Cuero Regional Hospital

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of a competency assessment for one technical consultant in 2022. Findings include: 1. A review of the laboratory's submitted CMS 209 form (signed by the laboratory director on 3/7/23) revealed the laboratory identified 1 technical consultant. 2. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of a competency assessment for the technical consultant in 2022. 3. An interview with testing person #1 on 3/7/23 at 3:40 p.m. in the conference room, after review of the records, confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting 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 3 -- performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel files, and staff interview, it was revealed that the technical consultant failed to perform a competency assessment on thirteen of fourteen testing personnel in 2022. Findings include: 1. A review of the laboratory's submitted CMS 209 form (signed by the laboratory director on 3/7/23) revealed the laboratory identified 14 testing personnel performing moderate complexity testing. 2. A review of the laboratory's personnel records revealed no documentation of the technical consultant performing a competency assessment for the following testing personnel in 2022: - Testing person #2 - Testing person #3 - Testing person #4 - Testing person #5 - Testing person #6 - Testing person #7 - Testing person #8 - Testing person #9 - Testing person #10 - Testing person #11 - Testing person #12 - Testing person #13 - Testing person #14 *Further review of the personnel records for the above listed testing personnel revealed the competency assessments from 2022 were performed by Testing person #1, not the technical consultant. 3. An interview with testing person #1 on 3/7/23 at 3: 30 p.m. in the conference room, after review of the records, confirmed the above findings. 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 laboratory's personnel records and staff interview, it was revealed the laboratory failed to have documentation of the education to determine the qualifications of testing personnel 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: -- 2 of 3 -- Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of education for five of fourteen testing personnel to qualify them to perform moderate complexity testing. Findings include: 1. A review of the CMS 209 form (signed by the laboratory director on 3/7/23) revealed 14 testing personnel who performed moderate complexity testing. 2. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of education for the following testing personnel: - Testing person #1 - Testing person #3 - Testing person #11 - Testing person #12 - Testing person #14 3. An interview with testing person #1 on 3/7/23 at 2:40 p.m. in the conference room, after review of the records, confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and certification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Entrance and exit conferences were held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. The laboratory was found to be in compliance for the specialties/subspecialties for which it was surveyed. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's WSLH (Washington State Laboratory of Hygiene) blood gas proficiency testing records from 2018 and 2019, and staff interview, it was revealed the laboratory failed to test proficiency testing samples using routine methods. The findings were: 1. Review of the laboratory's WSLH blood gas proficiency testing records from 2018 (events 1, 2, and 3) and 2019 (event 1) revealed the laboratory had documentation of each of the proficiency testing samples being tested on both analyzers. 2018 - Event 1 Sample ID: BG-1 Sample ID: BG-1 Serial #: 313246 Serial #: 313247 Date/Time: 03-19-18 @ 13:47 Date: 03-18-18 @ 13:47 pH = 7.02 pH = 7.03 pCO2 = 78.9 pCO2 = 73.6 PO2 = 17 PO2 = 23 Sample ID: BG-2 Sample ID: BG-2 Serial #: 313246 Serial #: 313247 Date/Time: 03-19-18 @ 15:24 Date: 03-18-18 @ 15:24 pH = 7.18 pH = 7.18 pCO2 = 66.3 pCO2 = 63.8 PO2 = 30 PO2 = 35 Sample ID: BG-3 Sample ID: BG-3 Serial #: 313246 Serial #: 313247 Date /Time: 03-19-18 @ 13:53 Date: 03-18-18 @ 13:52 pH = 7.32 pH = 7.32 pCO2 = 45.9 pCO2 = 46.7 PO2 = 193 PO2 = 173 Sample ID: BG-4 Sample ID: BG-4 Serial #: 313246 Serial #: 313247 Date/Time: 03-19-18 @ 15:27 Date: 03-18-18 @ 15:26 pH = 7.42 pH = 7.43 pCO2 = 36.3 pCO2 = 36.7 PO2 = 84 PO2 = 84 Sample ID: BG-5 Sample ID: BG-5 Serial #: 313246 Serial #: 313246 Date/Time: 03-19-18 @ 17:52 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 -- Date: 03-18-18 @ 17:52 pH = 7.22 pH = 7.22 pCO2 = 57.0 pCO2 = 57.0 PO2 = 145 PO2 = 145 2018 - Event 3 Sample ID: BG-11 Sample ID: BG-11 Serial #: 313246 Serial #: 313247 Date/Time: 11-12-18 @ 15:01 Date: 11-12-18 @ 15:01 pH = 7.17 pH = 7.17 pCO2 = 65.3 pCO2 = 67.2 PO2 = 29 PO2 = 33 Sample ID: BG-12 Sample ID: