Revive Medical Group

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to keep food materials away from hazardous reagents in one (nursing area "Revive Lab") of two refrigerators observed. Findings Included: 1. During a tour of the nursing area on 11- 28-22 at 2:54 PM, a refrigerator labeled "Revive Lab" was in the room. Inside the refrigerator was "MGC Primary DAU" control set and "Creatinine Detect Test" along with lunch boxes and soda. The refrigerator was labeled "Meds and Medical Only". 2. Review of "DRI Creatinine-Detect Test" stated "This test is for in vitro diagnostic use only. The reagents are harmful if swallowed. The assay components contain .0.09% sodium azide, 0.2% bovine serum albumin (BSA) and 0.5% Drug-specific antibody (Mouse). Avoid contact with skin and mucous membranes. Flush affected areas with copious amounts of water. Get immediate medical attention for eyes, or if ingested. Sodium azide may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to prevent azide build-up. Clean exposed metal surfaces with 10% sodium hydroxide.H317 - May cause allergic skin reaction. H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled. Avoid breathing mist or vapor. Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/eye protection/face protection. In case of inadequate ventilation wear respiratory protection. If on skin: Wash with plenty of soap and water. IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing." 3. During an interview on 11/28/2022 at 3:00 pm Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- with office member (nurse), they could not confirm what happens in the room due to laboratory staff leaving earlier in the day. 4. Annual test volume for Chemistry subspecialty of Toxicology is approximately 1500. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation, record review, lack of documentation, and interview, the laboratory failed to perform twice annual proficiency testing (PT) for fourteen of fourteen toxicology analytes with testing performed prior to ceasing testing in November 2022. Finding included: 1. A laboratory tour on 11/28/2022 at 10:28 am, revealed a BS-480 Chemistry analyzer in use for toxicology testing. 2. Review of the "Laboratories Standard Operating Procedures" given by SP#1 (testing personnel) on 11 /29/2022 at 11:57 PM in email, not signed by laboratory director, revealed no procedure on the performance of twice annual PT for Amphetamine, Barbiturate, Benzene, Bupropion, Cocaine, ethyl alcohol, 3, 4-methylenedioxymethamphetamine, OPIATE 300, Oxycodone, delta-9 tetrahydrocannabinol, creatinine, potential hydrogen, and specific gravity. 3. Review of proficiency records revealed no documentation of performance of PT twice annually for Amphetamine, Barbiturate, Benzene, Bupropion Cocaine, ethyl alcohol, 3,4-methylenedioxymethamphetamine, OPIATE 300, Oxycodone, delta-9 tetrahydrocannabinol, creatinine, potential hydrogen, and specific gravity for 2022. 4. During an interview on 11/29/2022 at 12: 18 PM SP#1 (Testing personnel) and SP#2 (owner 2) stated that they would send proof of proficiency testing for the toxicology analytes. An email was sent by SP#1 on 11/29/2022 at 11:57 PM, it did not contain information for proficiency testing for toxicology analytes. 5.During an interview on 11/28/2022 at 11:24 am, SP#1 (Testing personnel) stated the laboratory had cease testing due to deionized (DI) water problems in November 2022. 6. Annual test volume for Chemistry subspecialty of Toxicology is approximately 1500. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, lack of documentation, and interview, the laboratory failed to meet the preanalytic system requirements. The laboratory failed to have a written request or standing order for tests performed on thirty of thirty patients (PT#1-PT#30) on BS-480 Chemistry Analyzer in January 2022 through October -- 2 of 21 -- 2022. (Refer to D5301). The laboratory failed to have a system to document date and time urine specimen is received by the lab for 30 (PT#1-PT#30) out of 41 patients reviewed. (Refer to D5313). D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review, lack of documentation and interview, the laboratory failed to have a written request or standing order for tests performed on thirty of thirty patients (PT#1-PT#30) on BS-480 Chemistry Analyzer in January 2022 through October 2022. Findings include: 1. Review of patient (PT#1-PT#30) medical records indicated toxicology tests were performed on the BS-480 Chemistry Analyzer ran in 2022 as follows: PT#1 on 09/23/22 and 10/03/22 PT#2 on 10/03/22 PT#3 on 09/23/22, 09/26 /22 and 10/03/22 PT#4 on 09/26/22 PT#5 on 09/26/22 PT#6 on 09/23/22 and 09/26 /22 PT#7 on 09/26/22 PT#8 on 09/26/22 PT#9 on 09/26/22 PT#10 on 09/26/22 PT#11 on 09/26/22 PT#12 on 09/23/22 PT#13 on 09/23/22 PT#14 on 09/23/22 PT#15 on 04 /08/22 PT#16 on 03/29/22 PT#17 on 03/29/22 PT#18 on 02/22/22 PT#19 on 01/28/22 and 02/15/22 PT#20 on 02/11/22 PT#21 on 02/11/22 PT#22 on 02/11/22 PT#23 on 01 /28/22 PT#24 on 01/28/22 PT#25 on 01/28/22 PT#26 on 01/28/22 PT#27 on 01/28/22 PT#28 on 01/28/22 PT#29 on 01/28/22 PT#30 on 01/28/22 2. On 11/28/22 at 12:45 PM, upon request for tests requests or standing order for each patient tested, SP-3 (Owner) was not able to provide referral/ order for patient medical records. 3. On 11 /28/22 at 12:55 PM, SP-4 was provided email information and a copy of patient medical records to forward the referral/order to surveyors by the end of the day, but no referral/orders were received. 