Woods Cardiology Internal Medicine

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #2 (TP2), the laboratory failed to follow its policy for specimen collection for 1 of 1 venous blood collection observed. Findings include: 1. The surveyor observed TP2 on 4/6/22 at 9:10 am perform a venipuncture blood collection. Prior to the collection, TP2 asked the patient to hold gauze. Once finished filling the tubes, TP2 asked the patient to hold the gauze on the site where the needle was in the puncture site with their hand prior to TP2 pulling the needle out and sheathing the needle. 2. A review of the laboratory's "Specimen Collection by Venipuncture" procedure revealed a section titled "Performing the venipuncture stating, "After the last tube is filled, remove the tube, but maintain the needle in the vein. Once the tube is removed; place gauze just above the puncture site. In one clean movement, remove the needle and apply pressure. Be sure not to apply pressure until the needle is out of the arm, as this will cause pain to the patient." 3. An interview on 4/6/22 at 1:00 pm with TP2 confirmed they did not follow the laboratory's procedure for performing venipuncture blood collection. **This is a repeated deficiency from the 9/23/21 complaint survey and the 11/10/21 revisit survey** D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to indicate the address of the laboratory location where testing was performed for 12 (patients 18466, HF349694575, 6405, 6963, 50120, 97230, HF326124745, HF155360188, HF305150835, 22862, HF129584972, and 5190) of 12 patient test reports reviewed. Findings include: 1. A review of test reports revealed a lack of address of the laboratory location where testing was performed for the following patients: a. Patient 18466, reported on 04/01/2022. b. Patient HF349694575, reported on 03/10/2022. c. Patient 6405, reported on 03/02/2022. d. Patient 6963, reported on 02/21/2022. e. Patient 50120, reported on 02/10/2022. f. Patient 97230, reported on 01/12/2022. g. Patient HF32612474, reported on 12/08 /2021. h. Patient HF155360188, reported on 12/15/2021. i. Patient HF305150835, reported on 11/12/2021. j. Patient 22862, reported on 11/30/2021. k. Patient HF129584972, reported on 10/20/2021. l. Patient 5190, reported on 09/22/2021. 2. An interview on 4/6/22 at 1:00 pm with the TC confirmed the laboratory did not include the address of the laboratory on test reports for the patients listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint #MI00122664. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) and Immediate Jeopardy was identified for the following Condition: 493.1240 Condition: Preanalytic systems D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on a lack of documentation and interview with the Technical Consultant, the laboratory failed to retain quality control and test system maintenance records for 17 (September 2019 to March 2021) of 24 months reviewed. Findings include: 1. The surveyor requested quality control and test system maintenance records from the previous two years of testing on 9/23/21 at 10:14 am and records from September 2019 to March 2021 were not available. 2. An interview on 9/23/21 at 10:14 am with the Technical Consultant confirmed quality control and test system maintenance records were not retained for at least two years. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: . Based on a lack of documentation and an interview with the Technical Consultant, the laboratory failed to retain quality assessment records for 17 (September 2019 to March 2021) of 24 months reviewed. Findings include: 1. The surveyor requested quality assessment documentation from the previous two years on 9/23/21 at 10:14 am and records from September 2019 to March 2021 were not made available. 2. An interview on 9/23/21 at 10:14 am with the Technical Consultant revealed the laboratory did not retain documentation of quality assessments for at least 2 years. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to meet applicable preanalytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to follow their specimen labeling procedure. Refer to D5311 A. 2. The laboratory failed to establish policies and procedures for the acceptable conditions for specimen transportation. Refer to D5311 B. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interviews, the laboratory failed to follow their specimen labeling procedure for 4 (3 blood tubes and 1 urine cup) of 4 unlabeled specimens observed. Findings include: 1. The surveyor observed 3 unlabeled blood tubes in the draw station area across from the laboratory during a tour of the facility on 9/23/21 at 10:31 am. 2. An interview with Testing Personnel #1 (TP1) and Testing Personnel #2 (TP2) on 9/23/21 at 10:31 am confirmed the 3 blood tubes were in the draw station unlabeled. 3. The surveyor asked TP1 and TP2 how the laboratory would verify which patient these tubes came from on 9/23/21 at 10:31 am and was not given a response. 4. The surveyor observed a conversation between TP1, TP2, and a staff member in the clinic reception area on 9/23/21 at 10:31 am which revealed the staff member in the clinic reception area had drawn the tubes, did not label them, and left the draw station area to perform other tasks. 5. The surveyor observed the staff member identified as leaving the tubes in the draw station label the three tubes with a first and last name prior to placing them in the test tube rack near -- 2 of 7 -- the centrifuge in the laboratory on 9/23/21 at 10:33 am. 6. A review of the laboratory's "Specimen Collection by Venipuncture" policy revealed a section stating, "A. Specimen Identification: the following three things must be on each specimen patients full name, patients date of birth, date and time of specimen collection" and a section titled "Tube Selection" stating, "Specimen collection tubes are not to be labeled until after the collection of the specimen and before the patient is allowed to leave the collection area. Specimens must be properly labeled before proceeding on to any other task. A tube should not be allowed to sit unlabeled at anytime." 7. The surveyor observed an unlabeled urine cup in the laboratory sink on 9/23/21 at 10:55 am. 8. An interview on 9/23/21 at 10:55 am with TP2 confirmed the urine cup in the laboratory sink was unlabeled and had an aliquot sent for send out testing at the reference laboratory. B. Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to establish policies and procedures for the acceptable conditions for specimen transportation for 2 (September 2019 to September 2021) of 2 years reviewed. Findings include: 1. An interview on 9/23/21 at 10:53 am with TP1 revealed specimens from another clinic are transported to their facility for laboratory testing. 2. The surveyor requested a policy or procedure for the conditions for specimen transportation on 9/23/21 at 3:36 pm and one was not made available. 3. An interview on 9/23/21 at 3:36 pm with TP1 confirmed the laboratory did not establish a policy or procedure for the conditions of specimen transportation. 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 interviews, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1.The laboratory failed to verify the manufacturer-established performance specifications prior to reporting patient test results. Refer to D5421. 2. The laboratory failed to perform controls each day of patient testing and follow control procedures for the NanoEnTek Frend immunoassay analyzer. Refer to D5445. 3. The laboratory failed to perform and document

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 CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: urea nitrogen (BUN). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for two of two consecutive proficiency testing events for the chemistry analyte: BUN. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the analyte: urea nitrogen (BUN), which is unsatisfactory performance for the testing events. Findings include: BUN PT Event Score 1st event 2018 40% 3rd event 2017 40% 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 unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte urea nitrogen (BUN) in two of two consecutive testing events. Findings include: Unsatisfactory performance for two of two consecutive proficiency testing events constitutes unsuccessful performance for BUN: BUN PT event Score 1st event 2018 40% 3rd event 2017 40% -- 2 of 2 --