Baymeadows Healthcare

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 laboratory's proficiency testing records for 2018 and 2019, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on August 21, 2019 on or about 8:30 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, TSH (thyroid stimulating hormone) for two consecutive testing events in 2019. 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 -- 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the subspecialty of routine chemistry. Findings include: On August 21, 2019 on or about 8:30 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, thyroid stimulating hormone (TSH), as shown below. Event #1, 2019 TSH-40% Event #2, 2019 TSH-60% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On august 21, 2019, on or about 8:30 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analyte, thyroid stimulating hormone (TSH), in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for -- 2 of 3 -- the analyte, thyroid stimulating hormone (TSH) in the subspecialty of routine chemistry. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on August 21, 2019 on or about 8:30 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2019 TSH-40% Event #2, 2019 TSH-60% -- 3 of 3 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to enroll in a proficiency testing program for the requested addition of specialty of Bacteriology. The findings include: The review of proficiency testing records for the requested addition of Neisseria Gonorrhoeae testing and Chlamydia testing on the GeneXpert instrument showed the laboratory had not established means to verify accuracy of its testing procedures by enrolling in a proficiency testing program. The interview on 3/28 /18 at 12:00pm confirmed the laboratory had not enrolled in proficiency testing because they thought the analytes were waived. 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 record review and laboratory staff interview, the laboratory did not test proficiency test samples the same number of times it tests patient samples for 3 of 9 testing events reviewed for 2017. The findings include: A review of the laboratory's American Proficiency Institute (API) records showed the following: 1. The 2017 1st event for Hematology samples HEM-01, HEM-02, HEM-03, HEM-04, HEM-05 were 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 -- tested multiple times. HEM-01: 3/16/18 at 10:37, 10:40, 11:25, and 11:27 HEM-02: 3 /16/18 at 10:44, 10:46, 11:29, and 11:31 HEM-03: 3/16/18 at 10:49, 10:51, 11:33, and 11:35 HEM-04: 3/16/18 at 10:54, 10:56, 11:37, and 11:39 HEM-05: 3/16/18 at 10:58, 11:01, 11:40, and 11:43 The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Red cell distribution width (RDW), Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils. 2. The 2017 1st event for Chemistry samples CH-1, CH-2, CH-3, CH-4, CH-5 were tested multiple dates and times. CH-1: 1/24/17 at 12:50 and 1/26/17 at 11: 51 CH-2: 1/24/17 at 12:56 and 1/26/17 at 12:08 CH-3: 1/25/17 at 12:59 and 1/26/17 at 12:09 CH-4: 1/24/17 at 13:01 and 1/26/17 at 12:10 CH-5: 1/24/17 at 13:03 and 1/26 /17 at 12:10 3. The 2017 3rd event for Chemistry Samples CH-11, CH-12, CH-13, CH-14, CH-15 were tested multiple dates and times. CH-11: 8/29/17 at 17:23 and 8/30 /17 at 10:54 CH-12: 8/29/17 at 17:27 and 8/30/17 at 10:57 CH-13: 8/29/17 at 17:30 and 8/30/17 at 10:58 CH-14: 8/29/17 at 17:32 and 8/30/17 at 11:00 CH-15: 8/29/17 at 17:34 and 8/30/17 at 11:01 The tests performed were: Calcium, Albumin, Alkaline phosphatase, Aspartate transaminase, Direct bilirubin, Magnesium, Total bilirubin, Amylase, Glucose, Alanine transaminase, Total protein, Blood urea nitrogen, Creatinine, Gamma-glutamyl transferase, Creatine kinase, Uric acid, Potassium, Sodium, Chloride, Carbon dioxide, Triglycerides, Cholesterol, Thyroxine, Free Thyroxine, Thyroid Stimulating Hormone, and Free T3. The interview on 3/28/18 at 9: 40am with the testing person confirmed samples were not tested the same number of times patient samples are tested. 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 staff, the laboratory had not performed annual competency assessments on staff. The finding include: On 3/28/18, the laboratory lead testing person was asked to provide copies of the competency assessment for the testing personnel. The testing person acknowledged at 12:30pm that he was not able to provide the requested records. 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)