Guam Memorial Hospital Blood Gas Lab

Summary Statement of Deficiencies D0000 A federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey on 7/17/2025. The following condition level and standard level deficiencies were cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on direct observation, manufacturer's instructions, temperature records, and interview with the Technical Consultant, the laboratory failed to define room temperature ranges consistent with the manufacturer's instructions for 4 of 4 reagents. Findings Included: 1. In direct observation on 7/17/2025 at 10:38 AM, the following reagents and supplies were found: a. One box Siemens Rapid Complete Level 1, Lot #361124, Manufacturer storage temperature requirement 18 C to 25 C. b. One box Siemens Rapid Complete Level 2, Lot #362224, Manufacturer storage temperature requirement 18 C to 25 C. c. One box Siemens Rapid Complete Level 3, Lot #363224, Manufacturer storage temperature requirement 18 C to 25 C. d. 1 Tube Siemens Multicap blood collection capillary tubes, Ref# 04549544, Manufacturer storage temperature requirement 4 to 25 C. 2. Review of temperature records showed an acceptable room temperature range of 2 to 25 degrees C. The following dates between October 2024 to July 2025 (Random review), the room temperature fell outside of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- manufacturer's minimum temperature requirement of 18 C (64.4 F): a. October, 2024 i. 64 degrees F - 10/18, 10/21, 10/22, 10/24, 10/25, 10/26, 10/27, 10/28 ii. 63 degrees F - 10/23 b. November, 2024 i. 64 degrees F - 11/18, 11/19, 11/20, 11/21, 11/22, 11 /23, 11/25, 11/27, 11/28, 11/29 ii. 63 degrees F - 11/24, 11/26, 11/30 c. July, 2025 i. 64 degrees F - 7/14, 7/15 3. During an interview on 7/17/2025 at 11:48 AM, the Technical Consultant confirmed that the temperature range was not in accordance with manufacturer instructions, and routinely dropped below the minimum acceptable threshold of the reagents stored. II. Based on direct observation, manufacturer's instructions, and interview with the Technical Consultant, the laboratory failed to define, monitor and document the room humidity level where 2 of 2 Siemens Rapid Point 500 analyzers were in use. Findings Included: 1. During a tour of the laboratory on 7/17/2025 at 10:38 AM, two Siemens Rapid Point 500 analyzers (#42502 and #42504) were observed in use, with no room humidity monitoring or documentation. 2. Review of the operator's manual for the Siemens Rapid Point 500 analyzer revealed a humidity requirement of 5 to 85% non-condensing. 3. During an interview on 7/17 /2025 at 11:48 AM, the Technical Consultant confirmed that the laboratory did not define, monitor or record humidity. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on direct observation, instrument comparison records, and interview with the Technical Consultant, the laboratory failed to evaluate and define the relationship of blood gas testing performed at least twice a year, for 2 of 2 Siemens Rapid Point 500 analyzers. Findings Included: 1. During a tour of the laboratory on 7/17/2025 at 10:38 AM, two Siemens Rapid Point 500 analyzers (#42502 and #42504) were observed in use for blood gas testing 2. Review of the laboratory's twice annual instrument comparison records revealed linearity studies, but no comparison records to evaluate and define the relationship of blood gas testing for the two Siemens Rapid Point 500 analyzers in use. 3. During an interview on 7/17/2025 at 1:30 PM, the Technical Consultant confirmed the findings of no twice annual comparison records between the two analyzers. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of personnel records, and confirmed in interview by the Technical Consultant (TC), the TC failed to identify the need for training for 1 of 1 testing person (TP-2). Refer to D6066 -- 2 of 4 -- D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) 209 Form, personnel records, and interview with staff, the laboratory failed to ensure individuals performing testing met the required qualifications. The laboratory failed to ensure 2 of 21 testing personnel met requirements to perform moderate complexity testing. Refer to D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Centers for Medicare and Medicaid (CMS) 209 Form, personnel records, and confirmed in an interview with the Technical Supervisor (TS), the laboratory failed to meet testing personnel (TP) qualifications for 2 of 21 individuals performing moderate complexity testing. Findings Included: 1. Review of the laboratory's submitted CMS 209, Laboratory Personnel Report (CLIA), provided by the laboratory on 7/17/2025, identified TP-16 and TP-17 performing moderate complexity testing. 2. Review of the laboratory's TP educational credential records revealed Bachelor of Science degrees in Respiratory Therapy from the Philippines, but no foreign degree equivalency to U.S. standards to meet requirements of performing moderate complexity testing. 3. In an interview on 7 /17/2025 at 1:34 PM, the TS confirmed that TP-16 and TP-17 did not have record of foreign degree equivalency, in order to qualify for moderate complexity testing. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, -- 3 of 4 -- including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) 209 Form, laboratory policies and procedures, personnel records and interview with the Technical Consultant, it was revealed the laboratory failed to have documentation of training for 1 of 21 testing personnel (TP) performing moderate complexity testing. Findings Included: 1. Review of the CMS-209 Form included 21 testing personnel listed to perform moderate complexity testing using the Siemens Rapid Point 500 blood gas analyzers. 2. Review of the laboratory's policy titled, 'Guam Memorial Hospital Authority Respiratory Care Manual' stated the following: "D. Personnel Competency - Testing personnel must complete ten (10) arterial blood samples in the first (6) months of employment then Annual Personnel Competency Program which includes all aspects of the ABG Quality Assurance Program, successful completion of a proficiency examination, and direct observation of at least four arterial puncture and analysis procedure for the annual competencies." 3. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of personnel competency for TP-2 (Date of Hire 5/12/2025), according to the CMS-209 Form. 4. During an interview on 7/17/2025 at 10:10AM in the laboratory, the Technical Consultant confirmed the lack of competency documentation. -- 4 of 4 --

