Artesia General Hospital

Summary Statement of Deficiencies D0000 During a validation survey completed on 07/26/19 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following conditions: 493.1403 Laboratory Director, moderate complexity 493.1409 Technical Consultant 493.1421 Testing Personnel, moderate complexity 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, review of manufacturer instructions, email, May 2019 patient test records and interviews with laboratory staff, the laboratory failed to A) ensure samples received for ammonia testing were received, spun and tested within 30 minutes of collection and IB) ensure that samples were spun at the speed and time required by the manufacturer of the chemistry analyzer. The laboratory reported performing 174 ammonia tests per year. Findings are: Review of the Beckman Coulter UniCel DxC 600i Ammonia "Specimen Storage and Stability" instructions indicated: "Tubes should be filled completely, mixed gently by inversion, placed on ice, centrifuged immediately at an RCF (Relative Centrifugal Force) of 1500G and analyzed within 30 minutes. " A) The laboratory failed to ensure ammonia samples were received, spun, and tested within 30 minutes of collection. 1. Review of 17 patient records from May of 2019 revealed 2 patient samples were received in the laboratory more than 30 minutes after collection. AM1, collected on 05/04/19 at 12:49 pm, was not received by the laboratory until 13:23 pm, 34 minutes after collection. 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 -- AM2, collected on 05/10/19 at 12:45 pm, was not received by the laboratory until 13: 01 pm, 33 minutes after collection. 2. Review of 16 patient records from May of 2019 revealed 1 patient sample, AM3, collected on 05/13/19 at 11:35 am, was not received by the laboratory until 12:01 pm, 25 minutes after collection. With a minimum spin time of 5 minutes (See Part II below), the sample could not have been placed on the analyzer for testing in less than 30 minutes. B) The laboratory failed to ensure the ammonia samples were spun at the speed and time required by the manufacturer. 1. During interview on 07/25/19 at 01:00 pm, Phlebotomist #1 stated she used the STATSpin Express 4 for spinning ammonia samples. She also stated she spun the samples for 5 minutes. 2. During interview on 07/25/19 at 1:35 pm, the Laboratory Supervisor confirmed the centrifuge used and the spin time. 3. Observation of the centrifuge's maintenance label dated 7/10/19 indicated the centrifuge had 3 settings: 3 minutes (speed unknown) 5 minutes at a speed of 5,107 RPM (Revolutions Per Minute) 10 minutes at a speed of 4,558 RPM 4. Review of the manufacturer's website for the STATSpin indicated the settings were: 3 minutes/ 5100 rpm/ 4000 x g (+/-5%) 5 minutes/ 5100 rpm/ 4000 x g (+/-5%) 10 minutes/ 4500 rpm/ 3100 x g (+/-5%) 5. There was no documentation available during the survey indicating the laboratory had validated using the STATSpin Express 4 centrifuge for processing ammonia samples. F. Review of an email dated 07/29/19 from the Laboratory Supervisor confirmed the laboratory had not performed the validation study. 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: Based on the review of manufacturer instructions, laboratory policies, Individualized Quality Control Plan (IQCP) and interview with laboratory staff, the laboratory failed to perform or send out cell cultures for negative RSV (Respiratory Synclinal Virus) as recommended by the manufacturer. 64 of 74 patients were reported as negative 01/01 /19-07/08/19. Findings are: A. Review of the manufacturer instructions for the Meridian Tru RSV kit indicated under Intended Use and Limitations of the procedure: 1. "It is recommended that all negative test results be confirmed by cell culture." 2. "The antibodies used in the test may not detect all antigenic variants or new strains of RSV." "A negative test result does not exclude infection with RSV nor does it rule out other microbial-caused respiratory infections." B. Review of the laboratory's RSV IQCP for the Tru RSV kit approved on 12/07/15 indicated under Intended Use: "It is recommended that all negative test results be confirmed by cell culture.' C. Review of the laboratory's RSV policy approved on 07/13/15 indicated under Principle: "A negative result does not preclude RSV infection." D. During interview on 07/23/19 at 11:02 am, the Laboratory Supervisor stated that negative RSV tests are not sent out for cell culture. E. Review of a RSV patient report provided by the Laboratory Supervisor on 07/23/19 indicated 64 of 74 patients were reported as negative 01/01/19- 07/08/19. RSV patients 1-3, 5-11, 13-27, 28, 30-40, 42-45, 48-65, 67, 69-71, and 73- 74. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) -- 2 of 7 -- (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of maintenance records, laboratory policy and interviews with laboratory staff, the laboratory failed to follow laboratory policy and ensure alarm checks were conducted for the blood bank refrigerator quarterly. Findings are: A. During interview on 07/25/19 at 8:37 am, Testing Person #1 stated that she used the push button on the refrigerator to check response times from the Emergency Department and the hospital's Biomed Department performed quarterly checks of the blood bank refrigerator's alarm system. B. Review of the blood bank maintenance records revealed no documentation of blood bank refrigerator alarm checks in 2018 and only one check in 2019 on 7/10/19. C. During interview on 07/25/19 at 8:52 am, TP #8 stated that the person from Biomed that did the alarm checks had left and a new person had taken over his duties in the previous year. D. Review of the laboratory's policy approved on 12/05/2016 confirmed the Biomed Department was responsible for the alarm checks and that they were performed quarterly. 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 Laboratory Director's Delegation of Responsibilities, personnel records, and interview with laboratory staff, the Laboratory Director failed to provide overall management and supervison of the laboratory. A. The Laboratory Director failed to ensure the Technical Consultant duties were assigned to a qualified Technical Consultant. See D6032 B. The Laboratory Director failed to ensure policies for evaluating completency were followed. See D6030 C. The laboratory failed to maintain documentation of education for 1 (RT #7) of 8 (RT #1-R #8) testing personnel in Respiratory Therapy. See D6028 D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on the review of personnel files, email and interviews with laboratory staff, the Laboratory Director failed to ensure documentation of the highest level of education were maintained for 1 (RT #7) of 8 (RT #1-R #8) testing personnel prior to patient testing. Findings are: The laboratory failed to maintain documentation of education for 1 (RT #7) of 8 (RT #1-R #8) testing personnel in Respiratory Therapy. See D6063 D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on the review of Laboratory Director's Delegation of Responsibilities and personnel records, and interview with laboratory staff, the Laboratory Director failed to ensure policies for evaluating competency of testing personnel are established and followed. Findings are: The laboratory failed to perform and document competency evaluations for 4 of 8 (RT #1 - RT #3, and RT#8) Respiratory Therapy testing personnel at least annually. See D6054 D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the review of Laboratory Director's Delegation of Responsibilities, personnel records, and interview with laboratory staff, the Laboratory Director failed to assign a qualified Technical Consultant oversee blood gas testing in Respiratory Therapy. Findings are: A. Review of the Laboratory Director's Delegation of Responsibilities dated 04/01/19 indicated the following: 1. RT #8 was responsible for -- 4 of 7 -- review of daily patient reports, monthly quality control data, equipment maintenance, function verification and instrument