BG-12 Serial #: 313246 Serial #: 313247 Date/Time: 11-12-18 @ 16:50 Date: 11- 12-18 @ 16:50 pH = 7.43 pH = 7.42 pCO2 = 34.4 pCO2 = 35.9 PO2 = 81 PO2 = 83 Sample ID: BG-13 Sample ID: BG-13 Serial #: 313246 Serial #: 313247 Date/Time: 11-13-18 @ 08:31 Date: 11-13-18 @ 08:31 pH = 7.58 pH = 7.58 pCO2 = 21.6 pCO2 = 22.1 PO2 = 62 PO2 = 65 Sample ID: BG-14 Sample ID: BG-14 Serial #: 313246 Serial #: 313247 Date/Time: 11-13-18 @ 13:03 Date: 11-13-18 @ 13:03 pH = 7.32 pH = 7.32 pCO2 = 45.3 pCO2 = 46.3 PO2 = 194 PO2 = 196 Sample ID: BG-15 Sample ID: BG-15 Serial #: 313246 Serial #: 313247 Date/Time: 11-14-18 @ 10:03 Date: 11-14-18 @ 10:03 pH = 7.49 pH = 7.50 pCO2 = 31.5 pCO2 = 31.4 PO2 = 226 PO2 = 222 2019 - Event 1 Sample ID: BG-1 Sample ID: BG-1 Serial #: 313246 Serial #: 313247 Date/Time: 03-18-19 @ 18:03 Date: 03-18-19 @ 16:55 pH = 7.13 pH = 7.13 pCO2 = 74.6 pCO2 = 74.9 PO2 = 174 PO2 = 169 Sample ID: BG-2 Sample ID: BG-2 Serial #: 313246 Serial #: 313247 Date/Time: 03-18-19 @ 17:17 Date: 03-18- 19 @ 17:17 pH = 7.5 pH = 7.5 pCO2 = 31.3 pCO2 = 31.3 PO2 = 215 PO2 = 221 Sample ID: BG-3 Sample ID: BG-3 Serial #: 313246 Serial #: 313247 Date/Time: 03- 18-19 @ 18:03 Date: 03-18-19 @ 16:55 pH = 7.04 pH = 7.04 pCO2 = 71.2 pCO2 = 71.7 PO2 = 18 PO2 = 24 Sample ID: BG-4 Sample ID: BG-4 Serial #: 313246 Serial #: 313247 Date/Time: 03-19-19 @ 09:40 Date: 03-19-19 @ 09:40 pH = 7.56 pH = 7.55 pCO2 = 23.9 pCO2 = 24.9 PO2 = 68 PO2 = 67 Sample ID: BG-5 Sample ID: BG-5 Serial #: 313246 Serial #: 313247 Date/Time: 03-19-19 @ 18:03 Date: 03-19- 19 @ 16:55 pH = 7.33 pH = 7.32 pCO2 = 44.6 pCO2 = 46.0 PO2 = 201 PO2 = 177 2. An interview with the Director of Respiratory Therapy on June 4, 2019 at 11:05 hours in the Conference Room confirmed the findings. She stated that the re-run was sometimes used as instrument correlations. She also confirmed that when testing patients, the laboratory would only repeat patient samples that had critical values. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS-209, review of personnel records, and confirmed in interview of facility personnel, the laboratory failed to have a policy for retention of employee education records. The findings were: 1. Review of the laboratory's submitted Form CMS-209 signed by the laboratory director on May 31, 2019 revealed 10 testing persons. 2. Random review of the laboratory's personnel records for 5 of 10 testing persons revealed the following: Testing Personnel 1 Start Date: 11-04-1994 Testing Personnel 2 Start Date: 05-22-1990 Testing Personnel 3 Start Date: 05-26-1990 Testing Personnel 4 Start Date: 05-26-2005 Testing Personnel 5 Start Date: 04-26-2002 3. The laboratory failed to have a policy for retaining all of an employee's education records. The facility had retained each employee's current licensure and Associate's degrees or higher. The facility failed to retain high school diplomas or transcripts. 4. An interview with the Director of Respiratory Therapy on June 4, 2019 at 10:50 hours in the Conference Room confirmed the findings. D5537 ROUTINE CHEMISTRY -- 2 of 3 -- CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of manufacturer's instructions, review of quality control records, patient results, and confirmed in interview of facility personnel, the laboratory failed to test one level of control each 8 hours of patient testing for Arterial Blood Gases (ABGs). The findings were: 1. Review of the laboratory's policy titled, "ABG/Co-OX Calibrations & Quality Control ABL 80 Flex/ Co-Ox" approved by the laboratory director on July 18, 2017 stated, "G. Manual External QC Schedule: External liquid QC must be run according to CLIA requirements: two levels of external QC on each test system for each day of testing, when a new sensor cassette or solution pack is installed and following instrument maintenance." The laboratory's quality control policy is less stringent than the CLIA regulations, the laboratory did not develop an Individualized Quality Control Plan (IQCP) to reduce the risk of quality control testing. Therefore, the laboratory must test one level of external quality control each eight hours of patient testing. 2. Review of laboratory quality control records for April and May 2019 revealed the following 5 of 41 patients were tested when QC had exceeded 8 hours. April 19, 2019 Two levels qc @ 00:20 Patient ID: Account F13762505 @ 17:03 (greater than 8 hours since qc) May 6, 2019 Two levels qc @ 03:01 Patient ID: Account F13784889 @ 15:44 (greater than 8 hours since qc) Patient ID: Account V13782396 @ 18:02 (greater than 8 hours since qc) May 12, 2019 Two levels qc @ 13:33 Patient ID: Account F13793385 @ 2330 (greater than 8 hours since qc) May 20, 2019 Two levels qc @ 05:34 Patient ID: Account F137851183 (greater than 8 hours since qc) 3. Interview with the Director of Respiratory Therapy on June 4, 2019 at 12:00 hours in the Conference Room confirmed the findings. -- 3 of 3 --