Summary Statement of Deficiencies 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 the number and severity of the deficiencies cited herein, the Condition: Analytic Systems was not met. The laboratory failed to have a procedure manual that included the step-by-step performance of the procedure to operate the laboratory's Siemens Rapid Point 500 instruments (see D5403); ensure that test results of blood gas and hematology quality control materials met the laboratory's and the manufacturer's test system criteria for acceptability before reporting patient test results (see D5481); document the laboratory's system that twice a year evaluates and defines the relationship between test results using different instruments (see D5775); and establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283 (see D5791). 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 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 -- 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)

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on technical consultant remote interview and proficiency testing record review on May 12, 2021, the laboratory failed to ensure that the laboratory director attested to the routine integration of the proficiency testing samples into the patient workload using the laboratory's routine methods. Findings included: a. For the following proficiency testing modules and events, attestation statements provided by the laboratory's proficiency testing provider were not signed by the laboratory director: AQ-C 2020 (Aqueous Blood Gas) and SO-C 2020 (Blood Oximetry). b. These attestation statements were provided by the proficiency testing provider so that the laboratory director could attest to the routine integration of the proficiency testing samples into the patient workload using the laboratory's routine methods. 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- 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 -- 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 technical consultant remote interview and proficiency testing record review on May 12, 2021, the laboratory failed to successfully participate in a proficiency testing program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. Findings included: The laboratory failed to achieve satisfactory performance for hematocrit in two of three consecutive proficiency testing events in the specialty of hematology constituting unsuccessful hematocrit proficiency testing performance. See D2130. D2121 HEMATOLOGY CFR(s): 493.851(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 technical consultant remote interview and proficiency testing record review on May 12, 2021, the laboratory failed to attain a score of at least 80% of acceptable responses for each hematology analyte in each proficiency testing event resulting in unsatisfactory performance for the analyte in the testing event. Findings included: a. The laboratory failed to attain a proficiency testing score of at least 80% as follows: 2021 Q1 Hemoglobin 20% Q1 = First Proficiency Testing Event b. Failure to attain a proficiency testing score of at least 80% events resulted in unsatisfactory proficiency testing performance for the analyte hemoglobin. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on technical consultant remote interview and proficiency testing record review on May 12, 2021, the laboratory failed to achieve satisfactory performance for the analyte hematocrit in two of three consecutive proficiency testing events resulting in initial unsuccessful hematocrit proficiency testing performance. Findings included: a. The laboratory failed to maintain successful hematocrit proficiency testing performance by failing to obtain a score of 80% in two of three consecutive hematocrit proficiency testing events as follows: 2020 Q2 2021 Q1 Hematocrit 0% 20% Q1 = First Proficiency Testing Event Q2 = Second Proficiency Testing Event b. Failure to achieve satisfactory performance for the same analyte in two of three -- 2 of 3 -- consecutive proficiency testing events resulted in initial unsuccessful proficiency testing performance for the analyte hematocrit. 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 number and severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director was not met. The laboratory director, moderate complexity testing, failed to ensure that proficiency testing samples were tested as required under Subpart H of this part (see D6016). 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 technical consultant remote interview and proficiency testing record review on May 12, 2021, the laboratory director, moderate complexity testing, failed to ensure that proficiency testing samples were tested as required under Subpart H of this part. Findings included: a. The laboratory director failed to attest to the routine integration of the proficiency testing samples into the patient workload using the laboratory's routine methods. See D2009. b. The laboratory failed to attain a score of at least 80% of acceptable responses for the analyte hemoglobin in each proficiency testing event resulting in unsatisfactory performance for the analyte hemoglobin in the testing event. See D2121. b. For the analyte hematocrit, the laboratory repeatedly failed to achieve satisfactory proficiency testing scores in two of three consecutive proficiency testing events resulting in unsuccessful hematocrit proficiency testing performance. See D2016 and D2130. -- 3 of 3 --