Guam Dept Public Hlth & Soc Svcs Central Lab

Summary Statement of Deficiencies D0000 A federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted an announced CLIA recertification survey on July 17, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA regulations, and the following standard level deficiencies were cited. D3005 FACILITIES CFR(s): 493.1101(a)(3) (a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on observation of the molecular laboratory, and interview with the laboratory supervisor, the laboratory failed to ensure a unidirectional work flow for the molecular clean room, extraction rooms and PCR room from July 2023 to July 2025. Findings Included: 1. Observation of the molecular laboratory in July 17, 2025, revealed the molecular clean room, extraction rooms and PCR rooms were all attached to a central room in a cross pattern and did not have a unidirectional work flow. 2. By interview, the laboratory supervisor confirmed on July 17, 2025, at 5:00 pm the molecular laboratory did not have a unidirectional workflow. 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 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 -- 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 observation of the laboratory storage areas, lack of monitored temperature records, and an interview with the laboratory supervisor the laboratory failed to monitor and document room temperatures for areas outside the laboratory where laboratory reagents and testing kits were stored from 2023 to 2025 (2 of 2 years). Findings Included: 1. On July 17, 2025, at 2:15 pm., while on a tour of the laboratory, the following testing kits were observed being stored outside of the laboratory from 2023 to 2025 with the following temperature requirements: a. 35 bottles of Reagent through 170 ml, Catalog #990556, Store at 15 - 25 degrees Celsius. b. Six boxes of DNA tissue Kits, E2 1&2, Store at 15 - 25 degrees Celsius. c. Eight boxes of QIAamp 96 Virus QiaCube HT Kits, Lot#58101681, Store at 15 - 25 degrees Celsius. 2. On July 17, 2025, at 5:00 p.m., the laboratory supervisor confirmed, by interview, temperatures were not being monitored outside of the laboratory. II. Based on observation of the laboratory, review of storage room temperature records, and interview with the laboratory supervisor, the laboratory failed to define room temperature ranges consistent with the manufacturer's storage requirements for 28 out of 28 Blood Collection tubes containers stored in a storage room. Findings Included: 1. Observation of the laboratory on July 17, 2025 at 11:30 am revealed a storage room where, the following BD Vacutainer Blood Collection tube containers were stored with storage requirements of 4 to 25 degrees Celsius: a. Twelve BD Vacutainer Blood Collection tubes - Yellow Top - Lot#4236591. b. Five BD Vacutainer Blood Collection tubes - Red Top - Lot#4236618. c. Eleven BD Vacutainer Blood Collection tubes - Orange/Gray Top - Lot#4233264. 2. Review of the storage room temperature log on the wall showed temperature ranges of 20 - 38 degrees Celsius were being monitored. 3. By interview with the laboratory supervisor on July 17, 2025 at 12:00 pm, the laboratory supervisor confirmed the temperature ranges differed from the manufacturer's storage requirements for the collection tubes. III. Based on observation of the laboratory, review of TB room temperature records (Room B-2), and interview with the laboratory supervisor, the laboratory failed to define room temperature ranges consistent with the manufacturer's storage requirements for one of one box of Fisherbrand AFB check slides were being stored. Findings Included: 1. Observation of the laboratory on July 17, 2025 at 1:00 pm revealed one box of Fisherbrand AFB check slides with a storage requirement of 20 - 30 degrees Celsius. 2. Review of the TB laboratory room temperature log on the wall showed temperature ranges for Room B-2 were set at 18 - 28 degrees Celsius. 3. Further review of room B-2 temperature records revealed the following days the room temperature fell below the manufacturer's storage requirements (19 degrees Celsius) in 2025: a. February - 7 out of 28 days. b. April - 4 out of 30 days c. May - 10 out of 31 day. d. June - 10 out of 30 days. e. July - 5 out of 17 days. 4. By interview with the laboratory supervisor on July 17, 2025 at 5:00 pm, the laboratory supervisor confirmed the temperature ranges differed from the manufacturer's storage requirements for the Fisherbrand AFB check slides. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) -- 2 of 3 -- (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory reagent safety data sheets, and interview with the laboratory supervisor, the laboratory failed to include expiration dates for 56 of 56 bottles of chemicals. Findings Included: 1. Observation of the laboratory on July 17, 2025 at 1:15 pm revealed the following chemicals without expiration dates: a. 53 bottles of Spectrum Pheol Loose Crystals, Received June 21, 2005, Lot#AD501. b. 02 bottles of EKI Basic Fuchin Powder, no received date lot#1612516. c. 01 bottle of Methylyene Blue, Received December 1, 2011, lot#106583. 2. The laboratory SDS did not include expiration dates for the above chemicals used for clinical testing. 3. The laboratory did not have a procedure for assess expiration dates for chemicals received without one or a retest date. 4. By interview, the laboratory supervisor confirmed the above finding on July 17, 2025, at 5:00 pm. -- 3 of 3 --

Summary Statement of Deficiencies 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: Review of personnel records and interview with the technical supervisor, two of three testing personnel did not have academic qualifications required 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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: 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 -- Based on the lack of academic credentials and interview with the technical supervisor (TS) #2, the laboratory failed to provide academic credentials to qualify two of three testing personnel (TP) for moderate complexity testing. Findings: 1. The laboratory could not provide foreign equivalency documentation to verify academic credentials for TP #7, 8. 2. Interview with the TS #2 on September 24, 2021 at 3:30 PM confirmed the documentation needed to qualify testing personnel #7, 8 was not available for review. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Review of personnel records and interview with the technical supervisor, one of seven testing personnel did not have academic qualifications required to perform high complexity testing (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training -- 2 of 3 -- appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the lack of academic credentials and interview with the technical supervisor (TS) #2, the laboratory failed to provide academic credentials to qualify one of seven testing personnel (TP) for high complexity testing. Findings: 1. The laboratory could not provide foreign equivalency documentation to verify academic credentials for TP #2. 2. Interview with the TS #2 on September 24, 2021 at 3:30 PM confirmed the documentation needed to qualify testing personnel #2 was not available for review. -- 3 of 3 --