4. Annual test volume for Chemistry subspecialty of Toxicology is approximately 1500. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on observation, record review, lack of documentation, and interview, the laboratory failed to have a system to document date and time urine specimens are received by the laboratory for 30 (PT#1-PT#30) out of 41 patients reviewed. Findings Included: 1. Review of the "Laboratories Standard Operating Procedures" given by SP#1 (testing personnel) on 11/29/2022 at 11:57 PM in email, not signed by laboratory director, revealed no procedure for how urine specimens are received by the laboratory. 2. Review of Patients Records revealed the following: a. PT#23-PT#30 patient reports stated urine specimens were collected on 1/28/2022 but there was no documentation of when they were received by the laboratory with date and time. b. PT#3-PT#11 patient reports stated urine specimens were collected on 9/26/2022 but there was no documentation of when they were received by the laboratory with date and time. c. PT#1, PT#6, PT#12-PT#14 patient reports stated urine specimens were collected on 9/23/2022 but there was no documentation of when they were received by the laboratory with date and time. d. PT#20-PT#22 patient reports stated urine -- 3 of 21 -- specimens were collected on 2/11/2022 but there was no documentation of when they were received by the laboratory with date and time. e. PT#16-PT#17 patient reports stated urine specimens were collected on 3/29/2022 but there was no documentation of when they were received by the laboratory with date and time. f. PT#19 patient report stated urine specimens were collected on 2/15/2022 but there was no documentation of when they were received by the laboratory with date and time. g. PT#2 patient report stated urine specimens were collected on 10/3/2022 but there was no documentation of when they were received by the laboratory with date and time. f. PT#15 patient report stated urine specimens were collected on 4/8/2022 but there was no documentation of when they were received by the laboratory with date and time. g. PT#18 patient report stated urine specimens were collected on 2/22/2022 but there was no documentation of when they were received by the laboratory with date and time. 3. During an interview on 11/28/2022 at 10:27 AM, SP#2 (Owner) stated the laboratory could pull up patients results with orders and receive time from the rehab center in the cloud. The results with orders and receive times were never received. 4. Annual test volume for Chemistry subspecialty of Toxicology is approximately 1500. 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 observation, record review, lack of documentation, and interview, the laboratory failed to meet the analytic systems requirements: 1. The laboratory failed to have a procedure manual that included: urine specimen collection; step by step procedure for how to perform testing for toxicology analytes: Amphetamine, Barbiturate, Benzene, Bupropion, Cocaine, ethyl alcohol, 3,4- methylenedioxymethamphetamine, OPIATE 300, Oxycodone, delta-9 tetrahydrocannabinol, creatinine, potential hydrogen, and specific gravity, quality control procedure; calibration; reportable ranges; urine specimen labeling; urine specimen storage; criteria for urine specimen acceptability and rejection; and course of action if the toxicology test system becomes inoperable. (Refer to D 5403) 2. The laboratory failed to monitor temperature for one out of two refrigerators that held reagents and calibrators from January 2022 to October 2022 and 41 of 41 patients (PT#1-PT#41) reviewed. (Refer to D5413) 3. The laboratory failed to label reagents and calibrators to indicate expiration date, lot number and identify for the 28 reagents and 3 calibrators in the testing carousel of one of one analyzer (BS-480 Chemistry analyzer). (Refer to D5415) 4. The laboratory failed to remove expired reagents and calibrators in the RCR fridge and expired blood tubes from use during patient testing. (see D5417) 5. The laboratory failed to complete a validation of their BS-480 Chemistry analyzer for the following analytes: Amphetamine, Barbiturate, Benzene, Bupropion, Cocaine, ethyl alcohol, 3,4-methylenedioxymethamphetamine, OPIATE 300, Oxycodone, delta-9 tetrahydrocannabinol, creatinine, potential hydrogen, and specific gravity before performing patient testing for 41 of 41 patients (PT#1-PT#41) reviewed. (Refer to D5421) 6. The laboratory failed to perform the required daily, weekly and monthly maintenance for BS-480 Chemistry analyzer during patient -- 4 of 21 -- testing 1/28/22 -10/14/2022. (Refer to D5431) 7. The laboratory failed to perform calibration as required by the manufacture on the BS-480 Chemistry Analyzer in January 2022 through October 2022 for twenty-nine of thirty patients (PT#1-PT#24 and PT#26-PT#30) reviewed. (Refer to D5437) 8. The laboratory failed to establish the use of calibrators for fourteen of fourteen toxicology analytes in use on BS-480 and 41 of 41 patients (PT#1-PT#41) reviewed. (Refer to D5439) 9. The laboratory failed to run two levels of toxicology quality controls (QC) at least once each day patient specimens are assayed for fourteen of fourteen analytes tested for 41 of 41 patients (PT#1-PT#41) reviewed from 1/28/2022-10/14/2022. (Refer to D5447) 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)