign, and date the procedures located in the "Laboratory Manual." 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 observation and interview with the Laboratory Director (LD) and Testing Personnel (TP) #4, the laboratory was using expired blood drawing tubes for 3 (Becton Dickinson (BD) vacutainer plasma separator tube (PST) Gel and lithium heparin, BD vacutainer serum separator tube (SST), and BD vacutainer dipotassium 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 -- ethylenediaminetetraacetic acid (K2EDTA) of 3 tubes expired. Findings include: 1. On 2/17/2021 at 9:20 am, during a tour of the laboratory, the surveyor randomly pulled tubes from the storage container in the blood drawing station and the tubes had expired: a. BD vacutainer PST Gel and lithium heparin - lot 9315457 expired 11/30 /2020 b. BD vacutainer SST - lot 9196157 expired 7/31/2020 c. BD vacutainer K2EDTA - lot 8276808 expired 3/31/2020 2. A interview on 2/17/2021 at 9:20 am, the LD and TP4 confirmed the blood drawing tubes had expired. 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 with the Laboratory Director (LD), the laboratory failed to ensure the immunohematology Rh quality control was performed and documented before patient testing for 2 days (10/11/2019 and 10/12/2019) of 2 years of documents reviewed. Findings include: 1. A record review of the "Daily Laboratory Checklist" revealed for 2 days (10/11/2019 and 10/12/2019) of 2 years of documents reviewed, the laboratory did not perform and document the positive immunohematology Rh quality control before patient testing as follows: a. 10/11/2019 - no documentation of the positive Rh control, no patient testing performed b. 10/12 /2019 - no documentation of the positive Rh control, 4 patients were tested 2. A interview on 2/17/2021 at approximately 12:45 pm, the LD confirmed the Rh positive control was not performed and documented. *** Repeat Deficiency from the 5/22 /2018 survey*** D5785

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 Proficiency Testing (PT) data report (CASPER Report 155) and review of the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in immunohematology analyte D (Rho) typing. The laboratory had unsatisfactory scores for the 3rd event 2017, 1st event 2018, 3rd event 2019, and the 1st event 2020. See D2163 D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) 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 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 record review of the Proficiency Testing (PT) data report (CASPER Report 155) and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the analyte D (Rho) typing which has sustained a subsequent occurrence of unsuccessful participation in the speciality of immunohematology. Findings include: D (Rho) typing PT Event Score 3rd event 2017 0% 1st event 2018 0% 3rd event 2019 80% 1st event 2020 0% -- 2 of 2 --